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 says.
GlaxoSmithKline has agreed to pay $2.5 million (1.4 million pounds) and will register the results of clinical trials, detailing safety and drug effectiveness, for all studies done after December 27, 2000, and relevant earlier studies, New York Attorney General Eliot Spitzer said on Thursday.
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 behaviour.
The lawsuit said GlaxoSmithKline had conducted at least five studies on the use of Paxil, which is facing generic competition after generating world-wide sales of $3 billion in 2003, in children and adolescents, but released only one of the studies.
The company said the charges are “unfounded” and said it settled to avoid costly and time-consuming litigation.
GlaxoSmithKline on June 18 said it would reveal details of its clinical studies, but the settlement gives the company a formal timetable to disclose those studies, Glaxo spokeswoman Nancy Pekarek said.
Summaries of the clinical studies are expected to be posted online between now and December 31, 2005, Spitzer said.
The drug industry has been criticised for keeping quiet about negative results from clinical trials, since bad publicity would make product marketing more difficult.
GlaxoSmithKline published its Paxil studies on its corporate Web site in June in response the public concerns, the company said.
Eli Lilly 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 the 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.