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ABC News.com by Gene Emery. Routers. Boston, May 18th 2000
Drug companies that pay for research and clinical tests of the new medicines have been suppressing or manipulating the results, a report
in the latest issue of the New England Journal of Medicine said.
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 drug they were studying.
In a 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 posted on its website -- HTTP:\\www.nejm.org.
The Bodenheimer report
and the drug studies, along with a sharply worded editorial where Dr. Marci 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 in a time when "academic medical centers are no longer the souls citadels of clinical research" and the industry is wielding more power in conducting large-scale drug
tests, the Journal said.
Six of the twelve 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 the studies results by requesting changes to the manuscript to make their products
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 the
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 controlled the purse strings, they "may design studies likely to favor their product."
"Without industry funding,
importing adances 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. Berry Eisenstein, who heads the science and technology office at Beth Israel Deaconness hospital told Routers, there has
always been conflict of interest.
"I should also added that commercialization is an absolutely necessary in bringing importing 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 maintains 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 Angela, who will be retiring.
Drazen, a Brigham and Woman's hospital researcher who has
received grants or consultation feas 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.
Copyright 2000 routers all rights reserved. This material may not be published
broadcast rewritten or redistributed.
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