The US Department Of Justice Legal Complaint Against GSK (2012)


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http://www.quitam-lawyer.com/sites/quitam-lawyer.com/files/02.03.12%20-%20GSK%20–%207th%20Amended%20Complaint.pdf (GSK Dept of Justice Complaint)

Regular readers, and those interested in GSK, would likely be aware of the record breaking 3 Billion dollar fine which GSK had to pay the US justice department in 2012. The US justice department complaint which this fine is based on is absolutely huge, and the sheer scale of the abuses of ethics and morals which GSK were engaged in for many years is simply astounding. The full complaint can be viewed here, and at 243 pages, it’s quite a read, and I’m sure most readers won’t fail to be utterly appalled at the litany of charges contained within it.

However, according to some comments by an apparent whistleblower on my blog recently, this complaint should have been much wider in its scope, and should have been at least twice (or more) in its length of charges against GSK. It would be interesting to know why the department of Justice didn’t just go the whole hog and fine GSK on all the information which they had in their possession, why was the complaint supposedly much smaller than it should have been?

This blog is primarily about Paxil (Seroxat) because that is the drug which I was prescribed and it’s the drug that damaged me, therefore I find the information about Seroxat the most interesting, however, I also find it puzzling that the Paxil part of the complaint seems quite meager considering Seroxat/Paxil was one of Glaxo’s most notorious, particularly in the sense of the scandals, cover ups and controversy surrounding it.

Is there more about Paxil which should be in there? is there more about other drugs? or other fraudulent or unethical behavior? If so, where is that information? and how do we get access to it?

If anyone has any information regarding this, contact me on the e-mail provided.

truthman30@gmail.com

Thanks

paxil3p2P3



GSK1 GSK2 GSK3 GSK4 GSK5 GSK6 GSK7 GSK8 GSK9 GSK10 GSK11 GSK12

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3 comments

  1. kiwi

    Taken from Whittakers book ‘Under the Influence’ pg 96-101. Here is how GSK went on a Turkey shoot when it came to putting nonsense past the FDA time and time again in getting paxil approved for four conditions. Starting with MDD. [insert mine]

    In November 1993 – a year after the FDA approved Paxil for depression – SmithKline convened a meeting of its advisory board in Palm Beach, Florida. The planning document for the meeting identified 10 advisory board members (out of 20), three of whom were currently serving on the DSM-IV task force: James Ballinger, David Dunner, and Robert Hirschfield. The board members were flown first class to Palm Beach, where they stayed at the Ritz Carlton hotel, and each was paid $2500-$5000 for attending the weekend meeting. The advisory board was chaired by Charles Nemeroff, head of the psychiatry department at Emory University. According to the planning document, the advisory board at the Palm Beach meeting was expected to provide “helpful ideas and advice on issues faced by the Paxil marketing team.” Over the course of the two days, the advisory board would discuss the ‘strengths’ and ‘deficits’ of the competitors SSRIs and discuss how to educate primary care physicians so they would prescribe Paxil (instead of Prozac or Zoloft). They would also talk about ways to “generate information for use in promotion” of Paxil and identify “four or five patients subtypes for treatment with Paxil.” This last workshop which was focused on expanding paxil’s market was led by Ballenger, chairman of the psychiatry department at Medical University of South Carolina. At the end of the meeting, the advisory board would make recommendations for “future studies” that were necessary to support this expanded use of Paxil.

    For SmithKline, Ballinger was a good choice to lead a discussion on future studies related to anxiety disorders. He had helped lead Upjohn through trials of alprazolam for panic disorder in the early 1980s, and he had served on the DSM-III and DSM-IV work panels for anxiety disorders. In the wake of the Palm Beach meeting, Ballinger became the head of the paroxetine panic disorder study group for SmithKline Beecham, and in 1996, this group provided the study data that led the FDA to approve Paxil for this disorder. In a 10 week trial involving 278 patients with panic disorder, paroxetine proved “superior to placebo across the majority of outcome measures.” Ballinger and his co-authors concluded that “these data support the use of paroxetine for the short-term treatment of panic disorder and its long-term management.”

    One anxiety disorder down; three more to go.

    Next up on SmithKline’s agenda was social anxiety disorder (SAD).

    This was a disorder described as relatively rare in DSM-III, but that began to change in 1985, when Columbia University psychiatrists Michael Leibowitz and Jack Gorman published a paper on social phobia, calling it a “neglected anxiety disorder.” Two years later, Leibowitz served on a DSM-IIIR work panel that markedly loosened the criteria for diagnosing this disorder. People no longer had to have a “compelling desire to avoid” certain social situations, such as giving a public speech; instead, the diagnosis now only required that the situation caused “marked distress.” Partly as a result of this expanded definition, social anxiety disorder soon turned into one of the most prevalent mental disorders in the United States behind only major depression and alcohol dependence with an annual prevalence of 8%. SmithKline hired Leibowitz, who had been on the DSM-IV task force as a consultant. Leibowitz then helped lead a trial of paroxetine for SAD, reporting that in an 11 week study, the drug treatment produced “substantial and clinically meaningful reductions in symptoms and disability.” Then came the selling of the disease. In 1998, SmithKline paid for a symposium on anxiety disorders at the APA’s annual meeting, where Leibowitz told the audience that “if left untreated, social anxiety disorder is often a chronic disease and usually does not resolve spontaneously.” SSRIs, Leibowitz concluded, should be considered a first-line therapy for SAD. FDA approved Paxil for SAD in 1999.

    As SmithKline develop Paxil as a treatment for PTSD, it turned to Jonathan Davidson, a professor of psychiatry at Duke University, to serve as a primary thought leader. Davidson, like Ballenger, had been one of the six members of the DSM-IV work panel for anxiety disorders. Like many of his colleagues, Davidson served as an advisor, consultant and speaker to a number of pharmaceutical companies including Pfizer and Glaxo SmithKline (SmithKline Beecham Murray with Glaxo Wellcome in 2000). In his presentations at industry funded symposiums and in his articles on PTSD, Davison explained how PTSD was a “major health concern” with a “lifetime prevalence” of around 9%. PTSD he wrote was “poorly recognized” even though it should be “viewed as among the most serious of all psychiatric disorders.” Efficacy of several SSRIs had been demonstrated in clinical trials, he said, concluding in a 2003 paper that “paroxetine is especially well studied in this regard, with demonstrated efficacy in men and women, in both short-term and long-term studies, and in combat veterans and civilians.”

    The FDA approved Paxil as a treatment for PTSD in 2001.

    Glaxo SmithKline relied on both Ballinger and Davison as it marketed Paxil as a treatment for anxiety disorder (GAD). In DSM-IIIR, GAD was said to be “not common”, but by the year 2000 Ballinger and Davidson were promoting a new understanding….. SSRIs and other antidepressants which had proven to be effective in clinical studies, should be the first line therapy for GAD. The group’s consensus statement, with Ballinger listed as first author and Davidson the second author, appeared in the Journal of clinical psychiatry in 2001, the same year that the FDA approved Paxil as a treatment for GAD.

    From the initial advisory board meeting in 1993, it had taken SmithKline eight years to get Paxil approved for the four anxiety disorders.

    Note: Ballinger, Dunner, Hirschfield, Leibowitz, Davidson had all been on a specific DSM-IV workgroup, they had all been at SmithKline’s advisory board meeting in 1993, they had all authored an article for efficacy or safety of Paxil for a specific disorder and they had all been a consultant or adviser to Glaxo SmithKline or on speakers bureaus.

    Note: three of the four – PTSD, social phobia, and general anxiety disorder – had been seen as uncommon or even rare when they were first identified as discrete illnesses in DSM -III but now was seen as common disabling illnesses that often required lifelong treatment. The anxious person who had once turned to a psychiatrist or councelor for talk therapy was now someone with a medical problem that could be successfully treated with an SSRI. That was the story newly told by psychiatry’s thought leaders who were experts in anxiety disorders, and after SmithKline obtained approval for the four diagnoses, the next phase in its marketing plan kicked into action: the flooding of medical journals with ghostwritten papers, and the hiring of academic and community psychiatrists to serve on its speakers bureau.

    In the UK, SmithKline hired a firm called The Medicine Group to ghostwrite papers. In a fax to SmithKline dated January 21, 1999, The Medicine Group detailed its plan to write five “pharmacy review” articles. One of the suggested articles was “Pharmacoeconomics of depression and anxiety disorders”, which identified Jonathan Davidson as one of the proposed authors. For an article titled “Paroxetine – efficacy across the spectrum, the firm identified Columbia University psychiatrists Jack Gorman as a proposed author. The Medicine Group was eager to put pen to paper: “Is it possible for us to make a start on any of these articles?” it asked. A year later, the British firm provided SmithKline with an update on its “Paxil publication plan”, the report detailing the progress of the many articles moving through this ghostwriting process. The report noted whether SmithKline had approved the manuscript, and for manuscripts that had passed that hurdle, it named the psychiatrist that had agreed to serve as authors, and how it was now incorporating all the comments to manuscript. The article on “Paroxetine – efficacy across the spectrum”, had been written but The Medicine Group was still awaiting manuscript approval from SmithKline and as such the company had yet to sign up a psychiatrist to serve as the author for the article.

    In the United States, SmithKline hired Scientific Therapeutics Information (STI) to ghostwrite articles. One of STI’s projects was to write the articles that appeared in a 2003 supplement of the Psychopharmacology bulletin which was titled “Advancing the treatment of mood and anxiety disorders: the first 10 years experience with paroxetine”. STI when it sent medical school psychiatrist Kimberly Yonkers a first draft of the article she was authoring, helpfully noted that STI’s cover page on the manuscript was “to be removed before submission” by Yonkers to the journal. The supplement featured 16 papers on the merits of paroxetine, with Davidson, Sheehan, Nemeroff and other SmithKline thought leaders among the authors. Nemeroff who had chaired the company’s advisory board authored the introduction to the supplement and in it he acknowledged that STI had assisted in preparing the manuscripts.

    When SmithKline merged with Glaxo Wellcome in 2000, the new company – Glaxo SmithKline (GSK) – created a speakers bureau called PsychNet. This program, noted the company manual, recruited key influential psychiatrists and primary care physicians in each region of the country, with the purpose of developing them “into knowledgeable and engaging speakers on Paxil and its effective treatment on mood and anxiety disorders”.

    At weekend training sessions, they were trained on “a total of five (PowerPoint) presentations,” one of which was titled “contemporary issues and anxiety spectrum disorders.” This presentation, a PsychNet document noted, “reviews the prevalence of anxiety spectrum disorders, current treatment options, and the efficacy of Paxil to treat anxiety” the slides told of how 25% of all American adults suffered from an anxiety disorder at some point in their lives.

    The PsychNet faculty was composed of 65 physicians (mostly psychiatrists), each of whom was expected to give 4 to 15 talks per year. Each speaker was paid $1,000 to come to the training weekend, and $2,500 for every community talk. The faculty included a number of well-known academic psychiatrists, including Sheehan (who helped join the faculty, and served on the psych net scientific advisory board), John Zajecka, Michael Hirsch, and Paul Keck. The speakers had to sign a confidentiality agreement, which precluded them from disclosing “information about the PsychNet program, including compensation and content of materials.” The honorarium paid to these “key opinion leaders,” noted one GSK document, “is based on the speaker delivering a promotional Paxil presentation.”

    GSK’s star speaker was Charles Nemeroff. Even though he was chair of the psychiatry department and Emory University, he still managed to give more than 50 talks in 2000. GSK paid him $2,500 and up per talk, and at least $5,000 for attending Paxil advisory board meetings. From 2000 to 2004, GSK paid him $849,413 for his services.

    All of this proved quite profitable for GSK. In 2002, Paxil became the bestselling antidepressant in the world. It was now touted as an anti-anxiolytic drug, and as can be seen in this review, it was the APA and academic psychiatry that enabled this commercial success.

    Prior to DSM-III, anxiety was seen as arising from psychological stresses and those struggling with anxiety often sought out talk therapy. If they took a drug, a benzodiazepine was the minor tranquilizer of choice. But then the APA reconceptualised anxiety as a set of discrete illnesses in 1980, and over the next two decades, American psychiatry converted anxious feelings and behaviours into medical diseases, which was understood to be quite prevalent and best treated with an SSRI.
    Whittaker finishes with this:
    The question of whether this commercial process provided the public with a medical benefit, with the SSRIs and effective treatment for the various anxiety conditions, is difficult to assess.[If my experience is anything to go by no good thing comes out of paxil] Many psychiatrists believe that SSRIs are effective as anxiolytic’s. [Of course they would, yet they never try it for themselves…they might be ignorant but they are not stupid!] However, as this market was built, there was an absence of independent, non-commercial research conducted to study the effectiveness of SSRIs for the various anxiety problems. Academic researchers who led the trials and spoke about the validity of the disorders were paid to be the company’s thought leaders, and the medical literature was contaminated by ghostwritten papers, which universally concluded that SSRIs were safe and effective.
    Unfortunately, that doesn’t provide a scientific record of efficacy.

    …………………………………………………//………
    3 Billion fine was nothing …GSK must have been laughing all the way to the petty cash register.
    Its just so tragic.

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