From the Henry Kaiser Foundation Health report on Prescription Drugs
Tuesday, May 10, 2005
Some top medical journals have begun “cracking down” on prescription drug studies that “omit key findings” on safety and efficacy or “inconvenient details about how a trial’s design changed partway through” in an “era when articles are increasingly used as marketing tools,” the Wall Street Journal reports. According to the Journal, medical journals also are “responding to the escalating debate in Washington on ensuring side effects of drugs are properly disclosed.” BMJ this year will begin to require authors to submit original study designs with articles to allow peer reviewers to determine whether the authors revised the designs to make study results appear more positive. In addition, BMJ might make public the original study designs and comments from peer reviewers. The Journal of the American Medical Association also has begun to ask some authors to submit original study designs and in some cases has hired independent statisticians to review study results. JAMA also requires academic researchers who co-write articles with pharmaceutical industry scientists to sign statements “attesting that they have taken part in the data analysis and stand by their findings,” the Journal reports. In addition, several medical journals this year will begin to require study sponsors to register some details, such as study designs and size, in a public database as a condition of publication.
Catherine DeAngelis, editor in chief of JAMA, said, “We were burned very badly” in the past, adding that today “the single thing we change most often is the conclusion.” She said, “It comes in as, ‘This product is the greatest thing,’ and we say, ‘Under these circumstances, in this population, this medication seems to control a, b and c.'” However, some medical editors maintain that “it’s impossible to sift through thousands of pages of raw data to check a paper’s fairness” and that peer reviewers might “fail to notice suspicious omissions and changes in focus” in studies or “lack the time or inclination to follow them up,” the Journal reports. Kamran Abbasi, deputy editor of BMJ, said, “One solution to this is to publish the raw data. The way things are going in terms of openness, you can’t rule it out” (Wilde Mathews, Wall Street Journal, 5/10).Leave a reply →