GlaxoSmithKline Faces Wide Criminal Probe, Former Exec Claims

A judge has been asked to grant immunity to an executive at GlaxoSmithKline in return for his testimony against a key GlaxoSmithKline attorney. The request was presented by federal prosecutors, said BNET.

The request was made after Lauren Stevens, the accused lawyer and a former vice president and associate general council for Glaxo, said in court that feds initiated a broad, ongoing investigation into Glaxo through a grand jury in Boston, said BNET. The former in-house attorney and executive was just re-indicted in an ongoing debacle concerning <"">drug marketing practices.

Stevens was charged late last year, but that indictment was dismissed due to prosecution errors, according to the Justice Department. Stevens was re-charged with obstruction of justice (one count), making false statements (four counts), and falsifying and concealing documents (one count) during a U.S.-based investigation concerning <"">Wellbutrin SR being marketed for weight loss, an unapproved use. The Justice Department said the new indictment charges are, for the most part, the same as the original charges.

Original charges involved Steens having signed letters to the agency in which false statements were made and the magnitude of Glaxo’s illegal marketing were minimized. In November, Stevens was charged with withholding information concerning Glaxo paying one Vermont physician to speak at 511 events and a Michigan physician to give 488 talks touting Wellbutrin’s off-label uses.

Stevens leaking the fact that the Boston grand jury is conducting “a sweeping investigation of the company as a whole” and is continuing its probe has been described as an “unusual move.” While grand jury proceedings are confidential, defendant attorneys are not bound by that confidentiality; however, that privacy is typically respected, said BNET.

It remains unclear as to why Stevens went public, especially since knowledge of the probe only serves to harm her defense. Her former Glaxo colleagues now know they could be targeted and that could be given leniency for testifying against her, BNET explained. The strategy adopted by the fed is, quoted BNET, one of “divide and conquer” in which prosecutors are letting other Glaxo executives know they can cooperate in exchange for no charges or face a grand jury who will ask how they market products.

While physicians are legally allowed to prescribe medications for off-label uses, drugmakers are prohibited from marketing drugs for uses not approved by the U.S. Food and Drug Administration (FDA). The terms for the charges against Stevens range from five to 20 years.

Among other issues, Stevens sent three false letters in 2003 to the FDA in which she did not disclose that Glaxo directly urged using Wellbutrin for weight loss, that it paid physicians for promotional talks, and that Glaxo held “special issue boards” for the purpose of talking about the drug’s unapproved uses.

In addition to Stevens being accused of making false statements to the FDA in attempts to hide that Glaxo was illegally marketing Wellbutrin for unapproved uses, including weight loss, prosecutors also hope to get James Millar, vice president of strategic pricing, contracting, and marketing to testify against Stevens. “It is likely that James Millar will refuse to testify or provide other information on the basis of his privilege against self-incrimination,” prosecutors told the judge, quoted BNET.

Studies point to increased risks of miscarriages in pregnant women taking antidepressants; some have been linked to an increase in serious birth defects, including Wellbutrin. Although the risks are not yet fully clear, researchers do warn about potential effects between Wellbutrin and heart birth defects.

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