Clinical Trials May Come Out of Hiding

Staff Writer

Five trade groups representing pharmaceutical companies worldwide are urging their members to release more information about the clinical trials they conduct. The trade groups' proposal, announced on 6 January, comes as politicians are considering compelling the release of such information. The Pharmaceutical Research and Manufacturers of America (PhRMA), a Washington, D.C., based trade group, said it is merely advising prudence: Congress should wait "to see if the voluntary efforts are going to work" before acting, says Jeff Trewitt, a PhRMA spokesperson.

Drug companies have been under pressure to release more clinical trial data since revelations that they kept information from antidepressant and other drug trials secret. In the past, voluntary registries have included only a fraction of trials. And despite requirements that the companies post all trials for serious or life-threatening diseases on a government website (clinicaltrials.gov), a 2003 study of industry-sponsored U.S. cancer trials found that fewer than half of such trials appeared there.

Several members of Congress introduced bills last year calling for a mandatory clinical trials registry, with penalties for noncompliance (ScienceNOW, 10 September 2004). The co-sponsor of one such bill, Representative Henry Waxman (D-CA), said last week that "nothing" in the industry's announcements "is going to dissuade me" from pursuing legislation.

Among the new voluntary efforts by pharmaceutical companies to post clinical trial data, the Association of the British Pharmaceutical Industry, one of the trade groups behind last week's proposal, will recommend that its members post trial results on a World Health Organization (WHO) global trials database that WHO hopes to establish in July. In addition, the new PhRMA plan recommends adding trials for all ailments to clinicaltrials.gov, regardless of severity. Other groups behind the effort include the European Federation of Pharmaceutical Industries and Associations (EFPIA), the International Federation of Pharmaceutical Manufacturers' Associations (IFPMA), and the Japanese Pharmaceutical Manufacturers' Association (JPMA).

Critics like Drummond Rennie, deputy editor of the Journal of the American Medical Association, aren't optimistic. Says Rennie, "Marketing forces and self-interest ... are going to win out every time over the ethics of doing the right thing."

Related sites
PhRMA announcement of clinical trials policy
National Institutes of Health-funded clinical trials registry
Statement from medical journals on clinical trials disclosure

Posted in Policy