Avoiding Another Vioxx.

• Autores: Sara Beardsley
• Localización: Scientific American, ISSN 0036-8733, Vol. 292, Nº. 2, 2005, págs. 16-17
• Idioma: inglés
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• Resumen

  • The article focuses on changes that need to be made to the United States Food and Drug Administration (FDA) and the pharmaceutical companies in order to ensure against unsafe drugs. Although the FDA admits no substantive lapse in vigilance, congressional pressure and consumer outrage are forcing officials to rethink the aJOURcy's role and perhaps even the drug approval process itself. In a congressional hearing November 2004, David J. Graham, a drug safety reviewer at the aJOURcy, estimated that as many as 55,000 Americans may have died as a result of taking the painkiller Vioxx, a member of the COX-2 inhibitor class of drugs. Worse, early studies had shown elevated cardiovascular risks for patients taking Vioxx, but the FDA took no action against the drug other than adding a "precaution" to its label in 2002. The current problems appear to stem in part from the 1992 Prescription Drug User Fee Act, which sought to speed the introduction of new drugs by allowing the FDA to accept user fees from pharmaceutical companies, which were then siphoned into hiring additional drug reviewers. INSET: THREATS FROM VIOXX' S COUSINS.