This is the transcript of interviews conducted with James

Lee Goddard, M.D., between April 30 and June 19, 1969, as part

of an oral history project sponsored by the National Library

of Medicine relating to the history of food and drug regulation

in the United States.

     Dr. Goddard served as Commissioner of Food and Drugs between

1966 and 1968.
     James Harvey Young, Ph.D., the interviewer, is professor of

history, Emory University, Atlanta, Georgia.

     Dr. Goddard provided for photoduplication the cards of his

daily appointment schedules, which accompany this transcript.

     By terms of the Statement of Gift signed by Drs. Goddard

and Young on March 14, 1970, the transcript is restricted from

any examination and use until March 14, 1985.
Dr. Y.:

This is an interview with Dr. James L. Goddard being held

on April 30, 1969, at bis home at 1090 Churchill Downs

Drive in Atlanta, Georgia.   I am James Harvey Young of tl:te

Department of History of Emory University.    Jim, we've

known each other for quite a while.    I consider this a
wonderful opportunity to see your career as a whole, and

particularly as it reached a climax that's important for

this oral history project while you were Commissioner of

the Food and Drug Administration from January 1966 through

June 1968.   And I'd like to start out this morning by

seeking to understand how it is you got interested in

medicine and then in Public Health medicine and look at

your earlier career before you came to the Food and Drug

Administration.   How was it that you got interested in

medicine?


Dr. G.:
It started back during World War II.   At that time, the
Army had a training program, the Army Specialized Train­
ing Program, where they took enlisted men and sent them

to university campuses, primarily for training in engineer­

ing.   I was selected from a basic training group in the Air
Corps in Florida, I suspect just on the basis of the fact
                                                                   2




that I had been in college prior to entering the service.


Dr. Y.:

You had enlisted in the Air Corps?


Dr. G.:
No, I ••• well, yes, in the Army.   The Air Corps was part of

the Army.


Dr. Y.:

Right.


Dr. G.:
I wasn't drafted.     I volunteered through the draft mechan­

ism, however.     That was the easiest way to do it.   I simply

left college one week, turned up at the draft board and

asked them how soon I could enter the service and they said,

~Will next Friday do?"     And so, the following Friday, I went

iB.     At any rate, I was inLbasic training when I was selected

and shipped to what was called a "Star Center" where testing
was carried out and I passed apparently the test in basic
engineering, and we were sent to Washington and Lee Univer•

sity.     That was in, oh, early summer of 1943.   Late that flll,

or early in the winter, I would imagine it was in November,
the Army apparently had, some little time previously, bee0me:
concerned about the possibilities of~ shortage of medical
                                                              3




officers if the war were prolonged, and so they decided

to implement a program to take students through pre-med

and med school, also under ASTP.     The Navy had a compar­

able program, V-5, V-12 program.     They administered a
medical aptitude test at all the colleges and univer­

sities where there were ASTP units, and they gave one at

our institution.     Six of us that made the highest scores

were then selected and sent to Temple University, and a

pre-med group was formed from people sent from other in•

stitutions.     This happened at a number of universities

that were selected for their ability to train pre-medical

students.     Well, that was how I got into pre-med.   Now,

I wasn't a very good student in pre-med, not because I

was totally disinterested, or because I wasn't capable,

but simply I was young.     I had never lived in a big city

like Philadelphia before.     I was really having a time of
it.   I didn't study as much as I should.    But, nonethe­

less, ••• in fact, I came up to a certain point where a

decision was to be made as to whether or not each individ­
ual was to be eentinued and sent to medical school, and I

had to go before a review board made up of civilian phys­

icians because my grades were so bad.     Fortunately these

doctors were rather understanding people, and they asked

me if I thought I could make it in medical school.      I said,
                                                                  4




"Yes," and so they approved me to go in spite of the bad

academic record.     So I was assigned then to go to George

Washington University School of Medicine, but because of

the class starting date there was to be an eleven-months

period of time that I woulo work at Walter Reed Hospital

as a corpsman.     That turned out to be very significant in

my life, as I'll tell you later.      And so, a group of us

were sent to Walter Reed.     As I recall, from that pre­

med group in Philadelphia, Temple, there were four of us

assigned for George Washington, four for Howard Univer­

sity, and four for Georgetown.      The four for Howard were

Negroes, and they went immediately.      Their class cycle

was such that they didn't go into Walter Reed to work

as corpsmen.     The eight of us ••• the four for G.   w.   and

the four for Georgetown•••were assigned to the medical

detachment of Walter Reed to work as corpsmen, and I

was assigned then to work on the neuropsychiatric service

of Walter Reed Hospital as an attendant and office clerk
in the N. P. section.     It was there tnat I met my wife.


Dr. Y.:
Oh, she was working there at the time.


Dr. G.:
She was an Army nurse and had been overseas.       This was in
                                                                  5




November of '44 and she was working in the neuropsychia­

tric section.     We met that November and we were married

the following May.     I started medical school in Septem­

ber of '45 just after V-J Day.     Being married was an

important influence on my stability as a student, and I

did compile a good record in medical school.      I graduated

in the honor society group, the Smith-Reed-Russell Society.

We didn't have an AOA chapter at G.    w.   By the time I

graduated, we had two children and my wife was pregnant

with the third.     It was an exciting four years.     In look­

ing back on it, we had very little income.     We were for•

tunate we had the G. I. Bill, because the war ended, of

course, and I was discharged in March of '46.        The pro­

gram was dropped then and, fortunately, the Veterans

Bill came through and we received, I think, ninety dollars

a month.   And that, plus the fact that I worked two and

three jobs simultaneously the last three years in medical
school and my wife was able to draw unemployment compensa­

tion and work one summer as a nurse, that was the way we
got through medical school.    We had no other financial

assistance, but it was a great and exciting time for us.

We bad lots of fun and worked hard.     That was how I got

into medicine.    Now, I had an early interest in it back

before I went into the Army in World War II.      Our next
                                                           6




door neighbor was a professional man in my home town of

Warren, Ohio.




Warren, Ohio?


Dr. G.:
Yes.   That's where I grew up.   I was born in Alliance,

Ohio, thirty-six miles away from Warren, and most of my

mether and father's family lived in Alliance.




And that's where you went to college?




Yes.   I went to Mount Union College for one year before
going into the service back in Alliance, Ohio.    So, I

had observed this young, professional man, as I say, the

next-door neigbhor, and I had decided that that was an

excellent kind of career, but frankly, at that point in

time, I couldn't visualize having the financial assist­
ance or capability of getting through a professional
school.


Dr. Y.:
Had you read anything in the way of books that bent you

toward medicine?
                                                                  7




Dr. G.:

Oh, my.    Yes.     Oh, yes.    I was an omnivorous reader as a

child.     I still am.    I started out, we lived in the east

end of Warren, and by the time I was twelve I think I

had read my way through the East End Library, and I

don't think that, if you read a great deal in those days,

you could escape reading books that had some, certainly

some books that were, certainly Magnificent Obsession

or, Let me see, Sinclair Lewis' books.


Dr. Y.:

Did you read Arrowsmith?


Dr. G.:
Oh, indeed,       Just great.   I real all of his books.     I

would go on an author binge.           I would discover Thomas

Wolfe ano then do nothing but read Thomas Wolfe until I

bad read everything that I could lay my hands on that he

had written.       And so I not only read Arrowsmith but everything

else that Red Lewis wrote.


Dr. Y.:

Did you read Paul de Kruif?


Dr. G.:
Oh, yes.    .TI!!:_ Microbe Hunters.    What was the other.••?
                                                              8




Dr. Y.:

The Hunger Fighters?


Dr. G.:

The Hunger Fighters.     Yes.   There wasn't much that I

missed reading in those days.      It was a source of great

pleasure to me and still is, to enjoy reading as much as

I do.     I'm a fast reader which means that I can tackle a

book in an evening, get through a 5O0-page novel.      I can't
go through a scientific treatise in that fashion, but a

novel I certainly can.


Dr. Y.:

So that there was a kind of bent from reading and from

observing your neighbor, so that when this happened in

the Army •••


Dr. G.:

It was a welcome opportunity, I can say that without

question.


Dr. Y.:

Now, at George Washington, while you were in medical

school, I know that you became acquainted with Harry

Dowling.    Would you talk about some of the influences in

medical school and the way they may have shaped your interests?
                                                                   9




Dr. G.:

It's fascinating when you look back on your own career,

and this happens to all of us, to reflect on the kinds of
people who have had an influence and the kinds of events

that represent turning points in your life.          Harry Dowling

was one of our professors.          He was professor af medicine

at that time.      I felt him to be a very learned man, and
still do, as I've gotten to know him.          A scholarly person.
I'll never forget Harry Dowling at grand rounds one day

at what was then Gallinger Hospital talking about a

pa~ient who had a complicated medical problem, and a

resident raised the question of a new form of treatment

that had just been written up.          Dowling's answer was:

"Be not the first by whom the new is tried, nor the last

to cast the old aside."

Dr. Y.:

So he was an omnivorous reader, too.

Dr. G.:

Oh, yes, indeed.      I know he ~lways has been.      Harry Dowling
left G.   w.   shortly after   my   sophomore year in medical school

and went out to the University of Illinois in Chicago.             We
felt very keenly his loss, because he was an excellent pro­
fessor of medicine.     He was replaced by Thomas McPherson

Brown.
                                                               10




Dr. Y.:

Did you have any other professors in medical school who

exercised a special influence on your thinking or the

direction you were to take?


Dr. G.:
Well, that's the difficult thing to assess.      Oddly enough,

in medical school, I would say that the last area, the

lowest priority area on my list of choices for a career

would have been public health, and unfortunately, that was

probably true of most people in my class.      We had a pro­

fessor of public health and preventive medicine who was

just a dear old soul.     He's now retired.   He writes to

me   occasionally.   We write back and forth intermittently.

Leland Parr.    But Dr. Parr really didn't teach much public

health.    He would come in and talk about what he had read

in the newspaper that morning.     And, as a result, most of
us got sensitized against public health.      So, I had that
kind of influence.    Other professors•••we had some very

exciting young professors.    This was just after the war.

Benny Manchester in cardiology was a real:?hot shot in. this

particular field.     Brian Blades, professor of surgery, was

excellent, but I never cared for surgery.     He was an out­

standing surgeon; still is••• a thoracic surgeon.    A great
man in his own field.     I remember some professors quite
                                                                11




well:     Eritt Albritton, a professor of physiology.      I

really enjoyed physiology as a subject.        It made great

sense.     I later worked with Eritt Albritton after he'd

retired as professor of physiology at G.       w.   He worked
at the National Institutes of Health, and here was a man

who had to be retired because of the age limitations at

the university, and he was as excited at working at

N. I. H. in the Division of Research Grants as I was.
And he bad    a very youthful outlook on these new activi­
ties.     He was a wonderful fellow to know.


Dr. Y.:
I take it you didn't have any more idea about going into

public health medicine when you got your M. D. than you

bad about going to medical school when you were in college.


Dr. G.:
You're absolutely right.     I had no idea of that, in fact,
I had decided I would go into internal medicine.        This

was the area that appealed most to me as I finished       my

medical school career.     But I never aid.


Dr. Y.:
Well, did you have that kind of an internship?
                                                                    12




Dr. G.:

I bad a general medical internship in the Public Health

Service.   It was interesting.     I almost wound up in the

Army instead of the Public Health Service, and again, it

was one of those quirks of fate, you see, that influence

the rest of your life.    What had happened was that, through­

out medical school, a group of us in our class retained an

affiliation with the Army through the medical R.     o.   T.   c.
program at the University School of Medicine.      I think we

were paid thirty dollars a month.      I'm not sure of that,

but it strikes me that that was what we wer~· given and, in

exchange, fwe· had to spend one day a month or two days a

month drilling and lectures once a week.     And then, in

the summer, between our junior and senior year, we had

to spend six weeks at Fort Sam Houston going through the

Medical Field Service School, which meant we couldn't have

a job that summer, and so there was quite a trade-off, but

the thirty dollars a month was for the entire period of

time in medical sehool.   This was important.    Well, as we
came up on our senior year, of course, our main concern was

where would we take our internship.      Early in your senior

year, you make application.      You select the hospitals that

you think that you'd like to be considered by and send them

an application.   This was a change from what bad existed.
                                                                13




Where, prior to that, it had been entirely on the initiative

of the individual, they now had a national coordinating

mechanism.    Everybody was notified on the same day, so

that institutions weren't played off against one another.

Well, I applied for three separate internships:     one at St.

Luke's Hospital in Cleveland, Ohio.    Now, keep in mind that

I was married then.    My wife and I were just barely getting
by, and she was pregnant with our third child.     St. Luke's

paid fifty dollars a month, so that would have posed a

problem.     I applied for a Public Health Service internship
and an Army internship and that was all.


Dr. Y.:
They were more lucrative?




Yes.   The Public Health Service and the Army internships

both commissioned you as a list lieutenant or the ~.ctdivalent.

My number one choice was an Army internship.     We had been
assured because we were in the medical R.O.T.C. and had
spent all of this time, one day a week in lecture and once
a month in drill, and going to camp in the summer, you kn.ow,

for six weeks, that we would be given first priority in

•~leetion for Army internship.     So I had selected Walter

Reed General Hospital.    That was where I wanted to interne,
                                                                    14




as I recall.        Well, the day came when the announcements

were made as to which hospitals had accepted your bids.

I was on OB service at the time with Bob Greenley and Bill

Dixon and Bob Greenley called downtown to the R.O.T.C.

office to find out what our status was••• had we been ac­

cepted.         I can remember very clearly that he talked with
the colonel, and be said, "Well, this is Bob Greenley and

I'm calling about the internships.          There are several of

us here."         I could only hear that end of the conversation,

and apparently Bob had been accepted and he smiled.          He

said,    11
              Well, how about Bill Dixon?" and the colonel then

told him Bill was accepted for Battle Creek, Michigan,

and he said, "Well, Jim Goddard is here."         And he said,

"Oh?    Oh.       Is that so?"   He didn't say anything more and
hung up.         I said, "Well, how about it, Bob?"   He said,

"Well, the colonel said that you weren't acceptable under

any condition. 11      And I said, "Gee, what the hell.    Here I

am.     I'm in the honor society.       I've spent three years in
this rinky-dink medical R.O.T.C. operation and now I apply

for an internship and they tell me I'm not acceptable under

any condition."         I knew by then that the Public Health

Service and St. Luke's both had agreed to accept me, so

I accepted the Public Health internship offer and that

was that.        Except that a few days later, Bill Dixon, who
                                                                 15




was with us at that particular moment when we were being

informed, ran into the colenel, and he told the colonel:

"You knew that was funny the other day.        Jim Goddard was

really Jpset because he didn't get an internship offer

from the Army."    Now, this was in May or April, I've

forgotten which, of    1 49,   and the colonel said, "Why, I

don't know why he should be upset.        He's in the bottom
third of the class and, after all, you know, we are try­

ing to give these internships to people who are the hest

students, and we never promised everybody in R.a.T.C. an

internship."    Bill said, "Colonel, I think the Army has

ma4e another mistake.     You'd better look into this, because

Jim's in the honor society, and he's in the top third of

the class, and probably the top ten percent," and he said,

"I think yCl>u 1 ve screwed up."   So, the colonel did and that

same day he called me and he said, "Jim, I'm afraid an

awful mis take has been made on this in tern.ship thing.

I've just been talking to the medical people in the Penta­

gon."   He wasn't a medical officer.      He was a line infantry

lieutenant c0lonel.     "And," he said, "they have told
me I could offer you any Army internship you choose.

They•ll put yCl>u in any one of their hospitals, because
there•s been an awful mistake.       What's happened was tbat

when you filled out the forms, you indicated that you'd
                                                                  16




had some form of medical disability and injury in World War

II, and so they put your forms back on the shelf, and held
it there pending receipt of the medical records from the

Medical Depot in St. Louis.     Apparently, they just forgot

about it, and they never got the medical record, and it was

a clerical error.    They didn't follow through on it, and

they're very sorry, and they said now you can have any

Army internship you want." Well, by then I had decided.

I'd been in to talk to the people at the Public Health
Service, and I was going to Cleveland Marine Hospital.

That was fifty miles from where· I'd grown up, and    my

sister was living in Cleveland where her husband was a

dental student, and my mother was there.       So, I told the
colonel, "It gives me great pleasure to tell you what you

can de with yeur internship at this late date."      And he

laughed.    He was a good scout and so, just by that kind of

a quirk, I wound up in the    u. s.   Public Health Service for

my   internship.


Dr. Y.:
And your commission dates from that point?


Dr. G.:
¥es, it does, from July 1, 1949.      The internship was at
Cleveland Marine Hospital which had been built around 1929

and was being run at that time by Dr. John. Trautman, a very




                                                              C
                                                              17




excellent medical administrator, in my opinion, and I

thougbt it was a good internship, in general.    But to
follow through on this business of how these things can

alter your career, near the close of the internship, Dr.

Trautman tried to get me to stay in the Public Health

Service as a career.   He made long distance calls to see if

I could be trained as a flight surgeon at Pensacila, any­

thing I was interested in, be wanted me to stay in.     He

was a very thoughtful fellow, but I had already decided

that I would go 0ut into general practice in a little

farm town in western Ohio.


Dr. Y.:

What town was that?


Dr. G.:
Kalida, Ohio, a town of 500 people.    Now about June of '50,

the Korean War broke out.    However, there was no national

emergency declared, so the Public Health Service did not

come under the Department of Defense as it does in time

of war and national emergency, and so we were permitted
to revert to an inactive reserve commission if we so de­

sired, and I did, and went into practice.    Had I taken that
Army internship, you see, I would bave been frozen into the
service as my classmates who took Army internships were for
                                                           18




the duration of the Korean conflict.    Now, that's important,

too.


Dr. Y.:
Because that was one of your most important periods of

rapi« development in learning?


Dr. G.:
Well, that, and it just subsequently proved to alter the

entire course of my life.    I don't know what my career

would have been had I gone to Korea, for example, which

is where most of the young medical officers that year

wound up.    Ernie Beasley, who is now here in Atlanta,

Georgia, as an internist, wound up as a p:aramedic in

Korea.    He made a number of jumps and was in the front

lines quite a bit of the time.    I don't know what my out­

come would have been, but I wound up going into practice,

staying there sixteen months.


Dr. Y.:
Why was it that you did make the decision to go into private

practice?


Dr. G.:
Well, primarily because I wasn't really firmly decided
after having completed most of the internship that I wanted
                                                             19




to go into a residency in internal medicine.   I was unsure.

I felt that I could do general practice, which the general

rotating internship would permit you te do, and make up my

mind more finnly before I committed myself to a given

specialty.


Dr. Y.:
You really did view this as a time for making up your mind

rather than a beginning of a life-long private career?


Dr. G.:
Yes, I think so.   I'd been in private practice for about

fourteen months when I came home one night, on a Thursday

night, that was the afternoon that I closed the office.

The wife and I would occasionally go to a movie, a drive­

in, on Thursoay night just to get away from the telephone.

And, this being a small town, the telephone operator al­

ways kept track of all phone calls, and I called Molly

when I got back in and asked her if there were any mes­
sages, and she said, "Yes.   There's a telegram here, a

collect telegram, from Wright Patterson Air Force Base."
Well, I accepted the charges on it and said, "Go ahead and

read it," because I remembered having taken care of an air­
man who bad been injured in an automotive accident recently,

and I thought it probably was related to him, but the fact
                                                                   20




that it was collect seemed odd.      At any·rate, it was from

the Public Health Service, and they said that they had a

commission in the regular corps available for me if I

were still interested.       I think this was simply a routine

telegram that they sent.      The collect business, I think,

was because they were so hard up at the time.        They sent

these to all the fellows who had reverted to inactive re­

serve within a given period of time, and if I were inter­

ested, I was to let them know.      That sort of irked me that

they would send me a collect telegram, but I got to think­

ing about it more and more in the subsequent days and the

next couple of weeks and finally decided to drive down to

Washington and see what they were talking about.        I went

down to see the Director of the Division of Personnel, Dr.

Ii:v Dresher, and Dr. Dresher said, "Well, you don't want

to came back in.to the Public Health Serv.tce."      He said, "We

don't have any good assignments available.        You'd probably

get stuck out on an Indian reservation or Coast Guard
assignment."   He satd, "I just don't think that you'd

better come back in.     It's not for you.     You know, we
think you're good officei: material but we just don't think

that••• ".   I said, "No?"    "No," he said.    Irv was a pretty
shrewd amateur psychiatrist, and the more I thought about

it••• private practice was interesging but I could look down
                                                                   21




that road, you see, and I knew I could spend twenty-five

years in that endeavor and not really have any impaet,

and something made me feel •••well, that wasntt why I had

gone to medical school.    It was a dissatisfaction with that

type of activity, and so I went ahead and sold my office

and house to another physician, and this all took place in

the ensuing five or six weeks, and the first, oh, about

mid-September, you see, this happened in July, when it

all began, at4-September I showed up again in Washington

and I said, "Well, I've sold my house and my office.

Here I am."    And they gave me a blank look and said,

"Well, gee, we don't have any assignment for you."       I

said, "Fine.   What am I supposed to live on?   I thought

yeu wanted me to come back in."    "Yes, but you didn't

understand.    We have to have an assignment for you.        Our

budget is very tight right now."    So they then sent me

around to be interviewed by people, such as Dr. Jim

Schaeffer who was then in charge of the VD program.          The
only opening he had was in Puerto Rico, and he didn't feel
that that was a good place to send a married man because

housing was too scarce.    Most of the people that they sent

me to had no openings at all--they were tight on "slots" as

they called them.    I remember the last interview I had that

day, it was about 4 e'clock in the afternoon, with a Dr.
                                                                22




J. J. Weiskoff.   J. J. was a recent joiner of the Public

Health Service.   He had come over from Europe.      He spoke

English with a thick accent, and he was in charge of the

Employee Health Service Program for the    u. s.   Public

Health Service.   He was very cordial and genial, talking

to me, but he didn't have a job either for me, and so I

thanked him, and as I was walking down the hall to the

elevator, I was really quite depressed.      I had done some­

thing very foolish.   I had sold my house and office and
had to be out of it in a matter of weeks, and my income

would~stop, and they didn't have any job for me after

they had asked me to come back in.   I was just about to
the elevator when down the hall came J. J. Weiskoff run­

ning, and he was yelling, "Hey chief boy, chief boy, come

here."   That was his favorite descriptor:     he called

everybody "chief boy."   He said, "Guess what.      I just had

a phone call from the medical officer at the Denver Fed­

eral Center, and he decided to leave the Public Health
Service and go out in private practice.      Will you take

that job?"   I said, "You bet I will."    SG, tnis is how I

got back in••• in, really, into the Public Health Service

again.   I had that hiatus of sixteen months.      I came back
in on 8etober 31st of 1951 and was assigned to the Denver

Federal Center.
                                                                 23



Br. Y.:
Now, before we get into that, let me just ask another question.

When you got to be Commissioner, you very often referred to

your sixteen months in private practice.     I take it that it
was a good thing?


Dr. G.:
Oh, it was a very valuable experience.     In retrospect, I

drew on it under many kinds of circumstances, jobs that I

had, sueh as Civil Air Surgeon with the Federal Aviation

Agency.   I didn't have to have anybody tell me what the
problems of conducting physical exams were for the airmen

in the private physicians' offices, or how a private physi­

cian might view a form from a federal agency, because I

bad chafed under having to fill out some of the same kinds

of things.   And certainly as Commissioner of Food and Drugs,

where I was dealing with the pharmaceutical industry as a

major part of my responsibilities.   I could think back to
those days in private practice where I would see as many as
thirty detail men in a month.   I bew what their activities
were; I ltuew what their efforts were aimed at; I knew what

the promotional sehemea were in the firms.




Mad you had any bad experience with them?
                                                              24




No, not bad.    I saw, as I say, thirty detail men a month.

I did all of   my   own dispensing.   I didn't write prescrip­
tions except very rarely for extremely expensive items.
The cost of the office visit was two dollars including
the medicine when I was in practice.      So, I had to buy

drugs and had to see the detail men to find out what they
had.


Dr. Y•:
But you didn't ever•••


Dr. G.:
No, I never had a fight, no, •••

Dr. Y.:
Or feel that you were being misled particularly.       It's

just that you saw the system in operation.


Dr. G.:
I bad seen it••• that•s primarily it.     I did engage in a
good deal of questioning of what detail men told me.          Donft
forget I was perhaps newer in practice and closer to my

medical school, pharmacology training, than many of the
physicians they saw, so I would subject them to more question­
ing than perhaps some physicians would, and I used a limited
                                                              25




number of drugs.   I had a small drug room where I kept my

stocks of drugs.   But I didn't have any run-in with them

at all.   The detail men, most of them, were very courteous,

nice people to sit down and spend some time with.     It was
time-consuming, I will say that.    It was very time-consum­

ing.


Dr. Y.:

Bow about the problem of the education of the physician and

the physician's keeping up with the cutting edge of medical

practice and so en.    It was to become such a problem.


Dr. G.:
I could see that as a problem even when I was in practice.

I belonged to a county medical society.    There were nine of

us in that county medical society, and when I first started

in practice, I talked to one or two of the ether physicians

in the county, particularly the younger ones, and asked

them, "Now what do you do••• how do you handle the problem
when you want to go to the AMA meeting?"    I rem.ember one

was coming up in Cleveland, as I recall, that year.       I
thought I would like to go back as it was the clinical

session in December.   "Oh," they said, "you just close your
office up, and what we can do is if you've got any OB cases,

we sort of cover for each otner.   We make an arrangement."
                                                        26




This young physician from a nearby small town said he'd be

glad to help cover my practice when I went if I'd do the

same for him.     Dr. Lucas, I think his name was.   I can

recall thinking at the time that every time youc,closed your

office, your income fer tnat day stopped, you see, or for

that period of time.     That was a factor in my decision.     I

didn't think that was a very good thing, because I could

see how you would become sort of tied to keeping the office

open and not keeping up.     I think the isolation of a small

town practice in a town of 500 where I was driving the twenty

miles to the hospital usually twice a day.     I was doing home

OB.     My wife did all of my OB packs for me, keeping up my
office, although she did not work in my office.      The office

was too small, really.


Dr. Y.:
What about reading?


Dr. G.:
Well, I got my journals, JAMA; Post-Graduate Medicine, I
suascribed to that; a couple of free ones, like Medern
Medicine, I think, was out then;!!_, the Academy of Gen­

eral Practice journal.     Those were the main ones that I
read.     Now, when you worked in general practice like this

all alone,--the last twelve months, remember, out of
                                                                27




sixteen that I practiced, I had a hundred OB cases.        6n the

average of every third day, I had one OB case.     I closed
the office up for all of them and stayed with the woman

from the time she went into labor until she delivered, and

a third of those were home OBs.     I had about 25 to 30

patients a day whom I would see, plus my hospital calls,

the OB and home calls.     I drove about 4,800 miles a month,

and so you would put in a good long day of it, maybe 18

hours, 16 hours for sure.    And you really didn't see much

of your family and children, and you really didn't have an

awful lot of time to read journals.     So this created another

kind of dissatisfaction.    You felt really tied to a situa­

tion that you couldn't control.     I think that was a key

factor.   And you felt you could spend all of your life in
that situation, not really having control over the practice,

but being rousted out of bed in the middle of the night

because there had been an accident on one of the bridges.
The town had four roads, you see:     north, south, east,

west highways, and three of them had one-lane bridges within

2 or 3 miles of town, and I knew every Friday or Saturday
night there would be an accident on one of those in the

middle of the night, and I'd get hauled out by the State

Highway Patrol.   So these kinds of factors •••
                                                                  28




Dr. Y.:

You may have seen people who had gone that road and ended up •••

:Dr. G.:

@b, I saw some of them.      Dr. Niehyser of a nearby town died
of a heart attack, f~rty-eight years eicl, you see.     I said,
well, I don't think I want to spend my career••• ! didn't

have ~ti~t idea when I went there, and I think I want to

work in an organized structure.      That was when I decided to

go back into the Public Health Service.      I never regretted
that.      It was great fun to be in the Public Health Ser­

vice, the years from November of '51 to June 30 of '68.




You went to Denver then as your first assignment?


Dr. G.:
Yes.    Yes, I went to Denver as Medical Officer in charge

of the Denver Federal Center Employee Health Program, and
this was an activity that had been set up several years•••

two or three years••• earlier and it was to provide on­

the-job health care for federal employees.      There were

six thousand of them working at the Denver Federal Center,

and there was a staff of nine nurses, a housekeeper, and a
secretary when I went there, and I instituted at that time,
not knowing any better, the first executive health program
                                                                   29




in the federal government.     I didn't ask Washington for per­

mission.     I just started doing it.    It made sense, because

I looked at what we were providing, it basically was an

emergency·serviee, with some people coming in because they

wanted to see the doctor and that was it.       Well, that

didn't seem like a very rewarding kind of situation.          We

had a board made up of tthe heads of the federal agencies

that supported this activity out of their budgets, and I

suggested to them that one ef the things we ought to do is

to examine the key executives.     Well, that was so popular,

that within six months the board raised their contribu­

tions, of the agencies that participated (twenty-two

federal agencies,) in order that I could hire a second

physician.     It really became a status symbol to get an

executive exam, you see.     And this got written up in

Jerry Klutz's colunm in the Washington~•           I didn't

realize I was starting something that had never been done

in the federal government before.       Of course, now it's
rather commonplace.

Dr. Y.:
Had you learned about this from industry or was this some­

thing to de because you didn't b.ave enough••• ?

Dr. G.:
It just made good sense, because the largest investment was
                                                          30




in the senior agency employees who were at an age when

they might be expected to have some problems with their

health, and to try to find them at an early stage.        First,

we hired a lab technician in order to do this, and then

subsequently, we got the physician, and I was there from

November 1 of   1 51   until May of '53, I believe.   Let's see,

yes, May of '53, and at that time I left the Denver Fed­
eral Center.    Again, one of those chance occurenees.

There had been a cocktail party.       The regional medical

director, Dr. Aaron Christianson was the RMD in Denver

for the Public Health Service.


Dr. Y.:

The Rim?


Dr. G.:

The Regional Medical Director.


Dr. Y.:
I see.

Dr. G.:
And he was a very fine man whom I counted and still count,

as one of my friends; certainlytthroughout my career in the
Public Health Service, Chris was a good friend of mine.

And at this cocktail party, he just very casually said, "Jim,
                                                              31




would you be at all interested in a residency in Public

Heal th and Preventive Medicine?"    I said, "Why, sure. n

And that was all that was said.     And about six or eight

weeks later, Dr. Robert Leslie Smith came from Washington,

after calling me to find out if I would be in and to make

an appointment, to find out where I would like to go on

the residency.     I, in the meantime, submitted some papers

which Dr. Christianson had sent out to me.     Now, I think

Dr. Christianson was impressed by me as a physician be­

cause he had brought one of his children to me and I

diagnosed measles before the spots erupted, you see, and

Chris was puzzled as to what was wrong with his young

girl.   I sort of spotted the Koplik spots inside of the

mouth and I said, "Chris, it's nothing serious.     She's

going to ••• Dr. Christianson••• she's going to develop

measles within the next twenty-four hours,~ and sure

enough, she did.     Well, this simply was that I was closer

to clinical medicine than he had been as a regional medical
director.   As a career officer, he had gotten away from

clinical medicine.     So, he thought pretty highly of me
and was very nice to me and got me into this residency

program in Public Health and Preventive Medicine.     Dr.

Smith came eut ana went over all the residency opportunities

available in local health work.     That was where we started.
                                                                    32




Chapel Hill, N.       c.,   appealed to me because it was a univer­

sity town and in a nice part of the country, and a smaller

kind of town was more what my wife, Mildred, and I were used

to, and it wasn't a big city like Boston or San Francisco

where some of the other residencies were.          So we accepted

this assignment to go to Chapel Hill, and we went there in

May of 1953.


Dr. Y.:

And it was at the medical school?


Dr. G.:

No, this was in a local health department, a four-county
health department, Orange, Person, Chatham and Lee counties.

Dr.    o.   David Garvin was the health officer.    He was an in­

teresting fellow, an odd person in some ways.         He would

worry more about people getting in to work on time in the

morning and not leaving early at night than what they did
all day long.        But he was a very kind person, very nice to

me.     He bad had a series of young men such as myself there

as residents from the Public Health Service and I met one of
them, Dr. Will David, who was about to leave shortly after

I got there, and he introduced me to the people in the two

counties that I was to be given responsibility for.         They

were        Chatham and Lee counties.
                                                         33




Dr. Y.:

Now, the residency was a way of training you for kinds of
responsibility that you couldn't have without it?


Dr. G.:

Right.


Dr. Y.:

You were in the Public Health Service as an officer but•••


Br. G.:
That is correct.     I was then placed on loan to the State of

North Carolina and, in tum, reassigned to the Orange, Per­

son, Chatham and Lee Health Department to gain some exper­

ience in Public Health at the local level, because in work­

ing with the Public Health Seriice, you have to have an

understanding of what happens at the state and local levels

and not just the federal level, because the state and local

levels are where the programs are carried out.     And so, this
was essential.     It's also part of an approved program lead­

ing to your boards in preventive medicine, if you so desire.

And so I was accepted as one of the••• I think the Public
Health Service was supporting, at that time, oh, three or

four fellows and maybe as many as six, two in each year of

residency.   So I was sent, as I said, to Chapel Hill.   My
residency mentor was an interesting fellow, old Applewhite,
                                                           34




Dr. Applewhite, who had retired from the Public Health Service

where he had served, well, I kn.ow that Apple was in the ser­

vice before World War I, because he did a pit privy program

down here in Georgia, back before World War I, and he used

to tell us stories about his travels throughout the country­

side, by horse and buggy and by train.   So, Apple,--1916

to '46, would be thirty--he had been in the Public Health

Service about thirty-eight or forty years before he retired

and had taken the job as director of local health services

with the State of North Carolina.   There were two Public

Health Service men on residency training that year in North
Carolina, one in a town about forty or fifty miles away from

Chapel Hill, and we would meet every other Saturday with Dr.

Applewhite at ei,~her Chapel Mill or over in this other town

and discuss our training program, what we'd been doing, and

Dr. Applewhite would "take us up on the motmtain and shew

us the Promised Land," as he used to say, and tell us of
previous experiences that he thought were relevant to the
work we were doing.   Now, this was an important epportunity

for me because Dr. Garvin was permissive enough to let you

develop almost any kind of local health program in those

two counties that you chose to do so.    I did two major
things:   one was a cancer education program for cancer of

the breast for women, using a film that the American Cancer
                                                               35




Society had produced on self-examination of the breast.
I went around from community to community and got the
theater managers--! had once worked in the theater busi­

ness so I knew a little bit about that.


Dr. Y.:
Was that when you were in meiical school?


Dr. G.:

No, in Warren, Ohio, while I was on high school.          I worked
my last two years in high school.      I got the theater mana­
gers to let me use their theaters from eleven in the morn­

ing until one to have these sessions with women's club

members and whoever we could get to come and showed these

films, and I made myself available to answer questions.

That was one program that we carried out that I started,

and the other was ••• Dr. Garvin was very much interested in

tuberculosis work.     That was really his forte; he liked it,
and   so I   decided that if that was his pleasure, I would
give him more chest X-rays to read than you could shake a
stick at.     Now, we had a mobile unit.   We had   two   of them.
One was in a truck that the Public Health Service had loaned

him, and the other was in a trailer that Dr. Garvin had
gotten the commissioners of those four counties to go to­

gether and purchase and had fitted out with an X-ray machine.
                                                          36




Well, since one was a Public Health Service truck, I think

he reasoned that my,being in the Public Health Service, I

should have that one.   At any rate, my last six months

there, I put on an X-ray drive in those four counties and

took 10,000 chest X-rays myself, and kept him busier than

he had ever been reading chest X-rays.   I would drive the

truck, and using industry largely as a base and that meant

cotton mills in that part of the country, well, not just

cotton mills, but there were brick plants and a few other

kinds of industries.


Dr. Y.:

The mills, as a matter of fact, at least in the earlier days,

were days in which the kind of cotton lint•••


Dr. G.:

Oh, yes, a lot of lint in the air.


Dr. Y.:

So that it would be a •••


Dr. G.:

Oh, yes.   And they were available; the manager of the plant,

you could talk with him and say, "Well, we want to bring the

X-ray unit here, and it will only take a short period of time,

and your workers will only be away from the job for a short

period of time."   I would drive the truck and book it up to
                                                                  37




the power source, the 220 lines, and take the X-rays myself.

Now I would have   a•••

Dr. Y.:

A   one-man operation?


Dr. G.:

A one-man operation.      I sometimes would have the help of a

woman to supervise the filling out of the cards, but that

was about as far as it went.      I would stay and catch the

second shift and the third shift.      I would stay until after

midnight in those larger plants to catch the third shift.

Well, I not only took 10,000 in six months, I got very

proficient at doing this, and I would get a line of people •••

I'm afraid I got over-enthusiastic and I would take as high

as 60-70 in a minute.     And I burned out the main transformer

in this particular piece of equipment.      I'm not quite sure

how it happened.    The people who had to repair it up in

Washington in the Rockville shop said they'd never seen

anything like it before either, but Dr. Garvin still shakes

his head about how I managed to burn out that main trans­

former on that X-ray unit.     This kind of experience was

important because it was free enough and unstructured

enough that you had to learn by your own method, learn to

develop your own methods and you learned a lot of lessons
                                                         38




along the way.    They could afford to let you make mistakes

in that setting, and you made them, but they were valuable

mistakes to learn by.    I also first had a run-in with a

major corporation when I was there, and it was Sealtest

Dairies.   They were attempting to dump;?"some milk with high

bacterial counts in North Carolina that couldn't get passed

in other states, and we caught them bringing this milk

into tnis four-county district, and Dr. Garvin let me

handle it, and I met with the Sealtest regional man and

told him the next time we caught one of his trucks in

here and pulled a bacterial count that was in that range

of 3 or 4 million per centimeter, as I recall, or even

higher, we would just have the truck confiscated and dump

the whole load.   And that stopped that nonsense.   I learned

to do restaurant inspections; go out with sanitarians on

restaurant inspections throughout the four-county area;

school health werk; do examinations of school children,

the pre-school group in particular.    I had to set up and

organized those clinics.    I had the nurses in the health
department to help me, guide me on those things.    You always

learned a lot from the nurses and from the people in the

structure, because they had been doing it.    You are new to

it.   Now, on the other hand, you see things that they don't

because they're inured to it.   You bring a fresh viewpoint
                                                      39




to it, so you can sometimes innovate in ways that are

apparent to you need to be done but not apparent to those

who are there.    That's one value ef changing jobs occasion­

ally.     Sir William 0sler, you know, believed very strongly

that every five years an individual in this professional

field should pack up and go someplace else, because he

said that forces you to re-examine what you've been

doing, and you see things afresh because you move to a

new physical setting and are deaiing with people who ion't

know you and whom you den• t know.


Dr. Y.:
And that became a kind of doctrine that coincided with your

own individual bent?


Dr. G.:
Yes.    Yes, it did.   And so, in my subsequent career, I

never managed to stay anyplace more than three years, and

some combination of circumstances would then force a move.

I always committe4 myself to a five-year stay.     Intellectually,

I would say, "I am going to stay five years here."     But it

never was my privilege to have that happen.


Dr. Y.:
Now, did you, while you were in North Carolina, have any
                                                            40




contact with the Food and Drug Administration people on the

local level?


Dr. G.:

No.   We did the food work, by inspecting the food process­

ing plants and the restaurants that operated there, but I

never had any contact with the Foos and Drug people on the

local level.


Dr. Y.:

That just didn't happen?


Dr. G.:

That just didn't happen.   No.   The residency was, I thought,

an extremely valuable fifteen months.     I went then in Septem­
ber to Harvard School of Public Health.


Dr. Y.:
Now that had been a natural consequence of the residency?


Dr. G.:
That was one of the requirements of the residency training
program, that in your second year, you would go to a school

of public health and get a masters degree in public health.

Jou were allowed to select which school of public health

you would go to.
                                                        41




Dr. Y.:
How did you happen to pick Harvard?


Dr. G.:
Well, I read through the catalogs at the university library
of the varieus schools of public health, and, of course, I
think I had always been attracted to the idea of Harvard.
Do you recall that I was living in North Carolina at the
time and Thomas Wolfe, I bad. been a great admirer of his,
and he, in turn, was fascinated by Harvard and had at­
tended Harvard.

Dr. Y.:
So that quite possibly•••


Dr. G.:
Yes, I felt an attraction to Harvard that I didn't to
Hopkins, although I must say, that Hopkins was quite at­
tractive to me because of all that Osler wrote and he had
been at Hopkins.   Do you want to stop and change that?

Dr. Y.:
Yes, I think we'd better tum it over.

Dr. G.:
Yes.   Okay.
                                                                42




Dr. G.:

As I say, I was attracted to Hopkins because of Osler and

having read Cushing's book about him.     I thought Osler

was one of the real giants.     Of course, Cushing was a

great neurosurgeon.     Then I later read the book about

Harvey Cushing which was sort of written in the same style

as Cushing•s book about Osler.     And that covered then a

span of medicine and public health, because Cushing was

quite broadly concerned about health matters up through

the era of Franklin Delano Roosevelt, and up through the

early forties, the beginning of the war.


Dr. Y.:
Cushing, eh?


Dr. G.:

Jes.     Cushing's daughter married a Roosevelt, as I recall.


Dr. Y.:
Right.

Dr. G.:

I've forgotten which one.     Elliott, perhaps.   I don't know.


Dr. Y.:
I've forgotten, too, but Cushing was one of the ones who kept

pushing Roesevelt to get more interested in food and drug p1Uoblems.
                                                           43




Dr. G.:
I didn't realize that.     Yes.   But I knew he was quite con•

cerned about health matters in a general?way, not just

neurosurgery which was his particular specialty.      Those

kinds of writings••• the history of medicine interested me.

I've always enjoyed reading anything along that line.         But

those particular books covering that era of medicine, I

found perhaps more interesting than any other, because that

was a very explosive, dynamic period in American medicine.

That was the period during which we shifted from dependence

upon Buropean training for our specialists and the develop­

ment of our own specialty institutions.     That, of course,

embraced the period of the Flexner Report, the profound

influence that had on medical education.      It was thelsame

period, of course, during which public health developed

as a specialty in this country, and it was fascinating.

Well, at any rate, I didn't choose Hopkins as much as I
was attracted to it.     Now, I approached it, this was

graduate school.   I didn't have to work.     I was paid my

salary, even though I was reduced one grade, to go to
school.   The children were young.    We didn't particularly

live in a high style.     But I studied a great deal and

enjoyed biostatistics.     This was probably the best course

I've ever had ia any school.
                                                             44




Dr. Y.:
Who taught it?


Dr. G.:
Hugo "Hooks" Muench had a great department; Jane Wooster

and Bob Reed and Jane »roulette were the principal people

in the department at that time, although they had graduate

students working there as instructors.


Dr. Y.:
Now that's the Department of Biostatistics within the

scho0l.

Dr. G.:
Yes.   That was the department that I enjoyed the most and

learned the most from.   It was a very valuable experience

because we studied sampling methods, design of studies,

problems of this kind.   I took advanced courses in the second

half of the year beyond the basic course.


Dr. Y.:
Do you have any explanation as to why it was that this

seemed to be the most interesting course?


Dr. G.:
Well, it was the most factual course.    It was a mathematics-
                                                                45




based type of course, and I've always enjoyed mathematics.
It has been a strong area in   my   education, one that I was

fairly good at.    So, it bad those characteristics which

made it attractive.    It was well taught.   The instructors

obviously were concerned and made themselves available to

a far greater degree than any of the members of the other

departments.   The other c0urse that wassextremely good was

one in legal medicine, in Public Health law, by Bob Hamlin.

Bob was my faculty advisor, interestingly enough, even

though be was a year younger than I.     He bad just com­

pleted••• receiving his law degree from Harvard Law School,

which was very impressive and, as well, he bad, during his

last two years in law school, gone to Harvard School of

Public Health and gotten bis masterfs degree simultaneously,

and held a job in the State Health Department in Rassacbu­

setts.


Dr. Y.:
Did you say Hamlin?


Dr. G.:
Bob Hamlin.    HAMLIN, Robert Hamlin.        He now bas a private

consulting firm.   But Bob was, at that point in time, health

officer in the City of Brookline and held a faculty appoint­

ment teaching Public Health law, this was a seminar course
                                                                    46




in the second half of the year, with about eight students.

It was held at 5:30 in the afternoon, because of Bob's

work schedule.    So you really had to want to participate

to take this course, and it was a very good course in this

sense, better than the others again because you did parti­

cipate.   You were stretched; yeu had to think; there wasn't
any-set answer.    ~t wasn't spoon-feeding.      The problem of

most students in the School of Public Health was that

professors wanted t0   !!ll you.     It was;11,more teaching than

learning and so, tb.i·s, of course, was an exception, as was

biostatistics.


Dr. Y.:
Well, now the biostatistics:       had the background in North

Carolina, seeing the thing on the local level, made the

relevance of biostatistics seem••• ?


Dr. G.:
Yes.   And Public Health law, too, because you were up

against••• problems such as ••• for example, North Carolina
bad a law which permitted the sterilization of a married

female whose children were mentally defective, or if she

and her husband were borderline mentally defectives.         Now,

these kinds of issues are·more than just legal issues.

They become moral, societal issues.       So, when this type
                                                             47




of issue would come up in Public Health law, I could relate

back to problems I had dealt with in the real world.       And

North Carolina ae tjually had that type of problem to con­
                    1




tend with.     Again, the relevance ••• those courses were not

only relevant in view of what I had just experienced, but

proved to be very relevant later on as we had the opportun­

ity to turn these issues over in Public Health law and in

biostatistics, too, to examine all different methods of

getting at a problem, not just saying there is only one

way, but looking at the variety of ways you could set up

an experiment and what the virtues and the disadvantages

of each method were.      Well, those were extremely valuable

courses, not that I didn't leam anything••• It was in­

teresting, I became exposed for the first time to what

you might call sociology and the social sciences at

Harvard.     Now, this was through courses such as ecology

where Dr. Benjamin Paul, Ph.D., taught the course in

ecology.     And I became aware of books and writings of
sociologists that I never encountered before and never had
a chance to read.       I also realized that as far as a graduate
school was concerned, the School of Public Health really

wasn't.    It was sort of a Mickey Mouse school kind of

situation where you didn't have to work as hard as I was

working.     So the last half of the year, I did nothing but
                                                            48




read these books in the field of social science, and this

really was something exciting to me.         I hadn't been ex­

posed to it, and I felt that I had learned a great deal on

my own.


Dr. Y.:
As you look baek, could you spotlight any of the books that

were to be ••• ?


Dr. G.:
Well, no particular one book.        These were things, such as

Lewin' s "Theory ef In tei'.-Personal Relationships" and "Group

Behavicnr" and "Why People Are As They Are" type of thing,

Kluckhohn.   They were pt'.etty standarci things but I had

never run into them.      I think I learned a great deal in

that year about myself.


Dr. Y.:

You mean that your ideas about yourself, about your career
interests, got better     fc► rmulated?



Dr. G.:

Not   so much the idea   abc►ut   my career interests, but my ideas

of self in terms of reh1tionships with other people and a

better understanding of self.         A sort of self-analysis type

of thing.
                                                                   49




Dr. Y.:

Something much more bas:i.c really.


]])r.   G.:
Yes, that 'became much mo,re formulated during that••• don't

forget, I was, what?, 32 or 33 at the time.         I had led

really a fairly sheltered life up to that point, you might

say.      Mostly in an academic environment.    Although this

again was academic envir·onmen t, I began to think for my•

self more, began to mature a great deal more then.


Dr. Y.:

Did you have any kind of thesis to do as a part of this?


Dr. G.:

No.      This was the odd thing.     This was why it wasn't a

graduate school in     my   book.   You didn't have a master's

thesis to write.      You had to write examinations.    Now, you
know, this didn't strike me as graduate school, and I was
one of the ringleadfrrs within the student group, by the way,

demanding that the dean 1neet witn us and he did, the new

dean of the School of Pu'blic Health, Jack Snider, whom I've
since gotten to know quite well.         In fact, I'm on the Visit­

ing Committee at that school now, but we met with him and

explained to him and the faculty members that we were dis­

satisfied with the courHs they were presenting; that it
                                                                   50




was spoon-feeding; that they didn't stretch us enough; that

we leamed more from ourselves.       We organized evening semi­

nars••• students from other countries or from other disci­

plines or people such as Joe Garland, the very great editor

of the !,!!! England J0urn,al !£. Medicine, would come in and

meet with us.      These were seminars we, as students, arranged,

and we did this the last: half of the year.     We were an ex­

tremely active class.      It was a lot of fun te be in that

particular group.


Dr. Y.:
There was this international angle which, of course, was

to be important when you got to CDC.


Dr. G.:
Yes.     Yes.   We had a fair pumber of students from overseas

countries, Korea, Thailand, India, Sweden,     to   mention just

a few.

Dr. Y.:
And so they were to bring their background to the kind of
problems you talked about.


Dr. G.:
Right.     And we had the evening seminars where we could dis­

cuss the health care systems in other countries.        It gave
                                                             51




us a much broader exposure, and, as I say, we felt the

students probably learned more from each other than we

did from the faculty.   That may not have been really

true.


Dr. Y.:
That may generally by true.


Dr. G.:
Well, learning requires the active emotional involvement

on the part of the individual for learning to occur.    At

least, I feel very strongl_y it does.   And emotional involve­

ment isn't something that you acquire in a passive situation.

Sitting in a lecture room listening to someone talk doesn't

exactly lend itself to an emotional involvement.    But when

an interchange develops, and ideas begin to be tested

against reality structures and situations, when challenges

are hurled out and you are forced to think through positions,

then you begin to get emotional involvement and learning.
And that's what we found so lacking and wanted so much
and why we felt we learned so much from each other, because
we could challenge each other as peers on ideas much more

easily than we could faculty members, although most of us

didn't hesitate to challenge faculty members when given the

opportunity.
                                                               52




Dr. Y.:

The school wasn't too big for there to be discussion in courses.




No, it wasn't too big.   There probably, as I recall, were some­

where around 100 students in the class, which then was broken

down into your specialty areas.   Some of the group were Air

Force officers whom we seldom saw except in the required courses.

They were there because of courses in aviation medicine.   There

were nurses who were there who were involved in Public Health

Nursing and engineers who were studying Sanitary Engineering.

So, in general, you workedcin small groups, and it did afford an

opportunity for back-and-forth if the professor were willing to

do it.


Dr. Y.:
Were you confined pretty much to the curriculum at the school?


Dr. G.:
That was another major objection on our part that we met in the

dean's 0ffice and tried to get some resolution on.   We felt that

although Harvard University was just across the river, we never

got over there and never got a ~hance to get exposed to those

people.   This was all due to the curriculum being so rigid.    Well,

they did loosen it up after that, and provided in the subsequent

years a little microbus to go back and forth and take students      so
                                                               53




that they would have more interchange between the University and

the graduate school.   But the point being that I was not only

involved in getting my master's degree, but I waa also in­

volved in the student affairs.     For example, I helped on the

yearbook••• I wasn't the editor, but I was the manager, we put

out a yearbook the first time any class had put out one with a

hard cover, I managed that, put it tog~ther.     Oh, all sorts of

things going on.   Ford Hall forum, I found,. that very exciting

to go there on a Sunday evening.     It was ten cents, as I recall.

Fantastic ••• they would have great speakers.   Judge Justine

Pollier Wise on juvenile delinquency, and the next Sunday

evening it might he the president of the American Medical

Association debating with J. Howard Means and Walter Reuther on

the "High Cost of Medical Care and What Can We    l)o   About It?"


Dr. Y.:

Each of these episodes you told me about illustrates something

that I certainly observed in the later time that I knew you.
Somehow you got a lot more done with your time than lots of

people manage to do.

Dr. G.:

That's funny you would make that remark.     I think I'm very self­
indulgent and waste a lot of time.     I feel that I always have.
                                                                   54




Dr. Y.:

Well, if you look at it that way, I look at it from a different

perspective, I guess, but it seemed to me that here you were

doing all of these things at Harvard and you were doing these

extra programs at North Carolina.      Is it because you got less

sleep or ••• ?


Dr. G.:

No.   I never suffered from a lack of sleep.     But one of the

things I enjoy is innovation.      I like to innovate.    Now,

really you do very little that's innovative.      You apply what
you've learned in one setting to a different setting and that

then becomes innovative in that new setting, or you see things

slightly differently than you did before or than someone else

sees and that means you are innovative.      It's rare that someone

comes up with a truly new idea that bas never emerged before.

That's a rarity, but I derive great pleasure from developing

new ideas at least quote "new" in those settings.        Now, because
I like that, I think I ••• and I don't mind making decisions.
I'm a gambler and willing to take the risks of decision-making.
You have to be willing to do that to be a good administrator
in my book.      I get more things done maybe because of those

characteristics.      I don't really spend more time at it, because

I still indulge myself by reading a great deal.      While I was

Commissioner for Food and Drug, for example, I read more journals
                                                                     55




during that two and a half years than I had ever read at any time

in my life.    They came across my desk, and I always found some

new idea in them that made me think of something that we hadn't

been doing.     It was an intensive period of education for me,

because, although I had dealt with drugs, I had to look at them

now differently.       I bad never become deeply involved in the

pesticide matters and the food additives matters, although I

had an interest in them because of my work at the Communicable

Disease Center.     So, we are always harsher on ourselves than

others.    We know that there are three Jim Goddards, you see.




Now   what are they?


Dr. G.:

Well, this is true of any of us.      First, is the person we want

others to see, and second, is the person that others do perceive,

and third, is ourselves as we know ourselves really to be.         Now,

at best in life you can get that down to two, as you mature:
the person we want others to see and the person we know we
really are can coalesce.      It's difficult.   And then the other
person, that "you" as perceived by others, you have less control

over.     But at any rate, we do have those three persons, you see.

Well, on the FDA job, it still was one of expanding, you saw me

in a slightly different light than I saw myself.
                                                           56




Dr. Y.:

I'm sure that's true.      It certainly did strike me that way, and

you mentioned doing all of those things at Harvard, besides the

studies and your reading, and so I just thought I'd bring it

up.      Well, let me ask one question that I thought of awhile ago.


]l)r.   a.:
Sure.


Dr. Y.:
With respect to the biostatistics, was this a period of rapid

change within that field or broadening application of the know­

ledge in the field to different kinds of phenonema?


Dr. G.:

MoreGcif the latter certainly than the fermer.     Mathematics and

biostatistics as you know from your own experience isn't a highly

volatile field.      We are still using the theories that were de­

veloped with respect to probabilities of injuries on Prussian
soldiers, aren't we?      This field doesn't change all that rapidly,
but the broadening application would be a fair cenunent, yes,
during that period of time.


Dr. Y.:

And the hardware to handle it?
                                                                   57



Dr. G.:

Oh, yes.    Well, that was just beginning, you see, in '54 we had

computers but they weren't commonplace as they are today.


Dr.   Y.:
I was wondering if you learned things of this sort that would

have been important both to CDC and the FDA?


Dr.   G.:
Well, certainly, I learned through this particular part of the

program about computers but only in general terms, only what

they were capable of doing.      That's extremely important though.

That is as far as it went.     We didn't have a computer available

to us to work on at the School of Public Health.      They were

far too expensive for them to have had at that point.        They do

now, hewever, have computer capability.      But biostatistics was

well taught.      I would stress that that was one of the things.

You taught yourself.      It was a problem-solving course.   The

faculty simply helped you and said, "Oh, you've been looking at
it this way; look at it this way and if you were going to struc­

ture this, then here's how you •••wouldn't you consider ••• and why

don't ycm •• Z"   You really taught y0urself biostatistics under

their guidance.


Dr. Y.:

Was a sort of a case method used in a simulated situation?
                                                                     58




Dr. G.:

Yes.   Yes.   Very much so.    Very much so.   With problems that they

would give you and you w0uld turn in the reports on the problems.

I spent many, many hours working up those reports and, in fact,

I had had drafting at one time in my high school training, and so

all of my graphs were done with India ink, using a drafting pen

and French curves, whatever was necessary.       I had the technique
and all my work was typed.


Dr. Y.:

Had you had typing in high school?


Dr. G.:

No, I had to learn it on the job when I worked in the theater.

I had to get a payroll out every week so I taught myself to type,

but 1 recall Dr. Muench.      I turned in the first section and it was

returned marked "A"; turned in the second and it came back graded

"A".   And the third one, he appended a note to it and said, "I

would appreciate it very much if you would not hand in the pre­

vious sections.     I shudder to think of this getting lost some

place in our department.      You've taken such pains and it's so

beautifully done.    Please just turn in the appropriate section."

Well, that tickled me, you know.      They never had had anybody

turn in one like that before.      It was showmanship.   I had not

only done this work in high school; but working in the theater
                                                                      59




you learned how to present things.     That's an important thing in

life:     to learn how to present an idea.


Dr. Y.:

What do you mean that you learned this in the theater?


Dr. G.:

Well, we made displays.     We made billboards.   We had a workshop

backstage, and the man I worked for was a very imaginative guy,

Earl Bailey, and a very fine fellow.     He would hire us high

school students to work as ushers.     Then, the first thing you

knew, you were backstage working, making a sign that would go

across the side of the theater.     You learned how to do electrical

wiring, or how to make a lobby display, or a trailer display to

be driven around town to advertise a film that was currently

showing or about to start showing.     He took a liking to me and,

during my senior year, I was doorman and after I graduated from

high school, I was promoted to assistant manager.      That paid

twenty dollars a week, and I had to write the newspaper ads,

the radio ads and take care of ••• you had to learn how to handle

people, because you not only had twenty-two people working in

the theater itself, but you had the crowds that you had to learn

to handle.    You talked them into taking seats intI&ne front row

which really weren't very good seats, but you wanted to fill all

the seats in the theater.     So you learned a wide variety of skills
                                                                      60




and one of the things that you had to learn was how to present

yourself and how to present ideas.


Dr. Y.:

You mentioned that in North Carolina, you presented, as it were,

the films and also answered questions and spoke to women's clubs.

Was this your introduction to public speaking or had ••• ?


Dr. G.:

No.    I took public speaking in high school and college.    Because

I worked in the theater and I was interested in it, I gravitated

in that direction and took those courses as electives and, as a

result, I have never been afraid of public speaking.    That doesn't

mean to say that I haven't been nervous, but I've never backed

away from anything that required me· to meet the public, large

groups of people, 1500 or 2000 people, it doesn't matter, or

just in Congressional testimony, I always felt comfortable.       I

enjoy that kind of activity, as a matter of fact.    So, I look

back and, talk about influences on your career, I would have to

say that Earl Bailey, the manager of that theater, had a great

influence on my life, because of the many things I learned from

him, by observing him and working for him.     I remember one evening,

he came back from Pittsburg.    Back in those days, Franklin Delano

Roosevelt was our president, you recall. Jhis was in '39, '40,

'41.   This happened to be, however, in '41.   And I was assistant
                                                                      61




manager of the theater, and it was a Monday, and Roosevelt had

scheduled a Fireside Chat for that evening.       Before Mr. Bailey

went to the manager's meeting (this was a chain theater) in

Pittsburgh that Sunday, he spoke to me and said, "Jim, don't

forget there's a Fireside Chat," now the point being, that we

always arranged the -s·chedule on Monday so that the feature film

ended just at the time the Fireside Chat came on, or the short

subject, or the news or something, so that we had a natural

break.    And I said, "Fine."     He said, "Take that into account

in working out the schedule for tomorrow."       And 1 said, "I

will.''   And I did, and be came back from Pittsburgh late Monday

afternoon, and we were chatting and be said, "Did you work the

Fireside Chat into the schedule?"       I said, "Sure, it's okay;

It's at nine o'clock."     And he looked stunned and he said, "But

Gad dammit, the Fireside Chat tonight is at eight o'clock."

And I said, "Well, he always gives them at nine.tt      «well", he

said,"he's not giving this one at nine. 11     He said, "And you're

going out on that stage when we stop the movie in the middle and

explain to those people why they're going to have to wait to

see the last half of the film after President Roosevelt's Fire­

side Chat. 11   Well, I bad to do that.    It was one of those kinds

of things, you know.     There was a situation you had to cope with.

You had to handle people.       You offered them the opportunity to

have a refund, to come back, or anything to keep them satisfied.
                                                                  62




Well, a digression of sorts, but •••


Dr. Y.:

But an important digression, I think.


Dr. G.:

Well, you see, I did learn a lot from him.      He gave me respon­

sibilities.   That was the point I was getting at.     He gave me

responsibilities.    He also taught me that along with that respon­

sibility, you have to pay some consequences once in a while, if

you don't measure up properly.   And I tried to use that through­

out my career in handling the people that worked for me.      I was

quick to delegate.    I don't think people expand and grow in

their jobs unless you do delegate things to them, you see.        But

at the same time, I never hesitated to blister a guy because he

didn't do his job right.   My people knew that, in FDA or CDC.

They knew that I would give them the responsibility but also ex­

pected them to produce and I would follow up and ask them about
it.   They liked this.

Dr. Y.:

The ones who would produce would like this?


Dr. G.:

Oh, yes.   Most people want to do a good job.    This is an in­

teresting thing. Most people really want to do a geod job, and
                                                               63




the reasons that they don't, quite often are related to the

management philosophy that operates at a given point in time.

I think that if you give people responsibility and encourage
them, reward them, they'll measure up for you.


Dr. Y.:

How long into the Harvard year was it before you learned what

you were going to do after you were through with your master's?


Dr. G.:

Again, Robert Leslie Smith came to see me about halfway through

the year and said, "Well, where do y0u want ~o go next?"     The

thttd year you had to spend with a state health department to

give you state level experience.   Looking over and talking to

people in classes who worked for state health departments and

were knevledgeable about this and to a few friends I had made in

the service by then, I decided New York State and Calif0rnia

were the two best state health departments and I elected to go

to New York State.   Primarily because of Herman Hillabough.       He

was the commissioner of health, an outstanding public health

administrator, and I asked that I be sent there provided I

c0uld work in his office.   I was assigned to the New York State

Department of Health after graduation, beginning July 1, 1955.

Initially, I was given six months experience in the Albany

Regional Office with Dr. Ralph Vincent, and subsequently I was
                                                           64




placed in the Office for Program Development and Evaluation.         I

was given my choice of two projects to work on.       One was on a

meat inspection program which didn't appeal to me.       The other was

in highway safety and that was of interest to me.       So I developed

for New York State a Driver Research and Testing Center in co­

operation with the Bureau of Motor Vehicles and the Department of

Mental Health.   This was the first of its kind in the United

States.   During that six-month period, I attended meetings on

safety held in various parts of the   u. s.;    I talked and met
with officials of New York State trying to decide what New York

State should do in approaching this problem of highway accidents.

And the end result was the development of the Driver Research

and Testing Center.   Now, a choice, you see, played an important

role in my subsequent career.    I could have gone into the sanita­
tion field and maybe become drawn more into environmental problems,

if I had chosen to develop the meat inspection program; but I

chose to go to the highway safety thing.       Now, that has relevance

for the rest of my career because in the spring of '56, I was

asked, ''0kay, what are you going to do now?"


Dr. Y.:

This was the end of your training?


Dr. G.:

That's right.    I asked, "What's available?"     And the Public Health
                                                                     65




Service pe0ple that I met with said, "Well, all sorts of jobs

are available.     Look them over."   So I did.    One that nobody

wanted interested me.     They were talking about starting an

Accident Prevention Program.      That fit with what I had been do­

ing in New York State.     I was interviewed by Dr. Seward Miller
who was then head of the Division of Special Health Services.

He decided to take a chance on me.      I was 10ung for a program

chief.     I was thirty-three at that time.    So, July 1 I went

into Washington as Chief of the new Accident Prevention Pro­

gram.    Here again, I was invelved in starting something new.

That was fun.     I had a small staff, a biostatistician, a nurse,

and an engineer, a secretary and a statistical clerk.        Five

people and myself, and we got fifty thousand dollars which the

Bureau Chief obtained by what we call "tapping" other programs

or "tin cupping."    And that was what we operated on the first

year.    Dr. Chapman a few months later became the director 0f

the Division of Special Health Services, and he also had great

influence on my subsequent activities.        I have great respect

for him.    An imaginative man.   He had mere ideas in one day;;

than most Public Health people have in a year.       Three out of

ten of them••• four out of ten •••might not be any good, but Ted

Williams only batted .400, and Al was a very imaginative fellow,

just could keep you busy all of the time with little notes:

"What would you think of ••• ", "Why don't ye consider ••• n,
                                                                  66




Dr. Y.:
That was part of his administrative talent, wasn't it?


Dr. G.:
Right.     Yes and I grew up during that period of time, having

the responsibility of testifying before Congress, developing

a new program, selecting research projects to be developed, etc.


Dr. Y.:
Now, you had to do that in order ••• at the budget hearings?


Dr. G.:
Yes.     Right.   And also the Highway Safety hearings which Repre­
sentative Kenneth Roberts in the House was chairing then, I

testified a number of times in the period '56 through '59

before Kenneth Roberts' committee.


Dr. Y.:
What had been the reason for starting your highway safety program

which you came in to take over?


Dr. G.:
Well, it was the accident prevention program which meant home

safety, recreational safety, and highway safety.      My interest was

keenest, admittedly, in highway safety.      In fact, I proposed in

1957 that the Public Health Service develop a driving simulator.

This was a technique that I became aware of and knew of its
                                                         67




being used in some fields, and I saw that, going back to my

engineering training, possibly, you see, that this had ap­

plicability.    This also involved motion pictures, too, oddly

enough.    I met with people in Hollywood to check the feasi­
bility of doing this and made a proposal before Representative

Fogarty's committee for a driving simulator.     That unfortunately

never was funded.    It was unfortunate because I think many of

the problems that we have in design could have been avoided

had we had such a simulator available to ~rank them in and

studJ them in advance, problems with signing, intersections,

these kinds of things, as well as learning more about why

drivers react the way they do under certain situations.       High­

way safety was a very high-level interest for me in the accident

prevention field.    It was more challenging because there was a

relationship between design and injuries and accident patterns

that soon became apparent.    Hugh DeHaven did much of the early

work in this field at Cornell and John Moore had succeeded

Hugh and was doing this work at that time when I came on the

scene.    We, in fact, supported this project.   I got funds into

the research activities largely through NIH.     I had an arrange­

ment where l was an acting grants branch chief at NIB during

that time period, to get accident research started.    So we had

monies available.    I soon got to know everybody in that field.

As a matter of fact, when I left New York and took over the
                                                                68




accident prevention program, I got a young man to take my place

who was a Public Health Service officer and he was only to be

there a year.    The question then came, well, who would follow

him?   I had met a young doctor at the Harvard School of Public

Health••• named Dr. William Haddon.   Bill was an interesting

physician who had an MIT engineering degree and a Harvard Med

School degree and was working in virology at the Harvard School

of Public Health and wanted to take a master's in Public Health.

But the Public Health Service wouldn't support this bright,

young physician unless he would take a commission and come in

and spend a couple of years on an Indian Reservation.     "Then,"

they said, "we'll see whether we send him to the School of

Public Health.   After all, we just can't send him to a School

of Public Health."   So, I said, the heck with that.    They

wouldn't do it, so I got the New York State Department of Health

to support him while he went to the School of Public Health with

the understanding he would then work in the highway safety field.

We put Bill on the payroll and be subsequently took that job

over and really developed the Driver Research and Testing Center

and carried out some of the most imaginative research in highway

safety that anybody has ever done.    Bill is an outstanding expert

on study design, you see, and he wrote a book, in fact, on acci­

dent research methodology.    Bill Haddon and I stayed in close

touch and, as you probably know, he was the federal Highway
                                                            69




Safety Administrator until January of this year.     Actually,

February, I think he left.     And I happened to have been involved
in getting him into that job, too.


Dr. Y.:

Because you knew his whole background?


Dr. G.:

I knew his background and also this related to ••• I'm getting

ahead of myself, but while I was at FAA, I worked a lot with the

Civil Aeronautics Board, and Allen Boyd who was chairman of

the Civil Aeronautics Board.     Allen later became Secretary of

the Transportation Department.    When be became Secretary of

the Transportation Department••• or t:i\ther when he knew he was

going to become Secretary, he asked me if I had any suggestions

for someone who would make a good head of the highway safety

activities, because he knew I had worked in the safety field

both in aviation and highways.     I recommended Dr. Bill Haddon and
got them together for Bill to make a presentation.     Bill and I
used to do an "Ev and Charlie Sh0w. 11   We did that so many times,
it became a routine.   We did it for the President's Science
Advisory Commission; we did it for the Department of Commerce;

a Scientific Advisory Board; we did it for the Secretary of Com­

merce, and more importantly, Allen Boyd.     Going through the

whole business of highway safety and how the problem should be
                                                                 70




tackled.     As a result of that exposure, Bill was given the job of

Federal Highway Safety Director.     Well, that was great good fun,

and I met lots of people in the accident prevention field and

whose paths It keep crossing at different points in my career.

Some of them when I was Civil Air Surgeon for the Federal Avia­

tion Agency.


Dr. Y.:

How important is this in the success of a person, the network,

the web, of human associations?


Dr. G.:

Very important, I think, very important, and you have to pay

attention to it.    Of course, you understand the web you're in,

and you see some of the interlocking webs that others are in.

I've always maintained a good Rolodex file of these people, and

even though I may not see them for a number of years, I try to

keep current and know where they are, because something will

come up in a meeting or some situation will develop on a job,

and you'll suddenly think of a fellow at Antioch College in

Yellow Springs, Ohio, who, four years ago, did a project for

you of this nature.    You'll say to your secretary, ''Get him an

the phone.     I want to talk to him."


Dr. Y.:

When did you start this as a formal method?
                                                              71




Dr. G.:

In accident prevention.    I started then.


Dr. Y.:

Is it a name file or is it a subject matter file?


Dr. G.:

It's a name file, and I sort of keep the subject matter in my

head and try to think, when I've got a problem, "Well, who have

I ever worked with that has done something like this?"


Dr. Y.:

And then you did the same thing in connection with Public Health?


Dr. G.:

Oh, sure.   The Public Health Service has only about 5,000 com­

missioned officers.   There are many more civil servants, about

35,000 to be exact.   You get to know a pretty sizeable number of

the commissioned officers and know their capabilities.


Dr. Y.:
You'd see them so infrequently that you would want to have •••


Dr. G.:

Yes.   And they move, too, so it's interesting to keep ••• Well, just

a pers,mal aside here.    One of the fellows who worked for Dunlap

and Associates, a bright young mathematician, statistician and
                                                                    72




research psychologist, Herb Jacobs.     Herb and I took a liking

to each other.     I bad great respect for him and I   think he did

for me.     We just sort of kept in touch, not even letter-writing

much, but tb~ough mutual friends.     Now, oddly enough, Herb is

president of Hallmark Greeting Card Company, and our oldest

daughter is now at a commercial art institute in Denver and a

year from now, a year from August, she'll finish.       I saw her
last week and I said, "What kind of a job do you think you can

get?n     And she said, "Oh, Dad, some of the kids went to work
last year for Hallmark.''    I said, "Hallmark.   That's interesting.

Would you be interested in a job like that?" "Ob, yes," she saidi.

I said, "Well, let me know when the time comes."       Well, that's

just a personal aside •••


Dr. Y.:

But the thing worked•••


Dr. G.:
Isn't it odd that the network works.     And you encounter people
at different stages of your career, who drop out of sight for

awhile, and then pop back up again, and you are then in a dif­

ferent position, but you see they have some relevance to a

problem that you have at hand.


Dr. Y.:
Right, and so that you were able to call on expert counsel,
                                                                   73




whether formally or informally, hire a person or not, or just

ask him questions.


Dr. G.:
Sure.


Dr. Y.:
When you needed it.


Dr. G.:
That's very important, too.


Dr. Y.:
Well, the Accident Prevention lasted how long?


Dr. G.:
mhree years.   Just three years and thirteen days.         The reason I

know it was thirteen days ••• and here again, the long arm of coin­

cidence and circumstance.      By that time, that time being Spring

of '59, Bob Hamlin was a special assistant to the Secretary of
Health, Education and Welfare, who was Marion B. Folsom, and Bob

was working across the street in North Building and I was working

in South Building.    We didn't see much of each other.        He operated

with Congressmen on legislative matters and at a different level.

But, we knew each other.      We knew where we were, and be knew he

could get in touch with me and one day, he did.       He said, t1Jim,

would you do me a favor? 11    I said, uof course, .Bob.     What do you
                                                                        74




want?"          He said, "Well, I've been asked by the FAA to sit in         <i>n


a meeting and help advise them on a new job, the new medical

director's position, "and,n he said, "I promised them to do this,

and now the Secretary wants me to go out of town and give a

speech.         Would you go for me?"      I said, "Sure.''   I went to a

meeting at the old Executive Office Building, and Ford Luikart,

the director of personnel for this new agency, Dr. John Smith,

who worked for the CAA and then for FAA as a physician, was

there, and a Navy captain who later retired, and Dr. Bill Ashe,

Professor of Preventive Medicine and head of aviation medicine

at Ohio State, was there.          Mr. Luikart started talking about this

new job and we asked, "Who does this man report to?"              He said,

"Well, it works this way."          We asked him another question, and

it was obviously a very poor administrative arrangement.               We

made no bones in telling him this.             And he said, "Gentlemen,

let me tell you.         General Quesada, the head of the agency, has

decided that it's going to be this way.             Now this isn't my

view, but that's his."          We said, "Well, there's no point in us

writing the job description if you're going to have an administra­

tive bastard of an arrangement that doesn't permit the man to

work effectively.          He has to have line authority and you've

only given him staff authority."             He said, "Would you like to

have me get the general to come and talk to you?"              We said,
11   Sure. 11    So, Ford left the room.     A few minutes later, he came
                                                              75




back with this man who wore glasses, stood very erect, and

refused to sit down.     He said, "I just have a few minutes I

can spend with you, and I want to thank you for coming over here

to help us with this problem, but I want you to know that where

this man is in the administrative organization and how he

operated is none of your business.     It's our job.   Now, if you

can't write the job description, why then, we'll get another

group that can."    "But," he said, "that's our business."     And

I thought about what he had said and decided what have I got to

lose if I tackle him direct?     I looked directly at him and said,

"General, you couldn't be more wrong if yau tried."      Well, that

really started things.    He said, "What do you meant"     I said

"If you'll sit down, we'll tell you what we mean."       Although he

came in to spend five minutes, he wound up spending over an

hour with us.    And, at the end, he was very cordial and thanked

us very much for having helped him with the problem.       End of

story.    At least, I thought so.   A few weeks later, this, same
Federal Aviation Agency called and said, "Would you come over
and help us with a problem we have with respect to maximum age

of pilots for airline flight status?"     I said, "Why me?"   And
they said, "Well, General Quesada sort of took a liking to you.

Besides, you're working in the safety field and this is a safety

issue."    I agreed and went over to meet with them.     It was an

all-day meeting, and again the general was there, a very impressive
                                                              76




man.     After great debate, we finally agreed on age 60 as a maximum

age for flight status and age 55 as a maximum age for transition

to jets.     During the meeting the general asked us a lot of tough

questions and we put the answers back to him in a way that he

seemed to like.     Again, fine.   It was a nice day, intellectually

stimulating and fun, and I got .back to my office late that after­

noon and one of the participants, Dr. William Ashe, called ne

and said, "Dr. Goddard, you know we just spent the day together

here and I met you one other time.      I know what you're doing.

You probably think it's very important, but I want to ask you

would you consider taking over this new job as civil air surgeon

over here?     General Quesada has asked me to call you and find

out if you'd be willing to take the job."      I said, "Well, I am

very flattered.     I'm very impressed hy the general.    But the

answer is 'no'.     When I took this job as Chief of the Accident

Prevention Program, I committed myself to five years, and I've

only been on it three years and I've got a lot yet to accomplish."

Period.     End of story.   At least I thought so.   About a week
later••• I had taken the day off, but I had to come into town and
decided to stop by the office and pick something up.       So it was
just \lappenstance that I was in the office.     I was wearing a

sport shirt, a pair of slacks, sandals, the way I am dressed

today.     And while I was in the office, my secretary came in and

said, "The Surgeon-General wants" •••well, I left one element out.
                                                                     77




A week after that first phone call, I was in a staff meeting

with the Bureau Chief and he said, "Come on outside.        I want to

talk to you."   He said, "You know, you've been helping the       FAA

lately and the general has asked the Surgeon-General who has

asked me to find out if you really will take that job?"        And

I said, ttDave, no.   And I' 11 tell you why.''    And I told him

why.   So that was the second contact.     Now, a week following

that, I was in the office on    my   day off, without a tie and

without a suit coat, and the Surgeon-General called and said

he wanted to see me right away.      So, I borrowed a necktie and

a suit coat from one of my staff and went over to the Surgeon­

General's office.


Dr. Y.:
Who was he at that time?


Dr• G.:
Leroy Burney, and Lee and I liked each other real well.        I'll
tell you why later on, but I went in to see him and he saidI;.
"Jim, General Quesada has been over here to see me about you."
I said, "That's interesting."     He said, "Do you know what about?tt
I said, "Yes.   I've already told him 'no' twice; Dave asked me

and the general had somebody else ask me.n        And so Lee started

to talk to me and, the longer he talked, it became clearer and

clearer that I was going to volunteer to go over there.        So that's
                                                                  78




how I became Civil Air Surgeon.   Again, you see the chain of

circumstances that often determines our careers.    Bob Hamlin

bad to go out of town for the Secretary and so I subbed for him.


Dr. Y.:

That's right.   But you would have the kind of background to be

asked, too.


Dr. G.:

Well, Bob had respect for me and knew I would not let him down,

nor the Department down, in participating, and so that's why he

asked.    It's fascinating how these little events subsequently

seem to be important in how your career develops.


Dr. Y.:

So, it was in 1959 then that you •••


Dr. G.:

July 13th, you see.   I was transferred over there and that's how
it started me on this.   The general was superstitious and he

wouldn't let them date my transfer on July 13th, but insisted

that it be back-dated to July 12th.    I actually went to the agency

on July 13th.


Dr. Y.:

Well, while you were there, you had lots of opportunities to

observe the general, no doubt.
                                                               79




Dr. G.:
He was a great man.   One of the best decision-makers I ever

saw.   Let's take that up in the next session.


Dr. Y.:
All right, because the tape is just about to come to an end.


Dr. G.:
It's just an hour.
                                                                  80




Dr. Y.:

This is a continuation of the conversation with Dr. James L.

Goddard at his home in Atlanta.      Today is May 23rd, 1969, and

I am James Harvey Young.      When we talked last, you had described

some of your adventures while you were head of the Public

Health Service's Accident Prevention Program, and you had in­

dicated that it was in this role that you first began to run

into some kinds of consumers• problems and into lobbies of

industry, in this case, the automotive industry.      Jim, would

you say a bit about that?


Dr. G.:

Well, at that time, I remember this was in the period from

July 20th of 1956 to July 13th of 1959, I went in to head up

the Accident Prevention Program for the Public Health Service.

It was a new program, and I was selected primarily because no­

body else wanted the job.     At that time, I believe I was thirty­

three years old.   And that was fairly young for a program

chief in the Public Health Service, but it wasn't much of a

program to start with either.      There were five of us.   Well,

we looked at the accident data that was available, deaths,

injuries:   sources, types.     It was very easy to discern the

fact that--common sense would tell you--the highway deaths
and injuries were far the most impertant thing, con:tributing

over 50 percent of the total number of accidental deaths

each year in the United States, and generally striking at

younger people, more than the home accident deaths or other

kinds:    work accidents.     And so therefore, more man years lost

and, also, by virtue of work that had been started by Hugh De­

Haven back in the late forties at Cornell, it was also apparent

that these were deaths that could be prevented.       Primarily,

we are talking about the problems of deceleration.       Now, in

looking at highway accidents, people literally refused to do

much about them.    In fact, the automotive industry conscious•

ly aided and abetted this attitude by establishing in 1936

the Automotive Safety Foundation.       This came about because

there was a writer who had a story published and it was re­

printed in the Readers Digest, and it was called "And Sudden

Death."    It pointed up the problems of highway accidents, the

p0or design of the cars, as a source of contributing signifi­

cantly to the deaths.       This got the automotive manufacturers

very upset, so they ponied up jointly enough money, and have

continued to ever since, so that the budget of the Automotive

Safety Foundation when I was familiar with it, was a little

over a million dollars a year.      This, I always thought, was

conscience money that they were spending.       It was interesting.

The charter of that organization forbade that group to support
                                                                82




any research or to do any work on the vehicle; roads, driver,

human factors, anything but the vehicle.     Well, in.,1947, '8,

'9, Hugh DeHaven became very intrigued by the problems in­

volved in deceleration.     He had observed that people could

sustain tremendous, or rather fall from tremendous heights,

and survive under certain kinds of circumstances, and so, as

any good epidemiologi_st would, he began to look at the cir­

cumstances surrounding those exceptions.     People usually die

when they fall from fifteen-floor heights, you know, but he

found there were some that didn't, so, whenever one of those

happened in the New York area, he would go out there and study

all of the relevant factors, and, of course, he found what was

known by Hippocrates.     Hippocrates described the problem in

his day in connection with skull fracture.     Hippocrates noted

that if you hit a hard, unyielding object with your head, a

skull fracture is apt to occur and is apt to be fatal.     DeHaven

found that even a slight amount of energy absorption by virtue

of a person landing on a recently plowed area, or on a car

rooftop, would enable the human body to tolerate a fall from

great heights.   The more he looked into it, the more he was

convinced that something then could be done, not only about

aviation safety, which was one of his major interests, but

about automotive safety, that you had to design then in such

a way that would provide the added period of time for the body
                                                             83




to absorb the forces.   That's what happens when you provide

some means of cushioning, let's say.    You see, if an object

falls, if the human body falls a significant height and if a

person were to land on his feet, then the total force of that

impact is distributed over a very small area and the deceler­

ation distance, if it's relatively short, results then in a

transmission of forces throughout the body that can't be tol­

erated.   If that same person falling from the same height
were to fall lying completely flat on his back, you'd offer the

maximum surface for distribution of the forces and if, at the

same time, the object against which the body impacts is such

that it yields even a couple of inches, will then, decrease

the rate of onset, as we call it.    Well, now, this is impor­

tant and relevant to the automotive thing because this then

was the beginning of an automotive crash injury research pro­

ject that DeHaven got funded from the Public Health Service,

and then John Moore succeeded him.


Dr. Y.:

This was up in New York State?


Dr. G.:

In New York State.


Dr. Y.:
Where you had been.
                                                            84




Dr. G.:

Well, it's where I went later on.


Dr. Y.:

I see.

Dr. G.:

They were working out of New York City.   They were gathering

data on motor vehicle accidents, and so they had been in oper­

ation four or five years when I first started the accident

prevention program.   And I visited them and I found that they

were getting data from state highway patrols on speed of im­

pact, and make of the car, and nature of the accident, whether

it was head-on and what direction the impact was and the kinds

and nature of the injury, and they were beginning to relate the

injuries that caused death or were non-fatal to the design of

the car such as the hinter bar over the front windshield, and

put protuberances on the dashboard, and going thtough the

windshield, or going out of the open doors that tended to fly

open more in those days.   And so they began to build a mass

of data and they had a pretty good indication at that point

in time, a very good one, in fact, that seat belts could reduce

both the frequency and severity of injuries, all grades in­

cluding death.   Now the automotive manufacturers at this time

were also putting small amounts of money into this project.
                                                                    85




They were funding the research, but the results they were

ignoring.   So we had a situation where the scientific informa­

tion was available in 1956, '7, '8,   1 9,   in fact, fr:e.m that

point up until the Highway Safety Act of 1966.       The scienti­

fic data existed that would permit designers to design a motor

vehicle that would provide the maximum opportunity for sur­

vival in· the event of a crash, but corporate policy prevented

thoS=designers from using the knowledge that was available,

and vehicles, by and large, continued to be designed that didn't

really affect the death rate.    Now, I was exposed to their

attitudes, the corporate attitudes in the form of people from

the companies, high-level people, vice-presidents, etc., making

speeches, such as the one Chrysler vice-president who in a

meeting of scientists and legislators tried to tell us that

the problem was the trees along the road.       If we wanted to cut

down on the highway death rate, we ought to see to it that

all the trees were cut down alongside the highway.        Well, this

is the kind of utter nonsense that they engaged in throughout

these years trying to avoid the gasic issue.       The basic ·:issue

is that they had a responsibility for building a product that

could be used safely.   Or put it perhaps more properly, that

accidents are going to happen.    Human nature is the hardest

thing in the world to change, and you can study it from hell

to breakfast and learn all you will, but when you go to the
                                                               86




job of trying to implement and change human nature, you're

really up against something tough.     Therefore, the only

influence on highway death rate and injury rate, the thing

to do is to take those actions that you have available that

require no inter-action with the human being.      And that meant

better design of the vehicle, so the doors didn't fly open

as much, so the windshield wouldn't amputate a person's head

as it went through, so the dashboard didn't have protuberances

all over it, and all these features.    Now they resisted that

mightily, and they were alerted to the responsibility in

Congressional hearings held by Congressman Roberts, Kenneth

Roberts of Alabama, who, by the way, has told me that he lost

his Congressional seat in the election of 1964, I believe,

or '2, I don't remember which one, because the Ford Motor

Company poured a lot of funds in through dealerships in his

district and saw to it that he got beaten.


Dr. Y.:
So that he was persuaded that had happened?


Dr. G.:
Oh, yes.   Oh, yes.   He made no bones about it.


Dr. Y.:
Well, now, I take it that the people who made these speeches
                                                                  87




before Congressional committees, and so on, when your agency

was set up this new agency in the Public Health Service, would

be bound to come by and pay their respects to you.       Is that

true?


Dr. G.:
No.     They didn't.   They disregarded us.   We were so small.

It was so insignificant to them.      They felt we couldn't have

any influence.     And then we began to testify as we got further

information from studies we were supporting both through NIH

and our own program, that we were able to point out to the

Congressional committees changes that were needed.       Then, and

only then, did they begin to pay some attention to us.       And

even at best it wasn't too much.      The highway safety field

was a strange one to work in.      The motor car manufacturers

were most resistant to change on their own initiative even

though it was pointed out that if they didn't, then there would

be federal legislation.


Dr. Y.:
Was this a competitive thing that it was difficult to get the

team all together to do the same thing at once so that one

wouldn't gain a competitive advantage over the others?


Dr. G.:
Well, they claimed that, they claimed that.       But since then,
                                                              88




it 1 s been proven that this is!!.!.! the ease under the federal

highway safety standards that the Department of Transporta­

tion administers.     The Ford Motor Cempany, you know, claimed
they tried to introduc.e safety in one year and that they badly
got beaten in sales by Chevrolet that year.     But what they

failed to tell you, at the same time, to be fair they should,

was that they didn 1 t undertake a model change that year and

Chevrolet did.


Dr. Y.:
So other variables enter in.


Dr. G.:
Manyt)Gth.er variables.   Let me make perfectly clear.   I never

felt at that point in time that people were interested in buy­

ing safety.    But rather, they wanted an automobile or any
other consumer product for other kinds of values rather than it

being safe.    It was a sex symbol, or wnatever use ••• status sym•

bol, who knows.     Those were the kinds of things that appar•
ently motivated people to buy objects of this kind in our so•
eiety.    Now, I always felt that safety should not be a feature
that you tried to sell but you built it right into the product
unobtrusively.    In fact, if it didn't require anything on the

part ef the eonsumer, that was the optimum g0al that you could

arrive at.    You see, seat belts had been a problem because they
                                                                          89




require a conscious act, even though the evidence clearly

supports that seat belts will, if worn, help protect the in­

dividual in the event of a crash.               Now, there was another

kind of interesting thing with the motor car manufacturers.

In '56,      1   7 and   1   8, we tried to get them to introduce fasten­

ing points to their vehicles, so that a person could buy seat

belts and simply snap them on, you know.               "Oh," they said,

"those would cost fifty cents per installation point.n               Well,

that was a lie.               It cost pennies when they finally got around

to doing it, you see.               But they would go to all of these elabo­

rate kinds of self-deceptions and delusions, which for what

reasons I have never understood, other than to avoid having

to measure up to their responsibility.               It may well have been

that their lawyers advised them, and I'd like to find out

some day, that by doing these kinds of things they would, in

fact, be admitting culpability when accidents occurred and

therefore, avoided it at all costs kind of an approach.


I>r.   Y.:
But there might be some kind of a liability •••


Dr. G.:
That is product liability and law suits followed.               Well, since

then we've seen law suits, and they now, as the courts have

ruled, are held responsible for kinds of damages ••• I'm not
                                                             90




talking about monetary, but the principles have changed, and

they are held responsible in ways that they had never dreamed

of before.


Dr. Y.:

Well, what was your mission there?     Was it research?


Dr. G.:

No.   Ou~ mission was, through whatever methods were available,

to help reduce the number of injuries and deaths from accidents

of all causes.


Dr. Y.:

So propaganda was part of your mission.


Dr. G.:

Propaganda was part of our mission; research was part of our

mission; action programs.     I spent a great deal of time and

energy working on the highway safety aspects because that

was the largest single factor to be coped with and was killing

so many young people.     It was quite interesting to brush against

the motor car manufacturers, and to go to their meetings in

Detroit.     They were always very hospitable, lavish with their

entertainment, and yet resistant to any change, and theydwould

downright lie.     I remember going to the proving grounds one

day and watching with a Congressional committee some vehicle
                                                                   91




crash demonstrations that they had arranged and that one of them

was a longitudinal roll.      The vehicle goes down the roadway, leaves

at a slight angle, goes over a bank and rolls several times, like

a barrel roll, but in the same direction axises they were travel­

ing.     I asked one of the principal engineers and safety men from

General Motors who was there; I s~id, "Where is your evidence that

the hardtop sedans provide as much safety as the former centerpost

construction?"      Well, first of all, he tried to put me off by say­

ing, "Well, doctor, you don't believe in suspension bridges."             I

said, "Yes, I do.      They are a fact of life; I can see them.     That

wasn't what I asked you about."       He said, "Well, we use the suspen­

sion bridge principle."       I said, "That's fine.     I don't care what

principle you use.      Where is your evidence?"      He never would--in

spite of my making a formal request in writing--he would never show

me any hard engineering data to show that that top would provide

as much occupant protection.      Now just within the past ten days,

I've seen an article in a news magazine, in fact, I think it's the

9'Urrent issue o f ~ , where a woman has successfully sued a major

manufacturer because that hardtop didn't afford the protection that

she felt, as a buyer of a car, she required.          Well, in fact, it

was in t h e ~ magazine of May 23rd, which is today's date, on

page 66, in an article called "Torts" TORTS "Expensive Lessons"•

The    u. s.   District Court Judge in Pennsylvania held that accidents

are now so common that manufacturers are liable if their cars prove
                                                              92




unreasonably safe in a crash, and the suit that led to that de­

cision was brought by a woman who was riding in a Buick hardtop

that flipped over.     The same kind of accident I had witnessed, you

see.     Her roof collapsed and the woman contended that it was de­

fective and had added to her injuries.     General Motors replied

that accidents are not part of the normal and forseeable use of

the car.    Now if that isn't a bunch of hogwash, you see.   They

occur with such an amazing frequency that I don't know how you

could reasonably draw that conclusion, but they wanted it for

legal reasons, and that's why they did it.     The judge found the

defense too narrow.    While auto makers, he said, can not be re­

quired to build a crash-proof car, he said passengers must be

provided ,iith a reasonably safe container within which to make the

journey.    Now, that's an interesting conclusion he drew because

all of the evidence in the Cornell crash research projects,

Automotive Crash Research Project, said in fact that what was

needed was that cars should be built as containers which provided

the sort of the same kind of protection as an egg crate provides

for eggs.


Dr. Y.:

Right.


Dr. G.:
So that we don't rattle around inside this vehicle.
                                                             93




Dr. Y.:

And that was the principle that you had come to in your own mind

at the time you were part of this program?


Dr. G.:

Right.    And this was what we were trying to promote, and we sup­

ported research projects to try to improve design.    We supported

the Cornell project.    We engaged in meetings and symposia and

papers published.    We tried to get the National Safety Council

involved.    Now they astutely avoided getting involved in this

issue, even on seat belts.    They wouldn't support seat belts until,

oh, I think it was 1964, as I recall.    You see, it was quite a

few years later before they finally capit~lated on that issue,

because the National Safety Council has always been a handmaiden

of the automotive manufacturers.    They are a captive group and

this isn't just my opinion, but the opinion of everybody I have

talked to who has worked in the safety field:    Dr. William Haddon,

the former director of the National Highway Safety Administration;

Dr. Al Chapman, at one time in charge of accident prevention in the

Public Health Service, innumerable persons.


Dr. Y.:

So that in Dr. Goddard's education, you learned something about the

industries involved as a result of this experience that you were

to carry on with you.    How would you sum up what you learned?
                                                              94




Dr. G.:

That the industries, the large industries in this country, have

a very extensive network of relationships.     They have a very

large capability and influence in Congress.     They have the econom­

ic wherewithal to prevent rapid progress in the field.     Those were

the kinds of lessons I learned.     It was very frustrating to see

clearly from the scientific point of view what could be done, to

have those principles enunciated at meetings time after time

after time, and not see any action result.


Dr. Y.:

So that it would have to come in another decade after you were

on another responsibility?


Dr. G.:

Right.     It was very interesting to move from that field to the

Federal Aviation Agency.     It was a new agency that Congress had

created.    Again, they were responsive to disaster.


Dr. Y.:

Like Caesar, you were asked three times and the final time ••••


Dr. G.:

And the final time I said, "Yes, I'll go."    And I joined this new

agency which had been created by Congress because of the Grand

Canyon crash.    Now, there had been a lot of complaints about the
                                                              95




lack of coordination between the civilian and military and the

splinter agencies in the aviation field, but only with the

occasion of the Grand Canyon crash did Congress finally act and""'

create a Federal Aviation Agency, the administration under

President Eisenhower selected General Elwood R. Quesada, Pete

Quesada he was known as, to head this up, and it was my good for­

tune to wind up, as I've told you before, as his Civil Air Sur­

geon.   Well, to move from the field where you tried to persuade,

cajole, convince on scientific and rational bases, to a field

where there was a federal agency with a strong, statutory respon­

sibility and therefore, could act decisively, that was quite an

education.    Now, I had been involved in enforcement work at the

local level in health department work, but this was my first ex­

perience with an enforcement agency at the national level, and it

was quite intriguing to see how it worked.    We had all of the

responsibility that one could ••• and authority ••• that one could ask

for.    In fact, Congress demanded performance, and measuring up

to these responsibilities, and would have oversight periods

periodically.   Almost every airline crash was the occasion for

convening a hearing on the part of one senator or representative,

at least.    So what we did was carefully reviewed.   Now, we had the

authority that Congress gave us to suspend licenses, to ground

aircraft if necessary.    These were strong economic authorities,

you see, and I learned at that point in time that the use of
                                                              96




economic sanctions is perhaps one of the most powerful instru­

ments.     I don't mean an economic sanction of a fine of a hun­

dred dollars a day to an airline, or a two thousand dollar fine,

which would be a slap on the wrist to an airline for failing to

meet some required Federal Aviation Agency standard.     I'm talking

about the actual grounding of aircraft where they can't earn

revenue or where an airline pilot would lose his license because

of dispbediance of the civil air regulations, you see, for drink­

ing within the proscribed period.


Dr. Y.:

Now was pilot health the main thing you were responsible for?


Dr. G.:

Yes.     When I went there I was asked to set up this Bureau of

Aviation Medicine to get at the problems of medical licensure,

developing standards on aging, these kinds of problems.     But it

became quickly apparent there were other kinds of responsibilities

that we should meet that ha:dn't been met in the past, particularly,

for example, in civil air disasters, there was no policy that there

would be medical participation in the very intensive investigation

that followed each airline crash.    And so I instituted a policy of

providing a pathologist and medical team to assist in those inves­

tigations.    That was met with some skepticism on the part of the

agency.    And I can understand that, but there was a crash at Kure
                                                               97




Beach, N.   c.,   that soon changed the minds of the other persons

in the agency about the values of this kind of investigation.

There was a jet--this was shortly after the advent of the jets-­

due to leave New York for Miami.     They had some mechanical fail­

ure with the jet, and so they off-loaded the passengers, put half

of them in an Electra and the remainder in a DC 6 B, and sent them

on their way.     This means there was about a one-hour delay in

gett:ing out of what was then Idlewild, I believe.     I'm not sure

of the airport of origin, but, at any rate, they were one hour

late in getting out of New York.     The Electra went on and no

problems.   The DC6 B, however, just after it crossed the coast­

line of North Carolina at Kure Beach, something happened to it.

There was an explosion on board, but that wasn't known until later.

The side of the plane was blown off, and a hole made large enough

at least for one or perhaps two men to walk through in an upright

position.   The pilot was able to keep that plane under control,

even though he had crossed the ••• you know, he was flying out

towards ••• on that route you fly over water from that point down

to Miami.   So that's why the delay was significant, you see.       Be­

cause he had barely left the coastline, he was able to turn back

and make a descent to within about 1500 feet of the ground before

that aircraft broke up.     That old 6B was a tough bird.   Everybody

on board was killed.     All we knew was that the accident had occurred

and the approximate time and our team went out on that crash.         This
                                                              98




was, I believe, the first one, the first major crash we went out

on.


Dr. Y.:
After the teams were organized?


Dr. G.:
That's right.   And so, during the investigation, it was odd that

one body was washed up on Kure Beach, the rest of them were all

in the litter of the aircraft in the inland area.    Our patholo­

gist who was doing the autopsies for us connnented--he had been

in Korea during the war--he commented that this one body almost

had the kinds of wounds that saddle mines would cause in Korea.

Both legs were blown off in a funny way and this puzzled him.

You know, in an aircraft crash, the expert teams just descend on

that site, and they recover all the pieces they can, then take

them to some place nearby and then begin to reassemble, and

that means, in this case, they built a framework, put chicken

wire over it, and they'd hang the pieces of fuselage on it, and

try to fit it back together as much as possible.    Well, they

hadn't finished this.   The pathologist by then, who had fairly well

finished his work with the bodies, went and looked this thing over,

and he noted in the area where this hole had been created that

there was an air vent inside, part of the overhead rack, and it

had some blood spots on it, and he asked that that be removed so
                                                                 99




that he could see if he could match that blood with the blood from

the body that had been washed ashore to try to establish the

seating position, you see, for at least that one, because that

was an anomaly.     He got that back in the lab, and he noticed up

inside a grayish, powdery residue, and he called the FBI, or

called the senior investigator and they turn~d it over to the

FBI, because they then suspected dynamite.      Sure enough, it was

residue of dynamite.     Well, it turned out, of course, that a

young man had taken out a considerable amount of flight insurance,

loaded a satchel full of dynamite, put it under his seat, got on

board the jet, the jet was delayed, he was off-loaded and put on

the DC6-B, but the timer, he couldn't then adjust the timer,

or forgot or something, and instead of that plane going down!!!,

out at sea, it went down as I've described.     Well, after that,

of course, we had no problems.


Dr. Y.:

Then the medical teams went out always and still do, I take it.


Dr. G.:
And still do.     And they've been useful on other occasions since

then.     Now, I had some other interesting experiences there.        One

of the things that one of my staff said, and brought to my atten­

tion earlier on, was the desirability of installing a flight deck

voice recorder.     That made sense.   This would be a tape recorder
                                                            100




that would record on a continuous loop basis what had been said

and hold it only for the last thirty minutes' conversation.       So,

it would be constantly wiping out and only retaining that part

that might be significant should a crash occur.


Dr. Y.:

Now, this was on the plane?


Dr. G.:

This would be on the plane, you see, because •••


Dr. Y.:

Not necessarily broadcast•••


Dr. G.:
Oh, it wouldn't be broadcast at all, because the FAA routinely

records all of the broadcasts from the aircraft and holds those

thirty days, but this would be for on-board, in-the-cockpit con­

versations, because I was convinced just as my staff were that

when something goes wrong those pilots are talking to each other

and they are too busy sometimes to switch on the hand mike and

carry on their conversation so that it could be recorded even

though they know that those conversations are recorded in the

tower.    But at any rate, I proposed this as Chief of the Bureau

of Aviation Medicine to the General and the staff on a number of

occasions, and they wouldn't buy it.    Well, then General Quesada
                                                                         101




retired when President Kennedy was elected and President Eisen­

hower left office, and Najeeb Halaby came in.           I proposed it to

him and he wouldn't listen until one day in May of 1965, there

was a crash at O'Hare Field.        As I recall, it was May 30th,

Decoration Day, because I remember there was a regatta in the

Washington area and I got caught in the traffic and missed

catching the agency plane to go out on the accident because of that

regetta traffic, and I had to ride jump seat on a connnercial

plane to Chicago, but I got there.           It was an Electra that had

gone down shortly after take-off just on the edge of O'Hare Field

and all of us were up in the tower at O'Hare.           We had just finished

listening to the tapes of the conversations between the tower and

the pilot.    I turned to Halaby and I said, "You see, if we had a

flight deck voice recorder, we would have, I think, good know­

ledge of what had happened in that cockpit over and above the

conversations to the tower."        And I guess maybe I finally got

through to somebody just by being persistant, and he ordered

the Director/of the Bureau of Research to work on that project

and caused it to bring into being.           Don't you know it took about

two and a half years to develop that and get it into the aircraft?

No, I'm sorry.      I said it was   1   65; that was July of   1   62.   It took

four years to get that in.      It was in May of      1 62.




Dr. Y.:

Right.    May of   1 62.
                                                             102




Dr. G.:

Because this was before I went to the Communicable Disease

Center.   It didn't become widely used until '66, as I recall.


Dr. Y.:

This was not so much technological problems as it was admini­

strative red tape or ••• ?


Dr. G.:

Well, they claimed it was technological problems.   I couldn't
believe that we could send a man around the earth and have all

the hardware to do that and not be able to put a flight deck

voice recorder aboard an aircraft in a fashion that would protect

it against the forces of crash.   Now, they finally did, however.

The major point though is that sometimes you have to overaome

obstacles within the government•••


Dr. Y.:

Right.


Dr. G.:

That are just as tough as getting manufacturcers to adopt a dif­

ferent approach to a problem.


Dr. Y.:

Well, there were two different situations as you indicated here,
                                                                103




because in the FAA lobbying would be quite a different sort.          It

would be •••


Dr. G.:
Well, here is this resistance to change and the fact that it

wasn't invented here •••what we call the NIH factor, not invented

here ••• that somebody other than the Bureau of Research came up

with an idea.      It wasn't my original idea.   I want to make that

clear.     It was one of my staff; I don't even remember which one

now.     It was an idea that had been kicked around a long time.

Well, since then, that's proved to be of great value in deter­

mining the cause of aircraft crashes on several occasions:         ~ne,

an F27 in the Pacific Northwest, the other, a jet that crashed

into a motel in New Orleans.      In both of those accidents the

flight deck recorder has been instrumental in detecting the cause

of crash.      Then we had other sorts of benefits.   We were able to

find that myocardial infarction occasionally occurred in the

cockpit, in flight; you know, we changed the rules, requiring an

EKG of pilots, once at age 35, once a year at age 40 and there­

after.


Dr. Y.:
That hadn't been done before?


Dr. G.:
No.    That hadn't been done.
                                                                104




Dr. Y.:

There had been physical exams but not •••


Dr. G.:

Oh, yes.     Every six months an airline pilot had to have a

physical.    We made some changes in the standards; we, of

course, implemented the age 60 rule that pilots had to retire

at age 60.     That was a court case, it went all the way to the

Supreme Court who turned it down on a writ of certiorari.

Well, Judge Learned Hand, by the way, heard that case in the

New York District Court,    u. s.   District Court there, and ruled

in favor of the agency.     I've always been fortunate in my fed­

eral assignments.     I have been involved in a number of ••• have been
sued a number of times.     I was sued along with General Quesada on
the age 60 case and yet I have never had to appear in court.


Dr. Y.:

So you were a defendant?


Dr. G.:

Oh, on a number of occasions, at FDA as well as FAA and the

Communicable Disease Center.        I think I was sued for $6,000,000

as Chief of the Communicable Disease Center on one suit alone.


Dr. Y.:

Well, let's hold that one off.        I wanted to ask you to give a
                                  ------------------   ---------------------




                                                                         105




kind of personality sketch and analysis of Quesada.


Dr. G.:

Oh, yes.   Well, General Quesada had a great influence on my

perception of how a federal official meets his responsibilities

to the consumer.     The General was a no-nonsense administrator

to begin with.     He would listen to reason if you had facts.            He

didn't like yes-men around him, but he wanted people who had the

facts to back up their arguments.          He wanted answers to questions;

he didn.f t want a long discourse.       I think I could illustrate both

of these points perhaps by recounting a meeting in which we were

involved with the discussion of the Electra crash at LaGuardia

where one came over the end of the field- and busted its landing

~ear on a dike, a temporary dike, crash landed and there were no

fatalities, but the Electra by then had come under a considerable

number of••• had considerable problems and the General's neck was

out a mile and, by the way, that was one of the toughest and best

administrative decisions I have ever seen made in the government,

the one to allow the Electras to keep flying.               Najeeb Halaby would

have grounded the Electras.     You see, that would have been easy,

and everybody would have said, "Well, he had no choice."               But the

General made a different kind of decision.               Well, back to this

meeting ••• at stake, at one point in the meeting, the discussion was

what was the roll-out of an Electra?               H0 w far after touching down
                                                                106




did the plane roll out before it could be brought to a complete

stop and turned around and gotten off the runway.      He asked one of

the men from flight standards who reached down and got a thick

book, a manual, an Electra manual, out of his briefcase and looked

in the index and found the appropriate pages and started saying

something to the effect:      ''Well, General, of course, depending on

the wind and the temperature" and going into all of these factors.

The General said,   nr   asked you what the roll-out was?"    And the

fellow started over again, "Depending on the wind and ••• 11     And the

General said, "Would you take that black book and your little bag

and get the hell out of this meeting, and when you figure out

what the roll-out of an Electra is, come back and let me know. 1'

Well, the man, of course, wasn't used to being talked to this way,

and it shook him JP badly, but he did get out.      Now, the point is,

that the General, when he asked you a question, wanted an answer.

He knew that there was no single answer.      Hell, he wasn't dumb;

he'd been flying airplanes since Hector was a pup.      And he knew

all these operating conditions could vary, but what he wanted was

!. figure that gave him something that then he could crank in his
own factors and say: "Now, in a high wind, it probably would be

flying right into the teeth of it •••would be short, much shorter,

much shorter; no wind ••• "   What he wanted was a maximum roll-out,

you see.   Zero wind conditions and that kind of a thing.       So the

General was right sticky about those kinds of things.        Now, I've
                                                                 107




already recounted my first fight with him and I had a number of

others, but notwithstanding that, we were good friends.         We would

get together at the end of every day, his general counsel and

myself and we would talk over some of the battles that the agency

was then involved in.     And as a result of this closeness to the

General, during that hectic period of time when he put in all

sorts of restrictions on the airlines and requirements for

safety.    He used to make the point, "Look, we are the repre sen ta­

tives of the public.    No one else is interested in protecting

their interests.     That's what Congress said we should do."         In

effect he was saying, "We are their advocates."      You see.     I

can remember he used to say, "Now, when somebody buys a ticket,

they're counting on us to make sure that that pilot is fit to be

on that flight deck; fit in the sense of physically fit; fit in

the sense of knowing the technical procedures and understanding

and demonstrating how to fly that aircraft.     That was our job", he

said.     "There is nobody else that will do that.   That's our re­

sponsibility."


Dr. Y.:

So that no matter how much flak you might get and how many voices

elsewhere might be raised, you had to keep thinking of that.


Dr. G.:

Right.    That was the point.   He was roundly criticized.      The Air
                                                               108




Line Pilots Association was after him all the time for harassing

the airlines pilots, making it unsafe for them because he was a

threat to them.     All he said was, "You guys are responsible for

flying those planes.     You damn well ought to stay up on the

flight deck.    Your job isn't public relations back in the rear

end with the passengers, talking to them.      That's not your job.

You're to fly the airplane.     And these are new aircraft.    They

are faster.    They are far different fr~ what we have been flying

all of those years, and it's tricky.     You stay up there, fellows."

That was the flight deck rule.     Then he put in a requirement that

made the manufacturers install radar and DME, distance measuring

equipment, steps which they wouldn't have taken on their own

initiative.    Now, I n0t,iced, and I don't have that clipping here.

It's at the office, rim sorry to say.    Recently, the Civil Aero­

nautics Board, in a hearing it was revealed that Pan Am and the

other airlines had refused to install a piece of equipment that

cost less than a hundred dollars, for safety.     A piece of

safety equipment.    You see, it was held responsible for an air­

craft crash.   Well, you see, here again, it's an illustration

of the failure of the private sector of our economy to move for

public protection, and for some reason they are short-sighted on

these things and then there has to he a regulatory agency, and I

think that's unfortunate, but I've now grown to accept that as

a necessity.    Well, the General was tough.   He didn't run in a
                                                              109




popularity contest.    He wasn't there to win friends.    He was

fair though.   He had an innate sense of fairness about him.

He was just tougher than hell and demanding as hell.      But I

always thought fair and above all, he was the protector of the

public.   The public's advocate, in this setting.


Dr. Y.:

He wasn't mushy about it.


Dr. G.:

Oh, he was decisive.   He had a great ability to sort the wheat

from the chaff.   Other administrators I've watched would bumble

around with things and assign the job to a committee, but the

General wanted all the facts that he could get his hands on.        He

would listen to those and he would mull it over, and then he would

make a :d~cision and he didn't have trouble making decisions.       I

can remember we went to a crash in Boston one time.      He and I

flew up one morning.   The crash had occurred about 5:45 the even­

ing before and we went up in a DC3.    That's what the agency had to

put up with in those days.   They now have jets.    But we had a DC3

and we flew up to Boston and we got there and we were met by some

of the other personnel from the agency, and they had a car and we

were about to drive off to see the site of the accident and talk

to some other people when a man came running up to the car and

Pete put his hand up to his brow and said, "Oh, God, do I have
                                                               110




to talk to Crocker?"   And this man was Crocker Snow who was the

assistant manager of the airport there in Massachusetts, t)e

port authority at Boston and Crocker came to the car and stuck

his head in and said, "General, there's something I think you

ought to know."   And the General said, "What is it, Crocker?        I'm

busy."   Crocker said, "I know you're busy, General, but", he said,

''out here on this active runway that was active last night when

the flight took off and crashed, there are hundreds of dead birds.n

Well, the General's ears went up almost like antenna, you know.

He was the kind of guy you could look at and he would react and

you could see a sudden flash of interest.    He said, "Show me."

And so we went out to that active runway that had been the active

runway at sundown when the Electra went off the evening before,

and sure enough, there were hundreds of dead starlings.     The

General picked some up and looked at them and turned to me and

said, "Doc, did all of these birds die at the same time?"      I

said, "General, I don't know, but I'll get somebody from Harvard,

an entomologist, and we' 11 find out."   He threw them down on the

ground and said, "They all died at the same time, I know. 11       And he

walked around the runway and looked at the distribution pattern

of the birds, asked a few questions about the time of day, es­

tablished the facts again of the accident in his mind, asked me

specifically to find out what time they died, if I could, and then

we went inside.   The reporters were all there, you see.    They
                                                                 111




hadn't been able to get to him and they got to him then.         They

had TV cameras and movie cameras, the whole business, and they

started a press conference.     The General said:   0   It appears

to me that the aircraft was not at fault, that a large number

of starlings flew up in front of the aircraft and may have

gotten in the engine and caused the power failure."        We were

in the process then of trying to recover the aircraft from

the bottom of the harbor at the same time.     Well, the Chair­

man of the Civil Aeronautics Board was there, Allen Boyd, and

he was just furious that Pete would make such a statement.


Dr. Y.:

Shoot from the hip that fast?


Dr. G.:

That's right, because it was the Civil Aeronautics Board's

prerogative to say what the probable cause of an accident was.

Now, Pete, on the other hand, said:     "My responsibility is to

the public in terms of making a decision whether this aircraft

is unsafe or not and whether it would be permitted to continue

flying and I, therefore, have to make such judgments.        They are

not final judgments; they are operating judgments for this point

in time. u   And I mention that because this is how decisive he

could be, and he was subsequently proven to be right.        No ques­

tion about it, the starlings did get into the air intakes, block
                                                              112




the air intakes, cause arcing across the busses which then

made the aircraft uncontrollable because it was an electric

boost assist on the controls of the Electra, and it caused the

plane to crash.     But this was the kind of decisiveness that we

had from this man.     He would go to the scene himself, which

is another interesting thing, you see.     He wanted to see for

himself what had happened.     He wasn't the greatest scientist I

ever worked for by any means, but he had flown enough airplanes

of different kinds and had seen enough accidents and had enough

knowledge of the aviation field that a lot of that was cranked

into his computer and he was just so close to right so many times,

it hurt.    A great guy though.   But what I would stress about this

man above all was his character, his decisiveness, his feel for

his responsibility.     It's interesting••• from the Republican

administration.


Dr. Y.:
Right.     How did he differ as an administrator from his successor?


Dr. G.:
Well, his successor would vacillate.     His successor couldn't make

decisions and would refer things to committees, and yet Najeeb

Halaby had been a test pilot.     He was a lawyer; he was far more

educated than Pete Quesada was in the sense of academic training,

but, yet, he wasn't as good an administrator.     He didn't have the
                                                             113




leadership qualities that Quesada had.


Dr. Y.:

The ability to quickly make at least a temporary decision is

one of your key points in leadership, isn't it?


Dr. G.:

That's an important thing.   You have to •••now the decision may be

no decision for this point in time.   That's a valid decision to

make, too.   But, see, what people grow uncomfortable with is

a situation where decisions don't get made at all.    You see, it's

a nice balance between moving too soon and waiting forever that

you have to strike.   I've always been accused of being like Pete

and I don't mind that.   That's quite a compliment.   In shooting

from the hip, you see.   What do they mean "shooting from the hip?"

That means you haven't waited until you got all the facts.       Lots

of time, you have facts cranked in from previous experience, from

exposure over a long period of time to the field or other kinds

of knowledge.   It's difficult to substantiate by showing pieces

of paper, so, therefore, you don't have facts and you're shooting

from the hip.   Instinct is still an important part of administra•

tion, but sure, in this day of technology, you have to have lots

and lots of data and you have to rely on your people to give you

good data and when they don't, you get in trouble.    I got in

trouble at FDA on a drug survey because I relied on the data
                                                                      114




from a study that I asked to be carried out.           My people carried
it out and they really didn't think I was serious about it, and

they gave me bad facts and I got hung up by those.


Dr. Y.:

Now which particular case was that?


Dr. G.:

Oh, this was early in office, I asked that each district labora­

tory go out into the market and buy x number of drugs and bring

them into the laboratory and see how they measured up to stand­

ards.     And the results were just horrendous and we asked ques­

tions.     Mr. Rankin and I both asked questions of the district

directors, "Are you sure about these results?"            "Oh, yes.   Oh,

yes", they said.      But in the long run, the percentage wasn't

as high as I had stated, based on data they gave me.


Dr. Y.:

So, the manufacturers did their tests and found different, as I

remember.


Dr. G.:

That 11 s correct.   Then they said,   11   You see, you're shooting from

the hip.     You were wrong."   So, your agency people, your staff,

whether you are in the government or not, they have to be with

you.     And you have to rely on them and they have to understand

that.
                                                                   115




Dr. Y.:

And they have to be competent to do what you want them to.


Dr. G.:
Oh, indeed, they have to be competent.     Well, the General had

a great impact, I thought, on aviation.     We, all of us who

fly, owe him a great deal, because literally the most important

progress in the past decade was made under his leadership.       You

see, the important technological advances., in terms of what is

required in civil aviation, the main thrust was under General

Quesada, not under Najeeb Halaby.     Najeeb Halaby's handling

unfortunately of the supersonic transport was so inefficient

and wishy-washy that President Kennedy took that away from him

and gave it to Vice-President Johnson to handle.     We had a 144-

man committee for supersonic transport at FAA under Najeeb

Halaby.   Now, he came in and he was going to have a "lean,

clean, keen" administration.     That's the way he described it.

He was marvelous with words, very suave, smooth guy, and he,

of course, was inferring that under Quesada, we didn't have a

"lean, clean, keen" operation.    Within six months, the size of

that front office had more than doubled under Halaby.     Committees

proliferated; decisions didn't get made.     Inst£ad of delegating

more to the field, which is what he said he was going to do, no

decision got made until it got to his desk.     It was amazing to

watch and I learned a lot about administration from watching
                                                              116




that, too, and I decided if you ever have a job at the top of

an agency, one thing you have to be willing to do is to delegate

and mean it, because your people know whether you mean it or not-t,

doggone fast.   Those regional administrators who thought they

had had delegations of authority under Halaby found out that

they hadn't, and so this was a valuable lesson in administra­

tion, too, although I stayed there but 18 months.


Dr. Y.:

I read in one of the trade periodicals a statement that you

scared the agency, that you were so active that the agency

got afraid that the Public Health Service was going to take

over its whole medical set-up.


Dr. G.:
Yes, I think that was true when I first went there.   But let

me finish up on Quesada.


Dr. Y.:
Right.


Dr. G.:

He was attacked constantly, undeservedly so, by pressure groups,

I learned some other things about pressure groups through him and

through that experience.   One of the pressure groups was the Air­

craft Owners and Pilots Association, a self-serving group if I've
                                                             117




ever seen one, that is operated by a couple of characters out
in Bethesda who really do so for their own profit, and they
keep issues stirred up to keep readership in their magazine up
and to convince the membership that they•••Max Karant is the
editor of the Aircraft Owners and Pilots Association.


Dr. Y.:
How is that spelled7


Dr. G.:
KAR ANT, and I've forgotten the president of AOPA, I've
forgotten his name.    But those two people kept the pot stirred
all the time, and they were constantly attacking the agency in
articles, stirring up trouble with Congress, and there were a
couple of Congressmen who would listen to the AOPA.     One of
them was a senator from California who since has died, who used
to give us a lot of difficulty.   He was an AOPA man.   Another
was a senator from Indiana, and he didn't like the General because
the General came from the military.   Now, just before the Gen­
eral left, he went up on the Hill and almost, I would say, it
was his valedictory; is that correct speech?     He talked about
the vested interest groups, and he said:   "After this period of
a year and a half, I have observed a pattern."    He said, "First,
they attack the rule."
                                                             118




The rule?

Br. G.:
Yes.    Then they attack the way the rule is administered.   If
that fails, they attack the agency as being bureaucratic or
spending the taxpayer's money frivilously.     If that fails, they
attack the man.    He said, "I have now seen this happen." And
sure enough that has, and I've watched that since then in my       own

experience, and that is a pattern that these kinds of organiza­
tions use, you see.    AOPA, for example, got nowhere in attack-
ing certain laws and rules which had the force and effect of
laws, and then they would start complaining about the agency's
uneven administration of these.     They weren't fair in the way
that they administered them differently in one region versus
another.    Then that didn't get them anyplace, so then they next
attacked the agency itself in terms of having one employee for
every two aircraft in the United States.     True enough, they do,
but what's that got to do with anything, you see?     What they
neglected to say then was:     "What are all of those employees there
for?"     16,000 of them to maintain navigational aids for the air­
lines, you see.     17,000 in air traffic control work.


Dr. Y.:
They made it sound as if•••
                                                             119




Dr. G.:

They made it sound as ff there was one inspector harassing a

private pilot fer every two aircraft in the United States,

you see, and that was the common tactic that they employed.

Then they attacked the General personally, on a personal

oasis, you see, in their editorials and in their dealings
with Congress.    Now, r've seen that same kind of thing later

on in the drug industry when I went to FDA.


Dr. Y.:

Right.


Dr. G.:
Is that a good place to change tapes?


Dr. Y.:

Yes.     I think we are about at the end of this one.   Let me flip

it ever.


Dr. G.:
Okay.


Dr. G.:
Well, I left FAA September 1, 1,62, to take over the Communicable

Disease Center.

Dr. Y.:

Well, now in the leaving, tais was positive from your point of
                                                              128




view?     What about this reference in the trade press that there

was some pressure behind it because the agency worried about the

Public Health Service taking over?


Dr. G.:

No.     I'm talking about leaving FAA.


Dr. Y.:

Well, that's what I'm talking about, too.


Dr. G.:

Oh.     Well.   At one time there was some fear on the part of the

agency employees in the Bureau of Medicine that Public Health

Service people were going to take over.      This just wasn't so and

I was able to reassure them.      I brought some officers in from

other services on assignment, including the Public Health Ser­

vice, but that agency had been sort of ingrown, too, and I felt

it was desirable to expand their horizons a little by different

kinds of training and by different kinds of people on the staff,
and so I sought to accomplish that.      My leaving was an interesting

thimg in itself.      I hadn't been getting along well with Najeeb
Halaby, and I knew that I had to get out of there because we

were starting to fight in staff meetings rather openly.


Br. Y.:
What were the problems and issues?
                                                            121




Dr. G.:
Well, ·oue 0f the problems was that Najeeb started interfering
and making medical decisions that be wasn't competent to make
on pilot licensing, overruling the Civil Air Surgeon, in effect.

And if you can't work for a man and believe in what be does, you

better get out.    I can remember a sort ef amusing episode in
staff meeting.    Najeeb bad just come back from Texas where he
had gotten into a fracas with a congressman from San Antonio

of Mexican descent, a Mexican-American, Gonzalez, and Najeeb had

made some remark that gave offense to the local people and so

Gonzalez was mad at him.    Now, at that particular staff meet­
ing, Najeeb asked the staff, about twenty men in the room at the
time, "How many of you are going to the dedication of the new
air route traffic control center at Fort Collins, Colorado, next
week?"    And about fifteen people held their hands up, and be
was harrified.    He said, "My heavens, that's an awful number of
people toge out to the a ••• uh•••ub••• ," and he was searching
for a word to describe Fort Collins, and I used the phrase that
he had used in Texas.    I said, "A hick town?" God, if looks
could have killed you know, Najeeb would have bad me dead on
the spot.


Dr. Y.:

That was your impish puckishness.
                                                            122




Dr. G.:

That's right.    I just couldn't resist putting it to him, because,
hy then, he and I were at each other's threats, and he had used
this pprase and described this Texas town, and Gonzalez took
offense, ans it was in the paper and I knew about it, and so I
just gave it back to him, and twisted the knife as I slid it in.
Well, I knew I had to get out of there.    I went over to the Public
Health Service to see Dr. Kurlander who was ~sistant Surgeon
General, worked in the immediate office of the Surgeon General,
a sort of a right hand man to Dr. Luther Terry at that time.      I
had known Arnie for a number of years, going back to wen he was
sick one time.   He was more senior than I.   I was a four-striper,

you know, medical director is our title but it was four stripes.
I remember taking care of him once when I was a very junior
officer, in fact, I was interning and he was a two-striper, and so
I had knowa Arnie for a number of years, and I went to see Arnie
and told him I had to come back to the Service.   There was some
pressure being put on by the agency, interestingly enough, to get
me a star as Civil Air Surgeon, because the job warranted a star.
It was a bureau chief's job, and the military equivalent for
bureau chief in an independent agency is two stars.   Well, the
Public Health Service didn't want to put any more stars out on
officers on loan, so they indicated I should come over and talk
to them.   And I knew I had to get out of FAA, so I went out to
                                                                   123




see Arnie and he said, "Jim, why do you think that you should
get a star?"     I said, "Do you mean over there or back here?"          He
said, "Either one.''    I teld Arnie, I said, "Well, I 1ve noticed
some of the people you've put stars en lately, and I just happen
to think I'm about as good as any of those are."        Terrible
thing to say, but we'd known each other a long time.       He said,
"Well, you're pretty damn cocky, aren't you?"      I said, "No,
Arnie, I just think I know what I can do and what these other

guys are capable of, and I think I'm just as good."        He said,
"Well now, Jim, you 're only tb.irty•eigat years 0ldB-I was going
on thirty-nine at the time--and he said, "You've got a long time
to wait."     I said, "Well, Arnie, you bow.    I think I merit it,

I'• ready for a larger job, so here I am.      Now you decide whether
you want to give it to me over there or give it to me back here.
I'd just as soon come back here."     So lte laughed and he said,
"All right.     We've g<>t three star grade jobs open right now.
he of these is the Director of the Hill-Burton activities."
That's the program that for many years provided funds to communi•
ties on a one-third, one-third, one-third basis for hospital
construction.    And then be said, "That's a one-star job, but I
sort of think that's a dead end.     But there it is.     It's avail­
able.   The other is Indian Health Service, and yeu know what that
program is."     I said, "Yup." He said, "The third is the Cemmunic"
able Disease Center."     He said, ttNow, I'll tell you what.      You go
                                                                       124




home tonight and think about those three and come back tomorrow
and tell me which, in the order of your preference, and why you
want it."     I said, "Fine."     I went back to see Arnie the next
day and said, "Okay, I've thought about it and number one:              I
think I'm best qualified for the Indian Health Service, and I
want that job." He said, "Well, why are you qualified for that?"
I said, "Well, I've trained in local health work, I have a master's
in public health administration, I've been out on the Indian
reservations, I've seen some of the problems, I'm sympathetic with
the need, and I think I'm better trained for that particular job

than the other two." •kay", he said.          "What's number two? 11        I
said, "Well, the hospitals, even though it's a dead end job.                    You
know, I've worked in hospitals like all of us have.          I could be­
lieve in that program.        I think I'm reasonably well-fitted, not
the best in the world, but I studied hospital administration
while I was up at Harvard.        I have a little ••• a few ideas about
the field."    11   0kay," he said, "that means the Cemmunicable Dis­
ease Center is number three."        I said, "Yeah.   I den•t kaow any­
thing about communicable disease other than what you get taught
in medical school.       And, you knew, it's not my bag, Arnie."            He
said, "Cong,ratulations.       You •re the new chief of the Communicable

Disease Center."        I said, "You bastard. n




He aad bl.own it•••
                                                                  125




Dr. G.:
He had known it the day before, you see.     He and the Surgeon
General had deciaed where they were going to put me.      I said,
uwell, if you don't mind telling me, new why is that7i•     What's
all this nonsense about?"     "Well tt, he said, "Jim, we think
you still got a little growing to do, and we think that's a good
place for you to do your growing.     So you go down there to
Atlanta September 1. ''   So, sure enough, I did.


Dr. Y.:
Well, now, you mentioned last time about Dr. Burney.


Dr. G.:
That was vis a vis my appointment to FAA.


Dr. Y.:
Right.     I kind of wanted to get your view of him as Surgeon
General and also Dr. Terry as Surgeon General if you knew them

well enough.

Dr. G.:
Yeah.     Well, I think that we all knew them well enough, whether
we   knew them personally.   I knew them both fairly well, I think.
I wasn't a day-by-day intimate of either one, but I saw enough
of them in meetings, read enough of their pronouncements, talked
to enough people who knew them.     I felt I had a pretty good
                                                                126




understanding of them.     Let me start out by saying that we

really had ••• I worked under Len Scheele, too, you know, when

I first came in and prior to that, of course, was Tom Parran.
Now, Tom Parran was the last really good Surgeon. General that

we bad.


Dr. Y.:

Is that your judgment?


Dr. G.:

Oh, yes.

Dr. Y.:
Well, now, explain this.


Dr. G.:
Parran was a forceful guy; after all, don't forget, he tackled

the taboo on using the word "syphillis" on radio; he knew

Roosevelt well enough that he could be reasonably tough and be

was; he was a leader.    Now, Len Scheele was   my   idea of nething

as a leader.   He was a cold fish.   No personal relationships

with people that amounted to anything.    He was afraid of issues.

The birth coutrol thing came up one time.       Joe Dean under Len

Scheele put up a proposal with the Surgeon General's office

that birth control was a public health problem and we ought to

get competent in the field.     Now, don't forget, this was back in
                                                                 127




1 52.   Yeah.   Jee Dean got busted from a two-star to a four­
striper.


Dr. Y•:
Just for bringing up that subject?


Dr. G.:

You bet he did.    Yes, sir.   Now, Scheele didn't want anybody
rocking the boat, you see.     Now, Burney was an old line •••Scheele

got in by his acquaintantship with Harry Truman, you knew.        Burney
bad been out in Indiana oa loan as the state health officer, and
I think Mary Lasker was responsible for Burney's appointment.

Now Lee was an old-line V. D. man, old-line Public Health Service
officer who came in, as I recall, in the early thirties.     A good

group of people came in then, the thirties.     He was easier to re­

late to tban Len, but I don't think provided the level of leader­
ship that we should have bad, nor did Luther Terry who got in be­
cause he was a close friend of Senator Lister Hill.     In fact,
Luther was named for Lister's daddy, Luther Hill.


Dr. Y.:
I didn't know that.


Dr. G.:

Jes.
                                                             128



Dr.¥:
And Hill had this chairmanship of the most important•••


Dr. G.:
Oh, yes.   And so he bad a great deal to say, and Ma~ Lasker
ana the whole crew did.   Now, it was unfortunate, from my point
of view, that during this period of time there was one guy that
I think should have been Surgeon General, and that was Jim
Shannon.


Dr. Y.:
Who ran NIH?


Dr. G.:
Well, one of the major bureaus of the Public Health Service was
and is today the National Institutes of Health, and Jim was the
most imaginative, creative administrator in the Public Health
Service and the mest capable, bar none.   You know, as much as
I've fought with him, in staff meetings, on different occasions,
over issues, I never lost my admiration for that man's capability.
I think we would have had a far stronger Public Health Service
nad we had, instead of Len Scheele, Jim Shannen, or certainly
instead of Lee Burney or Luther Terry, because NIH under Jim, they
were able to fight tne Surgeon General's office successfully.
The Surgeons General, frankly, were afraid of Jim Shannon.
                                                                  128




Dr. Y.:

So that they grew virtually independent•••


Dr. G.:

That's right.   And many people thought NIH was not even part of
the Public Health Service, but was a separate health agency.


Dr. Y.:

The tail wagging t~e dog?


Dr. G.:
Oh, yes.   Now, it was unfortunate, therefore, in. my mind, that
Jim Shannon wasn't the Surgeon General.      I think he could have
been, but by the time he really was powerful in NIH, there
wasn I t much gain in him becoming, in   .!!.! opinion, Surgeon
General.   So, we have suf:fered for lack of strong leadership,
in my opinion, over the years.   Bill Stewart, my God, I think
he was chosen because he wouldn't put up a fight.


Dr. Y.:
At the time he was chosen, wasn't your name in the pot?

Dr. G.:
I've been told that I ran a very close second.       New John Gardner
was just new to the Department as Secretary.      He dicb1' t know any
of the cast of characters, and the politics were thick and fast•••
                                                            129



lots of pressure being generated by myself and supporters of
Carruth Wagner, et cetera, et cetera.


Dr. Y.:
What kind of backing did you have and what kind of backing did
Stewart have?


Dr. G.:
Well, I can't speak for what kind of backing Stewart bad, oth~r
than he had Wilbur Cohen in his comer, the tinder Secretary.
Now, there is a funny thing.    Don't forget that in early••• in that
year of '65, Luther Terry, we bad a new••• let•s see, Johnson came

in, elected in the fall of '64 and came into office on his own
electioa in January of '65.    Right?


Dr. Y.:
Right.


Dr. G.:
So, at that point in time, there was some talk that Luther Terry
might be leaving.   I went to see Luther in January of '65 and
said, "Luther, I don't expect yeu to answer me, but if you would,
it would be helpful, and I'm here to tell you what my plans are.
I've heard tbat you might be leaving.    Now, if you are and if you
can tell me in confidence, fine.    But whether you do or not, I
want you to know I'm trying to try to get your job as Surgeon
                                                                13()




General." And he laughed and he said, "Well, Jim, I appreciate
your coming in to tell me."      I was friendly witb these people.
I don't want the impression given that I was ungratefult~to
Luther, because he had appointed me as star grade officer,
and chief of CDC and so on.      But he wouldn't tell me, in fact,

and so I did start to generate some support at that time with

various groups.


Dr. Y•:

If and as he really re.tired?


Dr. G.:
Yes.     Yes.   And so right after seeing him, I'd given some thought,
and I knew that Bill Stewart was then working in the office of the
Secretary as a special. assistant, so I went around the corner and
saw Bill after seeing Luther, and I said, "Bill, I just talked to
Luther.     I'm going to try to make a run for it, and if I get it
would you be my deputy?''     He said, "Wh.y, sure.   I'd be happy to,
Jim."     A.ad we left it at that.

Dr. Y.:
He didn't say he was making a run for it?


Dr. G.:
No.     This was back in January.    Now, as it tumed out, Luther was
reappointed and did stay on until September, October.        The job
                                                             131



was tten vacant and, at that point in time, we really started
campaigning actively, and we really started trying to generate
as much political support as we could.     Now, by "political sup•
port,• I mean two kinds:     one, organizational support, AMA,
American College of Surgeons, et cetera, et cetera; the other,
support up on the Hill.     Well, I went to see John Fogarty and
I, for a number of years, had what I theugbt was a plan for an
effective reorganization of the Public Health Service.     This
dated back to, oh, 1962 reorganization when I first proposed
this plan.    And so I had this in hand and I knew John would ask
me that, and I went to see him about my candidacy as Surgeon
General.     Well, I told him what I would like to see done with
the Public Health Service, namely, doing away with all the
bureaus except the institutes and they have twelve or thirteen
institutes of health, with each one of the institute directers
reporting directly to the Surgeon General.    Now, that•s when
Fogarty, who for years had worked with Shannon, you see, be•
came concemed.     He said, nWb.at would you do with Dr. Shannon?"
I said, "I wouli make him Deputy Surgeon General for planning,
net for operations, but for planning, because," I said, "Jim is
a master at looking for and seeing wbat the needs will he in a
given area and developing new activities, and that's an area that

is extremely important." Well, Fegarty wouldn't buy that, it
was too much loss of prestige for Shannon with whom be had worked
                                                                132




so closely over the years.       So he told me he wouldn I t support my
candidacy at all, but be didn't say be would fight me, wb.ich was
equally important.     Well, Luther Hill wouldn't commit himself
one way or another, and I was asked if I wanted Mary Lasker's
support.     Friends of mine who knew what I was up to offered to
act as intermediaries, and I said, ''No, I wasn 1 t about to be
another one of Mary's little lambs."       Well, apparently, that
word got back to ber, too, you see, so it wasn't very wise on
my part.     I think she, as a result, actively 0pposed by selec­
tion.     Well, to wind up what could be a long story•••


Dr. Y.:
What about the organizational side?       Did you work at that, too?


Dr. G.:
Oh, yes.     I worked at that.    It was difficult to get commitments,
or at least it was on the ground rules under which I would operate,
because I wouldn't promise anybody anytbing.        If they wanted to
support me, I would welc0me that support.       So, John Gardner didn't
know the cast of characters.       He was getting all sorts of outside
pressure and that's just the wrong thing to do with a guy like
John Gardner, and he turned to Wilbur and told him, he said,
"Wilbur, who do you think we ought to make Surgeon General?"
Wilbur said,· ''I think Bill Stewart.     He's worked up here and he
knows the problems and I can work with him."       What he was really
                                                                 133




saying was that he could control Bill.      He knew Bill was ve'l!'y

passive and wouldn't fight, and all that subsequently bas been

proven to be true in my book, in my appraisal of what's happened

to the Public Health Service, and Wilbur didn't want anybody up

there that would fight him, because Wilbur doesn't like doctors.


Dr. Y.:

I see.     Well, I wondered.   There are some things about relation­

ships involving you and him later on that I think we need to go

into.


Dr. G.:
Well, this was how Bill Stewart came to be appointed, in my

opinion.    Well, that led then to ••• it was a funny thing.    I was

at CDC and I used to go and work out every day at Emory at noon

at the gym, and I was over there tying    my   tennis shoes, when

somebody came in, one of my staff who also worked out and said,

"Hey, they just announced the new Surgeen General on the radie."

I didn I t dare look up and I said, "Who?". He said, "Bill Stewart. 11

I thought, "0b., for Christ sake."    Well, I was disappointed as
hell, which you might expect.


Dr. Y.:
Sure.


Dr. G.:

But•••
                                                                  134



Dr. Y.:
But, you learned to take these things •••

Dr. G.:
Oh, yes.     If you can't stand the gaff, you can't play in the ball
game.     So, when they had aa exercise, that was, if I remember

correctly, that was late in October, about mid-October probably.
And so, I can remember clearly, Dave Sencer and I sitting areund
early in December, and Dave said, "Hey, I saw in the paper today
that George Larrick retired." And I laughed and said, "With my
luck, Dave, I'll get that job."     Just joking, and a few days
later, the Surgeon General called and said, "Jim, the Secretary
would like to see you."     ttWell, fine, when?   D0es he want me t0
ceme up tomerrow?"     Bill said, "Oh, no, just the next time you' re
in town, he'd just 1 ike te see you.    Nothing urgen~" I said,
"What about, BilU"      He said, "Well, the Secretary didn't tell
me."    Okay.   So, a week later I had to be in Washington, and I
called the Secretary• s office when I was there and I said, "Sec­
retary Gardner indicated be would like to see     me."   "Ob, yes,

Dr. Goddard.     Could you come in tomorrow at such and such a time?"
I said, "Yes, I'll be in town tomorrow and I'll come in." Well,
I went in and met this Secretary Gardner.


Dr. Y.:
This was the first time you had met him?
                                                                 135




Dr. G.:
The first time I had met him.     A tall man, sort of a rugged face,
a tanned individual, soft-spoken person and we talked around for
a bit.    He seemed right cold tosBme and he asked me some questions.
He said what he was trying to do was to become acquainted with
the major programs in the health area.       He didn't have a feel for
these and would I, therefore, tell him some of our major problems
and high priority items, which I did.        "Well," he said, as I
en.numerated the last one, "that last one's interesting.       I think
I need to know a little more about that.       Would you send me a
staff paper on that, outline?"     "Fine."     I left his office and
en the way out, I remember saying to myself, "Well, he tested
my verbal communicative skills.     Now he wants to test my written
communicative skills."    So I went back to CDC and prepared what
I had hoped would wind up as a one-page memorandum outlining the
laboratory inspection problem, laboratory standards problem, and
a seven or eight page attachment.     Try as bard as I could, I
couldn't get that memorandum down to but one and a third pages
and seven or eight pages of an attachment, and I sent it up to
him.   Well, I knew he was sizing me up for something.       The FDA
job was still open.    This was just arouad ••• gettiag close to
Christmas and he called me and asked me when I would be in Wash­
ington next?    I said, "Well, bttween Christmas and New Year."
Right after New Year's, I have forgotten now which it was, but he
                                                                136




said, "I want to see you."    He said, "I'd like to talk to you

about th4t vacant job at FDA.    You know, we've been looking for

somebody, and your name keeps coming up to the top of the list."

He said, "I would like to talk to you."        He said, "I'm just

alerting you to it now so that you can be thinking about it.

Don't tell me yes or no right now."        So, I went up to see him

the first part of January or tee last of December, the last of

December, as I recall, 28th or    1 9th,   and he told me that the

Miles Committee had recommended some changes be made at FDA.

There were certain problems and they had recommended a person

with certain kines of capabilities and I seemed to fill the bill.

Would I take the job?     I asked bim what bis expectations were if

I took the job and what kind of support would I have.        He reassured

me on support and said he expected that the person who would take

it, and if it were me that I would upgrade the competency of the

agency, bring new kinds of talents in and get them accomplishing
their mission, because he was quite concerned that they weren't

really doing their job.    So, I told him I would take the job.


Dr. Y.:
You teld him right then and there?


Dr. G.:
I said:   "I want to think about it, bat will let you knew in a
day or two.   I knew you are anxious to move, but I think I will
                                                                  137




say 'Yes.'"   He said, "I hope you will." And      SQ   I left.   I
called him back then the next day, as I recall, from Atlanta,
and told him I would.


Dr. Y.:
Did you talk to Boisfeuillet Jones at all during this peried?
He was on this committee.


Dr. G.:
No, not at that point in time.   An   odd thing:   when I first went
to CDC, I hadnJt been at CDC a month, and Boisfeuillet Jones was
Assistant Secretary for Health at that time, and he called me and
asked me to come up and see him in Washington or stop in the next
time I was in Washington.   Well, in those days, you got into Wash­
ington at least once a week as Chief of CDC, so I stopped and
saw Bo, and he said he was looking for new Director of the Bureau
of Medicine at FDA and would I take the job.       And I begged off
because at that time, our oldest daughter, Peggy, was being seen
by a psychiatrist.   We had just started in tte family therapy at
Emory with Dr. Alfred Messer, and Peggy had had some psychiatric
problems, emotienal adjustment kind of thing, family and social
adjustment thing, for several years.    We bad bad her at one time
in a school in Pennsylvania, not the Deveraux, but Wilkes Barre
Childrem.•s Social Center, it 1 s called, and she had been seen by
psychiatrists at Children's and so when we came here, we continued.
                                                               138




and got under Dr. Messer's care, and she was making progress, and
we aad moved so often that the doctor thought this could be a
factor, an4 here she was in the eleventh grade in high school
and we had just moved and she had just enrolled in a new school
and I said, ttBo, I've never said no to any request from the
Public Health Service, but I would like to be let off the book."
And be thought my request was not unreasonable, and so he said,
"Fine.      I'll find somebody else."   Well, as you knew, it took
him a long time to find somebody else.


Dr. t.:
It certainly did.



Well, at any rate, that was a right interesting thing to look
back   on   in retrospect, because when I went in as Commissioner of
FDA, Joe Sadusk was the Medical Director.

Dr. Y.:
Had you known him before?

Dr. G.:
Yes.     Joe baa been an assistant professor of medicine, of clinical

medicine, at George Washington University Medical School when I
was a senior medical student, and we used to have him on service,
as we said, out at what we called Gallinger, which is now D.     c.
                                                               139




General Hospital.    And so I had known Dr. Sadusk as one of my
assistant professors in medical school, and I had run into him
from time to time since then, in various capacities.      You know,
Joe worked in a number of places.    So I knew him before.     I also
got te know him while I was chief at CDC, because I went to him
once on a problem involving lab diagnostic tests that was bottled
up in tbe FDA, and it was on Francis Kelsey's desk, and he threw
his hands pp and be said, "Jim, I can't get her to do anything."

So, I had direct contact with Joe while I was at CDC.



I think I would like to go on and get this business of your

getting into the new office of Commissioner, and then we'll go
on back before we talk about the tasks of that position and look
at the CBC because it was important background, too.


Dr. G.:
After seeing the Secretary that time and calling him, then the
Secretary called me back one day and said, "Jim, you know one
thing that is most difficult to contend with in this town is
a secret."    He said, "I don't want any premature disclosure of
this."    I said, "I haven't told anybody, Mr. Secretary, except
my   wife, and she wen•t say anything to anyone."    He said, "Well,
wliat•s your schedule like the next few days?"      I told him it
ceuld be adjusted.    H.e said, ''Why don't yeu go someplace that
                                                                140



you're not too accessible?"     And so, I went to Puerto Rico after
he made the suggestion.     We had a laboratory in Puerto Rico, so
I had a perfectly reasonable basis for going down and visiting
Fred Ferguson's laboratory.     I quite often did this, once or
twice a year, usually once a year.     So, I just went down to
Puerto Rico as a routine visit.


Dr. Y.:

I know.    When it was announced, I called yeur heme and was told

you were in Puerto RiJo.


Br. G.:
That's right.     In fact, I had a call within a day after the
Secretary talked t<> me.    I had a call from Morton Mintz in

Washington, saying that he bad heard this and this and this
and I said, "Well, I'm sorry.     You know something that I don't
know." Now, it's just necessary to do this.

Dr. Y.:

Sure.     You had promised the Secretary.

Dr. G.:
That's right, and I said, "You kn.ow something I don't know."


Dr. Y•:
So that your dealings •••
                                                             141




Dr. G.:
I put him off successfully.


Dr. Y.:
Your dealings were entirely with Secretary Gardner?


Dr. G.:
Entirely.    No one else.


Dr. Y.:
If the White House was involved in the decision-making process•••


Dr. G.:
They were.    Because one of the things that tbe Secretary indi­
cated that he wanted to do, he didn't want any premature leak
because this upset the White House a great deal.


Dr. Y.:
I understand that.    I remember tnat•••


Dr. G.:
That was tbe kiss of death with Mr. Johnson, was for this to be
disclosed prematurely, and so the Secretary was doing something
that was absolutely necessary in telling me to get out of town

and protecting his own flank, because be felt that I could do
the job, and he wanted me in it, we had agreed and s0, therefore,
it was important.
                                                           142




Dr. Y.:
What kind of checks bad he made with the White House?

Dr. G.:
That was his business.   I had no knowledge of that.

Dr. Y.:
Or with Congress?

Dr. G.:
Or with anybody oa the Hill.


Dr. Y•:
Right.


Dr. G.:
I w0uldn't know.

Dr. Y.:

This ad hoc committee that•••



The Miles Committee?

Dr. Y.:
The Miles Committee had a number of people oa it, and it received

names from a great many sources, from industry, from within Food
and Drug.   They asked the members of this advisory council that
                                                              143




I was on and so en.



Who was on that committee?    I've forgotten.

Dr. Y.:
Rufus Miles who was chairman as you suggested.      Boisfeuillet
Jones was on and Edward Dempsey who had held the same position
right after Boisfeuillet.    John Corson who was from Princeton
and ence had been a management censultant man, and an Atomic
Energy Commission member named Dwight Ink, and then the staff
work evidently was done by two aides in HEW, one of whom was
Dean Coston.


Dr. G.:
Yes.   I know Dean.

Dr. Y.:
Wb.o was shortly, of course, to become Wilbur Cohen's deputy.

Now that was the group which sorted the names out, not only,
I take it, for this position but for a number of others.


Dr. G.:
I don't know about the latter.    I knew that they were involved.
I only knew two of those people, three, Rufus Miles, Dempsey and
Bo Jones, of course.   I knew none of the others.     I had never
heard of Dean Coston until I took the job and feund him as
                                                                   144




Wilbur's deputy.


Dr. Y.:
One   of   the other positions was an assistant HEW deputy secretary­
ship for environmental health that they were considering at the

time.      There wasn't any action as far as I know, and you weren't
talked to about that?      Bid you talk at all to George Larrick
during this process of consideration?


Dr. G.:
Never.


Dr. Y.:
Right.


Dr. G.:
I didn't see George.     You see, I bad dealt with FDA at Larrick 1 s
level too, on the egg problem.

Br. Y.:
The incubator egg rejects?

Dr. G.:
No.   We bad a problem with an epidemic of salmonellosis that was
traced back through our CDC efforts and joint efforts ultimately
with FDA to a farming area in Pennsylvania, and I had dealt with
him on a couple of other things.      I had dealt with him earlier
                                                              145




when I was with accident prevention on the cranberry episode.


Dr. Y•:

Well, now hew was accident prevention involved in that?


Dr. G.:
Well, we had the national clearing h0use fer p0ison control
centers and we were handling queries from all ever the country,
you see, the p<>ison control centers were.   And we had some com•
petency in toxicological capabilities, and so the Secretary cast

a wide net.




That was Secretary Fleming.


Dr. G.:
Secretary Fleming.     I can remember spending late evenings up in
the Secretary's office on that task force on cranberries.


nr. Y.:
What did yeu think ef Secretary Fleming from the point of view
of that episode?     Do you remember he carried the hall himself
in that episode, and did it not only right out in front of the
troops hut itKa very active way, and industry was really jumping

all over him.
                                                                     146




Dr. G.:

Yes.     But I thought that he did a right good job on this.   I was
sort of impressed by Secretary Fleming.     I didn't have much of
any other contact with him.     It wouldn't be fair for me to make

a judgment about him in general, other than the same kind I

could make about him in contrast with Ribicoff, whom I had met

while he was still governor and interested in highway safety,

or I could make about the Secretary, the one from Rochester.


Dr. Y.:

Folsom.


Dr. G.:

Folsom.    Marion B. Folsom, or indeed, anybody back through and in­

cluding Ewing and Madam Butterfly from Texas.


Dr. Y.:

Mrs. Hobby.




Gveta Culp Hobby.     I could make, you know, just general observa­
tions.    Oveta Culp, she was something else again.   She didn't want
anybody to leave until she left, and poor Len Scheele spent many

a night just sitting in his office waiting for a call that never

came.     Of course, the famous remark about the polio vaccine: "Who

could have anticipated such a demand?ff    I didn't think she was
                                                                        147



was very competent as a Secretary.       I thought Folsom, at least
among the peeple I spoke to and from what I could see from my

lowly vantage point, had the respect of a great many people in

the department.    He was well thought of as a Secretary within
the establishment.    Fleming:     there were strong admirers and
haters.   He evoked stronger emotions.      Folsom didn't evoke
strong emotieas, you see.     Ribicoff was viewed as being there

as a political expediency.       Celebrezze was sort of viewed as a

joke by the people in the department.       I had dealings with him
directly, too.    And you got the impression that Tony really
bad gotten one notch higher than he should have, if maybe not
two.   There•s a l>eok out now called "The Peter Principle" which
elucidates that phenomenon.       It points out that people tend to

get ene level above their level of competency because of the

system.   I had that feeling about Mr. Celebrezze.


Dr. Y.:
Well, now before you go up to the •••


Dr. G.:
I went to Puerto Rico and I stayed out of sight down there.         I
ran into Frances Kelsey, oddly enough.      She was there fer a meet•

ing.   Of course, the announcement came out while I was in Puerto
Rico, and it was in the New York Times.      And one ef my personal

friends, Dr. Mort German was there with me, and I hadn't told
                                                                           148




him even, and he came down and I was out by the swimming pool.              It

was the weekend, I don't remember the exact date.           But at any rate,

I was at the pool.      I wasn't going to work whether it was a work

day or not that particular day, and German came out with a news•

paper under his arm and he said, "You son of a hitch.            I rode

down on the airplane with you, and you didn't even tell me that

this was going to happen."       He was all excited about it, of course,

and so was I.      And then the newspaper men got after me, and       l!!!!.
Magazine's local photographer came.           My God, he took about twenty
rolls of film in one afternoon.           That's when he turned up with

Frances Kelsey, and got a picture that ultimately showed up in

I.!!!. Magazine.    I had all sorts of telegrams and phone calls and

most of tkem I disregarded because I felt it would he unfair to

give any interviews.     New,   I.!!!.,   'being a weekly, I knew that I

bad time to get back to tlle mainland and subject myself, make

myself available, to the press, but I didn't think it was fair

to give a telephone interview to one reporter and not to any

others, so I didn't give any interviews.           I did ge back to Atlanta
and then went to Washington for a press conference and swearing in.
I was sworn in on the 17th hy Secretary Gardner.


Dr. Y.:
Now, at taat time, a good deal was revealed about what this committee

had been a'bout, because they had not only been picking a person,

they had been laying down certain guidelines with respect to what
                                                                     149




they believed the future of the agency should be.


Dr. G.:
Wltat should be done.    I had to, in effect, reassure the Secretary

that I could, ia general, agree to tnose guideliBes.     They were

subject to modification, however, on further study.


Dr. Y.:
You had been given these to read?


Dr. G.:
I bad been given the Miles Committee report to read.


Dr. Y.:
Was this before you accepted?


Dr. G.:
Before I was sworn in.    Before I accepted it, in fact, as I recall.


Dr. Y.:
Right.    Now did you get any idea from the Secretary at the time
that you were being questioned aad instructed by hiim about any
kind of stipulations that came from President Johnsoa or frem

the White House that were higher thaa••• ?


Dr. G.:
Ne.   The suhject just didn't come up in that context.
                                                                     1.50




Dr. Y•:

Right.    So that even though the White House considered this so

important as to anaounee it itself rather than let it be announced

at   the departmental level, you didn't have any kind of persGm.al

association prior to ••• 7


Dr. G.:
None whatsoever.    None whatsoever.


Dr. Y.:
Right.    And it was only afterwards that you went down and saw

the President?


Dr. G.:
That• s correct.


Dr. Y•:

So that the contract that you signed, so to speak, with the
Secretary was fairly simple.    He didn't go over these points

in this Miles report point by point.


Dr. G.:

Oh, no.   He didn't say, "Wllat would you do about this?"   He was

quite realistic about it.    The Miles Committee report was one

set of viewpeints that a committee had arrived at, and these had

to be left open and flexible.    He simply said, "These may be
                                                                        151




helpful to you as a guide.       But feel free to move away from any
particular point in here."       He said, n1 tllin.k most of them are

probably valid, but you're going to have to determine that as you
go along.       Whatever you want in the way of help and support, you'll
get."     Within reason obvieusly, you know; you can't take the
whole budget.


Dr. Y.:
And I take it that•••


Dr. G.:
He was always good about support.       Just magnificent.   I would rate
him with General Quesada in terms of being a fine administrator
who had a sense of public obligation and exercised the duties of
high office with that always in mind.       Yei>u see, he knew the con­
stituency, plural, the constituencies that he had to represent, and
I think    ne   followed his ohligations and devoted himself to them in
a way that rarely is seen in the administration of high office.

Br. Y.:
He had such a broad domain that he had to delegate, but he did
have that ability?


Dr. G.:
And he had the remarkable ability, also as the General did, to sort
the wheat from the chaff.       I've found most great men de.   They can
                                                                    152



get right at the guts of an issue, you see, and John Gardner was

no exception.   You could go to him with a technical, fairly
technical issue, as I did oa a couple of occasions because they
were politically sensitive issues, and informed him of what was
about to happen.   At the same time, I gave him an opportunity
to overrule me if he so chose, but that'wasn•t why I went there,
and I said, "Mr. Secretary, I bring this issue to you not because

I haven't been able to make a decision, but because I've made a
decision.   I want you to be aware of the implications of that
decision.   And, of course, if you wish to change that and reeom•
mend that I take another course, that's another matter.   But,
here's what the issue is.n   Sometimes it would require technical
briefing.


Dr. Y.:

Do you remember specifics on this?


Dr. G.:
Let's lay that aside for the time.   There was one that was quite
technical in nature that would fit nicely that description.

Dr. Y.:
Well, let's postpone that because we have leaped over the CDC and
I would like to find out how it•••


Dr. G.:
Well, CDC was an interesting three-year peried.   At that time,
                                                                     153



Dr. Aaron Christensen was director of the Bureau of State Services

under which CDC was one activity.     Now all of the other activities

were headquartered in Washington, and so his staff meetings were

in Washington and I was expected to fly up once a week, just to

start on this level and we will work en the other thing.     NOW

Chris was a very conservative Republican, a mid-Westerner.     He

didn't like the boat rocked; he didn't like commotion; he didn't

like argument; and it soon became clear to him that be wasn't

going to have peace with me at his staff meetings.     It soon be­

came clear to me that it wasnit worth my while te fly ,, there

once a week for his staff meetings.     It was a complete waste of

my time and the taxpayer's money for the airplane flight.    So I

convincee him that it would be good to have a speaker phone put

in his office and I could have, then, because I had a speaker

phone in my office, opportunity of listening to the staff meeting

and make comments where I felt comments were appropriate from my

office, and then I would save the money flying to Washington
every week, which he agreed to and we did.     So I used that hour
every Thursday memimg to go through mail, Dave Seace would be in

there with me, amd sotto voce we would handle other matters.

Every ence in a while, Christensen would say, "Do you hear that,

Jim?"   And I would say, "Oh, yes.    Pm with you," and go on with

my work.   Well, the kind of bureaucracy that existed then is im­

portant to understand, because CDC got things done in spite of
                                                                       154




that bureaucracy.   For example, there was a character in the
bureau office who was supposed to clear all printed material.
One man.   Now he was a bottleneck to us.     We didn't send every•
thing up, admittedly, but once in a while when we had to go out•
side on eontract for printing jobs, we knew we bad to get it

cleared up there.   We had our own print shop, you see.     We
didn 1 t go jhrough the hid precedure for many ef these things,

and this man would tum out to be a bell of a bottleneck.         For
example, the VD Branch had a comic book that they felt would be
helpful with young ki:ds~•that's a format they knew as a means
of disseminating information about VD.      That sat in that man's
office for about two and a half months, and I found out he

wouldn't approve it because in one of the little boxes it showed

some young people in a drug store booth and they were smiling
and talking about VD, and he didn't think it was appropriate
that people smile when they talk about VD.     Now this is a kind
of uonsense, you see.   Well, I got fed up to the gills with that
so one Thursday in advance of that, I had the executive officer
of CDC pull every requisition for every bit of printing done in
the previous fiscal year, get a copy of every film we had made
the previeus fiseal year, a copy of every training manual, ef
every brochure we'd printed, and assemble them all at one end of
one room en a lng table and pinned to the wall eehind it.        Then
I bad him get the photographer in and take a color photograph of
                                                                            155




himself and this mass of printed material, stacks of cans of
films, stacks of training manuals, notebooks, all of these aids,
educational aids, that we bad produced and we useci in our w0rk.

And I had a blow-up made of that photograph that was about 24
by 16 inches.   I took it up to Washington to the next staff
meeting, and when Br. Christensen got to the part about, "Does
anybedy have any new business?" I said, "Dr. Chris, I've got a
little problem I want to bring up."     So I told him what the
current bureau of clearance precedures were.        I reached down

under the table and I said, "Now, Dr. Christensen, I'd like to
show you what CDC produced in the last twelve months."            I held
it up so that everybody could see it.     I said,    11   Now I come here

with one single question:   do you want us to clear this material
or do you want us to get our job done?     Because the two are
mutually exclusive.   If we are going to devote our energies to
clearing the material with the man that you have up here, wbo
is incompetent, technically and physically incapable of clearing

this mass of material, then we'd do that.     If, on the other
hand, you want us to get the job done, let's cut out this goddamn
nonsense."   He didn't like this and he said,   8
                                                    Aw, Jim, come on.
Now, you're making too much of it."     I said, "No, I'm not now.
I want a decision."   He tried to laugh it off, you see, and Chris
is just the finest guy I've ever known as a person, a comfortable,
warm, friendly guy to be around, but again, not decisive; he
                                                               156




didn't want te stand up and belt it out; I bad other problems as

examples of that.     Chris was non-combative in nature, you see.

Well, he never did make a decision on that point.


Dr. Y.:
So, you just went ahead •••


Dr. G.:
So I just went ahead and I told the people to disregard their

clearance procedure altogether.


Dr. Y.:
It was just settled hy lack of decision.


Dr. G.:
Indecision, and by my decision to handle it down at this level.

So CDC, you see, as an organization was a fascinating one because •••

they started out as the malaria control in war areas.     This was set

up at the request of the old War Department, because prior to 1941

when war was declared ••• on Decemoer 8th, wasn't it?


Dr. Y.:
7th.   0h, war was declared on the 3th.    Right.


Dr. G.:

Sunday was the 7th.    Prior to that time, you remember, about a year

and a half earlier, twe years earlier, we started the draft, and
                                                                157



the yeung fellows were drafted for a year and then they could go
back to their communities.   Well, at that time, around the South­
ern training camps, and many of the camps were in the South be­
cause of the patronage system, and the committee appointment
system was in effect then as it is today.    And around those

camps, a lot ef malaria occurred.   Well, the War Department got
concerned about that because for the first time, large numbers of
civilians were coming in; therefore, other politicians could get
complaints and so they decided that that mess had better start
to be cleared up and so they got the Public Health Service to
start this malaria control in war areas.    At that time, it was
largely ditching and drainage and Paris green, but at the heighth
of that operati<>n during the war years they had 5,000 people em•
ployed, with headquarters here in Atlanta, and they were producing
training films and manuals and everything that was aimed at malaria
control in war.   When the war ended, we had a very far-sighted guy
in Washington, a guy named Joe Mountia in the Public Health Service,
an Assistant Surgeon General, Director of the Bureau of State Ser­
vices.   It was Joe's idea that an erganization that bad been as
successful as that one was, and that's an interesting judgment
that we want to come back to later on, should not be lost, and
that this perhaps could be the first of a series of centers that
could be established, and this one could perhaps should be the
Communicable Disease Center, and Joe was able to get that
                                                              158




established.    That was the only one he was able te get established.
He envisioned a center for chronic diseases, as well.




Did this take, to get it settled••• ?


Dr. G.:
No Congressional action.    No.




Just decision within the Service?


Dr. G.:
That's right.   Well, so this became the Communicable Disease tenter
and its mission was broadened.    All through the war years, it was
under the leadership of sanitary engineers.    After it was converted,
it became put under the leadership of MDs, and the leadership was
good, bad, indifferent, you name it, they had a little of every­
thing.    But, generally, it was viewed as a place to put a guy to
further develop him before be took over a bigger joh in Washington.

And so, most of the leadership of CDC was good.



But indeed it may be partly because of the leadership and partly

because of the need fer that kind of mission, it constantly grew

in importance within the Service, didn't it?
                                                                    159




Dr. G.:
It did, indeed, and the fact that they bad been successful, or
thought they were successful, in malaria control, gave them, as
an organization, a good esprit to start with.      I think that's

extremely important in management of an organization.      I started
the accident prevention program with a small group, and I de•
cided that we should pick something manageable as our first task,
and it should be something that we could be successful at doing,
because I felt that tbat would give us an esprit de corps, you

see.   I think that's a good psinciple to go by.


Dr. Y.:

And they believed that they were good.


Dr. G.:
They believed that they were good.


Dr. Y.:
Well, now, you say this is debatable.


Dr. G.:
Well, Dr. Langmuir, in later years looked back at the malaria con­
trel, and it's true that malaria was, for practical purposes,
eradicated from the United States by about 1949, as I recall, but

he maintains that in all probability it was the improvement in the
standaras of living that occurred in the Southern area more than
                                                          160




anything else.   That people, beeause of jobs in defense plants

aad government work were able to afford better housing which

meant sereening and better standards of living, and he felt

this more than anything brought it down to where the pool of

suseeptibles wasn't large enough to maintain the reservoir for

infection, you see.   And the Paris green and ditching and drain•

ing, sure, that helped some, but really he felt that the other•••

But the esprit and the belief was there and that beeame important

in itself and so the organization has always had a feeling of

sueeess, that they were good, and NIH has had that same feeling,

and that 1 s an interesting parallel, so all through the years

as new responsibilities were added, everybody accepted them in

the spirit that, "Sure, we ean do that.     We're CDC."


Dr. Y.:
Right, so that made it an agency somewhat in line with your own

mood, I think.


Dr. G.:

Yes.   When I was told I was c0ming dGwn here, I said, "Well, some•

thing's wrong,'' I told Arnie Kurlander, "beeause I've always been
asked to take over the jobs that nobody else wanted or the organ•

ization was loused up.     From everything I can learn this ergani•

zation is in good shape.     It isn't a new one."   I was often asked
to start new things, you see.     "It isn·•t a new organization.   lt.1:,s
                                                                      161




a large one, and it 1 s got an established history in back of it,

and they're successful.     I can't figure why you're asking!!!. to

take it over, you see."     Me laughed and said, "Well, maybe you'll
get something from it."


Dr. Y•:
What did you get from it that was particularly relevant and ger•

mane to the Food and Drug Commissionership later?


Dr. G.:
I think there would have to be a number of things that I could

cite.     I gained an understanding of certain kinds of problems

in food-borne diseases that was important later on, in fact •••

the salmonellosis problem was rising while I was chief of CDC.

And I used to read food journals as much as any other kind of

journal when I was chief of toe Communicable Disease Center,

!!!!. Technology,   for example, publications of this kind that I
would get from our library and read.     So I gained an understand•
ing of the food processing industry before I ever became part of
FDA, and some of the dangers that existed, you see.     Beyond that,
I tnink I gained a great deal from the contact with both the

laboratory people and the epidemiology branch at CDC, just on

technical issues an assessment ef their competence, and knowledge

of what they could do, and I drew on that later on.     I saw what

kind of training course Dr. Langmuir ran for his EIS officers.
                                                                 162




Dr. Y.:
What does EIS stand for?


Dr. G.:

Epidemic Intelligence Service, young officers that he brought in

and trained for a couple of months and then assigned eut to the

states and communities to work on disease problems, outbreaks of

communicable disease, epidemics, try to understand their origins,

and institute corrective measures.   And that became important

later on because we had a comparable problem of training young

men at FDA.   I gained a lot more experience in testimony before
Congress, because I had to carry••• altheugh I had carried a

budget in an adversary kind of situatien with Congressman Thomas

at FAA who was a very tough examiner, knew yeur books better

than most people in the agency knew them.   I gained more ex­
perience with the committees, Fogarty and Hill committees, that

I still bad to deal with when I came up to FDA.   So I had the

Congressional experience of the contacts on the Hill.   I think
it considerably broadened my contacts with other organizations,
the AMA, the American Colleges of Surgeens, American College of
Pathologists, because we were involved with training activities.
I initiated seme kinds of programs at CDC that were of imterest

to tb.em.

Dr. Y.:
Die you work with universities at CDC?
                                                                      163




Oh, yes.   Oh, heavens, yes.     I spoke at meetings, sy1mposia at

universities.   We sponsored research and so I had a great deal

of contact with the university community.




You mentioned making speeches.      Certainly one of the tnings that

you were to do at FDA was to immediately get yourself in front

of your interested population, and was this a tradition with

you from the point of view of the preceding positions you'd

held?


Dr. G.:
Yes.    In fact, I think it goes back to my work in the theater

business where you tried to move people and lead them, you see,

get them to do something.      You had to get out in front of them

and talk to them.     You had to have some exposure.   They had to

know who you were.     Well, at CDC I showed up in the Public

Health Service uniform, you see.     Now, that set me apart frem
any ef the other chiefs they had ever had.      I established a

custom, while I was there, that at the awards ceremonies the
officers would be in uniform and so would I, because it was a

commissioned corps.     I brought the hand in from Fort McPherson

to play at those ceremonies.     We had flowers on the stage.     I

think we made it a more meaningful ceremeng.      It was interesting;
                                                                        164




the civilian employees used to say, "You know, we like that.            It
makes us feel better.    We're a part of an organization.       We're
proud to see you people wear the uniferm.        Why don•t you make
them wear the uniform all ef the time?"        New I have always been
a strong ene on the Public Health Service needing an identity,
and one of the ways of establishing an identity, I maintain,
would be through the wearing of the uniform, because it always
gives you an oppertunity to acquaint people with the Public
Health Service, because they'd say, "Oh, I see you're in the
Navy."    Yeu 'd say, "No, I'm in the Public Meal th Service.    Here's
the difference.    You know how we used to provide medical care in
the Navy back in 1795,    1   98, rather••• 11 And that was the kind of
exposure that got me in front of my people.        Beyond that though,
the exposure to the university community and other kinds of
audiences as the leader of CDC was valuable, too.        It sort of
fit my pattern of operation.

Dr. Y.:
Were there industry relations in connection with CDC?

Dr. G.:
Yes, particularly in the laboratory reagent area.        That was a
significant area where we were evaluating the quality of the
laboratoJY reagents and decided to go ahead and publish a list

even though it eould be viewed as a form of economic reprisal,
                                                                      16.5




you see, because it would be very meaningful if the manufacturer's

reagent didn't measure up and wasn't on the lis\t that we then cir­

culated to the state laboratories.     He'd lose business.   But we

did it.




And did you speak to their trade association?


Dr. G.:
Well, I don't recall.     I spoke to representatives of their associa•

tien.     They eame to see me very much concerned about this.   But

there were other kinds of innovations that I brought to CDC.


Dr. Y.:

I think I'm going to have to turn this off.


Dr. G.:
I think probably this would be a good place to end for today.


Br. Y.:
                                                               166




Dr. Y.:
This is our third conversation, Jim, for the tape, a conver­
sation heing held on June 4, 1969, between Dr. James L. Goddard
and James Harvey Young about Dr. Goddard's experiences as Com­
missioner of the Food and Drug Administration.    We're sittbig
on the deck of bis home, so Ltilhat maybe that waterfall will get

into the tape and I imagine certainly the airplanes will.     When
we last talked, we bad reached the point at which you were sworn
in as Commissioner on January 17, 1966.   You moved up from
Atlanta where you'd been Chief of the CDC into your new office
which was then over on the Washington side of the Potomac, and

you were faced with a pretty grave situation, with many eyes,

Congressional eyes, drug trade eyes, food trade eyes, upon you.

How did you go about familiarizing yourself witk your job, with
the staff that yeu'd inherited, .with the kinds of problems that
were left overt   You spoke of some of these problems as "dead
cats on my doorstep" ence.


Dr. G.:
First of all, I met individually with members of the staff.     For
example, on January 19th, I notice, I met with Mr. Fred Delmore,
Director of the Bureau of Education and Voluntary Compliance;
Mr. J. Kenneth Kirk, Assistant Commissioner for Operations; Mr.
James Cribbett, Acting Assistant Commissioner for Regulations;
                                                                       167




Mr. Robert Roe, Director of Bureau of Scientific Standards and

Evaluations; ane Mr. Daniel Banes, Deputy Director of Bureau of

Scientific Research.


Dr. Y.:
Now, §7 us t let me have you expla in what it is you' re laoking at.


Dr. G.:

I'm looking at my daily calendar.      I had a very efficient secre­
tary, Mrs. Beulah Sink, and when I left she gave me the daily
calendars that she had put on   my   desk every merning.   And so I

have two stacks of these about two inches tbbik each, and it

helps me recall many of the events that occurred.      But I did

meet with the individual bureau chiefs, assistant commissioners,

and tried to size them up as persons, and then, secondly, ask

them to describe to me what their operations consisted of.
Being a newcomer, I was completely free to ask the dumbest ques•

tions one could imagine, and these were the worst questions for

them to handle, for I would ask them, "Well, why would you do
that?"    Sometimes the responses would be entirely inadequate
and would ultimately have to come down. to, "Well, because we've

always done that."


Dr. Y.:
Right.    Now, when you came in, as far as the previous staff was

concerned, there had been a lot of key retirements and resignations.
                                                                 168




Dr. G.:
Oh, yes.   I was very fortunate in that.    When Commissioner

Larrick retired in December of 1965, shortly after!!!.!, announce­

ment of retirement, the deputy commissioner retired.


Dr. Y.:

Mr. Harvey.


Dr. G.:

Yes.   John Harvey.   And one or two others.    So, I bad, in effect,
a fair number of ¥acancies.    Well, that•s an optimum opportunity,

so to speak, for a new commissioner because he can then select

at least a few people whose loyalties are directly to     hma.   he

of my first appointments, by the way, was Mr. Theodore Cron,
the Assistant Commissioner for Information and Education.


Dr. Y.:
How did you come across Ted Cron?




Ted actually was with the Department of Health, Education and
W~lfare at the time I first met with him.      Se was at the Office
of Education.    He was referred to me by his boss in the Office

of Education, the Director of the Office of Public Affairs, in

effect, of OE.    I met with Ted and I liked him immediately.

He was a bright young man, thirty-four years old, as I recall,
                                                                   169




at the time, and bad the kind of background and experience that

I felt would be valuable to me and to the agency in the months

ahead, and so he was my first selection.     New, let me point out
that I swore in a director of the Bureau of Veterinary Medicine

prior to Ted's coming on board who had been selected actually

by Dr. Clarkson, the previous Director of the Bureau of Veter•
inary Medicine.     Dr. Clarkson selected Dr. Van Houweling as his

replacement.     Dr. Van Houweling came to us from the   u. s.   Depart­

ment of Agriculture.     I had no objection to him.   In fact, he

was quite capable and competent, but be wasn't my selection,

but he was the first man I think I appointed as Bureau Chief

after my swearing in as a Commissioner.     But Ted Cron was the

first person that I seiected and put in a slot and be came from

outside the agency.


Dr. Y•:
You made that decision very quickly after you came.


Dr. G.:
Yes, I @id.     Very quickly, in fact, and it was one that I never
regretted.     Because be came from outside the agency, be had no
inside loyal ties or ties, and I leaned very heavily on Ted in

the early months, making certain that be was always with me in

certain kinds of meetings.     Some of them were with inside people,

some with outside people, because he and I then could sit back
                                                                 170




later on in the day and size up what had happened.    We could
get a fix on what was going on, and this was very valuable to
us, to me, and Ted was my strong right arm throughout my tenure
as Commissioner.


Dr. Y.:
What were his particular advantages7   Did you see rather eye to
eye, was that what it was?



Well, we saw eye to eye on issues, on approaches; he 1 d had broad
experience in audiovisual public media fields.    In addition, he

was a Harvard masters in education, as well as a Harvard under•
graduate, you see, and this told me that he had a fairly broad
educational background.   And so, I had every expectation of a
man with great breadth of understanding of social issues, which

he did prove to have, and ke was very quick to perceive, much
quicker than I, in fact, to perceive bow what!!. were doing re•
lated to the problems of our society and bow the societal prob­
lems, certain ones, were properly ones that!!. should tackle,
too.   And Ted and I saw eye to eye very early.   In our first
meeting we took a liking to each other which is very important.
We could communicate easily with each other, which is extremely
important, and he was always the one fellow who would look me

in the eye and say, "Commissioner, that's a bunch of baloney."
                                                                    171




And everybody has to have that kind of person en their staff.


Dr. Y.:
He heeame one of the key persons in writing the first drafts

of your speeches, didn't he?


Dr. G.:
He did all of that and shaped and guided other writers who from

time to time worked on speeches.     We tried a number of speech

writers, by the way.


Dr. Y.:
Tell me about that.


Dr. G.:
Well, Ted was so involved in a variety of activities and his

time was so valuable.     I kept after him.     I said, "Ted, why

don't you get a speech writer for me?"        Because he had been

doing this and it was quite a burden.      I gave quite a few speeches
during the two and a half years.     And so, every six or eight

months he'd turn up with a speech writer, and we would then sit

down with the man, the both of us, and talk to him, and he would

talk to the man and have him read speeches I'd given, have him

listen to me in impromptu sessions where I had spoken with only

notes, so be w0uld understand how I talked, the phraseology I

used.     Ted had a great ear for that.   He could write a speech as
                                                                     172




if I had written it, you see.


Dr. Y.:

Right.


Dr. G.:
Because he understood my phraseology and how I put things to­

gether.    And we never could find a man who could do this.     So
every time the job fell back on Ted's shoulders,    The draft

would come in and I would read it.    I'd call Ted in and I'd say,
"Ted, this guy isn't cutting the mustard: on it."   And he would

look sheepish and say, "Well, all right, I'll write that one."


Dr. Y.:

You'd get some raw data you needed that way, but he had to put

it into your•••


Dr. G.:
Oh, yes.    It had to be put together, because when you're trying
to get an agency that bas been very backward in a way, very
reluctant to assume its proper responsibilities, when you're
trying to move it ahead, trying to recruit new people, meeting
with all those who thought they had to meet with the new Com­

missioner, do all the tasks involved in administrating an agency

of 5,100 people, then, on top:;; of that, to write your own speeches

would just be ridiculous.    You have to shape them, you have to
                                                                  173




give the speech-writer the point of view that you want to make,

but I was giving as many as three or four speeches a week.


Dr. Y.:
You, at the beginning, decided one way that you would make an
impact for the ~gency and for your new approach to the agency

would be through making public speeches.


Dr. G.:

In fact, I made a conscious decision that, in order to be fair,

and in order to let people know what to expect, I would meet

with all of the major associationsgand speak at their annual

meetings.     Now, Washington is filled with representatives of

trade associations, and I really didn't perceive how many trade

associations there were in this particular field of interest

until after I had made that decision.    And the invitations just

kept coming in and in, and it took me a year literally to get

around to all the major associations, but I felt this was neces•

sary, that they should know the person they were dealing with and
the philosophy that the agency would have as a result of new
leadership.    And so this was a conscious decision to move ahead

in this fashion.


Dr. Y•:

You have spoken before about how making speeches wasn't a chore;

in fact, it was almost a joy.
                                                                174




Dr. G.:
Well, yes.   It was fun.    I must say ~bat those weeks where you

had three or four speeches to give in one week and entailed a

great deal ef travel, at times, it became less of a joy than

others.


Dr. Y.:




Dr. G.:

Getting hack to the staff:    now, there were some vacancies.   I

had to have a Director of the Bureau of Regulatory Compliance.

I was very fortunate in that the man who had headed that particu•

lar bureau bad retired.


Dr. Y.:
That was Allan Rayfield?


Dr. G.:
Yes.   Now, Allan Rayfield was, in my opinion, and I never met the
man, a brilliant man, but he ran the agency.     In fact, he!!!. it;
it wasn't George Larrick.    Allan Rayfield ran FDA because he had
absolute control over the field personnel.     He decided who was

transferred to which of the eighteen district offices; what the

eighteen district offices would de; and, in fact, the eighteen

district directors really made no significant decisions on their
                                                                175




own.   Now, be retired in December, and went with a trade associa•
tion, no, went with a pharmaceutical firm, as I recall, out in
Cincinnati, Ohio, but, at any rate, his leaving really made it
possible for us to convert the district operation from one of
just blind obedience to orders from one individual to one where
the administrative capabilities of district directors could be
relied upon to perform the agency's missions.    Now, unfortunately,
this meant that a fair number of district directors who were so

steeped in the old pattern had to go.     Many of them were long­
time FDAers; had been there, one man, I think had forty•six
years of service.   So, it wasn't a questien of individuals being
eligible for retirement.   Most of them were past that p0int, and,
in fact, a couple of them bad been extended on age, even, which

meant they were past seventy.   In that first twelve-month period,
I felt one of the major tasks w~s to reshape the field structure,
bot~ by replacing most of tne district directors with new men
and by making the district directors and their immediate staff
responsible for the operation of that district, the use of the
personnel, and accountable for what happened in their district,
something that hadn't heen done before.

Dr. Y.:

Now, fi%st of all, how did you reach the decision about which men
would work under your new system and which men would not?
                                                                  176




Dr. G.:
Well, we had a district directers' meeting.     First of all, I

bad the Personnel Office gather•••work up a notebook which gave

me the background and photographs of each of the district d'irec­

tors, so I knew what all ef their past assignments had been, how

long they had been with the agency, just the hi0graphical data,

and I had their photographs.     Them I would talk to several people.

Winton Rankin by then was my Deputy.     I decided to keep Winton on.
He was acting deputy, or acting commissioner actually, when I

was sworn in.   I then asked him to become acting deputy and then
that was made final later on, within sixty days, as I recall.

At any rate, I did that over the advice of people, such as Don

Gray on Mr. Feuntain 1 s staff and one or two others in the Depart­

ment of Health, Education and Welfare, who cautioned me that Mr.

Rankin was an old-line FI>Aer and I shouldn't have him as my

deputy.   Well, I recognized that Mr. Rankin was a very strong
person and a very knowledgeable person aoout FDA procedures.
He knew all of the people, and I felt that I would take a cal•

culated gamble on this one and use an old-liner because, at some
point, you had to have an inter-face between a new person and the
existing personnel of the agency, and if two of us were new in

the head office, I felt it would he even more of a burden, and

I would rather know a man's biases and use him aeeordingly, which
is what I did with Mr. Rankin.
                                                                      177




Dr. Y•:

So that you kept him acting until you found out whether or not
you could work with him, whether or not this calculated gamble
weuld work eat.


Dr. G.:
Even after{dte was no longer acting but was S!!!, Deputy Commis­
sioner, it was still a calculated gamble, because Winton can
be a very devious kind of person who works behind your back.
Every once in a while I would let bim know that I knew what
he was doing.


Br. Y.:
What is an example of this kind of thing?     Do you remember
something specific?


Dr. G.:
Well, let me put it this way:     There would be meetings in his
effice early in the morning, and some of the eld-line FDAers
would constantly go to Winton with things, and Winten woula
try to see to it that I appointed men that he had selected for
certain jobs.     He WGuld make strong recommendations.   In many
instances, I did select those persons.     Others, I did not.   So,

Mr. Rankin was a very important person in the two and a half
year period.    He's a very strong individual, and it takes a
                                                                     178




strong pe:rson to work with him because of this.   We were never
personally close.   We never met socially, for example.   But we
got along on. the job.


Dr. Y.:
He was knowledgeable?




Indeed, so.   In fact, Ken ~irk, whom we also held over and made

Associate Commissioner for Compliance, probably was the most
bowledgeable man in the agency about regulations, past history
of cases, and Ken was extremely valuable to me during that     two

ana a half year period.   It was recognized that some of his
philosophy was not, peraaps, the most desirable, his approach
to certain problems, perhaps, could have been improved upon,
but nonetheless, on balance, Ken was a real plus ia that two

and a half year period.   I tried to mix up the appointments of

people•-the district directors, let me see, I think that within
a year, we had replaced fourteen of the eighteen district dir•
ectors.


Dr. Y.:

When they came in, then, I take it, to that first meeting, you
sought to use the paper background you had to size them up per­
sonally.
                                                                  179




Dr. G.:
I used that to size them up, coupled with my experience with
them in the first meeting, meeting then with people like
Rankin, Kirk, and others who knew them.

Dr. Y.:
Yeu went out to the field some, didn't you?


Dr. G.:
I visited every one of the district offices within the first
twelve months.   In fact, mest of them was within the first six
months.   Buffalo, I think, was the one that took the longest to
get to.   Who wants to go to Buffalo? At any rate, we did sue•
ceed in getting most of these people to retire.   In some cases,
it was in the nature of forcing them to retire.   You can't
force a man to retire against his wishes, but what we did do-­
what I did--was to offer them a transfer te Buffalo.     Once that
office was vacant, that became tne ploy that was used; call a
man up and tell him we needed him in Buffalo, anxious to re•
structure the district, I'd like him to think it over.    We wanted
him very much to make tne move.


Dr. Y.:

He recognized this as a hint of demotion?


Dr. G.:
Well, it wasn't a hint of demotion.   Buffalo•••nohody really
                                                                       180




wanted to live there.     The damn winters are so terriele, and so,

a couple of days later, generally, the individual would call up
and say, "Well, look Dr. Goddard, I appreciate the opportunity,
but I've decided I want to retire.        I've got enough time in,
I'm old enough, maximum retirement, so ••• "      I said, "I'm sorry
to hear that.     We hate to lose you."    And we weuld put on a
nice farewell party, and I would either go or send a telegram
and make sure it was handled in the best way we possibly could,
but we had to open those districts up.       The district directors
at their first meeting sat there like bumps on logs.        We would
raise a question and ask for their opinion, and nobody would
venture an opinion.     Now, this weat back to the experience of a
few years earlier when Allan Rayfield had a meeting of district
directors and convinced them that he really wanted their opinion
on an issue.     Well, they got together that evening and they, as

a group, selected Mccay McKinnon, who was Director 0f San Fran­
cisco region when I came in, to present their opinion the next

moniing at the meeiing.     Mccay got up the next morning and pre­
sented the district directors' opinion on this particular issue,
and Rayfield then proceeded to cut McCay's legs right out from
under him.     Well, this had apparently happened before, hut Ray­
field had conned them into thinking be wanted their opinion and
maybe he thought he did, but when it didn't agree with his, he
then carved McCay up.     That, effectively, I am told, was the last
                                                                    181




time anybody offered an opinion.     They just sat there and lis­
tened.    And this was what happened in eur first meeting of the

district directors.     Well, I couldn't run an agency with eighteen
people responsible for fifty percent of the agency's personnel
utilizatien who didn't have an opinion and weren't willing to
express it and use their admh.istrative talents to help run the
agency.    Se, it was very important to restructure the districts•

operations and get different men in.     Well, we picked younger
men for the most part, men who were in the middle management
group.


Dr. Y.:

They all came from within the agency.     ls that true?


Dr. G.:

Yes, every one of them came frem within the ageaey, in order to
have acceptance; one of them came out of headquarters, Maurice

Kinslow who was in charge of the Office of Congressional Liaison.


Dr. Y.:
That was rather late.


Dr. G.:
That didn't happen immediately.    No.   Most of them came from the
districts themselves.
                                                              182




Dr. Y.:

At least one of the district chiefs, Al Barnard, from Kansas

City, you moved up.


Dr. G.:

Yes.      Meved him into Director of Bureau ef Regulatory Compliance.

We had this opening; it was a difficult one to fill; it was an

important one, although the Bureau's role had been downgraded.

We felt that some of the functions should he parceled out:            the

Bureau of Regulatory Compliance, in effect,!!!!. l'DA under Ray­

field.     We wanted to make sure that that wasn 1 t going to happen.

Voluntary Compliance was separated from it, for example.         We

needed a man who could run it, and Al Barnard looked like the

person to do it.      Subsequently, I regretted that appointment.


Dr. Y.:

Why was that?


Dr. G.:
Well, beeause Al never could get on top of the backlog and handle

the problems effectively, and he came to me within a few months
of   my   leaving, before my leaving was public knowledge, and told

me if he hadn 1 t made it by that July, meaning July   1   68, he was

going to ask me to transfer him, but then subsequently, he found

out I was leaving and that was a whole new ball game.        Other men,
I'm skipping around a little here, some of the other men had to
                                                                    183




be disposed of:     Crihbett was one; there was an associate com­
missioner fer science.


Dr. Y.:
How do you spell his name?


Dr. G.:
Well, Cribbett was not associate commissioner for science.     Let
me see now what Cribbett•s responsibility was at that time.     He
was acting assistant cemm.issioner for r§:gulations.   C R I B B E T T.
He   was completely ineffective and bad to be moved out.   FortUBately,
the Director of the Bureau of Science wanted him in his shop, and
then I was able to move Kirk into the associate commissioner for
regulations slot.


Dr. Y•:

When Ted Cron came in, he, of course, took the place of Wallace
Janssen.


Dr. G.:
Well, be really took an upgraded job.    We expanded that job over
what Wally had been doing, and Ted was the assistant commissioner
for education and information.    We had to get rid of the man who

was in charge of•••he was associate commissioner for science, I
can't think of his name.
                                                                          184




Dr. Y.:
Was that Oral Kline?




Yes.     Yes.   It was Oral Kline.


Dr. Y.:
What was the problem there?


Dr. G.:
One major thing, we got into it on the vitamin, proposed vitamin

and mineral regulations.      He never informed me of the possible

problem with the National Academy of Sciences-National Research

Council, and yet he bad met with them, he knew that they were

upset, and yet he hadn't informed me of it.         When it became
apparent to him that I was about to find that out, plus one or

two other things, he simply didn•t show up in the office.            He
phoned in his resignation.


Dr. Y.:
I see.     That had te do with the situation in which these long­
standing regulations were going to be issued, and they were •••


Dr. G.:
There were, in fact, issued.         A notice was published in the

Federal Register, and then certain members of the Natienal

Academy of Sciences expressed their displeasure.         And it was at
                                                                     185




that time that I'm talking about that Kline decided to leave
the agency very precipitously.


Dr. Y.:
Because he had been aware of the displeasure but hadn't told you
about it?


Dr. G.:
Hadn't tole me about it at all.       In fact, that was his responsi­

bility, to carry out the liaison with the Academy and keep me
advised.      So that position became vacant very quickly, too.


Dr. Y.:
Well, one of the hold-overs which, of course, most interested

the drug industry and the medical profession was •••


Dr. G.:
Joe Sadusk.


Dr. Y.:
Right.


Dr. G.:
Well, Joe I had knewn as a medical student at George Washington
University.      Joe was an assistant clinical professor of medicine
at G.    w.   in those fiays, and so I had known h~i' oh, fifteen,

let 1 s see, 1948, I had known him ahout eighteen years earlier
                                                                       186




and intermittently had seen and talked to JGe over the years
at meetings, sort of kept track of him and knew were he
was.     He'd taught again at G.   w.   later on, he was in charge
of the out-patient clinics.        So, he was not an unknown quan•
tity to me when I came in, as Director of the Bureau of Medi­
cine.     It became apparent to me very quickly, though, that one
of the major problems in the bureau was Joe himself.         In this
way:     An   issue would come up for my review from the Bureau of

Medicine.      I would review the material and call Joe in to dis­
cuss it, and in order to try to have a good feel for the situa­

tion, you have to put a lot of probing questions to a person,
and Joe never really uaderstood these were probes, and he would
flipflop completely, and say, "Oh, well, it could be done the
other way." Aad so very quickly I Became aware that this was a
man who really didn't have a strong position on any particular
subject, and therefore, I couldn't rely on him, because I really
would never know when something came forward as a recommendation
whether this was a well-thought-through recommendation that could
be battled in the courts, because that was part of what was in•
volved.


Dr. Y.:
Right.
                                                                    187




Dr. G.:
Se, Joe saw, also, that he and I weren't geeting along; he
didn't like my style of operation, of moving things; he didn't
like my separatism from the pharmaceutical industry; he wanted
to meet with people and coneiliate and compromise.      That wasn't
my way of doing it.     I felt that we had gone that route long
enough and that we had to have a marked change.     And so Joe
left.     As I recall, in late February, he announced that he
was leaving.     He gave me a letter.   He left, I know, on March
14th •   We appointed Dr. Robert Rebinson as Acting Director of
the Bureau of Medicine.


Dr. Y.:
Well, it wasn't that you and Dr. Sadusk disagreed about the
major role of the agency?




Oh, I think there!!!. a philosophic difference there between us.

Dr. Y.:
Not only about method, hut about substance?


Dr. G.:
I think about substance, too.     There was a difference between
us that was irreconcilable.     Joe's basic concept was "Leave it
up to the doctor, the practicing physician.      Den•t worry about
                                                                  188




it.   The individual physician knows best."   My positi0n was

different.    I th0ught the individual physician bad to look to
us as an unbiased source.of_ infe>rmation on drugs, because I was

well aware that there was a lot of misinformation being delib­

erately peddled by the pharmaceutical industry in order to in­

crease tkeir sales, and that there was bad research being done.

I had to play catch up when I went inte this job, because most

of the people there had lived with the problems.   My wife and

family did not move up from Atlanta, because our youngest daughter

was in the midst of her senior year, no, junior year, in high

school, and I felt it best to wait until the summer.   And so I

took an apartment, and this meant I was batching it for the

first six--seven months.   This was extremely useful, because I

then could spend the entire evening reading, and I did.




Now, what did you read in this catching-up process?    What kinds

of things?


Dr. G.:
My heavens!   I read everything I could lay my hands on.   Some
of the trade journals, I had, oddly enough., been exposed to

as Chief~£ CBC and had regularly read them, altgough I suspect

from a different point of view than I read them as Commissioner

of Food and Drug.   So, I was fortunate in the area of food.      I
                                                                  189




had a fairly good feel for what was going cm in part of that seg­

ment of the agency's responsibility, but it meant, in effect, for
most of the other areas, and part of the food area, I had to read

all of the trade journals.     So I always kept a stack of them in
the car, and this is one of the real values for having a driver,

by the way, for an agency head, a little thing, out it's impor­

tant.     You can spend your time when you're being driven from

one building to another for a meeting, you can spend your time,
reading.    You can get a lot of reading done that way.


Dr. Y.:
Especially because FDA was spread out.


Dr. G.:
Yes, and I had to travel around.     Then I did a lot of reading in

the evening, not only journals, but I actually reviewed new drug

application material to get a feel for what the pharmaceutical

industry was submitting.


Dr. Y.:
One of the very first things I remember that seemed a bit dramatic,
that helped give you the kind of image that you quickly acquired,
was your reversing a decision with respect to some new drug ap•

plication which had been passed on to you from the Bureau of

Medi~ine.
                                                                    190




Dr. G.:

Well, that was based o~ my own reading of the new drug applica­

tion.     It was interesting.   On the Bureau of Medicine activities,

quite often, more often than not, in fact I would say about 90%

of the time, in those early days, when Joe Sadusk was still

there, a recommendation would come up to me for an action.      I
would look at it, and I wouldn't agree with what had been recom­

mended, or I would want to question it.     As I would dig into it,

I would find that staff at the next level down had proposed

something entirely d.iifferent, and in the office of the Director

of the Bureau of Medicine, their recommendation would be re­

versed.    It would get up to me, and I would reverse it back to

what the staff had recommended.     That told me something, too,

and that also made my job easier, by the way, with the Bureau

of Medicine, because it meant that once Joe Sadusk left, and we

replaced him, even on an acting basis with one of the people who

had been on the next level down, we then got a harmony in the

decision-making process that hadn't existed befom,i and it meant
a lot of memo writing could stop, because people were document•

ing their positions for the record before, and th.is,.:Jras a

fascinating tning to see.


Dr. Y.:
Was this all wrapped up with the question of industry spokesmen

seeking to find out about applications?
                                                                  191




Dr. G.:
Oh, my.   A very complex thing, Harvey.   Industry spokesmen•••

industry came into·the FDA Bureau of Medicine building at will.

They would camp on people's doorsteps; they were distracting

people from getting their job done.    The drug industry repre­

sentatives did spend too much time checking on the status of

the application.    Make no mistake, they were up against a

situation where they perhaps could be excused, because the

backlogs were excessive, they weren't getting decisions, and

this was then understandable.    But I didn't like it from the

security point of view.    If those applications are, as in­

dustry maintained, full of manufacturing secrets, then we

certainly were derelict in meeting our responsibilities by the

way we were handling them internally, because one could walk

into that Bureau of Medicine building, up and down the halls,

and there were applications stacked on desks and in rooms.

People weren't even in the office.    This was not too good.     So

we instituted a security S¥stem that required people to sign in
and to indicate whom they were going to visit, and they have a

definite appointment with the person before they could go inte

the building.    I thought this was important to do in order to

meet our responsibilities, preserving in secrecy that kind of

information.    Also, it made a more orderly operation out of

it.   God, anything we needed was a little more order in that
                                                                       192




Bureau of Medicine.    It was the most disorganized bureau of the

agency.


Dr. Y.:
It had been that way for a long time, or was this a management

problem or was it a workload problem?


Dr. G.:

It was a combination of both of them, a management and a work•

load problem.   First of all, they hadn't been adequately staffed

back in the pre-Kefauver-Harris days prior to       1   62.   After '62,

the agency had to give them more personnel, and then it became

a problem of being able to hire good people.        I can remember a
flight surgeon we got rid of at FAA, poor old Benny Moxness,

because Benny was getting a little senile, couldn't do his job

in flight standards, and when I went over to FDA, my God, there

was Benny.   I said, "Oh, my God. tt     I mention that because it is

just typical of the kinds of people that FDA could hire.


Dr. Y.:
They couldn't even hire enought at that.


Dr. G.:

That's right.   They still were short of staff in a major way at

the time I became Commissioner.        But it was that, and then we

had a nest of homosexuals in the Bureau of Medicine who were in
                                                                    193




charge 0£ the administrative activities, and, boy, they were

lousing things up with their little games.     They would deny

people supplies, just because they weren't nice to them, you

know, and we had to clean that mess up.     Fortunately, that didn't

get much publicity and we were able to effectively get them out

of there.     There was both the workload and the lack of admini­

strative capability.     We got a good administrator in, Vaughn

Choate, a very competent guy who understood what was needed.

We got a Bureau of Medicine Director.     Dr. Ley eame in.


Dr. Y.:

Tell me about that.


Dr. G.:

All right.     Dr. Ley, Herb Ley, I first met him when he was a

lieutenant colonel in the Army.     He was serving as a staff man

on the Armed Forces Epidemiology Board.     As I recall, General
McNinch was in charge of the board at that time and Joe's now

here in Atlanta, and a great guy.     But Herb Ley I met because I
was appointed as a member of the commission on. accidental trauma

when I was chief of the Accident Prevention Program.     That was

1956.     And I was very impressed by this young lieutenant colonel,

his capabilities, and later on•o•


Dr. Y.:

Impressed in what way?     What things did you notice?
                                                                       194




Dr. G.:
By his professional competency, by the manner in which he handled

difficult situations within the Board.   Later on, I saw more of

him.   He became professor of preventive medicine at G.   w.,    and

while I was at Feaeral Aviation Agency, in faet, he resigned or
rather reverted from an active duty status in the Army to a

reserve status, and I tried to hire him as deputy civil air

surge011 at FAA, so that he could take my place- when I left,

because I knew I would only stay there a few years.      Unfortunately,

Herb decided not to take that job.   He decided it was too alien

to his capabilities, which were epidemiology, virology and

bacteriology.   Herb was very competent both in the laboratory

and in the establishment and direction of field studies.        He

did some rather significant work on chloramphenical in its

early days, at Walter Reed and later over in Korea and in Malay.

So, he was a very competent scientist.   New, I next tried to hire

him when I was chief of the Communicable Disease Center, and by

that time Herb was disenchanted with the situation at G.    w.
University School of Medicine, and he moved from there to Harvard

School of Public Health.   So I didn't get him at CDC.    When I
was confrented with the faet that I had to find a Bureau of

Medicine Director, because Sadusk resigned fortunately, and it
was apparent that Robbie, Robert Robinson, although I could

work with him, he wasn•:~ g0ing to be the man that would heai up
                                                                   195




the Bureau of Medicine on a long•term basis.


Dr. Y.:
Why was that?


Dr. G.:
Well, one of the problems was a security problem.      It was a

very messy situation with Robbie having at that time a record,

at least.   It appeared that he had been married twice and hadn't

bothered to get a divorce, and then some question about validity

of records pertaining to bis education.      It was just••• even

tbough••• now Robbie is Negro, you know, and I probably could

have bulled it through using that as a •••


Dr. Y.:
Well, I can see part of the problem, if there was any suspicion.

You were in the middle of a situation in which the c~edentials

of the researchers who were doing background work on the applica•

tions was a matter of prime importance.


Dr. G.:
Well, indeed.   And so I wanted a man, and I turned to Herb Ley
again and fortunately for us, at that point in time, there were

problems at Harvard School of Public Health, and so Herb was

able to secure a leave of absence from Harvard School of Public

Health and come with the agency.   Herb did an extremely good job
                                                                       196




in   my   opinion as Director of the Bureau of Medicine.      Now, that

doesn't mean there weren't problems that he couldn't solve, or

that there weren't blind spots, because we all have those, and

there are always problems that some of us don•t see and others

do, but on balance Herb just did an outstanding job.          He got

rid of the backlogs.      He and I ••• I was able to borrow enough

Public Health Service officers, something that had been avail•

able to Larrick before me and to my predecessors, but they had

been t1t1willing to bring people into the agency on a loan basiso

They were afraid of the Public Health Service.       Hell, if there

was anything I wasn't afraid of, it was the Public Health Ser­

vice, because I grew up in that agency.      So we borrowed a bunch
of young, two•year men and brought them in to help get rid of

the backlog.      This worked.




You said earlier that Ted Cron and you got along quite well

together, partly because you had such similar styles.         Now,

certainly, you and Herl:i> Ley don 1 t have similar styles.




No, but one:      we'd known each other and had respected each other

for years, and we were friends, you see.      So, we had that in our

favor.     Two:   I respected his style, although it was different

than mine, and he recognized what I was up to as Commissioner,
                                                                   197




what I had to do.   I had to break the ground for nim, and he's

now finding out that that's part of the Commissioner's job, to

protect his people, to take the beating, but, at the same time,

to break ground and to break the trail.   So, you have to perform

a little differently.   I think Herb still has to grasp some of

the fundamentals of those requirements, you see.    You can't

vacillate.   It's like, I think back to General Quesada who was

criticized because he was so positive in bis actions.    Why,

hell, it you're going to inspire confidence in the people whoj;:;

work for you, you have to be positive, even at the price, at

times, of knowing it's not quite scientifically accurate.       Now,
I could depend on Herb to baek me up by being scientifically

accurate, you see, and so that's an important function that

the Commissioner fulfills of leadership, and you have to operate,

in my opinion, in a little different style in that job than you

would as Director of tbe Bureau of Medicine.


Dr. Y.:
You recommended him to succeed you?


Br. G.:
I not only recommended him, I deliberately leaked to the press
the fact that 1 1 d made this recommendation in order te call the

hand of the Johnson Administration-•it was in its dying days,

of course•-on making sure that Herb was put into the job.       That
                                                                       198




was the only time that I deliberately went against the establish•

meD.t and leaked something to the press. I was always a good team

player up until then, but I felt that this was important.          I

didn't want Wilbur Cohen to dump Or. Ley or not to take his

recommendation and so I leaked it to the press on purpose.




Right.     We had gotten to this point beginning with the point of

your own self-education as soon as you became Commissioner.

You were talking about the things you read.       I remember when we

came down to Atlanta on a plane maybe at the end of your first

or second week, you were talking a good deal about Morton

Mintz•s book,!!!!, Therapeutic Nightmare.


Dr. G.:
Yes, I read that.     I read several books, in fact, at that point

in time.    Ted had gathered up a number of background materials

for me.     I relied on him to do that and I read them.    F•rtunately,

I'm a fast reader, so I was able to read a great deal of back•
ground material.     I was able to get studies out of the files that

had been carried out by different groups.       For example, the

second Citizens Committee report.


Dr. Y.:
That seems to me to have been ••• to make •••
                                                                    199




Dr. G.:
The job was really easy, Harve, when you think about it.      All

the recommendations that had been made hy different groups were

just laying there.     Congress had acted and spoken; they passed

the Kefauver-Harris Amendment; they gave the agency the authority;

they said, "Do this; thou shalt."      And yet the agency hadn't.
So all anybody bad to do was to look at what had been studied,

what had been recommended, and then pick and choose.


Dr. Y.:

The Second Citizens Advisory Committee report seems to me admin­

istratively to have been almost like a blueprint.


Dr. G.:

It was.     It was.   It wasn't difficult to step into that situation,

as I say, because so many people had looked at it and said, "This

should he clone and that should be done," and then I just simply

bad to come along, and all you had to do is swallow hard and

say, "Let•s do it!"     Now, that's what the agency was suffering
from.     Nobody was willing to take the bit in their teeth and get
at doing the job.


Dr. Y•:

Now, Morten Mintz very early interviewed you, I take it.
                                                                      200




Dr. G.:
Yes, be did.    If I remember correctly, it was shortly after the

first of February.     We met one evening at Ted Cron 1 s house and

spent the entire evening, and then I drove Morton home that

night.    Morton never had a car, you knew, and I got a little

insight into Morton.


Dr. Y.:
What is the insight that you got into him?


Dr. G.:
Well, this is only a suspicion.     First, fact:   I know that the
Mintz• have a daughter who is institutionalized.      Suspicion:

I suspect that she is institutionalized possibly because of

being mentally defective, and Morton thinks this may have been

due to a drug that his wife took during pregnancy.      Now, that's

a suspicion.    I can't verify that, but it would be an interesting
correlation with his attitude toward the drug industry which, at

times, is excessive.     Morton is an extremely competent investi•
gative reporter; I must point out that in terms of digging up

a story, he and Jon Spivak are two of the best I've ever seen,
and Morton goes after it hammer and tong.      Jonathan works very

differently than Morton, but nonetheless just as effectively.

Morton's more apt to break a sensational story than Spivak, but

Spivak 1 s more apt to have a story that, although it's not as
                                                                    201




timely perhaps as Morton's, is more comprehensive and better.

balanced.   So, that was part it.     Then I began to appreciate

Morton• s very deep emational involvement; wba tever the reason,

Morton had a very deep emotional involvement with the phar­

maceutical industry and a very strong set of biases, and that

evening made this clear to me.      But I must say, Morton never

violated his word or trust that was reposed in him.      On a

number of occasions, I would talk to Morten, did talk to him and

say, "Now, M.Rrton, this is coming along, and here's what I see

at this point in time, but you can• t say anything about it.''

He never did.   He waited until the right time.


Dr. Y•:

But he, of all the drug reporters, was one who kept on top 0f

wllat was happening as much as any?


Dr. G.:
I would say he kept on top as much as any, although as I've

indicated, Jon Spivak knew what was going on.     Morton bad a
pre,occupation with the Pill which wasn•t perhaps misplaced in
view of what we've heard and seen since then.     Morton was very
disturbed by the data that apparently was used to support the

approval of the NDA and the fact that good studies weren't

being carried out by the agency.
                                                                      202




Dr. Y.:
Speaking of reporters, what about the staff members from the

F-D-C Report or the Pink Sheet?

Dr. G.:
We had some dillies from the P-ink Sheet.    There was ane young
man whose name I've forgatten who really was a pain in the ass

from the Pink Sheet.    He was an overbearing, afHcieus, pompous
s. o.   B., and he would buttonhale everybody in the Bureau of

Medicine.    He had just come with the Pink Sheet shortly be:fore

we instituted the security program in the Bureau of Medicine

building, and he was well hated by most af the people in the

Bureau of Medicine, and he did something to me that I never

forgave him for.    I called a staff meeting in the Bureau of

Medicine one day and he sat in on the staff meeting.      It was

a meeting of all of the physicians in the Bureau ef Medicine.

I wanted to meet with them to tell them what the job was, what
it was we had to get done, where we were going.     He sat in that
meeting.    Now, I know of no Wasb.ingten reporter worth J;is saU,,

once he found out he was in a staff meeting, who wouldn't get
up and get the hell out.    Steve Rippey corroborated this and
told me, in fact, that would be what he would have done, and

said any reporter worth his salt would have got out of there

because, after all, "We have to live and work with you people."

But this fellow sat through the whole thing.     Well, it was a
                                                                         203




meeting of perhaps 158 people, and so he was unnoticed.          He

wrote his story.


Dr. Y.:
He wrote the story that told everything that had happened?


Dr. G.:
Yes.   Yes.    We protested.




Was this editorial policy on their part?


Dr. G.:
I don't think so.      No.     No.   I don't think so.   This was just

a new reporter and be didn't follow the usual rules.


Dr. Y.:
Well, this Pink Sheet kind of Bible, certainly among the trade

part of the drug industry, as to finding out what's going on.

What was your general impression ef this, looking at it from the
time you were Commissioner?


Dr. G.:
Well, I thought it was biased towards the drug industry point

of view.      I read it.     Every week it came out and I read it.

I must say we improved their circulation a great deal while I

was Commissioner, but nonetheless there were enough inaccuracies
                                                                 204




in it that I used t0 get many a chuckle over reading their

stories, but I really think that there is an unconscious bias,

or was then, towards the drug industry, towards that reader•

ship.     Stories were slanted, perhaps not knowingly, but to that
readership.


Dr. Y.:

Earlier you mentioned Donald Gray.


Dr. G.:

Don Gray on the staff of Fountain's Committee.


Dr. Y.:

As part of your education, I take it, you read tbe Fountain
Committee hearings and conversed with•••


Dr. G.:
I read the Fountain Committee hearings; I read the Kefauver Com•

mittee hearings in    1 62.



Dr. Y.:
Taat was a big stack.


Dr. G.:
Oh, my God, yes.    Oh, my God.


Dr. Y.:

Did you go down and visit with Representative Fountain and his staff?
                                                                    205




Dr. G.:
I had lunch with him and Del Goldberg and Don Gray.     I had lunch

with the Congressman and met with Gray and Goldberg.     We sized

each ether up.


Dr. Y.:
I'd appreciate y0ur impressions as you sized them up and as yau

had further experiences with them.


Dr. G.:
Well, I thought that••• first of all, 1 was very bes tile to Don

Gray and Del Goldberg initially.     I felt that they were unfair
in their handling the agency.     Now, as I went further along, I

reversed my opinion of them.     I felt that they perhaps were
still somewhat unfair in the methods they used, but that they

had reasen to be concerned about the agency, this I agreed, and

I really worked out a fairly good working relationship with them.
They were good investigators.     Let me point out that Don Gray,

when he tackled a subject, he went into it very thoroughly,

and I came to respect the suggestions that Don and Del'\ would

make.     They were a channel of communication, an informal one,

albeit, that was quite useful in that if something came up that

was potentially a problem, they would be kind enough to call me
even and say, "Well, you may not know it but such and such in
the Bureau of Medicine •••• "   Or, "Have you looked at this?"
                                                         206




Dr. Y.:
Where would they learn these things?   From an investigation of
the files or from outside?




They would learn them either from an investigation of the files,
(in which ease I was more apt to know because we kept track of

what files they were looking at; they had to request them from

us), but more commonly, people within the agency still, three
or four echelons down, would call them.


Dr. Y.:

0h, really?

Dr. G.:

And confide in them and then in turn, they would let me know.

Dr. Y.:

Was there very much of that, generally speaking?   Were there

leaks like that?


Dr. G.:
Oh, that agency was like a sieve.   It was just like a sieve.     It
was almost impossible to keep something quiet or to keep it

buried, you see.   First of all, I decided that we should be as

open as possible about the agency's business.   We were a public
agency and so there was a bunch of nonsense to try to hide
                                                                     207




anything, and it really would have a salutary effect to open

the agency up as much as pessible.     Ted did that.     Ted Cron.

But there are certain kinds of items that at times you want

held very closely, because it's premature to expose what your

plans are.     If you 1 re working on, for example, an investigation

of a drug company, and you're going to take an action against

them, you don't want that disclosed prematurely, because as the

investigation proceeds, you may find you were in error, and it

would be unfair, if nothing mere.     And so we found it extremely

difficult to keep items away from the reporters.       They all had

their own channels, people that would open up te them and talk

to them.     The agency was like a sieve.   But Don Gray and Del

Goldberg ultimately--within, I would say, six months••we had

reached a point where they felt it was no longer d6sirable to
have the agency up en hearings.     That ~as a"i,·vote of eonf idenc.e

that I thought was very significant.


Dr. Y.:
What about Representative Fountain himself?


Dr. G.:
Well, Representative Fountain is a gentleman.       People have badly

maligned him, in my opinien.     He always treated me very c@urteously,

even during testimony, testifying before him; he was interested in

seeing the agency did a job; he was Chairman of the Oversight
                                                                      208




Committee; that was his job, to look into it.       So we got along

quite well right from the first meeting.       I had lived in North
Carolina.    I knew the district be was from, and we never had
any preblem between ourselves.


Dr. Y.:
You thought he was knowledgeable and sincere?



Oh, no question about his sineed,ty.     His knowledge level was

a reflection of what Goldberg and Gray were able to give him,

and they did a good job of that.


Dr. Y•:

And he was capable of•••


Dr. G.:
Oh, Jes.    He understood what was goiag oa, indeea, much better

than people like Frances Dwyer on his committee who was really

a pawn of the pharmaceutical industry.       Of course, she eomes

from New Jersey, and many compaaies were in her district, but
it was so elear that she bad no comprehension of what was going

on in those hearings.    It was just remarkable.     She had been

told what to say and ask.    There it was.


Dr. Y.:
I think 1 1 m going to have to turn this tape over.
                                                                   209




Dr. Y.:
You hold in your hand there the first stack of the appointment

cards which•••


Dr. G.:
These were for 1966.


Dr. Y.:
We were talking about the different things that you did in

order to plunge quickly into this new position to orient your•

self as to what the responsibilities were.    Now, one of the
things that was stated by the Miles Committee in the report

that was issued on the very day that you were sworn in re­

lated to these new management approaches that the committee

felt was needed.   We have talked about some angles here as they

related to personnel, hut it wasn't just a matter of personnel

to work with you •••


Dr. G.:
Oh, no.


Dr. Y.:
It was a much broader•••


Dr. G.:
It had to be a different philosophy of management, the involve•

ment of more people in managing the agency.    This was why it
                                                                    210




became important to turn the districts around, and why it be•

came important that the oureau chiefs, who had been dominated

by Rayfield also, had to become independent and run their own

bureaus.   You see, Rayfield really, by controlling the dis•

tricts and the manpower in the field which was where each of

the other bureaus had to turn to get jobs done, really con­

trolled the entire agency.     Now, he must have been an extremely

brilliant guy to have done as well as he did.     For one man to

keep all of this under control, he had to be very capable, but

nonetheless, it was bad because they weren 1 t using••• they

weren't getting what they were paying for in terms of leader•

ship from the second echelonir,staff, the district directors

and the bureau chiefs.    And so we had to instill and install

a different management philosophy, and that was perhaps the

hardest thing to do.     Now, one of the things we did to help us

with this was to hire Booz, Allen and Hamilton to come in and

study the field organization, how the field staff were being

used and to make recommendations to the agency as to what
changes should be made.    Now, this was an extremely expensive

undertaking, about $800,000 by the time we were through, and
Mr. Rankin, myself and the key staff members recognized that,

in effect, we were paying Booz, Allen and Hamilton to do a

study which would come out with conclusions that we knew in

advance, and we knew what the recommendations would be.        In
                                                                     211




fact, I don't think they came up with very many recommendations

that we hadn't foreseen.


Dr. Y.:
Even the Second Citizens Advisory Committee had had a number

of the same recommendations.


Dr. G.:
Sure.     Of course.   They were obvious ones, but we were willing

to pay that price because the way Booz, Allen and Hamilton

went at the job was to involve the district people to a great

degree and make them feel that this was their study and that

what was being recommended was in the interest of the field

personnel and, therefore, it had a better chan1e of being

adopted than if we aecreed it from headquarters.      And this to

me was extremely important and, therefore, worth spending

that large an amount of taxpayers' dollars on it.     And, in fact,

I thinkthat•s the way it did work out.


Br. Y.:

Right.    Now what about the way the lines of authority ran in the
new system in comparison with ';~:the old system?


Dr. G.:

In the ole system, of course, everything had to go through

Rayfield.     If the Washington Bureau Director wanted sometbing
                                                                    212




done in San Francisco, it had to be done through Rayfield's

office and with Rayfield 1 s approval and he could block every­

thing.     From the other end, Rayfield was like the constriction

in an hourglass.    Everything had to flow through his office,

whether you were in the district, in the field or in head•

quarters.


Dr. Y.:
Oh, even in headquarters?


Dr. G.:
Oh, sure.    The hureau chief in headquarters, if he wanted some•

thing done by field personnel, a study.    Let's say the Bureau

of Veterinary Medicine wanted to have something done in terms

of finding out the incidence of contamination of meat with anti•

biotics.    Then they had to get Rayfield's approval and get him

to direct the district staff to spend inspection time on collect•

ing samples and lab time on analyzing the samples, yei>u see.     S0,
everythitig was a bottleneck.   Now, in contrast, the style we
adopted and promoted was that there were parallel lines going

up within the bureaus to the bureau chiefs and then from the
bureau chiefs to myself, or within the districts through the

district directors to me.    And so I had a span of authority that

looked as if it was 35, there were that many people reporting

directly to me, bureau chiefs, district directors, assistant
                                                                  213




commissioners.   Now, we ultimately wound up with seventeen

districts.   If you have seventeen district directors reporting

to you, I submit that's not the same as the span of control of

seventeen, because their functions by and large are very com­

parable, and so the span of control is maybe more like three,

you see, and that would mean your span of control is much less

than thirty-five, more like twenty•one.   Now, there has been a

lot of argument in the management field about how broad a span

of control a manager exercises.   I think we've underestimated

at least, in my opinion, the span of control that one can

effectively work with.   I never felt particularly hothered

by the fact that thirty-five people were supposed to be re•

porting to me.   Now, it worked this way, too.   Mr. Rankin

handled a great many of the direct communications with the

staff, but I kept myself in reserve for problems they chose

to bring to me, and we would resolve those problems on the
occasions of those meetings or discussions.


Dr. Y.:
Did Mr. Rankin always report to you about the reports that were
made to him, whether or not they were problems, so that you
were aware of what had been brought up and said?    Or was this

at his discretion?

Dr. G.:
It was largely at his discretion but generally he did.   Now we
                                                                   214




had some checks and balances in the system.   Remember I told

you I wasn't exactly unaware of some of Winton 1 s propensities.

He could be pretty slippery on some things, you see.    If he

didn't want you to know about something, he could sort of bury

it away from you, but I asked each district director to r~port

to me by TWX.   We installed a system.


Dr. Y.:
That was a speed device?


Dr. G.:
Yes, a communications device.   We installed a system within a

month after my assuming the Commissionship which linked all of

our district offices with headquarters by TWX, and every Friday

I asked the district directors to TWX to me outstanding problems,

things they wanted brought to my attention.   Mr. Rankin and I

both personally reviewed those TWX's, and then referred them

for action to the appropriate bureau chief or assistant com•

missioner, you see.   And so there was another mechanism of
bringing problems to the attention of the Commissioner, and
in fact one of the district directors, I in effect forced him
out•-fired him••because he failed to bring a problem to   my

attention.   That was the Seattle District which had a signifi­

cant problem with canned salmon.   Now, it was in the warehouses,

bad seals, and they sat on it for a number of months.     It was a
                                                                    215




fantastically· large preblem.     It ultimately consumed a great

many hours of inspectors' time.      It was an industry type of

prohlem.     It represented a potential hazard in view of the

botulism problem of a few years earlier that just couldn't

be countenanced.     And yet, the district director sat on this

problem and never reported it to me.      In fact, in spite of
the fact that he was submitting every Friday a telegram telling

me nothing was wrong in Seattle, here he bad this damn problem

be was sitting on.     So, it didn 1 t always work, but at least

they bad a channel directly to my desk once a week, plus the

telephone.


Dr. Y.:

The TWX system is an example of an inn0vation of the hardware

of cemmunications and planning, it seems to me, that was part

of your new regime.     h   you want to talk about that?   You've

been interested in this kind of problem all through your career,

it seems to me.


Dr. G.:
Yes.   You have to take advantage of the hardware as a means of

facilitating communication.      It's nothing more than a device to

assist in communication, to speed it.      It's one more way of

opening a channel; it's a different channel.      Perhaps, each

type of channel of communication has its own virtues, the tele­

phone, the TWX, the written letter, the in-person confrontation
                                                                   21'



and discussion, the conference, these all have advantages, and

I simply wanted a range of these availahle to the key staff to
use.


Dr. Y•:

I take it with regard to automation all over, that the Food and

nrug Administration previously wasn't an agency that was at the

cutting edge of•••


Dr. G.:
No.    My God, no.   They weren't using a computer, not that you

need a computer for everything; certainly, with the masses of

data that the agency had to and does have to cope with, it just

became •••and their inability to retrieve any information when

you wanted it, which was the really significant thing.     Hell,

you could have information from hell to breakfast, that's fine,

but if you can't retrieve it, it's not worth a damn.     And so,

it became apparent, early on, that we had to have some kind of

automation in order to retrieve data.    The sheer volume af in•
formation on inspections of various firms throughout the nation
was such that we needed it, and so we did form a task force to
study the problem, and they recommended that we acquire a computer.

We did acquire a computer.    P·art of the Booz, Allen and Hamil ton

study waste leok at the inspection system; tbe report forms,

the information that was gathered, how it was stored and utilized
                                                                  217




and fit this in.   And that bas been done, you see.


Br. Y.:
And once you acquired that capability, there were other angles

you could push it into.   What are •••


Dr. G.:
Well, you could begin to develop an information system for

management of the agency so that you were consciously making

decisions based on information from the district offices, from

the inspectors' reports and you weren't managing as much on an

exception basis, or you wouldn't be when it was fully imple•

mented, or at least, you bad a fuller range of information

available.   You could do more critical analyses and show where

the productive man hours or man years of effort were derived

from; you could then redirect the use of personnel.   There were

all sorts of added benefits.   Ed Tuerk came with the agency

from the Communicable Disease Center, by the way, and I shouldn't

omit talking about Ed Tuerk, an unusual person.    Ed worked with
the VD program.    In fact, many say Ed ran the VD program at

CDC.   A very strong individual, an extremely intelligent guy.

And an abrasive sort of a person.    He rubbed people the wrong

way, because Ed made them aware of their own deficiencies.


Dr. Y.:
He always seemed very quiet and shy to me.
                                                                    218




Well, he bas that appearance initially, but in a meeting or in

a discussion with him, Ed would begin to ask questions that

soon get on people's nerves.     And I had many problems even with

the FDA staff that came about as a result of Ed having come

there, but, on the other hand, Ed did so much for the agency

that those are the kinds of problems that an administrator is

happy to put up with.     It was Ed who devised a different method
of reporting, who, in essence, worked out within FDA what turned

out to be the first significant program within the department of

Health, Education and Welfare eolleetion of agencies on PPBS.


Dr. Y.:

Now, that is •••


Dr. G.:

The plant performance budgeting system.


Dr. Y.:
Right.    The same thing that had been used in Defense?


Dr. G.:
Yes.     It was the Hitch-McNamara type of system.   Ed was respon­

sible for this in FDA, and we were the first agency in HEW to

get off the ground with it and probably did it a better way

than any other agency.     Some agencies maintained they couldn't
                                                                      219




do it, but be that as it may, Ed Tuerk was the assistant com•

missioner for planning.


Dr. Y.:
And, of course, this sort of analysis of the past was relateu



Dr. G.:
Extremely important, you see, and one thing that Ted Cron and

I soon perceived as.!!!!, major problem in FDA at every turn in

the road was "There's no data base."      It got to be so comm<1>n

that it became almost a joke between Ted and I.      We'd just look

at each other and say "data base," whenever this problem came

up throughout our stay at FDA, because, no matter what the

question was ••• "How many drug companies are there?"     I would

ask, lli., ask, early on.   "Well, we think there are 9001 "     I

said, "What do you mean 'think'?     Aren't you required to in•

spect them once a year by act of Congress?"      "Yes."   Then I'd

say, "Why don't you know?"     "Well, as near as we canaell, there
are 900."     And after Ed came, I said, "Ed, how many drug com­
panies are there?"     Be said, "Doctor, as far as I can find out,
there are 714, but," he said, "let me point out:       don't attach

any significance to that having a high degree of aceuracy. 11

And a few months later, I said, "Ed, bow many drug companies

are there?"     Fie laughed and Ile said, "I think there are 650."
                                                                     220




And before I left, I think it was down to around 572.      It was

interesting that we didn't have a good data basis in almost any

part of our work in FDA.      How many food companies are there?

Well, nobody really knew, you see.      And so it became extremely

important to have people such as Ed Tuerk.      Ed is fiercely

independent and, again, was extremely valuable to me because

of his independence.      Now, the FDAers, the old-liners, hated

Ed's guts, and many of them hated my guts, too.      I knew this.


Dr. Y.:

This was because it upset the familiar applecart?


Dr. G.:

Of course.   Of course.    And because Ed was very demanding of

them, and, you know, he took them te the wood shed.      They would

give him garbage, and where garbage might have gotten by at one

time, it didn't go with Ed Tuerk, because Ed, on the other hand,

knew that I weuld question him, and even if I hadn't, Ed would

have gotten good information.


Dr. Y•:
What kind of background training did he have to make him this

sort of person?


Dr. G.:
Well, Ed, as I recall, started as a VD rep, and worked up in
                                                               221




the management field.   Now, be had worked for a little more than

a year at Emory on his doctorate, just before coming to join FDA.


Dr. Y.:
He talked with me about his dissertation•••




Uh huh.


Dr. Y.:
About being on his committee, but I imagine that he just got so

busy that he just hasn't had•••


Dr. G.:
I hope he's followed up on it because •••


Dr. Y.:
He's got a whole, new political science department.


Dr. G.:
Yes.


Dr. Y.:
Well, one other area in which this data base problem and the
computer to help acquire a data base was of great significance,

I guess, was in the adverse reaction reports, wasn't it?
                                                                       222




Dr. G.:
Ob, my God.     That was a mess and it still is, I'm afraid.     The

adverse reaction reporting system theoretically was being managed

in the Bureau of Medicine by a Dr. Donald Lovett there.        Well,

it turned out that this was entirely unreliable.     So was Dr.

Lovett, and we had to get rid of him, and we fortunately did,

but Dr. Lovett was one of Joe Sadusk's favorites, and be was

a right engaging kind of a guy, but he was in private practice

at the same time that he was working at FDA.     A number of the
physicians were and I tried to eliminate that.     I was never

completely successful.


Dr. Y.:
Just a question:     This, I imagine was a financial situation.

Was one of the reasons you weren't able to do it the old old

problem of inadequate salaries?


Dr. G.:

Well, by the time 1 left, I didn't feel that that really was the
problem, because we got the salary levels up during my tenua as
Commissioner.    We were paying pretty respectable salaries to
these people, and I didn't feel there was justification for

them remaining in private practice, and so we tried to ••• Bon

was particularly active in practice and was often away from his

desk, and we made book on him and just before we were about to
                                                                     223




throw the book at him, he resigned, but the whole time he was

there, that adverse reaction reporting system was a mess.      The

practicing physicians were net reporting to either us er the

AMA.     The AMA, during the latter part of say, '67, early '68,

they dropped their adverse reaction reporting system because

it was totally unsuccessful.     We were paying from FDA money to

residents in hospitals five dollars a report to submit a report.

Reports we were getting were highly repetitive, penicillin re•

actions, sulfa reactions, et cetera, and I didn't think worth•

while.     I asked Here to dig into this one.   Of course, he had

so many other things to do and, in truth, nobody has come up

with a good method of gathering adverse reaction data.


Dr. Y•:

Did the Dakota experimental system work or was it the same ••• ?


Dr. G.:

It never was set up.


Dr. Y•:
It never was?


Dr. G.:

No.


Dr. Y.:

I thought that was ••• it was on the planning board, I guess, at
                                                                    224




the time I talked with you, but it never did get set up?


Dr. G.:
No.    The Public Health Service wouldn't fund it.


Dr. Y.:

I see.

Dr. G.:

Yes.     So the adverse reaction reporting system never functioned

properly and I don't know the answer to it.       I tried to get the

Bureau of Medicine in late '67, early    1 68,   to work out a system

where a physician could phone in an adverse reaction and in

exchange get information on drugs involved in the treatment of

adverse reaction or\ on any drugs he wished, and not necessarily

a quid pro quo.     I worked out with the telephone company and met

with AT~T officials to discuss the possibility, and they were

interested in the program.     It would have involved the use of

inbound watts from all over the United States, and we felt the
way to go at it was to start in the District of Columbia and

have the phones manned from 8 in the morning until 11 at night,
using medical students from the medical school in the evening,
or physicians who were on our staff.     I never could get the

Bureau of Medicine staff to actively go after this.       They could

be quite successful in resisting you.     Again, it was something

that Dr. Ley, being so busy getting rid of the new drug backlog,
                                                                      225




couldn't give much personal attention to.     He thought the idea

was worthwhile.   If the District of Columbia experiment was

successful, we were going to open it up to New England physicians

as a group and then, region by region, extend it.      Now the phi•

losophy behind that was that physicians are quite leary of making

a written record of an adverse reaction because of possible medi•

cal-legal problems.     But if they could telephone free of charge

and provide the information, thus help other physicians, and at

the same time, get any information they wanted on drugs, not

advice on treatment, but information on drugs, I felt that it

might work more successfully than the current adverse reaction

system.   But I never could get Arthur Ruskin, who was in charge

of this project, to get off his ass and get the D.     c.   Medical

Society moving on it.    So he just sat there.    Now those are

the kinds of things that are frustrating because you see the

possibility, you have the idea, and you then turn it over to a

staff person and he doesn't follow through.      Well, your time is

occupied by many, many activities and responsibilities, and so
you can't yourself do everything personally, and I never believed

in that as an operating philosophy anyway.       I always believed in
delegating and then seeing to it that the person got it done,

and Arthur just wouldn't do it, and Herb couldn't spend enough

time following it up, and I couldn't either.
                                                                   226




Dr. Y•:
But the data base in this field is indispensable to the •••


Dr. G.:

Terrible.    We need it badly, and y.et it doesn't exist, and there

doesn't seem to be, at this point in time, a good tne;thod of

siphoning that information off from the routine information

that's collected in hospitals.    I think it can be done when we
get computer-based hospital information systems.


Dr. Y.:

Right.    You even were looking into the possibility of having the

Food and Drug Administration be responsible for adverse reaction

reporting from the whole world, weren't you?


Dr. G.:
Well, we did work out a contract with the World Health Organization

where we would provide facilities and let them use our computer

on the WHO adverse reaction reporting from member nations, and

we simply were providing housekeeping assistance, some funding

of the project, and they were calling the shots with respect to

what infonnation they wanted, the format of the reports, et
cetera.


Dr. Y.:
Did that go ahead?
                                                                   227




Dr. G.:
Yes, that's operative.




That's operative.


Dr. G.:

But it has the same limitations as the   u. s.   system.


Dr. Y.:

One of the other segmeats that was very important right at the

start, of course, was the confrontation with the drug industry.

Would you talk a little bit about how you assessed what had been

the status of the relationship of the drug industry to the

agency before you came and how you sought to apprise yourself

of what the drug industry was about and tell of the contacts

.that you had, especi.ally with representatives ef the Pharma­

ceutical Manufacturers Association.


Dr. G.:
F:trst of all, my feeling was that the agency had gotten too

close to the drug industry.   Now, in part this was substan­
tiated by Morton Mintz 1 s book where he talked about that mole~

cule, the PMA, the FDA and the AMA.   And, indeed, it was in•

teresting if you looked at the hearings, and I used that in a

speech one time.    The PMA said this, the AMA said this, and the
                                                                    228




FDA said this, and they were all talking the same party line.

Well, that didn 1 t seem right.   Not that there necessarily has

to be a difference, but it seemed a remarkable coincidence.        So

I decided that there was too close an alignment there, that Dr.

Sadusk had been unwilling to step on people's toes, his philos•

ophy was that the practicing physician knows best.     So, in

looking at the drug industry, I first began by looking at

NDAs, the new drug applications, and reading those in the even­

ings.     I had a stack of them on my conference table in the

office.    And the more I read, the more I began to appreciate

the very complex and subtle problem that the drug industry was

posing, and yet the very serious problem it was posing, by

virtue of its wordsmanship in using Madison Avenue agencies

to distort the factual data in order to induce physicians to

prescribe drugs.    So, I had the strong feeling that they were

invelved in that kind of an activity; secondly, that their re­

search really wasn't as good as it should be or as good as it

needed to be.    These conclusions were formed well enough by
April 6th, I believe it was, when I spoke to PMA in Boca Raton
that I really laid out the agency's position at that time and
somewhat shocked the pharmaceutical industry.     They were watch­

ing with great interest, of course,    They had sent many dele•

gations to see me, and I had made a practice of meeting with

the medical directors and some of their staff in the evenings
                                                                    229




during the early months.   Perhaps once a week, I would meet at

the Madison Hotel and have dinner with them.    "Them" being the

medical director of Smith, Kline, and French, for example.


Dr. Y.:

You mean one at a time?


Dr. G.:
Yes, individually.   And I felt I was fair game for that.    They

wanted to know me, talk to me and be able to have an understanding

of how I looked at their world, so I tried to make myself avail•

able in that fashion and did.    So I was getting a lot of input

from different sourceso    I had those kinds of meetings where I

could probe the individuals.


Dr.   Y•:

Did yeu feel these were valuable or did you feel there was a

kind of conspiracy to give you the same kind of point of view

all the time?


Dr. G.:
Well, there was a remarkable similarity in point of view, but it

was helpful to get to know the kinds of people who were employed

by tke pharmaceutical industry, to know what I was up against.

I don't think there was any conspiracy.    1 1m certain they shared

information.
                                                                            230




Dr. Y.:
Well, that's all I meant.


Dr. G.:
I know that because it soon became apparent that my drink was
bourbon and ginger ale, and I would go   to. ,tb:etr .,s,ttiteifff,E<tthe
meeting in the evening, and, sure enough, there would be bourbon

and ginger ale.


Dr. Y.:
So that you didn • t even need to ask.


Dr. G.:
I didn't even need to ask.   The first couple of sessions I had,

there wasn't any ginger ale, and I had to ask, and they would

have it brought up, but it became apparent that the word got

around very fast, and I assume that if!!!!! word got around,

other kinds of information were shared by the medical directors

that I met with.




Well, in these sessions, did you mostly listen or did you in your

turn seek to present to these individuals the same point of view

you were later to present to the industry in your speech?


Dr. G.:
I did both.   I tried, first of all, to find out what it was they
                                                                  231




thought the problems of the FDA were.    This part was very useful

to me, because they, after all, were dealing with the Bureau of

Medicine on a day-by-day basis, and this gave me a good fix on

what the internal problems of the Bureau of Medicine were.     And
many of them were willing and responsible enough to be very open

and above board, very forthright, in their discussions of the

problems, naming individuals who they thought were blocking,

like Frances Kelsey whom we had to move aside to get at the

IND problem in an effective way.   They were willing to name

individuals.   Well, this was useful.   Then, secondly, I could

explain to them what my concept of the agency's reJponsibili­

ties in their particular field of interest were, and I think

that ~as helpful to them.


Dr. Y.:

A part of this, too, was speaking with the head man, I suppose,

in the pharmaceutical industry insofar as it was pulled together

in the trade association, Joseph Stetler?


Dr. G.:

Joseph Stetler, yes indeed.   I had known Joe when he was counsel

for the AMA.   I was working in the field of highway safety, and

I was on the AMA.ts committee on traffic safety which Fletcher

Woodward, Dr. Fletcher Woodward, was chairman of.   Joe attended

occasionally those meetings and talked about the legal aspects,
                                                                   232




and so I got to know him and I thought he was a very effective

AMA counsel.   Now, when I went into FDA, not immediately after

my appointment or swearing in, but within a reasonable period

of time, Joe invited me to have lunch with him, or perhaps it

was dinner, I don't recall now, but he then tried and!.!!, ex­

plain to me what he thought the role of PMA was, offered assist•

ance and willingness to work together.




What kind of a person is he, and how does he operate in his

position?


Dr. G.:
Well, Joe is an interesting man to watch at work.    First of

all, Joe will dedicate himself completely to the interest of

his employers, totally, in a way that I never could.    I could

never work for AMA and do the kind of jobs that Joe does, or

PMA, because inherently there are some things wrong about
those organizations.   Jee is able to accept those, throw himself
wholeheartedly into their werk, and I just eouldn 1 t do that.

So, he is an interesting person from that point of view.    Even

though he may personally have reservations about the way they

operate, an organization operates, he apparently can subjugate

those to his sense of responsibility for the job and not make

any effort to change them.   I may be misjudging him on that last
                                                                    233




point, but certainly he knows what the problems of PMA are.

He knows it's a lowest common denominator organization.     Joe

is extremely intelligent.     He's a shrewd operator; he's a good

infighter.     Joe knows how to handle Congressional liaison func­

tions.    He knows who to lean on to get something done.   Now,

what people often fail to perceive is that within the establish-

ment Joe can come to people like Wilbur Cohen and sit down and

tell him openly--and to me--when we had a bill pending:     "We

have x number of votes and you have x number and we have you

beat on this one."     I sat there and listened to this kind of

discussion.    There was no hiding of information on that bas.ts.

When the hattle lines were drawn, he knew what the issues were,

he knew who to go after, and he was very realistic and open

about dealing with you on that.     I never found Joe to go back

on his word.     He was a very direct person in dealing with me.


Dr. Y.:

How was he from the point of view of compromise, because lots

of the issues that there were between you and PMA, particularly

I think of the big issue of advertising regulations, were issues

that neither one of you wanted to get into the courts if you

could help it.


Dr. G.:
Well, Joe, being a lawyer by training, you see, Joe was very
                                                                   234




effective in the battling for position in a compromise.     He was

much better than I at this.    Now, the thing that bothered me

most about Joe in those dealings, when I was willing to com­

promise, when there was room to compromise and not give away

the public's interest, where we would state a position in

excess of what we really thought was needed to do the job and

thus had room to retreat, Joe would, far too often, fall back

on legalities.    Now, that was his major shortcoming, in my

book.     He would say, "Well, of course, that won't stand up in

court," or "If necessary we can go to court on this," and that

got my dander up at times.     I learned to keep my cool and not
get into a fight with him about it, but it became apparent that

this was a stumhling block for us and we could have more effec­

tively compromised a number of issues had Joe not been so legal­

istic in his thinking.


Dr. Y•:

At least by bringing the cases, whether or not he would have won

as he thought, he could have put off any sort of enforcement for

years.


Dr. G.:

Yes.     Well, provided there wasn't an imminent danger to the public

health.     Now, one of the things that Joe had to contend with that

I didn't have, Joe had a board of directors at PMA, and that may
                                                                       235


well have hampered him bi·,r,.his dealings with us, you· see.    Be•

cause, then it did come down to the lowest common denominator

type of decision that he could get from the board on bow to go

at a problem like advertising regulations, you see.      So, to be

fair, I didn't have that constraint that Joe had to work under.


Dr. Y•:

You had a certain eye over your shoulder on what Congressional

committees might do.


Dr. G.:
Oh, of course.   I had, more importantly than that, I had the

basic authorizations and responsibilities that Congress had

afforded the agency.    This meant that you had a public trust

that you had to meet.    You couldn't give that away.


Dr. Y.:
Well, I didn't mean that.


Dr. G.:
No, I know you weren't suggesting that, but always ••• I never

really worried ab0ut Mr. Feuntain and his Oversight C0mmittee.

I thought that if the agency met its responsibilities and I met

mine with respect to the public trust that Congress had given

us, then Mr. Fountain wouldn't have any complaints.      Sure

enough, that's the way it worked out, too, as you know.         But
                                                                 236




another interesting thing with the pharmaceutical industry, not
only did we have the dealings with Mr. Stetler and the PMA

which were very difficult, for the reasons I've cited, but also

we had the direct confrontations.   This is an innovation that

Mr. Goodrich has commented on (Mr. Goodrich was and is the

General Counsel for FDA).   For the first time I required the
president and/or the chairman of the hoard to come into the

Commissioner's office, on faulty advertising and misleading

advertising, and sat them down and went over it with them.

Billy Goodrich always felt this was an extremely significant

departure from what had been.   First of all, almost nothing had

been done in the past, but be felt that for the first time the

corporate head w,as beginning to feel the weight and pressure

of a public agency, and be felt this was an extremely important

venture that we undertook, as a change.


Dr. Y.:

Well, now, one of the first examples of this might very well have
been Peritrate.


Dr. G.:
That was when we got Dr. Len Scheele in.   Len and Bob Clark.

Bob Clark was the president of Warner-Chilcott which was part

of ••• in that corporate structure he worked with Len Scheele, who

in turn worked for the former governor of New Jersey who was
                                                                    237




chairman of the board of Warner-Lambert at the time, Alfred
Driscoll.    Now, I got Governor Driscoll, Len Scheele, who bad

been Surgeon General of the Public Health Service when I first

came on duty as a commissioned officer, you see, and Bob Clark

in on the Peritrate.


Dr. Y.:

This was the first seizure under the Kefauver-Harris advertising

provision.


Dr. G.:

That's right, for misleading advertising.     They were using

animal data and presenting it as if it were data on humans.

They had ignored the results of certain studies that had been

carried out that did not show Peritrate to be of value, the way

other studies did, which weren't as carefully controlled, which

they did present.     In their advertising message, they had an
eight-page color ad, a series of them, that they ran in dif•

ferent medical journals which were misleading, and so we did
seize the drug.     Now, I learned a very valuable lesson from
that, and, unfortunately, you have to make certain mistakes in
order to learn, and I perhaps should have perceived that this

could have happened, but the mistake was this:     The seizure of

the drug was not understood either by the public or the practic­

ing physician.    Our laws that we operate under go back to old
                                                                  238




admiralty laws, and this seizure was indeed a token seizure.

You seize an amount of the drug to provide a basis of issue

to bring before the courts in a speedy fashion, you see.


Dr. Y.:

Rigbt.




You don't seize the entire drug.   You don't withdraw it, order

it from the market, but you engage in the seizure in order to

get the issue before the courts, and that was deemed in the eld

days as the fairest way of handling this matter.   Now, what
happened, and this happened in spite of accurate reporting on

the part of the press, the public press, it created great con•

stemation on the part of the patients who were receiving this

drug, because they hadn't read the story carefully, they didn't

realize the safety of the drug was not in question, and tbey

besieged their physicians with phone calls, and it resulted in

physicians calling us and great consternation.


Dr. Y.:
Your attack, so to speak, was aimed at the advertising which

made the drug sound as if ibr;was useful for heart problems

other ~ban angina?
                                                                     239




Dr. G.:

Well, not only that, but that it was misleading with respect

to how useful it was in regard to angina.


Dr. Y.:

Is that right?


Dr. G.:
Oh, yes.     And that the data submitted••• , for example, they used

pigs for certain kinds of studies and didn't clearly indicate

to the reader of the advertising that this data was derived

from pigs.


Dr. Y.:

Did this seizure occur before or after your confrontation with

the officers of the company?


Dr. G.:
It occurred at the same time, as I recall.


Dr. Y.:
I see.


Dr. G.:
The seizure really is under the control of the    u. s.   Marshal.   It

probably, thinking back, w,as just before.    Now we seized subse•

quently a drug.     It happened with Upjohn and that seizure took
                                                                  240




place at the same time as my meeting with Mr. Ray Parfet, the

bead of Upjohn, and his staff.     So, I think the Warner-Chilcott

was just before.


Dr. Y.:

Do you want to talk about that particular meeting since this

was the first major ease, as an example.


Dr. G.:

Let me finish up on the other, and then we'll talk about the

meeting.   The lesson learned was that it's bad to seize a drug

unless there is a matter of safety and you wish the drug off

the marketplace, because neither the public, who you ean•t ex•

pect to be totally informed, nor the physicians clearly read

the stories and understood them.     So the press wasn't at fault,

but it created such alarm on the part of patients who, by the

way, in that instance, sheuldn 1 t have been alarmed••you don't

want to alarm cardiac patients-•that we decided after tee

episode not to seize any more but to use a different method.

Now, the meeting itself was quite interesting.     Len Scheele

never said a word, to my recollection.     He just sat and listened.

Bob Clark who was the president of that particular part of the

Warner-Lambert corporation, Warner-Chilcott Labs, I think it's

called, bad to hear the brunt of it.     He was very direct and open

in his dealings with us, very frank, and he was quick to admit
                                                                 241



after questioning some of his own people that the information

was not properly presented and that he did promise to remedy

it.


Dr. Y•:

So that you had a feeling that he was unaware of the fault as

of the time of the meeting?


Dr. G.:
In fact, I found that very commonly the president of the com-

pany wasn't aware of what was going on, and this was one of the
reasons that it was significant to bring them in, to force them

to become aware of what their advertising people were claiming

about their drugs, and to begin to view drugs in a little dif•

ferent way.   As you know, ultimately we brought some 24 companies

before the Commissioner in that two-year period, some 24 instances,

rather, because some of the companies repeated.   They had to be

brought in twice for misleading advertising.   So, this was a

departure, to bring the president and/or chairman of the board
into the Commissioner's office, let him see his medical director

being questioned and have to yield to the agency people on the

lack of validity of claims and let him see his advertising people.

At times you could just see the president begin to get mad, at

his own people, not at us, that they had been so stupid.   In

fact, let me say that, almost without exception, there was, in
                                                                  242




almost eve}'!Y instance, agreement between the corporate president

and myself on the company objectives and how their aevertising

should be pursued and what the ethics of the situation were.

Henry Gadsden of Merck Sharp and Dohme; Barney Mattia of Hoff­

mann•LaRoche, all of these individuals, pharmaceutical company

presidents, were not in disagreement with me, and I felt that

their agreement was a genuine one, not one that was contrived to

fit the situation.    That was reassuring.   It was upsetting, too,

because it also meant that they weren't paying attention to what

~heir people were doing.


Dr. Y.:
Well, if they did reach agreement with you in these individual

cases and •••


Dr. G.:

We began to see some change.    I think the advertising, even in that

short period of time, two and a half years, we began to see more

honest advertising.    It became tougher to find in the printed
journals examples of advertising as grossly misleading as it was

in the early days.


Dr. Y.:
Well, now, why was it, then, that you had so much opposition to•

ward getting the kind of guidelines that you,idrew up?
                                                                       243




Well, they •••


Dr. Y.:
Is that the lowest common denominator problem?


Dr. G.:
I think it's the lowest common denominator thing, and then,
secondly, they know that the regulations have the force and

effect of law, and they didn 1 t want the guidelines to go into

regulations.     They wanted the situation left as it was, so their

common plea-,was a lack of understanding of the regulations.      In

every meeting we had, they said, "Well, we didn 1 t understand that

that was what the regulations really meant.     That wasn 1 t clear."

And we set about to make the regulations more clear and more

explicit.   Now, then you see, they feared getting their hands

tied by these regulations and they would then have no defense.

So they didn't want this degree of explicitness to occur.


Dr. Y.:
They didn't want them to be either too vague they couldn't under•

stand •••


Dr. G.:
Oh, I think they much preferred them to be toe vague, because then
they had an easy out if they got caught.    Now, keep in mind that
                                                                 244




we had only six people working!!.!!!!, peak on misleading adver­

tising in FDA.    Now, in contrast, the pharmaceutical industry
spent that last year I was Commissioner about $800,000,000 on

advertising.     So there were literally hundreds and probably

thousands of people involved industry•wide in advertising activi•

ties.    So it was a sort of David and Goliath proposition as far

as we were concerned.    We couldn't begin to review all of the

aevertising, and we simply wanted to make them aware that, by

causing a "Dear Doctor" letter to be issued •••Now, that cost

them $40,000, just the mailing costs and the cost of changing

the ads; altogether the penalty probably was a hundred thousand

dollars.   Now, that's insignificant, because the risk was rela•

tively slight in getting caught, and they really depended on not

getting caught, and if they did, by that time they would have

gained enough of the marketplace that a hundred thousand dollars

really was a tap on the wrist.    This was one of the problems with

FDA.    It needs stronger penalties to invoke against manufacturers.

The most effective thing we did, the one that really got a manufac­
turer's attention the quickest, was when Bristol-Myers had negotiated

over labeling for a new penicillin called "Dynapen" for months,
quibbling over words in the final printed labeling, bringing to
us their advertising for pre•clearance because we perceived problems,,

and, after all this was done, a week before the NDA was formally

approved, in other words, when they had received notice that the
                                                                    245




NDA was going to be approved and began developing their advertis•

ing campaign, they came out within a week before the formal approv­

al and marketing of the drug with a letter to all physicians that

was misleading as,,hell.    In spite of all this negotiation and good

faith.    Well, it was an antibiotic, don't you know.    So I called

the president on Friday and said, "We are decertifying all the

stocks of "Dynapen" that you have sitting in warehouses.      Now,
first of all, I said, "We are having some problems with the ad­

vertising.    Would you like to come here Monday and discuss that?"

"Oh, no", he said, "I don I t think I could get there Monday.       I

have something else.     Perhaps, later in the week."   I said, "Oh,

I just wondered, because we are decertifying all of the .tnynapen. '"

He said, "Could we meet tomorrow?"      This was a very effective

thing.    This, of course, was why I think the pharmaceutical manu­

facturers fear registration, because if the agency could withdraw

registration, their drugs would then be illegal in the marketplace.


Dr. Y.:
The whole shebang.


Dr. G.:
The whole shebang.     Everything.   And this is the kind of penalty,

I think, that the agency is ultimately going to have to have
available to get at the problem and control it.
                                                                   246




Dr. Y•:

Well, now, some of these decisions in the small number of cases

that your small staff was able to check out, some of these were

really your own from reading?


Dr. G.:

A few.    Many of them came from doctors who wrote to the agency

who had worked on the drug during its IND stage, and some of them

were agency personnel getting mailing pieces at home because they

practiced medicine, and they'd bring them in and say to Dr. Mc•

Cleery, ttDr. Mccleery, look this one over.   I have reason to

think••• "


Dr. Y.:

I was getting around to him.    Would you speak about him a minute?


Dr. G.:

Well, Bob was an interesting person.    He had been a surgeon at

one time.    He worked for a Madison Avenue advertising agency that
handled pharmaceutical accounts, so he knew that end of the business,
and he was in charge of medical advertising review.     My first en­

counter with Bob, he asked for the opportunity to see me, and he

rode to Dulles Airport with me because my schedule was so jammed
that was the only time I could see him that week.     And enroute to

Dulles Airport, he told me the problems in medical advertising.
I was very suspicious of Bob McCleery at that point in time.       I
                                                                  247




asked him, in fact, point blank, I said, "Are you an iconoclast?''

And he said, "No, I don't believe so."


Dr. Y.:

You mean you thought he was so far out he was in the next county?


Dr. G.:

Yes, I did, and only later I came to have great respect and trust

for his capabilities.     He was a methodical workman, analyzing a

pharmaceutical ad.    He could take it to pieces and dissect it

beautifully and did so.    When Bob came to you with something•••

at first, I was very leary, as you might suspect, and I would dig

into it myself and leok at the references and read the ad and study

the literature.    I insisted on all of the background literature
being brought to my office so that I could personally review it,

and I did that for quite a few of them, and I never caught Bob

out on it.    As I came to understand this very complex individual,

who has since left the agency unfortunately, I respected his
capabilities and never found him to be wrong in the analysis of
an ad.    When he had it down, it was well documented.


Dr. Y•:
Do you believe that it was he who was important in getting your
                                     )

attention to this in the full degree that it•••
                                                                  248




Dr. G.:

Yes, I think Bob should be given credit for that, and I tried to

give him credit at the time of his retirement.     He and Billy
Goodrich.     Of course, Billy right from the start, as well as Bob,

said, "Doctor, this advertising is terrible and something's got

to be done with it."     Old Billy is an extremely shrewd guy.    He

knows what's wrong, where the bodies are buried.     I relied ••• in

fact, I should mention Billy Goodrich.     I gave serious considera­
tion to using Billy as a deputy.


Dr. Y.:

Is that s07


Dr. G.:

Yes.   At one point in time, when I was weighing Billy Goodrich

versus Winton Rankin.    Now, the reason I finally didn't was be­

cause I felt I couldn't afford to lose Billy in his other capacity.


Dr. Y.:

Exactly.


Dr. G.:

Not that I didn't think he wouldn't make a good deputy, but I then

said, "Gee, who would handle this other?"    And as we went furtller

and further down the road, I said, "Boy, I may have s1>me problems

with Winton, but I'm so glad I left Billy where he is because he
                                                                249




was such a pillar of strength for the agency and for me."      It

would have been a great loss to have had him••• he would have been

a good seputy, I'm sure.


Dr. Y.:
Sure.     He always had such an imaginative way of seeing what was

inherent in the law.


Dr. G.:
He was my idea of a go0d lawyer, because Billy would say, "Docter,

we can de anything you want to do.     The law says this.   Now, if

you want to do that, I' 11 guarantee you we can do that."     But he

could very subtly suggest to you the ways he thought you ought to

go.     I learned to listen to Billy very carefully.   Not that we

didn't disagree.


Dr. Y.:
What d:klyou disagree aeout particularly?


Dr. G.:
Well, let me think a minute.     There weren't very many things that

we disagreed on.     I'd have to give some thought back to dredge
up the one or two occasions where we disagreed.


Dr. Y.:
Well, let me put that down as a question for the future.
                                                                    250




Dr. G.:

Okay.     Now, on the advertising, Bob Mccleery was very important.

I relied on him.     He then worked up the material, and it took

about ten man days to work up one ad.      Then we would get the presi•

dent of the company.     He almost always brought his lawyer, his

medical eireetor, his vice-president for advertising, whatever

title he may have had, along with him, and he would be met in my

office by myself and Mr. Goodrich, Dr. Mccleery, Dr. Ley, or Dr.

Robinson prior to that time, and Mr. Cron.      Ted bad a good feel

for these things, too, very quick to perceive, and a good under­

standing of words, which is why _I had him there.




And probably no great sense of awe either.


Dr. G.:

Oh, none at all.     And we would then discuss the ad.   Dr. McCleery

would have prepared a brief that I would use, and I would make

copies available to the pharmaceutical company people, so that
they had everything except the recommended course of action
available.     We would then tell them, after discussing what was
wrong, getting their agreement, we would then say, "Alright, we

think a 'Dear Doctor' letter is indicated.     Why don 1 t you go write
one?"     Now, it was funny.   They would try ta weasel out from

under that "Dear Doctor'' letter and write it as if••• In fact,
                                                           251




most of them turned out on the first draft to be more promotional

than apologetic.   I guess that's a natural tendency, but, at any
rate, we then bad to hold their feet to the fire and force them

to do it in a responsible way.   This really wasn't a strong

enough penalty for them, as I've mentioned before, but another

effective one we got at was forcing on "Dynapen," not only forc­

ing them to write a second letter to all doctors, but also cor•

rective ads.   That was a different thing.   That was just before

I left.   We forced them to run in the same medical journals that

they bad run the misleading ad, corrective ads.


Dr. Y.:

Well, it looks as if we are going to have to take up the next

topic the next time.   Thank you, Jim.
                                                             252



Dr. Y.:

This is one more in a series of conversations with James L. God­

dard, and I am James Harvey Young, this one being held in Dr.

Goddard's home on June 11, 1969.   Jim, I happened to be with you

on the day that you turned in your resignation, or rather your

retirement, to the Secretary of Health, Edacation and Welfare

last May, a year ago May, and you told me right after that that

one of the reasons you felt free to take this step was that you

had kept a little list from the very beginning of your experience

as Commissioner, and on that list you had the things that you

needed to get done.   Now, what was this list?   Is it a document

that exists?


Dr. G.: -

Unfortunately, it's not a document that still exists.   This was

a habit that I had acquired over the years in a variety of jobs.

I would make a list of items that I could foresee as being needed

in the next six months, twelve months, one, two years, three years.
And I would keep that in the bottom, right hand drawer of my desk,
and periodically I would in an idle moment pull it out and check

off whatever had been accomplished, maybe add one or two, and over

a period of a year or so it would require being redone, and then

I would throw the original one away.   Well, I made such a list up

shortly after getting into the FDA job, and it expanded as I went
along and began to learn more about the agency and what might be
                                                            253




needed.   The first list had on it such things as an improved

communications system; a computer center for record-keeping pur•

poses, a data processing center for FDA.    They were without one

at that time, a computer-based one.   And these were the kinds of

things that would be on that list.    They were sort of objectives

that I would set, an improved professional recruitment program,

this type of item.   Now when I told you that I 1 d completed the
list, I meant I had fairly well completed what I had visualized

at the time I took the job, when Dr. Gardner requested me to

take over.    It shouldn't certainly be suggested that everything

was finished that needed to be finished.    There are still many

unfinished things at FDA.


Dr. Y.:
You told me at the time that you had "gotten them rolling."

That was the way you put it.




That I s right.


Dr. Y.:
Well, as one just begins to run down the calendar after you had

first come in, one finds this Peritrate ease, about which we

talked some last time, looming into view.    Now, as you look back

upon teat experience, which was the first major case as far as

yoa were concerned involving pharmaceutical advertising, how does
                                                                 254




this case and what arose from it look in retrospect?


Dr. G.:
Looking back on it, it was an important landmark for the FDA

because, as Mr. Goodrich has pointed out, this was the first time

we involved the chairman of the board of a company in discussion

with the commissioner.     It was the first time the agency really

became the agressor in trying to get the industry to live up to

what the law required.     It wasn't the abse.nce of good law that

prevented the agency from acting in the years following passage

of the 1962 Act, but they simply didn't take the initiative.        So

I would view that as a turning point in terms of the agency now

taking the initiative, getting at the industry, making known to

the industry what the agency would and would not countenance in

advertising.    They had really never done this, other than in

the spelling out in the regulations, which they then proceeded

not to enforce.    Now, we clearly demonstrated we were going to

enforce them.     Of course, I mentioned the last time we met the
lesson learned in terms of not upsetting the general public by
virtue of newspaper stories not being clearly read even though

they were accurately written reflecting the seizure as only being

a mechanism of getting the issue before the courts for discussion.

We learned that lesson. ~d from then on we moved rather promptly

against the firms that we could find.     I mentioned also earlier

the lack of adequate staff to police this area, but I'm satisfied
                                                              255



and was satisfied at the conclusion of my thirty months as coanis•
sioner that we had followed the spirit and the letter of the

Kefauver-Harris Amendments.    The drug companies then, in July of

1968, knew far better than they did prior to that time, prior to

1966, at least, what was required and what was expected of them.


Dr. Y.:
Right.    With regard to the Peritrate situation, shortly after that

had come to a head, you took a step with regard to that whole type

of product, the nitrates and the nitrites, and decided on what

could be said in advertising, and in this case, you decided to

notify the doctors first before there was a release that hit

public opinion.




That's right.     We were criticized and~~te properly in retrospect

for not advising the medical community first in order that they

could allay their patients' fears, because, as was pointed out and

talked about, these are not the kind of patients that you want to
deliberately upset or upset in any way.



But yet, the way of notifying the doctors that you tried this

time, at any rate, by sending each of them a letter •••


Dr. G.:
It was a very costly way.     It cost about $40,000 in postage to do
                                                             256




that, and we recognized that because of our budget limitations we

couldn't pursue that course on every 0ccasion, so then we turned

to using professional channels of communications.    We worked that

out with the AMA and other media representatives--Medical World

!!!!!,•-and they indicated a willingness to carry this kind of in•

formation on a timely basis.


Dr. Y•:

So that that worked out as far as the quick response from different

kinds of journals to printing the things ••• ,


Dr. G.:
Yes.


Dr. Y.:

••• since communications with doctors as fully and honestly and

frankly as could be devised was part and parcel of your whole

method.   Now with regard to the advertising as such, certainly

the Peritrate case was only the first salvo in what came to be a

war.   Youitive indicated how it ended up in '68 in midstream, so to
speak, but it took a while to get to that point.    One of the major

steps, it seems to me, in reaching that point was the speech that
you gave when you went down in April, April 6th, into Florida and

met at the Pharmaceutical Manufacturers Association convention with

the leaders of this trade and spoke to them in abeut as hard a hit­
ting speech, I suspect, as you may have made while you were com•

missioner.
                                                                      257



Dr. G.:
Well, it certainly was the hardest hitting speech they'd ever had

delivered to their annual meeting.      They literally were stunned

at the end of the speech.   They were quite polite, but nonethe­

less, the reaction was obvious.   No one had ever spoken to them

before in those terms.   I told them that their work was bad, it
was sheddy, and their advertising was misleading.     The new drug

applications were not in order.   They had to bear a large part of

the blame, and if they were going to profess to be part of the

health industries in the United States, which they certainly had

made many claims of being a part of, then they had t0 begin to

behave as if they were, because of the law.     At the end of that

long chain of research, back in the laboratory stage, the animal

stage, and then in humans, through the FDA clearance procedure

into marketing, there were human lives involved.      I think in
fact that that's the phraseology 0r close to it that I used in

that speech.


Dr. Y.:
You aimed at the management side, the lay people, for the most part?


Dr. G.:
Yes.   This was absolutely essential.     I was convinced even at that

early stage that the medical directors literally were powerless,

the professional people within the pharmaceutical firms, and my
                                                               258




suspicions were co~roborated, because I had a number of them
after that speech, at that same meeting, come up to me and mention
very quickly••and these were the professional people who were also
in attem.dance••:    "That was needed."   Now, in other words, they

couldn 1 t do the job although they perceived what needed to be
done.     I had a good friend, Dr. Cortez Enloe, who had heen in the •••

Dr. Y.:

Spell that, will you?


Dr. G.:
ENLOE, Cortez.        Well, Dr. Enloe had run a Madisen Avenue adver•
tising firm which largely handled pharmaceutical agency accounts,
although it also had some food accounts, Campbell Soups, to mention

one, but most of his business was with the pharmaceutical industry.
Cort had told me shortly after I took office and just, by the way,
after be sold bis advertising agency, whieh he did within a matter
of two to three months after my taking office•••

Dr. Y.:
Was this happenstance?



I don't think so.    At any rate, he told me after he had gotten out
of that business that the only way that we could really stop the
pharmaceutical ind1l11Stry from misleading advertising was to have one
                                                                 259



or more of the corporate officials arrested, convicted after trial,

and thrown in jail.    He said, ''This is about what it will take tG

get these people to get in line and begin to tell the truth about

their drugs."


Dr. Y•:

He thought they were terribly hard+aeaded?


Dr. G.:
And dishonest.


Dr. Y•:
Well, shortly after the speech, you yourself told the press that

there were some of the drug presidents who had let you know that it

was about time something like that had been said.


Dr. G.:

That's correct.    At least one or two of them had that feeling and
expressed it to me.




Do   you remember any particular••• ?


Dr. G.:
No, I can 1 t ••• here again, some of them simply on different occasions

came up and made the remark, "You know, I agreed with what you said
at Boca Ra ten."
                                                                 260




Dr. Y.:
NGt making a big thing out Gf it•••


Dr. G.:

No.   No.   Just in passing at a cocktail party or at some meeting.


Dr. Y.:

Now, you had had the Peritrate case.    Supposedly a certain message

should have been read by the industry from the case.    Why did you
feel it was necessary to g0 on down and hit so hard?




Because they obviously didn't read the message.     They continued to

pursue the same course.    In fact, some firms, after we had them in
ence, made them write a "Dear Doctor" letter, w~thin months, six

or eight months later, they repeated the same kind of mistake, and

we had to get them back in and go through the whole thing again.

That was the most discouraging thing of all.


Dr. Y.:
That was, of course, after this speech so that•••


Dr. G.:
Oh, indeed, they had had ample warning, and I think it basically

came down to this:    here was an industry that had gone unfettered

in general, some minor annoyances from the federal government and
the FDA, but generally had their own way from the very beginning,
                                                            261



and now they couldn't believe what was happening.    They just

couldn't react.    Dr. Mattia 1 s firm, Dr. Barney Mattia, MATT I A,

of Hoffmann-LaRoche, although we had made them do one corrective

letter, he perceived the climate and read it more carefully and

properly than anyone else, and his principal officers in that

company, they read him clearly.    He didn't want any nonsense.


Dr. Y.:

He said, "Let's don't get caught this way."    That's what you mean?


Dr. G.:

Yes.


Dr. Y•:
You indicated in the speech that there were almost a third of the

firms which were members of the PMA which your checking showed

were falling short of the law.


Dr. G.:

On   their advertising.


Dr. Y.:
Right.    Now, where did you get this data?


Dr. G.:
From perusal of the ads in the journals, discussion with my staff

members, principally Dr. Robert Mccleery, Mr. William Goodrich.
                                                                 262




Dr. Y.:
Had they deliberately set out on a kind of special campaign be•

ginning with your commissionership or beginning with the Peritrate

case or at some point?


Dr. G.:
Yes.




To make a survey?


Dr. G.:
Not a survey but to get the problem corrected.   Now as part of it,

I had to know how large was the problem, and so there was no formal

survey carried out, but it was an estimate based on experience of

the people who knew this field.




And Mccleery and one other man, I take it, were all there were

engaged in •••

Dr. G.:
That's right••• on the staff in the Bureau of Medicine looking at

misleading advertising.


Dr. Y.:
How big did that finally get?
                                                                    263




Dr. G.:

Six people.


Dr. Y.:
That was as big as it ever got?


Dr. G.:

As big as it ever got.   Six people aligning themselves against the

giants in the industry who were spending some $850,000,000 a year

on the promotion of pharmaceutical products, several hundred mil•

lion on direct mail and journal advertising, and, of course, it

was in this field that they concentrated because little could

be done about the detail man.     And so, I think that they compiled

an enviable record in that thirty months' period of time.    We had

twenty-four firms that we brought in and made write letters to

physicians.   Now keep in mind there were 140 firms in the PMA.

And so when I spoke to them about one•third I was talking about

forty-three firms perhaps.   Now we had twenty-four that we un•

covered with six people in thirty months, after they had been
warned.   I think that's an indication of how bad it was prior to

that period of time.


Dr. Y.:
Right.
                                                          264




Dr. G.:

Frankly, there were some cases that we didn't follow up on just

because of lack of staff time and the amount of difficulty and the

priorities.   Some of them were a lesser level of violation, but

still nonetheless misleading.   And we just didn't have adequate

staff time.


Dr. Y.:

Would you say that it would be a fair statement, that if one of

these ads that you seem to think was violative in a major way

appeared in the Journal!!,~ American Medical Association•••


Dr. G.:
Every one of them did.


Dr. Y•:

That made it a high prime target.


Dr. G.:

Yes.   In every one of these, as I recall from Dr. RcCleery's

statement, all of these had eeen accepted by the Journal of!!!!_

American Medical Association, which indicates that their at one

time effective program, when the advertising was the responsibility

of the Council on Drugs, was no longer an effective program after

the Council had lost the responsibility and the JAMA or the AMA

itself had a small professional staff that was supposedly taking
                                                              265




care of that function.   Now it's interesting their revenues in­

creased very markedly after the Council on Drugs was no longer

involved to where in 1967 their revenues from medical advertising

in the JAMA, as I recall, were eleven and a half million dollars.

So, they obviously weren't doing the job of screening these ads
and that was understandable.   After I met with Dr. Blasingame

and with some of the trustees, and in that meeting I heard Dr.

Blasingame say, "Well, Jim, advertising's just advertising.      It

isn't education.   It doesn't have any impact on the physician,"

I knew why the AMA wasn't doing a good job of taking care of the
advertis,ing, as far as its accuracy and truthfulness was concerned.


Dr. Y.:
Now, you met with AMA people in order to try to get y.our point

across in an informal way, in a way hopefully to get voluntary

compliance?


Dr. G.:

Yes.   I wanted their backing, but as Dr. Dale Console, former
medical director of Squibb, recently testified before the Nelson

Committee ••• He submitted a statement, to be more accurate, because

Dale has had a heart attack.   Dale made the point very clearly

that now the FDA has acted on the antibiotic combination products,

which are not rational, as a result of the National Academy of
Scieaces"NRC review which I established when I was commissioner.
                                                               266




He said, "Now that tba t action's been taken and the battle has

been joined, let's see the AMA throw it 1 s weight behind FDA and

show that they're really interested in the good practice of medi•

cine."    He said, "They won't do it because they are to0 closely

aligned with the interests of the pharmaceutical industry."    I'm
afraid he's right.    Of course, I was trying to get at them back
in those days in hopes that I could get their leadership to see
that they should change.


Dr. Y.:
Where did your meeting with him eceur?


Dr. G.:
In Chicago in AMA headquarters in the Board Room.

Dr. Y.:
Was this the time that you came out to that quackery congress or

was this an earlier time?


Dr. G.:

This was another time.


Dr. Y.:

That time when you came out, you had obviously spent part of the

day with the Council on Drugs of the AMA..


Dr. G.:
That's correct.   That was a different meeting then.
                                                                  267




Dr. Y.:
Now, did this in some measure involve the advertising problem?


Dr. G.:
No.     It was more involved with the compendium issue.


Dr. Y.:
I see.

Dr. G.:
Whether or not AMA. was going to publish a compendium, what the

Council on Drugs' position would be with respect to a federal

compendium, and those kinds of issues.


Dr. Y.:

Obviously, the Council on Drugs, or at least some members of it,

since that time have been at odds with the management's policy.




Well, John Adtiani, the Chairman of the Council, recently took a
strong stand against the advertising policies of JAMA and against

the pharmaceutical industry in terms calling for use of generic
drugs only.


Dr. Y.:
But certainly, some of them felt the same, I think, at that earlier

time.
                                                                       268




Dr. G.:

Yes.        But they hadn't evoked or stated their position clearly.

There tends to be some value in causing polarization to occur.

People do have to take a stand.           They can pretend up until that

point in time that, well, it's not really so bad, but there comes

a t:$ffle when they're pushed and they must take a stand and defend

it.        And I think that's valuable.


Dr. Y.:
One of the very early reactions after your PMA speech that came

from one of the members of the Pharmaceutical Manufacturers

Association was that you hadn't been specific enough in telling

the drug companies what it was that they had to do.


Dr. G.:

So    we    set about to remedy that lack of specificity by proposing

amendments to the advertising regulations which then would spell

out book, chapter and verse, and we did this, and we proposed it.

Then the industry very quickly said,         11
                                                  0h, that would hamstring
us if those went into effect.        You can't••• that wouldn't be proper;
you have to give us some latitude."          Which really tells you the
whole story.


Dr. Y.:

Who was it who worked those out?          Was that Dr. MeCleery?
                                                                     269




Dr. G.:
And Mr. Goodrich.


Dr. Y.:
Mr. Goodrich.


Dr. G.:
Ah, yes.   Mr. Goodrich.    Don!t underestimate the role that Billy

Goodrich had in that administration and still continues to have.

He's an extremely knowledgeable person.     He baa lived with the

pr0blems for 28 years.     He can look at a pharmaceutical ad and,

although he's not a physician, he can look at it, and he can very

quickly come close to telling you what's wrong with that ad and,

after careful study by the medical staff, sure enough, that's

what comes up.


Dr. Y.:
Now, you drew these up and decided among yourselves what would be

the proper kinds of specifics, some of which would be mandatory

and some of which would be discretionary, and you hoped that you

could get these new regulations about the ads into effect compara­

tively easily.


Dr. G.:
That wasn't to be.   We published them and then we were criticized

by PMA because we had published them without conferring with them
                                                             270




in advance.     We followed the Administrative Procedures Act, which

is an interesting point that kept coming up during my tenure as

commissioner.     Perhaps it's worth just spending a moment on.    T~e

Administrative Procedures Act was passed by Congress, applies to

regulatory agencies of the federal government, and it spells out
how one donducts the affairs of a regulatory agency with respect

to the promulgation of regulations, in that it requires, first,

that the agency publish a notice of intent to regulate, provide

those affected a period of time to comment.     The period of time

is discretionary but usually a minimum of thirty days is speci­

fied, unless the health of the public is being jeopardized.       And

then once those comments have been reviewed, the agency is re­

quired to make a determination of whether or not hearings may

be needed in order to serve the public interest prior to the

implementation of the regulations.     Then under the hearings por­

tion of that act, where it's spelled out how the hearings will

be conducted; the hearing examiner is appointed by the head of

the agency; review of the hearing findings is specified and spelled
out, how that will be conducted, the conduct of the agency employees
while those hearings are being carried out, vis a vis public state­

ments, et cetera.    All this is spelled out.   It's clear that Con­

gress had studied very carefully problems relating to regulatory

agencies and drew these rules in the interest of promoting fair­
ness with respect to the affected parties and the interests of
                                                                271




the public.   Now, my comment is that, having worked in two regula"

tory agencies, I've noticed that the business c0mmunity, in general,

does not like the Administrative Procedures Act.     They criticize

it time and time aga,in because they claim that the agency becomes

the judge, jury and the prosecutor under this act.    The pharmaceu­

tical industry in particular has fought to discredit this procedure,

and this time was no exception.   They immediately, instead of coming

in, as I had hoped Mr. Stetler would, with a series of items over

which we were in disagreement and could reach some compromise that

would still provide the public the protection that!!. felt was

needed and at the same time accommodate some of their points of

view.


Dr. Y.:

Just a minute.   Can I ask•••


Dr. G.:

Sure.


Dr. Y.:
Did you build in compromising features?


Dr. G.:
Yes, I think there were compromising features; it would be fair

to say that we didn't expect to get everything in that proposal.

But, instead, Mr. Stetler came in and challenged our authority to
                                                                272



promulgate such regulations on a legal basis saying that we did

not have the authority, and he had an obscure kind of rationale

behind his statement and threatening to take us to court.   Now

this, I think, typifies the kinds of problems I had with the

PMA and the reason that the PMA, in my judgment, is an ineffective

organization, because they concentrate on legal issues rather

than the substantive issues.   They don't wish to face up to the

substantive issues may be the reason that they do that.


Dr. Y.:
Well, certainly the Administrative Procedures Act was an act which,

if they didn't like, they were able to convert into Fabian tactics

of considerable delay.


Dr. G.:

Indeed.


Dr. Y.:
There are several examples ef that, it seems to me, that were
true from your commissionership, things that aren't anywhere near

settled yet.


Dr. G.:
Well, the vitamin and mineral hearings, of course, where there is

so much quackery involved and fraud, are still being fought; hear­

ings are still being held, and yet there's ample evidence now, as
                                                               273



the nutrition surveys as carried out by Dr. Schaefer show.     Food

is adequate.     The people who need and who are under-nourished and

who may have vitamin deficiencies are the very ones that can't

affoid those kinds of foods that are sold in health stares or

the vitamins that the pharmaceutical manufacturers promote on

television.     So, they are trying to discredit the hearing pro­

cedure, they are involved in these delaying tactics, and it looks

very clearly as if Dr. Ley, the present commissioner, is really

up against a series of such legal battles based on the initial

reaction to the proposed regulations on combination antibiotics

which grew out of the NAS-NRC studies, and it doesn't seem that

they've changed.


Dr. Y.:

And the advertising regulations that you sought to put into ef­

fect are still pending and the effort to secure compromise has

been, it seems to.me, •••




Unsuccessful.


Dr. Y.:

Unsuceessful ••• but kept open for months and months.




Oh, yes.   Months and months.
                                                              274



Dr. Y.:

Several times into the conversation has come this extremely in­

triguing and significant episode of another segment of the Kefauver­

Harris Act of 1962, the requirement that new drugs be proved ef­

ficacious prior to their going upon the market and that, in addi­

tion to that, the backlog of drugs that went back to the 1938 law

also be resurveyed so that their efficacy might be established or

shown not to exist.    Now, here was a tremendous task, and there

was all kinds of wonder about how it could ever be done.    Maybe

there was hope that it might never be done.


Dr. G.:

I think that latter is closer to the truth with respect to the
manufacturers.


Dr. Y•:
Because you had so much trouble even keeping up with the going

business.


Dr. G.:
Yes, it was a serious backlog with current business, let alone
not being able to handle what Congress had instructed the agency

to do.    Now there was another reason that isn't immediately obvious.

Dr. Joe Sadusk, who was the Director of the Bureau of Medicine

when I joined the agency, didn't believe in having that efficacy

review carried out, because philosophically he felt the practising
                                                                  275



physician was the person that should determine whether or not a

drug is effective.   He felt the physician was capable of doing

that, and this was such a fundamental difference that although

the mechanism that was finally adopted was available during his

administration as chief of the Bureau of Medicine and during a

predecessor's administration, George Larrick as commissioner of

FDA, it wasn't taken up.     They did not seek the assistance we did,

even though the mechanism was available to them because, I think,

Sadusk didn't believe in it.


Dr. Y.:
Well, just a little point, that may help explain something--does

it?--tbat was a little puzzling to me.     After Dr. Sadusk resigned,

he had a certain lame duck period that be was to serve before he

got out•••


Dr. G.:

That's right.


Dr. Y.:
And you indicated that it was this very responsibility, trying to
figure out what to do about this effectiveness review of the pre-1962

drugs that he was to have.     But then, as soon as he heard about

that, he said, ''I'm going to quit right today."


Dr. G.:

That's eorrec t.
                                                                    276




Dr. Y.:

Were you sort of mean to put that particular task in his lap or

what was ••• ?


Dr. G.:
No, I felt that it would afford Joe the ••• , don!t forget I knew

and had likEd Joe,.••


Dr. Y.:

Right.


Dr. G.:
I felt it would afford him an opportunity to serve the agency,

leave with having accomplished something that was meaningful

and that he couldn't be criticized for.     In fact, it would be

a very positive contrihution if he bad worked out the arrange­

ments with the NAS-NRC.     To do so I felt would be a feather in

his cap.     It would help the agency and it would make him look

better than he was going to look when he departed without that.


Dr. Y.:

So you were surprised then when he said he would quit,simmediately?


Dr. G.:

Well, I was disappointed more than surprised.


Dr. Y.:

I see.     At any rate, this was considered to be a tremendous coup
                                                                     277




at the time it was announced, the way you were going to achieve
this.


Dr. G.:
Well, let me point out this:     although some may have considered

it a coup, really the charter of the Academy, if one reads it,

says in effect that it exists in order to assist federal agencies

in the conduct of their affairs.     It was established under Presi­

dent Abraham Lincoln over a hundred years ago, about one hundred

and five years ago right now, as I recall, 1864, and a friend of

mine who was a very trusted advisor behind the scenes, Dr. H. D.

Estes, dug up the charter of the Academy for me.     He pinned it

down in that fashion before I ever went to see the head of the

Academy and then formally followed up by writing.     I knew that we
could get them on the hook to do this, in other words.


Dr. Y.:
Well, how did the idea originate?     Was this your idea?


Dr. G.:
No, I honestly don't know.     As I recall, it was my idea and I

asked Don to look into it.


Dr. Y.:

Right.
                                                                  278




Dr. G.:
Because it 1 s such an obvious thing.    It doesn't take any great

brain to figure it out, because the Academy had assisted the

agency, keep in mind, on DDT, on food additives, other kinds of

problems in the past.    As I recall, one of them, the caal tar
issue, was handled by the Academy.      So there was a history of the

agency having referred problems to the Academy.       I simply looked

at a much more massive problem that the agency had and thought,

"Why couldn' t it work with them on this one?"


Dr. Y.:

It was obvious that it couldn't be an onboard handling since you

were so far behind in more urgent matters.       Did you consider any

other possibility?   Some of the trade press suggested, for example,

that you might have been considering the National Institutes of

Health or even a private research agency like the Research Tri­

angle down in North Carolina.


Dr. G.:
Well, we did consider, and I really racked my brains trying to

figure out how to do this job, first, as you suggest, by looking

at internal resources.   That was immediately clear as an impossi­

bility.   Secondly, by looking at NIH because I had come from the

Public Health Service.    I had worked at NIH.     I began to explore

that and ran into resistance on the part of NIH officials who
                                                                 279




might discuss the issue in a preliminary fashion.


Dr. Y.:

Now, with whom would yeu•••


Dr. G.:

In the director's office, Dr. Shannon's office, Stu Sessoms, Bo

Mider.    I then thought about•••


Dr. Y.:

What kind of resistance?    Why?    Not their mission type of thing?


Dr. G.:

That's specifically it, yes.       They didn't want to become involved

in regulatory kinds of activity.       That was Dr. Shannon's attitude

througheut my tenure as Commissioner of Food and Drug.       It happened

to be his last two and a half years with NIH as well.       He consistent­

ly rejected any collaborative arrangements with FDA on the basis

that we were a regulatory agency, and he didn't want to get NIH

tarred with that brush.    I then thought of the university community.
It became obvious that using even segments of that really offered

no overall umbrella under which the project administratively could
be carried out.   And I did indeed think of research institutes,

non-governmental, Battelle Memorial Institute, Stanford Research

Institute, these places, but•••
                                                                 280



Dr. Y.:

Did you ever check with them?


Dr. G.:

No, I didn't check with them because I became a little worried,
having known some people who worked in them, worried because I

knQw from time to time they had among their clients members of
the pharmaceutical industry, and that was a little worrisome.          I
also had to look at the fact that Congress bad said, "You shall do

this," and "you", I interpreted to mean the federal government.

The NAS-NRC is a quasi-governmental agency, it's a federal charter

agency, as I recall, like the National Red Cross and, therefore,

that became my instrument of choice.


Dr. Y.:

Right.    Now, it was more appropriate for this kind of a task in

!!!.!!, year in which you turned to it than it would have been
several years before because there was a Drug Research Board •••


Dr. G.:
There still is.    There was when I turned that task over to him.


Dr. Y.:

Right.    But this was set up just a couple of years before as a

result of a big study that Dr. Coggeshall, is it? •••
                                                               281




Dr. G.:

Yes, Lowell Coggeshall.


Dr. Y.:

••• that he was the chairman of, and one advan~age that seemed quite

apparent to this was that if the Drug Research Board.within the

NAS-NRC took over the planning then all segments of society ought

to be happy because all segments of the drug world were represented

on this board.


Dr. G.:
They were part of, I called it "the drug establishment" in an

article I had in Esquire magazine in February of this year, and

it's true that the interest groups are all represented in that

Drug Research Board membership which has existed now for four or

five years.


Dr. Y.:

So_,,wben this was decided and announced in late April of 1966, Joe

Stetler of the PMA called the plan excellent.


Dr. G.:
Yes.   The pharmaceutical industry felt very good about it accord­

ing to their statements at that time.   They were thus given, they

felt, an opportunity to be heard in the planning of how the stuoy

would be conducted.   This they wanted and felt was very important.
                                                               282




There was some uneasiness on the part of people such as Don Gray

and Del Goldberg on Mr. Fountain's staff, and some of the long­

time observers of the scene felt a little uneasy because of the

very fact that PMA did have representation on the Drug Research

Board, and therefore the study might be done in less than an

appropriate way.   I didn't have that feat at all.    Right from the

very start I wasn't worried because this was such a massive under•

taking and there would be such a strong requirement laid upon

those who did the evaluation for documentation of their point of

view that I felt that it would be indeed difficult, if not im­

possible, for any shenanigans to occur.     And, in fact, that's what

did evolve and tum out.    Now Don Gray was most critical of the

fact that the study panels, 28 panels, their membership was not

to be made public until after the results of the study had all

been released by FDA.    That was felt necessary by the Academy

itself and the Drug Research Board in order to protect panel

members from potential pressure from industry, so only the chairmen

were named, you see.    Here again, the fact that we at FDA didn't
know those panel members didn't really bother me because again I

bad faith and confidence in the mechanism of the Academy, that

it would bring together scientists of sufficient stature that

there weuldn 1 t be any nonsense.   And there wasn't in my opinion.


Dr. Y.:
What's the behind-the-scenes story in your personal contacts in
                                                                  283




connection with getting this established?


Dr. G.:

Well, I went to see Keith Seitz after I had a good fix on the

charter, knew what they were required to do.      I'd talked to

several of my own staff about it.     Of course, Don Estes was the
key person in this.


Dr. Y.:

Now, explain Don Estes.


Dr. G.:

Well, Don Estes was a friend of mine dating baek to the time we

both went to Harvard School of Public Heal th,.   He had been in

the Air Force in World War II as a bomber pilot, test pilot, at

Wright Patterson, had worked in industrial medicine, and then

wound up going to Harvard School of Public Health the same time

that I did.     We had had similar interests.   I had done industrial

medical work; I had been in the Air Force in World War II, although

as an enlisted man.     I was interested in aviation.   Don and I

got along personally very well, and our wives got along, and so

our friendship grew over the years.     I ultimately hired him when
I was at Federal Aviation Agency to head the FAA Civil Aeromedical

Research Institute in Norman, Oklahoma, later in Oklahoma City,

which he did.     I got him commissioned in the Public Health Serviee

in order to bring him on board in that job, and he subsequently
                                                                        284




succeeded me as Civil Air Surgeon at FAA, and then had two heart

attacks and retired.     After he had retired, it was at this time

I became Commissioner.       He had nothing to do, and so I brought

him on board as a consultant.          I should say he was working as a
consultant to NASA at the same time, but he had lots of time
available is the point.


Dr. Y.:
And he was a close friend in whose judgment you trusted.


Dr. G.:
Yes, I trusted his integrity and his judgment, and he could "bird

dog" something for me.       He    later worked for me very closely with

the USAN Council.


Dr. Y.:
The what?


Dr. G.:
USAN ••• U-S•A•N, Council.        This is the group that names the drugs,
the generic names, you see, and that's another interesting fight

about the lengthy names of generic drugs which pharmaceutical

manufacturers proposed, the generic names, to the Council, and

the Council generally just accepted them.          Well, of course, I

think the pharmaceutical firms proposed unwieldly names delib­
erately.    Sure, they fit the general scheme that was required
                                                              285




of naming, but I think they went out of their way to make sure

that there was a wide margin between their simple trade name and

the generic name.        Don worked for me on getting that USAN Council
to work in a more meaningful way for simplified generic names.

So we were involved with the Academy study.        I went to Keith
Seitz •••


Dr. Y.:

How   is Seitz spelled.


Dr. G.:

SEIT        z,   not Keith, it's Frederick Seitz, and Seitz allowed as

how he would look at the issue and let me know.        I let him know

I had read the charter.        I made it clear in our discussion that

this looked to me as if it was somet,ing that fell within the

charter of the Academy.        He then subsequently agreed it was and

that they would do the job.        There were details to be worked out.

The Academy felt, the Drug Research Board felt, that it was an

important task to be undertaken, it was in the nation's interest,

and, although it would be a monumental task, one of the largest

they had ever undertaken, they would be glad to do so.        And they

did, and they did a magnificent job.        I have no quarrel about

the way in which they handled it, the way in which they organized

the meetings, the policy-making group, et cetera.        Beautifully done.
                                                                286




Dr. Y.:

Now, once the contract was signed that they would provide you with

th~se reports •••




I stepped out.      The FDA stepped back from that except in this

way:   they had a manpower problem, too, and by that time we had

secured the assignment of young Public Health Service officers

to FDA to help get rid of the drug backlog, the new drug applica­

tion baqklog.    Well, this was something else that my predecessors

had available to them, but they were fearful of the Public Health

Service.   I wasn't, so I got these young physicians assigned, and

they indeed proved to be, most of them, immensely valuable.         Well,

it was at that time that the Academy study was to start.      The

Academy study started, as I recall, the first of July of     1 66   and •••


Dr. Y.:

I'm not sure.


Dr. G.:

Yes.   And that was the reporting date for these young physicians.

So we gave Dr. Gilmer of the Drug Research Board the opportunity

to interview, after he had screened the records of these young

physicians, sixty-eight of them, as I recall.     Re then interviewed

a group of them and selected ten who were the best ten, we thought,

of the whole group.     These men were then detailed from FDA to the
                                                                    287




Academy to work as executive secretaries of the various specialty

study groups that the Academy set up.        And   they were the contin•

uing liaison and that was their entire job for two years.




So they didn't really work in FDA at all?


Dr. G.:
No, they worked on the drug efficacy review.         It was an extremely

valuable experience, because they got to know some of the top

people in    u. s.   medicine.   Every one of them were offered resi•
deneies in leading institutions as a result of that exposure and,

I think, nine of them did take such residencies.         One fellow,

bless him, said, "To hell with it.        I'm going out into general

practice."     But that had been his intent when he joined this

group and he stuck to it.        Nonetheless, we did provide that

staff.    We also provided Dr. Smith who •••




Ralph Smith?


Dr. G.:
Ralph Smith who was very difficult at times to get along with,

who was in the Bureau of Medicine.       He was high enough up in the

Civil Service structure that he could not be pushed aside in
terms of unblocking, and so this offered Dr. Ley••• offered us in
                                                                 288




the Bureau of Medicine an opportunity to put Dr. Smith full-time

on this job which was just about as important as the division

chief's job he had been heading up and permitted a new appoint•

ment there and again, unblocking, just as we did to Frances Kelsey.


Dr. Y.:

Right.    I want to talk about that.


Dr. G.:

We'll talk about that later.     That was the substance of getting

the Academy thing on the road.


Dr. Y.:
Dr. Smith was liaison.


Dr. G.:

And he did a good job on this. Jes.    Ralph was respected; he

had come from the university community; he was a good teacher and

a good scientist; and he handled the job nicely and earned the

respect of the people at the Academy and the members of the various
study groups, various chairmen that he had contact with, and he

had an enormous job of coordination to carry out, getting all
of the material from the files that these groups wanted to see

from FDA, because that was part of the accepted plan, that the

group could call upon the material that would be normally secret

to FDA and would be provided them in such a way to protect trade
secrets but nonetheless make the scientific data available to
                                                                   289




them, because during the period of their actual use by the Acad­

emy, although they were non-government scientists, they then be•

came government employees.


Dr. Y.:
So that they had the legal right under the law•••


Dr. G.:

Legally, we had an interpretation of that there was no problem.


Dr. Y.:
To   see new drug applications and things of that sort.


Dr. G.:
Yes.   That's right.


Dr. Y.:
Did any of this begin to come back before you retired?


Dr. G.:

Just a bare tridie started in January, as I recall, of     1 68,   and
it began to increase during the last six months of my tenure,
and I deliberately buried some of those in the safe.      We had to
handle them in a very secure way because keep in mind that in
some of these products there are millions of dollars involved,

and if it became public information it could be used to some­

one's advantage to sell short in the stock market.     Now this
                                                               290




was particularly true with some of the compounds which were over­

the-counter drugs, and because I felt that we should tackle and

have a good record behind us with respect to prescription drugs,

I deliberately put those over•the•counter drugs, many of them

toothpastes and mouth washes, in the safe and instructed the

staff, "Don't do the remaining staff work on these until we get

a backlog of experience in prescription drugs."


Dr. Y.:
I guess they are mostly still there.



They 1 re still there.   Things like Lavoris.


Dr. Y.:

Right.


Dr. G.:

Wow. Terrible reports on those items.


Dr. Y.:

Well, we'll be hearing about that in due course, I guess.


Dr. G.:

I really didn't see too many.   What I did see in the way of reports

from the Academy did convince me, however, they had done (a) a

very thorough job, (b) an impartial job, (c) a scientifically
                                                                     291



supportable job, and that there was no hint in any way, and I

saw, oh, I would say a couple of hundred of these reports, no

hint of any bowing to the drug industry pressure.     So, I was

enormously pleased by what emerged.


Dr. Y.:

Right.     Now I take it that out of all the reports that have been

put into the action sphere so far, there's only maybe one judg­

ment that the Food and Drug Administration has that is different

from the committee, and there may be only one legal action on

the part of industry, as yet, at any rate.


Dr. G.:

I think there'll be many more than one on the part of industry.

So far, the agency's judgment has been corroborated almost one

hundred percent, as you point out.     Well, there was an interest•

ing corollary to this business that I think is extremely impor•

tant.     That's one of the main failures of my administration and

that relates to the drug compendium.     I felt that the Academy,
in undertaking this review, was doing a great service to the

nation.     I characterized it in the opening speech of the organi­

zation meeting where, for the first time, the drug industry, FDA,

interested parties, came together under Academy auspices, as being

as significant in terms of today's p.t"actice of medicine.   Now
there were some who thought that was an excessive type of remark,
                                                                          292




that it was over~generous.       I think in retrospect it may well not

be.     I think it may still hold up to be almost of that same magni•
tude of significance.       But in order for it to become that signifi•

cant there was a corollary step that was needed and that would be

the development of a single drug compendium.       A   single source for

the practicing physician to turn to for reliable information about

drugs.    No   such source exists today, and here, when the Academy

picked up the responsibility, it was obvious that a unique oppor•

tunity was going to emerge because they would have timely informa"

tion having just completed the review of some thirty"four hundred

drugs as it ultimately turned out.       That combined with what had

gone through the new drug mill subsequently could be the 90%

level of a drug compendium.


Dr. Y.:
The raw data was right there.


Dr. G.:
It was right there, you see. And so I began pushing for a drug

compendium.     Now   let me point out that this, have   we   talked about

this?


Er. Y.:
No.


Dr. G.:
This issue originally came up on April 6 after the speech.          Joe
                                                                       293




Stetler got me aside to talk about the drug amendment.     I'm sorry.

It was before the speech.     At any rate, he pointed out that my

predecessor had been unwilling to exchange with PMA or compromise

with them, to put it more properly, on the drug compendium.        I

said, "Tell me what you mean by drug compendium."     He2:said, "Well,

our membership, our organization, would underwrite the cost of

publication of the compendium if the agency, in turn, would ex­

cuse us from the package insert requirement."     You know that the

present regulations call for every drug shipped in interstate

commerce to have accompany it a package insert.     This package

insert consists of what is technically known as the final printed

labeling and that is worked out just prior to marketing a new drug

by a series of discussions between the pharmaceutical firm involved

and the agency personnel.    Now, it originally has as its intent

the provision of information for the practicing physician.     And

that was fine.     But in today's "system" of drug usage, it almost

never gets to the physician; biological products that he uses in

his office, it does.     But with most drugs, it gets shortstopped

in the pharmacy of either the hospital or the corner drug store

and thrown away.    Now true enough, he can call the pharmacist and

get that information.    He can even have one copy sent to him or

get it from the drug company.     But he seldom bothers, and that's

not a handy way, because the insert is overburdened with details,

it's too fine print, and it's not the kind of information he
                                                                       294




really wants to practice medicine.     So Mr. Stetler said, ttWhat I

would propose, Dr. Goddard, is yea allow us to publish the com­

pendium and stop the package insert program at the same time.

Your predecessor was only willing to stop the package insert

requirement a year after the compendium had been published in

order to evaluate it. 11   Well, I decided right on the spot that

that was unreasonable and burdensome.     Mr. Stetler told me the

package insert program was costing the industry $6,000,000 a

year.     I didn't debate his figure; I acc~pted it.   Used it many

times after that and told ~im, yes, we would permit this to

occur; if they would publish a compendium they could stop the

package insert program.     He was very pleased.   That really was

the beginning of the comp~ndium.


Dr. Y.:

So that the compendium•••


Dr. G.:

Wasn't my idea.    The Drug Research Board had talked about its

necessity and the desirability for three years prior to that.

The Council on Drugs of AMA under Harry Dowling and then under

Adriani for ten years had recommended such a compendium, so it

certainly wasn•t my idea.     But once Mr. Stetler and I reached

that agreement, there began an extraordinary series of backslid­

ings on the part of the PMA, particularly because they found out
                                                                     295




that, to be approved by the FDA, the compendium would have to have

the drugs listed under the generic names, even though the cross­

indexing would be by trade name and the access thus in the cus­

tomary fashion that the physician looked up drugs.    They would

have no part of any system that described reserpine as the generic

name, described the drug, its actions, and then listed the brand

names underneath, the manufacturers and the dosage forms.    Now

this was absolutely essential in the view of our experts in the

agency in order to prevent a compendium from being ten volumes

long and unusable, and it certainly made sense scientifically, and

all the physicians I talked to thought it made sense, but the

drug manufacturers, once they found out this would be the format

and not the format to which they had become accustomed as in PDR,

where each drug is written up as if it was a different product

even though it's the same generic name, then they began to back­

water, tread water, and back off from the proposal, and since

then they have done nothing but drag their feet and fight it

openly and actively, because we then submitted a bill to Congress,
an administration bill, and it never got out ef Harley Staggers'
committee.   It never had a hearing by the sub-committee on health.

PMA effectively blocked that.   I must say that they did a good

job of work on the Hill on that particular issue.    Now, there is

no compendium today, and it's unfortunate because again it's timely.

It could still take advantage of the wonderful work done by the
                                                                296




Academy.     PMA doesn't want it for another reason.    They are fear­

ful that if ·doctors ever start looking at drugs and seeing that

there are 42 brands of rauwolfia, they might begin to prescribe

on a more rational basis.     That's why they don't want it.


Dr. Y.:

Well, I always had the wonder about, if you managed to have such

trouble with advertising which was supposed to reflect the basic

package insert in fair balance, how could you have an abbreviated

story••• ?


Dr. G.:

The only way you could do it is again to use a group such as the

Academy of scientists.     This was an issue that Billy Goodrich and

I disagreed on.     I'm glad that this came up, because Billy and I

differed; we were poles apart on it.     Billy was standing firm and

advising me to insist in all my discussions on the compendium

that we would hold the firm to the final printed labeling.         I

said it would not work; it would be too lengthy.       Billy pointed
out that it could lead to problems in advertising if     we   ,:ielded
on this. · I said, "It's not a question of yielding.     We must
actively promote a telegraphed version of the final printed

labeling.    You have to advise me legally on how we do it, but

that's what it's going to be, because otherwise, it will be of

no use to the physician.     It will be a waste of money."
                                                                        297




Dr. Y.:

But your idea was not to leave that up to industry.


Dr. G.:

No, but to get a group like the Academy.


Dr. Y.:

Or not to do it yourself•••


Dr. G.:

No.   No.   I wouldn't have done it within FDA.       A lot of people

refused to understand this; Walter Modell of Cornell refused to

understand the whole compendium issue and went around the country

shooting off his mouth about the FDA and bureaucracy never being

able to do this.        He never was willing to understand ,tha t I

wanted it done by the best experts in the United States on a given

class of drugs.     I wanted it kept up to date.      Ke said it couldn't

be kept up to date which revealed a total ignorance of modern

methodology.     With computer-based books now being used one can
edit and ~evise very easily, and we could publish a quarterly

supplement and indeed we planned to.        And it was unfortunate that

the industry was able to get people like Dr. Modell and use them.
Dr. Modell is well-meaning, but he sure as hell has been steered

nicely by PMA.     On    this and a number of other things.


Dr. Y.:
It looks like I'd better turn the tape over, Jim.
                                                                   298




Dr. G.:

It became interesting with respect to the compendium issue to also

see the shenanigans that went on with respect to other groups.

The Drug Research Board, for example, never was willing to get

the Academy firmly behind this bill that was pending before

Congress.     Nor were the members of the Drug Research Board non•

industry representatives ever willing to push for it.


Dr. Y.:

Not even the non•industry people?


Dro G.:

The non-industry people.         That's right.   They said that they were

for it, that it was good, but Gilman, for example, never was con•

vinced that this was the right approach, Alfred Gilman.


Dr. G.:
Finland ••• wasn 1 t he on it?


Dr. G.:
Max Finland, the little Napoleon.


Dr. Y.:
Yeah.


Dr. G.:
Yeah.     He, of course, does an awful lot of drug testing in the
                                                             299




antibiotic field for the pharmaceutical industry.     I 1 m not sug•

gesting that Max isn't honest.    Let me make that clear.    The

little Napoleon, the little dictator that he was and is, he just

wasn't willing to push this concept, even though the Drug Re•

search Board endorsed the idea for four years prior to that,

they didn't get behind it.   Now this was why in my article in

Esquire in February of this year, I mentioned this, you see.

Dr. Seitz didn't realize, he said, in a letter to me, that I was

unhappy with the Drug Research Board and with the Academy,         Well,

I wrote back to him and pointed out that yes, I was, and that

was the reason, because they hadn't fought for the compendium.

They weren't capitalizing on a unique opportunity in American

medicine.   Now the AMA similarly, the AMA claimed, of course, it

was going to publish its own compendium, and they still say they

are.   However, when asked, Dr. Hussey or any other representative

of AMA, they wouldn't say or couldn't say whether or not it would

be distributed free to all members.    Now, as you know, they have

published for a number of years a volume called~ Drugs, an'
excellent book, but it's not complete.    It only covers new drugs,
meaning drugs that have been marketed within the past ten years,

single entity drugs; it doesnJt cover combinations.     And it 9 s

used ••• I think sales run about, the maximum sales ••• , last year

32,000 volumes were sold.    That's a little better than ten percent

of practicing physicians.    On the other hand, what we envisioned,
                                                                  300




and I envisioned, was something that went automatically, just as

PDR now does, the most widely used book in American medicine,

Physicians~ Reference.        It goes free.


Dr. Y.:

It's advertising.


Dr. G.:

It's a compilation of paid advertising.       It turns up on every

physician's desk in January of each year.       I wanted, in fact,

PDR to have the job of publishing the compendium.       I wanted the
same name to be used because it would provide instant acceptance.

All I wanted was a change in format.     This again was something

people refused to accept and understand.      I didn't want to put

Bill Chapman out of business.     I wanted to capitalize on his

know"bow and the fact that physicians accepted it and they would

just see a minor change in format.     But that hasn't come about.

So the AMA bas not been helpful at all.

Dr. Y.:

Dr. Hussey was on that Drug Research Board also, wasn't he?


Dr. G.:

Yes, and privately Hugh Hussey would say to me periodically,

"Keep up the good work."   He said, "I can't say anything publicly,

but keep up the good work."     He was in favor of what I was doing
                                                                   301




at FDA even though AMA wasn't, and I think that tells you as

much as one can.     It speaks volumns about the AMA and their

pernicious attitude towards this problem which is an extremely

important problem in American medicine, the overprescribing, the

lack of good information, the misleading advertising.     And the

AMA, the principal professional organization, doesn't tackle that
problem because it derives so much revenue from the pharmaceuti~

cal industry.    It's iniquitous.


Dr. Y.:
Well, with regard to the compendium, the major support you had

came from certain members ef Congress, didn't it?


Dr. G.:
Yes.


Dr. Y.:
Not enough, I gather.


Dr. G.:
Not enough, because the bill never got out of committee.     Mr.

Hill, Senator Lister Hill, wouldn't take a position on it.       Mr.

Staggers wouldn't push his sub-committee.     Mr. Rogers of Florida,

a friend of the drug industry, certainly didn't do anything to

help the bill.     And so the idea, although I think it soundly con•

ceived, feasible, and I felt it should be financed, ••• by the way,
                                                                      302




and that's another interesting point.        I wanted the book to turn

up free each year on the physician's desk, not to be sold to him

and therefore, it was a financing problem.        We estimated the cost,

Ted Cron had estimates made that showed it would cost about six

million dollars, just about what the package insert program was

costing.        Well, in order to be fair, I proposed to Mr. Stetler

and to anybody that would listen, tJat we, instead of just ask•

ing PMA to pick up the tab, which is what I originally had asked

them to do since they manufactured the drugs that account for

95% of the prescriptions sold, and I felt they could carry the

other five percent in view of their small but steady profit&•••

small! •••number ~ne in the nation on return on investment.         But,

nonetheless, I felt they could do it.        But they weren't willing

for the reasons I've cited.        I then felt that the bill should

require or provide the secretary with the authority to charge a

registration fee to the pharmaceutical firms.       And the fee would

be a function of the number of drugs they marketed and the number

of units of each sold which then would put it on a sliding scale,
and I think be quite fair, and that would be in effect how the

volume would be paid for.       Now, this shouldn't have increased

the price of drugs any, which some contended it would, because

they would be excused from the six million dollars with respect

to the package insert program.       And so it would be a straight

trade ...off.     It would distribute it perhaps differentlJ, but
                                                                     303




nonetheless it shouldn't result in an increase in the price of

drugs.    All told, I thought it was a sound proposition, one that

was entirely feasible both from the publishing point of view in

terms of mechanics, using their computer-based system, and one

that certainly would fulfill a need that had been bespoken many

years by the AMA and later the Drug Research Board, but it's an

example, in my mind, a prime example, of why the pharmaceutical

industry is not a part of the health industry in the United States,

because they are not willing to take a leadership position.        They're

working actually in a way that's derogatory to patients' health

by confusing physicians about drugs deliberately and not being

willing to provide them a single source of scientifically valid

information about drugs.    End of story about the compendium.


Dr. Y.:

One of the other speeches, to shift rather sharply, that you made

in the early days of being commissioner was to the American Associa­

tion of Advertising Agencies.   This was April 30.


Dr. G.:
AAAS in Phoenix.


Dr. Y.:

Scotsdale.


Dr. G.:
Scotsdale, oh yes, outside of Phoenix, isn't it?     And Tucson?
                                                               304




Dr. Y.:

Arizona.


Dr. G.:

Arizona.   Barry Goldwater's home.




And in this particular address, among other things, you changed

your aim from prescription drug advertising in order to have

a little bit to say about over-the-counter drug or proprietary

advertising which you treated very sharply.    Now, you recognized

that the Federal Trade Commission had charge of this advertising.


Dr. G.:

And still do.


Dr. Y.:

And still are in charge of it.   Now what about the relationship

between FDA and FTC?   How did you begin to develop or strengthen

the already existing liaison that there was.   What was your ap­
praisal of Paul Rand Dixon who was the chairman of the Federal

Trade Commission2


Dr. G.:

Paul Rand Dixon, to begin with the latter, is a political creature,

and I preceived him as such and dealt with him as such.   We met•••
Paul and I met on several occasions, and it was quite clear that
                                                               305




if there was to be any work done, it would be done by our staffs

and not by ourselves.   We simply had to set the -climate so that

our staff people could get together and then get at the business.


Dr. Y.:

Did you take the initiative?


Dr. G.:

As I recall, I asked that the meeting be set up.   We had an in­

formal working relationship with the Federal Trade Commission,

but it in effect had become inactive.   Now behind the scenes, you

see, here again, going back to the Kefauver-Harris thing, Rand

Dixon had been a member of Kefauver 1 s staff. There was a woman

physician at the Federal Trade Commission.


Dr. Y.:

Barbara Moulton.


Dr. G.:
Barbara Moulton that called me shortly after I became commissioner
and said she wanted to talk to me.


Dr. Y.:
I noticed her name on your appointment list.


Dr. G.:
I spent an evening at her house, had dinner with her and her
                                                            306




husband.   She told me all the problems as she saw them from having

worked at FDA.   I think she really was asking to be rehired by

FDA; I know she was.     I appreciated her comments, but I didn't,

after checking, I didn't want her rehired.


Dr. Y.:

Why was that?


Dr. G.:

I thought that there was a good possibility of trouble developing

if Barbara came back.    Now, Frances Kelsey was frankly enough

trouble on the staff without bringing Barbara back.     Now, it did

set me to thinking, however, about the Federal Trade Commission,

and I talked to Mr. Rankin and Mr. Kirk and I found that there

was some sort of an agreement, but it wasn't really an active

one, so we set out to make it an active one.     Charles Sweeney,

"Chuck" Sweeney, of the FTC staff was the key person from there.

A marvelous person, a very fine man, now dead, but a real public

servant in my book.     Chuck set up the meetings and represented
the FTC.   It was because of he and Ken Kirk and a few people

on our staff that we were able to get a few things done for the

first time in a cooperative way.     The FTC is a creaky mechanism.

I think it was characterized in that fashion in a Saturday Evening

~    article, and I don't imagine if you set about to create an

ineffective mechanism of government, you could do much better
                                                                   307




than set up an FTC kind of operation.    It takes years for them

to get at and act on a problem.    At least, it has in our field.
It took them eleven years to get the "liver" out of Carter's

Little Liver Pills, and the only impact was greater sales, and

they have fought Geritol and Hadacol and not very successfully.

Now, my reason for striking at, by the way, the over-the-counter

drugs was not just because I was speaking to the AAAS, but I

was finding as I went to meetings that one question physicians

always raised was, 1'You said something about the drug companies

and their ethical drug advertising, but we think the over•the­

counter television drug ads are far worse."     And they were

right.    So that was why I decided to say something about that.

Now, FTC, subsequently, we did work out to provide them better

information from FDA.    I thought I saw some improvement in their

actions, but it's still not a good mechanism.


Dr. Y.:

Well, y9t1 had a tighter handle after 1962 even though•••


Dr. G.:

Yes.


Dr. Y.:

••• even though they still kept control of that advertising because •••


Dr. G.:
Yes.
                                                                     308



Dr. Y.:

••• you had control of the definition of what efficacy meant.


Dr. G.:
Thatts correct and also the final printed labeling, you see,

which even for over-theMcounter drugs had to be approved by FDA,

and so FDA had a better hold after    1 62,   there's no question.

But if you look at most of the over-the-counter drugs today,

they are pre- 1 62 drugs, a goodly number of them, you see.      And

most of the advertising goes in to trying to expand the sale of

aspirin and aspirin-containing compound.       I will say, I think

the over-the-counter drug advertising has for the most part

improved in the past three or four years.       I recently sat and

recorded television drug sales pitches on tape and listened to

them carefully time and time again.     Now, Geritol is still a

lying commercial.   They give on the one hand ••• they say, uof

course, you should see your doctor, if you think you have anemia,"

but then they take it away with the other hand by telling you

how great their product is and how fast you'll feel better if

you take it.   Now they don! t say, you know, they don!t say that

you need their product, they simply say, "If you do need it,

if your doctor says ••• " but they describe anemia in the process

in such a way that it encourages self-diagnosis.       Anemia is not

a condition that one can self-diagnose with any degree of confi­
dence, and, therefore, it's still an example of people being willi~g
                                                               309




to delude the American public.   "Responsible firms" engage in

this kind of nonsense all the time.


Dr. Y.:
A lot of the drugs that are over~the•counter are made by the

very same companies that•••


Dr. G.:
Of course, or a different division of the same company.

Dr. Y.:
Right.


Dr. G.:
American Home Products is a goed example, that has ethical and

over-the-counter divisions.


Dr.   Y•:

So you were trying to buck up the backbone.


Dr. G.:
That's rigbt.


Dr. Y.:
Offer the promise of more scientific help.


Dr. G.:
That's exactly right.
                                                             310




Dr. Y.:

What did you mean when you said that Dixon is a political creature?


Dr. G.:

Well, Dixon, I think, was more responsive to political realities

than I was.   Dixon, aside from the Ralph Nader thing, he's never

gotten whacked the way I did publicly, because Dixon was too

shrewd to ever take a position publicly, you see.


Dr. Y.:

I see.


It's my feeling.   Now Nader got to him.    I mean, Nader really

stung Rand Dixon, but apart from that Dixon never got really

taken over the coals publicly.   He   was a much more savvy person

than I was in the political arena.     Not that I don't know how to
handle myself in testifying before Congress, but in terms of

being candid and discussing very frankly with the press, I think

I may have set a record in Washington for candor.     Now, that was

really in the long run what hurt me, but I think I would rather

go that way than to go another way~     That's just my nature.


Dr. Y.:

I see.


Dr. G.:
Dixon will survive a long period of time in the political jungles,
                                                                     311




much longer than I could or a person like me could.     And that's

unfortunate when you're dealing with a technical area such as

the Food and Drug Administration.




Several times you referred to the problem of Frances Kelsey or

to her as a problem.    Now, she was a great heroine because of

the thalidomide episode.




Yes.


Dr. Y.:

Then one of the things that you undertook as soon as you arrived

was the reorganization of the Bureau of Medicine, and I take

it that what you mean by •••


Dr. G.:

Frances was a lovely woman, a kind person.    Frances couldn't run

an organization, and she was in charge of investigative new

drugs when I joined FDA.


Dr. Y.:

Now, she had been elevated probably as a result of•••


Dr. G.:

Without question.    Frances became a hero on the thalidomide dis•

aster.    Now, I wasn't at the agency, so anything I would say is
                                                                312



only hearsay, and it came from the principal staff people at

FDA.   It is an interesting little story though about how it

occurred.    In retrospect, one would have to say Frances became

a Presidential Gold Medal award winner and a heroine because

she procrastinated.    There had been an IND pending on thalido•

mide, and Frances couldn't make her mind up and just sat on the

material.    Two young physicians on her staff recommended that it

not be approved, and reports began to get to Frances and some of

her staff about some of the problems, and still nothing got done

about it.   Morton Mintz started poking around and wrote the

story that broke in the Washington press, and Frances became the

heroine because of this.    She had, in effect, held up the approval

of this drug.   Now, her husband, Ellis, who subsequently died,

he died about a year and a half ago, recognized the significance

of what Frances was involved with in the thalidomide thing before

she did.    She had taken some of these papers home one night, I'm

told, and Ellis insisted that she leak or report this problem

even though she had a working arrangement with the two young

men who were working on this particular IND that they would

jointly issue a statement on this.   He said it was far too im•

portant and these other two men were out of town and not to wait.

And so apparently she discussed it with Morton Mintz, and the

story broke and the President, President Kennedy at that time,

asked the Secretary of HEW, Celebrezze, to have a bill before
                                                                       313



Congress, an administration bill, within 24 hours, the FDA staff

stayed up all night, threw everything but the kitchen sink into

what became the Kefauver-Harris bill.     Now, also President Ken•

nedy wanted to pin a medal on somebody and that somebody happened

to be Frances Kelsey.     So that was basically how Frances came to

become a sacred cow in FDA.     You couldn't do anything about

Frances, and when I came she was director of the Investigative

Drug Division, chief of it.     Now, there was serious backlog in

that division.     Frances could not move people and get things

done.     Frances couldn't make a decision.   My appraisal of her

is that if it were raining, she'd drown before she could make

her mind up that she ought to go indoors.      Indecisive.   Now, in

order to get that division moving, Frances had to be given a

different job.     Here again you had the problem of Civil Service,

so we created a job for Frances, looking at the qualifications

of scientific investigators and actually investigating any sus­

picious cases where drug work had been carried on, and Frances

did get a couple of cases developed for us in that field, so she

became a useful person.     And that was mucb more her speed than

the IND which was a backbreaking job.     So that's basically what

I've been referring to as far as Frances Kelsey is concerned.


Dr. Y.:
Right.    Well, about the backbreaking nabure of the job, y~u

thought that a better organization of the Bureau would help
                                                                     314




and that, of course, these new young Public Health Service doc­

tors would help.     But I take it that this might have been the

problem you had about which there was the most pressure being

brought on you.    Wasn't this one that President Johnson himself

got•••


Dr. G.:

Yes, and Secretary Gardner certainly was involved with it.

Everybody recognized the seriousness, because, first of all,

the agency was vulnerable to any charge the drug industry chose

to level as long as we were sitting on a lot of new drug applica­

tions.    You see, the drug industry could claim that the bureau­

cratic practices of FDA were such and such and doing this to

American medicine.     It doesnt't matter what charge they levied,

then all they would have to do to prove it is to say, "At the

present time the FDA has 150 drugs in backlog status depriving

the physicians and the patients of these wonder~cures that the

industry has developed."    Well, that's a bunch of hogwash and

always was and still is when they try to say anything about it,

because most of those weren't new drugs as we've talked about

before.   Eighty-five percent of them are new combinations of

old products or molecular manipulations, so the American public

wasn't being deprived of wonder drugs.     In fact, just in fear

there might be some important ones in there, I asked Dr. Ley

when he came on board and accepted the charge of getting rid
                                                               315



of the backlogs, if he would have somebody and, preferably,

-he himself become in:v:olved, take a cut at what was pending,

and if anything looked promising, take it out of order, take it

out of sequence, if it was something really new and remarkable,

because we didn't want   to   have those that were more than six

months old have anything significant bottled up.     He did.     There

wasn't anything really significant in there.     Now, the most

 impooctant thing of all was to bring in some new management

 techniques, and to do this I turned again to somebody who had

worked with me in the past, Vaughn Choate.     Vaughn had worked

at one time with the National Institutes of Health, later on

at the Federal Aviation Agency as Don Estes' executive officer,

and Vaughn had reached a stage where he had made all the pro­

motions he could in the medical organization of FAA, and if he

were interested in moving ahead he had to move to a larger organ­

ization.   I knew him to be a capable, conscientious guy who under­

stood management principles, offered him the job, and fortunately,

he accepted.   This would be just before Dr. Ley came.    I then was

confronted with the problem of bringing on a new director of the

Bureau of Medicine although I had already hired his executive

officer.   I mention that in order to show you how much confidence

I had in Vaughn Choate, and he did work very well subsequently

with Dr. Ley, and Dr. Ley expressed on several occasions pleasure

that Vaughn had been brought on board and he said, "Although it's
                                                               316




not the best way to do something, after I got to know him, I

understood why you were willing to take that risk."       So, Vaughn

did come in, oh, about May or April of   1 66,   May, and, during the

subsequent period of two years and three months that I was there,

Vaughn was the executive officer to the Bureau of Medicine, and

he did make many changes and did make many improvements.      He

brought some order out of chaos there, working, of course, with

Dr. Ley and Dr. Minchew and people in those particular positions,

the division chiefs, and I think it was probably one of the most

significant things that happened to the Bureau of Medicine was

to get some real professional management capability in there.


Dr. Y.:

Well, was he the one then who, among the things that he might

have done, looked at what the new drug application was as a

kind of document and decided what might be done that would

speed things up if it were modified?


Dr. G.:

Yes, he looked not from the standpoint of subsequent modifica-

. tion; he looked more at the procedural aspects.    He was part

of Herb Ley's task force on modifying the procedures, and he

did put into effect a record tracking system that ••• hell, when

I first went there, nobody knew how many new drug applications

even were pending.
                                                                 317



Dr. Y•:

They were just stacked up everywhere.


Dr. G.:

They were stacked in corners and bunks and rooms.      My God, it

was terrible.    The manufacturers weren't required to paginate.

They weren't required to submit an index.     They weren't required

to have precis of the significant subjects.    Now, we did change

that.     Vaughn came in, and he and Herb and I got together and

decided that was absolutely essential.     It was nonsense not to

require that and we did it and we did get current.        Before I

left FDA, we were current, which means that we had all the drugs

that had been submitted in the previous 180 days either approved

or rejected.    Now, there was some, but I think very, very little,

returning in order to avoid the 180-day clause.     r•m    sure with

people being involved there was a small percentage of them.          A

lot of them were returned to the manufacturers because they were

inadequate, yes.    But not to avoid the 180-day time clause, you

see.    All told, I thought Dr. Ley did a magnificent job in getting

rid of those backlogs.    Now the IND backlog was a tough one, too,

and that hadn't been eliminated, although it was being whittled

down when I left to where it was in a reasonable •••


Dr. Y.:
Well, that was the newer problem since it had been so redefined
by the 1962 law.
                                                                       318



Dr. G.:
That's correct.        It was a newer one and a less critical one in

many ways, because the law, as you recall, only required that they

submit    h2!!   they were going to carry out the investigative new

drug work, and then they could proceed., It wasn't as if anything

were being held up.       This was a post hoc review of what was go­

ing on, in other words.


Dr. Y.:
Your problems here were problems of finding out occasionally

that something wasn't reported that should have been•••


Dr. G.:
That's correct.


Dr. Y.:
••• that was potentially hazardous.


Dr. G.:
Yes, or some danger was being perpetrated that shouldnft have

been.


Dr. Y.:
Right.     What was that, the MK.665?


Dr. G.:
That was one.       The MER29, of course, took place before I got
there.
                                                                      319



Dr. Y.:

Right.


Dr. G.:

But that's the kind of thing the IND work was designed to pre~

elude from occurring.


Dr. Y.:

And the DMSO, that was one of the •••


Dr. G.:

DMSO.     That, of course, had happened just before I got there.


Dr. Y.:

And so you had the aftermath?


Dr. G.:

Oh, yes.     I had the brunt of the problem.

Dr. Y.:

Right.


Dr. G.:
Now, it might be worthwhile mentioning that DMSO.     This was an

industrial chemical that a Dr. Stanley Jacob in Oregon felt was

advantageous in the practice of medicine.      This chemical primarily

was a by-product of the wood industry in the Pacific Northwest,

and a wood processing company was in fact the IND sponsor.      Dr.
                                                                        320




Jaco·b was   ~    principal investigator.   But Dr. Jactlb became

convinced that this was a wonder drug, and he was going to win

the Nobel Prize, and he was promoting its usage for every thing

that one could imagine.      He was shipping it illegally directly

to patients, to unqualified investigators all over the United

States, and there grew to be a tremendous trafficking in DMSO

which was illegal, and the agency was forced to act.


Dr. Y.:

There were a lot of very reputable pharmaceutical firms that

had it too, weren't there?


Dr. G.:

Yes.   Oh, yes.     There were a number of them.    Now, just ibefore

I joined FDA, the commissioner, Commissioner Larrick, had cut

back and had taken action on DMSO.      Well, this led, during my

tenure to an acrimonious exchange between the proponents of

DMSO and the agency on a number of occasions.         Unfortunately,

Dr. Jacob was able to get Congressman Wendell Wyatt on his side,
and I say "unfortunately" because the Congressman doesn't know

that much about drug work.      He has made some very naive proposals

in Congress.      He was able to get Hatfield.     He enlisted him on

his side, and generally kept things stirred up.        Now, if Jacob

had devoted the same amount of energy to seeing to it that

qualified investigators did carefully controlled studies, DMSO
                                                                   321




could have, by now, secured a rightful place.     It's an extremely

interesting compound.    I'm sure it will have some use, but its

value has been beclouded by the claims of miracles by the pro•

motional efforts of one Dr. Stanley Jacob, and it's been used

to make political hay unfortunately by some of the senators and

representatives.    Now, I think it's symptomatic of what's going

on in American medicine and on the scene in America today with

respect to politicians that so many bills were introduced to

requireLthe agency to approve DMSO.


Dr. Y.:

It was just like Krebiozen.


Dr. G.:

That's just exactly the point I wanted to get to.     It was put

then in the same category as Krebiozen, the Rand vaccine, and

these other kinds of quack cures.     And that's most unfortunate,

because when the day comes that Congress votes and requires FDA

to approve a drug or to permit a drug to be sold in the market­

place, then you have in effect, in my opinion, lost the consumer

protection that the agency was designed to provide.


Dr. Y.:

Right.    I think that may be a1i!ong time, and it may not happen.


Dr. G.:
Well, I hope it doesn't happen ever.
                                                                   322



Dr. Y.:

After the Krebiozen trial, the names of the senators who sponsored

bills along with Senator Douglas read like a Who's Who of some of

the most•••


Dr. G.:

Oh, that grand old man of American politics, Everett McKinley

Dirksen, that iniquitious bastard, was among them.     And he's

always among them.     He is one of the real friends of the drug

industry.     It's shocking.


Dr. Y.:

Yes, it really is, some of the names that are listed.     Of

course, with DMSO, it wasn't just a matter of making claims

that would elevate it into a miracle drug status.     There were

really hazards with this one, weren't there?


Dr. G.:

Well, that's still being debated.    We felt that there was suf­

ficient potential for risk that we had to be cautious.     There

was some evidence, in work with experimental animals, namely,

beagle hounds, that it did cause lenticular opacities, there­

fore, could have some serious repercussions with respect to visual

problems if this were true in humans., Now, keep in mind that we

had already been up against it with MER29 which caused cataracts

in humans, an investigative new drug.     In fact, the law suits
                                                                      323



are still going on with respect to MER29.    And so, the agency

was being cautious, but I think we are supposed to be.     Congress

instructed us in the legislative history to be cautious about

these kinds of problems.    Now, how much toxicity a product like

DMSO represents is difficult to estimate.     First of all, you know,

it's commercially available.


Dr. Y.:
That was one of the problems?




That was one of the problems, that everybody could lay their

hands on it and still do.


Dr. Y.:
And a commercial grade was a different grade?


Dr. G.:
Yes, it was a different grade.    And that's still the problem with

a couple of other drugs, lithium carbonate can be obtained from

chemical supply houses.     It's being used by psychiatrists in the

treatment of the mentally ill, and it hasn't ever been well

documented.


Dr. Y.:
And there's no   new drug application?
                                                                324




Dr. G.:

And it is a dangerous one.   And now, the NIMH is sponsoring some

new drug work, IND work, on lithium carbonate, but this is a

dangerous situation, because it can be purchased over the counter,

and yet it is one which you literally can't do much about.     You

don't want to get involved with prosecuting practicing physicians,

you see.


Dr. Y.:

No.


Dr. G.:

That's not the agency's mission. ~e did have one or two cases

though where we had to take action against physicians who were

doing investigative drug work.   Dr. Cass in Boston was one.    He

was guilty of supplying the agency with data on patients who

had died before the drug studies had ever started, therefore, it

was just phony data with lab results that were inaccurate.     They

were sink tests, what we call sink tests, meaning the lab work

had never been done.   Dr. Cass, we put him out of business.

This 'also happened with an investigator in Ph:iladelphia, although

he subsequently was allowed to resume drug testing.   It was under

tighter controls and stricter supervision.


Dr. Y.:

Was there anything behind the scenes in these situations with
                                                                      325



respect to the amount of research that these people proved to

have done?


Dr. G.:

They were doing so many studies that this is what drew Dr. Kelsey's

attention to them, and her staff.


Dr. Y.:

They showed up so often?


Dr. G.:

They showed up on so many investigative new drug work applica•

tions, you see, or NDAs, that it became a serious question as

to whether or not any one individual could do this volume of

work and do it well.   And so this was how the matter came to the

attention of FDA.   They subsequently began investigations.      We

put trained investigators into the field, documented our case,

called the individual in, presented him with the evidence before

any action was publicly announced of any kind, and notified the

university 'in both cases ahead of :time that we were going to

take the action and then took the action.


Dr. Y.:

And this must have thrown tremors throughout the drug industry

because there must have been a good deal of research on all

these other cases you were speaking of that would be put in
                                                                       326




jeopardy or uncertainty.


Dr. G.:

Well, again, it was symptomatic of what the drug industry had

been doing, you see.        Every drug company has a list of investi•

gators that they know--I am told this by people who work for

the drug industry--that they can get results from to fit their

needs.     And they all have a black list, too, of investigators

who aren't any good at all, who you'll get in trouble with.

Now, they won't share that information with the FDA.          Again,

they're not really members of the health community.          They're

not concerned about anything but making profits.


Dr. Y.:

But there is this lore about the researchers, you say.


Dr. G.:

Yes.     Yes.     The drug companies themselves like to help perpetrate

the myth that they had done this outstanding research, and that

it:t:s only through their e.fforts that the American public has a

continuing supply of new drugs.         They never mention the very

sizeable amounts of money spent by the National Institutes of

Health on drug research.        The fact that they in effect by having

studies carried out in medical centers are being subsidized by

public monies, by medical schools, et cetera, this they don't

mention.        They really don't spend ••• they talk about a five
                                                                327




hundred million dollar a year research budget.   Well, they don•t

really expend as much as they'd like to have people give them

credit for.   And their work, certainly I found it to be shoddy

in many instances.   Now look, nothing is an all or none principle.

Some of the finest work that's done in American medicine has been

done by people in the drug industry.   Some of them••• Dr. Maurice

Heilman, the virologist, for example, at Merck, Sharp and Dohme,

an outstanding person.   He may well some day receive a Nobel

Prize, and I certainly, if I were on the committee that selected

Nobel Prize winners in medicine, I would give Maurice Heilman

serious consideration.   There are people at Merck, Sharp and

Dohme who have done some exquisite work in DNA, and, in fact,

have been recognized for their scientific contribution.   So,

some very important and basic work has been done.   But, on the

other hand, there is some of the lousiest clinical research that

one could imagine supported by the drug industry.   Let me say,

as an interesting sidelight, I have visited facilities that are

used by drug companies for research, both their own facilities

and public facilities where drug research is carried out, and

it's interesting the discrepancy between the research carried

out on laboratory animals, which is very sophisticated, which

they do beautifully, ;which is instrumented to a tee, direct

linkage between the sensor mechanisms and the analogue digital

converter right into the computer, on line, you see, and then
                                                                     328




you go into their clinical facility, and you find the good old

doctor with the stethoscope, his sphygmanometer, and the urine

tests, you see, not well instrumented, not the modern technology,

and there's the difference.


Dr. Y.:

What lies behind that?


Dr. G.:

First of all, of course, it's easier to do research on animals.

I'm not that naive.    I know that you can' t ins ttumen t humans.

But secondly, what lies behind is, I think, they take the path

of least resistance.     They often don't want to know, in my

opinion, all there is to know about a drug before it's marketed.

If they know too much, then they might have too much trouble

perhaps.   That may be their reasoning.    I can't imagine their

reasoning, I just have to guess at it.     But it is true as Billy

Goodrich has pointed out that for every drug that is marketed,

you can look at the claims at the time of marketing and three

years later you 1 re going to find those claims substantially

modified, qualified, because the research that has been con­

ducted is limited, and as the base of experience grows, so does

our uneasiness with the drug because we do encounter more problems

with it.
                                                                    329




Dr. Y.:

It is adverse reactions more than it is lack of efficacy or ••• ?


Dr. G.:

Both.     Both occur.   Now with Talwin, for example, it was mar­

keted with great fanfare.


Dr. Y.:

With what?


Dr. G.:

Talwin.     T A L W I N.   And a former director of the Bureau of

Medicine of the FDA is the medical director for that corpora­

tion.     And it was marketed with great fanfare as being a non­

addictive narcotic, or non-addictive pain killer.      I should have

known better than that.     We as an agency should have known better

than that, but we let them go ahead, because the evidence on hand

did not show it to be addictive.     Now, they are having to admit

in their advertising and it's known that it is an addictive

substance.     Doctors, many doctors all over the country are now

addicted and using it as a drug, just the way Demoral, which was

also hailed as being a remarkable breakthrough, is being used.

And this is just an example.     Now efficacy.   I think Merck,

Sharp and Dohme's product for the treatment of arthritis was

hailed by the •••
                                                                    330




Dr. Y.:

Indocin?


Dr. G.:

Indomethacin.   Indocin's their trade name.   It was hailed by

them in their advertising as just a fantastic discovery,. Now,

a few years later, it isn't as good as they claimed, and, in

fact, the efficacy••• some physicians who have studied it say it

isn't any better than aspirin, you see, double blind experiments.

Well, that's basically the way I see the problem of the research

in the drug industry, not as well carried out as it should be.

Now, I am sympathetic with some of their problems.   Part of

their problem is related to the physicians who do the work, who

often don't keep the proper records and aren't timely in submit­

ting their reports and •••


Dr. Y.:

They're not skilled •••


Dr. G.:
They're not skilled and properly trained, but the drug industry,

one could say, maybe consciously uses these kinds of people.

That's an accusation I can't back up, or a suggestion, at least,

but you begin to wonder about it after so many times when you

find that they've lied, aren't willing to take a responsible

public position, and their only interest does seem to be money.
                                                                  331




You begin to have these cynical attitudes.


Dr. Y.:

On   the rest of this tape let's talk about another thing that

had been created the year before you arrived, but for which

you had to assume the major responsibility, for its youth, at

any rate, and that was the situation stemming from the 1965

law that related to dangerous drugs.


Dr. G.:

Right.     I'll take full responsibility for the implementation of

that.     It's true that Congress did pass the Dangerous Drug Act

of 1965, the Drug Abuse Control Amendments as they were called,

DACA, but it was my responsibility in     1 66   to implement them,

and so I was fortunate in getting Mr. John Finlator to join the

agency.    He had been with GSA and prior to that with security in

the State Department.    John was a very attractive person, an ex­

perienced administrator.     I put him in charge of this activity

and then we started off in May of '66.      A year later, we had

over three hundred qualified agents working all over the United

States.    We had a.'.,good record behind us in terms of arrests,

in terms of meeting the responsibilities that Congress had laid

out for us, and we then came into a very interesting chapter

which I would have to    entitle "The Transfer to Justice of

Dangerous Drugs."
                                                                     332



Dr. Y.:

What lies behind that that would be hard to find in the printed

record?


Dr. G.:

That's an interesting story.     In 1962 the Prettyman Commission

reported to President John Kennedy and recommended that the

Bureau of Narcotics be transferred from the Justice Department

and that Dangerous Drug Work be assumed by them, too.     It would

be a single agency within government that would handle this.

This recommendation was not adopted.     In late 1967 and early
1   68, or beginning first in late '67, I recommended to Secretary

Gardner that we transfer •••no ••• I want to check the dates on

that ••• at any rate we took the initiative.   I recommended to

Secretary Gardner that we transfer the Bureau of Dangerous

Drugs from FDA to the Department of Justice, that this really

was not the kind of operation we should have in the Department

of Health, Education and Welfare and in FDA, that the Department

of Justice was more capable of coping with the problem, they

were dealing with criminal elements ••• the same people all of the

time ••• and more importantly that the Bureau of Narcotics in the

Department of the Treasury and our agents were often working

unknown to each other on the same case, same people, and on

some arrests we would make we would find marijuana which was

under their jurisdiction as a hallucinogen, ~.rv.en though it was
                                                              333




classified by them as a narcotic and their agents would find

hallucinogens, LSD or amphetamines, when they were working on

a narcotics case, and it didn't make any sense at all.     Now

Henry Giordano was director of the Bureau of Narcot~s, and I

met with him early in the development of our Bureau of Dangerous

Drugs, because we were recruiting agents and, to get a quick

start on a problem, we did turn to agencies that had trained

agents, and the Bureau of Narcotics was one of them, and so

we recruited some of their people.   We recruited some from the

Department of Justice, the FBI, and other agencies, Army In­

telligence, et cetera.   But Giordano complained, and so I met

with him and had lunch and talked with him on a couple of

occasions and said, "All right, we won't recruit any more of your

people."   We discussed at one luncheon that we had philosophical

problems of drug abuse and marijuana, and he assured me that they

were not arresting young people, making felons out of them,

which was a lie, and Henry was a dangerous man, in my opinion,

in our society.   But he ran the Bureau of Narcotics in the same

style that he'd been trained.   He was Harry Anslinger's boy.

So I recommended to the Secretary that we give up the Bureau of

Dangerous Drugs provided that the Bureau of Narcotics was pulled

out of Treasury and the two brought together in Justice.    Now,

behind that was more than just the matter of rationale--it made

sense because of what I've already explained.   But behind that
                                                                334




also was the suspicion that there was some hanky-panky going

on in the Bureau of Narcotics.    The hippies in the Haight­

Asbury section of San Francisco and in the Village in New York

had told me on a number of occasions when I met with them that

the Narks, they called them Narks NARK      s,   the Narks are on

the take, they would say.    The Narks are peddling drugs.     Now

you hear this once, you discount it, because the hippies tended

to be a little paranoid anyway about the Narks, but when you

start hearing it on both coasts and every time you encounter

hippies you begin to wonder, and then as you have an operation

develop under your guidance and you see how the opportunity

certainly exists by virtue of the up-front money that's used

in these kinds of things, you begin to wonder.     And also that

the Bureau of Narcotics is in the Department of Treasury, really

not an enforcement agency in general terms, you see, left alo~:,

run as a domain by Anslinger and now Giordano.     So I insisted

that that would be part of it, and indeed it did become part

of it.    Now Giordano fought politically very hard to prevent

this from occurring.    The reorganization bill, Congress must

act within thirty days or what the president proposes becomes

law and the reorganization takes place.    That bill was within

five votes of being defeated.


Dr. Y.:

Well, it seems to me that it was not only Narcotics, but, at
                                                                335




least to go by the trade press, there were lots of people who

were more or less adherents of the Food and Drug Administration

who didn't want this to happen also.


Dr. G.:

Well •••


Dr. Y.:

But within the agency you wanted to get rid of it?


Dr. G.:

Oh, yes.


Dr. Y.:

This is unusual for an agency to give away a big chunk of power.


Dr. G.:

Yeah.      Well, I thought it was wise to do it, and I went to see

Ramsey Clark a week before we turned it over to him, and I told

him about the organization we were turning over to him, what I

thought of the principal people, and I thought we had a good

organization.      I asked him to do one thing.   I said, "Look very

carefully at what you get from the Department of Treasury.       I

have reason to believe there is something going on in the Bureau

of Narcotics. 11    Now, within six months, thirty-two agents in the

New York office alone were indicted for selling drugs.      That's

just the New York office.      That was ten percent of their total
                                                                     336




national work force.     So, I think there was good reason for

the suspicions that I had based on what the kids had told me.

And I think that as a result we have a stronger organization.

Now keep in mind the Bureau of Narcotics for years reported

that the heroin problem was stable.       Well, their agents were

selling heroin, you see.     This is a terrible situation.    It's

awfully ugly work.     Make no mistake.


Dr. Y.:

And it was a different kettle of fish from the kind of work

that traditionally the Food and Drug agents had done.


Dr. G.:

Yes, undercover agents, wearing guns, using surveillance, wire­

taps, Kell units.    This was dirty, vicious work.


Dr. Y.:

You even set up a completely separate outfit.


Dr. G.:

Set up a completely separate operation and that again was one

of the justifications.


Dr. Y.:

It was one of the rumors in the years before you came, within

the Food and Drug Administration, that some time narcotics and

dangerous drugs--this was when the amphetamines and barbiturates
                                                                  337



began to be a problem more than before-•that these two kinds of

regulations would be fused, but the hope was that it would be "fused

within the Food and Drug Administration.


Dr. G.:

Well, if you stop and think it really makes sense to do that

work in the Justice Department, because increasingly the same

criminal elements, the Mafia, were involved.   They'd been in­

volved in the heroin trade, that's been one of their bulwarks,

Qf course, for lo, these many years, and since Justice, the
FBI, has the capability and has been working on the Mafia and the

criminal problem in general in the United States, it made good

sense to get this responsibility under them, too.


Dr. Y.:
Well, now I take it that Secretary Gardner went along.


Dr. G.:
He enthusiastically endorsed it.   He thought it was good, and

Jim Kelly1 who is the real power in HEW, he thought it was great.

He was just tickled pink that I would not fight to keep that,

because he'd long wanted to see it go over there.


Dr. Y.:

And then the Secretary had got the President to make it one of

his administrative recommendations?
                                                                 338




Dr. G.:

Right.    I remember very clearly the last time I saw Giordano

was a meeting that took place in Assistant Secretary Lee's of­

fice, where the Assistant Secretary of the Treasury came over,

Giordano, and one or two of their people, met with Assistant

Secretary Lee, myself, Mr. Goodrich, Mr. Kelly.     And it wasn't

a very successful meeting, and Giordano apparently felt very

happy about it, because I happened to walk out in the hall after

the meeting was over and Giordano was doing a little dance of

glee with a big smile on his face which he instantly erased as

soon as he saw me, and I've often thought•••


Dr. Y.:

It wasn't successful, so he was happy, that is what you mean?


Dr. G.:

It wasn't suceessful in the sense that the two department rep­

resentatives couldn't agree to the merger, and that Giordano

felt that his point of view was going to win out.    And I've

often thought, since Giordano has been pushed out by Ingersoll,

the new head of this Bureau of Dangerous Drugs in Treasury, and

has now retired, I've often wondered what it would be like if

we encountered each other again.   Some merit and truth in that

old statement, "He who laughs last, laughs best," you know.
                                                                 339




Dr. Y.:

What about the residual problem of the location of the decision

of what should be a dangerous drug?


Dr. G.:

Well, I felt confident that, if people were of good faith, that

could be worked out between Justice and FDA.     But that really
wasn't as great a problem as people were making it out to be.


Dr. Y.:

But it seems to be a highly controversial thing.


Dr. G.:

It seems to be one point that people are stuck on now.        But I

think that can be solved.


Dr. Y.:

I hadn't realized that •••


Dr. G.:

Justice would be in bad shape if FDA ever recommended, like

Talwin, that something go on that list, and the Justice Depart•

ment wouldn't put in on the list.     They'd be in bad shape to ex•

plain why they wouldn't.     They'd have to have good documentation.


Dr. Y.:

Right.    Well, that's just a kind of a twist because I •••
                                                                  340




Dr. G.:
Well, it's not the usual bureaucratic practice, I'll admit.


Dr. Y.:
It certainly isn't.


Dr. G.:
It was fun to see that transfer take place.    It made good sense

administratively.


Dr. Y.:
Even though all of your ideas and Finlator 1 s ideas-•and Garfield

must have been a kind of important fellow in that outfit.


Dr. G.:
Yes, he was.   Fred did a good job.   He•s still with them now.


Dr. Y.:
Your ideas had gone into creating and building•••




Right.


Dr. 1:
••• the sort of structure that it was.


Dr. G.:
But even so it was well worth it because we delivered a good
                                                          341




organization to Justice, and I think they are doing an important

job.


Dr. Y.:
Well, good.   Maybe this is a good place to stop.


Dr. G.:

I think this is a good place to break for the day.


Dr. Y.:
Okay, Jim.    Thanks so much.
                                                               342




Dr. Y•:

Well, this is the fifth conversation, Jim, between you, James

Lee Goddard, and me, James Harvey Young about your experiences

in life leading up to your position as Commissioner of the Food

and Drug Administration.   This like the others, is being held in

your home, and today is June 13, 1969.   As I was going over

transcripts of our first two conversations, it occurred to me

that I had talked with you something about your background.      We

had gotten back as far as the job you had at the movie theater

in Ohio when you were in high school.    But I hadn't gone back

before tha~ and I wondered if a historian ought not to be in­

terested somewhat in heredity and what you might like to say

about heredity and your relationship to your parents and your

family and so on, as this may have helped make you the man you

became.


Dr. G.:

Of course, Harvey, as far as heredity is concerned I think the

immediate environment in the formative years is even more im­

portant than what genes you start with, although they are im­

portant.   They may be most important with respect to longevity.

They certainly have a bearing on intelligence, some of the other

facets of our character.   My family came originally to this
country from England on my father's side, back in the 1600s,
                                                                          343




and the original Goddard to emigrate from England was a cabinet

maker who settled in Rhode Island.     He came over actually to

track down a man who owed him some money and liked the New

World and decided to go back and get his wife and sons who were

in England and brought them over on another ship and settled in

Rhode Island.    He did very fine cabinet work.         I've had the

pleasure of seeing one of those pieces he created, and he was

extremely successful.     From that beginning the family ••• the sons,

as they matured and married, moved westward, some of them•••

one of them at least up into Connecticut.        That's the branch of

the family my grandfather and his father were descended from.

My grandfather Goddard, to get down to the more immediate family,

was in business; he was a painter and decorator, as were all of

his sons.   He had four sons and o~e daughter and one daughter

by his second marriage.     His first wife died, my grandmother,

whom I never knew, on my father's side.     C.    v.    Goddard, Clifford

Virgil, was his name.     He was an interesting person.        I remember

him well, as a child.     He was a rather stern, forbidding type of

man, to me at least, and yet, later in life, I came to know of

him.   He died when I was about ten years old.          I came to know

of him through my aunts and uncles.     He really wasn't as stem

as he had seemed, according to them.     My father, Frederick Oscar

Goddard, was born in 1892 in Alliance, Ohio, and married my

mother who lived across the street from him.           Her maiden name
was Calhoun.    C A L H O U N.   Beryl Calhoun     B, . E R Y Lo   They
                                                                 344




had grown up, at least in high school days, living across the

street from each other.   They were married in 1917 at an Army

camp outside of Chillicothe, Ohio.     My father was in the service

at that time, the time of World War I.     I was born in 1923.

We lived in Alliance, Ohio.   I was born at home on Geiger Street.

I was two months premature.   We lived in Alliance until I was

five years of age and then moved to Warren, Ohio.     My father

went into business for himself, painting and decorating, in

Warren, in 1928.   Now, of course, in 1929 we had the crash and

from then on it was very difficult.     He was unemployed, except

for finishing up a few painting jobs, from 1929, the winter

of '29, to 1933.   At that time he obtained employment with

the Republic Steel Company as a mill policeman, and we were able

to move to •••we had been living in a small cottage in the east

end of Warren, Ohio, at that time after a series of furnished

rooms and apartments ••• and we were able to move to a larger house

which cost at that time fifteen dollars a month, as I recall it,

for rent.   And I grew up •••well, we lived in that house until

1940, at which time my parents were separated and subsequently

divorced.   At that time we moved.    My mother and sister and I

took a furnished apartment again in the downtown area where we

lived ••• perhaps two or three different furnished apartments

between that time and the time I graduated from high school.

During those formative years, I was interested a great deal, as
                                                              345




I've mentioned earlier, in reading.     I was encouraged a lot to

read and to apply myself to my studies by my mother.     My father

wasn't too interested in my activities.     I had always felt that

he was somewhat disappointed in m~ because I was a very scrawny,

thin, non-athletic type, although I enjoyed and e~gaged a great

deal in sand lot baseball and football, not organized.     We didn't

have little leagues and those activities.     I had an uncle, Eugene

Calhoun, who was married.     He and his wife had no children.      I

was one of two nephews in the family, on he and his wife's side

of the family; naturally they were quite nice and quite good

to me and encouraged me also a great deal with presents of books

and games.   Subsequently he proved to be an even more decisive

factor in my life, .because he encouraged my mother ••• and me •••

to help me go to college.     Now, in order to do this, I worked

for a year after graduating from high school in the theater as

assistant manager and had been able to save two hundred and

fifty or three hundred dollars.     Now, with that money and with

the assurance of a job, he lived••• Mr. Calhoun lived in Alliance,

Ohio ••• ran a restaurant.   He owned a restaurant, I should say,

just off the college campus, Mount Union College.     With the

assurance of a job waiting table which would provide my room and

board and spending money, a dollar a week, I was able then to

enter college.   The tuition was a hundred and t~enty-five dollars

each semester.   So I had enough for one year when I started, and
                                                               346




he and my Aunt Gladys were very kind to me and looked after me

and saw to it that I •••


Dr. Y.:

Were you or your sister the older?


Dr. G.:

My sister is five years older.      She was born in 1918.   Although

five years different in age, we've always enjoyed each other's

company.     She and I have been very close.   We were the only two

children.


Dr. Y.:
Right.     Were your interests ••• this reading which seems sort of

unusual to me, that you should develop both the breadth and the

speed of reading which you have •••was this kind of on your own

and from the encouragement of your mother and uncle or was

there some other influence?


Dr. G.:

It seems largely on my own.     There was no program of any kind

at that time.


Dr. Y•:
There weren 1 t any teachers who had tremendous impact?


Dr. G.:
I can remember some of the teachers in grade school who were
                                                             347




very encouraging and in junior high school.     We were fortunate,

more fortunate perhaps than children are today.      I do think we

had more dedicated teachers in the public sehools at that time

than we have today.     Of course, unfortunately, fewer children

were able to stay in school throughout the twelve years at that

time, so the burdens weren't as great on society.


Dr. Y.:
So you really knew what the depression was.


Dr. G.:
I remember it quite vividly, not only because my father was out

of work.    We lived in a town that depended upon the steel mills

by and large for employment.     Work was ••• the mills were closed

down and so money was extremely scarce.     Everyone who had any

land available to them grew their own vegetables during the

summer months and canned them in order to have food for the

winter months.    The grocers carried everybody on credit.     I

don't know how people would have survived had it not been for

the fact that the grocers ••• how they got the money to pay the

wholesalers ••• the wholesalers must have been carrying the gro­

cers.     It was an amazing set of circumstances.   There was very

little money.    Ten cents was a highly respected sum, you see.


Dr. Y.:
That's right.
                                                                            348



Dr. G.:

You remember that well, too.


Dr. Y.:

I do.        I can remember things of the same sort.


Dr. G.:

And you see, that again relates to my reading, my love of reading.

We didn't have a radio, in fact, until 1933 or 1934, the summer

of   1 33,   and so, reading was ••• that was my pleasure.    I had very

few toys, but books were free.        You could go to the East End

Library, walk to the library, get the books and return them in

a week.       I always had a stack of books around the house.      And

so I was able to occupy myself between that and the usual games

of childhood.       Thinking of childhood reminds me of that book,

nwhere Did You Go?       Out. )/hat Did You Do?   Nothing."    Because

that was typical of the kind of childhood I had, and remember,

at least.


Dr. Y.:

Now, you spent the one year with your uncle.           You went to school

at Mount Union the one year and worked at your uncle's restau­

rant and so on.       As I remember, you joined the service at the

end of that year.


Dr. G.:

That's right.
                                                              349




Dr. Y.:

Was this because that money ran out or were you moved by patriot­

ism?


Dr.    G.:
Oh, a combination of factors.     I wasn't satisfied with what I

was ioing in college.     Patriotism was running high at that point

in our history, if you remember correctly.     That was January of
1 43   and I got itehy feet and I decided to volunteer and so I

went back to Warren, Ohio, at the end of the term, after mid­

terms, the end of the semester, I should say, and went to the

draft board and asked them could they take me.     They said, "Well,

how about next Friday?"     The following Friday, I went to Camp

Perry, Ohio, first to Cleveland, then to Camp Perry, Ohio, and

I wasn't there more than about a week before I came down with

pneumonia and was very ill.     But fortunately, they had sulfona­

mides available, treated me with those.     I was in the hospital

for some six or seven weeks, eight weeks, and then I was shipped

to the Air Corps, to Florida for basic training.


Dr. Y.:

And that's where you took the tests that got you back into the

pre-medical work in Philadelphia?


Dr. G.:

No.
                                                                     350




Dr. Y.:

No?


Dr. G.:

That's where I was ••• I had finished basic training.   I had had

another siege in the hospital again during that basic training

period, but I had finished basic training and was working at

pulling targets.     They sent a jeep out, took me back to town~••

this was St. Petersburg, Florida, and the sergeant said that I

was being assigned to ASTP.     I'd never heard of it and didn't

have any idea what it was.     But he told me it was a program where

the army sent people to college.     I was being assigned because

a young man who was supposed to go that same day as one of a

group had come down with appendicitis and they needed somebody

to take his place, so they simply went through their records to

look for somebody who had been in college before the War, and my

name being in the Gs, I came up fairly early, or he may have

started at random, I don't know.     They simply said I was going.

I wasn't given a choice, I was told.     I got on a train that same

evening and went to what they called the Star Center at Savannah,

Georgia, at the Citadel, took some examinations there and was

sent to Washington and Lee University in the engineering pro­

gram.     While I was attending the engineering course, after

about two terms, the early part of the third term, they did

give this medical aptitude test.    All three hundred of us had
                                                            351




to take it.     I was one of the six that scored the highest, and

we were then sent to pre-med at Temple University in Philadelphia.


Dr. Y.:

Right.    That kind of brings us up to what we talked about before.

One of the other things that I put on the list to come back to

was this:     at one point, we postponed a discussion of Secretary

John Gardner in action, when you would take him, as you said,

fairly highly technical issues that you had already decided, but

that had such potential political repercussions that you wanted

him to be aware of them, and this would give a picture of what

you thought were issues of this kind and of how he operated under

such circumstances.


Dr. G.:

One of these issues that I remember vividly was the one that

surrounds the present hearing on vitamins and minerals and, let

me see, what else is involved?


Dr. Y.:
Special dietary foods.


Dr. G.:
Special dietary foods, the labeling, low calorie, those issues.

These were not new issues when I took over as commissioner.

Most of them had been put out in the previous administration as

a proposed set of regulations.
                                                                     352



Dr. Y.:

In 1962 •••


Dr. G.:

In 1962 for the first time.     But they were withdrawn very quickly

because the storm clouds gathered very quickly, and the Admini­

stration decided to pull in its horns.     Well, Mr. Goodrich and

other staff members briefed me on those proposed regulations.

They certainly seemed to be needed in terms of what was going

on in the marketplace.   The irrational combination of vitamin

products, the deceptive packaging and labeling on dietary foods,

particularly the low calorie items, and so I decided to rein­

stitute these regulations as proposals. they were up-dated and

they were about ready to be issued and I decided this was the

type of thing the Secretary should know about because there had

been such a furor before.     And so I went to him, accompanied by

Mr. Goodrich, and we briefed the Secretary.     Now, you know, from

your own work, Dr. Young, that in this particular field of

quackery, and certainly the nutritional quacks are numerous in

our society, you know from working on those kinds of issues that

some of this is fairly complicated.


Dr. Y.:

That 9 s one way it's so successful.
                                                                      353




Dr. G.:

That's why ••• its very complexity.   But the Secretary listens •••

Secretary Gardner's good at listening to what was being said, and

he grasped very quickly what the issues were and was able to

sort out the really significant parts of what we were doing.      I

was amazed, because it was an involved set of proposed regula­

tions, very complex, and yet within a matter of thirty minutes

he had a good grasp of them, was asking the kinds of questions

that it had taken me much longer to arrive at in preparing to

brief him, and at the conclusion of the briefing and the ques­

tioning, he leaned back in his chair and looked at Mr. Goodrich

and myself and he said, uwell, batten down the hatches and let

it go, boys."


Dr. Y•:

So he was all for it.


Dr. G.:

He was all for it.


Dr. Y.:

His quick lines were one thing that impressed you.


Dr. G.:

Wonderful to work with a man like Secretary Gardner.     There were

other kinds of complex issues that I watched him grasp in brief­

ings just as readily as this so it wasn't a one-time performance.
                                                                  354




He had a good understanding and a good appreciation for fairness

in our society and the need to promote it.     Of course, his books

speak for themselves.


Dr. Y.:
He supposedly backed you up in almost everything.


Dr. G.:
Without exception.    Without ~xception.   One good ·example was in

the case of the furor that surrounded the marijuana flap.     I

remember I had been misquoted by a Miss Judy Vick•••


Dr. Y.:
Let's just go into that since you have mentioned it.


Dr. G.:
••• in Minneapolis.   I was there to speak on some issue related
to industry and the public.


Dr. Y.:
Can you remember when this is.    I've kind of forgotten.


Dr. G.:
Oh, let's see.


Dr. Y.:
1 661
                                                                 355




Dr. G.:

Hold on just a second.     I've got it right here.    There was the

other day a clipping here, my son was bringing out something•••

it doesn't have a date on it.     Isn't that a shame?


Dr. Y.:

Well, I can pin it down.    I just didn't happen to have a note on
it.


Dr. G.:
October 17th in Minneapolis.


Dr. Y.:

I see, of 1967?


Dr. G.:
Yes.   A Miss Vick was the stringer for the UP.      She worked at

the University.


Dr. Y.:
Was she a student or was she a staff person?


Dr. G.:
A staff person, as I recall, at the University.      She filed the

story with the UP to the effect that I would not object to my

daughter's smoking marijuana any more than her taking a drink.

In fact, I would rather she smoked marijuana than drink a cock­

tail, was, I believe, the way the story was written.      Now,
                                                                    356




fortunately for me, in one sense, although it was a minor con•

solation, there was an experienced science writer at that press

conference.   Had I made such a statement, I'm sure that this

particular science writer, Vic ••• I can't think of Vic's last

name right now.   He 1 s now the staff writer for the Washington

Post on medical sciences.    I'm sure Vic would have filed the

story, because he knew a good story when he saw one without a

question, but he didn't, and so the UP had to back off and had

to issue a retraction and wrote me a personal letter, the Wash•

ington bureau chief, apologizing for any trouble the misreporting

may have causa:lme.   Well, the trouble was simply this:   I had

to appear before a number of Congressional committees within a

very short period, within a week thereafter.    In fact, one of

the problems was that Secretary Gardner and Under Secretary

Coben and I had to work out which committee would have the first

crack at me, because a number of them wanted jurisdiction and

wanted to get me before them and to •••


Dr. Y.:

It certainly did mean headlines.


Dr. G.:

Oh, all over the United States.    All our newspapers carried it.

Now we did work out that Representative Staggers of the House,

inasmuch as his committee was the substantive committee for HEW,
                                                                       357



would have the first chance.    Then, as I recall, the Senate com­

mittee was next; then the third committee was Mr. Fountain's

committee, as I recall, and then there was a fourth committee, in

the Senate, Senator Dodd's committee.    So they all had a chance

at me.    Four of them within a five-day period.


Dr. Y.:

You say Secretary Ga·rdner was very understanding.


Dr. G.:

Secretary Gardner was extremely understanding.     He called me

one evening at home, and he was an extremely busy man with many

other important issues,~ important issues, in fact, and he

said, "Jim, don't let this get you down. 11   He said,   11
                                                              1 1 m with

you and we can ride it out.    Don't let it bother you."         At

that point, the public press was ••• things were being fanned to

a peak by statements such as Representative Dan Kuyk.e,ndall, Re­

publican of Tennessee, said, ''Because of Dr. Goddard's sick and

utterly intolerable advice, he should be summoned immediately

before the House Commerce Committee and explain himself."             And

this was seconded by Representative Clarence J. Brown, Jr., a

Republican of Ohio, an idiot if I ever knew one.


Dr. Y.:

Well, this gave your enemies a kind of handhold, a presumptive

one, at any rate •••
                                                            358




Dr. G.:
Yes.


Dr. Y.:
••• to try to attack you.    In fact, there were lots of calls for

your resignation.


Dr. G.:
Oh, a number of calls by Congressmen and others for my resigna•

tion, but it was at that point indeed that Secretary Gardner

said, "Don't worry about it."     He said, "We can ride this out."

And we did.     That proved not to be the major issue ••• a major

issue ••• although it's something that every place I go, when­

ever I go to speak at a university or on campus, particularly

in Georgia, the issue comes up again.


Dr. Y.:

Did you ever hear from the young woman who made the mistake?


Dr. G.:
Never.


Dr. Y•:
How did she ever make such a mistake?


Dr. G.:
I don't know.
                                                             359




Dr. Y.:

She just cooked it up?


Dr. G.:

No way of knowing, no way of knowing.     But it was interesting.

During the Congressional hearings, three of the Congressmen took

their allotted five minutes, because this was the full committee

and Mr. Staggers had to give every committee member a chance to

question me and so he had to ration the time and allowed each

of them five minutes.     Three of them took their five minutes

asking me how I got an apology from the United Press, complain­

ing that they had been misquoted by the UP on a number of occa­

sions and they had never gotten an apology.     So, the fact that

I did get a written retraction from UP was a very significant

thing, it was clear.     Now, it was an important issue for other

reasons.   It got the whole issue out in the open.    It made the

public and the Congress begin to think and talk about this set

of laws which was so unrealistic, that classified marijuana as

a narcotic.


Dr. Y.:

They haven't done anything yet though, have they?


Dr. G.:

It also got others interested in the subject.     The furor dragged

the National Institute of Mental Health into the whole field,
                                                            360




because one of the points I made very strongly was that there

had been no good research, and Dr. Stan Yolles had to go before

Congress and admit that there was none and that they would see

to it that there would be some good research conducted.     In the
long run, I think it helped topple that Bureau of Narcotics em•

pire in the Department of Treasury and hasten the day of its

transfer to the Department of Justice.   And so, I don't feel

badly, in fact, I noted with some interest last week that

Philip Handler, the new president of the National Academy of

Sciences--NRC, who takes office July 1, testified before Con•

gress and said that he didn't think marijuana was as dangerous

as alcohol, and he cited practically the same ••• made practically

the same statements that I had and cited some of the same re•

ports that I had used.


Dr. Y.:

In briefing yourself on the background of this issue, from whom
did you draw evidence?


Dr. G.:

I real all of the world's literature that the staff could assemble,

going back to the Indian Hemp Commission Report of 1868 or••• r•ve

forgotten the exact date on that.


Dr. Y.:

In other words, you said: •••
                                                                   361



Dr. G.:

I personally read the literature.

Dr. Y.:

"I want to make a speech on this, and I ••• "

Dr. G.:

I knew I had to make a number of statements to Congressional

committees and so I had to be well-briefed.     I found the La­

Guardia Commission's report probably the best that had been

done in this country.     That was back in the mid-40s, around

1945,   1   44.


Dr. Y.:

Just a technical point:    You would do something like tell Ted

Cron or somebody, ''I want••• "


Dr. G.:

In that instance, I told John Finlator, the Director of the

Bureau of Dangerous Drugs, of BDAC, that I wanted the literature

on marijuana, the world's literature without exception.     I

wanted it as far back as they could get it together, and I gave

him a time period and they delivered it, Verifaxes or Thermo­

faxes or whatever you wish to call them.


Dr. Y.:
So you had the vast stack of •••
                                                                 362




Dr. G.:

I had a stack of them, but being able to read rapidly was of

great help.


Dr. Y.:

And so you drew your own judgment.


Dr. G.:

That's right.   There was a series of sessions with Mr. Goodrich

and Mr. Cron and the people from BDAC again were involved and

then the Congressional statements were drafted, based on my

discussions with them, what I had read in the literature, and

what we thought we should say to the Congressional committees.


Dr. Y.:

This wasn't to say to the committee about this report.    This was

general policy statement or judgment?


Dr. G.:

I felt I had to make a defense before the Committee.     One, that

I had not said what I was attributed by Miss Vickas having said.,

Two, however, there was reason for Congress to be concerned be­

cause the penalties were indeed excessive, so, three, Congress

should seriously consider reducing the penalty from a felony

for possession to a misdemeanor.   Now, in order to make those

recommendations, I had to have some justification and that was

where having read the world's literature and having looked at
                                                                 363




all of the available data was of help.


Dr. Y.:

But you had done this reading before you made your speech or was

this in between?


Dr. G.:

This was between.    I had done some of it before, but the in­

tensive part came between the misquote and the Congressional

hearings.


Dr. Y.:

So it was a rapid proposition?


Dr. G.:

Oh, it was a pressure proposition.    Fortunately, the National

Institute of Mental Health had the references fairly well assem­

bled for other reasons, and I was able then to tackle those and

read them in the evenings and get at the business of a statement

over the weekend.    So the whole issue now is being studied.

There is some good research going on and, as I've mentioned, Dr.

Handler also now has said basically the same thing that I said

before the House Committee and before the Senate Committee.       I
can•t find his statement right now, but we can get a copy of it.


Dr. Y.:

Right.    When you were talking a while ago in connection with
                                                                364




the vitamin and mineral and special dietary food matter as you

brought it before Secretary Gardner•••


Dr. G.:

Let me give you another example •••


Dr. Y.:

All right.


Dr. G.:

••• of the Secretary's ability to absorb the technical details.

There was an item pending before I went to FDA surrounding the

use of trash fish.   These are fish that normally don't find

their way into commercial markets, except sometimes in the form

of fertilizers, to create a product known as "fish meal" or "fish

protein concentrate," whose advocates suggested could help a

great deal in alleviating hunger on a global basis, but the

FDA up until that point in time had been unwilling to approve

the product for marketing in the United States.   Now, let me

make clear that the law at no time precluded the product from

being developed and sold overseas, but because of political

necessities it was felt best to have it approved for marketing

in the United States before ever exporting it to India.


Dr. Y.:
Diplomatic..
                                                            365




Dr. G.:

That is correct.     For diplomatic reasons.   Now, there was a pro­

moter whose name was Ezra Levin.     He had a process that produced

a whole fish protein concentrate which he called Viobin, and who

was his friend but Senator     Paul Douglas?   Senator Douglas used

to get me up to the Hill, as did Senator Teddy Kennedy and one

or two others, quite often, to inquire about the progress on

whole fish protein concentrate.


Dr. Y•:

Back in Larrick's regime, the reason that they had kept this off

the market was •••


Dr. G.:

George Larrick felt that to process the entire fish would result

in a filthy product because the intestinal tract and all would

be processed into a flour or meal that could be used as a protein

base for other foods.    You see, primarily, this would be a high

protein food and could be used in soups, a small percentage in

bread and biscuits and baked goods, or eaten as a supplement on

rice and in whatever fashion, in a paste, fish paste.     So there

were a variety of possible uses and the major purpose was to get

more protein into the undernourished countries, countries with

malnutrition problems.    But Commissioner Larrick felt that this
could not be marketed in the United States, even though he was

sympathetic with the problem with respect to other nations.
                                                                  366



Dr. Y.:

He thought the law flatly forbade it.


Dr. G.:

He felt indeed that the law forbade it.      Now, on the other hand,

if you examine the feeding habits of fish, you see that the deep

water fish, their intestinal tracts are practically clean, prac­

tically no bacteria at all.      And if you look at the fact that

we permit sardines to be marketed which are intact and eaten by

the Ame~ican public, you begin to wonder about the rationale,

even though sardines are held for a period of time, you see, in

the water, in nets, before they are brought aboard and processed.

Nonetheless, they are processed with the entire intestinal tract.

Well, this was the issue.      Now, I felt strongly that that kind

of thinking could no longer be tolerated and that, therefore,

we would approve the   u. s.   Department of Interior's request

which would permit them to market whole fish protein concentrate

in   the United States but limit it to one pound bags in order to

prevent consumer deception.      If it went out in 1500 pound bags,

you might find some millers or some bakers mixing it with other

higher priced items in order to deceive the public.      And we felt

that if it were sold as a consumer item, directly to the con­

sumer, and properly labeled, "Whole Fish Protein Concentrate,"

then the consumer would know and have a choice.      If they chose

to exercise that choice in favor of the product, just as they do
                                                                    367




sardines, then there really wasn't any problem.      Now this was

basically what we presented to Secretary Gardner.      Mr. Goodrich,

to help, played the devil's advocate and pointed up the classical

arguments about filth in the marketplace, the fact that the fish

with bones, scales, heads, eyeballs, intestines, everything,

would be included.   The Secretary listened very attentively and

after Mr. Goodrich finished, he said, "I guess you don't believe

that cities ~stream on the Ohio River from Pittsburgh should

use the water that Pittsburgh has used, because we recycle, and

filth isn't really a relevant issue.   It's a technological

problem today.   Can the product, Dr. Goddard, be marketed in

such a way. that it's clean, it's wholesome, it doesn't have any

potential for infecting anybody?"   I said, "Yes."    He said,

HBless you."


Dr. Y.:

There~ a problem of some sort of alcoholic residue.


Dr. G.:
Ah.   Now we did find out that the Department of the Interior

hadn't done their homework properly, and, in fact, there was

a problem with a too high concentration, as a result of the

particular process the Interioi Department was going to use, of

flourine, flouride residue in whole fish protein concentrate

which could cause mottling of the teeth.   Now, we were able
                                                             368




to work out with them, however, a change in methodology that

would remove the headbone, the head of the fish, and decrease

the flouride, and then they were able to go ahead, and they are

now building the pilot plant, as I understand.


Dr. Y.:
Oh, is that what's happening?


Dr. G.:
Yes, I understand •••


Dr. Y.:
I remember the big argument one day at the Advisory Council in

which you presented this issue and Tex Cook of General Foods

was all upset about this one pound package business.


Dr. G.:
Yes.




Is this still the situation?


Dr. G.:
That's still the situation, and I don't think that's a bad thing.

As the experience grows with it, that can be changed, but I

don't think he should start off with no holds barred.     Really,

the people backing this they were telling us the truth.     They
                                                                   369




said, nwell, Doctor, we don't expect there ever to be a u. S.

market.    It's only a political necessity to have approval, FDA

approval, in order to send it overseas. 0


Dr. Y.:

Because India couldn't accept it if Americans were too high and

mighty to eat it.


Dr. G.:

So if they never foresaw a market in the United States, why

was it such a problem when we put a one-pound limitation on it,

you see?   But at any rate, they now are going ahead.


Dr. Y.:

But that was another point of interest.


Dr. G.:

Secretary Gardner saw the technical issues very quickly.      Again,

I had made the dee is ion.   Of course, if he had said, "We 11, don' t

do that,n I would have respected it.      But I didn't take this

issue to him to ask him to decide it.      I didn't think that was

fair.


Dr. Y.:

You had worked it out ahead of time •••
                                                              370




Dr. G.:

Right.     I wanted to alert him to the political sensitivities

involved, because every congressman and senator from every

coastal state was interested in this particular process and in

seeing this approved, because it had been blocked for so many

years.


Dr. Y.:
And they even thought you were dragging your heels.


Dr. G.:
Oh, yes.     They thought I was dragging my heels because of the

flouride problem.


Dr. Y.:
And on this conference, you and Billy Goodrich had figured out

ahead of time you were going to present it this way in order

to make the thing sparkling clear.


Dr. G.:
Yes.


Dr. Y.:
Well, you were talking about the vitamin and mineral proposed

regulations as an example of an issue which Secretary Gardner

grasped.     I had some things about this down to raise questions

about.     The Federal Register did carry the first draft of your
                                                              371




new revised set of regulations on June 18, 1966.


Dr. G.:
It was unfortunate that we had some errors that we hadn't caught.


Dr. Y.:
I wanted to raise a question about how you got acquainted with

this question and who brought it up, who was responsible for

taking the 1962 version and converting it into what became the

1966 version, and how it•••




Billy Goodrich and Ken Kirk.


Dr. Y.:
They were the two?


Dr. G.:
Were the two.   This was again in the category of pending business •••

something that had been left hanging fire for a considerable

period of time, and so Billy had brought it up, and Ken Kirk took

it over, and McLaughlin, as I recall, on his staff, did a con•

siderable rewrite on this, and in spite of going over it a num-

ber of times and asking as many questions as I could think of,

we still made some mistakes in that original draft that went

out.   On portion size for infants ••• it was most embarrassing to

find the portion sizes for infants were ridiculously off, which
                                                             372




meant that we just hadn't done our staff work even though it

had been looked at by, I would judge, eight people, at that

point in time.


Dr. Y•:

Well, one of the biggest black eyes that you got, of course,

came from rather a protesting voice that was raised by the

chairman of the Food and Nutrition Board of the National Re-

search Council.      A   fellow whose name was •••

)

Dr. G.:
Henry Sebrell.


Dr. Y.:

Dr.   w.   Henry Sebrell.


Dr. G.:

That's right.      Public Health Service Officer, retired.


Dr. Y.:

At Columbia.


Dr. G.:

At Columbia, former NIH director.


Dr. Y.:

And his sub-committee, at any rate, was in charge of the recom­

mended daily allowances and what they should be.
                                                              373




Dr. G.:

Minimum daily requirements, until that point in time.     Only

subsequently to then did they shift to "recommends dietary al­

lowances", RDAs.


Dr. Y.:

Well, I thought that it was only the food and drug that had the

minimum.


Dr. G.:

We followed their recommendations, and because the minimum was

such a problem in terms of misleading people, because the people

engaged in this business would say, "You don't want just the

minimum daily requirements.     You want three times the minimum. u

So, in order to avoid this, the Academy went to recommended diet­

ary allowances.     But they were responsible for setting the RDAs

which the agency then followed.


Dr. Y.:

Right.     The trouble was, somehow, that in the transfer, the

agency had gotten more precise than the somewhat flexible system

that the committee had had, and at any rate •••


Dr. G.:

There were a couple of problems.
                                                               374




Dr. Y.:

••• he jumped on the Food and Drug Administration pretty hard

for that and for quoting them, as it were, in the so-called

crepe label that you were •••


Dr. G.:

That's right.


Dr. Y.:

••• saying should be on every package.


Dr. G.:

That's right.   Well, unfortunately, this was the issue that

Kline, remember, we talked about Dr. Kline •••


Dr. Y.:

Right.


Dr. G.:

Dr. Kline.   This was one he was supposed to be gum-shoeing and

he didn't.   He didn't do the coordinating work that was expected

of him, and one would have to reason to think he was capable of,

and that fell between the cracks, and Sebrell was mad and, un­

fortunately, he criticized us publicly without ever giving us

a chance to smooth over the difficulties and get our house in

order.    Dr. Seitz, Frederick Seitz, the head of the Academy,
I went to him and complained about that.    Now this is relevant
                                                              375




at a later point in history, because of my article in Esquire.

Dr. Seitz wrote me and said he had no reason to think that I'd

ever been unhappy with the Academy.     He'd forgotten all about that

problem that Sebrell had caused for FDA and for me personally,

you see.     So, it's interesting how these work in cycles.


Dr. Y.:

You did get it straightened out and get back in liaison?


Dr. G.:

Yes, we did.    We got back in liaison, so I personally attended

conferences that the nutrition group at the Academy held, spoke

at a luncheon meeting they had and worked much more closely with

them.     That need never have happened had Kline done his job,

and if I had been checking on Kline, but that was in the early,

extremely hectic days, and I gave Kline an assignmen,t and had

no reason to doubt that he wouldn I t follow through on it.


Dr. Y.:

One of the problems with this is that it was so complicated,

and another obviously is that it hit so many segments of in­

dustry.


Dr. G.:

Oh, yes, this brought together all sorts of unholy alliances.

It was complicated to begin with, as you point out.     For example,
                                                                376




the diet food store operators, who also tend to sell vitamins,

mounted the campaign again which was comparable to the one of

1962, but they misinformed their followers, their clientele,

by telling them the FDA was going to prevent vitamins from be~

ing sold over the counter.     That was not true.   We were going
to prevent the sale of vitamins in therapeutic dosage forms

as over-the-counter items, but the ttone-a-day" type vitamin,

we were not going to take that off of the market place, so it

was a complex set of issues.


Dr. Y•:

So that the ones that were wild and had seventy-five different

ingredients in, they were going to be badly hit, no question.


Dr. G.:

They were going to have to come into conformance with the recom•

mended dietary allowances.     We put the crepe label statement in

as a give-away, as a trade item.     We never had any thoughts of

keeping that in.


Dr. Y.:

Oh, I didn 1 t know that.


Dr. G.:

Oh, yes.   That was a straight trade.    Billy Goodrich and I agreed

ahead of time when push came to shove we would have that deleted
                                                                   377




in order to get the rest of the package through, and that may

not have been good judgment in retrospect, but at least that

was why it was put in there.


Dr. Y•:

Well, one~a....day- brand people were also upset.   That is, the

makers, the pharmaceutical manufacturers.


Dr. G.:
Oh, of course, because they 0have a multi-million-dollar, hun""

dreds of millions of dollars a year, vitamin business selling

these to people who don't need them.     And, of course, they don't

want to lose that business.    What we were going to do though,

was, and we were realistic enough to know not to have unrea-

sonable expectations of the public, we knew that the public would

continue buying these products.     We, therefore, wanted to make

sure that, at least they had some basis, rationale in science,

and that a firm wasn't bilking the public by suggesting that

their product was one~a-day when, in fact, it was deficient in

some of the major elements and had too much of some of the less

important elements in the formula.     In fact, that was a quite

common thing.   The more expensive items would be cut short.

The inexpensive ones, they would put three and four times the

recommended dietary allowance in.     And so it was a hodge podge.
                                                                    378




Dr. Y.:

Well now, why should the biggest pharmaceutical manufacturers

who made these on the side have been upset at a proposal that

would have curbed their competition from the more quackish

operators?


Dr. G.:

They were afraid of the label restriction, that their sales

might fall off.     That's a very profitable field.    The margin

is extremely high on these products.     They simply didn't want

any restrictions.     It goes back to their lack of foresight.

But, you are right.     There were many other groups involved:

the National Canners Association was upset, the Grocery Manu­

facturers Association was upset.


Dr. Y.:

Millers?


Dr. G.:

Millers.     You name them and there was somebody.    About the only

people who weren't upset were the Pepsi and Coca Cola companies,

because they had Diet Coke and Diet Cola.     Those would have been

low calorie foods, and they weren't badly labeled at that time.


Dr. Y•:

One of the things that was done was an effort on the part of
                                                            379




the Pharmaceutical Manufacturers Association to stop things •••


Dr. G.:

Again, on a legalistic, procedural basis.   They weren't success­

ful.   This again, was typical of Joe Stetler and his whole ap­

proach to the Food and Drug Administration when I was commissioner.

He said that we had no right to do this, the fact that this had

been published once in 1962, then made it•••


Dr. Y.:

It had to do with a particular section of the law.


Dr. G.:

That's correct.   We could no longer do it the way we proposed.

Well, we did.


Dr. Y.:

One of the big questions that was only in a minor sense present

at the beginning but that has grown larger as there has been

more attention to the poverty problem and to a recognition of

how much poverty there is and how much malnutrition was this

question about malnutrition.   You say that this crepe label was

put there in order to have a kind of a bargaining give•away.


Dr. G.:

Uh huh.
                                                                 380




Dr. Y.:

Well, it said rather straightforwardly that the foods a person

had available had the vitamins within them which he should take.


Dr. G.:
That his body needed.


Dr. Y.:
That his body needed.    Now, •••


Dr. G.:
And that's true still.


Dr. Y.:
Right.    But the tremendous argument that has arisen since, a

great crescendo, against the con.tinuing hearings which are still

going on, has been made that no such statement as this crepe

label statement should be made because malnutrition is a bigger

thing, so obviously people aren't getting from their food the

vitamins that they neede


Dr. G.:
Well, that's a statement, not a fact.


Dr. Y.:

Right.
                                                                 381




Dr. G.:

There are generally not good facts yet.     Dr. Schaefer's group

had been doing a survey.   There is suggested data from that sur­

vey to show that some of the vitamin levels, Vitamin C levels

in particular, some of the Vitamin A levels, in serum obtained

from children, show some level of deficiency.     Frank malnutri­

tion has been extremely rare.     It has been surprising, however,

that five percent of the population examined in one area showed

evidence of thyroid goiter.     Now, we thought this problem was

pretty well solved by the introduction of iodized salt.     But

many of the food companies, such as Campbell Soup, do not use

iodized salt in the preparation of their food, because it's a

cent or two per pound more expensive than non~iodized salt.

Now, whether or not if Campbell's Soup had iodized salt it would

prevent the goiter, no one ean say.     I didn't use that as one

example.   Frankly, I'm skeptical that malnutrition is as wide•

spread as some would have you believe.     Even if it were, vita­

min and mineral tablets aren't within the pocketbook reach of

that section of the population.     What they need is the opportunity

to have a sufficient number of calories in the major categories

of food stuffs, then you won't have to worry about their malnu•

trition or their vitamin levels.     That's the major problem.

The major problem is getting a good school feeding program in

the South which is where much of this exists.     Another major
                                                            382




problem is proper education of the low-income population as to

how to use their food dollar properly, rather than some of the

ways people on welfare unfortunately now spend their dollars.

Another problem is to see to it that the super markets in the

low-income areas don't bilk the people by shooting the prices

up the day before the welfare checks come out, and that's been

observed, you see.   So, there are all sorts of problems to be

solved, but certainly the sale of vitamin and mineral tablets

isn•t one of them related to malnutrition.


Dr. Y.:
It isn t t an answer to the question.




Of course not.   It's ridiculous.


Dr. Y.:
In fact, insofar as people who should use the money to buy food,

buy these, it's a waste, it's a risk.


Dr. G.:
Yes.


Dr. Y.:
But this argument has been made and that •••
                                                                   383




Dr. G.:
Well, the people involved in the hearings from industry, there's

no question in my mind that the health food store operators as

a lobby are the most disreputable, dishonest group in the Ameri­

can society today.    They will use any tactic available to them.

They will lie and it has been documented that they have lied.

So, the fact that some of the people involved in this hearing

say that this is justification doesn't sway me at all.     Now,

unfortunately, some of the other trade associations will engage

in some of these same tactics.     The National Canners Association,

I think, has had the worst leadership of any major trade associa­

tion in Washington.    It 1 s been terrible.


Dr. Y.:
Well, do you want to be specific?     Can you recite an instance

where you ran into this?


Dr. G.:
Yes, they lied on the canned salmon problem in Seattle.     They

said they were doing one thing and they were deliberately con­

cealing the problem even after they had reached agreement with

our agency on what procedure would be followed.


Dr. Y.:

That was where they had self-inspection, wasn't it?
                                                                    384




Dr. G.:
Yes.   And I told them they were jeopardizing the existence of

the program.     But it went beyond that.    The leadership of the

association, the individual involved just was afraid of his

own shadow.     He was an Aunt Nellie.    He couldn't see what the

future held or holds and was unwilling to make any change.              On

labeling on the Fair Packaging Act, he had the greatest dog­

in-the-manger attitude I have ever seen.       He just said it was

impossible for them to do this job.       It wasn't.   We worked out

through the GMA the procedures that could be followed.        His

attitude was always, "It can't be done; it can't be done.           I

don't want any change.     Let's just leave things the way they

are.   The industry's comfortable.tt     Well, they're comfortable

alright.   So these hearings ••• I'm not surprised that several of

those groups whose financial interests are threatened want this

to be the outcome.


Dr. Y.:
Well, obviously here it's more than seven years and nothing

finally done.    Partly, the procedural issue, the complex method

of coming to grips with the problem•••


Dr. G.:
We do need a different mechanism, I will agree.        Our society

deserves and merits a better mechanism than we now have for
                                                              385




these very complex and sophisticated problems which involve

to a large measure science and public policy.    We do not have

a good mechanism today.   I certainly agree and I was hard put•••

I can't think of a better mechanism.   No one seems to be able

to.


Dr. Y.:
There was no way to speed this up.


Dr. G.:
No.   You have to use the Administrative Procedures Act and that

means that lawyers get in.   There are all sorts of tactics used.

In fact, one of the things the industry occasionally does is to

try to discredit the whole Administrative Procedures Act, the

mechanisms involved, by making the hearing a laughing stock.

Now, that doesn't do anybody a service.


Dr. Y.:
It has been suggested that maybe the peanut butter hearings is

an example.




Indeed, I think they were.   Indeed they were.   The hearings on

that, as you know, went on for about nine months as I recall.

The bread hearings, another example.   But, it 1 s unfortunate.
                                                                  386




Dr. Y.:

Okay.     I think I'll turn over the tape.

Dr. G.:

Okay.


Dr. Y.:

One case that looked to me as if there must have been something

behind the scenes was the case that involved Measurin •••

MEAS UR I N•••which was a timed-release aspirin which was

being put out by Cheseborough-Pond.     When this case surfaced,

it appeared as if maybe you were running into your first trouble

in what up to that time had been a relatively smooth relation­

ships with the staff of Representative Fountain's committee.

This began because this aspirin compound had been tested clin­

ically by the Cass Research Associates Laboratory in Massachu­

setts and you found out that this was one example of clinical

research that supposedly had been done but hadn't been done or

hadn't been done adequately, and so there was a decision you

had to make as to what you were going to do about the.product.

At the time you decided to leave the product, which had gotten

on to the market through an NDA, on the market, giving the com""

pany time to try to bring in some new clinical evidence.     But

later on, the Fountain Committee wondered why you hadn't elimi­

nated the product immediately by revoking the· NDA.    I notice
                                                                387




that you talked to the company officials on March 16th, and

you handled a prescription analgesic somewhat differently,

taking it off of the market rather peremptorily, and you

didn 1 t do that with this.   There was also some feeling that

maybe one reason the Fountain Committee got upset was delib•

erately in order to take a crack at Winton Rankin who signed

one of the orders instead of you yourself signing the order.

Yet, you yourself, when you were asked about it took full re•

sponsibility for the decision.


Dr. G.:

Well, no question about the decision, it was mine.


Dr. Y.:

Right.    Well, now what was all this about?   I have given you

a kind of trade press view of the situation.


Dr. G.:

This was sort of a tempest in a teapot situation really.     Now,

legally, I think Don Gray and Del Goldberg were right.     I should

have acted and withdrawn the product from the market place.           It

was an over~the•counter drug.     It was a timed-release aspirin.

It did seem to serve a useful purpose for some people.     It

wasn't any more dangerous in my book than the other aspirins

on the market place.    It was more expensive, yes, but not more

dangerous.    Therefore, I couldn't get upset about it.   In fact,
                                                                    388




I think in testifying I said, "Why, it's only aspirin, Mr.

Fountain."    Not knowing at that point in time, as I later

learned, about the sophistications of aspirin with respect to

the research that we ourselves supported at Georgetown Univer­

sity.     It was a very complex subject, but nonetheless, at that

point in time I viewed it as only aspirin.     Keep in mind in

over-the-counter drugs we require a margin of safety about

five times greater than for prescription drugs.     So I felt

safety wasn't really an issue,    Therefore, I didn't see much

reason for disrupting the market place.     I refused to take it

out of the market place and gave them time to do more studies.

Now, they really didn't do good studies even though we gave

them more time and Cheseborough-Pond lost several million dollars

on that product.    He ultimately got out of that business.


Dr. Y.:

Well, ultimately you did in August of '66 revoke the NDA, on

grounds of both safety, because too much of it was being absorbed

within a certain period of time •••


Dr. G.:

That's right.    By the studies we had then.   But, you see, I

didn't have that data available at the time the decision was

initially made, and, as I say, I was surprised by the sophisti­

cation that was involved in an issue like aspirin.     So, I was
                                                                           389




wrong, as I said, but again, it seemed like the right thing to

do at the time.


Dr. Y.:
But a good deal more was made out of it in the press •••


Dr. G.:

Oh, yes.     As you said I think that Gray was trying to get Winton.

He never liked Mr. Rankin.               He hated his guts.   He didn't want

me to take him as my deputy commissioner, and he thought he had

something he could pin on Winton, but it wasn't Winton 1 s fault.

It was mine.


Dr. Y.:
So that was all there was about that.


Dr. G.:
There wasn't anything •• ~no, there wasn't any hanky panky going

on, really.      What was the other analgesic, "Norgesicn?


Dr. Y•:

Right.     Riker 1 s   11
                            Norgesic."


Dr. G.:
Yeah.


Dr. Y•:
Well, one of the other big things has to do with the whole
                                                                   390




internal reorganization in connection with the Department of

Health, Education and Welfare on the health side.    There had

been stirrings of this, I suppose, almost from the beginning.

President Johnson had sent a message to Congress in April of

1966 that dealt with the reorganization of health agencies

within the Public Health Service, and there evidently had been

a committee headed by John Gorson of Princeton •••


Dr. G.:

Corson.   CORSON.


Dr. Y.:

••• who had made certain recommendations to Stewart who was then

Surgeon General, and one angle of this that came up at the end

of your first six months, about, was that you rather publicly

hinted that you'd be glad to take over the pre"marketing approval

of biologics into FDA from the Division of Biologics Control.


Dr. G.:

Yes.


Dr. Y•:
You said indeed that Secretary Gardner had this under ~onsideration.


Dr. G.:

He did.
                                                                     391




  Dr. Y.:

  And you told a House Interstate Sub-Committee this and later on

  Representative Rogers recommended in a report that he issued

  that this occur.     So, what about this particular thing?   This

  obviously shows rivalry for a certain power function within

, agencies, both of which are part of the health part of HEW.

  What about this matter?


  Dr. G.:

  I never viewed it as rivalry or as empire-building.      I didn't

  think DBS was doing its enforcement job, and that they were too

  close to industry.     That was their modus operandi, was work

  right with industry.    And I felt that logically••• we always got

  left in FDA with cleaning up the mess that grew out of DBS' un"

  willingness to take any action.     For example, the Rand vaccine.

  They delayed and were dilatory in that.     They were dilatory on

  Krebiozen, if that's the right word.    They certainly piddled

  around, is what I am trying to say, and couldn't come to a

  decision about prosecution.     But, you see, once they decide to

  go after somebody, then they turn the enforcement over to FDA,

  but they have to make the basic decision.     They never really

 wanted me to take a tough line.     So I felt it made sense, and

  I recommended it, and, in fact, Secretary Gardner and Assistant

  Secretary Lee were kindly disposed to the idea.     Now, Rod Murray

  and I weren't old friends.    Let 1 s make that perfectly clear.
                                                                 392




Dr. Y.:

Who was this?


Dr. G.:
Rod Murray, the Director of DBS.     We fought on different sides

of issues in the past, when I was Chief of the Communicable

Disease Center, in fact.     But there wasn't any personal animos­

ity involved in this.     But Rod made it perfectly clear that be

would leave before he would work for me.      And Rod's a good man.

So, there was that to be considered.     Frankly, also it wasn't

a major issue with us because we had enough to say grace over.

We had our own house to clean up and that was a job, an Augean

stable as it turaed out.     And so I really wasn't looking for

more for the agency to do.     This was more in the sense of it

was a logical kind of thing.    NIH is not an enforcement agency,

not a regulatory agency, and yet they had a regulatory function

housed there.   It didn 11 .t make any sense to Dr. Lee.   It didn't

make any sense to Secretary Gardner, and it logically belonged

in FDA, so that was what that was about.


Dr. Y.:

Why did it get stifled?


Dr. G.:

Well, it got stifled because of politics between NIH and Public

Health Service and the Office of the Assistant Secretary for
                                                                393



 "t
Health, and I really wasn*t all that aetively interested in pur•
suing it to make a big issue over it.     So, it just sort of died.



Another recommendation that came from HEW, this was early in
1967, related to the up•grading of the post of Assistant for

lealtn to the Secretary of HEW.     I rememher when Boisfeuillet
Jones had it, it was a statutory position, but it really wasn't
called an Assistant Secretaryship.



That's right.



It had been defined the way it was by Congress.


Dr. G.:
Well, th.ere was a mere basic issue.    What turned out to be
Assistant Secretary for Health or what had been Assistant te
the Secretary for Health, really what was involved was should
it be a line or a staff function.

Dr. Y.:
I see.

Dr. G.:
And as it turned out, it beeame a line funetion, and tne power
thus moved from the Surgeon General's office to the Assistant
                                                                    394




Seeretary, Dr. Lee•s office, and this meant that staff had to

be developed at his level, it meant that decision-making shifted,

the power base changed.     I would say_ it was the beginning of
chaos.     Let me make it clear, I liked and enjoyed Pbil Lee•s

friendsnip, but I don't th.ink Phil was a eapable aElministrator.

He would be swayed by the last person to see him on an issue

and change his decisions.     Let me give you an example:   at

issue was the question of whether budget people and the Assistant

Secretary for Health and his staff would work under!!!!., super­

vision or under Mr. Kelly, the comptroller•s supervision.         Dr.

Shannon and I argued almost vehemently, certainly vigorously,

in Dr. Leets staff meeting with him to retain control over those

twenty-six positions, not to have those people work in Mr.

Kelly 1 s snop, because we had had experienc.e with Kr. Ke·lly.
The remainder of the staff watched interestedly but didn't get

into the fight.     Shannon and I fought with Lee, and Lee reassured

us that this could be done without losing any control, whieh

is utter nonsense, because if you give Jim Kelly twenty-six

positions, those people are going to work for Jim, even though
they technically are on your staff.     If they report to him day
by day, they're going to be under his supervision.      Well, this

was the kind of dec.isicn tnat PhU made that upset many of us
so much.     I also think. that he made some poor selections.     I've

made some from time to time, and I know how they can occur, but
                                                               395




I thought that he made a higher percentage.      Joe English, for
example,    c. c.   Johnson, and a few people like this, aren't
really strana administrators.


Dr. Y•:

Now, this proposal was made to up•grade the job under the Presi­

dent's authority, or was this a special ••• it wasn't a Congres­
sional aet?

Dr. G.:
It wasn 1 t a Congressional act.


Dr. Y.:

And, at the time it was rumored that perhaps you might be given
this job.

Dr. G.:
Ne.   I wasn•t even interested in it.     That was .strictly a rumor.
There was no interest on my part and never any consideration on
the part of the Seeretary that that job would become mine.

Dr. Y.:
Well, one of the most intriguing, behind-the-scenes stories that
seems to me that needs to be taken account of in our conversation

is this story that came out just this last January and I'd kind

of like to read it into the record.
                                                                    396



Dr. G.:
You go ahead and I'll get another can of beer.

Dr. Y.:
All right, and then let you comment on upon what is said.    Now,
this story was written by one of the deans of the Washington
drug reporters named Stephens Rippey who was the Washington
editor of Drug Trade!!.'!!!. and it appeared on the front page of
the issue of Drug Trade!!!:! for January 13, 1969.    /! photo•
duplicated eopy of this article follows on the succeeding page;]'

Dr. G.:
Finished reading?



No, I've just gotten started.    It starts off•••,lihe article is
reai7••• and that's the end Gf the article, and there ts plenty
in there to eommen t on.


Dr. G.:
God, yes.   Let me have it.

Dr. Y.:
You just take it and take off.


Dr. G.:
Well, Steve Rippey normally was pretty accurate.    He was off base
                                                                    397




on this one, though, with reJpect to the following.     First of
all, I never proposed to Secretary Gardner the assemblage of
all the government health activities into one agency.    Wbat I
did present in formal presentation to Secretary Gardner in the

presence of Wilbur Cohen, Phil Lee and Jim Kelly, however, was
a proposal that went back to 1962 when the Public Health Service
was being reorganized.   I proposed at that time to the then
Director, Bureau of States Services, Dave Price, that the Public
Health Service be reorganized into twelve institutes of health
and that the bureaus be eliminated.     It was very clear in 1962
that Jim Shannon was stronger than the Surgeon General, that the
NIH had captured the imagination of Congress and the public.
My reasoning, therefore, was to build on that strength, eliminate
the Bureau of MecH.eal Services and the Bureau of State Services,
and have twelve institutes with each institute director having
under him a man responsible for research programs and the imple­
mentation of community action programs.    Now, on this, I had one
ally, Dr. Bob Felix, who was then director of the National In­
stitute of Mental Health, who always maintained control as direc­
tor of one of the institutes over his extramural community action
programs.   There was never a division in mental health, of the

kind we had in cancer, heart disease, etccetera.     I thought that

Boh was right on this point.   However, I could not get support

within the Public Health Service.     They were unwilling at that
                                                                            391



time.        Dr. James Hundley was Chairman of the Surgeon General's
Committee on Reorganization.          That committee would not take a
stand       on a bold, imaginative reorganization proposal, because
it would have meant a snowdown with Jim Shannon.            Either he
would have moved up and become Surgeon General, which I felt
would have been good, or he would have been Deputy Surgeon
General.        But the Institute Directors would have reported di•
rectly to the Surgeon General, each one aceountable and respoa*
sible for both nis research and his action program.            I felt this
was still a valid reorganization plan in 1967, when Secretary
Gardner, in the winter of •66, spring of '67 and all of this

period of time, when we were talking about reorganization up
until the time that he left in 1968.           And so I presented that

late ••• it was in December or January••• Deeember of '67 or Jan•
uary    1   68••• to the Secretary and the people I've mentioned.       I
also presented it to John Corson and one or two others.            At no
time did I present it to Dr. Hornig.           I want to make that per•
feetly clear.        If ke heard about it, he heard about it from sources
other than myself.        My   plau was not aeceptable to Secretary Ga:t:'4-
ner, Rr. Cohen, Phil Lee or Jim Kelly.           Mr. Cehen did not want
a strong Surgeon General, in my opinion.           I think the record will
show tnat he wanted a weak Surgeon General, that he influenced

Secretary Gardner to select Dr. Bill Stewart          no   was a very weak

Surgeon General, in order that he, Wilbur, could dominate the
                                                                          399



health activities of the department.     And so, to that extent,

Steve Rippey is entirely wrong.     I never visualized all of the

federal ••• First of all, Wilbur was the one who visualized all

of the health activities being brought together under        ow.
He got a very grandiose idea, and he proposed something and,

f0r a while it looked like he had M.r. Johnson sold on it, and

the Veterans Administration and the military agencies, the

health people of the military agencies, really rose up in uni­

sen and smote him down, deserted him.     Now, I was ..never naive

enough••• I was naive about some things••• I never believed that

you eeuld iring together those things.     I made the point in
discussions with people from time to time tnat ideally we should

have a single Department ef Health, yes, idealistically.           That

would be fine.     It would make great, good sease••• use a single

hospital system.    You would always have then enough physicians

at the ready state by taking care of veterans, merchant sea­

men, military dependents on civilian bases, etc., to handle the

needs in ease of war, you see.     You could do it.   !!!,   I also
recognized that one could not do this, that the Veterans Ad•

ministration power block with Congress was so strong that you
couldn 1 t possiblj do it.   So in that, Steve was wrong.     I aimed
my presentation exclusively at the idea of twelve or fourteen

institutes of heal th.    Now, in fac~, when I was trying to he•

come Surgeon General, I discussed this same proposal with John
                                                                      480




Fogarty which was before Jobn 1 s death.      John asked me very point•

edly what would become of Jim Shannon if I were named Surgeon

General and put this plan into effect.        I said Jim would have

to take a position until his retirement two years hence as Depu­

ty Surgeon General in charge of plans, and Jim is great on plans

and develepment of new activities.        He•s just great on that

activity.   FogaWty then said that be would not support me in

my quest for the Surgeon General•s post, because be bad been

friends with Jim Shannon for many years, and he would not stand

by and allow Jim to be downgraded.        That was tbe word he used.

In fact, it wasn't, oeeause the deputy surgeon general for

plans, if this nad been implemented, was a higher level job than

director of NIH.     But Fogarty nevertheless did feel that it would

be a down.grade.    So that didn 1 t occur.   I mention this only to

show tnere was a coBsisteney.        I first presented the plan in

1902, and presented it to Fogarty in the late fall of '65, when

I was trying to become Surgeon General.        And it wasn't anything

new.

Dr. Y.:
Well, when you presented it again in late '66 or       1 67 •••




Well, it was late    1 67   to Secretary Gardner.
                                                                  401




Yes.     If it had come into effect, did you have any ambition,
within the structure, of your own?


Dr. G.:
I think one always bas ambitions.     I knew Phil Lee was in there
as Assistant to the Secretary at that time, that he had strong
pelitical baeking.     I wasn't unaware of wb.at his power source
was, and if some of the•••


Dr. Y.:
What was it?

Dr. G.:
California based.    Some time in the future I thought that perhaps
I could go beyond the commissionersbip of FDA, yes.     No ,uestion
about it.    But I was still interested in the possibility of be•
coming Surgeon General, don 1 t forget.


Dr. Y.:
Sure.

Dr. G.:
Even though I was Commissioner of Food and Drugs.




Right.
                                                                  402




This reorganizatien then would have in mind the idea in the
future of still being Surgeon General.     Now•••

Dr. Y.:

And the Surgeon General's position under the plan bave been made



Dr. G.:
Strong operating position, yes, not••• it wasn•t a weak Surgeon
General•s position.    Now, Wilbur didn•t want a strong Surgeon
General.

ll)r.   Y.:
llight.

Dr. G.:
Let me go on and tell you the other side of this.



Right.


Dr. G.:
Rippey 1 s right about the difficulty finding an associate commis­
sioner for science.     I did find a good man.   Dr. Daniel Banes is
in that post now.     He was within FDA, and I think a good scientist.
                                                               403




Dr. Y.:
Did you find Dr. Summerson, or had be come in before?

Dr. G.:
He had eome before.      He was brought in by Larrick.   Now Dr.
Charles Johnson, I tnink the record will have to show whether
or not    c. c.   is going to do a good job as head of CPEHS, or

whatever it is.


Dr. Y.:

Well, whose idea was it to ereate this present system?

Dr. G.:
Well, after Gardner tumed me down, then I had to throw my
shoulder behind an organization of CPEHS, which was, as I recall,
largely Kelly and Lee• s baby.     I e itber had to support it or
get out.    Well, I did both.    I supported it and then I got out,
but it wasn't my idea even though at one time I was eonsidered,
even told, in fact, that I was going to head it up.

Dr. Y.:
What was the problem on tkat?

Dr. G.:
The problem really came up with respect to Willard Simmons, the

bead of National Association of Retail Drug Stores, who got to
Viee•President Humphrey.
                                                                  404




Dr. Y.:
And Simmons was upset because of what you had said about the
drug stores?

Dr. G.:
Yes, I said that twenty years from now the corn.er drug stores

ought to be closed dewn.      Well, Simmons didn 1 t have any issue
to keep his position a lively one before ais trade association.
He seized on this as an issue and said that I had to be gotten
rid of.    Well, he went to the Vice-President.     The Vice•President,
altllough he reeognized he couldn''t get rid of me as Commissioner
of FDA, he eould see to it that I was bloeked, and he told Wil•
bur he was net to appoint me to any other job.


Dr. Y.:
So you say, you had been told that you were to get the joh?




Oh, yes.    It was clear and•••



Who had told you that?

Dr. G.:
Phil Lee and Wilburx,C0hen.

Dr. Y.:
And they told you why you couldn't, then, later?
                                                                      405




Dr. G.:
Yes, and Phil kept saying, "Jim, we t11 work it out.       We''re
                                                    '
working with. the Wb.i t.e Bouse."   And I kept telling Phil, "Look,

if it takes this long, forget it.        There's a problem."   And at

one point in time, Mrs. Goddard was sick, she was in Walter

Reed Hospital.    They thought sbe had a brain tumer, which was

in early February, of '68, and that was when this came up, and

Wilbur was trying to reassure me.        You know, he got me one day,

and said, "I•m having some problems."        I said, "If I'm one of
them, that's easy,   r•u   quit today.     t•ve got twenty•ene years
in."   "Oh, no, no, no," he said, "we ean take eare of that.

We'll handle that.    We'll get the Waite House to agree."      So

I agreed.    I don*t know why I agreed to stay on until August,

the first of September.     I said, "I'll stay on until one Sep•

t.ember."   Then a couple of months later, I said, "he August."

Then I changed it to the thirtieth of June.


Dr. Y.:
Was there any reason for your pulling back the time7

Dr. G.:
Only that the "lame duc.k" is in an awfully poor positien to be

in in. Washington.   I had seleeted my successor, Dr. Herbert

Ley.   I had leaked the story to the press.      He bad been named

as my successor, and therefore, quite reas0nably, people started
                                                                     406




going to see Dr. Ley, and if you'll look at my appointment

ealendar those last few weeks, yeu'll find that there is almost

notbing on it.   Well, tb.at•s reasonable.    Se th.ere wasn't any
point in my staying, and then I wanted to get started with. this

new firm.


Dr. Y.:
Sure, and you tol4 me that day that you went to see Mr. Cohen

that you also were reading the politieal ealendar.


Dr. G.:
Oh, yes •. I felt very elearly that Mr. Humphrey was goiug to
lese, and the Republicans would be coming in, and there wasn't

any point in my staying around.


Dr. Y.:
Would you pull ·together yeur relationships with Mr. Cob.en?    And

give a judgment of him7


Dr. G.:
Wilbur Cohen is one of the greatest taetitians in Washington in
getting a piece of legislation through.      I don't see him as a

good leader.   As Secretary, he wasn't a good leader, in my book,
nor, in fact, with my confreres with whom I discussed this, the

heads of other agencies.   The staff meetings were quite different

under Wilbur tban they were under the Secretaxy, in the sense
                                                                 407




tkat one left without any feeling that they 1 d been exposed to

a leader.     When you met with John Gardner, you came away in•

spired.     You really felt great about working for tnis man.
With Wilbur, no.     We didn 1 t.   Now Wilbur, as I mentioned was

an extremely capable and shrewd politician.        I give him credit.

He engineered par excellence the social security legislation,

medicare, et cetera.




Was he more interested in that aspect of things than he was

in health?




Well, I think Wilbur has a basic mistrust and dislike of phy8

sieians.     Why, I dontt know.     I only observed his dealings with

tbem, ane 1.ds faeial expressions, and I"t ve wat.ehed him pretty

earefully at times, and this is my conclusion, that he doesn't

like physicians.     Now, I ean understand some of the reasons he

doesn•t.

Dr. Y.:
Beeause of the power structure, you mean, that he bad to fight?


Dr. G.:
Yes.   He had to fight, and his basic beliefs about society, and

some of this I don 1 t disagree wi.tht but I found that Wilbur dealt
                                                           408




in politic.al expediencies.   The thing that really made me decide

to get out fast was I fouad that Wilbur had c.ommitted the Food

and Drug Administration to a position on an issue with a senator

without consulting me ahead of time, and that was when I decided

that if polities were going to have that much to say, I eouldntt

stay on.




What kind of an issue was it?


Dr. G.:
It wasn't a major issue, but that isn't the point.




Right.




The point was that John Gardner would never have done that.


Dr. Y.:
I understand that.

Dr. G.:
I ran the Food and Drug Administration.


Dr. Y.:
Exactly.
                                                                 409




Dr. G.:
And then all of a sudden, Wilbur made a decision and thea ad•
vised me be had made tnat.     Now, that was his prerogative.      I
understand that, but it's poor leadership in that situation, as

it.was a technical issue.     It happened to be a technical thing,

and be wasn't competent to make that kind of judgment.



Then it was made for not the right reasons.



It was made for politieal reasons only, and solely on the basis

of political expedieney.     So, tnat was when I decided I had to
get out.     I could have swallowed my pride and stayed oa as Com•
missioner of the Food and Drug and even werked for      c. c.   Jonson.
Maybe not too long from what I learned afterwards from some of
my   friends who did stay on, but once I saw that happen, I really
bad to get out.    So my problem basically was with Wilbur.      But

there•s never!!!!. single issue.       It was a culmination of eireum•
stanees.     I had spent twenty•oae years.     I had done those things
that I felt Joan Gardner asked me to do.       He had left; the poli•
tical party change was coming; I knew I would be a dead duck
with the Republicans.     I had an opportunity to join a company,

the president of which was a friend of mine, and it looked in•

teresting.    Hy wife wasn 1't well.   There were all of these factors
                                                                    410




weighing on us at once, and the crowning blow or the straw

that broke the camel's back was that little political thing

that Wilbur pulled en me.     So I said, "To hell with it.   I am

getting out. 11   And that's wh.en I told him I would leave, and

th.en I just kept moviug the date up.    That's all there was.

Mr. Johnson••• I never had any problems, the President and I.

Now, Humphrey quit speaking to me after the thing with Wilbur

Simmons.    That was pretty ch.ildish, but he's purely a politi•

cian and a drug store man himself.


Dr. Y.:
Had you had•••

Dr.   G.:
Alth.ough I must say I understand that he got his diploma in

pharmaey from a diploma mill in Denver, Colorado.


Dr. Y.:

Had you had very close relationships since he was so interested

in drugs prior to then?




No, not close, but we bad spoken at these dinner functions and

things the Vice-President always had to attend.     He always made
a point to speak to me and he was quite nice.     Julie Cahn of
his staff would call me on th.e issues but no, we weren't clese.
                                                                   411




Dr. Y.:

Did you have much association with Cahn?


Dr. G.:
Ob, no, telephone, seeing him at cocktail parties.     Vic Cahn,

by the way, was that writer 1 s name for the Washington Post,

wbo was in Minneapolis that day I had the problem.


Dr. Y.:
Well, it looks as if most of the points •••




Well, I think maybe it's four-thirty and we ought to quit for

the afternoon.   Wb.at do you think?   We ean do the rest up the

next time.


Dr. Y.:

Well, okay.   That•s good.   Well, thank you very much.
                                                                  412




Dr. Y.:

Well, tkis is toe sixtn conversation that we've had of an after­

noon at the home ef James L. Goddard.    I am James Harvey Young

and today is June 19, 1969.    I've gene through a few records,

mostly published records so far, to eover those eventful years

and months, and I've got some more questions that I'd like to

ask, some that have to do with tne evaluation and appraisal of

persons ane groups, and some that have to do with decisions

and projects.    So how about my just running down my listl


Dr. G.:
Fire away.


Dr. Y.:

First of all, the Toilet Goods Association.    In January of •06,

you said that ttthe cosmetics industry was not without its prob­

lems."    That was a quoted phrase, and in September of that year

you warned the cosmetics manufacturers to clean house.    Yet,

despite the fact that TGA was engaged in earnest litigation with
the Food and Drug Administration ahout color additive regulations,

which FDA eventually lost in January '61, yeu began, at the ini­

tiative of the trade association, a series of conversations with

their leaders that ran from July, 1966, virtually up until the

time you retired.   Now, in midstream you termed these discussions

good, and you spoke in a very conciliatory vein to the 1967 TGA
                                                               413



convention.     Itve got some questions about this general situation.

Who was there for the Food and Brug Administration and who was
there for TGA, and would you evaluate the 'IGA people, the key
people, as to their leadership?


Dr. G.:
Well, Food and Drug was always Billy Goodrich, Ken Kirk and my­
self.     We were the principal ones involved.   Occasionally Dr.
Summerson beeause some of the issues got down to technical ques­
tions having to be discussed or at least bow we would approach
the solution of technical problems.     TGA••• I might have diffi­
culty recalling the names, it's been some time now•••


Dr. Y.:
Their general counsel was named•••

Dr. G.:
Leiberman.


Dr. Y.:
Fuller Holloway?

Dr. G.:
Fuller Holloway, yes.     Fuller would come most of the time, but
in later months generally Fuller did not continue to be involved.
Leiberman of Toni Company; the president of TGA in '67 who was •••
                                                                        414



Dr. Y.:
Breck?


Dr. G.:

Breck at that time.       I can't recall the others.

Dr. Y.:

Did James Merritt ever get involved in this?


Dr. G.:

Oh, yes.      Jim came in after •••Jim came on board with TGA in
'67, as I recall, and      s0   Jim was characteristically or usually

involved in these meetings.         N&w, one or two others came and

went.     The purpose of the meetings was to try to resolve some

problems between TGA and Food and Drug, quite apart from the

color additives suit that was in the courts at the time, that

were of long standing duratien.         It was my hope and the hope

of Leiberman, Breck, Merritt, Fuller Holloway, and the otkers,

Billy Goodrick, Ken Kirk, that we might reach agreement on what

could be called the GR.AS list--generally recognized as safe.

At least, the scientific people could do that, and if that were

done we could perhaps come to some understanding of a m~thod

by which toilet goods manufacturers could market a new product,

and if it were completely constituted of GRAS elements, they

could    ee   assured, reasonably assured, that they would have no
problems with the Food and Drug Administration.        They wanted to
                                                                 415




av0id a pre-market clearance system like the dew drug sy:stem.
We recognized some of the problems inherent in a field that moved

as quickly as toilet goods does, because fashion becomes involved,

and we're sympathetic to their point of view.      At the same time,

we felt that we just couldn't let them bring anything into the

marketplace.     Some mechanism 'bad to be established.   And so our

discussions throughout that time period were centered on what

kinds of mechanisms would be acceptable.     We finally got down to

a list of nine points, and of those nine we were in agreement,

as I recall, on seven of the nine, which, if you think of it,
is not too bad between an association and a regulatory agency.

Now, the last two we never could come to an agreement on, so

I suggested that the TGA take the proposal te Congress and let

the committee then be the arbiters, tne substantive committee

of Congress, that would be the Interstate and F~weign 6ommerce

Committee, and decide which point of view on these two issues

had merit.     That, after all, would really co~stitute a sub­

stantial achievement.     Tne TGA was somewhat fearful of doing
that and never did go befere Congress, and so when I left
they were still wrestling with the agency over two issues.




Do you remember what they were?
                                                                   416



Dr. G.:
I ean 1 t rememher now what tbey were.   One, as I reeall indeed
eame down to, let's see, oat appeal mechanism would be pro­
vided.     They weren't too happy with the Administrative Proce­
dures Act.     As I recall the other issue was again related to
a matter of approval of sorts, that the agency had to act witkin
a specified. peried and, if they did not, then the product could
be marketed.     That was what TIA wanted.


Dr. Y.:
I bad some feeling that they bad come up with the proposal that
they would he willing to tell you all the ingredients, exeept
possibly the fragrance, and that there was some sort of worry
OD   the part of some of them about letting even the Food and
Drug Administration know wllat fragrances were in, granted that
there was a generally recognized as safe list of fragrances.


Dr. G.:
Yes.     There was some concern on fragrances.   That particular
portion of the industry is perhaps the most difficult te com•
promise with.     They feel very keenly the need fer secretism
and muck of their work is based oa secret formulas.     So we

didn't ~iach any agreement.

Br. Y.-:
Did they pretty 1D11ch have a united front throughout the discussions?
                                                                 417



Dr. G.:
Well, I would characterize them as ••• yes, they had not only
a united front, hut I th.ought a realis_tic. apprGach to tb.e

problems, and they were not unmindful of the consumer protec­
tien aspect involved.   So, I felt they were a respoasihle group.

Mr. Breck was a fine gentleman to deal with, Mr. Lieaerman also.


Dr. Y.:
Were they the ones who took the major roles?

Dr. G.:
They had the major role to play.    Aad, of course, Jim Merritt.
In terms of association secretaries, I think Jim Merritt is

about as good as any that I've ever dealt with.     So, fer this
reason, we were perhaps somewaat more tolerant and patient of
tae long time elapse between initiatien of discussions and

reaching agreement even Gn minor points.    We worked in good
faith with them and they with us.    I felt that it was worth­

while to continue.

Dr. Y•:

Now, this was an approach that was different from some possible
approaches to settling issues between industry and government.

Did the Boez-Allea report that came in abeut this time bolster
your own natural bent on this approach toward regulation?
                                                                 418




No, I weulcin' t way that it belstered it.   The Booz•Allea report
really contained notking that we did not suggest to them for

inclusion.


Dr. Y.:
Well, I wondered about that.   There was some sort of indicatien

that you got the report.   There mast have been something you
didn't like because quite a while went by and yeu made sug­
gestions and then a new version came ia and finally it was
publicly announced.   What was going on behind the scenes then?


Dr. G.:
Well, tlley were doing their h.omework.   We dicln•t th.ink they'd
giv~n us $450,000 worth in their report; we dian't feel taat
zt;-measured up to what we had a rigat to expect.     Keep in mind
now that we were consciously using this as a mechanism to gain
acceptance from our field personnel.      It wasn't that Boez­
Allen had discovered any magic formula, but rather that we
felt that we needed to bring most of the agency perseaael on
board with a different approach, and that tae best possible
way of doing it was to get them involved through asing Booz,

Allen and Hamilton to help them, the field people, formulate
new approaches to regula:tory matters.    Now this particalar
report really had no relationship to the preblems of the
                                                                   419



cosmetic industry per se.     It was more aimed at the field

use of inspection time, the more optimum use of personnel than

had been possible in the past.


Dr. Y.:
Bow, I guess yeu•ve answered this question about hew close to'­

agreeing with them .yeu were on the terms of wh.at might be a

possible new law.


Dr. G.:

Well, to comment further, we were very close and yet very far

apart.     Because the major point really was the point relating

to how products got into the marketplace, whether or not there

had to be any form of approval by FDA or not.      On this point,

Mr. Goodrich and I and Mr. Kirk were together.      Mr. Goodrich
felt very strongly, for example, that we must have some mecha•

nism.     That point prevailed in our meetings, and so therefore~
we were quite far apart.     But, yet, it was a substantial gain

over what previously had existed between the industry and
FDA, and I really felt strongly that the industry should go

te the Congressional committee.     That was the point of view
that I advocated to trade associations consistently throughout

my tenur~, that they shoull take the initiative in seeking

good legislatioa.     Tkey should help frame it.   They shouldn't
                                                                 420




wait anti reaet in response to a presidential or executive

department proposal fer legislation, wb.ieh meant that they

quite often would be in oppositien to wllatever was proposed,

but rather a responsible association would see the need for

legislation and work te help it become a fact, and in so

doing eeuld help steer the development of the legislative

ppekage in such a way that it would represent legislation

they could live with and still provide the protectien that.

was   needed.




Right.    A.ad so to some extent these conversations, the hope

was, would 1 imn out the outl iae aacl to SCi>me extent maybe

settle issues that then wouldn't even need to be put into

the form of legislation at all.


Dr. G.:
Gr if they were put into the form of legislation, we could
feel certain there would not be points of controversy.




Ia connection witk another one of the trade associations, the

Proprietary Association, there was the possibility of a law

ia eonaeeti0n with eh.ildren's aspirin, and then conversations

evidently reached a point at which that issue was at least
sufficiently settled so that no legislation could come whether
                                                               421




or not it was still aesirable.     Is there any baekgrouad on this
particular episode that the doeuments mi9ht not reveal?

Dr. a.:
Howard Prentiee of the Proprietary Association who has since
retired worked very elosely with us.     Tneir medical director

was a former FDA Bureau of Medicine deputy chief under Sadusk,
Joe Pisano.    Ke alse was involved in these discussions, although
Joe never had mueh to say, I must admit.     He was the mest
silent physieiaa I've ever seen.    We beld a series of meetings
involving outstanding pediatricians, Karry Shirkey then of the
University of Alabama~ Allan Deane of the University of Utah,
Jay Arena of Duke University, industry representatives, parti•
cularly from firms who marketed aspirin as a major product,
St. Joseph's aspirin.    These meetings were aimed at trying to
pinpoint what was the exact nature of the childhood aspirin
poisoning problem.   As I reeall, it became very clear that a
mje_r part of the e.hildh0ecl aspirin poisening prehlem was re•

lated to the iggestion of adult size aspirin aad net just
flavored children's aspirin.     The industry, however, reeog•

nized that there was eneugh aceidental poisoning eecurriag
that they sheuld assist in the prevention efforts through bet•
ter investigatiens en elosures, safety elosures, and so they

did agree that taey would sponsor more resea~eh and heceme
more aetive.    Now, as far as legislation, this was not a major
                                                                      422




proposal for the agency.     We were simply anxious to get. at
the problem and I think we aceemplished our objectives.


Dr. Y.:
As I remember, you had a minimum      aumoer of ehildren's aspirin
you wanted in a eontainer, and your own witnesses didn't seem

to feel !!!!!, small a minimum was necessary• so that it eame
out a bit ef a compromise, a bit bigger than that.

Dr. G.:
Yes, based on the evidence that people like Deane, Sbirkey,

Coleman of Wasb.ingtoa, D.   c.,   Ch.ildrents Hospital, et cetera,

were ahle to make ava ila'ble, we reeogn.ized that a compromise
was indicated.   We cempremised at the level tney suggested.



Now, how would you say the feel was he~ween you and these
Proprietary Association people%       As you leek en baek to the
'JOs, let'1's say, it was really chilly between the commissioners

and the high proprietary presidents who were members of the
Preprietary Association board and even the former FDA man who
was their executive man at the time, it was really arm's leagth..
It took a long time for aay kind of warmth. to develop, and then

aaere wasn't tee much.     Now, how would you say the elimate was

with them while you were there?
                                                                423




 Well, my feeling was that any regulatory ageney should deal at
 arm's length., generally, with those who are ttegulated.   As far
 as their feeling towards us, you weuld have te interpret what
was saict, tb.e attitudes displayed.   Howard Prentice c.ertainly
was friendly enough.   He dropped by oeeasionally to see me wken

 I was commissioner and was interested in working on the poison
, prevention projeet, the medieine chest project, as a Proprie­

 tary Association activity.   He always seemed interes,ted at
 least in gaining suggestions with respect to what the Associa•
 tion could do to assist in this partieular.field.    The leaders

 from the companies I had relatively little contact with, aside

 from one or two of the medical directors, whom I would see
eceasienally and not too often than.



This was really a very side issue as to amount of time?



They posed relatively few problems for us.     They gave Rand
Dixon many proDlems.   One ef the most diffieult problems was
with respect to toe advertising of aspirin products    ea   tele•
vision, and the television industry itself, their eode people,
eame to my offiee one time and informed us that they were
having difficulty with the aspirin manufacturers, specifically
                                                               424




with ene company at that point in time, who proposed to ad•
vertise en television, "Don~t wait for the headaehe to strike.
Take the aspirin now."    This, they thought, was quite ridieu•
lous, and I certainly agreed.     We did suggest privately to the
various eompaaies through the Association that they had better
reduce their empkasis on using aspirin,,.;as a tranquilizer.
That was as far as we could go.



Did you get any reaction from these trade association people
to your efforts with Dixon to try to tie togetker the adver•
tising controls and the labeling controls, so that whenever
you made decisions about what eeuld be said n     the labeling,
advertising might rather quickly have te get into line?



Ne, I got ne overt reaction from them.     I would have to guess
again, and I feel very confident that industry wasn't too

happy with the idea of FTC and FDA working together.



But you didn 1 t get any•••
                                                                    425




Dr• Y.:
New a eouple of members of Congress.    Your first testimony
before a committee after you became Commissioner, relatively
seon after, was before Congressman Fogarty•s committee.        He

gave you advice on that occasion, if I remember rightly, to
set out to make Fll>A very visible to the public.   You must have
seen him several times before his death.    Wllat kind of an
appraisal and evaluation would you make of him?

Dr. G.:
John Fogarty was the key person as far as public health in
this eeuntry was concerned, threwghout his tenure as chairman
of the su~•co11111ittee for health appropriatiens in the House.
I bad known. him first, testified before him, in 1957 when I
was Chief ef the Aceident Prevention Program, and through the
years subsequent to that, I had seen John in the course of
business quite frequently.    However, I didn't begin to know him
socially until after becoming commissioner.    I had at one
time sought his assistance when I was trying to &ecome Sur•
geon General, as you'll recall, and he refused to give me that
assistance because I would not promise to leave Jim Shannon
alone.    After becoming commissioner, I began to see Mr. Fogarty
more, socially at cocktail parties, overseas meetings, parti•

cularly at WHO in Geneva, meetings in Puerto B.ico.    I became
more aware of the fact that he had a serious drinking problem.
                                                                           42€,




He had, by that time, of course, had a rather serious heart
attaek.       He had a myocardial iafaretion.       He bad recovered
very well but hadn't followed his physieianls adviee with
re1pect to losing weight or cutting back on his drinking or
modifying his style of life.          John would stay up until all
hours of the night and ask that you stay with him.             He
could drink a prodigious amount of whisky, starting early in
the morning and just going all day anci all evening and all
night.    For example, we were at the World Heal th Assembly
meeting in Geneva, and at the end of the first day's session

I went hack to the hotel.       We happened to be staying at the
same hotel.       I believe all of the American offieials were there.
I ran into Hr. Fogarty in the bar along with Dr. Murdoch Head
and we started drinking at that point in time.            We cent.inuetL
until suppertime, went out to eat as a group, four of us, then
went to a night elub after supperift · and went baek to the hotel
at 2 o~cloek.      Re insisted that we come to his suite for a
nig'htc.ap.     I ebeeked out aaout    3   o'elock in tb.e morning, and he
anc:l the others went en until .5.         And yet at 8 o'clock the next
morning, be was at the meeting in Ambassador Tuaby:ts office,
bright, shaven, looked fine, ready to go.            low at 10 o 1 cloek

that morning, he ducked out of the general session,i,:.and at
the coffee break I ran into him and Dr. Head and one or two
others, and they were sitting around having a drink.             And that
                                                       427


would continue all day long, and that evening he asked me to
join him again.    I refused because I just couldn • t keep pace
with John.    So he had that prohlem.   Nonetheless, he was a

very effective man in tbe health field.     Re was interested

in what FDA was trying to do.     He privately suggested that I

could build FDA to a size equal to that of NIH.     This horri­

fied me, and I told John that I saw nothing in the future that

would lead me to believe that that would be feasible.        He

was somewhat disgusae4 with this and made plain to me that he

thought I wasn't taking advantage of the opportunity.

Dr. Y.:
What kinds of expansion did he have in mind?

Dr. G.:
Through research grants, programs in pharmacology at the medical

schools, through the construction of additional facilities

throughi~hiring more people.    Just a repetition of the NIH

pattern.

Dr. Y.:
But not necessarily enlarging your sphere of action?



No.   I didn 1 t feel that it would be a worthwhile use ef the tax

dollar.    So I refused to engage in that, and Jokn would chide

me privately from time to time up until his death for my failure
                                                       428



to really come to his committee with substantial requests.

Dr. Y.:
He was a layman.

Dr. G.:
He had been a brick layer, by the way, was always very proud
of it.

Dr. Y.:
Do you think this suggestion that he made to you about iapan­
-sion was indicative of the kind of understanding he had of

medical problems?   Was he thinking of it•••



I don•t think Jehn had a good uaclerstanding of what FDA was,

what it was supposed to do.   He simply saw it as an opportunity
for his committee and for himself to assist in another area.



Because he got a sense of fulfillment from seeing taings grow
that he had responsibility fer.



Of course.



So it was a quantitative rather than a qualitative judgment?
                                                               429



Is that what yQu•re saying?


Dr. G.:
I'm saying tb.at it was just a poor juclgmeat on John's part.
This wasn•t what was really needed.


Dr. Y.:
But his scale of values had the quantitative angle, you're
thinking?

Dr. G.:
Yes.   But Jeha clied, as you bow, ia fac.t the very morning that
he ancl others were to be sworn in for the 90ta Congress.      Re
dropped dead in his office sb.ertly before 10 o 1 eloek that
morning.    We lost a really fine leader in tne health field as
far as Congress is eoncernee.


Dr. Y.:
kegardless of his sensitivity toward the detailed problems,
he weuld work hard?

Dr. G.:
If it hadn't been fer John Foaarty and Lister Rill, much of
what nas been aeeomplished in the health field in the past
two decades I don 1 t believe would nave been accomplished.
Jetm was instrumental in the House.    You had to have that kind
of leadership.    He had enough seniority that he could effectively
                                                                  430




ge ar0und what the party leadership waated••• get around it
by taking a bill to the floor and aetting additional funds

direetly from bis eonfreres, which he was known to      eo.


You menticmed earlier the group er power structure of a certain
sort that was centered around Mary Lasker.       I take it that she
was ene of the outside bases of support for Fogarty.

Br. G.:
Yes, she supported his political campaigns.       She worked closely,
ber man in Washington worked closely with Mr. Fogarty and his
staff on getting legislation drafted, oa having it introduced,

helping secure support for it, making certain that the bud­

getary requests were large enough.       Mary then was able to
work directly with the Waite House, witn President Kennedy and
later with President Johnson, to get programs initiated.         She
used people suen as Mike DeBakey of Texas with President
Johnson very effectively.      Mary Lasker was a ld.ag maker in
these days.   I believe that no longer exists, but during the
years from 1954,   1 53,   along in tnere, 'SS, aeginning there,
until this past year, Mary Lasker was indeed a king maker.



So that this wasn't a myth?
                                                               431




No.   No.   Indeed it was no myth.     It was an actuality.   In
fact, when I was trying to become Surgeon Oeneral of the
Puhlie Health Service, a friend of mine, Herman Hilleboe,
asked me if I wanted Mary Lasker•s support.       Herman knew that
this would be important.    He was a Public Health Service
ifficer wb.o had been on loan to New York State for many
years prior to his retirement.       I knew of the problems that
her support brought with it.


Dr. Y.:

Now what do you mean by that?

Dr. G.:
Well, the Surgeon Generals that she assisted really couldn 1't

call Qe shots, and I told Herman that I didn't want te be'
another one of Mary's little lambs, and that rematk got back
to her eventually.   Because of that Mrs. Laskar never was very
prone to support anything that I was invelved with..

Dr. Y.1

Well, what kind of a person was she?



Very friendly.    I think Mary would like to buy immortality
through support of research.     She's very afraid of death.
                                                            432




She•s an intelligent persen.!i, She had used a relatively small
amount of money to wield a great deal of influence.       The
Lasker fortune is not very large by contrast wita, say,
the Rockefeller or other family moneys that are engaged in
support of the health field.    But she has used her influence
politically to multiply the Lasker investment in nealth.



Do you remember any incident where you were involved with her
that serves to reveal her personality or her mode of action?

Dr. C.:
Ne, I had very limited personal contaet with her.       I had
lunch with her at one time in New York City.     I attended a
lllllcheon on another eeeasiont the Lasker Awards luncheon,.
to be a guest and sit at the head table.    But apart from
these and occasional ;ecktail parties in Washingten, some•
thing like Senator Lister Hill's retirement party, where I

would encounter Mary Lasker, hut apart from those I had
relatively ne•••



No business dealings?

Dr. G.:
No dealings wit.b. her because I wasn•t in h.er eamp.
                                                            433



Dr. Y.:
Riaht.    Surely.    Did she support Lister Rill?

Dr. G.:
Indeed sb.e did.


Br. Y.:
Hew did ae compare with Fogarty as a man acting in this field?


Dr. G.:
Senator Hill operated quite differently than Jehn Feaarty.
You would have to characterize Senator Rill as a Seuthern
senator ef the old school, full ef charm, graee, and eourt6sy,
with a great deal of effeetiveness in getting legislation
through the Senate aecause of his long tenure, his eeaiori ty
as ehairmaa ef the committee, tke fact th.at his fellow senators
respected b.im for his work in the health field, and looked up
to him for it.      He was a most affable person te eeal with, a
very courteous individual, a fine person.



Toward the elose of your eemmissioaership, Senator Nelson of
Wisconsin began to get deeply involved in making investigations
in the general area of drugs, and you testified and must have
become acquainted with him.      How would you characterize him and
his motivations and mode of operation?
                                                                434




Dr. G.:
Gaylerd was well•motivated in tais field.     He really wants to
do a job, aut at times he doesn't do his homework properly,
ner does Ben Gordon on b.is staff, and tha t 11's afortuna te be•
cause it is sueh an impertant area.     Generally, though, if you
are given time to work with him, he can do a very effeetive
job.     I found by going up to his offiee and sitting down with

him in advance of a hearing, I eould get him to understand tke
issues involved in a way that would permit us to have a mueh

more effective nearing thaa we otherwise might have.


Dr. Y.:
Otherwise, he might go off on some kind of a tangent?



He really woulda•t understand the issues, if you didn't do tnis.

Some of them were right difficult, of eourse.



Do you anticdpate that he has the sort of staff werk. and sort

of drive himself that might lead to legislatien?      There's
something similar to what he's interested in and what Estes
K.efauver was interested in.   Do you see b.im in the same mode

as •••
                                                                   435



Dr. G.:
No, I don't. see 'him in tile same mode as Estes Kefauver, be•
eause Kefauver really had a very effective staff, Rand Dixon,
wasa•t Sonofsky on it?



t•ve forgotten.   I'm just not sure.      There was an eeoaomist

named Blair, I know.




But he had a very effeetive staff.      Now, I don't think that
Nelsoa has a staff that is that strong.       Furthermore, he's
got some eompetition.    Senator Phil Hart is nibbling away at
some of these areas; Magnuson weuld like to but hasn't
gotten into this area very much.


Dr. Y.:
Senator Long, to some degree.

Dr.   a.:
Russell Long on drugs.      Yes.   He doesn't have the elear field
that Estes Kefauver hacl.



That makes a good deal of differeuee.

Dr. G.:
Nelson felt very strengly that the PMA. bad used money to
                                                            436




iafluence the outcome ef the campaign in his district, in

his state, on the last election.     He saicf he coulda•t prove it,
but there was evid'.ence that they had spent substantial sums.

There were sigaa, I sheuld say, that they bad spent suestan•

tial sums in trying to prevent bis reelection.


Dr. Y.:
That would probably tend to keep him interested in the subject.


Dr. G.:
It was the wrong thing for PMA. to de, again, hut tnat deesn•t

surprise me.




Okay.     How about toe American Pharmaceutical Association and

Dr. William Apple.

Dr. G.:
Well, Bill is a very hard working executive, an easy man to
work witn, very perceptive.     He understood the issues.     I had
ne prohlems with Bill right from the very beginning.


Dr. Y.:

Now, generally speaking, their policy was a good deal more in
accori with what you had in mind, I take it, than would be

true of NARD.
                                                            437




Yes, it happened to fit much more elesely than PMA or any other
greup.


Dr. Y.:
Right.


Dr. G.:
Or NARD.   William Simmens ef NARD was a far different person

than. Bill Apple.   Bill, I would classify, as a professienal.
Simmons simply was a pelit~ciaa.    Now, Simmons did get after
me on that elosing the ~•mer drug store issue, of eeurse,
and stirred his mem1sership up because he had no other issue to

fight at that time or to justify his existence, so he carried

that as a major issue and it really was a minor ene, as far
as, I think, any objective appraisal of it is concerned.


Dr. Y.:

But it did have eertain political mexey.



Oh, yes.   He had geed ability in terms of setting to Vice•
President Humpnrey, and he did cm that particular issue.

Dr. Y.:
You mentioned Dr. Harry Shirkey in connection with the aspirin
bearing.   He also was an official advisor to the NAS•NRC
                                                            438



efficacy review project.

Dr. G.:

Well, he was also used a great deal by FDA for other things,
too.   He sat in on a l\Ulllber of Bureau of Medicine committee
meetings of various kinds. ·Harry was both a pharmacist and an
M.D., with a lively interest in pharmacology and therapeutics,
with particular emphasis on the need for special studies for
establishing proper childhood drug dosage, something he felt
the pharmaceutical industry was most remiss in not doing and
that they oftentimes simply would scale down adult dosage
without showing any understanding ef pediatric physiology.

Dr. Y.:
Or else they would say it shouldn I t be used for children•••

Dr. G.:
Yes, denying children an appropriate drug that might have been
helpful.   They weren't willing to spend the money n    research
with little probaeility of any financial gain, again, illustra•

ting that they are not members of the health team and that

they 4idn 1 t understand the health professions.



A person that perhaps aad a considerably different stamp was
Mrs. Margaret Kreig wno wrote the book called Black Market Medicine.
                                                            439




Dr. G.:
She was sick.   She was a problem for us.

Br. Y.:
I understand.   In what way?



She was emotionally ill.   She was a mental case by the ti.me I
saw her.

Dr. Y.:
She nad been given permission, evidently under tbe-previeus
regime, to go along with inspectors when they went on raids.

Dr. G.:
Yes, in the New York District, and I think it caused enougn
trouble that the agency hopefully learned that you don't give
somebody carte blanehe of that type.     She was not an accurate
reporter of the scene, to begin with.     She. tended to see plots
where none existed, in my opinion.     All told, 'before she was

done, she was a great deal of trouble for the ageney.



She had testified before Representative FQ.scell 's Government

Operations Subwcommittee that you really didn't know what was

going oa in the area of blaek market drugs.
                                                                             44@



            Dr. G.:
            Well, did she mean me persemally or the ageney?




            I'm aot really sure.     You, at any rate, perseaally replied

            by testifying hefore the eommittee.


            Dr. G.:
            Yes, ancl we, I think, demens tra teci that we   !!! know what   was

            going oa.


I       •



I   t


            Wil1n1r Cohea, onee again.     You told me th.at he went over your

            head to make a decision that was really yours to make at the
            request of some senator and that this episode influenced you,

            at least in the timing of your retirement.


            Dr. G.:
            He didntt go over my head.      He simply made the deeisi0a and

            informed me after the faet.




            Right.    New I sheuitld · have asked you if you 'cl be willing to tell

            me what was tlte   issue and who was the senator.


            Dr. G.:
            I'd be happy to hut I really eaa 1 t even reeall now.       It wasn't
                                                             441



of great significance in terms of its own merits, but it was
simply the faet tnat he made it and told me, and I remember
talking to Mr. Goodricb and telling him about it, and he was
sympatbetic.   He   wasn't unmindful that such an event could take
place.


Dr. Y.:
Right, so that you rememher your feel and reaetiens to some•
taing that wasn't that important to rememher the facts.

Dr. G.:
That's eorreet, at least it wasn't to me at the time.




Now, one further thing••• in the trade press there was the
suggestion that Secretary Cohen may have let you down some•
what by not backing you up sufficiently at the time tb.at Sim•
mens of NARD did let loose bis blast at you fer your comment
about the drug stores.     Is there any truth to that?

Dr. G.:
I think there is.    Keep ia mind that Mr• Humphrey was running.
Mr. Cohen was anxious to help Mr. Humphrey.     In fact, Mr. Cohen
made political speeches even though the President had asked
that none of the cabinet members do so.    Mr. Coben made it
quite clear that he was actively and strongly supporting Mr.
                                                                  442




Humphrey.     Therefore, it is not unreasonable to assume that
if Hr. Humphrey baa been influenced by Kr. Simmons that Mr.
Cohen woulda•t strongly plead a case before him on my behalf.
Quite to the eeJititary.   Mr. Ceben, being a politician above

all, would be happy to·see me leave.        That was !I. feeling.



Me didn't say anything to you about this speech, seeld you or
anything?


Dr. G.:
Gh, no.     Well, wait a minute.     Yes, I'll take that baek.      He
did call me in and said he was very unnappy abeut it.         I
take that back.     I'd forgotten.     He called me in and said be
was most unhappy, and he used a phrase.        lie said, "That was a
shitty thing."     I told him wllat was involved., I was talking
about sometbing twenty years off.

Dr. Y.:
It was more or less a symbolic. thing in any ease, wasa.•t it?




Tbat•s right.     But he had asked me during this transition period
earlier not to get into any flaps, you see.
                                                           443




Dr. G.:
Yes.     Ana he felt I had let him down, so, of eourse, he was
justified in ehewing me out.     Now, I didn't feel that this was
all tkat important, but it proved to be beeause of Mr. Sim•
monsJ1 involvement with Mr. Humphrey, and thus it aad an in•
fluence on Wilbur.



What do yeu mean by this transition period••• the one hetween
Seeretary Gardner's going and presumal>ly a new president be•
ing elected?


Dr. G.:
That is correct.


Dr. Y.:
Aad he said that because of the trouble in connection with
the marijuana business or even before?


Br.    G.:
No, don't forget the marijuana business took plaee earlier
while Secretary Gardner was still there.




Right.
                                                                    444



Dr. G.:
I'm now talking about the period of time after Secretary
Gardner had departed and in advance of the nomination of
Humpb.rey.

Dr. Y.:
I see.     Rigbt.   While tbat eontest was going on and presum•
ably things like that might have hurt Humphrey at tae een•

vention.     I take it tb.at 1 s what ne4hacl in mind.


Dr. G.:
Well, I don•t know what he had in mind.        I only know he was

unhappy.



Did you ever talk to Secretary Gardner about why he made his

resignation in such a quiek and precipitous fashion!


Dr. G.:
Ho, l didn't and I didn't think it was my plaee to.       The staff•••
the principal staff was very unhappy to see John Gardner leave.
We were dejected by his departure, as we all respected him so
much.     But I don't believe any of us would have felt it would
have been proper for us to have asked the Secretary.       He was
a man of deep feeling, high motivation, and we assumed whether
properly or not that it was related to an argument that sup•
posedly took place between him and President Johnson down on
                                                         445



the ranch when Secretary Gardner was trying to get Presideat
Jolmsoa te restore moneys that the Direeter of the Bu~eaa of
Budget had taken out of HEW's budget, and Seeretary Gardner
was pushing for restoration of the Great Society programs
which had heen effectively handicapped hy the hudget cuts.
Apparently, tbe story we heard was that he and the President.
got into quite an argument and that that was when he decided
to leave.     Now, perhaps Mr. Gardner will validate tb.at at a

later date.


Dr. Y.:

Right.    Now, as to the President, you saw him at least twice
officially.


Dr. G.:

I saw him mere than that•••at.signing oills ••• at cocktail
parties tltat would be given or dinners at the White House.
I went on one occasion to a dinner, taese minis of affairs.
If you are talking ahout going to his office to see him,
yes, I saw him t.wiee in his office.

Dr. Y.:
Now, I think that I ought to ask you what were your reactions,
what impressions did you get about how he looked at the Food

and Drug Administratien and its problems, hew seriouslp he

had it in mind?
                                                                446




Dr. G.:

I don't think that Mr. Johnson bad the food and drug problems

seriously in mind or firmly in mind.     He was aware there were
some problems.   He was very much interested in the possibility

of collusion and price-fixing in the drug industry.     He   brought

that up of his own initiative in one meeting, and I pointed out

tbat that wasn't any area for Food and Drug, and we weren't

competent, and I therefore knew nothing about it.     He snorted
and said, "Well, I do and I have the Justice Department look­

ing into it right now. 11   My impression was that this was a

very hard working individual who every conscious moment of

the day was trying to be a good president.     As I said, I saw
him on a number ~f occasions under different circumstances

and at different times of the day.     He was preoccupied every

moment of the day with accomplishing some objective that he

bad in mind at that moment.    He wasn't one for idle chatter.

I think the most painful thing for him was to stand in a re~
ceiving line and shake those hundreds and hundreds of hands.
How he ever did it, I don't know, or how any president does

it, I don't know.   At other oceasiens, a cocktail party, for

example, he would move from person to person, and you could

see he would do so with great purposiveness in mind.    He had
something he wanted to accomplish, and he would buttonhole

a senator or representative and talk to him about some issue
                                                                  447



that was b0thering him at tkat peint in time.      I was very im­
pressed by this aspeet of Mr. Johnsen's persenality.      You

know, he gave up smoking, he gave up drinking, he lost weight,

he did everytking that one ean think ef to make sure that he

was fit, physically fit, to do the j<!>b.   Beyoad that, just as

a personal o'bservation, I would say he tried hard t0 be a geod

president of this country.    He was badly maligned.    Now, he

made one serious mistake that Ted Cron and I discussed at the

time that was righl, interesting to both of us.     In the 89th

Congress, the President, President Johnson, was able to get

what will probably be juaged to be a record am0unt 0f social

legislatiea passed.   He pushed tne Congress hard.     They were
tired.   Re kept them on through the summer.    At that point in

time, Ted Cr0n and I talked about it, and he said, "You know,

he would be smart if he weuld call the Congress together at
this pCl>int,"::,ask them to allow bim to speak to them, compliment

them for what they had done, remind them there was more to be

done in January and sencl th.em home." Instead, he kept them
until the last moment, pushed, cajoled, bullied, used every
tactic in the hook to get more legislation passed, and they

did pass it, hut when they came back in January, that was it.

Congress was a different Congress.    He no longer could get

wb.at he wanted from them.   That was a critical decision that

he must have made and I often wondered if he's regretted it
                                                                448




sinee then.


Dr. Y.:
That•s aa interesting observation.




To be specific on Food and Drug.     He kept in teach through

Joe Califano, Marvin Watson, Doug Cater.     Me didn•t have a
strong persnal interest in it.


Dr. Y.:
Were you in more or less frequent toucn with these White

House staff men or did that come througn the Department?




That came more through the Department, but occasionally, I
would say no more than onee every six weeks, I would get a
call from Doug Cater or Califano or Marvin Watson on some

specific question er a request to see a perses..   Tnis would

be about the extent of it.



They didn•t make themselves particular specialists in this
area, they were just•••




No.   If anybody had the assignment te handle that, it was
                                                               449




Doug Cater, and Doug was a very sensitive, fine writer, an
interesting person to work with.


Dr. Y.:
Well, now, I've got some questions listed here as I eame to
them that are related to deeisioas and projects within the
agency; First, as to the big policy deeisious that were made,
how were these made?   With whom did yeu talk?   What kind of
reeerds did you keep of them?   Were there mi.autes of staff
c.onferenees?



Big policy decisions were seldom made in staff meetings.      An

issue might come up in a staff meeting that would ultimately
lead to a policy decision, but in general, the individual
bureau chief would be asked to work up a background paper and
oe prepared to discuss it, on a potential peliey issue.    After
that was done, and I had aigested the paper and listened to
bis cliscussion, questioned him, along with, generally, Mr.

Rankin, and if it were in an appropriate area, Mr. Kirk and/or
Mr. Goodrich.   Quite often, Ted Cron, whom I had great trust
in, weuld sit in on these kinds ef presentations.    In additien,

I would ask the opinion. oceasieaally ef somebody in the field,
occasionally of somebody in HEW, Dr. Lee, te sound him out,
occasionally, aot often.   But mere often, I would discuss tne
                                                            450



issue with Ted Cron, Winton Rankin, Ken Kirk; if there were
any Congressional implications, I 1 cl talk it ever with Con•
gressional liaisen, Mauriee Kinslow at first, get their feel•
ing for it, try to get as many inputs as I could, then I would

simply make the decision.    Now, there wet:e ne i:eeords kept of

!!!!.! deeisin-making process, of those individual discussions.



What about those position papers?




Tnose would be in the files.




Probably according te the theme.


Dr. G.:
Subject matter involved, and pt:obably in the bureau files and/or

in, as well, the commissioner's office files.     I took no papers

of that kind from the office when I left.     I didn't feel that
that was appropriate.    I took only those personal files that
were pers<>QJU. correspondence of mine.   It was limited to that.


Dr. Y.:

Right.    So that somewhere some of that material would be th.ere

hut not necessarily reflecting what it was •••
                                                           4.51




Dr. G.:
Ne.   Unfortunately I'm not mueh of a person for ereating a
written record of my aetions.     I felt it was more importaat
to get the job done than to have the written verification, and
we were moving at a very rapid pace •••


Dr. Y.:

I understand.


Dr. G.:
•• .for taose two and a half years, and I felt that someeae

was putting something in the paper but lt wasn't going to be



Dr. Y.:
Right.    Well, I understand that.   I'm a guy who, to some ex­

tent, has to come along afterwards and try through the paper
to find out what was g1Ding en.


Dr. G.:
It makes it hard.    8a major policy issues, if the timing was

right, we also talked it over witn the advisory eouneil, but
many times th.ere wasn•t an opport.uaity to, but we did get a
fair number te them.



Right.    Well, in due time, things will probably show up for
                                                                   452




me that will be l>lank and tllen I'll have more eonerete, sharply
aimed questions than I ean at this momeat.        he thing that in­

terested me in toe reporting was what might be called the

problem of the consistency of your posture.        The trade press

was rather fond of contrasting what they believed to be your
two alternating faces toward industry.       Sometimes, especially

early in your tenure, you were mean and tough.         You took the

low road, as they were fond of saying.       And at ether times,

espeeially later, you were, in tneir language, more states­

manlike, more diplematie.    You took the nigh road.       There was

even speculation that you were being pushed into a more docile

role by your superiors so that you'd fit better into LBJ's
consensus pattern of rule.


Dr. G.:
That wasn•t the case at all.     It•s interesting to read what•s

in the press when you kaow wb.at the ease, what the background,
really is.   It 1 s often amusing.   !!!!_ !!!'. !!!!, Times, whieh I
have revered for lo these many years, was as prone as the rest
te make those kinds of errers and that was somewhat dismaying
to find out that they had feet of &lay as well.         But wb.at hap•

peaed more than anything••• there certainly was no interference

from on high, let me make that clear to begin with.         But, as
you move along in a job, you don't have to keep beating people

ever tb.e head.   They know that you have that eapability and
                                                              453



that you're not uawilliag to use that method if necessary,
and se tney beeome more suseeptible to the eonciliatory methods

than they weuld otherwise have aeen, and you can thus afford
to adopt a different approach and accomplish the same objec•

tive.     There's no point in creating friction where none is
needed.




You did deliberately, as I think you said, stir things up
when you came.

Dr. G.:
Aosolutely.     It was essential.   We had no creeibility as an

agency at that point in. time.      Who believed FDA7   They were
patsies fer industry.     There had been a long series of good

examples of how FDA had failed.      The Congressional committees
were beating them over the head and bloodying them badly.           I
felt it was necessary to instigate a series of caanges, to
create a change in the agency's image, public image, to my­
self provide the image of a strong, forceful leader in order

that the employees would have someone they eould identify
with, and so I set about very deliberately to do this.




And then when you changed, with respect to aiffereat segments
                                                             4.54



of industry, this wasa 1 t a hluepriated thing, this was a prag­
matic feel as to whether or net tlle new appreaeh was now proper
and fitting.

Dr. G.:
Exactly.     That• s rigbt.

Dr. Y.:
A.ad indeed sometimes yeu•d revert a little.


Dr. G.:
At the slightest sip of backsliding on their part, I was
perfeetly willing to revert to the original approach and whaek ·
them again.



Right.     Well, that is rather the way I felt aoout it,
ana I wanted you to cGmment on what was, in seme of the trade
press, especially in drug trade press, a kind of pieture that
emerges as you read through..    Now we've talked about some of tlle
pcohlems ef internal reorganization. There doubtless were maay
that 1 1 m unaware of, but I ran acress a few that surfaeed into
print that I would like just to see whether you have anything
to say that might not be in the records or might be hard to
dig out.     In tke Bureau of Hedieine reorganization, it was
reported that Jolla Nester was upset.    Now, what about him?
                                                                 4.55




JoJm was a very controversial figure.       It was felt by many that
he was the source of leaks to the Feuatain committee.         I don't
know.     He may well llave &eea.   Jolm. was a pedia trie surgeon,
as I recall, of very strong opinions.       I occasionally had
break.fast with John Nestor, particularly after we moved to
Crystal Plaza.     He had ao significant influence en the oper•
ation of the Bureau ef Medicine dtn:iDg my tenure.       He was a
them in the flesh of some of the bureau staff durin& that

periocl of ti.me, 1,ut he really wasn't a majer problem for us.

Dr. Y.:
Now, ia a way, oae might have guessed that the kind of vigor
that you would bring would have been something that would have
pleased him.     His role earlier had been to give testimony to
Cengressional Committees that was critical of the agency, but
critical heeause it wasn't vigorous enough.        I ean 1 t remember•••
I think it was the Humphrey committee, particularly.



Yes.


Dr. Y.:
And so •••
                                                                456



Dr. G.:
That criticism no lo-ger could oe valid, you see.


Dr. Y.:
But yet he was reported to be upset.    There wasn•t any 4e•

liberate action•••




I think Jo1ln will be upset until the clay he dies.   Re•s al­

most Don ~uixetic in his nature, and John will find something

to be upset ahout all of the days of his life.    That's my

appraisal of him as an individual.     He's almost like!!!!,~

An.arr Man, if you recall that hook.

Dr. Y.:
I see.    So it was a temp1erameatal thing as well as a prin­

ciple thing.


Dr. G.:
A very strong set of persoaality factors at work in this
individual.


Dr. Y.:

Also, there was some stir during tne Bureau of Medicine re­

organization, and members of the staff were allecedly upset,
when Julian Hauser was meved from the Bureau ef Medicine into •••
                                                                    457



Dr. G.:
Ken Kirk's office.



Ken Kirk's compliance office.


Dr.   a.:
That was absolutely essential.     Keep in mind that we were
trying to reorder the administrative activities of that
bureau.     Julian had been the crown prinee of the bureau, so
to speak, under Joe Sadusk.     Now unfortunately, we had some
practices develop that were poor aeministrative practices.
These were apparent.     We didn't knCi>w how many NDAs were
pending.    We didn't know their status• who had them.    We
had no sign.•out system that would work.     There just wasn•t
any administrative order and so we bad to change that.         To

facilitate that, I asked Julian to transfer to Kirk's offic.e.
I felt that Julian c.ould do a good deal in a positive way
for the agency working in Kirk's office.      At the same time, he
wouldn't handicap the new team 0f Ley and Vaughn Choate.        Cer•
tainly, if he were to stay in the Bureau of Medicine, there
could be a power struggle develop.     Now, that was the last
thing we needed.     So I had to move Julian, had to do it in
such a way that he had a meaningful job, and fortunately Ken
had enough. things fer him to do that were meaningful, and Julian
                                                         4.H




-did a good job to his eredit in that set•up.
Br. Y.:
This was blamed on Rankin.     It was one of the efforts to show

tb.at th.ere were people within the agency whQ didn•t like tb.e

way he operated.     But, as you said, you did th.is.




Yes.     Winton and I did it together.   There are always people
willing to east blame, find reasons, other than the actual
reasons that the Administration may nave had at that point in

time.




Right.     That was why I asked it••• to find out whether there
was    fire hehind this thing or not.

Dr. G.:
No.     We knew that Julian could cause trouble.   Winton and I
talked about it and we agreed.     He had to be moved.    But we
weren't trying to get rid ef him.




And he certainly did rather a major job after he did get moved.




Yes b.e did.
                                                              459




Also, in conneetion with the sudden shake•up in the anti•

bioties and insulin division in October, 1967, in which the
leadership, especially William Jester, tne nead of it, was
ousted, there was some secrecy about this, at least before
the publie, and tnis was attributed eitber to tae fact that
the situation was so terrible that the men had to be fired
to protect the whole agency and your reputation, or the fact

that tne situation was not especially bad but it was sort ef
bumbled and again Rankin was blamed.     Of course, either
interpretation damned you.

Dr. G.:
Rankin was wrengly blamed.     Rankin, on these kinds of occasions,

would be the man wtio would actually carry out the orders, but

he didn't initiate them.     The Jester thing, the whole business
of the antibiotics certification activities and the problems

related thereto, I was intimately involved with that.        I was

horrified to find what a mess we had in that activity aad hard

put to un4erstand, except that if eae thinks baek he finds
that it goes back really to tke days when taat particular
division was riding fairly high, and sort of had a free rein

within tke agency, and there was never any strong administra­
tive review or control placed over tb.at group• and it oeeame
apparent that there were shortcomings that could hurt the
                                                                   460




agency badly.

Dr. Y.:

Do you mean just administrative snafus or inadequate •••



Administrative snafus.      Tb.ere was some suggestion of illegal
aetivities.     We, in faet, had a prisoner interviewed in a
federal prison to try to pia down any tie between••• it
wasn't Jester••• it was one of his staff.      And there was a

suggestion that some money had changed hands for the approval
of certain batches of antieiotics, ehloramphenieal, in fact,
as I recall.     We never could get corraborative evidence,
but we knew that this was a powder keg, and it was clear that
Jester wasn't running the organization the way he should.
Now, Jester was sort ef a hopeless pawn. in this, or helpless,
I skould say.     He was sort of hopeless, too.    (That was just
a psyebolegieal lapse. )t' He hada•t been running the organiza­

tion.     He badn 1 t been ci0ing his job, and yet he had been a
loyal, faithful employee.      We didn't want to force this to
a hearing.     We wanted te protect Jester and, at the same time,
clean up the mess, and that was why it was hasically handled
that way.     But it wasn't Rankin's fault, again.    Heavens, I
sweat that one through along with Winton and Ted Cron.
                                                         461



Dr. Y.:
So that there was a potentially terrible situation in this
case •••

Dr. G.:
Yes.


Dr. Y.:
••• that would have been embarrassing to some degree.




There were aetions and things that had taken place before my

ever coming on the scene, but nonetheless, it would have just
helped feed ammunitien to those who were opposed to the agency,
and 1 felt we had to handle it properly and yet do so to pro­
tect some of the ones who were innocently involved and get at

the person that we really could never prove of being guilty.


Dr. Y.:
There was never any•••

Dr. G.:
There was no evidence of misfeasance or malfeasance ever un­
covered in our investigations, and we did have a very com•

prebensive investigatien carried out in this.
                                                             462




Dr. Y.:
Tbis was the same division that had come under a cloud before,
and so I suppose that made it even more urgent tbat you cheek

things out.

Dr. G.:
Yes, it did.   Art Davis, our security man, worked for a eoa•
siderable period of time on that investigation.     It was he
who interviewed the man in prison, and, as I reeall, it was

in Detroit, and we also had asked for additienal, outside
investigation assistance from one of the other federal agencies
whieh we had received, but we, as I said before, could not pin
down any evidence of misfeasance or malfeasance.



Right.    In 1967, you made a speech placing great emphasis on
trade asseciation voluntary advertising codes, seeming to
urge PMA really to mean business with their code, which soon

was expected then and did indeed come out several months later,
a code that llad a sort of built-in mechanism for self-regula•

tion that the Justice Department had approved.     Then you made

another speech in which you seemed to express disappointment

with the peor results of the Propriatory Association code re•
vision which was then a year old.   How ahout these codes?
                                                                463




Dr. C.:
After careful study, I have to conclude that they really
aren't worth a damn, that they eeme down to the lowest com•

men denominator level, that they are unenforceable by and
large, and if you really have public issues involved, then
a voluntary eode isn't going to solve the problem.


Dr. Y.:
At one point I helieve it was you who used the phrase, "self•

protecting pious documents."


Dr. G.:
Yeah.     All tee often that's what they were.   H1.m an eternal

optimist.     It woule be great to see an assoeiatioa adopt a
meaningful eode, enforce it, and relieve our society of the
necessity of creating a governmental organization to carry out

that function.


Dr. Y.:

It would he interesting to draw a graph of tbe revisions of

the codes •••

Dr. G.:
••• and relate them to the level of activity of the agency
charged with surveillance and enforcement in that field,
wouldn I t it?
                                                             464




It weuld be, and I think it would probably shew•••



•••a close correlation, I would suspeet.


Dr. Y.:
8kay.     Now another question, about LSD.   ln February, 1968,
an AP story suggested that President Johnson tried to block
your testifying before tne Dodd Committee on LSD, since you
could be expected to disagree with the reeommendation of his
recent erime message to Congress that mere possession of LSD
be made a misdemean9r.     It was also suggested that the White
Bouse later changed its mind, albeit reluctantly, and ggve
yeu permission to testify.     You gave fairly moderate testi•
mony both before a House committee and the Dodd committee,
giving your owa opinion, but saying also that the new agency
had a right to have a different view, and to Dedd you denied

that you had, in fact, heen muzzled.

Dr. G.:
Well, the fact that I testified showed that I wasn't muzzled.
There was a problem about the timing of when I should ge

before Dodd, and the administratien dicin' t want me to go in
response to the first request and asked that I hold that up.
I did.    Now, what Mr. Cohen, who was actively invelved in this,
                                                             46.5



wanted done was, be wanted me to work out a position tbat
would pe:rmit me to support the legislation that tne White
House bad proposed.     Well, I felt strongly enough that 1••• 1
just said that I eould !!!! in good conscience give whole•
hearted support.     I had to qualify my testimony, and so I

was then permitted to establisb a date and testify on that
basis.

Dr. Y.:

There was a little heel-dragging and a little pulling and

hauling.


Dr. G.:
0h, yes, a fair amount of heel•dragging on that, and constern•
ation.     fiere were many meetings at 5:30, 6:30, 7:(l)O o'eloek
in the evening, trying to figure out--not many but several-•
trying to figure out what position I could take.      And I would

simply, in these meetings, say, "It's easy.      I know where I
stand and that's where I'm going to be."

Or. Y.:
Aud so you came out of it saying what you really believed,
but at tbe same time, not seeming to make the •••



Well, the President wasn•t very happy abeut tllat.     TIie White
                                                                     466



House staff weren't too happy about the whele tiling, but there
wasn't mueh they could do about it.


Dr. Y.:
As to a device control bill, this was a matter that eertainly
one way and another had been before Congress long eefore your
commissionership, and soon after Dr. Ley eame ne worked out
a set of categories wnieh formed the basis of the bill that
President Jonason recommended to Congress at the start of

1967.       Nothing happened.   But then, when 1968 came, it was
rather suspected that he would suggest a device bill onee
again, hut he didn't do se.       What was the matter here?   What
was the snag.?


Dr. G.:
The problem was at the department level.        There were just so

many issues that could be placed in the legislative package

that this didn't come out on the priority list high enough to
permit it to be included.        It was just tnat simple.

Dr. Y.:
I see.

Dr.   a.:
There wasn't anything on the part of the White House having
lost favor, or it certainly wasn't due to any intervention
                                                               467



that I was ever made aware ef.       I'm not saying that it couldn't
have oecurred.     But I wasn't aware ef it.   Now, it's unfortunate
that that deviee bill never had a hearing in its original intro­

duction, or that it didn't become reintrodueed, in a way, and

I think industry now regrets that did not take place, because

since then the Supreme Court has ruled on the Difeo case and

on the AMP ease, both.    And, in effect, FDA now has control
over devices as a result of those decisions, and it's the sort

of back•door interpretation t'hat industry doesn't care for.

Theyfre now thinking ab0ut going to Congress and asking for

legislation.     It's obvious they want legislation to limit

FDA ts p0wers, because the Supreme Ceurt deeds ions were such.

that there was almost    ~   1 imi t on FDA.


Br. Y.:
Do you think that these court decisions give FDA the kind of

power over quaekish•type devices that they got from the Ke­

fauver-Harris Bill over quackish-type cancer drugs?



I think it gives them more than the quackish devices.      It gives
them the authority over the ethieal devices.


Dr. Y.:
I realize tba t.
                                                                 468




Dr. G.:
This was one of the bones of contention between the ethieal
devices manufaetu:rers and FDA.    They dicin't want to get thrown

into the same bag of tricks along with the quack deviees, and

we were really never too sueeessful in sorting that out for

them.


Dr. Y.:
Even despite all the efforts that Herb Ley made?


Dr. G.:
Right.    I thought Hero had aceomplished ·that objective, but

that there was still some unhappiness.     Now, I believe the
industry is even unhappier that they didn't go along wita the
idea of legislation.     Now they feel they''re going to have to.


Dr. Y.:
Right.    Okay.   We talked some too once before about the prob­

lem of data storage and retrieval.     This was a modern manage•
ment technique that you stood for.     There was an Arthur D.
Little report that eame after three years of study that reeom•
mended a very complicated system, and this report arrived in
Washington at FDA abeut the time yeu did.     What were the hang­

ups in getting such a system?     Later one high Food and Drug

official was quoted as saying that tberetd been a number of
false starts.     Was the t•ouble leadership, was it manpower,
                                                             469




was it dictionaries to be used in coding?     What was it7


Dr. G.:
All of those, and then a few more.     First of all, we didn'1 t

have the manpower.   It wasn • t a 1 ine item in the budget.     We

had to secure funding, and we had to identify personnel, and

they are not easy to find.     It took a considerable time to

find the appropriate kinds of people.     Then there was the matter,

as you suggested, of coding:    working out the coding alone was

a f0rmidable task.   The drug code directory which eame out

late last year was the first attempt at this.     And th.at still

has some proolems that have to be resolved.     The Arthur D.

Little report was a very complex system proposal.      We didn't

buy it.   I didn't personally buy it in toto, so we wound up
with a modification of that.    We encountered the usual problem
internally as to who was going to run the computer center,

whether it would be run by the management people or by the

scientific people, and we had, as every agency or every

organization does, the not insignificant problem of educating

the staff as tQ what the computer would do or eouldni.t.:t de,
how it would be operated, what their relationship would be with

the faeility, and we had to gain support.     This was essential.

That's a time•eonsuming process.     So, these were the reasons.

Now, I•m convinced that Henry Kissman who came to us to work

on the professional aspects of the data bank is a eapable
                                                           470




individual.    He is doing a goed job.    The management people
who were operating it for the eemputer center alse, I think,
have been deiag a good job.      Kottler wno I at one time thought
we would have to fire, we gave another chance to, and he

squared around.     I give Ray Landon credit for that.




What was his position?


Dr. G.:
Well, Kottler was in this data management division, and a

source of trouble when I first went with the agency, and

thanks to Ray Landon we got this man squared around where

ne's   doing a good job.    Before I left, it was my pleasure to
rewa~d Kottler for his performanc.e, but within a month afte1::i:
I took office he was one of the sore thorns in the manage•

ment team's side that I had to take care of.


Dr. Y.:
And this, to some degree, is just that eemplex?

Dr. G.:
Oh, yes.    Oh, yes.   The problem was not limited to FDA alone.
We got involved with the question of the National Toxicology

Data Bank, who would operate that, the environmental health

people, FDA, NIH?      It got very involved, as these issues can.
                                                                 471



We, fortunately, however, were able to keep working at the
problem.    We didn•t suspend work waiting for decisions on those
matters, and a fair amount was accomplished.

Dr. Y.:
The drug potency study.     You mentioned earlier how, with
respect to this study, you were let dowa by inaccuracy of
analysis and reporting from the field.     I neglected to ask
bow this hurt.    What were the short-and lcmg-range repercus•
sions that were harmful to the agency?

Dr. G.:
That h111rt us in terms of credibility ia the pharmaceutical

industry.   The field people viewed this just as one more de­

mand that Washington was putting on their backs, and that this
new administration was no different than the previous, and
they really didn't tun to and do a good job on this.      They
didn't validate their results.     So, as a result, we got some
bad figures.     I used those figures, and the companies were
quite concerned, and they demanded••and quite properly--to
know whose drugs were involved.    We did in every instance let
them know when their drugs were involved, but the outcGme in
my book was that the industry felt that there was lack of

seientifie competency at FDA and this was just one more ex•

ample.
                                                                 472




Dr. Y:
Tney might nave even thougnt that there was worse, that tnere

was some deliberate effort to bit them, I suppose.


Dr. G.:

Yes.     It wasn't a deliberate effort.   I won't say that Mr.

Rankin and I weren 1 t pleased when we originally got the

results, but that pleasure was •••


Dr. Y•:

So you just backed away from it as gently as you could.


Dr. G.:
I had to.




Tnere wasn't much to be done.


Dr. G.:
You couldn 1 t do anything about it.


Dr. Y.:
The salmonella problem of 1966 and after in dried milk, drugs,

coloring agents, other places.    Anything about this that

should be said from an overview on which tne records might

be silent?
                                                                473



Dr. G.:
he thing that the records should show is that we consistently
had a peliey of allowing the firm whose product was involved
te make tbe announcement.     Borden would not make an announce•

ment on Starlae.     In retrospect, I think they probably regret
not having done so, because we were forced to make the announce•

ment.     It was our position that this was a public agency.
These were public matter.s.    One eouldn' t keep a seeret of
this kind, nor should one.     Borden didn't want the story re•

leased.    They didn't want to release it themselves and didn't

feel that we should, but we felt we had to.


Dr. Y.:
You mean even while they were withdrawing all of it from the

market?


Dr. G.:
Yes.    I didn't feel that you could withdraw from that many
sources in the market that large a supply of Starlac and not
have a story break.    Totally unreasonable and, furthermore,
I think that the publie bad a right to kaow about it.     Now,
if Borden had released the story, I suspeet it would have been
buried in the inside fourth page of the newspaper, but sinee

we released it, it was front page.     Borden felt we killed

their preduct, a twelve million dollar lGss.     I feel that
                                                           474




they killed their own product by nf1>t perceiving that they
should have told the public of the dangers.     Now, we con­
sistently permitted the company, encouraged any company
involved, to notify the public of the problem in order to get
the product returned, to get it out of eireulation, and to
minimize the hazard.     So I feel that that point should be

made.     Secondly, the Grocery Manufacturers Association be­
came concerned about this, and George Cook, their executive
director, worked very closely with me and set up a number of
meetings where this problem could be discussed, first of all,

with the heads of corporations, technical meetings.    The GMA.

siaee then has put money into the problem trying to help solve
it, trying to educate people in the various segments of their
membership so that the problem can be minimized througn bet•
ter sanitation in the household as a part of breaking this chain
of infection.    All told, again, I feel that they took a respon­
sible position and that was characteristic Qf that association.

Dr. Y.:
Was it with a group from this assoeiatien that you held a series
of eo,tinuing conferences?



Yes.    I met periodically with men such as Tex Cook, chairman of
the boarcl of General Foods, Ted Gamhle of Pet Milk Company, the
                                                                  475


president ef Hershey, the president of Mueller macaroni, the
president of Pillsbury.


Dr. Y.:
Was it just the salmonella problem or was it•••


Dr. G.:
No.   We talked about general issues, packaging and labeling.••
fair packaging was a major point at many ef the meetings,. and
lff!' were ahle te work out some of the problems that. I wasntt

aware of and I•m sure the legislators didn't anticipate when
that bill was passed.     Specifically, one of the problems that
came up was the timing, the time period in which the agency
would require all labels to comorm.     We had originally one
set of expectations.    It became apparent, though, very seen
that there was a majer iottleneek.     The bottleneck was in
getting the lahels printed.    The reason there was a iottleneck
was 'because in the process one particular type of employee
called a "spotter" is very critical.    Now, keep in mind that

these labels are gang printed on large presses.     They are col­
ored labels, and once a run is started they will stop the
machine at a given point, let's say after 150,000 impressions.
This gang press, you see, prints maybe six different kinds of
labels, ten kinds of labels, simultaneously.     So, after   1so,eoo,
thetil they stop and take the peach label off and replace it with
                                                      476




0ne for pears or pizza or n0odles, who knows?    And start the

presses and run it again for a period of time.   Well, that

job of replacing that portion of the plate is called "spotting."

'!Spotters" are in short supply, and the laber union laws are

such that, although one could he trained realistically in a
few months, the union requires a year as an apprentice.     And

s0 it came down t0 a practical matter of union regulati0ns

thwarting the intent of Congress in the transition on fair

packaging and labeling.   This was the kind of thing that we

were able to sit down. and discuss.


Dr. Y.:
This was while you were in the process of making the regula­

tions under the law?


Dr. G.:
Yes, it was, indeed, and we were able to resolve many kinds of
problems.   We made some errors again in our prop0sed regula­

tions, failing to take into account certain of the problems

within the industry.   And through this mechanism, those err0rs

were brought ~uickly to our attention.   They would raise ques­

tions that we hadn't thought of and I think in toto made the

whele program work much more effectively and reduced the need

for enfercement.
                                                                 477




Dr. Y.:

In cennection with this food industry group, what did you

eall it incidently?      Be you know?   Did it have a name?



Food Processors Council, I believe it was called.




Did you talk about the self-eertifieation program at this

group?


Dr. G.:
Yes, this came up with this group.       It had its erigins in

my having been with the Federal Aviation Ageney.       In the

aviation field, the airline companies themselves, who are

certified carriers, carry out a program of determining that

their pilots are capable of flying the equipment they're

scheduled on.     They do this by pulling a competent pilot off

of the line for a six-month period, and then he, in tum, in•
spects his fellow pilots, puts them through cheek rides and

observes their capabilities, and this, at one stage in FAA,

led to the discussion of self-certification, and so it was a
carry-over from   my   experience in the aviation field.


Dr. Y.:
So you introduced it into the discussions of this committee?
                                                                478




Dr.    a.:
Yes.     It also was related to the fact that the food industry
was becoming quite different.       It no longer was as visible to
the naked eye in the inspection process as to what was taking
place.       If you were to go into the Sara Lee plant in Chicago,
you would see that very modem equipment out of sight of the
human eye mixes all ef the cakes and the varieus preducts that
Iara Lee markets, causes them to be baked, carried through on
a conveyor belt, packaged, and emerge from the other end,
completely invisible in the sense of not being able to ob­
serve the process of mixing, et cetera.      Well, this is typical
today of the food industry.       It's a highly automated industry,
because they work en such large volumes.      And so FDA's in­
spection process is no longer as meaningful as it once was,

and I felt that if the industry could be placed in a position of

taking a greater responsiaility, an individual company, for
example, by reporting to us their use of certain additives
and any problems they encountered, we, as an agency, would
further the public's interest.      Keep in mind that in the food
industry, although approval had to be obtained for a food
additive to be originally used, once that approval was
granted, the company no longer had to divulge at any time or
in any way how much of the food additive was being used, which

is an anomalous situation, you see.       If it's potentially
                                                               479



dangerous enough to require animal feeding studies, toxicity

data, et eetera, then why should the company be given free

rein and use it without disclosing the extent to which they

use the product.    Well, these were some of the factors.     And

so the idea was discussed at food processing eouneil meetings.

Mr. Cook of General Foods like!tbe idea, the possibilities

inherent in it, and volunteered that they would be the first.

And so their Dover, Delaware, plant was the first involved.

And it was quite an educational experience for Mr. Cook, his

people, myself, and our people.    We found that there were

many kinds of iroblems that we badtl't anticipated in terms of

the reporting.     It led to a general tightening of their

quality control, which was already a very good QC program

in industry, to help further reduce the possibility of con­

tamination of their products.




Mow, quality eonj:sol must be automated too, then?


Dr. G.:
Yes.   We were mainly interested in concentrating initially on
high risk items in the product line, anything with dairy in•

gredients, eggs, milk, butter, et cetera, because the possibility

of salmonella infection contamination was greater.
                                                               480



Dr. Y.:
Is that what was done at the Dover plant?



Yes, we worked out a reperting system between the Baltimore

district office and the Dover plant wnere the Dover plant would
routinely provide certain information to the Baltimore office
whieb they hadn 1 t been receiving before, and would enable them
t0 look at what kind of quality eontrol was being maintained

and spot any possible problems.


Dr. Y.:
Was a contract drawn?


Dr. G.:
A   letter of agreement•••


Dr. Y.:
So that the record•••


Dr. G.:
••• that I signed.   Yes, it's in the record.

Dr. Y.:
The records will have this letter of agreement?


Dr. G.:
0h, yes, indeed.
                                                              421



Br. Y.:
And the teehnical points that were involved.     Right~



Yes.


Dr. Y.:
"Written eonsent, 11 this phrase under the 1962 drug amendments.

Early in your administration you suggested a rather strict

interpretation that academics and industry protested against,
saying it was too strict.   You evidently had conversations
then with PMA, AMA, university researchers and later on•••


Dr. G.:
A few others, too.


Dr. Y.:
A few others?


Dr. G.:
Well, a few other· :professional associations and these individuals

involved in pharmacological research.   A numher of professional
associations called on me and Representative Paul Rogers of
Florida, who I would have to say was a friend of the pharma­

ceutical industry, sponsored a meeting of interested parties
whieh I attended to present our point of view.    It was quite
obvious that a number of the people involved had not clearly
                                                              482



read the proposed regulations, beeause, to eite an example,
at a meeting whieh Mr. Rogers had sponsored, seated at the
table oa my left was an internist from the Cleveland Clinie.
He made a statement that made it perfectly obvious that he
had 11ot read the propesed regulations.    He said, "Why, Jim,
this requirement would mean that we couldn't even administer
a dose of cligitalis ,rithout getting the formal conse11t."
I said, "Now, Doctor, you haven't read the regulations, have

you?" Well, he was man enough to admit, well, no, he really
h.adu't, and therein lay much of the prohlem.    There was a
great deal of talk but very little careful reading of what was
proposed.    As a result, we had not only that meeting, we had
a meeting at PMA headquarters of all interested parties,
tbe clinical pharmacologists, the AMA, the PMA, the Pedia•

tries Society, you name it.    Everybody was sending represen­
tatives.    And what it all boiled down to, we modified a
couple of phrases which Mr. Goodrich assured me did not in
any way weaken the proposed regulations.     In fact, he thought
that the doctors had put themselves in a somewhat worse posi•
•ion than they realized, and we then went ahead and published
the regulations.    But, again, it was a good illustration of
how a lot of sound and fury and really not mueh light was
cas• on the matter because the individuals had all shouted
hefore they had carefully read what the proposal was.       Now,
                                                                   483



the Cengress intended that this be done.     The agency hadn't

done anything about it.     Here again, this was something that

was just sitting there waiting to be picked up, and the Public

Health Service, in fact, even in advance of our getting our

regulation out-•because we were delayed due to the interest

on the part of tbe Congress, Mr. Rogers; and Dr. Lee's office

further delayed the publication of the final notice-•PHS

just get theirs out earlier.     Theirs simply shifted the burden

to the research institution where the grant was held, but none•

theless, HEW collectively throu1h PHS and FDA now required that

the individual involved in experimental procedure be notified,

it be discussed with him, that he be given an option, whieh

certainly wasn't happening up until that point in time.




Right.     So that you think that it did shake down pretty well?

Dr. G.:
Yes.     We subsequently tried to find out how it was working,
and we found relatively few problems in spite of all the foo

fa tnat went on about the proposed regulations when it was in

the proposal stage.     After all, what we were proposing was

what iad been adopted in the Helsinki declaration, which was

basically what the AMA bad preposed itself, add we were simply

putting it in as a requirement.     I taink the physicians and
                                                                    484



the groups involved became fearful that we would try to enforce
this, and it gave credence to the belief that Congress had

in incerporating it in the bill that the patients weren't

being notified, that they were being used as experimental

subjects.     But we, of course, would not be able to enforce it.

We eouldn'tt go into a physician's office and ask his patients

were they notified.       This is just not practical.   It serves

as a reminder to the physician that he has a professional

re spons ib il i ty.


Dr. Y.:
And if there should be tales circulated of gress violations,

then it would give a way to dig back into the situation before.


Dr. G.:
Yes indeed.




At several times, especially after the FDA Obstetrics and
Gynecology Advisory Cemmittee would report, you would see
reporters or go on television and make fairly bullish state­
ments about oral contraceptives.


Dr. G.:
Oh, my, yes.       Unfortunately.
                                                               485



Dr. Y.:
Are you now satisfied that FDA followed the proper polieies
on oral eentraeeptives1

Dr. G.:
I'm not satisfied that the original approval was an appropriate
one, hut by the time l assumed the offiee approximately five

million women in the United States were using the oral contra•
eeptive.     I would have been hard put to remove the product
from the marketplaee with no more evidenee than there was
then available.    The committees that studied the problem I
thought were objective as far as they possibly eould be.       Their
reports to the commissioner I felt were a fair reflection of
what they pereeived and learned in tneir travels and at in•
terviews and in studies of literature.     But it's again a good
illustration of•••we have a serious dilemma in our society
of marketing products and then subsequently finding out that
the products have more problems than originally bad been per•

eeived and that ehanges have to be made.     Now, the oral eon•
traeeptive, of eourse, is unique in that it was the first
time a medication was designed to be taken by a well person
basically.     Its proponents are almost fanatie about the
desirability of the produet, it's opponents almost equally
fanatic about its dangers, and we're aow finding that the
truth seems to be somewhat in between.     It's not entirely
                                                          486




safe; it's not as dangerous as some would have had us believe,

                                           -
but it certainly is more dangerous that I suspected at the

time following those committee meetings.       Now, Roy Hertz

was a member of one of those committees, and Roy constantly

made the point that this, The Pill, as it was ealled, had a

potential for earcinegenisis because of the estrogen eom-­

ponent.   There is still debate on this point.      Some of the

studies that have been carried out do suggest that possibility.

However, those studies aren 1 t c.lear-eut either, and_ we still

have no final answer.   I felt compelled fc>llowing those meet-·

ings to report in a meaningful way to the American pu.bl ic,

and that meant that 0ne had to swallow hard and say the Pill

is safe or it's not safe, or, at best, on one occasion, you

remember I said a yellow light.    I used that as an analogy but

you have to get down to terms that people can understand.

You can't equivocate all over the place in discussing something

of this nature.


Dr. Y.:
But making a speech now, was there •••


Dr. G.:
I'm more cautious than I would have been then, because the
evidence certainly is different t0day than what we had avail­

able at that point in time.
                                                             487




Dr. Y.:

Right.    Generie equivaleney versus elinieal equivaleney.


Dr. G.:

Or physiologic equivaleney.


Dr. Y.:

Right.    Did your view change here as a result of new evidence?


Dr. G.:
Not so far.    You know, Gilman suggests, Alfred Gilman of

NAS-NRC, suggests that FDA now have to require proof of

equivalency, clinical equivaleney, on all so-called generic

drugs.    Gilman does this still on the basis of a very limited

number of eases where equivaleney has not been demonstrated,

therapeutic or pnysiological equivaleacy, to be exact.


Dr. Y.:

Tbat 1 s blood levels?




Blood levels mostly.     This emerged as a result of Parke Davis

trying to protect its own interests on ehlorampnenicol, to

begin with, where they came in in advance of the expiration

of the enlorampbenical patents and pointed out that we should

require the companies that tried to enter this marketplace to
                                                                488




submit clinieal data, which they had been required to do on
two   occasions when they made substantial changes in their
process for the formulation of chloramphenicol.     I rejected
that.     I said eno~gb was probably known by now that these
other firms could enter the field.     This did!!!_ prove to be

a case.    We found later, or Parke Davis found later, after
several of these firms were in the marketplace that blood
levels were not sent up to required standards on certain
products made by competitors.



This was more than just the excipient?


Dr. G.:
We never really found out what the problem was, a very com­
plex problem, particle size, excipient.    We dissolved the
product in a liter of water and had subjects drink that, and
they got an adequate blood level, so it wasn't the fact that
the cbloramphenieal wasn't present in adequate amounts.        It
certainly was present.     It was something delaying in the
absorption; the absorption patterns were wrong.    Now this
strengthened Gilman•s belief apparently that this was a more
widespread problem than had been suspected, and he had gotten

the Academy apparently to produce a white paper which I as

yet have net seen.    This white p~per purportedly recommends
                                                               489




to FDA that clinical studies be required.      I think this would
be unfortunate.      The FDA. is doing some studies of physiologic
availability of certain drugs, because they happened to be

more eritieal drugs.      Those studies haven't shown the preb•

lems to be all that significant.


Dr. Y.:
F~tst of all, there was the chleramphenieal.      Then there

were certain other antibiotics.


Dr. G.:

Yes.    That's true.


Dr. Y.:

And then, did you go on7


Dr. G. :'--

Oh, yes.      Went on••• they were doing some studies on Dilantin

when I was with FDA.


Dr. Y.:

Was this dene out in the St. Louis •••



Georgetown, originally.


Dr. Y.:

The clinical thing that was done at Georgetown?
                                                               490




Dr. G.:
Then the St. Louis group was doing the laboratory studies.


Dr. Y.:

Right.


Dr. G.:
Row, I think it would be unfortunate to reaeb a decisien now
with no more evidence than is in hand that every drug to
enter the marketplace had to have clinical data.   I'm talk•
ing now about generic drugs that are "me, toos" and have
been in the marketplace for some time.   I, of course, would net
feel-•on !!!! drugs you have to have clinical data. ~And it
may ultimately be proven that you should have at least physio­
logic availability data on!!!. marketed drugs, but I say that's
a substantial cost factor that would be involved and that
judgment should be reserved on that issue for a while.

Dr. Y.:
You tend to feel that the chloramphenieol was unusual and is
not going to be generally typical?

Dr. G.:
I don't feel that that problem is as widespread as Gilman

suggests.   I have asked him where is the evidence that the
problem is that widespread?
                                                              491



Dr. Y.:
Right.


Dr. G.:

Of course, PMA loves this because it helps their members

maintain their position in the marketplace.


Dr. Y.:
Right, and if they say it's true or likely to be true of

every drug, then that blots out generic production.




Yes.     Yes.


Dr. Y.:
In connection with this, in December of 1966, you and other

Public Health Service people went up to the Defense Personnel

Support Center, and I kind of got the idea that that conver•

sation might have alerted you to this problem initially.




Well, the Defense Support Center handled the purchasing of
drugs for the military services, and we met with the staff

which was responsible for that activity, and it was quite an

education for me.   I wanted to find out what procedures they

went through.   They, in fact, carry out factory inspections,

pre-award factory inspections, what their criteria for
                                                               492



selection were, ho~ they ruled bidders out of consideration,

how often did they have to rule out bidders that FDA bad per­

mitted in the marketplace, and so it was felt very worthwhile.


Dr. Y.1

And they had done some kind of tests that involved equivalency?


Dr. G.:
Yes, they had had some problems with equivalency on a couple

of products, Griseofulvin and Dilantin, as I recall, were the

two they brought up as examples.     They had switched their

supplier of Dilantin from Parke Davis to a generic equiva­

lent.     The clinic physicians noted a more frequent rate of

epileptic seizures, complained, this complaint was dismissed

as nonsense, but when they actually went out in the field

and investigated it, they found that there was substance to

toe complaint, and they then switched back to the old source

of supply. They had some problems with some antibiotic too,

as I recall.




So that you went back from Philadelphia to Washington some­
what more alert than you had been?


Dr. G.:

Yes.    I was somewhat more conditioned.   This convinced me we
                                                              493




had to do more work in our Georgetown faeility.      I then asked

Dr. Ley for a priority list of drugs that he would have George•

town tackle, and they did produce such a list and Georgetown

started on that ~ask.     Now, unfortunately ihe Georgetown activ­
ity has not worked out well.     Dr. Chris Martin has never been

sympathetic with the idea of doing work on demand for the

agency, and the medical school hasn't really backed the FDA's

hand on this, and I understand the contract is now being ter­

mha-~

Dr. Y.:
Well, the agency needs something like this.


Dr. G.:
I felt that they did.     And so it 1 s unfortunate that it hasn't

worked out.


Dr. Y.:
Well, that's about all the questions I've got now.      Certainly,
the high priority ones.
          Dr. Goddard;s
                a"' (
               1J'rN .;.ft.( ( j    3   l-'1) f
                                                                               Fades Away
              - BY STEPHENS RIPPEY              alter ego and assistant commis­ memo to Mr. Gardner, followed
                 Wash-ington E&itor             sioner for education and in­ by briefings, replete with charts
                                                formation, within a few months and other more or less sophisti­
             w ASHINGTON-The Consumer after Dr. Goddard became com­ cated "presentations" to other
          ·Protection and Environmental missioner in January 1966.                  HEW officials whose ap,proval
          Health Service of the Depart­            It seemed logical to gather un­ was needed.
          ment of Health, Education and          der a single department the vast     They were not impressed,
          \Velfare is all that remains of a     health activities and facilities of despite the charm and eloquence
          dream of former Commissioner HEW, plus the bound-to-grow of Dr. Goddard. Nor was Donald
          of Food and Drugs James L. environmental health activities.               F. Hornig, President Johnson's
          Godda·rd of a Cabinet-level De-_ This still may happen at some science advisor, who had a dream
          partment of Health with-who time in the hazy future, but Dr. of his own which is still afloat-a
          but?-James L. Goddard, M.D., Goddard's idea really never got Department of Science, which
           as Secretary.                        off the ground despite some would encompass not only the
             The idea of a separate Depart­ rather        strenuous    efforts   to health activities of the gove:n1-
          ment of Health did not, of launch it.                                     ment, but its scientific activities
          course, originate with Dr. God­          The dream was presented to as well.
           dard. It has been around Wash­ Secretary John W. Gardner by                Mr. Gardner didn't: push the
          ington for many years. But, signs      Dr. Goddard and he was given movement himself and there was
          of germination appeared in his the signal to go ahead with a_ definite coolness on the part 0f
          mind and in the hyper-active plan. This was done, beginning in then Under Secretary Wi-lhur J.
          brain of Theodore 0. Cron, his December 1966 with a formal Cohen; the assistant secretary
                                                                                    for health and scientific affairs,
                                                                                    Dr. Philip R. Lee; the assistant
                                                                                    secretary comptroller, James F'.
                                                                                    Kelly, and· other key officials
                                                                                    whose support would be needed
                                       if the new job for which he was              for such a major upheaval. The
                                                                                    matter never was presented to
 Dr. Goddard's                         bypassed had gone to an out­
                                       standing, nationally known scien­
                                       tist-administrator under whose
                                                                                    the chairmen of kev Congression­
                                                                                    (Continued on pag; 43, column 1)

Dream Disappears                     - shadow Dr. Goddard's pride
                                       would permit him to work.
                                          But, this was not to he and Dr.
 (Continued from page 1, Col. 4)       Goddard had few iHusions that it
 al committees without whose sup­ could be. For one thing, he had
_port nothing could have been searched t-he country, even call-­
 done.                                 ing on the National Academy of
    By the time Mr. Gardner Ieft Sciences for · help, for an od­
 HEW in July 19G8, the Goddard         standing scientist-administrator
 dream· had shrunk to an jntra-. to become FDA's associate com­
 departmental reshuffling which missioner for science. No such
 would put all HEW activities man was found who was willing
 relating to the "ecology. of man,"    to take that job, and there was
including the Food and Drug Ad­ Ettle chance that any would
ministration, under a single ad-. interested in becoming 2.drr.inis­
                                                                      be
mini~trator. Mr. Gardner and trator •)f CPEHS. Secondly, Mr.
Dr. Goddard understood that the Cohen and Dr. Lee weren't look­
latter would be appointed.            ing for a wave-maker. They
   However, with Mr. Gardner's wanted a solid man who wouldn't
decision to leave HEW, Dr. God­ rock the boat.
dard lost his strong friend and          They looked inward and found
supporter who wasn't perturbed Charles C. Johnson Jr., a s&ni­
by Dr. Goddard's other-world tary engineer with 20 years of
sorties, such as his misquoted engineering and administ:~:ative
marijuana remarks, and his not responsibilities in the U. S. Pub­
misquoted remarks about closing lic Health Service, but for the
down drugstores. :Mr. Cohen and preceding year New York City's
Dr. Lee were not wave-makers, assistant commissioner for health
and let it be known they consid­ and environmental health. A per­
ered Dr. Goddard a liability, who sonable man, and apparently a
                                                                                           - ..
might be permitted to continue a.s. capable administrator, Mr. John­
FDA commissioner but wouldn't son has let it be known that he
be considered for a higher job.       wants to stay on in his job and
   Some of those who know Dr. demonstrate his ability to provide
Goddard well believe he might stronger and more cohesive all­
have swallcnved his ego and re­ around protection for American
mained as commissioner of FDA consumers.




  .   .