GSK and Martin Keller contd.

Academic Researchers Escape Scrutiny in Glaxo Fraud Settlement

By Paul Basken

Federal prosecutors triumphantly announced the nation's largest-ever health-care-fraud settlement last month, when the pharmaceutical maker GlaxoSmithKline admitted marketing its drugs for unapproved purposes.

Virtually unpublicized was a key detail: One of the central pieces of evidence in the case was a 2001 scientific journal article listing 22 authors, most of them university researchers, that was actually written by Glaxo-hired authors to overstate the benefits and understate the risks of a highly profitable Glaxo drug.

For years, critics had been pointing out flaws in that study of the drug, the antidepressant Paxil, and warning that the study's recommendation of the use of Paxil on children had dangerously misrepresented data and hidden information indicating that the drug promoted suicidal behavior among teenagers.

And yet for years, the publisher of the article, the Journal of the American Academy of Child and Adolescent Psychiatry, and the universities whose researchers' names were on it resisted calls to retract the study and publicly rebuke its "authors." In the meantime, the government has continued to provide those researchers with millions of dollars in federal grant money.

Now Glaxo has admitted its guilt with regard to marketing Paxil and other drugs and agreed to pay a record $3-billion fine. The plea includes an admission that the Paxil study article was part of the fraud. And yet the universities, the journal, and the government are largely avoiding questions about whether they should finally take or force corrective or punitive action.

"At this moment I don't have any comment," Andrés S. Martin, a professor of psychiatry at Yale University and editor in chief of the journal, said in a brief telephone interview following the settlement, which was announced July 2.

Dr. Martin said his journal was still considering its options with regard to the article, which the journal published in July 2001. Asked how long the journal's review of the article might take, Dr. Martin again declined to comment.

The article listed Martin B. Keller, then a professor of psychiatry and human behavior at Brown University, as its lead author. Other listed authors included Karen D. Wagner, then also at Brown and now a professor and vice chair of psychiatry and behavioral sciences at the University of Texas Medical Branch at Galveston, and David T. Feinberg, president of the UCLA Health System.

Yet e-mails and evidence uncovered through investigations long before the federal prosecution—including a 2007 documentary by the BBC and a 2008 book, Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial, by Alison Bass—and then the charges that Glaxo pleaded guilty to, show that the article constituted scientific fraud and that Dr. Keller relied on a Glaxo-hired author to draft it.

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