GlaxoSmithKline Will Release Drug Studies
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ALBANY, N.Y. – GlaxoSmithKline PLC agreed Thursday to release information on its drug studies, including negative findings on the antidepressant Paxil, to settle a lawsuit in which New York’s attorney general accused the company of fraud.
The company is the first major drug maker to agree to disclose all its studies. GlaxoSmithKline will put summaries of studies since December 2000 on its Web site. The company also will pay $2.5 million to the state as part of the settlement.
Attorney General Eliot Spitzer sued the company in June, alleging it withheld negative information and misrepresented data on prescribing Paxil to children.
The lawsuit asserted that drug companies have a responsibility to show whether antidepressants increase suicidal tendencies in children. It also argued that the companies skew information on their products by not publicizing all the studies conducted on medicines or editing information on published trials.
A GlaxoSmithKline spokeswoman, Nancy Pekarek, said the company still feels Mr. Spitzer’s civil charge of fraud is unfounded and that the settlement accepts disclosure policies the company had been working on for months, even before Mr. Spitzer’s lawsuit was filed.
She said the company would try to post data by December 31, 2005, on clinical trials since the company was created in a December 2000 merger. Test results from this week forward will be posted within 10 months of a drug’s approval, she said.
Mr. Spitzer said GlaxoSmithKline’s standard will drive the industry, in part because investors and funders of research will be drawn to a company that is a leader in disclosure of product data.
Investigations into other drug companies continue, said Mr. Spitzer’s health care bureau chief, Joe Baker. “We will continue to do that until we feel this industry as a whole has stopped this practice,” Mr. Baker said.
Mr. Spitzer said Glaxo conducted at least five studies on the use of Paxil in children and adolescents, but he accused the company of suppressing results that failed to show Paxil was effective and might increase the risk of suicidal thoughts or acts in some youths.
Mr. Spitzer also accused the company of omitting the negative data from “Medical Information Letters” to physicians, according to the settlement filed in U.S. District Court in Manhattan.
Only Prozac, made by Eli Lilly & Co., has been approved to treat depression in children. But doctors can prescribe drugs as they see fit and routinely recommend other such medicines for children suffering from depression and other psychological disorders.
In May, a Journal of the American Medical Association article found that 50% of efficacy outcomes and 65% of harm outcomes were incompletely reported.