GlaxoSmithKline last week agreed to pay $2.5 million to settle charges from the New York Attorneys General’s office that it had concealed information about the safety and effectiveness of Paxil in treating children and adolescents with depression.

As part of the agreement, GlaxoSmithKline (GSK) will become the first major drug manufacturer to publicly disclose information on clinical studies of its drugs, New York Attorneys General’s office said in a statement.

“This settlement holds GSK to a new standard of disclosure about studies concerning its drugs, a standard that helps to ensure that doctors and patients have access to all scientifically sound information so doctors can prescribe appropriate medication for their patients,” Spitzer said. “By agreeing to release both positive and negative studies about the safety and efficacy of its drugs, GSK has set an example for the entire pharmaceutical industry.”

The Attorney General sued GSK in June alleging that the company withheld negative information about Paxil, a drug used to treat depression. Specifically, GSK conducted at least five studies on the use of Paxil in children and adolescents but only released one of these studies, which showed mixed results on efficacy, Spitzer said. The lawsuit alleged that the company suppressed the negative results of the other studies, which failed to demonstrate that Paxil is effective and which suggested a possible increased risk of suicidal thinking and acts in certain individuals. The suit further alleged that GSK failed to disclose this information in “Medical Information Letters” that it sent to physicians.

In settlement documents submitted to the U.S. District Court in Manhattan, GSK agreed to continue its online posting of clinical studies of the use of Paxil in children and adolescents. Those studies were made available after the Attorney General filed his lawsuit. In addition, GSK will establish an online “Clinical Trials Register” that will contain summaries of results for all GSK-sponsored clinical studies of drugs conducted after December 27, 2000 (the date Glaxo Wellcome and SmithKlineBeecham merged) and any earlier studies that may be relevant.

(via Office of New York State Attorney General)