Medical Journals Issue Policy on Pharmaceutical Company Influence

About a dozen of the world's "most prominent" medical journals this week will issue a joint editorial intended to prevent "excessive control by drug companies over how the results of studies they sponsor are analyzed, interpreted and reported," the Washington Post reports. In an "unprecedented stand," the medical journals -- which include the Annals of Internal Medicine, the Journal of the American Medical Association and the New England Journal of Medicine -- plan to reject studies that do not offer "assurance" that the sponsor "gave researchers complete access to the data and freedom to report the findings." The medical journals "will routinely require authors to disclose details of their own and the sponsor's role in the study" and "ask the responsible author to sign a statement indicating that he or she accepts full responsibility for the conduct of the trial, had access to the data and controlled the decision to publish." Sponsors of studies will be asked to review manuscripts only 30 to 60 days before publication and "should not be able to suppress aspects of a study that are detrimental to their products." In the past, companies have blocked or delayed publication of "unfavorable" findings for years, the Post reports (Okie, Washington Post, 9/10). The editorial states, "The use of clinical trials primarily for marketing ... makes a mockery of clinical investigation" (Burton, Wall Street Journal, 9/10). Bert Spilker, senior vice president for scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said in a statement that the group supports the medical journals' new policy, adding, "We respect their rights and encourage all authors to abide by their rules regardless of their affiliation" (Washington Post, 9/10). Last month, Spilker called journal editors' concerns "patently absurd" (Reuters/Philadelphia Inquirer, 9/10).