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The Whistleblower and Penn: A Final Accounting of Study 352

Written by Peter Simons, read by James Moore, first published on Mad in America, December 29, 2019.

Although the general story of ghostwriting in trials of psychiatric drugs is now pretty well known, the details of the corruption in specific trials are still emerging into the public record, often a decade or more after the original sin of fraudulent publication. The latest study to finally see the full light of day is GlaxoSmithKline's study 352.

Perhaps the most infamous ghostwritten study is GSK's study 329, which, in a 2001 report published in the American Journal of Psychiatry, falsely touted paroxetine (Paxil) as an effective treatment for adolescent depression. The company paid over $3 billion in penalties for fraud.

That same year, study 352 made its first appearance in the research literature. That was when Charles Nemeroff, who in the years ahead would become the public face of research misconduct, "authored" an article on the efficacy of paroxetine for bipolar disorder. It has taken 18 years for the full story of that corruption to become known, the final chapter recently emerging when a large cache of study 352 documents—emails, memos, and other internal correspondence between the key players—was made public.

The documents reveal a web of corruption that went beyond the fraud of ghostwriting into the spinning of negative results into positive conclusions, and the abetting of that corruption by an editor of the scientific journal that published the article. The documents also reveal a whitewashing of the corruption by the University of Pennsylvania.

However, it was the publication of these documents that provided Jay Amsterdam, an investigator in the trial who turned whistleblower after he smelled a rat, with a chance to say "case closed." Amsterdam and Leemon McHenry have now published two articles that provide a step-by-step deconstruction of the study—the ghostwriting, the spinning of results, the betrayal of public trust.

Here is the story of that whistleblowing.