Professor and chair of the department of Family and Geriatric Medicine at the University of Louisville. From 2009 to 2013 she was a professor at the University of Missouri Kansas City’s department of Biomedical and Health Informatics. From 1996 to 2009 she was a professor at Dartmouth Medical School and…
THE ALIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Avenue, Suite 28P New York, NY 10023 www.ahrp.org FDA Docket Number 02N-0466 Comments re: Proposed smallpox vaccine trial to test the safety of Dryvax administration to children 2 to 5 years of age Recent public and professional debate about smallpox…
Risks: Drugs / Vaccines / Trials / Treatment Evidence of antidepressant harm Oct 14, 2005: Andrew Finkelstein Letter to Dr. Russell Katz, Director, Neuropharmacological Drug Products, FDA about FDA’s Failure to Warn about Neurontin-Suicides Aug 29: FDA Response to Utah Court Must Be Truthful Re: Zoloft / SSRI Suicidal Risks…
Incentives to Pharma Companies but Health Care Leaders Voice Doubts on Smallpox Inoculations Thu, 30 Jan 2003 The New York Times reports (below) that serious doubts about the president’s smallpox vaccination plan emerged at a Senate hearing Wednesday. The Washington Post reports (below) that "The hearing illustrated the growing tensions…
CNN / Mercury News: Bioshield Vaccine Contracts to mfg with “closest ties with the government” Sun, 18 Sep 2005 Questions are being raised (again) about the government vaccine purchasing program, ostensibly as a measure to protect the American public in the event of a bioterrorist attack. Mercury News (Twin City,…
NIH Under Fire: Longtime Favorite of Congress – Wash Post / WSJ Sun, 27 Jun 2004 Under fire from Congress with evidence of NIH staff engaging in secret outside contracts and consultancies, NIH Director, Dr. Elias Zerhouni, turned a corner. He acknowledged the problem at a hearing (June 22) of…
Soldier’s Death Tied to Vaccines / Experimental Ebola vaccine attracts no volunteers Wed, 19 Nov 2003 Two civilian medical panels that looked into the death of 22-year old Army reservist, Rachel Lacy, agreed that the death was “probably” or “possibly” an adverse reaction to a vaccine. Since Specialist Lacy had…
Infomail Archive 2003 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 19, 2003: Eli Lilly Prozac UK Fact Sheet: “Not Recommended” for Children – PMDD Withdrawn in UK Dec 19, 2003: Not-So-Public-Relations: Drug Industry & Bioethics – is it casuistry or sophistry? Dec 18, 2003:…
Recent public and professional debate about smallpox vaccine and its risks provides the framework for evaluating the ethical justification for conducting clinical trials on children. Dryvax is a particularly impure product made of live vaccinia virus harvested from the pustules of calves infected with (it is believed) cowpox. Although the vaccine, which is scratched on the skin, only causes mild infections in most people, in a small but significant number the infection caused serious adverse reactions similar to the complications of the disease they were designed to prevent: painful, disfiguring skin disorders, blindness, neurological impairments and death.
