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N.Y. Sues Paxil Maker Over Studies On Children
Negative Data Withheld, Attorney General Says

By Brooke A. Masters
Washington Post Staff Writer
Thursday, June 3, 2004; Page E01

NEW YORK, June 2 -- Drug manufacturer GlaxoSmithKline PLC misled consumers and committed fraud by suppressing clinical studies that raised doubts about the safety and effectiveness of its top-selling antidepressant Paxil when used to treat children and adolescents, New York state Attorney General Eliot L. Spitzer alleged in a civil lawsuit filed Wednesday.

The complaint filed in New York state Supreme Court alleges that Glaxo systematically withheld negative information about the drug, also known as paroxetine. While the company's representatives and sales literature drew attention to a single study that showed Paxil had positive results, they hid four other studies, the complaint says. Unmentioned were studies that that found no clear evidence that the drug is effective in minors and that suggested it could increase the risk of suicidal thoughts and behavior.

The complaint cites a 1998 internal Glaxo memo that said the company's "target" was to "effectively manage the dissemination of these data in order to minimize any potential negative commercial impact."

The Food and Drug Administration has not approved Paxil for use by children, and Glaxo is not allowed to market the drug for minors. But doctors can prescribe Paxil for children as a "off-label" use. More than 2.1 million paroxetine prescriptions for children were written in 2002, the complaint says.

The complaint also alleges that Glaxo gave sales representatives copies of the positive study with a cover memo that said, "Paxil demonstrates REMARKABLE Efficacy and Safety in the treatment of adolescent depression."

GlaxoSmithKline said in a written statement that the firm "has acted responsibly in conducting clinical studies in pediatric patients and disseminating data from those studies. All pediatric studies have been made available to the FDA and regulatory agencies worldwide. We have publicly communicated data from all pediatric studies. As for the 1998 memo, it is inconsistent with the facts and does not reflect the company position."

The unpublished studies cited in the Spitzer lawsuit have been under discussion in the medical world for some time. British regulators cited them last year last year when they warned doctors against prescribing Paxil and several other popular antidepressants to children. The FDA recently urged doctors to watch patients carefully for suicidal behavior in the first weeks after prescribing antidepressants and ordered further study of possible connections between the drugs and suicide risk.

A separate study sponsored by the National Institute of Mental Health found that the antidepressant Prozac reduced the risk of suicide in teenagers, especially when combined with psychotherapy. Prozac is approved by both U.S. and British regulators for use in children.

In the case of Paxil, Spitzer is arguing that Glaxo's sales representatives had a duty to discuss the negative studies when promoting the drug.

"The manufacturer cannot rely exclusively on the positive study. . . . Where they affirmatively state this drug is 'remarkably' efficacious and safe, and they are withholding information that challenges that, that's wrong," Spitzer said in an interview.

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Antidepressant Use in Children Soars Despite Efficacy Doubts (The Washington Post, Apr 18, 2004)
New Warning Urged On Antidepressants (The Washington Post, Mar 23, 2004)
FDA Links Antidepressants, Youth Suicide Risk (The Washington Post, Feb 3, 2004)
FDA Cautions on Antidepressants and Youth (The Washington Post, Oct 28, 2003)
Britain Warns of Paxil's Risk to Children (The Washington Post, Jun 11, 2003)

_____FindLaw (pdf)_____
Complaint: N.Y. v. GlaxoSmithKline
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