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Journal fuels conflict-of-interest debate
Boston Globe
By Larry Tye, Globe Staff,
01/06/98
The prestigious New England Journal of Medicine has the toughest
conflict-of-interest policy of any science publication - and the
toughest to enforce.
Just
how difficult has become apparent during the last two weeks. First,
the Journal acknowledged it shouldn't have run a book review downplaying
the risks of chemical carcinogens because the review was written
by the medical chief at chemical giant W.R. Grace & Co.
Since
then, however, Journal editors have defended their decision to publish
an editorial arguing that environmental estrogens do not cause breast
cancer, even though it was written by a researcher who until recently
got 20 percent of his funding from a trade group representing firms
that produced those estrogens.
Readers
weren't told of either author's affiliations. The two cases are
spawning a debate among medical journalists and ethicists nationwide
over how to protect the public from conflicts of interest and the
distorted judgments they can yield, while at the same time protecting
scientists from a political correctness that can stifle the exchange
of ideas.
At
the center of that debate is the Boston-based New England Journal,
the world's most esteemed medical publication. Arthur Caplan, who
runs the Center for Bioethics at the University of Pennsylvania,
says the controversy is useful if it gets the public to focus on
how science is supported and how it sustains its integrity.
While
tough judgment calls are required, Caplan added, ''I'd rather see
us err on the side of picking up on the potential conflict rather
than minimizing it.
''Conflict-of-interest
standards are the thin blue line of morality,'' he said. Editors
at the New England Journal agree, and say that's why in 1990 they
tightened their policy on conflicts of interest. Rather than simply
requiring authors to disclose potential conflicts the way other
medical publications do, the Journal said it no longer would accept
reviews or editorials from anyone connected to firms with a financial
stake in the drug or device being discussed.
In
November, however, that policy was breached when the New England
Journal let Dr. Jerry H. Berke of W.R. Grace review Sandra Steingraber's
book, ''Living Downstream: An Ecologist Looks at Cancer and the
Environment.'' The Journal recently apologized for the breach, saying
that the editor who handled the review inexplicably had not recognized
Berke's conflict of interest, and promised to run a ''complete explanation''
in an upcoming issue. Since then another, less clear-cut case has
come to light.
In
October the Journal editorialized that environmental estrogens like
PCBs and DDT are not causing breast cancer. The editorial was written
by Stephen H. Safe, a toxicologist at Texas A&M University who
for three years had accepted grants of up to $150,000 a year from
the Chemical Manufacturers Association.
Was
that a conflict? Safe doesn't think so. He said he didn't tell the
Journal about his ties to CMA because he had formed and stated his
views on environmental estrogens before accepting CMA funding, had
stopped taking industry money five months before his editorial ran,
and ''there's hardly any life scientist in the country who hasn't
had funding from the industry.''
Still,
while he doesn't perceive a problem, he said, ''I can see why people
would bring it up. ''I felt a little twinge'' about the potential
for a conflict, he added, ''but it was not much of a twinge.''
Dr.
Jerome P. Kassirer, the Journal's editor-in-chief, says that while
he didn't know about Safe's CMA funding when the editorial ran,
that wouldn't have stopped him from publishing it. That's because
Safe's funding had stopped several months earlier, he also was getting
money from neutral sources like the National Institutes of Health
and the US Environmental Protection Agency, and, most important,
because CMA funds made up just 20 percent of Safe's research budget.
''You
could argue that 20 percent is too much, or $150,000 is too much,
but we have to have some cutoff,'' said Kassirer. ''In my perspective
Safe doesn't qualify as a case of conflict of interest.'' Others
are less sure. George Annas, professor of health law at Boston University
School of Public Health, said that CMA would seem to pose a conflict,
and yet ''almost all experts in the field at some point have taken
grant money or an honorarium from someone.
It's
a very, very difficult area that's fraught with land mines.'' Annas,
who writes a column on legal issues for the New England Journal,
applauds the publication for going further than any other in guarding
against conflicts, but he adds that implementing the policy ''has
turned out to be much harder than they thought it would be.''
Dr.
George D. Lundberg, editor of the esteemed Journal of the American
Medical Association, says the New England Journal has boxed itself
in with its all-or-nothing policy banning anyone from writing an
editorial who has a potential conflict of interest. JAMA, he explained,
is like most other technical journals in letting people with financial
stakes write reviews and editorials ''as long as we know about that,
and as long as we disclose that to the reader.''
''If
we were to eliminate all such people we would be depriving our readers
of the knowledge of the best people in the field,'' said Lundberg.
''Our readers are not children. They're physicians, scientists,
health policy experts, and medical reporters. They can figure this
thing out so long as we give them the information.''
As
for Safe's ties to CMA, ''I would see that as a financial disclosure
necessary for the author to provide us, and useful for us to provide
readers,'' the JAMA editor added, but such ties would not disqualify
Safe from writing an editorial.
Even
with disclosure, however, there are questions of how much is too
much. Brookline author Eve LaPlante wrote a book in 1993 called
''Seized,'' about temporal lobe epilepsy, that was panned in a May
1994 New England Journal. She is still angry that the Journal never
mentioned that thereviewer, Dr. Gregory Bergey, was president of
the Maryland chapter of the Epilepsy Foundation of America.
The
foundation, LaPlante says, ''has made a practice of not publicizing
the form of epilepsy my book dealt with ... it's a conflict of interest
and, at the very least, I would have liked the Journal to point
this out.'' But Bergey, a professor of neurology at the University
of Maryland School of Medicine, says there is a point where you
can ''go overboard with political correctness.''
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