FDA Is Flexing Less Muscle where Safety is the Issue – Wash Post Thu, 18 Nov 2004 The Washington Post examines FDA’s record of surveillance and the evidence is clear: since 1992 when Congress required drug companies to pay users fees to the FDA, the agency’s focus changed from safety…
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…
FDA Critics Slam Plan for Safety Reform – Nature Thu, 17 Feb 2005 This is smoke and mirrors and musical chairs. Vera Sharav Alliance for Human Research Protection, New York http://www.nature.com/news/2005/050214/full/050214-11.html Published online: 17 February 2005; | doi:10.1038/news050214-11 FDA critics slam plan for safety reform Emma Marris Calls grow for…
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…
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,…
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…
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…
CBS News: Smallpox vaccine fiasco Thu, 21 Aug 2003 Tonight CBS news will include an interview with Dr. Meryl Nass about the government’s questionable vaccine policy that coerces military personnel to be inoculated with highly controversial vaccines such as the smallpox vaccine. A report just issued by the Institute of…
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…
Senator Jeff Bingaman resolution: Review military vaccine program Thu, 4 Dec 2003 After months of denial, on Nov. 19, the Pentagon acknowledged that multiple vaccines may have caused the death of Army nurse Rachael Lacy, who died in April after receiving shots for anthrax, smallpox and three other diseases. Critics…
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…
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…
