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US: U.S. Probe of Glaxo's Paxil Widens


by ALICIA MUNDYThe Wall Street Journal
June 20th, 2008

WASHINGTON -- A Justice Department investigation of GlaxoSmithKline PLC's handling of its blockbuster antidepressant drug Paxil, including its marketing and safety research, appears to be widening.

Glaxo, one of the world's largest drug makers, confirmed Thursday that a previously disclosed Colorado-based Justice Department investigation of marketing practices also includes the Boston U.S. attorney's office 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 information, 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 to the Food and Drug Administration.

In addition, recently released documents questioning Paxil's safety prompted Sen. Chuck Grassley (R., Iowa) to demand an FDA investigation of Paxil's 1992 approval.

Glaxo said in a statement Thursday that the company has responded to questions from the government and cooperated fully with the department.

"We cannot comment further on an ongoing government investigation," Glaxo said. The company's statement said that it has requested a meeting with Sen. Grassley's staff to clarify "misunderstandings."

Paxil has been one of Glaxo's best-selling drugs, but it has come under attack. In 2005, after criticism from doctors and the public over its handling of information on antidepressants and suicidality, the FDA added strong warnings to a class of antidepressants called selective serotonin-reuptake inhibitors, or SSRIs, which include Paxil. The warning also noted the increased risk of suicidal behavior among teens and children.

On June 14, 2007, two lawyers from the Los Angeles law firm Baum Hedlund met in Boston with Assistant U.S. 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 information 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.

They were also asked if they had information about any activities by company representatives involving the promotion of Paxil's safety and efficacy for teens and children, they said.

"They [government officials] wanted to know about the research Glaxo did that said there were no suicidality problems, and what the data really showed," said Mr. Murgatroyd.

Glaxo says it didn't promote Paxil off-label to adolescents.

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, Ms. Menzies said, Mr. 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 he was asked about Paxil's safety data; he declined to give the date of his appearance.

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

In the meeting, Justice officials asked detailed questions related to a controversial medical analysis paid for by Glaxo that has become known as Study 329. That analysis indicated Paxil was safe and efficacious for teens and children. 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," said Mr. Murgatroyd.

The company defended its safety research in a statement that said, "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."

Glaxo hasn't allowed Baum Hedlund's lawyers to share with the FDA the same sealed information that 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 Oct. 15, 2007, letter.

In March of this year, British authorities concluded a four-year investigation on whether Glaxo failed to inform the United Kingdom drug regulator in a timely manner about a link between Paxil and suicidality in children and teens. The government said it didn't pursue a criminal prosecution of Glaxo because U.K. 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."

--Jeanne Whalen and Louise Radnofsky contributed to this article.

Write to Alicia Mundy at alicia.mundy@wsj.com





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