New York Attorney General Files Suit Against GlaxoSmithKline for Alleged Concealment of Information on Paxil
In a "novel claim testing the way that the $400 billion worldwide pharmaceutical industry is regulated," New York State Attorney General Eliot Spitzer (D) on Wednesday filed suit in New York State Supreme Court accusing GlaxoSmithKline of "fraud in concealing negative information" concerning its antidepressant Paxil, the New York Times reports (Harris, New York Times, 6/3). The lawsuit alleges that GSK concealed data from trials that showed that Paxil was no more effective in adolescents and children than a placebo, and in some cases could be more likely to cause suicidal thoughts. The lawsuit is the first to contend that the suppression of negative trial results is illegal, the Wall Street Journal reports (Martinez, Wall Street Journal, 6/3). Spitzer said in a statement Wednesday, "By concealing critically important scientific studies on Paxil, GSK impaired doctors' ability to make appropriate prescribing decisions for their patients and may have jeopardized their health and safety" (Silverman, Newark Star-Ledger, 6/3). Spitzer contends that although the company conducted at least five Paxil clinical trials, it published only one "that held out hope that the drug might combat depression in children," USA Today reports. The lawsuit alleges that GSK still marketed the drug to doctors and claimed that Paxil had "remarkable efficacy and safety in the treatment of adolescent depression" (Fackelmann, USA Today, 6/3). Spitzer said in an interview Wednesday, "The manufacturer cannot rely exclusively on the positive study. ... Where they affirmatively state this drug is 'remarkably' efficacious and safe, and they are withholding information that challenges that, that's wrong" (Masters, Washington Post, 6/3).
The lawsuit cites New York Executive Law 63, which allows the attorney general to gather restitution and damages from companies that make "any deception, misrepresentation, concealment or suppression" of data. According to the Journal, Spitzer's use of consumer-protection laws "against a major drug company for not disclosing clinical research that could be interpreted in various ways is a novel approach" (Wall Street Journal, 6/3). Spitzer's argument is that "[i]f a company's marketing message is at odds with the results of its own suppressed clinical trial, ... the company is liable for damages under consumer fraud laws," the Times reports (New York Times, 6/3). The Baltimore Sun reports that some observers say the case "could effectively force companies to make public scientific data the government now allows them to withhold as trade secrets" (Bell/Niedowski, Baltimore Sun, 6/3). Spitzer said that similar cases against other drug companies are likely, adding, "This is an area that we're interested in and I think there are other cases out there that are analogous" (New York Times, 6/3). The lawsuit seeks the return of all GSK profits obtained from the sale of Paxil to adolescents in New York (Agovino, AP/Anchorage Daily News, 6/2).
The lawsuit cites five studies that GSK sponsored to qualify for a six-month extension of Paxil's patent granted by a federal law that encourages testing of drugs in children. The studies looked into Paxil's effect on adolescents with major depression (New York Times, 6/3). Two of the studies showed that Paxil was not more effective than a placebo for treating children and adolescents with depression, the suit states. According to the suit, in one trial, the placebo outperformed Paxil on a primary efficacy test. The suit says that three of the studies revealed that "certain possibly suicide-related behaviors" were about two times more likely among children who were given Paxil than those given a placebo, the Journal reports. The suit contends that in one unpublished study, 7.7% of the youth given Paxil demonstrated behavior that included "suicidal thinking and acts," compared with 3% of the placebo group (Wall Street Journal, 6/3). The suit cites a 1998 internal memo that said the company's "target" was to "effectively manage the dissemination of these data in order to minimize any potential negative commercial impact" (Washington Post, 6/3). According to the Journal, the document "recommended that Glaxo publish a full article only on the one study out of the five that had some favorable conclusions." That study, whose authors included two GSK employees, appeared in the Journal of the American Academy of Child and Adolescent Psychiatry soon after the memo was written, according to the suit.
The suit also contends that GSK gave sales representatives "a positive picture" of the drug's use in adolescents, the Journal reports. A member of Paxil's product management group allegedly sent a memo saying, "Paxil demonstrates remarkable efficacy and safety in the treatment of adolescent depression." According to the Journal, although the memo stated that its information was only intended for sales representatives, the lawsuit contends that "sending that message to physicians through GSK's spokespeople was [the company's] intent" (Wall Street Journal, 6/3).
According to the Times, "Spitzer is entering regulatory terrain that has been largely the preserve of the federal government," specifically FDA (New York Times, 6/3). In March, FDA issued a public health advisory that called for new warning labels on antidepressants and improved efforts to monitor patients who take such medications. The advisory asked several companies that manufacture 10 different antidepressants, including Paxil, to revise the labels of the products to include detailed warnings about the potential risk of suicidal tendencies in patients who take the medications. In addition, the label would ask physicians to monitor for worrisome behavior changes -- such as agitation, anxiety, irritability and recklessness -- among patients recently prescribed the antidepressants. However, FDA officials said that studies have not established a link between suicidal tendencies and such antidepressants, adding that the agency would continue to study the issue. An FDA advisory committee in February concluded that the agency should issue warnings about a potential link between selective serotonin reuptake inhibitors and suicidal tendencies in children and teenagers. Although Prozac, manufactured by Eli Lilly, is the only SSRI approved by FDA to treat depression in children, many physicians prescribe to children other SSRIs only approved to treat depression in adults (California Healthline, 3/23). The Post reports that Spitzer said that off-label uses are "in a gray area and that he is just trying to make sure that doctors have the information they need" (Washington Post, 6/3). According to the Times, he said that FDA has been "hamstrung by court rulings that have used free-speech arguments to limit the agency's power to regulate what drug companies can say to doctors" and that "[s]uch rulings do not limit his powers" (New York Times, 6/3). Spitzer said, "The last thing I should be doing is making clinical decisions," adding, "We don't want to discourage off-label uses, we just want more complete information" (Washington Post, 6/3). An FDA spokesperson declined comment on the trial but said that the FDA requires companies to submit all data that is related to a drug's safety (New York Times, 6/3).
GSK said in a written statement Wednesday that the company "has acted responsibly in conducting clinical studies in pediatric patients and disseminating data from these studies. All pediatric studies have been made available to the FDA and regulatory agencies worldwide. We have publicly communicated data from all pediatric studies" (Washington Post, 6/3). GSK spokesperson Mary Ann Rhyne said that the company had released data concerning all of its trials at public meetings, in medical journals and to regulatory agencies (Clarke, Reuters/Houston Chronicle, 6/2). Rhyne added that FDA has not approved Paxil for use in children and that GSK never promoted it for such use (Wall Street Journal, 6/3). The company said in the statement that the cited 1998 memo "is inconsistent with the facts and does not reflect the company position" (New York Times, 6/3).
According to the USA Today, "[e]xperts hope that such lawsuits will discourage drug firms from hiding negative scientific findings that might affect drug sales" (USA Today, 6/3). Barry Perlman, president of the New York State Psychiatric Association, said, "Any unnecessary restriction or limitation on physicians' access to relevant clinical data raises the possibility that patients will not receive proper treatment or, worse, that patients may be harmed" (Newark Star-Ledger, 6/3). Wayne Goodman, a University of Florida psychiatry professor who was on the FDA advisory panel that reviewed studies on antidepressant use in children, said, "A lot of these negative studies do get buried, and it's intentional. That's not a particular concern in the early stages (of testing) and hasn't been approved. But, this is in use." The Post reports that outside legal observers said Spitzer appears to be on "solid legal ground by bringing his case under the state's law against consumer fraud" (Washington Post, 6/3). Frank Palumbo, a lawyer and a pharmacist who is executive director of the University of Maryland Center on Drugs and Public Policy, said, "If they're successful here, they're going to be carving out some new law. And it's law that's going to be troublesome to the pharmaceutical industry." Palumbo added that if the suit influences companies to more broadly release clinical data, physicians might receive more complex information that could be difficult to interpret, the Sun reports. Court Rosen, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said that issue of releasing negative data "is being looked at within the industry and within PhRMA" (Baltimore Sun, 6/3).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.