AHRP Comments Re: Best Pharmaceuticals for Children’s Act of 2002

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…

Best Pharmaceuticals for Children Act of 2002


Comments submitted by The Alliance for Human Research Protection
to The National Academy of Sciences
Committee of the Institute of Medicine on Clinical Research Involving Children

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

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Commentary by Vera Hassner Sharav Dec 19, 2003: Eli Lilly Prozac UK Fact Sheet: “Not Recommended” for Children – PMDD Withdrawn in UK Dec 19, 2003: Not-So-Public-Relations: Drug Industry & Bioethics – is it casuistry or sophistry?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:…

Once Misdiagnosed, Writer Teaches Psychiatrists About Treatment – Psychol Today

Once Misdiagnosed, Writer Teaches Psychiatrists About Treatment – Psychol Today Fri, 27 Jun 2003 An article in Psychology Today is about an incredible story of survival. A teenager misdiagnosed with schizophrenia, then wrongly incarcerated in a psychiatric hospital. Mindy Lewis survived for three years of being “drugged and locked away…

CNN: Drug Argument Embroils Psychiatrists, Pharma Companies

CNN: Drug Argument Embroils Psychiatrists, Pharma Companies Sun, 30 Mar 2003 The seeds of doubt have begun to taken root and the media is beginning to ask probing questions about the unholy alliance that created the big lie resulting in the indiscriminate diagnosing of mental disorders. Even perfectly normal children…

References: Impact of FDA inclusion of children as test subjects

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…

MassHealth: Children overwhelmed with Psychiatric Drugs_Globe

MassHealth: Children overwhelmed with Psychiatric Drugs_Globe Sun, 9 Mar 2003 The Boston Globe reports that the top official for health and human services in Massachusetts plans to take action to stem the abusive “haphazard” prescribing of psychiatric drugs for children: “The use of stimulants, antidepressants, and antipsychotics among children has…

Infomail Archive Pre 2003

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,…

FDA approves anti-psychotic, clozapine, to treat suicide

FDA approves anti-psychotic, clozapine, to treat suicide December 20, 2002 The first of the so-called atypical antipsychotic drugs, clozapine (Clozaril), has been approved by the FDA as a treatment against suicide in patients with schizophrenia. The drug has been hailed as a miracle for some, but deadly for others. The…

Article

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Tel. 212-595-8974               142 West End Ave Suite 28P               FAX: 212-595-9086 New York, NY 10023 www.ahrp.org December 5, 2002 Mr. Edward Swindell Acting Associate General Counsel for Ethics Office of General Counsel, Ethics Division Department of Health and Human Services 200 Independence Ave. SW…