US Investigation Into Glaxo And Paxil/Seroxat Widens

This just in from Pharmalot:

A Justice Department investigation of Glaxo’s handling of the marketing and safety research of its antidepressant, appears to be widening, The Wall Street Journal reports. The drugmaker confirmed that a previously disclosed Colorado-based Justice Department investigation of marketing practices also includes the US Attorney’s office in Boston and is being coordinated by the agency in Washington.

At a meeting convened in Boston by an agency prosecutor last year, plaintiffs’ lawyers representing families suing Glaxo say they were asked about info, documents and depositions concerning Paxil’s potential link to suicidal behavior in adolescents and adults, and how the company portrayed that risk to doctors and the FDA, the Journal writes.

This follows a recent demand by Chuck Grassley, the ranking Republican on the Senate Finance Committee, for an FDA investigation. Glaxo issued a statement to the paper saying it has responded to questions from the government and cooperated fully with the department, but couldn’t comment further, but has requested a meeting with Grassley’s staff to clarify “misunderstandings.”

According to the Journal, on June 14, 2007, two lawyers from the Los Angeles law firm of Baum Hedlund met in Boston with Assistant US Attorney Patrick Jasperse, a lawyer in the Office of Consumer Litigation, FBI agents and representatives from the Health and Human Services Department, at the Justice Department’s request.

The lawyers, George “Skip” Murgatroyd and Karen Barth Menzies, said in interviews that they were asked in detail about info they had collected for lawsuits about what Glaxo told the FDA about Paxil’s potential risk of suicidal behavior, between 1989 and 1992, while the drug’s approval was pending, the Journal writes.

They were also asked if they had info about any activities by company reps involving the promotion of Paxil’s safety and efficacy for teens and children, they told the paper. “They (government officials) wanted to know about the research Glaxo did that said there were no suicidality problems, and what the data really showed,” Murgatroyd tells the Journal.

Glaxo says it didn’t promote Paxil off-label to adolescents. However, the paper writes that, in 1998, the FDA sent a warning letter to SmithKline Beecham, which merged with Glaxo Wellcome in 2000, about a T-shirt distributed “by or on behalf of SKB” at a children’s health affair in Florida, saying the T-shirt “is promoting an unapproved use of Paxil.”

In setting up the conference, Menzies tells the paper, Jasperse told her his efforts “could take a while.” The Justice Department said it doesn’t comment about ongoing cases. A different witness who testified later in Boston confirmed to the Journal that he was asked about Paxil’s safety data, but he declined to give the date of his appearance.

The Justice Department was particularly interested in controversial documents disputing research conclusions that Glaxo submitted to the FDA on suicidality. Those documents had been sealed at Glaxo’s request, but the Journal reports the Justice Department asked Glaxo to release confidential material to them prior to their meeting.

In the meeting, Justice officials asked detailed questions related to a controversial medical analysis paid for by Glaxo that has become known as the infamous Study 329, which indicated Paxil was safe and efficacious for teens and children. You can read about 329 here.

The 2001 study has come under fire from several independent medical researchers. The prosecutor and FBI “were quite interested in how Study 329 was used to promote Paxil for teenagers and kids by clinical researchers Glaxo had underwritten,” Murgatroyd tells the paper.

The company defended its safety research in a statement given the Journal: “We acted properly and responsibly in the conduct of our clinical trials program for Paxil, documentation and submission of results from studies to regulators, and communication of important safety information to regulatory agencies, the scientific community, and the public.”

And this is interesting: Glaxo hasn’t allowed Baum Hedlund’s lawyers to share with the FDA the same sealed info the company gave the Justice Department. Glaxo’s outside counsel wrote, “If the FDA wanted additional information, such as the internal documents you propose providing it, they could have requested them from GSK,” in an October 15, 2007, letter. This is the letter.

This past March, UK authorities concluded a four-year investigation on whether Glaxo failed to inform regulators in a timely manner about a link between Paxil and suicidality in children and teens. But the government didn’t pursue a criminal prosecution of Glaxo because UK laws were unclear on whether companies were obligated to report certain drug data.

But the regulator said it was “concerned that GSK could and should have reported this information earlier than they did.” Glaxo at the time said: “We firmly believe we acted properly and responsibly.”

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