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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Article
FDA response to AHRP procedural questions From: Cerny, Igor Sent: Wednesday, January 07, 2004 11:52 AM To: Cc: Patel, Anuja; Laughren, Thomas P Subject: RE: FDA Advisory Committee Meeting: Procedural Concerns Follow Up Flag: Follow up Flag Status: Flagged Dear Ms. Sharav: Thank you for your email of December 1,…
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Vaccines the culprit – Not-So-Crackpot Autism Theory – NYT
Vaccines the culprit – Not-So-Crackpot Autism Theory – NYT Sun, 10 Nov 2002 A report in Sunday’s NY Times Magazine (excerpt below) reveals as much about the culture of arrogance exhibited by those who formulate public health policy, as it does about the link (long-denied) between a vaccine preservative containing…
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Merck Baby Vaccines Not Pure – LAT/ FDA Advisory-Crestor / Zyprexa Lawsuit charges Lilly concealed Diabetes risk
Merck Baby Vaccines Not Pure – LAT/ FDA Advisory-Crestor / Zyprexa Lawsuit charges Lilly concealed Diabetes risk Fri, 11 Mar 2005 The FDA’s failure to carry out its watchdog responsibility to protect the public from unsafe drugs, has encouraged the pharmaceutical industry to conceal the risks and deceive the public….
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Integrity in Scientific Research : Peer review ineffective
Integrity in Scientific Research : Peer review ineffective – Institute of Medicine / Lancet / Science August 25, 2002 Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct This report and by the Institute of Medicine (IOM) and two current editorials in major scientific journals-the Lancet (Aug 17)…
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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…