The first research to track every prescription drug approved by U.S. regulators over several years concluded that many studies finding the medicines ineffective were not published in medical journals. To win approval from the Food and Drug Administration, companies must submit at least two studies demonstrating a drug is safe and effective, even if other clinical trials find it is not. The researchers tracked all studies submitted to the FDA by drug companies seeking approval for new treatments from 1998 to 2000. By 2005, five years after the last FDA approvals of the drugs, most of the studies finding the drugs ineffective hadn't been published in journals. Other trials finding them effective were much more likely to be published. The analysis was published today in the Public Library of Science journal, PLoS Medicine.
Some critics have said drug companies selectively publish results that show a drug works and fail to publish those suggesting it doesn't. Concern that publication bias -- the tendency for positive studies to be more frequently published than negative ones -- may mislead consumers -- led Congress last year to mandate the creation of a registry of clinical trials. Under that legislation, drug companies must submit the results of all trials they conduct for posting on a government Web site that lists trials and results.
Steve - when transparency is demanded, the truth comes out.