FDA -Conflicts of Interest to be expanded May 23, 2002 FYI The Washington Post reports that the 1992 Prescription Drug User Fee Act that introduced coporate influence and corporate money into the FDA is about to be renewed and greatly expanded: "There’s no doubt in my mind that bigger and bigger [user fees] harm…
Psychiatry Research 117 (2003) 127135. Premature mortality in schizophrenia: a 7.5-year study. Maria G. Morgan , Paul J. Scully , Hanafy A. Youssef , a,b a,b a Anthony Kinsellac, John M. Owensa, John L. Waddingtona,b,* http://psychrights.org/Research/Digest/NLPs/MM-PsychRes2003.pdf (100 KB pdf via psychrights.org) Abstract While premature death in schizophrenia is well recognised,…
Human Pesticide Experiments “Allowing human experiments, such as those conducted recently in the United Kingdom, to serve as the basis for registering pesticides, is ethically indefensible.” Ken Cook, President Environmental Working Group January 8, 2003 "Should the EPA Accept Human Pesticide Experiments?", testimony by Vera Hassner Sharav before the Committee…
OHRP Response to AHRP re: Surrogate Consent to Research Office of the Secretary Department of Health & Human Services Office of Public Health and Science Office for Human Research Protections Rockville, Maryland E-mail: mcarome@osophs.dhhs.gov August 28, 2002 Vera Hassner Sharav President, The Alliance for Human Research Protection John H. Noble,…
Anne, comments 1, 2, 3 are (more or less) short repeats… the others are more substantive so I separated them vera Sent: Monday, December 02, 2002 6:07 AM Subject: RE: Docket No. 02N–0466 I DO NOT support the smallpox vaccine study, Docket No. 02N–0466. I oppose this study!!! Vaccines are…
Johns Hopkins University Experiment on Lead Paint Puts Children in Danger August 24, 2001 FYI Additional details are emerging about the lead-paint study conducted on infants and children by researchers at the Kenney Krieger institute which is affiliated with Johns Hopkins University. Today’s New York Times reports (below) that the…
Linguistic Tinkering with Regulatory Terminology Increases Risk of Harm for Children: "minimal risk" "minor increment of minimal risk" and "disorder or condition" January 28, 2001 A cornerstone of the Declaration of Helsinki (adopted by the World Medical Association in 1964, and reaffirmed on Oct. 2000) is the distinction between research…
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…
Unreported Paxil suicides: company abandons “No Addiction” claim Sat, 10 May 2003 GlaxoSmithKline, Britain’s biggest pharmaceutical company will change the label in the UK to reflect the severe withdrawal that its antidepressant drug, Seroxat (Paxil in US) generates in many patients. In Britain, the package label will no longer claim…
DANGEROUS DRUG LICENSING GAME THE FDA PLAYS Thu, 6 Mar 2003 In her column on Red Flags Weekly, Dr. Meryl Nass describes how the FDA in concert with the Justice Department have been lowering the bar for safety of drugs and vaccines used on military personnel. The significance is that…
FDA approves Paxil for Premenstrual cramps Wed, 3 Sep 2003 On September 2, the FDA approved Paxil (Seroxat) for yet another newly invented “condition.” Inasmuch as those most likely to complain about premenstrual discomfort which has been labeled, premenstrual dysphoric disorder (PMDD)–are likely to be pubescent girls, FDA’s approval is…
Medication switched for research purposes – patient nearly dies Tue, 11 Nov 2003 The Boston Globe reports that an investigation by a state oversight agency, “uncovered numerous ethical violations at the Solomon Carter Fuller Mental Health Center by Boston Medical Center physicians contracted to treat patients there.” Boston University Medical…
