Over Half Of Drug Safety Studies Never Published

November 5th, 2008

The September 23, 2008 issue of Public Library of Science (PLoS) Medicine published a report that says more than half of drug safety and efficacy studies that the U.S. Food and Drug Administration (FDA) used to approve new drugs goes unpublished, their information unavailable for public review.

In the study, researchers examined the approval of 90 new drugs approved by the FDA between 1998 and 2000. Of 909 separate clinical trials involving the drugs approved, only 43% (394) of the safety studies were published in scientific journals.

The researchers found evidence of “publication bias”. That is, the articles that did get published tended to be the ones that showed the most significant results for the drug being tested. Articles that didn’t get published were the ones that showed non-significant results, such as those that used a larger sample size of test subjects which gives more accurate results.

According to the report, “publication bias harms the public good by impairing the ability of clinicians and patients to make informed clinical decisions, and the ability of scientists to design safer and more efficient trials based on past findings. Publication bias can thus be considered a form of scientific misconduct.”

Sir Iain Chalmers, founder of the Cochrane Collaboration (an independent organization that reviews medical evidence) in Oxford, UK says it is vital that all research on new medicines be made public.

“The people who participate in a trial have a right to expect that their participation and their data will be made available publicly so that people can take whatever decisions seem appropriate in the light of that information.”