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

Publisher Name: 
The Wall Street Journal

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

AMP Section Name:Pharmaceuticals
  • 182 Health