GlaxoSmithKline had reached a settlement with the New York Attorney General's office over its lawsuit regarding the disclosure of data on the use of Paxil (paroxetine) in children and adolescents with depression.
As a result of the settlement with the Attorney General's office, GSK has agreed to make all reasonable efforts to post data to the company's register within stated timeframes.
Although GSK believes the charges made in the litigation by the Attorney General are unfounded, the company has agreed to pay the State of New York $2.5 million to avoid the high costs and time required to defend itself in protracted litigation, GSK said in a release.
"We are pleased that the Attorney General believes the Clinical Trial Register we have been developing will provide useful information to the medical and scientific community," said Mark Werner, senior vice president for US Legal Operations at GlaxoSmithKline. "We believe that GlaxoSmithKline's initiative to launch this register is a responsible step in ensuring transparency of our clinical trial data," added Mark.
In response to public concern about access to paroxetine data in children and adolescents with depression, on June 10th GSK voluntarily posted on its corporate website full study reports of all GSK-sponsored trials with children and adolescents on Paxil. Separately, on June 18th, the company announced plans that had been underway for some months to create a clinical trial register that will provide open Internet access to clinical trial data on its marketed medicines, the result added.