GSK Settles On Paxil Data Disclosure, Will Post Past Study Results By 2006

GlaxoSmithKline will post summaries of studies conducted since the merger of Glaxo Wellcome and SmithKline Beecham by the end of 2005 under a settlement with New York Attorney General Eliot Spitzer.

"Summaries of clinical study reports with a study completion date that occurred between Dec. 27, 2000" and the settlement date "or which occurred prior to Dec. 27, 2000, but are likely to be material to a physician's medical judgment, will be posted by Dec. 31, 2005" to GSK's clinical trials register, an Aug. 26 ¹ consent order says.

Spitzer filed suit against GSK in New York Supreme Court June 2 based in part on the company's failure to publish clinical data on the use of the antidepressant Paxil (paroxetine) in younger patients (² (Also see "GSK Faces New York Suit Over Paxil: Publish Or Punish?" - Pink Sheet, 7 Jun, 2004.), p. 3).

GSK announced its intention to create an electronic database to provide summaries of trial protocols and results for GSK-sponsored trials on June 18 (³ (Also see "GSK Posts Paxil Pediatric Data On Website; Plans U.S. Clinical Trial Register" - Pink Sheet, 21 Jun, 2004.), p. 7). The website will be active shortly, GSK said.

For ongoing studies of currently marketed products, GSK has 10 months from the completion of the trial to post the data. Trial summaries for products approved after the settlement must be posted within 10 months of first marketing.

The study completion date is defined as "the date on which the last observation is made either of the last patient who remains enrolled in the clinical study or following a decision to terminate the clinical study early, whichever happens first."

A posting deadline of eight months from study completion is imposed on studies for which a peer reviewed journal has not accepted an article for publication or a journal agrees to publish an article whether or not GSK posts the summary of the study, the ⁴ settlement documents state.

"GSK will also make reasonable effort to encourage the publication of...studies in which GSK had a significant participation but did not sponsor," the document states.

Confidentiality agreements with other parties may postpone posting of trial data, the document notes. Therefore, "in all future clinical studies GSK will use reasonable efforts to exclude provisions limiting the publication of summaries of clinical study reports."

Spitzer hailed the settlement as setting a new standard for the disclosure of drug information. "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 industry," the AG's office said.

Aside from the data posting requirements, GSK will pay a relatively modest $2.5 mil. disgorgement fee. Spitzer had sought disgorgement reflective of GSK's profits on its $55 mil. in 2002 Paxil sales for treating mood disorder in children and adolescents

In negotiating the settlement, GSK had a opportunity to shape what could become de facto industry standards for release of trial information. Future legislative or legal action will likely look to the settlement as a framework for the timing and nature of trial disclosure.

Industry faces pressure from medical groups and Congress to be more proactive on trial disclosure. The American Medical Association called on HHS to create a national clinical trials registry (⁵ (Also see "HHS Registry Of Clinical Trials Proposed By AMA To Limit Publication Bias" - Pink Sheet, 21 Jun, 2004.), p. 6). Sen. Edward Kennedy (D-Mass.) has been working on legislation for a database that might be modeled after FDA's ClinicalTrials.gov, and the Pharmaceutical Research & Manufacturers of America has endorsed the concept of an industry database (⁶ (Also see "Clinical Trial Database Endorsed By PhRMA; Proposal Coming Soon" - Pink Sheet, 16 Aug, 2004.), p. 3).

Congressional committees have also been questioning industry and FDA about the disclosure negative safety data in pediatric antidepressant patients. FDA is considering further revisions to class labeling based on additional analysis (see ⁷ (Also see "Antidepressant Suicidality Needs Interim Risk Management, FDAer Maintains" - Pink Sheet, 30 Aug, 2004.) ).

The effects of the GSK-Spitzer settlement should be quite publicly visible; the company must advertise its register in seven prominent, peer reviewed journals.

GSK must arrange and pay for ads to run "between the front cover and the first article in the journal," and "each advertisement must be at least one-half page in size." Publication of the ads will be arranged within two weeks of the settlement date to run in the next available print and electronic editions.