2000 Study by Merck Showed Vioxx Risk: Results Not Given to FDA – Star Ledger Sun, 3 Jul 2005 News reports reveal that Merck failed to disclose Vioxx lethal effects to the FDA. Sheldon Krimsky, a science policy expert at Tufts University states: “if there was evidence the drug was…
Text of AHRP Amicus Brief filed with the Maryland Court of Appeals in support of the Court’s ruling against Kennedy Krieger Institute for exposing children to lead poison in an experiment. The Court of Appeals Decision Validates AHRP’s Stand Against Using Children in Harmful Research Experiments.
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.
July 25, 2001 Bioethics and Big Bucks – US NEWS In a July 14 infomail about the ethics of cloning, and bioethicist Glenn McGee’s letter of resignation from the “ethics advisory board” of Advanced Cell Technology, I asked: “how can bioethicists retain their professional integrity when they become servants of…
AHRP recognizes that to include children in clinical trials for any medication presents a dilemma of truly Solomonic proportions. It is a choice between continuing the practice of prescribing untested drugs for children, as is currently the operational system, or conducting meaningful trials to determine both safety and effectiveness.
Washington Post_Harvesting China’s Blood_installment 4 December 20, 2000. Washington Post. In what is, so far, the most devastating installment in the Washington Post series about the unholly alliances that comprise the booming human research industry, America’s premier academic research center is shown–not only to have violated ethical research standards in…
Harvard-affiliated gene studies in China face federal inquiry – Boston Globe. August 1, 2000. Harvard-affiliated gene studies in China face federal inquiry, by Deborah Nelson. Genetic research in China is booming. The biotech industry, in collaboration with scientists from America’s elite research centers & the U.S. government, is looking at…
Is it ethical to expose healthy children to risks of drug- induced pathology on a speculative, unproven theory?
Chemically Induced Psychosis Experiments: An Inhumane Paradigm in Psychiatric Research Congressional Testimony submitted by Vera Sharav * February 2, 2000 Statement For the Record Submitted To U.S. Senate Sub-Committee: Public Health & Safety of the Senate Health, Education, Labor & Pensions Committee Hearing Our efforts helped bring to public attention…
Statement For the Record Submitted to
The U.S. Senate Sub-Committee: Public Health & Safety of the Senate Health, Education, Labor & Pensions Committee Hearing
Our efforts helped bring to public attention major medical ethics violations in Federally-funded research in which uninformed, vulnerable American citizens are put at high risks without justification. As a result, such individuals have often suffered severe consequences – some have lost their lives unnecessarily. Based on the evidence – including testimonies by families and patients – we believe five factors contribute to unethical human experiments:
May 30, 1998. St. Louis Post-Dispatch. Editorial. “Protect the mentally ill.” p. 38 What sort of physician would take schizophrenics off their medications and give them drugs known to cause paranoia just to see how the patients react? What sort of unscrupulous researchers would give psychotic patients amphetamines to worsen…
The New York Times May 19, 1998 Psychiatric Researchers Under Fire By PHILIP J. HILTS ANDREW BROWNSTEIN, a severe manic-depressive, was desperate. None of his medicines could keep the anxiety and depression of his illness at bay. So in the fall of 1994, he agreed to become a research subject…
