Adverse Drug Reaction


Credibility Crisis:Survey FDA Scientists – Death in NIH-AIDS Trial – Tauzin Moves to PhRMA Thu, 16 Dec 2004 A credibility crisis in medical research is smoldering: like the Enron accounting scandal, the prescription-drug debacle is a matter of systemic corruption, including gross and widespread failure by the regulatory process. Unlike […]

Credibility Crisis: Survey FDA Scientists – Death in NIH-AIDS Trial ...


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 […]

Hoffman LaRoche Rebuffed Call to Monitor Accutane Users – USA ...


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 […]

How Health Care in America Became Big Business–And Bad Medicine ...



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 & […]

Yale Complaint


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 […]

Analysis of paroxetine Yellow Card adverse drug reaction reports (Seroxat/Paxil)




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 […]

UK issues ban on second SSRI antidepressant for children


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 […]

Risks: Drugs / Vaccines / Trials / Treatments


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 […]

Wyeth Pharma Warns Doctors Against Rx Effexor to Kids



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 […]

The Impact of the FDA Modernization Act on the Recruitment ...