GlaxoSmithKline agreed Thursday to release all data on the safety and effectiveness of its drugs to settle a lawsuit by New York's attorney general, who accused the pharmaceutical maker of withholding negative information about its antidepressant drug Paxil.
Glaxo will put summaries of all its studies since December 2000 in a clinical trial registry on its website. The London-based company is the first major drug maker to agree to disclose all its studies. The company also will pay $2.5 million to the state.
New York Atty. Gen. Eliot Spitzer sued the company in June, alleging the company fraudulently misled the public about the use of Paxil in children, specifically whether the drug increased suicidal tendencies in young people. The suit said Glaxo had conducted five studies on Paxil in children but disclosed only the study with the most favorable results.
Glaxo said the company still believed Spitzer's civil charge of fraud was unfounded but settled to avoid the cost of litigation.
In June, after Spitzer filed suit, Glaxo posted on its website the Paxil studies that the attorney general had accused the company of hiding. Glaxo spokeswoman Nancy Pekarek said the information also had been released on posters, in letters to healthcare professionals and during meetings.
Pekarek said the company would post data by Dec. 31, 2005, on clinical trials since the firm merged in December 2000. Test results from this week forward will be posted within 10 months of a drug's approval, she said.
Spitzer said that in settling, Glaxo "has set a standard for the entire pharmaceutical industry." He added that Glaxo's action would encourage others companies to follow suit, in part because investors and funders of research would be drawn to a firm that is a leader in disclosure of product data.
Glaxo shares rose 66 cents to $40.94 on the New York Stock Exchange.