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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Featured News
AHRP Speaks Out AHRP Press Briefing 9/14/04: Antidepressants & suicide-related risks for children Open Letter to NIMH re Prozac & Concealed Suicide Attempts Open Letter to Officials at NIMH AHRP Briefing 2/2/04: Scientists present suicide evidence Conflicts of Interest policy – New York Times Phase I Drug Trials Used Foster…
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Federal Investigation of ARDS Study (Accute Respiratory Distress)
Federal Investigation of ARDS Study (Accute Respiratory Distress) OHRP conducted a compliance oversight evaluation of the 12 major sites participating in this clinical trial. OHRP’s determination letters documenting the outcomes of these evaluations can be viewed at the OHRP website at the following URLs: Note: OHRP found that federal informed…
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Protecting Human Subjects in Research: Are Current Safeguards Adequate?
Protecting Human Subjects in Research: Are Current Safeguards Adequate? AHRP Testimony submitted to Congressional Committee April 23, 2002 Vera Hassner Sharav, President, and John H. Noble, Jr., Ph.D., steering committee member, The Alliance for Human Research Protection (AHRP), before the Subcommittee on Public Health, Committee on Health, Education, Labor, &…
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NIMH Offers Grants to Study SSRI relation to Suicidality – FDA to Examine SSRI- Suicide in Adults
NIMH Offers Grants to Study SSRI relation to Suicidality_FDA to Examine SSRI- Suicide in Adults Mon, 14 Nov 2005 A fifteen year struggle by critics of the drug-centered treatment paradigm in psychiatry is being indirectly validated both by the FDA and the National Institute of Mental Health who are addressing…
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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…