Former GSK Lawyer Charged in Wellbutrin Cover-Up

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Former GSK Lawyer Charged in Wellbutrin Cover-Up

Charge Follows Depression Drug's Illegal Marketing as

Weight-Loss Aid

By EMILY P. WALKER MedPage Today Washington Correspondent

Nov. 11, 2010

The U.S. Department of Justice has charged a former vice

president and lawyer at GlaxoKline with trying to cover up

evidence that the company was illegally marketing the depression

drug Wellbutrin as a weight-loss aid.

s 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.

Read this story on www.medpagetoday.com.

The indictment doesn't name the company or the drug, but a lawyer

for s confirmed to the Wall Street Journal

that s was a vice president at GlaxoKline 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 GlaxoKline confirmed that s was

employed in the company's legal department and that she is now

retired.

According to the indictment, the FDA in 2002 asked

GlaxoKline 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 s 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 s 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 s, 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.

The indictment alleges that s withheld the physicians'

slides from the FDA, and that a legal memo was prepared for

s laying out the "pros" and "cons" of giving the slides to

the agency.

"This indictment demonstrates that those who purposely subvert

the regulatory functions of the FDA through false statements and

misleading information will be held accountable for their

deception," stated Dara Corrigan, FDA's Associate Commissioner for

Regulatory Affairs in a prepared statement.

Brien T. O'Connor, one of s' attorneys, told the New York

Times in a statement: " s is an utterly decent and

honorable woman. She is not guilty of obstruction or of making

false statements. Everything she did in this case was consistent

with ethical lawyering and the advice provided her by a nationally

prominent law firm retained by her employer specifically because

of its experience in working with [the] FDA."

GlaxoKline has not been charged with a crime.