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News of the Day ... in Perspective


Journal articles can be misleading on drug safety, effectiveness

Some major medical journals are tightening editorial scrutiny of articles that drug companies might use in marketing their products, in response to a study showing that 65% of findings on adverse effects were not completely reported.

The BMJ will start demanding that authors submit the original study design so that peer reviewers can judge whether the goals were changed.

One dispute concerns a study on the suitability of selling the “anticholesterol” drug Mevacor over the counter. Merck and Johnson & Johnson set up mock drugstores and solicited customers through advertising. An article summarizing the results in the November 2004 issue of the journal of the American Journal of Cardiology said that two-thirds of the customers who chose to try the drug met the conditions set out on the label, or came close. The authors said the results made a “compelling case” for the suitability of OTC sales. The FDA, however, highlighted a figure that did not appear in the article: only 10% fully met conditions on the label.

“One solution to this is to publish the raw data,” said Dr. Kamram Abbasi, deputy editor of the BMJ (Wall St J 5/10/05).

Additional information:

Kauffman J. Bias in Recent Papers on Diets and Drugs in Peer-Reviewed Medical Journals. J Am Phys Surg 2004;9:11-14.

Reviews of On the Take: How America’s Complicity with Big Business Can Endanger Your Health by Jerome Kassirer, and Let Them Eat Prozac: the Unhealthy Relationship Between the Pharmaceutical Industry and Depression by David Healy, J Am Phys Surg 2005;10:24-28.

NIH rules to require free public access to research results. News of the Day, Sept 8, 2004.

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