GlaxoSmithKline Agrees To Settle Paxil Lawsuit, Post Clinical Trial Results in Online Registry

Officials for GlaxoSmithKline on Thursday agreed to settle a lawsuit filed by New York Attorney General Eliot Spitzer (D) that will require the company to post all clinical trial results by the end of 2005 and pay $2.5 million to the state of New York, the Washington Post reports. The settlement places GSK "at the forefront of a burgeoning debate about whether pharmaceutical manufacturers should be required to tell doctors and the public when new research shows their drugs in a negative light," according to the Post (Masters, Washington Post, 8/27).

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. The lawsuit alleges that 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 said 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 (California Healthline, 6/3).

A spokesperson for Spitzer said that 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 (Martinez, Wall Street Journal, 8/27).

The settlement also requires GSK to add summaries of the results of new clinical trials to the registry within 10 months of their completion (Washington Post, 8/27).

Spitzer said, "This settlement is transformational in that it will provide doctors and patients access to the clinical testing data necessary to make informed judgments" (Harris, New York Times, 8/27). He added, "This is what we were looking for when we announced the case. We hope this represents a sea change in the way pharmaceutical companies handle marketing. Doctors will not now have to rely on what the pharmaceutical representatives say about the studies of the drugs. If the other companies follow this model, something dramatic will have changed" (Washington Post, 8/27). However, he added, "Nobody should believe that we think this is a panacea and that there will be perfect understanding of testing and clinical variables" (New York Times, 8/27).

David Fassler, a University of Vermont psychiatry professor who supports the establishment of a national registry of clinical trial results, said, "This is a positive development. I expect other pharmaceutical companies will pay close attention. But ultimately, it's important to have a national registry, not separate listings by different companies. Doctors need a place that has all of this information" (Silverman, Newark Star-Ledger, 8/27).

GSK officials denied the allegations in the lawsuit, saying that the company agreed to settle the case to avoid the expense of further litigation, the San Francisco Chronicle reports (Tansey, San Francisco Chronicle, 8/27). GSK officials said in the settlement, "Although GSK believes the charges made in the litigation by the attorney general are unfounded, the company has agreed to pay the state of New York $2.5 million to avoid the high costs and time required to defend itself in protracted litigation" (Wall Street Journal, 8/27).

GSK spokesperson Nancy Pekarek added that the company had begun to develop a registry of clinical trial results months before Spitzer filed the lawsuit. Mark Werner, chief attorney for GSK in the United States, said in a statement, "We are pleased that the attorney general believes the clinical trial register we have been developing will provide useful information to the medical and scientific community" (Washington Post, 8/27). ABC's "World News Tonight" on Thursday reported on the settlement. The segment includes comments from Dr. Alastair Benbow, head of European clinical psychiatry for GSK, and Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen (McKenzie, "World News Tonight," ABC, 8/26). An excerpt of the segment is available online.