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Biotech / Medical : Agouron Pharmaceuticals (AGPH)

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To: billkirn who wrote (2332)10/15/1997 5:50:00 AM
From: jay silberman   of 6136
 
From Wed NY Times. More on AIDS and ethics:

October 15, 1997

In Protest, AIDS Experts Quit Journal of Medicine

------------------------------------------------------------------------
Related Articles U.S. AIDS Research in Poor Nations Raises an Outcry
(Sept. 18) Tuskegee Experiment Legacy: Distrust of AIDS Treatment
(April 21) How Lives Were Ruined at Tuskegee (April 21)
------------------------------------------------------------------------

By LAWRENCE K. ALTMAN

Two members of the New England Journal of Medicine's editorial board,
both internationally recognized experts on AIDS, are resigning in
protest over the content and handling of articles criticizing the ethics
of a number of federally funded AIDS studies in developing countries in
Africa and elsewhere.

Third World countries have undertaken the studies to seek a drug regimen
less costly than those used in the United States to thwart transmission
of the AIDS virus from mothers to infants.

In the trials, which involve more than 12,000 pregnant women infected
with the AIDS virus in Africa, Thailand and the Dominican Republic, some
women receive a drug, AZT, that has worked in studies in the United
States, while others receive dummy pills.

The journal's attack on the experiments has led to widespread
discussion, including harsh criticism of the journal itself, and focuses
attention on the role of the 25-member editorial board, including the
two who are resigning, Dr. David Ho, a virologist at the Aaron Diamond
AIDS Research Center in Manhattan, and Dr. Catherine M. Wilfert, a
pediatrician at Duke University in Durham, N.C..

Dr. Jerome P. Kassirer, the journal's chief editor, said the board's
function is to give advice on major issues and suggestions of authors
for editorials and reviews, but that the board is not routinely
consulted.

Drs. Ho and Wilfert are the journal's chief advisers on AIDS.

A third editorial board member, Dr. Richard P. Wenzel, chairman of
medicine at the Medical College of Virginia in Richmond, said in an
interview that he agreed with much of Dr. Wilfert's criticism but was
withholding a decision about resigning until after the issue was
discussed at the board's annual meeting in December.

Ho and Dr. Wilfert said in separate interviews that they had resigned
independently largely because the journal had not consulted with them
before publishing an editorial that likened the new experiments to the
notorious Tuskegee experiment, in which poor black men suffering from
syphilis were left untreated.

Ho, Dr. Wilfert and many others have taken issue with the comparison
with the Tuskegee study because, among other differences, the subjects
in the AZT studies are told that some will get dummy pills.

In the Tuskegee study the men were not told that penicillin had became
available while the study was under way, and thus did not know that
effective treatment was being withheld.

"It was clear that my role was not crucial" in the editorial process, Ho
said.

A full-time staff of editors produces the weekly journal. But Ho said
that "the reason you have an editorial board to help with policy is to
get some input when you have major issues like this one, and that
clearly did not take place."

Ho said he was deeply concerned how the editorial would affect the
future of studies to evaluate experimental AIDS vaccines in developing
countries.

Dr. Wilfert said she was resigning because the journal published the
editorial and another critical article on Sept. 18 without presenting
the other side.

"It was like ignoring half of it on purpose," Dr. Wilfert said. Because
her name was on the masthead, "it implied that I agreed with it when I
didn't," she said.

"It is an error and bad policy" and "a grievous misuse of the journal's
power," Dr. Wilfert said.

"Those are not decisions that a few people in the editorial office ought
to feel comfortable with, because no one small group of persons, no
matter who they are, can cover the waterfront well enough" in
translating health policy and practice in developed countries to those
in developing countries, Dr. Wilfert said.

Dr. Wilfert said she was resigning effective Dec. 31 in order to "vent
my spleen" at the annual meeting. She said she feared that if she
resigned sooner "the issue might not be discussed at the meeting."

The journal published a rebuttal two weeks after its attack. It was
written by Dr. Harold Varmus, the head of the National Institutes of
Health, and Dr. David Satcher, the head of the Centers for Disease
Control and Prevention, and would not have been printed so quickly had
not Varmus received a leaked copy of the orginal editorial before
publication, all sides of the issue said.

Dr. Marcia Angell, the journal's executive editor, wrote the editorial.

Wenzel, the board member from Richmond, said that if the authors of the
critical articles "really knew the facts they would have done a better
job."

The journal's chief editor, Kassirer, said he regretted Ho's and Dr.
Wilfert's decisions to resign and was unaware of any similar
resignations at the journal, which was founded in 1812. The editorial
board members, who have no set term, according to Kassirer, are named by
the chief editor, who can and has dismissed them at will, he said.

But, Kassirer said, Dr. Wilfert "wanted to have prior consultation of
the material in the journal, which is just not acceptable to me because
prior consultation is not what the editorial board is for."

Kassirer said the journal intentionally did not strive to present all
sides of each issue "because if you did you would end up with a kind of
Talmudic discussion in which readers could end up having no particular
view one way or the other and it would be rather boring."

Varmus, the NIH director, said that "the New England Journal of Medicine
is trying to attract more attention by making political, ethical,
philosophical and economic statements that have traditionally not been
in that journal in such an inflammatory way." But, he also said, "before
you inflame the public and attract so much attention, you might want to
ask experts on the editorial board what they think."

The Massachusetts Medical Society owns the New England Journal of
Medicine. Dr. Ronald A. Arky, a Harvard Medical School professor who
heads the society's publications committee to which Kassirer reports,
said he first learned of the resignations last Friday.

The committee generally "stands back and gives the editor and editorial
board license to express their opinion."

However, Arky said, "this is something I need to look into" and "the
committee will want to hear from the editor about the resignations" at
their next meeting in early November.
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