A Come Back for Psychosurgery? Wed, 6 Aug 2003 The Los Angeles Times reports that experimental psychosurgery is once again on the rise – at Harvard’s Massachusetts General Hospital and Brown University. It is acknowledged that “Researchers still do not fully understand how the operations affect the brain, or why”……
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Commentary by Vera Hassner Sharav Dec 19, 2003: Eli Lilly Prozac UK Fact Sheet: “Not Recommended” for Children – PMDD Withdrawn in UK Dec 19, 2003: Not-So-Public-Relations: Drug Industry & Bioethics – is it casuistry or sophistry?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:…
AHRP Letter to the editor re: editorial ARDS trial July 10, 2003. The New England Journal of Medicine. Volume 349:188-192 Number 2 http://content.nejm.org/cgi/content/extract/349/2/188 Note: The April 3, 2003 the NEJM contained an editorial in support of a controversial multi-site, clinical trial sponsored by the National Heart, Lung, and Blood Institute…
Hopkins Asks Patients to Waive Privacy Rights to Facilitate Research Recruiting – AP/ ABC Tue, 8 Jul 2003 In the 19th century doctors robbed graves to obtain cadavers for medical training purposes. Today, medical researchers are far more ambitious– they seek backdoor access to living patients for medical experiments. A…
On June 10, 2003, a panel of experts convened by the federal Office of Human Research Protections (OHRP) heard presentations by critics who had filed complaints about $37 million government sponsored, multi-site experiment conducted by major academic institutions participating in the ARDSNetwork, and by the ARDSNet investigators who defend the trial.
The experiment tested two extreme, rarely used methods of mechanical lung ventilation in 861 critically ill, vulnerable patients suffering from acute lung disease (ALD) or acute respiratory distress syndrome (ARDS).
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) April 10, 2003 Letter to the Editor The New England Journal of Medicine View letter as finally published in NEJ Sir: The April 3, 2003 New England Journal of Medicine (NEJM) issue contained an array of articles largely in support of a disputed…
The April 3, 2003 New England Journal of Medicine (NEJM) issue contained an array of articles largely in support of a disputed multi-site, clinical trial sponsored by the National Heart, Lung, and Blood Institute (NHLBI), one of the National Institutes of Health (NIH), involving critically-ill, mentally incapacitated human beings with acute respiratory distress syndrome (ARDS) – who did not give their informed consent.
The accompanying editorial, "Controlling Research Trials," by Dr. J.M. Drazen, who serves on the NHLBI advisory committee that had approved the disputed trial, reveals much about the NIH attitude toward the rest of the world.
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave. Suite 28P New York, NY 10023 April 4, 2003 Tommy Thompson, Secretary Department of Health and Human Services Dockets Management Branch (HFA–305), Docket Number 02N–0475, Food and Drug Administration, 5630 Fishers Lane, Room 1061 Rockville, MD 20852. Re: Docket…
References for 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 Agency for Health Care Research & Quality. (1999). Treatment of attention-deficit/hyperactivity disorder: Summary, evidence Report / Technology assessment…
Infomail Archive – Pre 2003 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav December 28, 2002: Will 2 to 5 year old Amer. kids be exposed to Smallpox Vaccine? Israeli Intelligence says “No immediate threat” December 24, 2002: Moral turpitude: Herpes experiment surpasses Tuskegee December 20,…
Ethics Questioned in Lung Disease Trial–Feds Demand Patient Data – Newhouse News December 13, 2002 A news breaking story by Bruce Seeman of Newhouse News (excerpts below) reveals a major systemic breakdown in medical ethics–“there’s something rotten in the state of [biomedical research].” Complaints about a lung disease air ventilation…
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.
