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…
FDA Accepts Adverse Drug Reaction Reports from Consumers Sun, 22 Jun 2003 Doctors report only 1% to 10% of adverse drug reactions experienced by their patients to FDA’s MedWatch service. The FDA has extended an invitation to the public to submit adverse drug reaction reports directly to the agency: http://www.fda.gov/medwatch/report/consumer/consumer.htm…
Intimidation, Politics and Drug Industry Cripple U.S. Medicine – FDA Permits Dr. David Graham to publish Vioxx Report Wed, 5 Jan 2005 FDA officials could not maintain their iron grip in an effort to suppress evidence of far reaching lethal effects of Vioxx when their actions were in full public…
BBC Panorama: Unprecedented public response to evidence of SSRI drug harm Wed, 21 May 2003 In a stunning follow up to its investigative report, The Secret of Seroxat, aired October 13, 2002, the British Broadcasting Company (BBC) featured the public responses to its earlier program as the focus of its…
September 16 2002 Note: Paroxetine Hydrochloride is also known as Seroxat or Paxil 800 hooked on drug seek legal action Patients say warning on side effects inadequate The Guardian Sarah Boseley, health editor More than 800 men and women who have found themselves hooked on the antidepressant Seroxat are seeking…
Prescription: Suicide? – A Documentary Film about a 12 year old child prescribed Zoloft Sat, 15 Oct 2005 Prescription: Suicide? is a documentary film about Candace Legh Downing, a 12-year old girl who was anxious about certain school tests. A child psychiatrist prescribed the antidepressant, Zolfot, and soon after she…
Leading Antipsychotic Drugs Come Under New Scrutiny – NYT Tuesday, May 20, 2003 A front page article in The New York Times reveals that the pillars of American psychiatry–including Dr. Jeffrey Lieberman, Dr. John Kane, Dr. William Carpenter–are acknowledging that evidence is lacking to support the claims that the new…
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…
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…
Lilly duloxetine drug trial–19 Quit after a suicide – Philadelphia Inquirer Fri, 13 Feb 2004 19-year old Teri Johnson’s suicide occurred one week after an FDA advisory committee had urged the FDA to issue warnings about prescribing antidepressant drugs for children under 18 because of an increased risk in suicide….
Spitzer Expands drug Probe: Johnson & Johnson / New FDA analysis Confirms SSRI Risks to Kids – WSJ Thu, 5 Aug 2004 A front page article in The Wall Street Journal reports that a second FDA analysis of 25 clinical trials of SSRI antidepressants in children was conducted after a…
THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Abstract This paper argues that contrary to the claims made by the research stakeholders in industry, academia and government, the…
