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.

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,

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.

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.

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

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.

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?

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.

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.

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.