Pubdate: Mon, 10 Sep 2001
Source: Chronicle of Higher Education, The (US)
Copyright: 2001 by The Chronicle of Higher Education
Contact:  http://chronicle.com/
Details: http://www.mapinc.org/media/84
Author: Lila Guterman

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."
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