PRESSURE MOUNTS TO MAKE ALL CLINICAL DRUG TRIALS PUBLIC

In what appears to be an effort to keep the pharmaceutical industry on the high road and to protect the public, the American Medical Association on June 15, 2004  approved a policy recommending that the Department of Health and Human Services develop a public registry of the results of all clinical trials. 

The AMA’s policy carries with it a firm and potentially quite effective recommendation: that the Institutional Review Boards that have the responsibility of monitoring the participants of drug trials require the registration of all clinical trials in a publicly accessible database. 

Since drug companies, at least in the United States , consider unpublished clinical trials to be proprietary information, they do not permit the release of such studies by the FDA or, for that matter, anyone else.  Unfortunately, these studies may often include information about the safety and effectiveness of prescribed medications that is important for the public to know, but at present there is no way for members of the public generally to access this information.

The AMA’s move may not succeed, however, because of potential resistance by the drug industry.  Major medical publications, such as the Journal of the American Medical Association (JAMA) and the New England Journal of Medicine have urged that unpublished clinical trials be made public for some time, without success.

Following the AMA's announcement and perhaps in response to the recent furor over GlaxoSmithKline's drug Paxil, the Pharmaceutical Research and Manufacturers of America, an industry group known by the acronym PhRMA, responded with a "guidance" of its own concerning publication of clinical trials.  In this Guidance PhRMA suggests that all late-stage or Phase III trials be published.  However, the Guidance, which is not mandatory, only applies to studies conducted after October of 2002 and will not cover early clinical trials, which may still be considered company "trade secrets".

In early August of 2004, Indianapolis based Eli Lilly and Co. became the first major pharmaceutical company to announce plans to disclose data from all early to late stage clinical trials of Lilly drugs that have been approved for use by the FDA.  The plan is expected to be in place by the end of 2004.