Update: Ramifications of Swine Flu Vaccine Immunity
In 2006, PREPA was passed due to fear of an avian flu pandemic, in the event the avian
flu virus mutated to enable person-to-person spread. Avian flu then had a 70% death rate.
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Does the FDA have the authority to trump the Declaration of Helsinki?
The FDA is sliding rapidly down the slippery slope, abandoning widely accepted, international ethical research standards articulated in the internationally accepted, Declaration of Helsinki–to facilitate commercial medical experiments.
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AHRP in the News
Alliance for Human Research Protection in the Press Feb 17, 2005: FDA Critics Slam Plan for Safety Reform – Nature “This is smoke and mirrors and musical chairs,” says Vera Sharav, president of the New York-based Alliance for Human Research Protection. “They will be using the very same officials that…
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Sharav / Cassidy – OHRP Testimony, 4/01
Testimony Submitted to the Office of Human Research Protection (OHRP) by Vera Hassner Sharav and Marie M. Cassidy, Ph.D, D.Sc. April, 2001 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…
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UK Doctors told to stop giving antidepressants to children – Glaxo Warns of Paxil Birth Defects
UK Doctors told to stop giving antidepressants to children – Glaxo Warns of Paxil Birth Defects Wed, 28 Sep 2005 Related Link – See Guidelines at: http://www.nice.org.uk/page.aspx?o=273073 The UK National Health Service has taken a decisive, responsible step to protect the lives of children who are being exposed to serious risks…
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Death of Baby Prompts Scrutiny of Research Risks_St. Louis Post Dispatch
Death of Baby Prompts Scrutiny of Research Risks_St. Louis Post Dispatch 16 Feb 2003 Eighteen month old, Daniella Rogers, died on May 3, 2002, two months after undergoing a clinical trial of chemotherapy treatments at St. Louis Children’s Hospital. When her parents, John and Oksana Rogers, learned that their baby…
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OHRP Response to AHRP re: Surrogate Consent to Research
OHRP Response to AHRP re: Surrogate Consent to Research Office of the Secretary Department of Health & Human Services Office of Public Health and Science Office for Human Research Protections Rockville, Maryland E-mail: mcarome@osophs.dhhs.gov August 28, 2002 Vera Hassner Sharav President, The Alliance for Human Research Protection John H. Noble,…
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Intimidation, Politics and Drug Industry Cripple U.S. Medicine – FDA Permits Dr. David Graham to publish Vioxx Report
Intimidation, Politics and Drug Industry Cripple U.S. Medicine – FDA Permits Dr. David Graham to publish Vioxx Report Wed, 5 Jan 2005 FDA officials could not maintain their iron grip in an effort to suppress evidence of far reaching lethal effects of Vioxx when their actions were in full public…
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AHRP Speaks Out | Informed Consent Waivers | NIH -- Ethics Violations | Unethical Experiments | Vulnerable Groups
AHRP Letter to Editor re: ARDS published NEJM
AHRP Letter to Editor re: ARDS published NEJM Fri, 11 Jul 2003 A truncated version of a Letter to the editor submitted by John H. Noble, Jr., PhD and Vera Sharav appears in the current July 10, 2003, issue of The New England Journal of Medicine. Note: On April 3,…
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Ethical Violations and Investigations Today
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…
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Infomail Archive, 2005
Infomail 2005 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Subscribe to the AHRP infomail list Dec 16: Drugs, Devices & Doctors – NYT Paul Krugman Dec 11: Scientific Fraud & Corruption on Both sides of Atlantic: Merck / Proctor & Gamble Dec 11: Gov Accountability…
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DHHS Report: Contradicting itself on drug imports – OpEd Peter Rost
DHHS Report: Contradicting itself on drug imports – OpEd Peter Rost Wed, 5 Jan 2005 Dr. Peter Rost, a Pfizer Vice-President of Marketing knows about the financial underpinnings of drug pricing. He has taken a consciencious public position (unsusual in that industry) because he believes the American public has a…