“Glaxo Settles Suit Over Paxil Studies”
Reuters - August 26, 2004
NEW YORK (Reuters) - GlaxoSmithKline has agreed to disclose information on all clinical studies of its drugs to settle a lawsuit that accused it of withholding negative information about the antidepressant Paxil, the New York Attorney General's office said on Thursday.
GlaxoSmithKline has agreed to pay $2.5 million and will register the results of clinical trials, detailing safety and drug effectiveness, for all studies done after Dec. 27, 2000, and relevant earlier studies, New York Attorney General Eliot Spitzer said.
Spitzer, in a lawsuit filed in June, had accused GlaxoSmithKline of concealing studies that showed Paxil may not work when used to treat children and could lead to suicidal behavior.
The lawsuit said GlaxoSmithKline had conducted at least five studies on the use of Paxil in children and adolescents, but released only one of the studies.
The company called the charges "unfounded" and said it settled to avoid costly and time-consuming litigation involving Paxil, which now faces generic competition after generating worldwide sales of $3 billion in 2003.
GlaxoSmithKline said on June 18 it would reveal details of its clinical studies. Spokeswoman Nancy Pekarek said the settlement gives the company a formal disclosure timetable.
Summaries of the clinical studies are expected to be posted online between now and Dec. 31, 2005, Spitzer said.
The drug industry has been criticized for keeping quiet about negative results from clinical trials, since bad publicity would make product marketing more difficult.
The American Medical Association (AMA) said in June it was urging the U.S. Department of Health and Human Services to create a registry for clinical trials to address growing concerns about clinical trials.
Some medical publications are mulling a proposal for trials to be listed in a registry before results would be considered for publication, the AMA said.
GlaxoSmithKline published its Paxil studies on its corporate Web site in June in response the public concerns, the company said.
Eli Lilly and Co. (LLY.N: Quote, Profile, Research) said earlier this month that it will publish data on clinical trials for the drugs it sells. For trials conducted after approval of a particular drug, Lilly would publish results as soon as possible, but no later than a year after completion of a study.
GlaxoSmithKline's summaries of clinical studies completed after the settlement for drugs already receiving approval will be posted online no later than 10 months after the drug is first marketed, Spitzer said.
GlaxoSmithKline will also advertise the availability of the clinical trials register in major medical journals, Spitzer said.
Shares of GlaxoSmithKline (GSK.N: Quote, Profile, Research) rose 66 cents, or 1.64 percent, to $40.94 on the New York Stock Exchange.