Drugmaker GlaxoSmithKline agreed Thursday to settle charges that it hid and misrepresented unfavorable data about the effectiveness and safety of its top-selling anti-depressant Paxil for children and adolescents, agreeing to post all clinical trial data on its drugs by the end of 2005.
The settlement with New York Attorney General Eliot L. Spitzer also includes a $2.5 million payment to the state of New York. It puts the British-based firm at the forefront of a burgeoning debate about whether pharmaceutical manufacturers should be required to tell doctors and the public when new research shows their drugs in a negative light. Currently companies are required to share information about newly discovered risks and side effects only with regulators, though the editors of leading medical journals and the American Medical Association called in June for that to change.
Spitzer drew national attention to the debate that same month by filing civil fraud charges against Glaxo, citing a 1998 e-mail in which company officials discussed the Paxil studies and the need to "effectively manage the dissemination of these data in order to minimize any potential negative commercial impact." Within two weeks, Glaxo had put the Paxil data on its Web site and promised to create a public registry of studies of its other drugs.
Glaxo spokeswoman Nancy Pekarek said the company continues to believe it did nothing wrong. She said Glaxo had been working on the registry idea for months before Spitzer's lawsuit. Under the settlement, new studies will be added to the registry within 10 months after their completion.
"This is what we were looking for when we announced the case," Spitzer said of the settlement. "We hope this represents a sea change in the way pharmaceutical companies handle marketing," he said in an interview. "Doctors will not now have to rely on what the pharmaceutical representatives say about the studies of the drugs. If the other companies follow this model, something dramatic will have changed."
Two other big drug companies, Johnson & Johnson and Forest Laboratories, have said they also have been contacted by Spitzer's office about their test data and marketing practices, and Eli Lilly, the maker of the antidepressant Prozac, promised last month that it would create a public registry for its drug-testing data.
"We are pleased that the Attorney General believes the Clinical Trial Register we have been developing will provide useful information to the medical and scientific community," Mark Werner, Glaxo's chief U.S. lawyer, said in a statement.