Under the provisions of the Food, Drug and Cosmetic Act, a company in its application to the FDA must specify each intended use of a drug. After the FDA approves the product as safe and effective for a specified use, a company’s promotional activities must be limited to the intended uses that FDA approved. In fact, promotion by the manufacturer for other uses – known as “off-label uses” – renders the product “misbranded.”
Paxil: In the criminal information, the government alleges that, from April 1998 to August 2003, GSK unlawfully promoted Paxil for treating depression in patients under age 18, even though the FDA has never approved it for pediatric use. The United States alleges that, among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, the United States alleges, GSK did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18. The United States further alleges that GSK sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents. GSK paid a speaker to talk to an audience of doctors and paid for the meal or spa treatment for the doctors who attended. Since 2004, Paxil, like other antidepressants, included on its label a “black box warning” stating that antidepressants may increase the risk of suicidal thinking and behavior in short-term studies in patients under age 18. GSK agreed to plead guilty to misbranding Paxil in that its labeling was false and misleading regarding the use of Paxil for patients under 18…
I will admit that my capacity to read legal documents is primitive and without much experience, but my reading of these document finds them unambiguous and clear. So, now we read this:
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Journal Article Didn’t Mislead, Drug Company Asserts
Chronicle of Higher Education October 1, 2012 [full text available on-line] |
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To the Editor:
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As counsel for GlaxoSmithKline LLC in its recently concluded settlement with the United States government, I write to correct some significant factual inaccuracies in "Academic Researchers Escape Scrutiny in Glaxo Fraud Settlement" [The Chronicle, August 6]. The piece focuses on a peer-reviewed journal article published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry reporting the results of a clinical trial sponsored by GlaxoSmithKline [Study 329] of Paxil® [paroxetine hydrochloride] for the treatment of major depressive disorder in adolescents [the article was "Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial," by M.B. Keller et al., in the July 2001 issue]. Unfortunately, your piece incorrectly states that, as part of its government settlement, GlaxoSmithKline admitted that the journal article "was part of the fraud" and "constituted scientific fraud." In fact, GlaxoSmithKline made no such admission and vigorously disputes that the journal article was false, misleading, or fraudulent.
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As part of its settlement with the government, GlaxoSmithKline pleaded guilty to a misdemeanor violation of federal law related to the marketing of Paxil for use by patients under 18, an unapproved, "off label" use for Paxil. While the law permits physicians to prescribe medications for such off-label uses, manufacturers are not permitted to market them for such purposes. The charging document filed by the United States, known as an information, contains many allegations that are either inaccurate or incomplete, that tell only part of the story, and that draw unwarranted conclusions from disputed facts. Throughout the investigation, the settlement process, and the guilty-plea proceeding, GlaxoSmithKline made clear to the government and to the court that it did not agree with all of the factual allegations made in the information. In particular, GlaxoSmithKline has consistently denied and disputed the allegations that the journal article was false or misleading. Nothing in the settlement or the guilty plea has changed GlaxoSmithKline’s position on the journal article. Most important, GlaxoSmithKline did not admit and has not admitted that the journal article was part of any fraud or that it was false or misleading.
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Your piece also incorrectly states that the journal article "was actually written by Glaxo-hired authors to overstate the benefits and understate the risks of a highly profitable Glaxo drug." While GlaxoSmithKline did hire a medical writer to provide editorial assistance to the clinical investigators, a fact that the journal article itself acknowledged, control over the contents of the manuscript remained at all times with the clinical-investigator authors who provided substantial comments on and input into the manuscript. GlaxoSmithKline believed then and continues to believe that the journal article reflects the honestly held views of the clinical-investigator authors.
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Thomas H. Lee II
Philadelphia |
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Editor’s note: The federal "criminal information" document in the Paxil case repeatedly describes the journal article as "false and misleading." It also notes that GlaxoSmithKline distributed the article to its marketing department and its sales representatives, who used it to promote the use of the drug for children and adolescents. In addition, the criminal information says that a contractor hired by GlaxoSmithKline wrote the first draft of the article and incorporated changes made in the article by researchers and another GlaxoSmithKline employee. The plea agreement between GlaxoSmithKline and the U.S. Department of Justice states that GlaxoSmithKline "expressly and unequivocally admits that it committed the crimes charged in the information, and is in fact guilty of those offenses."
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Mr. Lee appears to be talking about the DOJ Complaint [here] from a year ago, and not Exhibit A, which is what they agreed to.
I freely admitted already the absence of a legal mind, but there is one thing I’ve gleaned in my years. For lawyers, there are two realities. The first is what actually happened [the truth we call it in everyday parlance]. Then there’s a second more important reality which is something like those things proven in a courtroom and certified by a Judge or Jury [whether they’re true or not]. But Mr. Lee is talking about a third reality that actually makes little sense. And since he’s an unlikely guy to be reading the Chronicle of Higher Education for pleasure, his letter must’ve been written for someone else for some legal reason.
One obvious possibility is that GSK is trying to avoid the shame of being fraudsters which is pretty silly – like some legalistic letter in this very esoteric journal would convince anyone. These readers are smart people. But if you read the plea agreement documents, there are a number of places where it says that the agreement absolves no person from future prosecution. So a more likely motive is to protect the GSK people, the authors, and the ghostwriter from prosecution. And since the article Mr. Lee chose to respond to was this one among the many he could’ve gone after, and he copied the editor of the Journal of the American Academy of Child and Adolescent Psychiatry, Dr. Andrés Martin, I would suspect he is protecting the editor that approved the article, Dr. Mina Dulcan, and the twenty-two academic authors – the Academics [something of an honor among thieves act]. If GSK admits to fraud, it implicates the editor, the real author, and guest authors.
“So a more likely motive is to protect the GSK people, the authors, and the ghostwriter from prosecution.”
Bingo!
What role did the US Attorney General Eric Holder play in all of this?
Great blog, Mickey. I’m so happy you’re on top of these developments and continuing to report on them. Bravo!