The prestigious, peer-reviewed Journal also warned the
likelihood that drug test results will be manipulated or
suppressed is even greater when for-profit companies set up
specifically to test drugs conduct the trials.
The findings appear in an article, “Uneasy Alliance —
Clinical Investigators and the Pharmaceutical Industry,”
written by the Journal’s national correspondent, Dr. Thomas
Bodenheimer.
Doctors Tied to Industry
To illustrate the point, the issue includes two major drug
studies — one on depression and one on Parkinson’s disease —
in which most of the key researchers have financial ties to the
makers of the drugs they were studying.
In the depression study, so many authors had potential
conflicts of interest, the Journal decided for space reasons not
to publish the complete list, choosing instead to post it on its
Web site — http://www.nejm.org.
The Bodenheimer report and the drug studies, along with a
sharply worded editorial where Dr. Marcia Angell raises the
question “Is Academic Medicine For Sale?” appears one week
after the Journal’s publisher, the Massachusetts Medical
Society, announced it would replace her as editor with a
prominent asthma researcher who has strong ties to the drug
industry.
Unfavorable Studies Stopped
Bodenheimer’s report comes at a time when “academic medical
centers are no longer the sole citadels of clinical research”
and the industry is wielding more power in conducting
large-scale drug tests, the Journal said.
Six of the 12 investigators Bodenheimer interviewed “cited
cases of articles whose publication was stopped or whose content
was altered by the funding company,” the Journal reported. The
companies are not identified.
In one instance, a drug maker delayed publication of a
study’s results by requesting changes to the manuscript to make
the product look better.
“During the delay, the company secretly wrote a competing
article on the same topic, which was favorable to the company’s
viewpoint,” the Journal said.
Another investigator “found that a drug he was studying
caused adverse reactions. He sent his manuscript to the
sponsoring company for review. The company vowed never to fund
his work again and published a competing article with scant
mention of the adverse effects,” the Journal said.
In a case where the drug did not work, the company stalled
publication until the investigator lost interest.
The Journal article also warned that when drug companies
control the purse strings, they “may design studies likely to
favor their product...”
“Without industry funding, important advances in disease
prevention and treatment would not have occurred... [But]
academic-industry drug trials have been tainted by the profit
incentive,” the Journal said.
Without Drug Money, Less Research
Harvard Medical School professor Dr. Barry Eisenstein, who
heads the science and technology office at Beth Israel
Deaconness Hospital told Reuters, “There has always been
conflict of interest.
“I should also add that commercialization is an absolutely
necessary in bringing important products to the public,” he
said.
The Journal’s findings, he said, “underscore the need for
broad and consistent conflict of interest policies.” Eisenstein
noted that, like the Journal, Harvard maintained strict research
rules “that protect patients, the public in general, and at the
same time, allow physicians and faculty to engage in appropriate
commercialization efforts.”
Harvard is reviewing its conflict of interest policies that
now bar researchers from having more than $20,000 worth of stock
in the companies whose products they are studying, the Journal
editor Angell noted in her editorial.
“There is now considerable evidence that researchers with
ties to drug companies are indeed more likely to report results
that are favorable to the products of those companies,” Angell
said.
Last week, the Massachusetts Medical Society, which owns the
Journal, named asthma researcher Dr. Jeffrey M. Drazen as the
new editor, replacing Angell, who will be retiring.
Drazen, a Brigham and Women’s Hospital researcher who has
received grants or consultation fees from nine pharmaceutical
companies, defended alliances between researchers and drug
companies.
Under the Journal’s conflict of interest rules, he is
required for the next two years to avoid editorial decisions
related to asthma or the companies that have paid him.
