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Consider the case of the anti-depressant Paxil, produced by the drug company SmithKline Beecham (now part of GlaxoSmithKline). GSK got approval from the FDA in 1999 for treatment of depression in adults, but not in teenagers. That meant that while doctors could prescribe the drug to adolescents — a so-called “off label” prescription — GSK could not promote the drug to doctors for that purpose.

But the company did just that, according to criminal and civil complaints filed by the Justice Department and a suit by then-New York Attorney General Eliot Spitzer. What’s more, the Justice Department claimed, GSK selectively and misleadingly released information about three studies it had conducted of the drug: It hired a consulting company to write a journal article that played up evidence from one study that the drug worked better as a treatment for pediatric depression than a placebo, played down (better) evidence from the same study that it hadn’t, and soft-pedaled the side effects.

These side effects included suicidal thoughts and actions.

… Read More

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