Antidepressant Ban for Kids Puts Pressure On U.S. / Canada Mon, 15 Dec 2003 The British government ban for use of all but one SSRI antidepressant drug in children and teens (Dec 10, 2003) is reverberating wherever these drugs are widely prescribed. The action was taken after an independent committee…
Lead author of JAMA article rethinks positive Zoloft report – Guardian Wed, 1 Oct 2003 In August 2003, the Sertraline Pediatric Study Group reported: “Sertraline-treated patients experienced statistically significantly greater improvement than placebo.” Their report was published in the authoritative Journal of the American Medical Association (JAMA). The authors claimed…
FDA Warning Letter: child died from overdose during clinical trial Monday, May 05, 2003 The FDA’s letter of warning to Jacqueline M. Halton, M.D. Children’s Hospital of Eastern Ontario, a participating investigator in a National Cancer Institute pediatric trial describes multiple safety violations–including massive overdoses–that led to the death of…
FDA Is Flexing Less Muscle where Safety is the Issue – Wash Post Thu, 18 Nov 2004 The Washington Post examines FDA’s record of surveillance and the evidence is clear: since 1992 when Congress required drug companies to pay users fees to the FDA, the agency’s focus changed from safety…
FDA Official Calls Newsletter Unethical – WP / Senate Considers Safety Reform at FDA – LAT Fri, 4 Mar 2005 The Washington Post reports about yet another instance of a high FDA official who misspoke. Dr. Sandra Kweder, Deputy Director of FDA’s Office of New Drugs, sent a letter, “written…
10 of 32 FDA Vioxx Panelists Had Industry Ties_NYT / Cozy NIH Review “Clears” NIH Industry Ties_WashPost Fri, 25 Feb 2005 The latest example of the corrupting influence of the pharmaceutical industry on health care policy is the composition of FDA’s advisory panel that last week endorsed the marketing of…
FDA says it Screened Panelists for Conflicts of Interest Tue, 1 Mar 2005 Bloomberg News reports that the Center for Science in the Public Interest had identified not 10, but 27 panelists on FDA’s advisory panel who had financial ties to drug manufacturers. Last week The New York Times reported…
FDA Requests Anticonvulsant Suicide Data Analysis – Boston Globe Wed, 20 Apr 2005 Thanks to the persistent advocacy efforts of attorney, Andrew Finkelstein, the FDA has finally sent letters to 14 manufacturers of anticonvulsant drugs, such as Pfizer’s Neurontin, to examine the suicide data from these drugs. Finkelstein began his…
Dissenting Opinion: Against Waiving Parental Permission for Research July 25, 2001 To: Mary Faith Marshall, Ph.D, Chairperson, National Human Research Protections Advisory Committee Department of Health and Human Services Re: Specific Comment on FDA’s Decision to Adopt HHS 45 CFR 46 Subpart D, EXCLUDING §46.408 (c) Dissenting opinion of Vera…
FDA response to AHRP procedural questions From: Cerny, Igor Sent: Wednesday, January 07, 2004 11:52 AM To: Cc: Patel, Anuja; Laughren, Thomas P Subject: RE: FDA Advisory Committee Meeting: Procedural Concerns Follow Up Flag: Follow up Flag Status: Flagged Dear Ms. Sharav: Thank you for your email of December 1,…
Infomail 2004 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 31: FDA to review “missing” drug company documents Dec 30: Family of Woman Killed by AIDS Drug Test Sues Doctors, Manufacturer Dec 30: Doctors, Too, Ask: Is This Drug Right? Dec 29: Bill would shield…
Accutane Suicide Controversy–small study finds depression reduced Tue, 17 May 2005 Accutane–a drug prescribed for acne has been linked to suicide and birth defects–it carries bold warnings about birth defects. A small non-blinded study finding is being touted by Hoffman-La Roche, manufacturer of Accutane. The study found the drug did…
