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Spitzer sues Glaxo over Paxil
N.Y. attorney general alleges fraud regarding company's marketing of antidepressant for children.
June 2, 2004: 1:35 PM EDT

NEW YORK (CNN/Money) - New York State Attorney General Eliot Spitzer sued drugmaker GlaxoSmithKline Wednesday for alleged fraud regarding information about adolescent use of its antidepressant medication Paxil.

Spitzer's lawsuit alleges that, starting in 1998, the company moved to withhold negative information concerning Paxil and misrepresented information about the drug's safety and effectiveness when prescribed for depression in children and adolescents.

Read the lawsuit
N.Y. vs GlaxoSmithKline (PDF)

The suit, filed in New York Supreme Court, claims the company conducted at least five studies on the use of Paxil in children and adolescents, but only published and disseminated one of them.

GlaxoSmithKline (GSK: down $1.47 to $41.30, Research, Estimates) shares tumbled on the news, sinking more than 3 percent in afternoon trading on the New York Stock Exchange.

According to the lawsuit, the company suppressed negative results from the other studies, which failed to show that the drug was effective and also demonstrated increased risks of suicide.

"Doctors should have access to all scientifically sound information so that they can prescribe appropriate medication for their patients," Spitzer said in a statement.

"By concealing critically important scientific studies on Paxil, GSK impaired doctors' ability to make the appropriate prescribing decision for their patients and may have jeopardized their health and safety."

A GlaxoSmithKline spokeswoman defended the company's actions.

"We haven't seen the lawsuit, but GlaxoSmithKline has acted responsibly in conducting clinical studies of Paxil in Pediatric patients, and in disseminating data from these studies," spokeswoman Mary Anne Rhyne said.

"All pediatric, studies were made available to the FDA and regulatory agencies worldwide. The 1998 memo that Eliot Spitzer cited was inconsistent with the facts and does not express the company's position," she added.

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Spitzer's office is looking for Glaxo to surrender profits obtained by the alleged fraud. In its first quarter ended in March, Glaxo's sales of Paxil totaled $533 million worldwide, with $271 million of that in the United States, according to the company's latest quarterly report.

The only antidepressant approved to treat depression in children is Eli Lilly's Prozac, but physicians can prescribe Paxil as they see fit, according to the suit. In 2002, doctors prescribed the drug to children two million times, the statement from Spitzer's officer reported.

Separately, a government-funded study found that use of Prozac in combination with talk therapy proved most effective in helping adolescents overcome depression, according to a study published Wednesday by the New York Times.  Top of page

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