But using consumer-protection laws against a major drug company for not disclosing clinical research that could be interpreted in various ways appears to be a novel approach. Mr. Spitzer is seeking disgorgement of Glaxo's profits from the sale of Paxil to children and adolescents in New York. He said he did not approach Glaxo about a potential settlement prior to filing his case.

Mr. Spitzer said he isn't making any commentary on whether Paxil causes suicidal behavior in children. Instead, his focus is solely on the failure to disclose negative information. Glaxo "had done several studies and only one of [them] generated the affirmative results they wanted to use in promoting the drug," he said. "Their effort to suppress the other studies was harmful and improper to the doctors who were making prescribing decisions and it violated the law."

But a spokeswoman for Glaxo said "we did publicly communicate" the results of other studies in various forums, including medical conventions and letters to physicians. "There are many, many studies each year," said Mary Anne Rhyne. "It's impractical to believe that every company in the industry will be able to publish from every study." Paxil has not been approved by the U.S. Food and Drug Administration for pediatric use and Ms. Rhyne said Glaxo has never promoted it for such use. She said all of Glaxo's data on the drug were made available to the FDA and other regulatory agencies.

In an editorial published in the Lancet, the journal noted an internal Glaxo memo published elsewhere that said "it would be commercially unacceptable to include a statement that efficacy had not been demonstrated." Glaxo's Ms. Rhyne confirmed the authenticity of the memo but said its content wasn't consistent with company policy. In addition, the company sent a letter to the Lancet saying that rather than hide data, and "because we were uncertain as to how to interpret the data, we brought this information to the attention of regulatory agencies around the world and sought the advice of experts in the field on interpretation and potential further analyses."

Glaxo submitted the negative studies to drug regulators in the U.S. and other countries in 2002, four years after the company began to get results about Paxil's efficacy and safety on children, according to the lawsuit. Because of concerns of suicidal behavior, drug regulators in the United Kingdom announced in June 2003 that Paxil "should not be used in children and adolescents under the age of 18 years" to treat depression. In the U.S., citing similar concerns, U.S. regulators also recommended last June that Paxil not be used in children and adolescents for depression.

The New York lawsuit describes five Glaxo studies of Paxil use among children and adolescents. Two of the studies failed to show that Paxil was more effective than a placebo for treating depression in children and adolescents, according to the suit. In one, the placebo actually outperformed Paxil on a primary efficacy measure, the suit says. And three of the studies showed that certain possibly suicide-related behaviors were about two times more likely among the Paxil users than the others. In one study that wasn't published, 7.7% of the youth on Paxil had behavior that included "suicidal thinking and acts," compared with 3% of the placebo group, according to the suit.

An internal Glaxo document said the company would have to "effectively manage the dissemination of these data in order to minimize any potential negative commercial impact," according to the suit. That document recommended that Glaxo publish a full article only on the one study out of the five that had some favorable conclusions. Soon after, that study was published in Journal of the American Academy of Child and Adolescent Psychiatry. The authors included two Glaxo employees, according to the suit.

Meanwhile, the company was giving its sales representatives a positive picture. Zachary Hawkins of Paxil's product-management group said in a memo "Paxil demonstrates remarkable efficacy and safety in the treatment of adolescent depression" -- a claim Mr. Spitzer's suit calls completely untrue. Though the memo said it was intended for the sales representatives' information only and said, "do not use it with or distribute it to physicians," the lawsuit contends that sending that message to physicians through the salespeople was Glaxo's intent. A spokeswoman said Mr. Hawkins doesn't turn up in her online employee database.

In June 2003, Glaxo put out a news release in Britain that said the company had "seen a difference between [Paxil] and placebo in terms of suicidal thinking or attempts" in its depression studies, particularly in adolescents. A few days later, a U.S. news release read that "there is no evidence that Paxil is associated with an increased risk of suicidal thinking or acts in adults" and that "not a single person" who participated in the trials committed suicide.

Mr. Spitzer said in an interview that there wasn't a lineup of other drug makers that he planned to go after immediately over this issue, but he left the door open. The problem, he said, "is one that runs throughout the industry. And it is an area of continuing interest."

Write to Barbara Martinez at barbara.martinez@wsj.com⁷.

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