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…
Artificial Heart Implant Leads to Suit Over Consent Process Recipient’s Widow Says She and Her Husband Were Misinformed and Misled on Risks, Benefits By Debbie Goldberg Special to The Washington Post Saturday, November 30, 2002; Page A03 http://www.washingtonpost.com/ac2/wp-dyn/A54921-2002Nov29?language=printerwashingtonpost.com PHILADELPHIA, Nov. 25 — When James Quinn, a 51-year-old Vietnam veteran dying…
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…
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 Warning Letter Below are images of the warning letter regarding prescribing information for the use of Effexor in children and adolescents. It was sent by Wyeth to health care professionals on August 22, 2003. You may click on each image to see a larger version. Wyeth letter, page 1:…
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…
Psychiatry Research 117 (2003) 127Â135. Premature mortality in schizophrenia: a 7.5-year study. Maria G. Morgan , Paul J. Scully , Hanafy A. Youssef , a,b a,b a Anthony Kinsellac, John M. Owensa, John L. Waddingtona,b,* http://psychrights.org/Research/Digest/NLPs/MM-PsychRes2003.pdf (100 KB pdf via psychrights.org) Abstract While premature death in schizophrenia is well recognised,…
Evidence of Antidepressant Harm that the FDA Sought to Suppress from FDA’s Public Advisory Committee Meeting on February 2 Evidence was presented on February 2 at AHRP’s press briefing by the following scientists: David Healy, MD, Director of the North Wales Department of Psychological Medicine and Visiting Professor, University of…
Eli Lilly’s new Prozac Fact Sheet (image below) sent to UK physicians–but not to US physicians–states that Prozac is NOT RECOMMENDED FOR CHILDREN for any indication. For a larger view, please click on the image.
U.K. Government Issues New Warnings Re: Use of antidepressant drugs for children Sept. 2003 note: click on text image for larger picture related link: Sept 23, 2003 infomail
Below is an image of an Eli Lilly letter which informs doctors in the UK that Prozac is no longer authorized for use in (so-called) premenstrual dysphoric disorder (PMDD). For a larger view, please click on the image.
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…
