GlaxoSmithKline To Post All Clinical Trial Results for Certain Products on Web Site
Officials for GlaxoSmithKline on Friday announced that the company would create a Web site to publicly list results of all clinical trials for its marketed prescription drugs, the New York Times reports (Meier, New York Times, 6/19). The announcement comes "amid mounting pressure" on GSK and other pharmaceutical companies to disclose the results of all clinical trials, the AP/Washington Times reports (Agovino, AP/Washington Times, 6/18). Earlier this month, New York Attorney General Eliot Spitzer (D) filed a lawsuit alleging that GSK since 1998 withheld negative trial information about antidepressant Paxil's side effects in children and adolescents, and misinformed sales staff about its effectiveness. GSK last week posted on its Web site the previously unreleased Paxil trial results. 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 more information about the drugs, including possible side effects not mentioned in public literature and to disclose all trial results, including negative ones. 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 anticipated 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. Currently, drug companies must submit all clinical trial results to FDA, but the agency is prohibited from disclosing all the information because it is considered proprietary. Officials 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).
GSK officials said that the Web site would include clinical trial results for medications approved since 2000. The Web site would include the results of all clinical trials of a medication before its approval for marketing as well as any subsequent tests of the medication for new uses or on new types of patients, the Times reports. The information would not be listed until after the medication was approved or after the subsequent tests were completed. (New York Times, 6/19). GSK officials did not say exactly when the Web site would be operational but added that it should not take more than six months, according to the AP/Washington Times. GSK Chair and CEO Jean-Pierre Garnier said that the new Web site was not a reaction to Spitzer's lawsuit but to the AMA resolution. Garnier said that he hoped the Web site would convince Spitzer to drop the suit, the AP/Washington Times reports. "We think more transparency is better," Garnier said, adding, "We don't want to be accused of anything about the way we deal with trials." However, Garnier said that the Web site and any future public registry of clinical trials could present a problem for doctors and patients because "[s]ome studies need to be seen in the entire context of all the research. There is always a risk of junk science through isolating just one trial" (AP/Washington Times, 6/18). Dr. Alastair Benbow, medical director for GSK, said that the current media attention on drug clinical trial disclosures played a role in deciding to launch the Web site because the media focus could "reduce public confidence in medical research and the pharmaceutical industry."
In a statement issued on Saturday, Spitzer said, "The availability of this information is in the best interest of the consumer" (New York Times, 6/19). According to the AP/Washington Times, doctors were "largely unimpressed" with the GSK announcement because they say that one central place is needed to gather information rather than "having to scour multiple sites." In addition, doctors criticized the decision by GSK not to disclose when a clinical trial has begun because the company would not "have to account for what happened in the study if the results are negative," the AP/Washington Times reports (AP/Washington 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.