May 20, 1969

Corps of Engineers, Lieutenant General
Cassidy, to appear before the committee.
A similar invitation is being extended to
the Governcr of Florida.

Mr. President, the problem of the Ever-
glades National Park requires a reason-
able and an early solution. Resolution is
important because of the many scenic,
recreational, wildlife, and scientific val-
ues found in the park which are found
nowhere else. We cannot allow these to
be destroyed; they must be preserved.

The Everglades is of importance for
still another reason. It is a manifesta-
tion of what happens and what is hap-
pening in this country under the pres-
sures of population, development, and
man’s applications of new technology. In
pursuit of convenience and material
wealth we are too often insensitive to
the environment and to the values of the
natural world,

 

NOTICE OF HEARINGS

Mr. KENNEDY, Mr. President, I wish
to announce that the Subcommittee on
Administrative Practice and Procedure
of the Senate Judiciary Committee will
hold a 1-day hearing on Monday, May
26 at 1:30 a.m. in room 2228, New Senate
Office Building. The subject of the hear~
ing will be S. 1144, a bill to remove the
statutory ceiling on appropriations for
the Administrative Conference of the
United States.

 

RECESS

Mr. JAVITS. Mr. President, I ask
unanimous consent that the Senate
stand in recess, subject to the call of the
Chair. .

There being no objection, (at 12
o’clock and 31 minutes p.m.) the Senate
took a recess subject to the call of the
Chair.

On the expiration of the recess (at 1
o'clock and 51 minutes p.m.), the Senate
reassembled, and was called to order by
the Presiding Officer (Mr. Atuen in the
chair).

 

THE HIGH COST OF DRUGS

Mr. LONG. Mr, President, this morn-
ing a great doctor, Dr. John Adriani, of
the Charity Hospital of New Orleans
made a statement that I believe every
doctor in America should read. His
statement was about the abuses of the
drug industry as it exists in America
today. As chairman of the Council on
Drugs of the American Medical Associa-
tion, Dr. Adriani is one of the outstand-
ing experts on this subject.

I believe that Dr. Adriani qualifies for
an award for service to humanity for
the kind of work he has done in trying to
provide for American citizens the best
drugs at the lowest cost. Dr. Adriani, in
the beginning of his remarks, made the
following statement:

I preface my remarks to the committee
with the statement that I am strongly biased
in my views on matters pertaining to drugs
and that my bias in this regard is 100 per-
cent pro-patient and only pro-patient,

Dr. Adriani is a man who has spent
his life working with drugs. He has done

CONGRESSIONAL RECORD — SENATE

this not for money, but for the service
that he could render to humanity. He
understands the subject as well as any-
one. Any doctor or any drugstore owner
who would like to know why the public
is complaining about the drug prices and
practices and why people like the Sena-
tor from Louisiana and the Senator
from Wisconsir. complain and keep mak-~
ing speeches about the fact that the
public is being victimized, oppressed, and
outraged by the high prices charged for
drugs producec at a low cost, ought to
read Dr. Adriani’s statement.

It taxes great courage for a man such
as Dr. Adriani to stand up and speak the
honest truth when the drug companies
are spending hundreds of millions of dol-
lars trying to spread misinformation cal-
culated to misiead and confuse the Amer-
ican people.

Dr. Adriani is perhaps second only to
Dr. Alton Ochsner as a private citizen of

Louisiana seeking to serve humanity as _

best he can.

Dr. Ochsner made the courageous fight
in America to prove the connection be-
tween smoking and cancer, heart disease,
and emphysema. He has insisted that the
American Cancer Society and the Amer-
ican Heart Society should do something
about it. He insisted that the Federal
agencies should do sornething about the
health hazard, meaning no ill will toward

the tobacco industry, but thinking in’

terms of suffering humanity.

I have mentioned Dr. Ochsner’s name
in connection with Dr. Adriani because
they are both presently citizens of the
New Orleans area. In terms of men in
medicine who have done great work for
suffering humanity, these two great
Americans are persons of whom Louisi-
ana can justly be proud. :

Mr. President, I ask unanimous con-
sent that the ‘prepared text of Dr.
Adriani’s remarks be printed in the Rec-
orp. I challenge any drug manufacturer
to prove Dr. Adriani wrong on a single
major point.

There being no objection, the remarks
were ordered to be printed in the Recorp,
as follows:

STATEMENT OF JOHN ADRIANI, M.D., Caarrry
HosprraL, NEw Orveans. La., To SENATOR
GavYLorD NELSON’s SUBCOMMITTEE ON Mo-
NOPOLY, OFFICE OF THE SMALL BUSINESS
COMMITTEE, U.S. SEnaTz

Mr. Chaitman and Members of the Com-
mittee: It certainly is a compliment to me,
who is familiar with so little of the vast fund
of available information on drugs, to be in-
vited to appear before this committee. You
do me honor by indicating that I may be
of assistance to you. The accumulation of
knowledge pertaining to drugs over the.past
several decades has been so phenomenal that
no single individual, be he a practitioner of
medicine, pharmacologist, pharmacist or
other person whose primary interest is drugs,
can be expected to Know all of the important
details concerning all drugs available for use
in the treatment of disease.

I preface my remarks to the committee
with the statement that I am strongly biased
in my views on matters pertaining to drugs
and that my bias in this regard is one hun-
dred percent pro-patient and only pro-pa-
tient,

BACKGROUND AND QUALIFICATIONS

Iam John Adriani of New Orleans, Loutsi-
ana. I am a Doctor of Medicine who gradu-
ated from the College of Physicians and Sur-

$5415

geons of Columbia University in 1934. My
specialty has been surgery, but my interests
have been diversified since I began medical
practice. I majored in chemistry before en-
tering medical school and. gave strong con-
sideration to becoming a chemist and con-
centrating my interests in drug chemistry
before I finally decided to study medicine.
TI also had training in physiology under the
renowned Doctor Homer Smith at New York
University. My Contact with surgery made
me aware of the woeful lack of knowledge of
the action of anesthetics and the primitive
methods of administering these drugs which
existed in the early 1930’s. The methods were
nearly as primitive as they were in 1842 when
ether was first introduced as an anesthetic.

Anesthetics are drugs which are used to
carry @ patient halfway to eternity and back,
Obviously, these drugs are lethal and the
responsibility of administering them ts great.
The science and specialty of anesthesiology
has developed as a result of the recognition
by a few physicians three decades ago of
the importance of the actions of these drugs
and of the knowledge of their proper ad-
ministration.

An anesthesiologist is one who uses and
studies pain relieving drugs in patients. An
anesthesiologist must also possess broad
knowledge in matters pertaining to other
types of drugs because the specialty encom-
passes the use of drugs which are either an-
tagonists and overcome the effects of anes-
thetics or are used as adjuncts to augment
the effects of anesthetics. In addition, some
drugs are used prophylactically to prevent
unanticipated and unwanted side effects.
Another point of importance is that patients
who require anesthesia often are taking drugs
prescribed by personal physicians, interntsts,
and other specialists to treat diseases not
directly related to the surgical disease for
which they are hospitalized. An example
would be the use of digitalls in a patient to
treat existing heart disease, reserpine for the
treatment of the high blood pressure which
caused the heart to decompensate, a diuretic,
which facilitates the elimination of salt
and prevents accumulation of water in the
tissues, quinidine to make the pulse regular,
a tranquilizer to prevent excitement and
apprehension, a vasodilator to prevent angi-
nal pain, an anticoagulant to prevent clot-
ting in the vessels of the heart and brain,
and insulin to control diabetes. It is not un-
common to find a patient who needs an
operation having all these conditions and
recelving all these drugs. How these drugs
interact with those prescribed by the an-
esthesiologist and surgeon is a matter of
great importance. Little is known about
many drug interactions and the subject is
now becoming one of intensive study.

The anesthesiologist is, in essence, a ¢lin-
ical pharmacologist who is knowledgeable in
the behavior of many drugs. He ts familiar
with their use in human being who are ill
and who are under treatment. His knowledge
of drugs stems from their actual use in pa-
tients and not merely’ from information
gathered in studies from normal human
volunteers or from animals.

My experience in matters pertaining to
drugs has been quite diverse, encompassing
research in pharmacology, testing of new
drugs, the teaching of pharmacology for over
thirty years to undergraduate medtcal, den-
tal, and postdoctoral students. In addition,
I am engaged in the training of nurses to
administer anesthetics, gases and mists for
treating pulmonary (lung) diseases.

I have been a member of the Council on
Drugs of the American Medical Association
for six years and Chairman from the latter
half of 1967 to date. J have been a member
of the Revision Committee of the U.S. Phar-
macopeia for the past nine years and was a
member of the panel on anesthetics of the
Subcommittee on Scope of the U.S.P. ten
years before I was made a member of the
Noe tan
85428

Revision Committee. I have been a consult-
ant to the Food and Drug Administration
since 1963 when the Kefauver-Harris Amend-
ment was first i:nplemented. I am now also
Chairman o? the Advisory Committee to the
FDA on Anesthetic and Respiratory Drugs.

Yor the past nine years I have been Asso~
ciate Director at Charliy Hospitel of New
Orleans, Louisiana, in which capacity I have
gained considerable insight inte the budg-
ctory probloms concerning the care of the
sick and the cost of medical supplics, par-
ticularly drugs. I have also heen a member
of the Pharmacy and Therapeutics Commit-
tee of Charity Hospital, serving in the ca-
pacity of pharmacologist.

iy entire professional life as a physician
has been devoted as a salaried employee in
upporved institutions (Bellevue Hospi-
tal, New York, and Charity Hospital, New Or-
leans) in caring for those unable to’ finance
a

 

 
  

privale practice except occasional consulta

tions, testifying as an expert in medicolezal
raatters, or the treatment of special cases
referred to me for proslems pertaining to
pain, I submit this resumé of my activities
to YOU oud vo your Committee, Mr. Cha:rman,
to apprise you of the areas of my interest
and experience and background in matters
pertaining to drugs.
TOPICS REQUESTED TO DISCUSSED

Tam appearing by invitation as an indi-
vidual physician, representing no organiza-
or institution. My statements reflect
my Own thinking and opinions and are not
to be construed as refiseting opinions of any
organization or institution with which I
am associated. I have been asked to express
any general views I may have on drugs, but
specifically to comment on antibiotic com-
kinations, antibiotic overuse, and particus
javly the overuse of Chloramphenicol.

GENERIC NAMING

The problems of drug utilization and pre-
scription methods are complex and are in-
creasing in complexity as the number of
drugs introduced into therapeutics increases,
The situation can now be described as nearly
chaotic. No semblance of order can be made
of the existing chaos until all drugs and
combinations thereof are designated by
given, common, or generic names and not by
proprietary, or brand names, Proprietary or
brand names are, in essence, aliases, An
alias, no matter how used, tends to confuse
or to be deceptive. An alias is intended to
conceal the true identity of whatever or
whomever is being designated by an alias,
The use of brand names for drugs serves no
constructive purpose; on the contrary, the
practice hampers rational drug utilization,
rational prescribing and dissemination: of
drug information. Brand names should be
abolished. The public's best interests shall
not be served until this is done.

It is a function of the government to do
for the people what the people cannot do for
themselves. No private group or scientific
organization possesses the capability or is
empowered to institute refcrms in drug
nomenclature which are so sorely needed.
Obviously, then, this is something that the
people cannot do for themselves, Govern-
ment, therefore, must intervene and act in
the public’s behalf. The record of the U.S.
Governracnt in assuring the public that food
products supplied to a consumer are pure
and properly labelled is commendable and is
known to all. The citizens of no other na-
tion on earth have the assurance that food
products which enter interstate commerce
are safe, as dces the citizenry of this nation.
Foods are dispensed by their given names and
not by allases. The brand and the name of
the vendor or producer is inscribed on the
dispensing container to permit the consumer
to purchase the commodity of his choice and
preference, It is dificult to understand why
drugs, which are equally as important, if not

 

DE

 

“if the phy:

CONGRESSIONAL RECORD — SENATE

more importa
nation and we
mitted to x
ssence, tna
ing granted

allowed

 
 
 
 
 
  
  
  
 

winaint by being
tO cistri Ss brand

of one

 
 
     

g
manufac

 
    
   
 
   
 
   

It is ludicrous to
a8 SG vital to the public
brend names, un-
9 Go Gtherwise would he
jan’s prercgative
& man
for his patient. The
DE advanced for
g brund names
are not only illc uperfiuous, but
even pucrile, If it is the object of the phar-
maceutical industry to promote. ienorance

conceive +
health are
der the
interfer
of select

   

 

arguments wh
justifying the

  

   

    

OTS,
35, 1S ta promote salcs, to establish mo-
nopolics and to stifie competition of rival
manufaccurers,
GENERIC LAntLING

It is my helief that cz iy and thought-
fully prepared legislatic ould be adopted,
advocating thet comp Inbelling of pre~
scription drugs dispanscd cither in bulk to
pharmacists and nhycicians or prescription
drugs dispensed in individual packages be
done by generic, or common names. “BY
“common names” I refer to names that are
Shorter or better known than the generic
nirin is 2 more common name than
the generic ramo—ccctyisalicylic acid. The
generic labeling should appear in large,
bold-faced type om the label, wrapper, con-
tainer, brochure and all other identifying
devices or documents. The brand name of
the manufacturer, if such a drug has a brand
mame, shouid be in parentheses beneath the
generic name in type no larger than one-
elghth the size of the type used for the
generic name of the drug. Interposed be-
tween the generic name of the drug, in type
mo larger than that used for the menufac-
turer's Name anc the brand name but large
enough to be easily legible, should be inter-.
posed the chemical name of the drug. .

A pharmacist who Cisyenses to a patient,
on & prescription from a physician, a portion
of the contents of a drug packaged in bulx
should be required to label the package of
the drug so dispensed to the purchaser with
the generic, or coramon name of the drug.
Ii the physician has specified dispensing a
drug of a particular manufacturer, the man-
ufacturer’s name should be indicated in
parentheses below the gencric name, in or-
der that the physician, as well as the patient,
Will Know whether or net the specified item
has been supped, The labelling on the con-
tainer gis to the patient should be omitted
clan indicates “do not label’ on
the prescription.

NAMING OF MIXTURES AND CORIBINATIONS

Mixtures of drugs would be Gesignated as
Mixtures. For example, the mixture now
available as Coricidin would be labelled as
Chiorpheniramine, Aspirin and Phenacetin
Mixture. The brand name Coricidin would
not be included in the labelling. Instead, the
name, Chiortrimeton, since it is a proprie~
tary ingredicnt, would appear in parenthesis
in type one-eighth the size of type used to
name the ingredients of the mixture beneath
the name of the ingredient Chiorphen-
iremine, together with the manufacturer's
name. The lahelling of mixtures should also
carry the chemical names of cach ingredient,

     
   

    

Us

 

 

 

 
 

 

May 20, 1969

in fine print, with the generic or common
name in parentheses and the amount o? each
ingredient in each tablet, capsule, or unit of
quid measure should be indicated in hoth
milligrams and in grains. The latter stipula-
tion would not be a requirement of the label-
ling applied to the package dispensed py
prescription to a patient. These are of inter-
est primarily for the pharmacist, pharma-
ceutical chemist, or the toxicolozist in the
évent this information is requircd in cases
of poisoning, homicide, determination of
purity or biologie assay. An expiration date
Should be indicated for drugs which have
expiration dates.
LABELING OF OVER-THE-COUNTIN BRUGS

Producers cf “over-the-counter drugs” are
likewise enjoying special privileges which are
far from being in the publie’s best interest.
As a matter of fact, the surveillance of the
firms packaging over-the-counter drugs is
not as close as that of firms packazing pre-
scription drugs. The FDA has no surveilicnce
over claims of efficacy of over-the-counter
drugs made in advertisements, in newspa-
pers, Magazines, telecasts, ete., and Vcdcral
agencies empowered to take action seldom
do so,

Pharmaceutical firms which package a
prescription drug which may also be sold
over the counter in certain dosage forms
often make claims in advertising in nows-
papers and nonprofessional magazines that
would not pass the scrutiny of the FDA. I
am thinking specifically of Neosynephrine,
packed by Winthrop, in the form of nose
drops, which is available over the counter,
which, in lay Journals is claimed to be effcc-
tive for “colds.” The labeling of over-the-
counter drugs should follow the same pat-
tern as that of prescription drugs and the
advertisements should be as informative con~
cerning full disclosure and efficacy as pre-
scription drugs.

REPACKAGING OF DRUSS

Drugs dispensed by “repackaging firms”
should indicate the source of cach ingre-
dient, that is, the name of the manufac-
turer from whom each chemical was pur-
chased, The same requirement should apply
to firms distributing a repackaged drug under
a brand name or to mixtures. The large
manufacturing firms who buy drugs from
other firras should indicate on the package
that they did not miake the drug, by indi-
eating its source, in the same manner as
required of the “repackaging houses.”

In addition, the American Medical Asso-
ciation should indicate in its code of ethics
that physicians should own no stock or in-
terest in any pharmaceutical firm, repack-
aging firm or pharmacy, and insist that this
be enforced at the county society level. No
conscientious, ethical physician who lives up
to his oath should object. The patient js at
his mercy and purchascs what he specifics
and there should be no conflict of interest.

IMPACT OF GENERIC LALELING

Should one ask, “Will such a change in
labeliing as 1s being proposed be in the pub-
lic's best interest?”, the answer will obviously
be, “It will.” If one asks, “How?”, the answor
would be, “Everyone will learn and know the
real name of a drug’; the physician, the
pharmacist, the nurses who take care of the
patient, the pharmacist’s attendants and the
relatives. Pseudonyms and aliases ultimately
will disappear, without one bit of harm to
the public. .

Will physicians be restricted in their pre-
scribing prerogatives if such a plan were
placed into effect? The answer is, “Not at
all." The physician will still be able to
prescribe the drug he chooses, manufac-
tured by the firm he prefers and in which he
has confidence. He still will be abie to pre-
scribe in the dosage form he chooses and
has always used in prescribing the drug. If,
for medical reasons, a physiclan docs not
 

May 20, 1969

wish 2 patient to know the identity o2 a
arug, it Will still be hls prerogative to request
this.

Pnarmacists will still be required to sup~
ply to a patient a drug a physician requests,
made by the manufacturer that the physi-
cian indicates and prefers. An ethical phar-
acist wEl not substitute an inferlor druz,

 

 

 

as has been argued that he might do by those ~

who feel that the brand names protect the
patient and protect the physician’s right to
prescribe as he sces fit. If a physician does
not cbhject ta labelling, the patient is then
told what he is to receive and can insist
that the pharmacist supply exactly what is
prescribed and what the patient is paying for.
Patients may be able to shop and obtain a
dsug at its lowest cost.

The days of mystery in medicine are over.
Medicine is a science as well as an art, Pa-
ticnts are not mcrons. They read, and they
are becoming more knowledgeable, and there
is no reason for not disclosing all pertinent
formation to everyone for the proper and
ta use of a drug. By using a standard name
sor each drug, full disclosure will be pro-
vided for ail persons involved. The chemically
oniented physician will have the ¢hernical
mare. The pharmacist, the pharmaceutical
chemist, the toxicologist and the physician
wao have become accustomed to using brand
mames wiil have them at their disposal
should they wish them, but in time they will
be de-emphasized and brand names hope-
fully wil disappear. Existing hospital formu-
es can be abbreviated and new ones pre=-
pared in hospitals where none now exist.
Pharmacists will find that in due time physi-
cians’ prescribing habits will change and
they will need fewer items on the sheives,

GENERIC EQUIVALENCY

The arguments for retaining brand names
prescribing have been shrouded and wrapped
ia that nebulous cloud referred to as “gene~
ric equivatency.” The paucity of convincing
and well-documented data of clinical signifi.
cance Causes one to suspect that this sit-
ustion has been grossly exazgerated, Should
a product -of one pharmaceutical firm be
chemically equivalent and more effective bio-
logically, then this would be a selling point
which a pharmaceutical firm could use in its
aavertising. The frm could, with justifica-
tion, capitalize upon this point in its ade
vertising and utilize it as a reason for select-
ing the drug of that particular frm, The firm
thus could boast that its product is superior
and has this advantage over that of compet-
ing Srms, Considerable stretch of the ima-
gination is required for one to see the jus-
tification for the use of an alias for desig~
nation of a product merely on the basis of
generic equivalency. For example, should
Ether prepared by SQUIBB be found to be
biologically and clinically more effective
than that of competitive manufacturers, and
I doubt that it would, a physician who is
aware of this would request Ether-Squibb,
In the event Lidocaine U.S.P. prepared by
Astra were demonstrated to be biologically
and clinically superior to products distrib-
uted by & competing firm, this would not
necessarily interfere with a physician’s choice
to prescribe Lidocaine-Astra instead of
the alias, Xylocaine. Neither would have
be interference of the physician’s preroga-
tive to prescribe the product he deems most
eifective clinically, if indeed he can make
such a distinction, and the best interest of
the patient will still be served. The question
of generic equivalency has been ‘“Yallyhooed
with both scientific and pseudo-scientific
data, so that it is virtually impossible to
dctermine what is fact and what is faney.
The situation is almost laughable. Much is
said about crystal size, the effect of binders
and mordants, coating, ete. This all sounds
impressive and has some basis of fact, no
doubt, Mr. Chairman, but no one has said
what happens to one of these elite, “non-

 

  
   

  

 

 

 

CONGRESSIONAL RECORD — SENATE

generic brand name drugs” when It is in-
troduced into the stomach of a patient, the
contents of whic are x OW, the acidi
of the juices in the s ¥

 

   
    

.reé Rot known
ch are bound
to exist are n 1at happens to
one of these S OF capsules after they are
introduced into the stomach and are fol»
lowed by & martini, potato chips, shrimp

 

 

 

    

remoulade, turtle soup, cak, potatoes,
some wine, salad and dc . ff a drug is
readily soluble, 1G Cchanees are excellent

 

 
 

that cheraical eci tency equals biological
and clinical equivalency. :

One carnot deny that in some cases bi-,
Ologic potency may vary from one product
of cone manufacturer to another or even from
batch to batch a given drug by a given
manufacturer, but how much is known about
ail of this which ‘is factusl and elinically
Significant? It apnears to me that no one
has given this matter much thought over
the years and mow the m ér is being called
to the attenticn of the scientific community
and we are bocoraing aware of something
that only vi @ whether or not is
important. Ti s33 Of a drug taken
before breakfast may differ from that of tak-
ing the same drug before lunch or before
supper or at bedtime, or from one day to
the next. Such variable factors as fever, the
Presence of other drugs, hydration and liver
and kidney function may infinence the
efficacy of a drug. Generic naming must not
be confused with generic equivalency, Tne
two terms are distinct, separate entities and
not synonomous.

ACCEPTAELE STANDARDS

Standards formulated by the U.S. Phar-
macopeia, the National Formulary and other
agencies are acceptable, reliable standards
and should be adhered to at this time until
additional well documented information is
available, at which time these agencies and
scientific groups can revise their Standards,
As time passes we will no doubt learn more
about the so-called “piologic equivalency”
and its clinical importance. The standards
will then be modified in accordance with our
added knowledge, but un+il such a time the
present-day standards are adequate.

There must be a beginning to make order
out of chaos, and now is the time to eect
changes. The vociferous displeasure which
will be voiced will be intense but it can be
readily pazried by asking, “Is what is being
cone in the public’s best interest?" How can
full disclosure of al! cetails Pertaining to a
drug be anything other than in the Patient’s
best interest?

COMPLEXITY OF GENURIC Nazxs

The greatest objection and difficulty that
one will encounter in attempting to establish
uniform nomenclature of drugs will be the
complexity’ of some of the generic names
which have deen assigned to drugs. This is a
matter that will have to be resolved with
time. Some names undoubtedly will have to
be simplified. Chiorpheniramine, mentioned
in the description of Coricidin, is a name that
borders on the complex side. Tuere ts a ten-
dency among physicians to abbreviate names
or use “nicknames.” For instance, cyclopro-
pane is usually referred to as “cyclo” by
anesthetists. Muscle relaxants are facetiously
referred to as “arrow poisons.” In the case
of the muscle relaxants, for example, De-
camethonium is the generic name for Syn«
curine and succinylcholine is the generic
name for Anectine or Sucostrin. Tubocura-
rine is a nofi-patented generic name for
Curare and should be retained, These
generic names are not dificult to pro-
nounce or spell,

The purpose, Mr. Chairman, in my recom-
mending that the chemical names be in-
cluded on the packaze and in the other types
of labelling is that one wishing to know the
chemistry would have it available. The Unit-
ed States Adopted Names, a committee com-

 

 

   
 

 

   
 
  
    

 
 

S5417

posed of members of the U.S.P., NF., Council
on Drugs of the AMA, and the FDA, now at-
tempts to incorporate in the name an in-
dication of the chemical nature of the drug.
if it were known that the chemical names
are required on the labelling, perhaps the
USAN would be more inclined to adopt the
simpler names and not attempt to follow a
chemical type of nomenclature.

LICENSING SYSTEMS

A code of good manufacturing practices
and other criteria with a licensing system
and registration for all individual pharma-
ceutical products is essential. All drugs would
then meet the same standards, This, of
course, would be imposing the same require-
ments on all firms manufacturing drugs
equally and would do much to solve the
problem and obviate the objection which
allegedly exists that some drugs are chemi-
cally equivalent but not biologically equiva-
Jent. This is mot an impossible problem to
resolve,

FIXED RATIO COMBINATIONS

Physicians have, for years and years, used
drug combinations. They wil continue to
use drug combinations in the future, I see
no end to this practice. It 1s Teasonable and
logical in some cases. There is a difference,
Mr. Chairman, between combinations and
fixed ratio combinations, Combinations are
essential and not necessarily objectionable.
However, there are objections to the use of
fized ratio combinations because no two in-
dividuals respond to the same manner to a
given drug. The argument advanced in the
use of jfized ratio combinations ts that a
patient then would receive all the medica-
tion in one tablet, capsule or teaspoonful of
solution or injection. The use of fixed ratio
combinations is as logical as selling combi-
nations of salt and pepper in fixed propor-
tions. Iam sure that if Pepper were combined
with salt in a fixed ratio and sold on the
Premise that one would require only one
shaker on-the table instead of two the prod~
uct would have limited sale, Individual tastes
vary; some people would like more salt and
less pepper and vice versa.

The same principle applies to drugs in com~
binations of fixed ratio, particularly when
they are dissimilar chemically or therapeu-
tically. I have in mind a particular fixed ratio
combination which has been recently intro-
duced on the market under the brand name
of Innovar. This is a mixture of a new nar-
cotic of great potency, Fentanyl, and a new
“tranquilizer,” Droperidol. The narcotic
causes rigidity of the muscles and interfcres
with respiration. The tranquilizer has the
oupabiiily of paralyzing Ue nerves supplying
the blood vessels and causing a fall in blood
pressure. The combination is packaged in a
ratlo of fifty parts of the tranquilizer to one
part of the narcotic. When this combination
is used, certain individuals overreact to the
narcotic while others overreact to the tran-
quilizer, Such a mixture of fixed proporvions
is illogical, It has been promoted and, because
of its newness, detailed information of its
Pharmacologic properties is lacking or it has
not as yet drifted down to the practicing
physician through the normal and unbiased
drug information channels; that is, from
physicians who actually are familiar with the
drug and recognize its side effects. When
an N.D.A. of a new product of this sort is
approved by the FDA, the “detail men” are
the first to acquaint the physician with the
product, The package insert, in these cases,
provides all of the required available infor-
mation but this is not sufficient because in
many cases the drug has been tested by indi-
viduals whom we facetiously refer to as “tes-
timontal writers.” Seasoned researchers are
not interested in testing drugs in the manner
Proposed by a sponsoring manufacturer. The
data on the N.D.A. applications is not always
obtained from research of the highest quality.
Side actions and other adverse effects often
S5418

remain virtually unknown until a drug is
subjected to widespread general use or is
studied carefully by seasoned researchers.
When a drug is firse introduced, we are not
fully aware of its actual usefulness and
limitations, It is only with tirne und sad exz-~
periences that a drug finds its prope? niche
in therapeutics.
ANTIBIOTIC FIXED RATIO COMBINATIONS
Some fixed ratio combinations of anti-
biotics and chemotherapeutic agents avail-
able on the market are deemed ineffective in
certain cases, from data studied by the Re-
view Comraittee of the NAS-NRC. Inasmuch
as the physicians and other scientists on
these committees are knowledgeable in their
fields and net biased, I would accept their
recommendstions. In instances where they
say that a cd ratio combination is not
clive, : uid be with-
from the u supploemen-
tary data of prec? of eMicacy is supplied by a
manufacturer, Withdrawal of mixed ratio
combinations of these types does not hamper
the physician from using combinations. A
physician will still be able to prescribe two of
three Grugs in quantities to suit an individ-
ual patient. Antibiotics and chemothera-
peutic drugs are far from innocuous drugs.
iach type is capable cf producing sensitiza-
tion, kidney, liver, and in some cases nerve
damege. Where fixed ratio combinations are
used, only cone ingredient may be effective
but the amount in the mixture is insuffi-
cient. The physician may increase the dose if
the response is good but not as great as an-
ticipated. Tt is thus possible for the amount
cf the incffective agent to be increased above
the toxic level and cause harm to 4 patient.
CHLORAMPHENICOL
I have been asked to comment on the use
of Chloramphenicol (Chloromycetin). Chlor-
amphenicol is a valuable drug and certainly
nothing should be done to curtail th’e intelli-
gent use of the drug by knowledgeahle phy-
sicians in instances in which it is indicated.
It not only would be difficult to legislate
waoen s physician should or should not use
Chloramphenicol, but such a step would be
ill advised. Tnere is no doubt that there has
been and probably still is some abuse of the
drug. This appooars to be decreasing, There
are, however, other drugs in other categories
that are equally as hazardous as Chloram-
phenicol but in other ways. They, too, are
used thoughtlessly and indiscriminately in
certain cases,
PE,

 
  
   

     

 

 

 

MACY AND THERAPEUTICS COMMITTEES
The hospital pharmacy and therapeutics
retui yo the Jai Commnise
sion on Accreditation of Hiespitals im ac-
credited hospitais could manage the prob-
lem of proper drug usae? quite etectively.
These committees, however, should be
strongthened and be more active than they

 

           

  

mow ars, Their scope should be broadened to
iInclhuce the reporting, not only of adverse
reactions, but a review of a drug utilization

and

romotion of drug education to the hos-
The premise upon which
the Joint Commission for the Accreditation
of riospitals bases its requirements of accredi.
tation, as far as the medical and surgical visit-
ing staff is concerned, is that the visiting
staff governs itself. The philosophy that the
staff governs itself can be workable. It ts
elective in cericin, but not all, hospitals.
Tissue committees are quite effective in most
hospitals in preventing unnecessary surgery.
Utilization review committees which review
duration of patient stay and hospitalization
likewise have been effective; therefore, the
same principle could be applied to drug util-
ization. The pharmnacy and terapeutics com-
mittee could challenge a physician for using
a drug such as Chloramphenicol in situa-
tions where it was not indicated or for ad-
ministering the drug without performing
the proper bacteriologic and sensitivity stud-~

  
 
 

CONGRESSIONAL RECCRD — SENATE

tion is not the
. The sclution must be by education
if-rezulaticn by the medical profes-
sion, The use of drugs presenting hazards

  

answer to this

      

  

 

 
 
   
 

simflier to Chicramnhenicol could be
“policed” in @ similar manner,
ROLE OF THE Az ASSOCIATION

IT realize thas
ciation has, ov

ciical Asso-
acred with
ional ads governmental
agencies in its concerning the dis-
pensing of health core to the public. I pre-
fer not to say that I agree or disagree with
the pronouncements that have been made
by the Asscointion because I must admit
teat IT ara mos i with both sides of
the st i I have either heard

ented by physicians

4

 

 

 
 

   

   

    
    
          
    

in doubt, I apply
my guide—‘is what is

-ng proposed in the
best inte

of the public?’, I would like
Mir, Chairman, thay medicine,
Practiced taday, ts the best in the
history of the world. It would not be in the
state of development that it is today had it

   
 
 

   

t
not becn for the American Medical Associa-
tion. Many years avo Abraham Flexner sub-
mitted a report on the deplorable status of
the various medical schools in the United
States, Fol 1g the presentation of this re-
port the American Medical Association took
the initiative and established uniform stand-
ards of cical education in this country.
We then surpassed the rest of the world as
far 28 medical standards of medical educa-
tion and medical practice are concerned, The
tovical Association is a scientific
1 can, if it wishes, assemble sei-
dicai talents of the highest
ation has and must have
The part of the

   

 

 

 
 
 
  

   
 
 
  
 

the “political portion,” which is a small pore
tion, After all, the American Medical Asso-
ciation is a democratic organization. It is
organived and operates in many ways as does
the Congress or the various State legisla-
“sures, It is governed by an elected House of
Delegates. The actions of the Congress, as
depicted in the press, sometimes appear ab-
surd. Likewise, tae actions and resolutions
of the American Medical Association may
appear to be ridiculous and ill conceived to
ong on the outelde looking in who does not
know all the ifcations involved in a de-
tion of the American Medical
%OnG Cues et see is the con-
gloraera s&cicnvile counclis and cther
ions mos involved in medico-political
. Phe Assoclation may be likened to an
iceberg, one-eighth of which protrudes above
the water. This portion is the political por-
tion whieh the puislic sees.

The functions of the American Medical As-
sociation of which the public is not aware
are the scientific functions. This fs the por-
tion lixened to the iccherg which is bencath
the Waser, The Council on Medical Education,
Which inspects and approves medical schools,
S, residencies and postgraduate
costiy and important undertak-
Known body of the Association,
Wich serves the best interests of the public.
The Council on Drugs, of which Iam a mem-
ber, is promcting the formulation of drug
utilization policies, adverse drug reaction re-
porting and dissemination of medical knowl-
edge to physicians. The activities of the Asso-
clation are financed to a large extent by
physicians’ dues and voluntary contributions
and to a lesser extent from income from ad-
vertising in periodicals published by the As-
sociation.

I may appear to be idealistic and naive in
making this statement, but I believe the ZOve
ernmental agencies should take into their

 

 

  
 

   

 

i OL

 

 

 

  

ing
ing,

 

 

 

May 20, 1969

confidence and work closely with the various
scientific bodies of a national stature, includ-
ing the AMA, and attempt to cooperate and
work jointly for the bencfit of all. Any legis-
jation which is hastily passed, ill conceived,
is restrictive and appears to encroach upon
the physician’s prerogative to make decisions
and to practice medicine as he deems best
for the patient will be construed as punitive
and will arouse resentment and resistance,
A frustrating situation will be created and
the main goal, namely, providing the best
health care possible for the public which
both the government 2nd the American Med-
ileal Association are obligated to provide, wil
not be attained.

THE PHARMACEUTICAL INDUSTRY

In advocating uniform nomenclature I am
not castigating or opposing the pharmaccuti-
eal industry. One must remember that the
pharmaceutical industry operates in a man-
ner similar to any other industry and its
primary goal is profits. It has, however, a
greater responsibility to the public than any
other industry, The patient docs not make
the decision as to which and whose drug is
to be brought. The physician does. The in-
dustry should remember this fact but docs
not always do so, If the profit incentive is.
removed, then expansion and progressive de-
velopment of the industry will be stunted
and this would not be in the best interests of
the public, I am sure that you have infor-
mation from your hearings which indicates
that some pharmaceutical firms have been
ruthless, have fixed prices, and have com-
mitted acts which have not been tn the pub-
lic’s best intersst. Nonetheless, the pharma-
ceutical industry has also contributed its
share to the progress of medicine in this
country. We need an active and vigorous
pharmaceutical industry. There should be
regulation of the industry but such regula-
Aon should be nonrestrictive in nature. Is
should create a more conapetitive environ-
ment than now exists and permit a firm to
expand and progress and to develop signifi-
cant and better products and not duplicate
products. Any restrictions which are placed
upon a firm that remove incentive will not
be in the best interests of the public or the
medical profession. Restricting monopolistic
practices will, of course, encourage competi-
tion which is healthy and which is in the
best interests of the public.

The question, Mr. Chairman, then is not
should we abolish brand names and use
generic names, but when? The sconer the
better, It can be done, and it will be a step
forward in medicine.

I think I have sald enough, Mr, Chairman:
thank you.