Conflicts of interest in drug research
are now so widespread that many journals are no longer
bothering to disclose them. Instead, they overlook them
because they can't find authors who aren't in the pay
of Big Pharma. That's the damning conclusion of a report
by the Center for Science in the Public Interest (CSPI),
an independent US thinktank.
The study examined 163 articles
in the New England Journal of Medicine (NEJM), the
Journal of the American Medical Association (JAMA),
Environmental Health Perspectives (EHP), and Toxicology
and Applied Pharmacology (TAP). It identified at
least 13 articles where authors didn't disclose relevant
conflicts of interest where they should have in accordance
with the journals' policies. They also found a further
11 cases in which there were undisclosed conflicts of
interest not immediately related to the subject in question,
but which should have been made clear nevertheless.
The examples are seemingly endless:
A University of Arkansas College of Medicine professor,
Dr John Shaughnessy, published a NEJM article
outlining the potential efficacy of a treatment for
multiple myeloma, but did not disclose that he intended
to apply for a patent on the underlying technology.
EHP identified researcher William
Owens as an official of the Organization for Economic
Co-operation and Development in an article that validated
a toxicity test that would likely be used on various
Procter & Gamble products. But the editors failed
to mention that he was an employee of Proctor &
Gamble even though they were aware of the fact.
A National Institutes of Health
(NIH) senior scientist published a study in JAMA
on predictors of kidney disease, but didn't disclose
his consulting relationships with Merck, Bristol-Myers
Squibb, GlaxoSmithKline, and Pfizer, all of which sell
products whose marketing could benefit from the insights
gleaned from his study.
I
DON'T DECLARE
The CSPI study's author, Merrill Goozner, director of
their Integrity in Science project, said the failure
to disclose drug company ties "threatens the credibility
of scientific journals and rightly undermines public
confidence in studies about the safety or efficacy of
various drugs."
A poll conducted by the CPSI shows
the public isn't blind to the significance of authors'
financial connections. Forty-eight percent of respondents
said they would have confidence in a statement from
"a Harvard professor" that a given drug is safe, but
only 24% would trust such a statement from a "Harvard
professor who owns stock in drug companies."
Of the four journals reviewed by
the CSPI, JAMA had the highest nondisclosure
rate at 11.6%, and NEJM the lowest, at 4.8%.
But the CSPI only checked the backgrounds of the first
and last authors of each article reviewed, so they probably
missed several conflicts of interest.
EVERYONE'S
DOIN' IT
The NEJM might breathe a sigh of relief at emerging
relatively unscathed, but many critics accuse the august
journal of leading the race to the bottom. In 1984 it
became the first journal to insist on disclosure of
conflicts of interest. In 2002 it became the first to
relax its rules and allow submissions from authors paid
by drug companies. NEJM's editor, Dr Jeffrey
Drazen, argued that everyone he approached to write
for the journal had financial ties of some kind to companies
that made the drugs they were being asked to write about.
"These authors would have been unable to contribute
to the journal under the previous policy that allowed
no associations at all," he said. "Not all financial
associations are the same. Some, such as the receipt
of honorariums for occasional educational lectures sponsored
by biomedical companies, may be appropriately viewed
as minor and unlikely to influence an author's judgement."
The NEJM now allows authors to receive up to
$10,000 US a year from interested drug companies.
At the time, Dr Drazen pointed
out that the NEJM's criteria were the very same
as those used by the venerable NIH. He must regret making
that association now, because the NIH is currently swamped
in its own giant conflict of interest scandal. It was
forced two months ago, by congressional pressure, to
change its rules governing conflicts. But its new rules
aren't much better — NIH scientists are not permitted
to augment their salary by more than 50% with outside
consultancies. These restrictions are widely derided
as totally insufficient.
Interestingly, just weeks before
taking over the NEJM in July 2000, Dr Drazen
was himself criticized by the FDA for making "false
or misleading" statements about a new asthma drug, levalbuterol,
whose manufacturer Sepracor had engaged him as a paid
consultant. Reviewing studies of the drug on behalf
of the manufacturer, Dr Drazen concluded that it represented
"the first real advance in rescue asthma therapy in
over 20 years." After the FDA censured him for overstating
the drug's efficacy and safety, Dr Drazen issued a statement
admitting, "We were probably a little overzealous."
STIFF
UPPER LIP
Dr Richard Smith, outgoing editor of the British
Medical Journal (BMJ), who led the drive
within the scientific publishing industry to clean up
its act, says honest scientists are reluctant to publish
drug company ties because they fear it will discredit
valid work. The BMJ has replaced the term "conflict
of interest" with "competing interests," which Dr Smith
hopes will "reduce the sense of wrongdoing and encourage
people to disclose."
But he acknowledges that it's hardly
a complete solution. So far, scientific journals' spasmodic
efforts have been overwhelmed by a tidal wave of money
from the drug industry, who are now even starting to
offer money to the very medical ethicists who've acted
as their funding practices watchdogs. In Dr Smith's
farewell editorial, he offered a gloomy assessment of
the current state of affairs: "It is at least arguable
that medical journals are more an extension of the marketing
arm of pharmaceutical companies than independent scientific
forums."
Competing interests: The
author also writes for the BMJ (which is why
he didn't say anything bad about it)
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