GlaxoSmithKline settles lawsuit, agrees to release negative data on antidepressant Paxil
Thursday, August 26th 2004, 10:38 am
By: News On 6
ALBANY, N.Y. (AP) _ GlaxoSmithKline PLC agreed Thursday to release negative data on the safety and effectiveness of its antidepressant drug Paxil to settle a lawsuit by New York's attorney general that accused the pharmaceutical maker of misrepresenting data on prescribing the drug to children.
GlaxoSmithKline will put summaries of all its studies since December 2000 on its Web site. 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 as part of the settlement.
New York Attorney General Eliot Spitzer sued the company for fraud in June, alleging the company withheld the negative information. The suit struck at drug companies' responsibility to show whether antidepressants increase suicidal tendencies in children and whether the companies skew information on their products by not publicizing all the studies conducted on medicines or editing information on published trials.
A company spokeswoman had no immediate comment.
``This was nothing more than an attempt to let doctors be doctors and make informed decisions,'' Spitzer said Thursday.
Spitzer said GlaxoSmithKline's new standard will also drive the industry, in part because investors and funders of research will be drawn to a firm that is a leader in disclosure of product data.
``The immediate impact is sending a signal to the other pharmaceutical manufacturers that this is the new standard with regard to disclosure of clinical studies,'' said Joe Baker, Spitzer's health care bureau chief. Additional investigations of other drug firms continues, he said.
``We will continue to do that until we feel this industry as a whole has stopped this practice,'' Baker said.
Spitzer said Glaxo conducted at least five studies on the use of Paxil in children and adolescents, but released one that showed mixed results on its effectiveness. The Democrat accused the firm of suppressing the negative results that failed to show Paxil was effective and might increase the risk of suicidal thoughts and acts in some youths. Spitzer also accused the firm of omitting the negative data from ``Medical Information Letters'' to physicians, according to the settlement filed in U.S. District Court in Manhattan.
A key to Spitzer's case was an internal 1999 Glaxo document showed that the company intended to ``manage the dissemination of data in order to minimize any potential negative commercial impact.''
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 such medicines for children suffering from depression and other psychological disorders.
In May, a Journal of the American Medical Association article that reviewed 102 clinical trials found that 50 percent of efficacy outcomes and 65 percent of harm outcomes were incompletely reported. The article concluded that trial outcomes are frequently incomplete, biased and inconsistent with protocols.