N.Y. Sues Paxil Maker Over Studies On Children
Like previous investigations of biased research on Wall Street and trading abuses in the $7.5 trillion mutual fund industry, Spitzer's lawsuit uses New York law to take on an issue generally the province of federal regulators, particularly the FDA.
But Spitzer argued that "off label" uses, prescribed without FDA approval, are in a gray area and that he is just trying to make sure that doctors have the information they need.
"The last thing that I should be doing is making clinical decisions about which medicines are good or bad," Spitzer said. "We don't want to discourage off-label uses, we just want more complete information."
An FDA spokeswoman declined to comment on the lawsuit. Under federal law, when drug companies run studies of their drugs' effectiveness against new illnesses or in new population groups, they must submit the results to the FDA. But the data are considered proprietary commercial information and do not have to be disclosed publicly unless the FDA determines that important issues of safety are involved.
Some medical organizations and patients groups have become increasingly concerned that the drug companies are hiding information that doctors and patients need.
"A lot of these negative studies do get buried, and it's intentional. That's not a particular concern if it's a drug in the early stages [of testing] and hasn't been approved. But this is in use," said Wayne K. Goodman, a University of Florida psychiatry professor who sat on the FDA advisory committee that reviewed studies of antidepressants and adolescent suicide last winter.
Several medical groups and experts in adolescent psychiatry said they supported Spitzer's goals but did not know enough about New York law to comment on the lawsuit itself.
"Physicians, researchers and patients need and are entitled to as much information as possible to make decisions about treatment," said David G. Fassler, a Vermont psychiatrist who is on the council of the American Academy of Child and Adolescent Psychiatry. "The issue is significant and important. It doesn't just relate to psychiatry and antidepressants."
Outside legal experts said Spitzer appears to be on solid legal ground by bringing his case under the state's law against consumer fraud. States have a history of bringing legal actions against drug companies over pricing and marketing. Just last month a subsidiary of Pfizer Inc. paid $430 million to settle federal and state investigations into the way it promoted the drug Neurontin.
"It is not unusual for state attorneys general to be involved in pharmaceutical cases, and it is not unusual for them to bring cases against unfair and deceptive practices," said James E. Tierney, who heads Columbia Law School's National State Attorneys General Program. "This is a natural outgrowth."
Britain-based Glaxo's stock closed at $41.39, down $1.38, Wednesday on the New York Stock Exchange.
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