N.Y. AG Spitzer Criticizes FDA "Silence" On Disclosing Rx Trial Data

In a speech at the National Press Club, Eliot Spitzer discusses his lawsuit against GlaxoSmithKline that resulted in a settlement in which the company will publicly disclose clinical trial data. He says FDA "has not said a word" that would require other drug manufacturers to do the same.

FDA has been "nowhere" on the issue of drug manufacturers posting data from clinical trials of their products, New York Attorney General Eliot Spitzer said.

During a speech at the National Press Club Jan. 31, Spitzer described his recent lawsuit against GlaxoSmithKline for concealing pediatric trial data for the antidepressant Paxil . The suit resulted in a settlement in which the company agreed to post summaries of clinical trial protocols and results on a GSK website (¹ (Also see "GSK Settles With N.Y.; Company Will Post Past Trial Data By End Of 2005" - Pink Sheet, 26 Aug, 2004.)).

"Where has the FDA been on this issue? Nowhere. Silence," Spitzer said.

"It's simply a matter of decency, disclosure and integrity, and yet this FDA has not said a word about revealing this critically important data so that doctors can make informed judgments," he added.

By law, drug companies are required to post trial information for serious or life-threatening diseases on a website, www.ClinicalTrials.gov, maintained by the National Library of Medicine. FDA has not taken enforcement action against any companies that failed to comply.

The Pharmaceutical Research & Manufacturers of America member companies recently committed to posting study information to the ClinicalTrials.gov database for all diseases and conditions.

Forest is also posting trial information on its own website after a settlement with the New York AG (² (Also see "Forest Settles With Spitzer, Will Post All Phase III-IV Results On-Line" - Pink Sheet, 7 Sep, 2004.)).

Spitzer is seeking the Democratic nomination to run for governor of New York.

- Scott Steinke