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.
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…
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION Testimony by Vera Hassner Sharav Committee on the Use of Third Party Toxicity Research with Human Research Participants Science, Technology, and Law Program The National Academies of Science January 8, 2003 My name is Vera Sharav and I am the president and founder of…
Testimony by Vera Hassner Sharav before the Committee on the Use of Third Party Toxicity Research with Human Research Participants; Science, Technology, and Law Program; The National Academies of Science Committee on the Use of Third Party Toxicity Research with Human Research Participants
My name is Vera Sharav and I am the president and founder of The Alliance for Human Research Protection (AHRP) a citizens’ watchdog organization monitoring human research to ensure that the moral principles enshrined in the Nuremberg Code and the Declaration of Helsinki are preserved and followed in experiments involving human beings.
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,…
Patient vs. Portfolio: ImClone_Salon December 10, 2002. Salon.com looks at how conflicts of interest impact on patients who are recruited to serve as subjects of clinical drug trials. “Patients affected by the ImClone scandal have been lost in the media’s rush to cover the tale of Martha Stewart and other…
Patient vs. Portfolio: ImClone_Salon December 9, 2002 Salon.com looks at how conflicts of interest impact on patients who are recruited to serve as subjects of clinical drug trials. “Patients affected by the ImClone scandal have been lost in the media’s rush to cover the tale of Martha Stewart and other…
October 11, 2002 Editorial: Trial Lawyers and Clinical Trials_WSJ Daniel Hennenger, the editor of the Wall Street Journal would give doctors free reign to experiment on human subjects unencumbered by ethical or regulatory considerations: just let every self-proclaimed ” genius who somewhere is dreaming of the next L-dopa, lithium or…
September 2, 2002. South Carolina Judges Voted to Ban Secret Court Settlements. By Adam Liptak – New York Times. The NY Times reports that South Carolina’s 10 active federal trial judges unanimously voted to ban secret court settlements “that have made the courts complicit in hiding the truth about hazardous…
REASONS FOR OPPOSITION:
Researchers would not be required to first try approved treatments, if any exist, before entering the patient into a medical experiment that may be "risky."
Researchers would not be required to consult with an independent medical expert, a non-researcher who would consider the patient’s best medical interests as paramount.
Researchers would not be required to disclose their own professional and financial interests deriving from the experiment.
Researchers would not be required to fully disclose to the patient’s family what happened to other patients who had already participated in the experiment.
Dr. Jeffrey Levine, a psychiatrist from Albert Einstein dubbed this year's annual meeting in Philadelphia, "the American Psychiatric Association GlaxoSmithKline Convention."
