12 Medical Journals Issue Joint Policy on Research Supported by Business By LILA GUTERMAN
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."