A clinical trials registry, once more with (at least a little?) feeling

February 1, 2005

A sense of déjà vu is unavoidable: Last summer, in an attempt to come out from under allegations that it conceals unfavorable results in clinical trials of drugs, a good part of the pharmaceutical industry announced a program to voluntarily post notice of clinical trials on their public Web sites (see Updates, September 2004 ). Months have passed but not much of significance has turned up. According to an analysis in the

A sense of déjà vu is unavoidable: Last summer, in an attempt to come out from under allegations that it conceals unfavorable results in clinical trials of drugs, a good part of the pharmaceutical industry announced a program to voluntarily post notice of clinical trials on their public Web sites (see Updates, September 2004 ). Months have passed but not much of significance has turned up. According to an analysis in the Boston Globe in January, only five of 26 clinical trials publicly posted by the Pharmaceutical Research and Manufacturers of America (PhRMA) contain previously unpublished data. Drummond Rennie, MD, associate editor of the Journal of the American Medical Association (JAMA), called industry efforts "pathetic," adding: "They get all the publicity from saying they will do it, and then they don't."

Last month, PhRMA, in conjunction with three industry trade groups in Europe and Japan, again announced a voluntary plan to provide results of clinical trials on a public Web site. Beginning in July, data will be posted when a trial begins and again within one year of FDA approval of the drug or the end of the trial. There are conditions: Data from phase-1 safety trials or data that would reveal competitive information are excluded. Critics remain skeptical. Catherine D. DeAngelis, MD, MPH, editor in chief of JAMA, called fears of competitive disadvantage "hogwash." Congressman Ed Markey (D, Mass.), a sponsor of legislation for a mandatory registry, called the proposal a way for the drug industry to "continue its game of hide and seek."

While all this was going on, the British Medical Journal accused Eli Lilly & Co. of concealing documents that demonstrate a link between the antidepressant fluoxetine and a heightened risk of suicide. Lilly denies the allegation. And so big pharma's troubles go on (see Updates, January 2005, http://www.contemporarypediatrics.com/contpeds/article/articleDetail.jsp?id=143417).