Press Statement – FDA & Concealment of Suicide-Related Risks of Antidepressants

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.

AHRP Press Briefing: Antidepressants and Suicide-Related Risks for Children


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,

Response to Washington Post Editorial “Missing Drug Data”

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.

AHRP: Published NIMH Funded Prozac Trial Report Concealed Suicide Attempts by Teens

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.

NIH Rule change Re: Whistle blowers – Comments due before June 15

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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Complaint: Phase I AIDS Drug/Vaccine Experiment on Foster Children

ALLIANCE FOR HUMAN RESEARCH PROTECTION Homepage 142 West End Ave. Suite 28P New York, NY 10023 March 10, 2004 Dr. Michael Carome Chief of Compliance Office of Human Research Protections David Horowitz Director, Office of Compliance Food & Drug Administration Dept. of Health and Human Services cc: Dr. Bernard Schwetz,…

AHRP Calls for Federal Investigation of Drug Trials Using Children in Foster Care

RE: Phase I Drug trials used foster children in violation of 45 CFR 46.409 and 21 CFR 50.56

The Alliance for Human Research Protection (AHRP) has reason to believe that federal regulations for the protection of children as research subjects have been seriously violated in federally funded HIV research.

We have learned that a series of Phase I and Phase II drug experiments were conducted on infants and children who were under the guardianship of the New York City Agency for Children’s Services (ACS), and living at Incarnation Children’s Center, a foster care facility under contract with ACS.

AHRP Press Briefing: Scientists Will Analyze SSRI Data, Families Will Tell Their Tragedies

Excerpt: The British drug authority has banned the use of most SSRI antidepressant drugs for the treatment of depression in children under 18, citing a two-to-threefold increased risk of suicidal behavior and lack of evidence of a benefit for depressed children. Two SSRIs – Paxil and Effexor – are no longer recommended by their manufacturer for use in children. Prozac is no longer recommended by Eli Lilly for children in the U.K.

In contrast to the British medicines authority review of the evidence, the FDA has refused to allow independent scientists to present documented evidence related to these drugs’ hazards and their failure to demonstrate a benefit for depressed children.

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:…

Letter Submitted to New England Journal of Medicine re ARDS Investigation

The April 3, 2003 New England Journal of Medicine (NEJM) issue contained an array of articles largely in support of a disputed multi-site, clinical trial sponsored by the National Heart, Lung, and Blood Institute (NHLBI), one of the National Institutes of Health (NIH), involving critically-ill, mentally incapacitated human beings with acute respiratory distress syndrome (ARDS) – who did not give their informed consent.

The accompanying editorial, "Controlling Research Trials," by Dr. J.M. Drazen, who serves on the NHLBI advisory committee that had approved the disputed trial, reveals much about the NIH attitude toward the rest of the world.

Children are Humans: Don’t Sacrifice their Rights, Dignity & Welfare

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.

AHRP Comments on Smallpox Vaccine Testing on Children 2 to 5 Years of Age

Recent public and professional debate about smallpox vaccine and its risks provides the framework for evaluating the ethical justification for conducting clinical trials on children. Dryvax is a particularly impure product made of live vaccinia virus harvested from the pustules of calves infected with (it is believed) cowpox. Although the vaccine, which is scratched on the skin, only causes mild infections in most people, in a small but significant number the infection caused serious adverse reactions similar to the complications of the disease they were designed to prevent: painful, disfiguring skin disorders, blindness, neurological impairments and death.