Tuesday, November 30, 2004

A Taxpayer-Funded Clinical Trials Registry and Results Database
Essay at the Public Library of Science web site by Erick Turner - "Over the past several years, there has been growing concern about selective publication of clinical trial results. The debate has intensified since New York State Attorney General Elliot Spitzer filed suit against GlaxoSmithKline on June 2, 2004, alleging that the company was hiding data regarding the efficacy and safety of selective serotonin reuptake inhibitors in pediatric patients with depression. ... In this essay, I argue that a highly valuable but underused registry and results database for US trials already exists within the Department of Health and Human Services, specifically within the Food and Drug Administration."  
  

Reform of Postmarketing Drug Surveillance System Needed, Experts Say
Medscape Medical News story - "Early approval of new drugs in the U.S. is a double-edged sword, allowing the public rapid access to the health benefits of new drugs, yet potentially exposing them to serious adverse effects recognized after the drug launch. Much of the burden of early detection falls on the U.S. postmarketing systems. Recent congressional testimony by a reviewer from the U.S. Food and Drug Administration (FDA), and a study and several articles published in the Dec. 1 issue of JAMA and released online Nov. 22, have fueled the controversy over whether conflicts of interest could influence evaluation of suspected adverse drug reactions." [Viewing Medscape resources requires registration, which is free].