TIME – Medicating Young Minds with Mood / Behavior Altering Drugs Sat, 1 Nov 2003 A TIME magazine cover story (excerpt below) looks at the inordinate popularity of prescribing mood altering psychotropic drugs for children begins to raise troubling questions about the specter of doing long-term harm to children. Doctors…
Walk-in Drug Trial Clinic NYC Upper East Side Wed, 17 Sep 2003 While ethics is currently a hot topic at universities, and ethics committees and conferences have become a growth industry within the research community, ethics has not affected the increasing commercialization of medicine and clinical trials. Dr. Ronald Fieve,…
Comments submitted by The Alliance for Human Research Protection Re: Best Pharmaceuticals for Children’s Act of 2002 The National Academy of Sciences Committee of the Institute of Medicine on Clinical Research Involving Children August 18, 2003 Vera Hassner Sharav, President John H. Noble, Jr., Ph.D, Treasurer David Cohen, Ph.D, Secretary…
AHRP has been closely monitoring pediatric research trends since passage of the FDA Modernization Act of 1997. We believe that medications used in children should be thoroughly tested for safety, effectiveness and appropriate dose. But unlike adults who can exercise their autonomous right to informed consent, children who are enrolled in clinical trials are non-consensual human subjects. They should not, therefore, be made to assume the burden of testing possibly toxic drugs whose safety is unknown.
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Commentary by Vera Hassner Sharav Dec 19, 2003: Eli Lilly Prozac UK Fact Sheet: “Not Recommended” for Children – PMDD Withdrawn in UK Dec 19, 2003: Not-So-Public-Relations: Drug Industry & Bioethics – is it casuistry or sophistry?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:…
New AJOB InFocus article Examines Children in Clinical Research For immediate release May 7, 2003 (Philadelphia, PA) — The comprehensive study by Vera Hassner Sharav, President, The Alliance for Human Research Protection, examines a wide range of clinical research trials conducted on children and the ethical conflicts that arise from…
We are writing about the Pediatric Research Equity Act of 2003 (S 650). We are in full agreement that children should have the same safeguards as adults; that medications used in children be thoroughly tested for safety, effectiveness and appropriate dose. However, S 650 does not do this. Instead, it requires that children be used to test all drugs as a condition of licensure by FDA – unless a waiver is obtained from the Secretary of the department of Health and Human Services under section 505B.
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…
