October 8, 2012
‘Any Reasonable Person’ Would See Glaxo Study as Fraud
To the Editor:
“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.”
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.
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.
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.”
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.
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.
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.
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.
Leemon B. McHenry
Department of Philosophy
California State University<
Jon N. Jureidini
Discipline of Psychiatry
University of Adelaide