GSK settles US antidepressant lawsuit with $2.5 million
pharmafile | September 1, 2004 | News story | |
GlaxoSmithKline has paid $2.5 million to the State of New York in an out-of-court settlement of the lawsuit alleging it deliberately withheld data about the safety of antidepressant Paxil in children.
The company says it maintains that it did nothing wrong, and that allegations brought by New York State Attorney General Eliot Spitzer are unfounded, and said it was paying the sum to avoid the high cost and time required for a lengthy trial.
One condition demanded by the State Attorney was the publication of all data relating to the drug, a demand pre-empted by GSK, which in June became the first pharma company to pledge complete online access to all data for marketed drugs.
The settlement will be a welcome relief for GSK, whose marketing and data publication practices would have faced intense scrutiny in a court case, which could potentially have resulted in a large fine, further undermining public confidence in the company and its products.
Reports of patients suffering from a number of serious side-effects on Paxil (known as Seroxat in the UK) sparked an inquiry by regulators in the UK and then the US into all the drugs in its class, the SSRIs.
Both regulators have now demanded label warnings of suicidal feelings, but these could be strengthened in the coming months when their inquiries are concluded.
Spitzer's lawsuit alleged GSK had committed 'repeated and persistent fraud' by withholding negative information about its antidepressant, including a possible increased suicide risk in children and adolescents.
The State Attorney welcomed the settlement and said its insistence on the company's new openness was a breakthrough for patients and healthcare professionals.
"By agreeing to release both positive and negative studies about the safety and efficacy of its drugs, GSK has set an example for the entire pharmaceutical industry," Spitzer said.
The company has agreed to put online by the end of 2005, summaries of results for all GSK-sponsored clinical studies of drugs conducted since 27 December 2000, when Glaxo Wellcome and SmithKline Beecham merged, and any earlier studies that may be relevant.
Mark Werner, senior vice president for US Legal Operations at GSK said: "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. We believe that GlaxoSmithKline's initiative to launch this register is a responsible step in ensuring transparency of our clinical trial data."
The register will include information about the effectiveness of the drug, the type and severity of any adverse side-effects, whether the trial endpoints or other components were changed after it started, and whether the study was terminated early and why.
Summary clinical trial information will usually be available no later than ten months after the drug is first marketed and GSK will advertise the availability of the Clinical Trials Register in major medical journals in the US.
GSK will also ensure all Medical Information Letters and other communications with doctors concerning off-label use of Paxil and other drugs will 'fairly and accurately' reflect data from clinical studies.
The suit also alleged GSK then failed to disclose this information in 'Medical Information Letters' that it sent to physicians.
Related links:
GlaxoSmithKline 'misled doctors' over antidepressant safety
Thursday , June 03, 2004
