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.

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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.

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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.

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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.

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The Washington Post reports (below) that the Environmental Protection Agency (EPA) announced plans to enroll 60 young children in Duval County, Florida – infants to age 3 – exposing them to pesticides to study how the children absorb poisonous chemicals!

In this experiment children will literally be relegated to the status of human guinea pigs. This experimental abuse of children demonstrates what the chemical / pharmaceutical industry buys when it “contributes” funds to government agencies, public officials, scientists and academic institutions.

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We are witnessing the unraveling of a system that was intended to ensure that marketed drugs met high safety standards; that physicians were informed about potential, serious adverse drug effects – so that they would prescribe judiciously; and that the integrity of the scientific literature was preserved. But that system has been hijacked by the drug industry – which has infected medical practice and medical research with detail men and informercials that make false claims while manipulating partial data to conceal adverse drug effects.

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Scientists’ Presentations at AHRP Press Briefing in Conjunction with FDA Hearings:

  • Peter Mansfield, MD, University of Adelaide (Australia), Director of Healthy Skepticism discussed the illusion of potency in light of the meta-analyses in the British Medical Journal (which he co-authored) and the Lancet.
    Dr. Mansfield’s power point presentation
  • Peter Breggin, MD, a psychiatrist with a sub-specialty in clinical psychopharmacology, who was among the first to recognize adverse antidepressant drug reactions
    Dr. Breggin’s presentation
  • Lawrence Diller, MD, a pediatrician and family therapist who has evaluated and treated more than 2,500 children
    Dr. Diller’s presentation
  • Stefan Kruszewski, MD, a clinical and academic psychiatrist, and Associate Medical Director of Physicians’ Health Programs, Pennsylvania Medical Society
    Dr. Kruszewski’s presentation
  • David Healy, MD, Director of the North Wales Department of Psychological Medicine and Visiting Professor, University of Toronto,
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Today’s (6/30/04) editorial, “Missing Drug Data,” misses the point and argues with the pharmaceutical industry and its allies in the Congress, the NIH and the FDA that data can be selectively reported to satisfy commercial interests. This is a blatant attack on Karl Popper’s falsifiability principle on which empirical science depends to make progress. One needs all the data in order to verify the results of clinical or any other kind of research. Most academics and pundits know that any case can be made if allowed to manipulate the data and assumptions. The AMA, the medical journal editors, and Eliot Spitzer, all deserve applause from the Washington Post editor-not quibbling about the possible damage that somehow, somewhere might result from strict embrace of the principles and practice of scientific inquiry. It’s all about transparency.

John H. Noble, Jr.

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Recent revelations indicate that pharmaceutical companies have selectively reported partial (favorable) clinical trial results from pediatric antidepressant trials and concealed evidence of harm from physicians, other health care professionals, and the public. It is universally agreed in the literature that failure to disclose all trial results compromises physicians’ ability to provide professional care – thereby increasing the likelihood of causing preventable harm. More generally, failure to disclose trial results in scientific publications taints the scientific literature (by rendering it not credible) and, as New York State Attorney General Elliot Spitzer charged recently, constitutes plain and simple fraud.

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The National Institute of Mental Health (NIMH) has issued an inaccurate, obfuscating, and misleading statement ON April 23, 2004 — Antidepressant Medications for Children: Information for Parents and Caregivers — that continues to encourage the use of antidepressants for children: “Many times, psychotherapy accompanied by an early follow- up appointment may help to establish the persistence of depression before a decision is made to try antidepressant medications.” This statement appears to demonstrate the inordinate influence of Big Pharma on NIMH. http://www.nimh.nih.gov/press/StmntAntidepmeds.cfm

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A request for comment about NIH proposed new research misconduct rule

See Fed Register:
http://ori.dhhs.gov/multimedia/acrobat/42CFRParts50and93.pdf

The new rule, I believe is meant to protect research institutions from the effective sting of a knowledgeable whistle blower.

The new rule would redefine whistle-blower as “complainant” and would limit the role of the complainant. Under the old rule, the whistle-blower participated in the process helping investigators by leading them to the evidence, etc.

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Friday’s New York Times included the following Editor’s Note on the paper’s Op Ed page: “An Op-Ed article on Tuesday discussing the vulnerability of the proposed Freedom Tower to terrorist attack should have included additional information about the writer, Daniel Benjamin. Mr. Benjamin was once paid to serve as an expert witness on Al Qaeda in a lawsuit involving Larry A. Silverstein, the developer of the tower. Although the lawsuit had nothing to do with the Freedom Tower, that relationship should.”

That editor’s note represents responsible journalism. Why does the Times consistently fail to apply the same conflict of interest disclosure policy to its medical news reports and opinion columns by guest writers?

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