Hoffman LaRoche Rebuffed Call to Monitor Accutane Users – USA Today Tue, 7 Dec 2004 An investigative cover story in USA Today – Drugmaker Rebuffed Call to Monitor Users–affirms the indispensable role of litigation in bringing the facts about adverse drug effects to public knowledge. Lawsuits against Hoffman-La Roche, manufacturer…
ALLIANCE FOR HUMAN RESEARCH PROTECTION* (AHRP) April 10, 2000 Gary Ellis, Ph.D, Director Michael A. Carome, M.D. Chief Compliance Oversight Branch Division of Human Subject Protections Office of Protection from Research Risks Rockville, MD 20892-7507 Re: High Risk Experiment With Children Who Have No Medical Diagnosis Dear Dr. Ellis &…
How Health Care in America Became Big Business–And Bad Medicine – OpEd NYT Zoloft NYT Ad Fails to Disclose Suicide risk Mon, 25 Oct 2004 An Op-Ed in Sunday’ New York Times by Time magazine editors, Donald Barlett and James Steele, is a MUST READ assessment of what ails America’s…
Analysis of paroxetine Yellow Card adverse drug reaction reports (Seroxat/Paxil) Thu, 20 Nov 2003 A unique analysis of the British Yellow Card Reporting system for adverse drug reactions (ADR) found that the nature, the scope and severity of ADRs relating to drug dependency and suicidal behavior from the antidepressant paroxetine…
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…
UK issues ban on second SSRI antidepressant for children Sun, 21 Sep 2003 The UK Observer reports (below) that although antidepressant drugs of the SSRI class have not been approved for children, last year doctors (who are unaware of the severe risks associated with SSRIs) wrote 170,000 prescriptions of antidepressants…
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…
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…
Wyeth Pharma Warns Doctors Against Rx Effexor to Kids Tue, 2 Sep 2003 View Wyeth Warning Letter The Hartford Courant reports that the latest warning against prescribing an antidepressant drug for children comes from Wyeth Pharmaceuticals, makers of Effexor, a drug just like Prozac, Zoloft, and Paxil–a class known as…
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…
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…
