[e-drug] Scientific independence

[E-drug <e-drug@usa.healthnet.org>]

E-drug: Scientific independence
-------------------------------------------------------------------------

[Copied as fair use. HH]

"A Stand for Scientific Independence"
Washington Post (08.05.01)::Susan Okie

The New England Journal of Medicine, the Lancet, the Annals of
Internal Medicine and the Journal of the American Medical Asso-
ciation (JAMA) are among the journals that have agreed to adopt a
uniform policy that reserves the right to refuse to publish drug
company-sponsored studies unless the researchers are guaranteed
scientific independence. They plan to publish a joint editorial in
mid-September outlining the new policy, which was drafted by
editors over the last few months.

The editors said that the new policy is a response to the industry's
increasingly tight control over research results and, in many cases,
over whether and how results are made public. In recent years,
drug companies have become the dominant funders of biomedical
research. The editors acted after several recent cases involving
charges that drug companies tried to withhold research results or
present them in a favorable light. "It's become a huge problem,"
said Frank Davidoff, editor of the Annals of Internal Medicine.
Catherine D. DeAngelis, editor of JAMA, said, "the goal would be
that all of the major journals would adopt similar ... principles," with
respect to researcher autonomy.

Marcia Angell, former editor-in-chief of the New England Journal of
Medicine, sometimes received manuscripts from company-
sponsored studies that had the "methods" section - the explanation
of how the study was carried out - left blank. "They'd say, 'This is
proprietary,'" she said. In large, company-sponsored drug trials
involving multiple hospitals, the company typically holds the
information collected. "Not even the principal author sees all the
data," Angell said.

Several observers of biomedical studies who have become alarmed
about the influence praised the decision of the editors. In one case,
University of California-San Francisco pharmacologist Betty J. Dong
found that cheaper generic versions of thyroid hormone worked as
well as a brand-name drug, Synthroid, made by Knoll Pharmaceuti-
cals. Knoll, which had funded the research, successfully blocked
publication of Dong's findings for seven years. In 1999, Knoll
agreed to pay 37 states almost $42 million to settle a suit alleging
that it had made false claims that Synthroid was superior to compe-
ting brands and had interfered with the publication of the study.

Bert A. Spilker, senior vice president for scientific and regulatory
affairs at the Pharmaceutical Research and Manufacturers of
America, called the journal editors' concerns "patently absurd."
"The journals are becoming more and more antithetical to even
considering an industry perspective," he said. "Except for some
very, very rare exceptions...[the process] is working well."


--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Information and archive http://satellife.healthnet.org/programs/edrug.html
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to:  `owner-e-drug@usa.healthnet.org'.