12 MEDICAL JOURNALS ISSUE JOINT POLICY ON RESEARCH SUPPORTED BY BUSINESS

Twelve medical journals, including several of the world's most prominent,
announced today a uniform policy intended to assure the independence of the
academic researchers whose work they publish and whose work is supported by
businesses. The journals released a joint editorial announcing that they
will reject manuscripts submitted by authors who did not have control of
either the data or the decision whether to publish.

"Over the past four or five years, there's been an increasing awareness of
the role of pharmaceutical sponsors of clinical research in specifying the
design of research, what goes into the article, whether it gets published
at all, and how it gets analyzed," said Harold C. Sox, the editor of Annals
of Internal Medicine.

Several incidents have received substantial attention during that time.
Drug companies have been accused of trying to silence researchers who
produced results disadvantageous to the company's interests, or of trying
to change the way the results were reported to present them more favorably.

In one case, Nancy Olivieri, a medical researcher at the University of
Toronto, published findings in 1998 from a clinical trial that showed
severe side effects of an experimental treatment for a blood disease.
Apotex Inc., a drug company that had financed her study, terminated her
contract, claiming she was forbidden to publish because she had signed a
nondisclosure agreement.

The medical journals' joint editorial decries not only companies'
increasing say in what gets published but also the influence corporate
sponsors have over clinical trials themselves. "Investigators may have
little or no input into trial design, no access to the raw data, and
limited participation in data interpretation," the journal editors write.
"These terms are draconian for self-respecting scientists, but many have
accepted them because they know that if they do not, the sponsor will find
someone else who will."

Dr. Sox, of Annals of Internal Medicine, said that the editors of the 12
journals -- including, besides his journal, the New England Journal of
Medicine, The Lancet, and the Journal of the American Medical Association
- -- intended the new policies to increase academic researchers' power in
negotiating contracts with companies. He said that publishing in the
forefront medical journals is valuable to the companies, so they may be
willing to accept the new terms of publication. He hoped other medical
journals would establish similar rules.

Despite decrying editors' concerns as "patently absurd" in an article last
month in The Washington Post, an employee of the Pharmaceutical Research
and Manufacturers of America released a response supporting the new
policies. In the Post article, Bert A. Spilker, senior vice president for
scientific and regulatory affairs of the organization, said, "The journals
are becoming more and more antithetical to even considering an industry
perspective." But in response to the new policies, he said his organization
agrees that "it is essential that academic researchers who participate in
clinical trials have complete freedom to participate in and approve all
aspects of a trial, including any publication that may result from such a
trial."

"This group of editors is taking a principled approach," said Sheldon
Krimsky, a professor of urban and environmental policy at Tufts University
and an expert on the impact of financial ties on scientific research.

"They're helping the investigators to re-establish their rights as
researchers. They are setting a standard that other journals can now aspire
to. They're sending a message to drug companies that they have to pull back
on using the bottom line to control research." He noted, however, that many
forefront journals, such as Nature Medicineand Cell, do not have such
rigorous policies.

Dr. Olivieri, of the University of Toronto, applauded the new policy as "a
large step in the right direction." In an e-mail message, she said, "These
editors have decided to attempt to protect the lone researcher who stands
up to (in my case) a billion-dollar corporation."

But she fears the policy can't solve some ethical problems relating to
clinical research, because some researchers will still be "bought" by drug
companies, she wrote. Such a scientist "will affirm that there is no
problem with data he/she presents to the journal because he/she wants the
data published for the same reason some drug companies do -- their goals
(finance, not truth) are the same. Hence, the policy doesn't guarantee
honesty in publication of data -- but no policy can police this, of course."