FDA Officials Tried to tone Down Report of 27,000 heart attacks on Vioxx – WSJ – WashPost Sun, 10 Oct 2004 The FDA attempted to block a senior medical officer from making his findings known about the lethal hazards of Vioxx: Senator Chuck Grassley stated: “Instead of acting as a…
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…
Schizophrenia drugs increase diabetes risk Fri, 29 Aug 2003 A large scale study by the Veterans Administration corroborates a body of evidence demonstrating that the much touted “improved” newer drugs for the treatment of schizophrenia–Zyprexa, Risperdal, Seroquesl– are precipitating the onset of diabetes at alarming rates– especially among younger patients….
Was Traci Johnson driven to suicide by anti-depressants? That’s a trade secret, say US officials Sun, 19 Jun 2005 The dirty secret is finally tumbling out: Government agencies that are supposed to protect the public interest are shielding drug manufacturers by helping to conceal deaths and suicides in drug experiments….
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…
Lead author of JAMA article rethinks positive Zoloft report – Guardian Wed, 1 Oct 2003 In August 2003, the Sertraline Pediatric Study Group reported: “Sertraline-treated patients experienced statistically significantly greater improvement than placebo.” Their report was published in the authoritative Journal of the American Medical Association (JAMA). The authors claimed…
Additional information as of late Wed Oct 19: Although I was assured that attendance for a presentation by Dr. David Healy (at Columbia University School of Public Health on Oct. 20 at 12:30) would be open to the public, a problem seems to have emerged after an AHRP Infomail about…
Protecting People with Mental Disabilities and Impairments against Biomedical Research Abuse[*] By John H. Noble, Jr., Ph.D, The Catholic University of America, Washington, DC, USA Vera Hassner Sharav, MLS, Alliance for Human Research Protection, New York, USA People with mental disabilities and impairments historically have been targeted by biomedical researchers…
Scientific Misconduct Notices News Stories on Human Research Protection and Commentary by Vera Hassner Sharav April 22, 2002 Scientific misconduct is a big problem undermining the integrity of the scientific literature. Data falsification leads others to erroneous conclusions that may have adverse consequences for patients in clinical research and clinical…
Data from Unpublished Trials Suggest that Most SSRI Antidepressant Drugs Unsuitable for Children Wed, 21 Apr 2004 An independent analysis in next week’s The Lancet compares the published and unpublished data of pediatric SSRI antidepressant clinical trial data, finding the published reports not to be evidence-based. “In a global medical…
Are SSRIs and Atypical Antidepressants Safe / Effective for Children / Adolescents/ Neonates? Wed, 2 Mar 2005 The American psychiatric establishment continues to operate within a “head in the sand” culture of denial when confronted with compelling evidence that has been scientifically replicated showing that their prescribing of antidepressants for…
Hormone Replacement Raises Dementia Risk in Women_NYT Wed, 28 May 2003 The false premises that for 50 years had guided gynecologists to prescribe hormone replacement therapy (HRT) for menopausal women is the most compelling case demonstrating the health hazards that follow when medical practice comes under influence of the drug…
