Behind Paxil's black box

07/20/2008 12:00 AM

07/20/2008 6:48 AM

Nortin Hadler's book tells how Americans are overtreated and alludes to the power of the big pharmaceutical companies in creating this situation. In "Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial," Alison Bass tells a disturbing story of deception and possible fraud by companies, doctors and public officials charged with keeping Americans healthy and safe.

In this well-told story, Big Pharma uses Big Money to encourage Big Slick University Doctor to spin the results of Big Drug trial data while the FDA -- funded in part by Big Pharma -- looks the other way. In the story, Big Pharma is GlaxoSmithKline; Big Money is (among other payments) an $800,000 research grant; Big Slick University Doctor is Martin Keller of Brown University; and the Big Drug is Paxil, a hugely popular and profitable antidepressant. The spin? Paxil, it seems, causes suicidal thoughts in some children and pushes others to actually do it. This fact is discovered in a clinical trial but kept quiet. A few whistle-blowers uncover what's going on. They are harassed and intimidated but survive to see the story end.

Paxil is still being marketed by Glaxo. But, thanks to the whistle-blowers, every prescription of every antidepressant must now carry a so-called black-box warning stating that these drugs increase the risk of suicidal thinking and behavior in depressed children and adolescents. Furthermore, as part of a settlement of a lawsuit brought by the attorney general of New York, Glaxo was required to disclose all results -- including negative ones -- of all clinical drug trials. Congress has now extended that mandate to the clinical trials of all drugmakers.

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