Healthy Skepticism Library item: 13866

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Publication type: news

Mundy A.
U.S. Probe of Glaxo's Paxil Widens
The Wall Street Journal 2008 Jun 20
http://www.wsj.com/redirect/health.html

Full text:

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.”