Letter from David Healy, MD to Peter J. Pitts Executive Summary of suicidal evidence not addressed by FDA In the light of Traci Johnson’s death on February 7th 2004, will FDA obtain Pfizer’s entire folder on the 1982 Hindmarch study in which healthy volunteers were given Zoloft, and make a…
Analysis of 94 OHRP Letters of Determination, July 1, 2000 to January 31, 2001 Research Compliance Note. Thomas Dalglish, JD, PhD * The views expressed in the ‘Research Compliance Note’ below are the personal opinions of the author, do not reflect any official position of the University of Washington, and…
Smallpox Comments Sent: Saturday, November 30, 2002 11:46 PM “I DO NOT support the smallpox vaccine study, Docket No. 02N-0466.” However, I would consider supporting the study if it involves only the children and grandchildren of the people proposing, advocating and conducting the study. You have no right to use…
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…
Cover Letter – AHRP Ethical and Scientific Objections to FDA’s Proposed Licensure of Anthrax Vaccine related links: Comments Submitted to FDA re Anthrax Vaccine (312K pdf) Who Is Protecting The Public Health? By Meryl Nass, Z Magazine March 29, 2005 Lester Crawford, Ph.D., D.V.M. Acting FDA Commissioner U. S. Food…
MedicAlert lifeline lent to patients in drug trials Thu, 1 May 2003 The Modesto Bee reports that MedicAlert Foundation International which maintains an electronic database of its members’ medical records which are accessible in to treating physicians and paramedics in emergencies, is venturing into the clinical drug trial arena. The…
FDA Requires Bar Codes on Drugs-IG resigns Date: Fri, 14 Mar 2003 On a positive note, the FDA has finally come up with a proposal to cut medical errors in hospitals. Drug manufacturers will be required to put drug bar codes on every prescription drug to protect patients from fatal…
Ethics of U Penn surgical “drug implant” experiment Tuesday, October 07 Notwithstanding a legion of prominent bioethicists at major universities such as the University of Pennsylvania and Johns Hopkins University, researchers at these institutions are not deterred from engaging in high risk human experimentation whose ethics are questionable. One has…
“Orgasmatron” implant experiment – legitimate or dubious? Fri, 28 Nov 2003 The FDA has approved what one can only call a bizarre expriment to test a surgically implanted device (orgasmatron) in the spine, of women–ostensibly to treat “sexual dysfunction.” To implant the device, “wires connected to a battery pack are…
Bush signed Pediatric Research Equity Act Fri, 5 Dec 2003 Bush signed the Pediatric Research Equity Act into law, ensuring additional income for the drug industry and for an army of physicians who are in the drug testing business at universities, clinics, and in private practice. This collaborative business arrangement…
EPA Opens the Door to Testing Bug Killers on People: Spoon- Feeding Poison_VillageVoice Sat, 19 Jul 2003 The Village Voice reports that the EPA has “quietly begun lifting a 1998 ban” on human pesticide experiments that expose human beings to poisons meant to kill. Republican legislators have been recipients of…
Suicide in Psych Drug Trials: FDA Orwelian doublespeak – Insight Magazine Date: Mon, 14 Oct 2002 Insight Magazine’s interview with Dr. Thomas Laughren, team leader for the neuropharmachological drug-products division of the FDA, shows that FDA was caught off guard when Dr. Arif Khan independently analyzed FDA’s data revealing that…
