$4. Million
For Unsought
NIH Study

By Morton Mintz
Washington Post Staff Writer

The National Institutes of
Health, one of the few agen-
cies on which Capito] Hill
regularly showers more money
than it requests, may get $4
million it did not seck this
year for a heart drug study it
did not recommend,

The drug is) Atromid-S,
which tends lo lower the level
of cholesterol and other fatty
substances in the bloodstream.
The special study is designed
to see whether the drug tends
to prevent heart attacks.

Sen. Lister Hill’ (D-Ala.) was
so impressed by testimonials
on the new drug’s prospects
that he dropped tiie $4 mil-
lion into the NUT money bill
at othe last minute without
bothering to get the views of
the agency that would spend
i—NIH's National Heart In-
slitute.

The Atromid-S story ilu
strates the informality and
warm generosity with which.

|
See ATROMID, Aj, Col.1 |
ATROMID—From Page Al

NIH Is Given $4: Million
For Study It Didn’t Seek

the Congressional appropria-
tion process for medical re-
Search is sometimes carried
out. It also depicts the influ-
ence exerted on NIH appropri-
ations by philanthropist Mary
Lasker, famed heart surgeon
Michael E. de Bakey and
others dedicated to generous
outlays for biomedical re.
search.

A key date in the story was
last April 27, when the Sen-
ate Appropriations health
subcommittee, headed by Hill,
met to hear the fiscal 1968
budget requests of NIH.

A key witness was Dr. Don-
ald S. Frederickson, director
of the National Heart Institute
— part of the NIH research
family. Frederickson men-
tioned an already established
study being conducted at the
Heart Institute on five cor-
onary drugs — including Atro-
mid-S.

No one at the hearing
questioned Frederickson’s as-
surance that the broad study,
known as the Cooperative
Drug Study, was “progressing
smoothly.” No one so much as
hinted ata need for a separate
project to test Atromid-S.

The existing study is ecx-
pected to cost up to $40 mil
lion over its ten-year life. The
newly proposed special! inquiry
into Atromid-S would be $48.6
million over a five-year period.

Had Been Considered

Actually the Heart Institute
had considered a separate At-
romid-S project. But the cost
and inefficiency of such a
study, Heart Institute officials
concluded, outweighed the
“pro” argument that the drug
had unusual promise because
it might produce fewer and
less serious side-effects than
ather cholesterol - jowering
drugs.:

Underlying afl of this were
still - unanswered questions
about lowered blood choles
terol levels and the prevention
of coronary disease.

The restraint felt in the In-
stitute about requesting a
large appropriation for an
iffy special project on Atro-
mid-S was not shared by three
researchers in California,

Close Friendship

One of these was Dr. Jessic
Marmorston, a ciinical profes-
sor of medicine at the Univer-
sily of California, who ac-
knowledged that she has de-
veloped close friendship with
Sen. Hill and Mrs. Lasker
growing out of their common
interest in biomedical re-
search. She said in an inter-
view that she has probably re-
ceived more Heart Institute
funds than any other single
investigator.

Dr. Marmorston has per-
formed extensive research on
Premarin, a drug that was also
included in the Institute's Co-
operative Drug Study. Her
work on Premarin was criti-
cized in a March, 1961 issue
of the Medical Letter, a lead-
ing drug-review publication for
doctors. It described as “ques-
fionable” published claims by
Dr. Marmorston of Premarin’s
life-prolonging qualities in
heart attack victims.

Premarin is manufactured

by the makers of Atromid-S—
the Ayerst Laboratories divi-
sion of the American Home
Products Corp.

After the FDA approved At-
romid-S for sale earlier this
year Dr. Marmorston and Dr.
de Bakey conferred in Britain
with doctors who investigated
it there,

Important Roles

The second of the three re-
Searchers was John
Weiner, a statistician associ-
ate of Dr. Marmorston who de-
Signs clinical experiments.

The third was Dr. Louis R.
Krasno. Since November, 1964,
he has been testing Atromid-S
with 1200 male employes of
United Air Lines in San Fran-
cisco who have suffered heart
attacks. They were matched
against an equal number of
comparable patients who were
not given the drug.

The three Californians and
Dr. de Bakey, who has been
mentioned as a possible suc-
cessor to Dr. James A. Shan-
non as head of the National
Institutes, all had important
roles in a second- Senate
Appropriations subcommittee
hearing last June 6.

They appeared as citizen-

this point an unanswered
question. “I make no claim,"
he said.

Special Project

Weiner then unveiled his
proposal for the special Atro-
mid-S project. The  partici-
pants would number 16,000—
almost (twice as many as are
planned for the Institute’s
five-drug study. Of the 16,000,
half would be women; no
women are in the Cooperative
Drug Study. Half the women
and half the men would be
persons who have never had
heart attacks — would Atro-
mid-S prevent them? Other
participants would be studied
to see if the drug would pre-
vent a second or a third heart
attack.

In an interview later, Hill
made it clear that the pro-
posal impressed him. At the
hearing, he asked no ques-
tions about the soundness of
the experimental design
{which is questioned in the
Heart Institute), about the
cost estimates (which are con-
sidered low in the Institute)
or about any other significant
aspect,

witnesses—a concept adopted |No NIH Reaction

about 15 years ago at the urg-
ing of Mrs, Lasker. She saw it
as a device that might win
larger appropriations for the
Institutes than Congress would
grant if only their officials
could appear.

The list of citizen-witnesscs
is prepared by Mike Gorman,
executive director of the Na-
tional Committee Against
Mental Illness and a self-de
scribed “over-all bird-dog” for
Hill. But, he told a reporter,
he merely passes along the list
of citizen-witnesses for the
Heart Institute; the actual
selection is made by Dr. de
Bakey.

Shared Friendship

One selection was statisti-
cian Weiner, who was pro-
posed by Dr. Marmorston in
Los Angeles. Dr. de Bakey’s
approval was assured. He and
Dr. Marmorston shared a be-
lief that Atromid-S tad ex-
traordinary promise. They also
shared ihe friendship and
trust of Mrs, Lasker, Sen. Hill
and the late Rep. John E. Fo-
garly (D-R.I.), Hill’s counter-
part in the House,

Hill was the only Senator
present to hear Dr. de Bakey,
Dr. Krasno, Weiner and two
other citizen-witnesses for the
Heart Institute.

Dr. de Bakey led off with
an impassioned plea for more
research funds, Each year, he
emphasized, cardiovascular dis-
ease causes the deaths of more
than 1 million Americans.

The idea of a separate Atro-
mid-S was broached by Dr.
Krasno.

He said his studics with the
drug, which have not been
published, showed three times
as many heart attacks in pre-
vious victims who did not re-
ceive the drug as in those who
did. But he cautioned that
whether Atromid-S prevents
heart attacks—‘the most im-
portant consideration”"—is at

Nor did Hill check to see
what reaction the Heart Insti-
tule might have. This clicited
reactions of surprise in the
interviews with Dr. de Bakey
who had testified that he and
his fellow  citizen-witnesses
were appearing before the sub-
committee “particularily . . .
on behalf of the National
Heart Institute,” and with Dr.
Marmorston and Weiner.

They assumed, they later
said, that “someone” must
have known about the propos-
al. Yet the Institute's director,
Dr. Frederickson did not know
what was proposed until long
afterward, when a transcript
of the closed hearing was pub-
Uished.

Asked about all of this, Hill
said that checks with the In-
stitutes are made “sometimes.”
The clerk of his Appropria-
tions health subcommittee,
Herman EF, Downey, was blunt-
er. “Mast of this stuff that
we do, we don't consult with
NIH,” he said.

Following the June 6 hear-
ing, Hill.recommended a re-
duced starter appropriation of
$4 million for the Atromid-S
project. He said it was ap-
proved without opposition by
the subcommittee, the full
committee and the Senate.

When the original commit.
tee “print” of the appropria
tions bill was published, how-
ever, it made no reference to
the Atromid-S project.

Downey said that the $4 mil-
lion seed-money item was
“omitted by me by inadver-
tence.” In any case, Hill said,
he wanted the item in the bill
— and it was included in the
final committee report pub-
lished 24 hours later, on Aug.

ray

Whether the $4 million—or
anything — actually will be
appropriated for Atromid-S is
uncertain. One reason is that
with the death of Rep. Fogarty
the House Appropriations
health subcommittee has
shown signs of taking a more
critical look at funding of the
National Institutes,