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Commentary by Vera Hassner Sharav Dec 19, 2003: Eli Lilly Prozac UK Fact Sheet: “Not Recommended” for Children – PMDD Withdrawn in UK Dec 19, 2003: Not-So-Public-Relations: Drug Industry & Bioethics – is it casuistry or sophistry?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

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…

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American Eugenics: Bad Seed or Bad Science?

American Eugenics: Bad Seed or Bad Science? Sat, 8 Feb 2003 The New York Times reports: “For more than a century, the Juke clan was presented as America’s most despised family.” The Jukes family was categorized by social scientists as “congenital misfits, criminals, harlots, epileptics and mental defectives.” But the…

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…

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,…

Investigative series finds kids drugged without cause – Journal News

November 08, 2002 Investigative series finds kids drugged without cause – Journal News The Journal News, a regional NYS newspaper conducted a three month investigation of residential treatment centers (RTC) for troubled children in NYS. The findings reported in a 7-part investigative series show “a pattern of increasing use” of…

Ritalin Outrage: Congress – Big Media Under the Influence of Big Drugs

Ritalin Outrage: Congress_ Big Media Under the Influence of Big Drugs September 30, 2002 Two hard hitting editorials–one by Nicholas Regush of Redflagsweekly.com. the other by Tony DiGirolamo of CutureShockTV.com focus on the scorge of Ritalin and the victimization of millions of children who are pushed to becoming addicted to…

NIMH director blames HMOs for ADHD-Ritalin problem_NYPost

Subject: NIMH director blames HMOs for ADHD-Ritalin problem_NYPost Date: Fri, 27 Sep 2002 18:08:19 -0400 FYI The NY Post reports that there were heated exchanges at a Congressional hearing convened by the House Government Reform Committee overdiagnosing and overmedicating of children. Dr. Richard K. Nakamura, head of the National Institute…

NY Post Prompts Cong Hearings re: Children prescribed Ritalin

Subject: NY Post Prompts Cong Hearings re: Children prescribed Ritalin Date: Wed, 25 Sep 2002 14:23:26 -0400 An investigative series by the New York Post re: the pressure brought to bear on parents to medicate their normal children with psychostimulant drugs–despite the risk of addiction and other serious adverse reactions–…