FDA Urged to Ban Drug Used
In Effort to Bar Heart Attacks

By Morton Mintz
Washington Post Staf( Writer
Ten years ago, leaders of the medi-
cal research establishment—mainly
philanthropist Mary Lasker, then-Sen,
Lister Hill (D-Ala.) and famed heart

surgeon Michael E, de Bakey—began |

fo lead a chorus of acclaim for the
seeming potential of a prescription
drug called Atromid-S to prevent
heart attacks,

De Bakey appeared before Hill’s
Senate Appropriations subcommittee
io make an impassioned plea for a $49
million government study of the drug.
Hill nearly got a $4 million down pay-
ment through Congress, Lasker in-
vited reporters 1o her home to hear a
report on Atromid’s supposed won-
drous promise, and shortly a front-
page story, headlined, “Drug Curb
Hinted for Heart Attack,” appeared in
the New York Times.

The effectiveness of Atromid in pre-
venting heart attacks has yet to be cs-
tablished. But a report being. pub-
lished today on a carefully controlled
study In mon shows a 54 per cent
higher incidence of gall bladder dis-
ease in Atromid users than in compa-
rable non-users,

On the basis of the report, the
Health Research Group (HRG), which
is affiliated with Ralph Nader, peti-
tioned the Food and Drug Administra-
tion to start proceedings to take
Atramid off the market.

An FDA spokesman said the agency
will study the report, published in the’
New England Journal of Medicine.
The manufacturer, the Ayerst Labora-
tories division of American Home
Produets Corp,, did net reply to are
porter's request for comment. Its
Atromid sales have been at an annual
rate of $30 million.’

Dr. Sidney M. Wolfe, director of the
HKG, estimated that 1,000 men a year
will get gall bladder disease because
of Atromid. He calculated the number
of current users at 743,000, including
450,000 men, and speculated that the
drug may cause the disease in women,
too, .

Ayerst holds the American patent
on Atromid (clofibrate), which was
first sold in Britain. ‘The FDA re-
Jeased {t fo the American market in
May, 1967.

In approving it, the agency permit-
ted Ayerst to make no claim that
Atromid would prevent heart altacks.
Instead, it limited the prescribing in-
structions, or physician labeling, to
what Ayerst's dala demonstrated: the
drug lowered blood levels of fatty sub-
stances known as serum lipids, partic-
ularly triglycerides and cholesterol,

Then and now, the labeling empha-
sized that scientists have not estab-
lished whether drug-induced towering
of serum lipids has “a detrimental,
beneficial. or no effect" on cardiovas-
cular death or disease,

Medical scientists hotly dispute
whether decreasing serum lipids is
therapeutically beneficial, just.as they
dispute whether the so-called hypogly-
cemics, drugs which lower blood
sugar, protect against the dread car:
diovascular complications of diabetes.

In 1966, what is now the National
Heart, Lung, and Blood Institute, a
unit of the National Insitutues of
Health, starfed the huge Coronary
Drug Project to find out if the risk of
a new. heart attack In men who al-
ready had had one’ would be lessened
by any of the following: Ayerst’s Pre-
marin, an estrogen, in either of two
docses; Travenol Laboratories

_Chtoxin (sodium dextrothyroxine);
niacin (nicotinic acid) or Atromid.

‘The results were discouraging. The
project stopped using Premarin in one
dose in 1970 chiefly because it caused
an excess of nonfatal heart disease,
and the other dose because of an ex-
cess of blood clotting and cancer;
Choloxin in 1971, because the death
rate was higher among users than
vion-users, and niacin and Atromid in
1974, because neither signifleantly de-
ereased the death rate below that
achieved with a dummy drug, and be-
cause of unpleasant and hazardous ad-

verse reactions affecting the digeslive
and cardiovascular systems.

Dr. Robert S: Gordon Jr, an NIH
official, and four colleagues who pre-
pared the New England Journal re-
port disclosed that 4 per cent of 1,051
men on Atromid developed gall blad-
der disease, compared with 2.6 per
cent of 2,670 men on a placebo, or
fake drug. Gordon said the resulls ap-

‘ply to all middle-aged men on the

drug, not merely to those who have
had heart attacks. ~

. The HRG's Wolfe said the report
“refocuses attention” on the question
of why more than 1 million persons
are taking any drugs to lower serum
cholesterol,

In 1967 and 1968, without the know!-
edge or backing of Heart Institute di-
rector Donald S. Frederickson; row
head of the NIH, philanthropist
Lasker and her allies proposed gdv-
ernment funding of a separate
Atromid study that would have: en-
rolled 16,000 men—twice as many as
in the entire Coronary Drug Project.

The proposal originated with “Dr.
Louis R. Krasno, a United Airlines
medical official who said’ a study. he
had done in 1,200 middle-aged men in-
dicated that for every, heart attackvin
Atvomid users, non-users had 3.7, Sup-
porting him, statistician John'W.
Weiner told Sen. Hill that Atromid
was “free of serious side effects.” --