2 to 5 year old children targeted for Smallpox Vaccine trial_DHHS Sat, 2 Nov 2002 An announcement in the Federal Register, Oct 31, 2002, by the Office of Public Health and Science and Food and Drug Administration calls for public review and comment about proposals to the Secretary of Health…
Twin Pharma Give-A-Ways: Biodefense Vaccine /Drug Development Act–S. 1873_ $7 bill Bird Flu Plan Wed, 2 Nov 2005 If the Administration were serious about preparing for an avian flu pandemic–or for ANY health disaster for that matter–the money would be spent on developing reliable infrastructures at the state and local…
AHRP Campaign to Protect Children from Harm Oct 15: FDA Orders Black Box Warnings on Antidepressants labels and Patient Information Guides to Warn about Suicide risk Oct 3: BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical Deception Sep 30: GSK Sales Reps told NOT to Divulge Paxill Data…
August 26, 2002 OHRP Retreats from Providing Public Info re: Compliance Activities FYI A newly posted announcement by the Office of Human Research Protection (OHRP), dated July 15, rescinds the agency’s announced policy of making public the content of its letters of determination following the agency’s investigation of compliance /…
NIMH Offers Grants to Study SSRI relation to Suicidality_FDA to Examine SSRI- Suicide in Adults Mon, 14 Nov 2005 A fifteen year struggle by critics of the drug-centered treatment paradigm in psychiatry is being indirectly validated both by the FDA and the National Institute of Mental Health who are addressing…
The Children’s Hospital of Philadelphia Department of Anesthesiology and Critical Care Medicine Robert M. Nelson, M.D., Ph.D. 34th Street & Civic Center Boulevard, Rm. 1513 Chair, Committees for the Protection of Human Subjects Philadelphia, Pennsylvania 19104-4399 Associate Professor of Anesthesia and Pediatrics (215) 590-9180 Office (267) 426-5035 Fax November 25,…
UK Doctors told to stop giving antidepressants to children – Glaxo Warns of Paxil Birth Defects Wed, 28 Sep 2005 Related Link – See Guidelines at: http://www.nice.org.uk/page.aspx?o=273073 The UK National Health Service has taken a decisive, responsible step to protect the lives of children who are being exposed to serious risks…
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave, Suite 28P New York, NY 10023 212-595-8974 ahrp@researchprotection.org September 4, 2002 Michael Carome, MD Associate Director for Regulatory Affairs Office for Human Research Protections The Tower Building 1101 Wootton Parkway, Suite 200 Rockville, Maryland 20852 Re: Acute Respiratory Distress…
July 08, 2002 Critique: U.S. to Vaccinate 500,000 Workers Against Smallpox 7 Jul 2002 FYI Dr. Meryl Nass, a member of the board of The Alliance for Human Research Protection and a recognized expert on Gulf War Syndrome and the use and consequences of experimental vaccines, raises serious concerns about…
Intimidation, Politics and Drug Industry Cripple U.S. Medicine – FDA Permits Dr. David Graham to publish Vioxx Report Wed, 5 Jan 2005 FDA officials could not maintain their iron grip in an effort to suppress evidence of far reaching lethal effects of Vioxx when their actions were in full public…
Federal Investigation of ARDS Study (Accute Respiratory Distress) OHRP conducted a compliance oversight evaluation of the 12 major sites participating in this clinical trial. OHRP’s determination letters documenting the outcomes of these evaluations can be viewed at the OHRP website at the following URLs: Note: OHRP found that federal informed…
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…
