Medical Journals to Call for ‘Scientific Independence’
Responding to what they view as drug companies' "increasingly tight hold" over how research is conducted and presented, editors from several of the "world's most prominent medical journals" will publish a joint editorial next month outlining a new policy designed to enhance researchers' "scientific independence," the Washington Post reports. Under the "unprecedented" guidelines, the journals, which include the New England Journal of Medicine, the Journal of the American Medical Association and the Lancet, will "reserve the right to refuse to publish drug company-sponsored studies" unless the researchers involved are "guaranteed" the right to publish freely. Currently, most drug research is performed by medical school professors, but is sponsored by and often conducted in part by drug makers with "an enormous financial stake in the outcome." The companies "usually collect and analyze the data," and often determine "how it should be presented and write the reports." According to the journal editors, the new policy is a reaction to several instances where drug companies have attempted to "withhold research results or present them in the most favorable way." Those instances include:
- Last year, researchers at the University of California-San Francisco "defied" sponsor Immune Response Corp. by publishing a study that found that the drug Remune, developed as an HIV treatment, "did not benefit patients who were already receiving standard treatments." The company is suing the university for $7 million to $10 million in damages.
- The Canadian drug company Apotex Inc. ended its contract, which contained a non-disclosure clause, with University of Toronto physician Nancy Olivieri after she "spoke out" and published an article in 1998 describing a "serious side effect" of the blood disorder drug deferiprone.
Several biomedical study observers "praised" the journals' decision, the Post reports. Marcia Angell, former editor-in-chief of the New England Journal of Medicine said that in many large-scale studies, drug companies hold all of the collected data. "Not even the principal author sees all the data," she said. And according to Lisa Bero, a professor of clinical pharmacology and health policy at UCSF, surveys have found that drug industry-sponsored studies "are more likely than those with other sponsors to show results favorable to the product tested." She added that while many universities have clauses in their contracts with companies allowing researchers to publish negative results, drug makers can still "hassle" professors, who may fear a loss of future funding.
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However, Bert Spilker, senior vice president for scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said that the journal editors' concerns are "patently absurd." He said, "The journals are becoming more and more antithetical to even considering an industry perspective," adding that academic researchers who participate in studies "are given every opportunity to review, make suggestions and sign off" on manuscripts. Still, the new policy will likely lead drug companies to support "scientific independence" because they depend on the journals to inform doctors about new drugs, according to James Wright, a professor of clinical pharmacology at the University of British Columbia. He said, "The company wants (its drug) to be in one of these prestigious journals. All [the journals] need to do is say, 'We won't publish it unless it has all the information'" (Okie, Washington Post, 8/5).