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Complaint about a surge of FDA administrative approvals for expanded use of highly toxic antipsychotic drugs for children. Approvals were determined by Dr. Thomas Laughren after secret deliberations–without disclosure of scientific data, without  an advisory panel or open public discussion. 

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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 this profitable enterprise have until…

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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 are the problem.” Feb 12,…

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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 that the Seroxat is not…

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AHRP Campaign to Protect Children from Harm Oct 15: FDA Orders Black Box Warnings on Antidepressants labels and Patient Information Guides to Warn about Suicide risk Oct 3: BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical Deception Sep 30: GSK Sales Reps told NOT to Divulge Paxill Data / Merck Withdraws Vioxx Sep…

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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 statement as to whether data…

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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 maker having all the relevant…

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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 a new and accurate method…

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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 product Relafen, and weaker sales…

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