One can only imagine the motives of GSK in having their counsel write this letter to the editor of the Chronicle of Higher Education, a letter so contrary to the plea agreement they signed in the recent DOJ case. The editor’s response [in italics below] adequately refutes Mr. Lee’s assertions, but why bother to write it in the first place? It completely undermines Sir Andrew Witty’s loud claims that GSK is turning over a new leaf:
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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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Herein lies the problem of settling the case rather than allowing it to go before a jury – an endless regress of not-so-plausible denials and word play. While it may seem that GSK is protecting the authors, they’re really throwing them under the bus. And the comment that GSK "continues to believe that the journal article reflects the honestly held views of the clinical-investigator authors" achieves high tragicomedy in substituting the authors’ views for scientific proof and including the word honestly in anything that has to do with Paxil Study 329. Drs. Leemon McHenry and Jon Jureidini make quick work of Mr. Lee’s ingenuous arguments:
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‘Any Reasonable Person’ Would See Glaxo Study as Fraud
Chronicle of Higher Education October 8, 2012 [full text available on-line] |
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To the Editor:
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"Academic Researchers Escape Scrutiny in Glaxo Fraud Settlement" [The Chronicle, August 6] raises the correct questions about GlaxoSmithKline’s recent $3-billion settlement with the Department of Justice. But in a letter from its attorney Thomas H. Lee II ["Journal Article Didn’t Mislead, Drug Company Asserts," The Chronicle, September 23], GlaxoSmithKline seizes on a one-line "escape clause" from the July 5, 2012, plea wherein another of GlaxoSmithKline’s attorneys states that GlaxoSmithKline "agrees that there’s a sufficient factual basis to support the guilty plea," but the company "is not by that guilty plea agreeing to each and every factual allegation that’s set forth in the information."
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This is a standard maneuver in plea agreements, but it does little to change the role that Study 329 played in the fraudulent conduct. Any reasonable person who examined the reporting of Study 329 ["Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized Controlled Trial," published in the names of Martin Keller et al. in the Journal of the American Academy of Child and Adolescent Psychiatry in 2001] would conclude the article was false and misleading and part of the fraud. We also find it interesting that GlaxoSmithKline cc’d the journal’s current editor, Andrés Martin, on Mr. Lee’s letter at a time when Dr. Martin was being pressured by demands from the international scientific community to retract the article.
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Mr. Lee’s response to The Chronicle’s article claims "to correct some significant factual inaccuracies." In turn, we wish to respond to some inaccuracies in Mr. Lee’s letter.
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Having been engaged by the plaintiffs’ law firm, Baum, Hedlund, Aristei & Goldman, to provide an independent evaluation of the reporting of Study 329, we studied over 10,000 pages of confidential documents relating to Study 329 and published four papers in medical and bioethics journals on our findings. While Mr. Lee admits GlaxoSmithKline hired a medical writer to provide "editorial assistance to the clinical investigators," he claims that 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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In fact, Sally Laden of Scientific Therapeutics Inc. testified in her deposition that she wrote the first draft of the manuscript from a summary provided by GlaxoSmithKline. We are not sure what Mr. Lee regards as "substantial comments on and input into the manuscript," but the documents we saw show clearly that the minority of named "authors" who made any contribution to the manuscript at all provided little more than "editorial assistance" to Ms. Laden. A comparison to the published paper shows that few significant changes were ever made to Ms. Laden’s first draft.
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Contrary to GlaxoSmithKline’s claims, control over the contents of the manuscript did not remain "at all times with the clinical-investigator authors." In accordance with GlaxoSmithKline’s corporate intellectual-property policy, since the company paid for the trial, the data, and the manuscript, it was the company’s intellectual property, which GlaxoSmithKline only transferred to the "lead author" once the paper was ready to be submitted for publication. The ghostwriter, Ms. Laden, continued to manage the manuscript throughout the process, under guidance from GlaxoSmithKline. This allowed GlaxoSmithKline to control the message, minimizing the possibility of a contrary view by an "author" who might compromise the company’s manipulation of the data. The investigators signed off on the manuscript without seeing the raw data from the trial.
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Only a fraction of the thousands of documents concerning Study 329 that we reviewed have been released into the public domain, a subset of which can be found on the Web sites of Healthy Skepticism and the University of San Francisco’s Drug Industry Document Archive. If GlaxoSmithKline is serious about "vigorously disput[ing] that the journal article was false, misleading, or fraudulent," the company should release the rest of the documents concerning Study 329 so the public can judge whether the results of Study 329 were reported honestly and accurately in the journal.
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The journal article on Study 329 has become the paradigm case of medical ghostwriting, one that facilitated the misrepresentation of study results for both efficacy and safety, and as a result harmed young patients who were prescribed Paxil in reliance on this article. The fact that GlaxoSmithKline continues to dispute vigorously the report of this study demonstrates, in our view, that the company is still out of step with the companywide overhaul initiated by the new CEO, Andrew Witty, to prevent "unacceptable" mistakes that led to the record $3-billion fine.
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Leemon B. McHenry
Department of Philosophy California State University Northridge, Calif. |
Jon N. Jureidini
Discipline of Psychiatry University of Adelaide Adelaide, Australia |
Drs. Leemon McHenry and Jon Jureidini were also clear about the widely reported change in GSK policy, "The fact that GlaxoSmithKline continues to dispute vigorously the report of this study demonstrates, in our view, that the company is still out of step with the companywide overhaul initiated by the new CEO, Andrew Witty, to prevent ‘unacceptable’ mistakes that led to the record $3-billion fine." This exchange highlights the reason that this article must be retracted from the literature. The ethical obligation to patients lies within the medical profession – in this case with the American Academy of Child and Adolescent Psychiatry.
The fact that "GlaxoSmithKline cc’d the journal’s current editor, Andrés Martin, on Mr. Lee’s letter at a time when Dr. Martin was being pressured by demands from the international scientific community to retract the article" makes it infinitely clear that GSK has been in charge of this article from its inception, and remains at the helm rather than the stated authors. Likewise, copying Dr. Andrés Martin who had nothing to do with publishing this article implies that it is the editor’s journal, rather than the official journal of the American Academy of Child and Adolescent Psychiatry. The only enduring contract in this case is between the Academy and the patients of the physicians they represent…
Denial ain’t just a river in Egypt. – MARK TWAIN
There, they said it — fraud!
Is their willingness (or not) to sue McHenry and Jureidini
a test-case of GSK’s authenticity in denial?
Probably pretty safe to have a field day with these creeps right about now…