Letter of Complaint to FDA Commissioner, 2007

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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.  Continue reading →

MEDIA ALERT: Drug Victim advocates and Expert Scientists and Physicians

Expert Scientists, Psychiatrists, a Primary Care Physician, a Leading Attorney, will shed light on FDA’s Review of selected data Re: Antidepressants and Adult Suicidality  One day prior to FDA’s  Advisory Committee Hearing, December 13.

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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 . . . Continue reading →

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 . . . Continue reading →

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 . . . Continue reading →

Research Protection for Children

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 . . . Continue reading →

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 . . . Continue reading →

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] . . . Continue reading →

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 . . . Continue reading →