Former GSK Lawyer Charged in Wellbutrin Cover-Up
Charge follows depression drug's illegal marketing as a weight-loss aid.
Nov. 11, 2010— -- The U.S. Department of Justice has charged a former vice president and lawyer at GlaxoSmithKline with trying to cover up evidence that the company was illegally marketing the depression drug Wellbutrin as a weight-loss aid.
Lauren Stevens of Durham, N.C., was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the FDA, according to a press release from the FDA.
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The indictment doesn't name the company or the drug, but a lawyer for Stevens confirmed to the Wall Street Journal that Stevens was a vice president at GlaxoSmithKline and that the indictment relates to Wellbutrin and an ongoing investigation into the company marketing the depression drug to treat weight loss -- an indication for which it is not approved.
A spokeswoman for GlaxoSmithKline confirmed that Stevens was employed in the company's legal department and that she is now retired.
According to the indictment, the FDA in 2002 asked GlaxoSmithKline for information about the company's promotion of the drug for an unapproved use -- weight loss. The agency asked the drugmaker for all materials related to its Wellbutrin marketing program.
The indictment alleges that Stevens responded to the FDA that GSK was not promoting Wellbutrin off-label, despite having clear evidence that doctors paid by the company, were, in fact, touting the drug for uses not approved by the FDA.
The indictment states that Stevens sent letters to 550 of 2,700 paid speakers for GSK who gave talks on the drug, asking to review their slides. According to the indictment, 40 speakers returned slides to Stevens, and she determined that 28 of the speakers were promoting Wellbutrin off-label.
A Michigan physician had given 488 promotion talks on Wellbutrin to other physicians, in which he repeatedly promoted the drug for off-label uses, including weight loss, according to the indictment. A Vermont doctor did the same thing in 511 presentations on the drug.
