Rehnquist Warns Drug Makers _Marketing Actimune for Unapproved Use_NYT Mon, 28 Apr 2003 1. The New York Times reports that Janet Rehnquist, the Inspector General of the Department of Health and Human Services, has issued “a compliance guide for drug manufacturers” in which they are waned that many of their…
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) April 10, 2003 Letter to the Editor The New England Journal of Medicine View letter as finally published in NEJ Sir: The April 3, 2003 New England Journal of Medicine (NEJM) issue contained an array of articles largely in support of a disputed…
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.
Infomail Archive – Pre 2003 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav December 28, 2002: Will 2 to 5 year old Amer. kids be exposed to Smallpox Vaccine? Israeli Intelligence says “No immediate threat” December 24, 2002: Moral turpitude: Herpes experiment surpasses Tuskegee December 20,…
Lawsuits & press info RE: SSRI addiction / suicide risk–not scientific literature Fri, 25 Oct To gain knowledge about the scope of a serious threat to public health–i.e., severe adverse drug effects of antidepressant drugs– physicians and consumers must turn to the popular and alternative press, rather than “peer reviewed”…
October 9, 2002 Smallpox Vaccine plan: HHS Messengers Still Stumble_NYT_WP The Administration’s shift in its smallpox vaccination policy is meeting with criticism from medical experts who are unconvinced that it is wise or justified to put millions of people at serious risk in (what amounts to) a massive human experiment–without…
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) New York, NY 10023 212-595-8974 July 29, 2002 Greg Koski, MD, Ph.D. Office of the Secretary Office of Public Health and Science Office of Human Research Protection The Tower Building 1101 Wooten Parkway, Suite 200 Rockville, MD 20852 RELATED PAGES OHRP Investigation of…
Acute Respiratory Distress Syndrome – ARDSNet experiment criticized – OHRP Fri, 28 Feb 2003 An Acute Respiratory Distress Syndrome (ARDS) study conducted between 1996 and 1999, on critically ill patients at 20 medical facilities (14 major research centers belonging to the ARDS Network), was published in The New England Journal…
Presented by Vera Hassner Sharav
14th Tri-Service Clinical Investigation Symposium
Sponsored by The U.S. Army Medical Department and The Henry M. Jackson Foundation for the Advancment of Military Medicine
The cornerstone of public trust in medical research is the integrity of academic institutions and the expectation that universities, which rely on public funding, have a responsibility to serve the public good. Financial conflicts of interest affect millions of American people – those who are subjects of clinical trials testing new drugs and those who are prescribed drugs after their approval.
CONFLICTS OF INTEREST Presented by Vera Hassner Sharav 14th TRI-SERVICE CLINICAL INVESTIGATION SYMPOSIUM Sponsored By THE U.S. ARMY MEDICAL DEPARTMENT And THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCMENT OF MILITARY MEDICINE May 5-7, 2002 The cornerstone of public trust in medical research is the integrity of academic institutions and…
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.
