Doctors and patients who rely on articles in prestigious medical journals for information about drugs have a problem: The articles don't always tell the full story.
Some omit key findings of trials about a drug's safety and efficacy or inconvenient details about how a trial's design changed partway through. A study published in the Journal of the American Medical Association last year reviewed 122 medical-journal articles and found that 65% of findings on harmful effects weren't completely reported. It also found gaps in half the findings on how well treatments worked.
In one example cited by the Wall Street Journal, Merck and partner Johnson & Johnson set up 14 mock drugstores and solicited customers through advertising as part of a bid for FDA approval to sell the anti-cholesterol drug Mevacor without a prescription,. The store shelves were lined with products including over-the-counter Mevacor. A label on the drug instructed potential users that they should take it
only if they met several conditions, such as having moderately high cholesterol and at least one risk factor for heart disease. The idea was to simulate the real-life circumstances under which the pills would be sold.
An article summarizing the results of the experiment in the November 2004 issue of the American Journal of cardiology said about two-thirds of the people who decided to try the drug met the conditions or came close. The authors, who worked for Merck and J&J, said the study's full results made a "compelling case" that Mevacor was suitable to be sold over-the-counter.
In reviewing the case, the FDA highlighted another figure, one that never appeared in the article: Just 10% of the people who took the drug fully met the label's conditions. The others included in the two-thirds figure met many of the conditions but not all. After hearing a presentation by agency officials, an FDA advisory committee in January voted to reject the drug companies' request.
Some top journals are now cracking down. This year, the British Medical Journal started demanding that everyone who submits an article also submit the original study design plans, so that peer reviewers can see whether the authors changed the goalposts when publishing the
study. It's weighing whether to make the plans and the reviewers' comments public.
Read more about the deplorable behavior of many study authors at:
http://online.wsj.com/article_email...IcaWCm4,00.html