FDA reviews depression drugs–Intense or Cautious? WashPost/ NYT/ Herald

FDA reviews depression drugs–Intense or Cautious? WashPost/ NYT/ Herald Wed, 29 Oct 2003 The Washington Post correctly reports: “The association between antidepressants, particularly the selective serotonin reuptake inhibitors (SSRIs), and suicide has been controversial since the first SSRI, Prozac, came on the market in the late 1980s.” But stakeholders in…

AHRP in the News

Alliance for Human Research Protection in the Press Feb 17, 2005: FDA Critics Slam Plan for Safety Reform – Nature “This is smoke and mirrors and musical chairs,” says Vera Sharav, president of the New York-based Alliance for Human Research Protection. “They will be using the very same officials that…

Unreported Paxil suicides: company abandons "No Addiction" claim

Unreported Paxil suicides: company abandons “No Addiction” claim Sat, 10 May 2003 GlaxoSmithKline, Britain’s biggest pharmaceutical company will change the label in the UK to reflect the severe withdrawal that its antidepressant drug, Seroxat (Paxil in US) generates in many patients. In Britain, the package label will no longer claim…

Article

Letter from David Healy, MD to Peter J. Pitts Executive Summary of suicidal evidence not addressed by FDA In the light of Traci Johnson’s death on February 7th 2004, will FDA obtain Pfizer’s entire folder on the 1982 Hindmarch study in which healthy volunteers were given Zoloft, and make a…

IMR Model for Extrapolating Number of SSRI-Related Suicides

27 April 2004 Background Information Representative, U.S. The Honorable Mr. Joe Barton, United States House of Representatives. Washington DC. Representative, U.S. The Honorable Mr. James Greenwood, United States House of Representatives, Washington DC. Number of US Citizens at Risk to SSRIs This letter is to advise you that there is…

What’s in a Warning? Antidepressants and Risk of Suicide – FindLaw

What’s in a Warning? Antidepressants and Risk of Suicide – FindLaw Thu, 22 Apr 2004 Contrary to the published reports in the peer-reviewed journals, the preponderance of evidence demonstrates that antidepressants pose a greater risk than a benefit for children. *[References below] Informed medical treatment decisions hinge on the decision…

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Risks: Drugs / Vaccines / Trials / Treatments

Risks: Drugs / Vaccines / Trials / Treatment Evidence of antidepressant harm Oct 14, 2005: Andrew Finkelstein Letter to Dr. Russell Katz, Director, Neuropharmacological Drug Products, FDA about FDA’s Failure to Warn about Neurontin-Suicides Aug 29: FDA Response to Utah Court Must Be Truthful Re: Zoloft / SSRI Suicidal Risks…

GlaxoSmithKline CEO: "We had to absorb a number of hits"

GlaxoSmithKline CEO: “We had to absorb a number of hits” Mon, 16 Feb 2004 Antidepressant drug safety issues are beginning to have a financial impact. Dow Jones reports: “GlaxoSmithKline PLC said its net income fell 6% in the fourth quarter, hurt by previously announced legal costs related to its anti-inflammatory…

Infomail Archive 2004

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…