GlaxoSmithKline To Begin Posting Clinical Trial Results Online Today
GlaxoSmithKline on Wednesday plans to begin posting online the results of 65 clinical trials of the diabetes medication Avandia, the first part of a plan to post all company trial results online by the end of 2005, the New York Times reports (Meier, New York Times, 9/1). GSK officials last week agreed to a settlement in a lawsuit filed by New York Attorney General Eliot Spitzer (D) that requires the company to post all clinical trial results online and pay $2.5 million to the state of New York. Spitzer in June filed suit in New York State Supreme Court over allegations that GSK withheld negative clinical trial results related to the antidepressant Paxil. According to the lawsuit, GSK withheld data from clinical trials that indicated Paxil is no more effective in adolescents and children than a placebo and in some cases is more likely than a placebo to cause suicidal thoughts. The lawsuit involves five clinical trials that GSK sponsored to qualify for a six-month extension of a patent on Paxil awarded under a federal law enacted to encourage pharmaceutical companies to test their products in children. The lawsuit also cites a 1998 internal memo that stated GSK seeks to "effectively manage the dissemination of these data in order to minimize any potential negative commercial impact." The memo allegedly recommended that GSK publish a complete article on only one clinical trial of Paxil with favorable results. The article later appeared in the Journal of the American Academy of Child and Adolescent Psychiatry.
Settlement Details
Under the settlement, GSK agreed to establish an online registry with summaries of results for all clinical trials conducted after Dec. 27, 2000. The summaries will include more than 20 categories of information, such as the effectiveness and side effects of medications, the original intent of the clinical trials and whether the trials ended early. The settlement also requires GSK to add summaries of the results of new clinical trials to the registry within 10 months of their completion (Kaiser Daily Health Policy Report, 8/27). The registry also will include the results of earlier clinical trials that GSK considers medically significant, according to Ronald Krall, GSK senior vice president for worldwide development. According to Krall, the assembly of clinical trials results for Avandia took one month and 30 employees to complete. Krall said that GSK in the next few months will post online clinical trial results for Avodart, a treatment for benign prostatic hyperplasia; Advair Diskus, an asthma medication; and Valtrex, a herpes treatment.
New Trend?
The move by GSK to post online all clinical trial results "is another step by drug producers to get out ahead in disclosing data from clinical trials after ignoring the issue for years," according to the Times. Eli Lilly recently announced plans to establish a similar online registry of clinical trial results. In addition, the American Medical Association has called for a national registry of clinical trial results, and several medical journals have said they could make registration of trials a prerequisite to publication of articles on the results. According to Krall, GSK had concerns that an online registry of clinical trial results could affect the ability of researchers to have their articles on the results published in medical journals. However, Krall said that based on recent discussions with the editors of two medical journals, such a registry would not affect the publication of articles discussing and interpreting clinical trial results. Krall said, "If we don't confound the two, then I think we are in safe territory" (New York Times, 9/1).
