Texas Attorney General Joins Whistleblower Lawsuit against J & J
Two ground breaking legal actions in Texas to rein in out of control psychotropic drug prescribing will have nationwide reverberations.
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Anthrax Vaccine Not Safe and Effective – Emergency Medicine News
July 18, 2002 Anthrax Vaccine Not Safe and Effective – Emergency Medicine News FYI In her letter in the July issue of Emergency Medicine News (below) Dr. Meryl Nass cites a body of evidence linking the anthrax vaccine with systemic adverse medical reactions, and 100,000 to possibly 200,000 veterans who…
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The Impact of the FDA Modernization Act on the Recruitment of Children for Research
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…
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FDA Official Calls Newsletter Unethical – WP / Senate Considers Safety Reform at FDA – LAT
FDA Official Calls Newsletter Unethical – WP / Senate Considers Safety Reform at FDA – LAT Fri, 4 Mar 2005 The Washington Post reports about yet another instance of a high FDA official who misspoke. Dr. Sandra Kweder, Deputy Director of FDA’s Office of New Drugs, sent a letter, “written…
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Infomail Archive, 2005
Infomail 2005 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Subscribe to the AHRP infomail list Dec 16: Drugs, Devices & Doctors – NYT Paul Krugman Dec 11: Scientific Fraud & Corruption on Both sides of Atlantic: Merck / Proctor & Gamble Dec 11: Gov Accountability…
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Director of OHRP Dr. Greg Koski resigns
Director of OHRP Dr. Greg Koski resigns Date: Wed, 16 Oct 2002 Dr. Greg Koski has tendered his resignation as director of the federal Office of Human Research Protections. We agree, in principle, with Dr. Koski’s assessment: “to preserve public trust in research, the scientific community must go beyond a…
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Credibility Crisis: Survey FDA Scientists – Death in NIH-AIDS Trial – Tauzin Moves to PhRMA
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…
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Research Protection: SCIENCE / Fed Paper
Research Protection: SCIENCE / Fed Paper Mon, 28 Oct 2002 SCIENCE magazine (below) reported about “the bumpy road” of Dr. Greg Koski’s tenure as director of the federal Office of Human Research Protections (OHRP), and how his resignation is being perceived by some. An article in The FEDERAL PAPER focused…
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IOM Committee Considers Prison Research
IOM Committee Considers Prison Research Sun, 24 Jul 2005 Today¹s New York Times Magazine cover story, Planet of the Retired Chimpanzees By CHARLES SIEBERT, reports that chimpanzees who have served as subjects in biomedical research can look forward to being set free in one of 12 specially built chimp sanctuaries…
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Safety of American Drugs Questioned – Assoc Press
Safety of American Drugs Questioned – Assoc Press Thu, 2 Dec 2004 In his CNN news program last evening, Lou Dobbs said the question is no longer whether something is wrong with the FDA’s performance in protecting the public from unsafe drugs–but whether the FDA can even be salvaged? The…
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IOM Panel Misses the Point Test Subjects
Institute of Medicine (IOM) Panel Misses the Point re Test Subjects October 3, 2002 See also the following Institute of Medicine of the National Academy of Sciences documents: IOM Report: Responsible Research: A Systems Approach to Protecting Research Participants. Oct. 3, 2002 (Adobe Acrobat document) IOM Public Briefing – October…
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Congress Bars EPA from accepting human pesticide data
Congress Bars EPA from accepting human pesticide data Thu, 28 Jul 2005 Thank you Senator Barbara Boxer and Representative Hilda Solis for leading the charge to stop the Environmental Protection Agency in its tracks. The EPA was formulating rules that would have oveturened the Nuremberg Code prohibition against using poisonous…