Pharmaceutical Research and Manufacturers of America To Issue Clinical Trial Publication Guidelines
The Pharmaceutical Research and Manufacturers of America is expected this week to post on its Web site new standards on the disclosure of clinical drug trials, a move that would represent the "most specific response by the drug industry" to allegations that it downplays unfavorable trial results, the Wall Street Journal reports (Hensley, Wall Street Journal, 6/30). There have been several calls in recent weeks for the disclosure of all clinical trial results. The American Medical Association in mid-June approved a resolution requesting that the federal government establish a database that would allow more information about the drugs tested in clinical trials and would necessitate the publication of both positive and negative results. In addition, the International Committee of Medical Journal Editors, which includes 12 major medical publications, including the New England Journal of Medicine and the Journal of the American Medical Association, has begun to draft a proposal that would require registration of all clinical trial results in a public database or registry as a condition for publication consideration (California Healthline, 6/25). Meanwhile, New York Attorney General Eliot Spitzer (D) recently filed suit against GlaxoSmithKline over allegations that the company since 1998 has withheld negative clinical trial results about the side effects of the antidepressant Paxil in children (California Healthline, 6/21).
Pharmaceutical companies currently must submit all clinical trial results to FDA, but the agency cannot disclose all of the information, which is considered proprietary. FDA officials in most cases must obtain consent from pharmaceutical companies before they can make clinical trial results public (California Healthline, 6/25). According to the Journal, PhRMA's new guidelines call on drug manufacturers to publicize on the Internet, in journals or at scientific meetings all positive and negative results of trials that:
- Test drugs that are currently on the market or "destined for market";
- Test a medical hypothesis, such as whether a drug is superior to a placebo;
- Are phase III trials;
- Allow conclusions to be drawn that support product claims; and
- Began after October 1, 2002.
Mark Barnes, an attorney specializing in clinical research issues, said, "This guidance is much more specific and affirmative on the publication of clinically meaningful study results than anything the trade association has set forth before." Peter Corr, senior vice president for science and technology at Pfizer and a contributor to the PhRMA guidelines, said, "I can't imagine a company would sign on to these policies and not do it." He added, "We're not going to sit on something because it's a negative trial." According to the Journal, "the honor system would prevail" under the guidelines, which could raise criticism from proponents of full disclosure (Wall Street Journal, 6/30).
"[I]t would be better, in principle, for more information about drugs to be available to the public in general and to doctors in particular," a Washington Post editorial states. However, compelling drug manufacturers to publish the complete results of trials could "backfire and wind up discouraging companies from conducting any trials at all." The Post continues, "Congress -- not the New York courts -- needs to take up this issue again and look at incentives that might persuade companies to conduct more and better clinical trials, even if they aren't commercially advantageous," adding, "It should also consider establishing a routine, nationwide system of comparative drug testing, using university and other academic researchers" (Washington Post, 6/30).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.