Merck Supports National Database of Clinical Trials
Drug maker Merck supports the creation of a government-run clinical trial database, indicating the "first major sign of pharmaceutical industry support" for such an inclusive database, the New York Times reports (Meier, New York Times, 6/18). On June 15, members of the American Medical Association at the group's annual meeting unanimously approved a resolution urging HHS to create a national database for all clinical trials and their outcomes. The resolution aims to provide doctors and consumers with additional information about prescription drugs, including possible side effects not mentioned in public literature, and to disclose all trial results, including those with a negative outcome. The International Committee of Medical Journal Editors, which includes 12 major medical publications such as the New England Journal of Medicine and the Journal of the American Medical Association, also is working on a proposal expected to be completed this summer or fall. The proposal would require registration of all clinical trials in a public database or registry as a condition for publication consideration.
The recent drive to publicize clinical trial data comes as a lawsuit filed this month by New York Attorney General Eliot Spitzer (D) alleges drug maker GlaxoSmithKline since 1998 withheld negative trial information about antidepressant Paxil's side effects in children and adolescents, and misinformed sales staff about its effectiveness. GSK this week posted on its Web site the previously unreleased trial results. Currently, drug companies must submit all clinical trial results to FDA, but the agency is prohibited from disclosing all the information it receives because it could be considered proprietary. Officials also must receive the drug maker's consent before making results public. In some rare instances, FDA officials can publicize information if they deem it necessary for the public to know (California Healthline, 6/16).
In addition to supporting the database, Merck spokesperson Janet Skidmore also suggested that an existing registry, ClinicalTrials.gov, which is maintained by NIH and the National Library of Medicine, could serve as the comprehensive listing if it were expanded to include clinical drug trials conducted by private companies and academic institutions. She also said that the registry could be modified to include Phase three trials -- the late-stage trials of a drug that are conducted before it receives regulatory approval -- and Phase four trials, which are conducted after FDA has approved a medication. Skidmore noted that Merck already releases the results of all the important trials the company has conducted, regardless of the outcome, in the company's publication, medical journals or other means such as abstracts or summaries presented at industry meetings, the Times reports.
According to the Times, many drug manufacturers "appear to have been caught off guard" by the recent AMA decision and journal editors' proposal. Pharmaceutical Research and Manufacturers Association of America Vice President Dr. Alan Goldhammer said that the organization has not seen a proposal for a specific registry but indicated that PhRMA did have some concerns that proprietary company information could be disclosed to competitors, the Times reports. He also said that any proposal should apply to anyone who conducted pharmaceutical research, not just drug makers, and added that listing clinical trial data without contextualizing it could be of little value to doctors, according to the Times. Goldhammer said, "For a practicing physician who is not a clinical researcher, this may be far too complicated." Representatives from Pfizer and GSK said that they were not prepared to take a position on the issue. Pfizer spokesperson Mariann Caprino said, "There is no proposal for us to react to." She added, "The devil is in the details." NLM Biomedical Communications Director Dr. Alexa McCray said that she supported expanding ClinicalTrials.gov to serve as a comprehensive database but also cited concerns about the quality of the data that would be included in the registry. McCray said that disclosing previously nonpublished information would be helpful to both the professionals and the public. "We would dearly love to have the maximum information" she said, adding, "if we could balance it with quality" (New York Times, 6/18).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.