Medscape Cites AHRP Concerns Re: New Law Mandates More Testing of Drugs in Children Wed, 17 Dec 2003 Medscape Medical News reports about passage of the Pediatric Research Equity Act (PREA) which replaces FDA’s Pediatric Rule. The Pediatric Rule was struck down by a Federal court in Oct. 2002 because…
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…
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…
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…
Senate Finance Committee Investigating FDA brain stimulation device approval – WSJ Thu, 19 May 2005 Another major scandal is erupting about FDA’s approval decisions that contradict its medical officer’s safety concerns. The Senate Finance Committee is investigating what led the FDA to suddenly reverse its disapproval of Cyberonics’ brain stimulation…
FDA Response to Utah Court Must Be Truthful Re: Zoloft / SSRI Suicidal Risks Mon, 29 Aug 2005 Related link: FDA Amicus Curiae–Kallas–claims FDA infallibility pre-empts state safety laws (warning: large 1.6 MB file) A federal judge in Utah has asked the FDA to explain its position as it relates…
Minn. Shooter Described As Deeply Disturbed-He took Prozac – Wash Post Thu, 24 Mar 2005 The Chicago Tribune and The Washington Post confirm the suspicion that like the other adolescents who went on a school shooting rampage, Jeff Weise was taking an SSRI antidepressant. The Post identifies the drug as…
SAMHSA Backs Away From TeenScreen & TMAP Mon, 24 Oct 2005 On October 17, a meeting took place with Charles Currie in Washington DC – with some in attendance by conference call. Currie is the Administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA), the federal agency charged…
WSJ: Debate Over Antidepressants: FDA role in suppressing damaging data Tue, 25 May 2004 How were drug manufacturers able to conceal vital evidence of harmful antidepressant drug effects? The answer is becoming clearer by the day: federal regulators and the psychiatrists who tested these drugs in clinical trials are invested…
FDA Foot Dragging – Three Months After Expert Panel Urged “Black Box” Warnings for Antidepressants, No Action Thu, 23 Dec 2004 Why is the FDA failing to enforce the "Black Box" warnings on SSRI antidepressant drug labels? When questioned by the NJ Star Ledger, Robert Temple, director of the FDA’s…
Antidepressant Controversy: Media Conflicts of Interest – New York Times Thu, 25 Mar 2004 FDA’s advisory warning about antidepressant drugs received wide press coverage nationally. But few in the national media mentioned conflicts of interest as the obstacle to disclosure of evidence showing these drugs’ adverse effects. Among the few…
October 18, 2002. Pediatric Drug Tests_CNN / NYT Editorial Children are increasingly being exploited for profit by the biomedical industry. Between 1983 and 1997, children had been protected from medical experiments that are not in their best interest. But in 1997 Congress passed the FDA Modernization Act (FDAMA), providing a…
