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FDA: Regulatory Protections for Children
Comments submitted by Vera Hassner Sharav, John H. Noble, Jr., Ph.D and Howard Fishman, MEd, MSW for AHRP
To: Dr. Bernard Schwetz Acting Commissioner Food and Drug Administration, Dockets Management Branch (HFA-305) Food and Drug Administration
Re: COMMENT ON: Docket #00N-0074 April 24, 2001 Interim Rule: "Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products
Excerpt: The FDA rightly chose not to permit the section 46.408 (c) waiver by IRBs of parental or guardian permission, as it leaves the specific circumstances for such a violation of parental rights to the discretion of local Institutional Review Boards (IRB). Given the stream of revelations of gross ethical and procedural violations at one after another of the nation’s premier research institutions, assumptions that “procedural safeguards are in place,” or that IRBs can be relied upon to make decisions that protect the best interests of human subjects – adults and children – has been debunked.
- Corrupted Science | Medical Atrocities | Nazi Medical Atrocities | Newsflash | Presentations by AHRP/Board Members | Presentations of Interest | Vera Sharav, AHRP Board Member
The White Rose — Vera Sharav Historic Visit to Sophie Scholl’s Grave
‘Evil is something that we really need to understand. It’s real.’ — Vera Sharav pays respects to Sophie Scholl’s grave in Munich, Germany. Scholl was a German student and anti-Nazi political activist, active within the White Rose non-violent resistance group in Nazi Germany. She was convicted of high treason after…
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.
Anthrax Vaccine Not Safe and Effective – Emergency Medicine News
July 18, 2002 Anthrax Vaccine Not Safe and Effective – Emergency Medicine News FYI In her letter in the July issue of Emergency Medicine News (below) Dr. Meryl Nass cites a body of evidence linking the anthrax vaccine with systemic adverse medical reactions, and 100,000 to possibly 200,000 veterans who…
An Open Letter to Officials of the National Institute of Mental Health
An Open Letter to Officials of the National Institute of Mental Health Fri, 30 Apr 2004 ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting openness and full disclosure https://ahrp.org From: Vera Hassner Sharav, President David Cohen, Ph.D. Secretary The ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) To: Thomas Insell, MD,…