Ethical Violations / Investigations Today Congressional Investigations Office of Human Research Protections (OHRP) Letters of Determination: http://ohrp.osophs.dhhs.gov/detrm_letrs/lindex.htm Office of Protection from Research Risks* (OPRR) List of Compliance Oversight Investigations Resulting in Restrictions or Actions to federally licensed Institutions between 1990 – 2000. *Reorganized in 2000 as OHRP Mar 30: AHRP…
Anthrax shots may be required in military – Assoc Press Thu, 1 Dec 2005 After a US District Judge suspended the forced anthrax vaccine program in the military, the Bush Administration is attempting to reinstate mandatory anthrax vaccine inoculations for military personnel. The less evidence, it seems, that there is to demonstrate…
Critical GAO Report Belies Safety of Anthrax Vaccine – Insight Mon, 18 Nov 2002 A highly critical 50-page report by the General Accounting Office (GAO) has put into question the safety of the Anthrax vaccine and the credibility of government officials who have withheld information about the vaccine’s serious health…
Smallpox vaccine: Experts Urge Caution, Administration Pushes Hard Sat, 29 Mar 2003 In our earlier Infomail today, the focus was on the Administration’s difficulty in recruiting volunteers for the anthrax vaccine trial. This Infomail focuses on the determined push to implement the smallpox vaccine program, despite the advice of medical…
Dr. Scott Gottlieb’s ties to drug firms spark questions over agency hiring policies
An Epidemic of Overreaction /The scare Scenario / The Fear Epidemic Thu, 27 Oct 2005 Dr. Marc Siegel, a practicing internist and an associate professor of medicine at New York University School of Medicine, and a subscriber to the AHRP Infomails, forwarded 3 recent Op Ed articles he has published–in…
AHRP Speaks Out Dec 12, 2005: Mental Health Screening: A PhRMA Friendly Remedy for Societal Problems. Presentation by Vera Sharav, American Public Health Association Nov 2005: Analysis of S. 1873 – The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 – Karen R. Effrem, MD June 1-3, 2005:…
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, Full Disclosure, and Accountability www.ahrp.org Statement by Vera Hassner Sharav Founder & President, AHRP April 1, 2005 Anthrax Band Reunion Press Conference New York City My name is Vera Hassner Sharav, and I am president of The Alliance for Human Research Protection:…
EPA Nominee Challenged in Senate Over Children’s Pesticide Experiment Thu, 07 Apr 2005 AHRP applauds Senator Barbara Boxer for pledging to hold up the confirmation of Stephen Johnson, the President’s nominee to head the Environmental Protection Agency, until he pulls the plug on “the appalling, unethical, and immoral” children’s pesticide…
My name is Vera Hassner Sharav, and I am president of The Alliance for Human Research Protection: a national human rights organization that exposes unethical research practices which undermine the dignity, rights, and safety of human subjects.
In 1947, an American military tribunal sat in judgment of the Nazi doctors at Nuremberg, and laid down ten essential principles that define “permissible medical experiments” in a civilized society. Those principles are enshrined in the Nuremberg Code which is the cornerstone of all medical research ethics. The nations of the world adopted the Code as a safeguard to prevent future medical atrocities.
When a federal judge ruled the vaccine to be an "investigational drug and a drug being used for an unapproved purpose" on December 22, 2003, FDA hurriedly issued a Final Rule for anthrax vaccine. The agency submitted its Final Rule just eight days after a federal court injunction, having failed to do so for 19 years. In a January 7, 2004 court hearing the same judge called FDA’s actions "highly suspicious." On October 27, 2004 FDA’s arbitrary and capricious promulgation of this Final Rule resulted in a permanent injunction, remanding the license to your agency to complete according to the law. The injunction also halted what the judge called DoD’s "illegal" mandatory anthrax vaccination program.
Thank you for the opportunity to submit this testimony for the record.
My name is Meryl Nass, M.D., and I have worked for the past twenty years as an emergency physician and internist in community hospitals in the northeastern US. I have also studied many aspects of bioterrorism since 1989. I am the person who first demonstrated, in 1992, that one could investigate an epidemic retrospectively, and prove that it was due to biological warfare, using Rhodesia’s 1978-80 anthrax epidemic as a model.[1]
