Saturday, June 28, 2008

Alison Bass's SIDE EFFECTS: Another Hall of Shame candidate

The most recent book on Pharma issues that I've seen is by Alison Bass, formerly of the Boston Globe, called Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial (Algonquin Books, Chapel Hill, NC, 2008). Essentially it tells the story of Paxil and the suit filed by then-NY-Attorney-General Eliot Spitzer in 2004, charging GlaxoSmithKline with fraud in state court for concealing unfavorable evidence about the antidepressant's effectiveness and adverse-effect profile in children. She particularly profiles Rose Firestein, the assistant AG in Spitzer's office who led the GSK suit; and Donna Howard, a whistleblower who revealed the concealment of adverse research outcomes in the key Paxil study in adolescents. (She also discusses Martin Teicher, a Boston psychiatrist who reported the first cases of suicidality related to SSRI drugs and was roundly vilified by his colleagues as a wacko or anti-psychiatry cultist.)

At one level the book tells us experienced Pharma watchers little that we did not already know. In HOOKED, I suggested that the filing of the New York suit against GSK in the spring of 2004 might have been a critical tipping point, after which the momentum that had previously favored the influence and dominance of the pharmaceutical industry first started to swing in the opposite direction. Many would have said that this was silly, an the real tipping point came later, on September 30, 2004, when Merck withdrew Vioxx from the market and admitted its link to excess heart attacks. So it is at least somewhat reassuring to read a book that views the New York AG lawsuit as a critical event. Bass even goes so far as to suggest that the way Merck elected to deal with the Vioxx expose later that same year was predicated in part on the drubbing that GSK had taken in its legal tussle with the NY AG; so that the two "tipping points" are more closely linked than might at first appear. Still, the "smoking guns" in the GSK suit seem rather cool to the touch; for example, we discover that Rose Firestein became aware of the single most incriminating internal GSK memo, on how the critical negative study of Paxil in kids was spun deliberately to make it seem positive, by the simple expedient of reading an article about it in the Canadian Medical Association Journal--whose editor kindly then faxed her a copy of the original memo itself.

At another level, the book solidifies the case against another academic psychiatrist whose ties to Pharma seem to have reached legendary proportions. Dr. Martin Keller, chair of psychiatry of Brown University and the principal investigator of the major Paxil study in adolescents (the now-infamous Study 329), was originally outed by Bass years ago in the Boston Globe, as earning the princely sum of nearly a half million dollars annually in drug company money, on top of his salary as department chair. The book makes a strong case to show that Keller acquiesced, at the very least, in a ghostwritten version of the study that re-spun a study that actually was negative and made it appear to be positive. Moreover, the testimony of the Brown whistleblower suggests just as strongly that Keller deliberately concealed and misclassified serious adverse reactions among study participants--saying, for instance, that teens who had to stop taking the drug because of suicidal impulses or serious bizarre behavior quit the study due to "non-compliance" rather than due to adverse effects.

Dr. Keller refused to be interviewed for Bass's book. Brown University responded to Bass's query by stating that "Brown takes seriously the integrity of its scientific research. Dr. Keller's research regarding Paxil complied with Brown's research standards." When a prestigious Ivy League medical school says that its research standards support ghostwriting and suppression and misclassification of data, then somebody has some explaining to do. (I know that some of our esteemed colleagues who are affiliated with Brown have protested this situation, based on information that was publicly available even before Bass's book was published.)

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