A former executive with pharmaceutical giant GlaxoSmithKline Plc has been charged with both obstruction and making false statements during a U.S.-based investigation concerning its antidepressant, <"http://www.yourlawyer.com/topics/overview/wellbutrin">Wellbutrin SR, said Bloomberg.com
The former in-house attorney and vice president, Lauren Stevens, was accused in an indictment concerning impeding a 2002-2003 inquiry by the U.S. Food and Drug Administration (FDA) concerning how Wellbutrin SR was marketed off-label, said Bloomberg.com. Stevens is charged with one count each of obstructing an official proceeding and falsifying and concealing documents and four counts of making false statements, said Bloomberg.com. The terms for the charges range from five to 20 years.
It seems that the disgraced former attorney signed letters to the agency in which false statements were made and the magnitude of Glaxoâ€™s illegal marketing were minimized, said Bloomberg.com. Stevens also withheld information concerning Glaxo paying a physician in Vermont to speak at 511 events in 2001-2002 touting Wellbutrinâ€™s off-label uses and its paying a physician in Michigan to give 488 talks, according to prosecutors, wrote Bloomberg.com.
â€œThere is a difference between legal advocacy based on the facts and distorting the facts to cover up the truth,â€ Carmen Ortiz, U.S. attorney for Massachusetts, said in a statement, quoted Bloomberg.com. â€œFederal agencies such as the FDA cannot protect the public health if entities and individuals they regulate provide false information,â€ Ortiz added.
Although the indictment does not mention Glaxo or Wellbutrin SR, Mary Anne Rhyne, a Glaxo spokeswoman confirmed by email that Stevens did work in its legal department and has since retired and that the drug involved is Wellbutrin SR, said Bloomberg.com.
Stevens advised the agency that she would collect materials concerning the drug makerâ€™s promotion of the medication, said Bloomberg.com, which noted that the single use medication was approved for â€œthe treatment of a major depressive disorder in patients age 18 or older,â€ said the indictment, quoted Bloomberg.com.
Meanwhile, emerging studies have pointed to increased risks of miscarriages in pregnant women taking antidepressants and that some have been linked to an increase in serious birth defects, including Wellbutrin. Also, although the risks are not yet fully clear, researchers do warn about potential effects between Wellbutrin and heart birth defects.
Speaking via teleconference with the FDA last week, Stevens acknowledged that the firm would write to those health care professionals who spoke about Glaxo during a specific time, according to the indictment, said Bloomberg.com. According to the drug maker, some 2,700 speakers gave promotional talks; Stevens wrote to 550 requesting presentation materials, the indictment said.
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 â€œspecial issue boardsâ€ for the purpose of talking about the drugâ€™s unapproved uses, wrote Bloomberg.com, citing the indictment.
In 2003, Stevens contacted the agency, providing slide sets she knew the agency had in its possession, writing that she found â€œisolated deficiencies,â€ the evidence â€œclearly demonstratesâ€ Glaxo didnâ€™t engage in off-label promotions, quoted Bloomberg.com. In actually, alleges the indictment, Stevens was aware that Glaxo â€œhad held what was likely more than 1,000 programs that were led by speakers whose presentation materials included off-label informationâ€ about Wellbutrin and were, thus, not â€œisolated deficiencies,â€ quoted Bloomberg.com.