Dr. Marcia Angell, a senior lecturer at Harvard Medical School, and former editor of the New England Journal of Medicine and author of The Truth About Drug Companies, describes Sharav as an extraordinarily observant and valuable critic.   "I see her as someone the research establishment badly needs."

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Slide 2: I'll begin with the President's New Freedom Commission on Mental Health[1] recommendation to screen the US population for mental illness - 52 million children first. In no other democratic country has the government adopted a policy to screen the population for presumed, undetected, mental illness. The rationale behind this mind-boggling Orwellian nightmare is not improving mental health, but rather increasing life-long consumers of psychoactive drugs and to control behavior. Two NFC recommendations are designed to do just that. TeenScreen is promoted as a suicide prevention model when it in fact, increases the number of children labeled suicidal and depressed.

INTRODUCTION: This bill seriously endangers, if not completely undermines, the democratic process and the rule of law. It will absolutely destroy the unalienable rights of trial by jury and informed consent. It is a radical transfer of the US Treasury into the hands of unaccountable private companies whose record shows far more concern about profits than in protecting and improving the health of the American people. It also concentrates the power of life and death in the hands of one very fallible human being and creates an unaccountable federal bureaucracy not subject to disclosure, independent oversight or the safeguards of accountability necessary in a free republic.

"Forgotten Children" is an investigative report by Carole Keeton Strayhorn,[1] the Texas Comptroller (2004) who uncovered evidence that 60% of children in the Texas foster care system are being drugged with powerful psychotropic drugs, most of which have not been tested in or approved for use by children. The Food and Drug Administration (FDA) acknowledges that many of these drugs have serious adverse side effects, both physical and psychological. The Comptroller said she was alarmed that in her review of a single month (November 2003), two powerful antipsychotic drugs -- Risperdal and Zyprexa -- made up half of the drugs prescribed to foster children in Texas. These two drugs have been approved only for adults for the treatment of psychosis - primarily schizophrenia - yet, she found that children as young as four, were receiving these powerful, mind-altering drugs.

The Alliance for Human Research Protection (AHRP) welcomes the opportunity to respond to the question "What is the Best Way to Protect Children?"

Our recommendation - which is backed up by evidence that children have suffered harm in medical research - is to significantly limit the discretion of IRBs to approve greater than minimal risk research without direct benefit for the child-subjects under 46.406.

We recommend staying the course in requiring that any such proposed experiment undergo a transparent open evaluation with ample opportunity for public oversight and comment - as required under the provisions of 46.407.

My name is Vera Hassner Sharav, and I am president of The Alliance for Human Research Protection: a national human rights organization that exposes unethical research practices which undermine the dignity, rights, and safety of human subjects.

In 1947, an American military tribunal sat in judgment of the Nazi doctors at Nuremberg, and laid down ten essential principles that define "permissible medical experiments" in a civilized society. Those principles are enshrined in the Nuremberg Code which is the cornerstone of all medical research ethics. The nations of the world adopted the Code as a safeguard to prevent future medical atrocities.

When a federal judge ruled the vaccine to be an "investigational drug and a drug being used for an unapproved purpose" on December 22, 2003, FDA hurriedly issued a Final Rule for anthrax vaccine. The agency submitted its Final Rule just eight days after a federal court injunction, having failed to do so for 19 years. In a January 7, 2004 court hearing the same judge called FDA's actions "highly suspicious." On October 27, 2004 FDA's arbitrary and capricious promulgation of this Final Rule resulted in a permanent injunction, remanding the license to your agency to complete according to the law. The injunction also halted what the judge called DoD's "illegal" mandatory anthrax vaccination program.

Thank you for the opportunity to submit this testimony for the record.

My name is Meryl Nass, M.D., and I have worked for the past twenty years as an emergency physician and internist in community hospitals in the northeastern US. I have also studied many aspects of bioterrorism since 1989. I am the person who first demonstrated, in 1992, that one could investigate an epidemic retrospectively, and prove that it was due to biological warfare, using Rhodesia's 1978-80 anthrax epidemic as a model.[1]