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Paxil Settlement Requires Disclosure Of Early Phase Research

Executive Summary

The Paxil settlement between GlaxoSmithKline and New York Attorney General Eliot Spitzer sets a standard for clinical trial disclosure that goes beyond the position taken by the Pharmaceutical Research & Manufacturers of America

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A criminal investigation of whether GlaxoSmithKline delayed informing MHRA about safety issues associated with use of Seroxat (paroxetine) in patients under 18 years ends March 6 with no action against the firm. Government prosecutors conclude "there is no realistic prospect of a conviction" because laws in effect at the time were not sufficiently strong or comprehensive. Then-New York Attorney General Eliot Spitzer called GSK on its delayed reporting of the pediatric safety of paroxetine, marketed in the U.S. as Paxil, in a 2004 suit. GSK settled by agreeing to post summaries of studies for all its products on the Internet (1"The Pink Sheet," Sept. 6, 2004, p. 11)

U.K. declines to prosecute GSK over paroxetine data

A criminal investigation of whether GlaxoSmithKline delayed informing MHRA about safety issues associated with use of Seroxat (paroxetine) in patients under 18 years ends March 6 with no action against the firm. Government prosecutors conclude "there is no realistic prospect of a conviction" because laws in effect at the time were not sufficiently strong or comprehensive. Then-New York Attorney General Eliot Spitzer called GSK on its delayed reporting of the pediatric safety of paroxetine, marketed in the U.S. as Paxil, in a 2004 suit. GSK settled by agreeing to post summaries of studies for all its products on the Internet (1"The Pink Sheet," Sept. 6, 2004, p. 11)

Clinical Trials Registration Bill From Democrats Includes Monetary Penalties

A House and Senate bill mandating clinical trial registration uses institutional review board approval and civil monetary penalties to enforce compliance

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