One of the world's most influential medical journals
is tightening its conflict-of-interest policy in response
to scientists' failure to disclose all financial
ties to pharmaceutical companies.
"Because we've had some experience where
it may not as clear to authors as it should be, we
have tightened our conflict-of-interest statement,"
said Dr. Catherine D. DeAngelis, editor-in-chief of
the Journal of the American Medical Association.
"We want utmost transparency."
The move came as welcome news to outside observers.
"The earlier policies left some discretion for
individuals to determine what was a 'relevant'
conflict of interest," said Dr. Mark Fendrick,
a professor of internal medicine at the University
of Michigan School of Medicine in Ann Arbor. "Given
the multitude of examples where investigators and
authors could not police themselves, I believe the
new JAMA conflict-of-interest policy is unfortunately
required."
The announcement comes in response to the revelation
that authors of a recent article on antidepressants
had failed to disclose ties to several different drug
companies.
Three letters-to-the-editor in the July 12 issue
of JAMA responded to the original study, which
found that pregnant women who discontinued their antidepressant
medication were at a five times higher risk of relapse
than women who didn't.
Two of the letters discussed the science of the study
but the third, from Dr. Adam Urato of Tufts University-New
England Medical Center, noted the "apparent failure
[of seven of the authors] to provide appropriate financial
disclosure."
According to Urato's letter, readers weren't
privy to the fact that "the majority of the authors
have been paid by companies that manufacture antidepressants,
and that the lead author [Dr. Lee Cohen of Massachusetts
General Hospital] appears to have received support
from at least eight such companies."
In reply, the authors stated that they had omitted
the disclosures because the article did not deal with
any specific medications. In retrospect, however,
they conceded that "given the implications of
these findings relating to potential antidepressant
use during pregnancy, we regret that we failed to
include disclosures of the financial associations
of all of the authors. Such disclosures would have
provided utmost transparency with respect to potential
conflict of interest, and we wholeheartedly support
such a practice."
But this wasn't the first time such an episode
had unfolded in the pages of the journal and the editors
of JAMA have now decided to formalize their
quest for "utmost transparency."
"Just in case authors are not quite understanding
our policy, we published this editorial, mostly to
eliminate -- at least as far as we know now -- any
way for people to misinterpret what we mean,"
DeAngelis said. "We now make it very specific."
Authors now must disclose any financial or other
relationship with any company, even if a specific
medication is not mentioned in the article. Also,
mention of any relationship must be made not just
at the end of the article, but also in the body of
the piece.
The editors give an example: Authors of a manuscript
about hypertension need to report all financial relationships
with manufacturers of hypertension products, not just
relationships with companies whose specific products
are mentioned in the article.
This latest installment is really a minor episode
in an ongoing saga which casts doubt on the independence
of medical research.
Recent studies focused on conflict of interest (some
of them published in JAMA) have found that
doctors who participated in a drug-company-sponsored
trial of asthma medications were more likely to prescribe
that company's drugs; that clinical trials funded
by drug companies and other for-profit entities were
more likely to report positive findings for the drug
in question than similar trials funded by nonprofit
groups; and that industry is paying for more and more
medical research.
Perhaps the most egregious example of drug company
influence on clinical trials involved Vioxx, the cox-2
inhibitor painkiller removed from the market in September
2004 after a study tied its use to increased cardiovascular
events.
Last December, editors of the prestigious New
England Journal of Medicine editors published
a rare "Expression of Concern" letter charging
that a major study on the drug was submitted to the
journal only after data on cardiovascular events
among Vioxx trial participants was deleted by Merck,
which makes Vioxx and funded the trial.
Just last month, the NEJM issued a rare correction
on another influential 2005 study on the painkiller.
The correction retracted the author's initial
claim of an 18-month delay before patients experience
increased cardiovascular risks. The correction now
states that there is no such delay in the risk. That
study was also funded by Merck.
