2005: “Cheaper than Chimpanzees” by Vera Sharav

On behalf of the Alliance for Human Research Protection, or AHRP, I want to thank the members of the Committee, for this opportunity to share with you our understanding of the complex problems presented by medical research involving vulnerable populations, such as prisoners and children. We appreciate your difficult job, and recognize that you will need to exercise courage in your assigned mission, which is to protect prisoners from research abuse and exploitation.

“Courage,” in this context, means the courage to acknowledge uncomfortable facts about current practice and to speak truth to power,

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AHRP Testimonies and Presentations

AHRP Testimonies and Presentations Sep 8, 2005: AHRP Testimony: NYS Hearing –AIDS Drug /Vaccine Experiments on Foster Children July 18, 2005: Cheaper than Chimpanzees Statement by Vera Hassner Sharav before the Committee on Ethical Consideration for Revisions to DHHS Regulations on Protection of Prisoners Involved in Research July 2- 8, 2005:…

AHRP Speaks Out

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:…

Conflict of Interest

Conflict of Interest: Profits vs Safety Congressional Investigations US Senators Pharmaceutical industry holdings, 2004: http://www.consumerwatchdog.org/resources/SenPharma.pdf Oct 12: How Did the Vioxx Debacle Happen? USA Today / Lancet Oct 4: Op Ed: Psychiatry on the Ropes–WP / Evidence-based Psychiatry Oct 3: BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical…

NIH Rule change Re: Whistle blowers – Comments due before June 15

A request for comment about NIH proposed new research misconduct rule

See Fed Register:
http://ori.dhhs.gov/multimedia/acrobat/42CFRParts50and93.pdf

The new rule, I believe is meant to protect research institutions from the effective sting of a knowledgeable whistle blower.

The new rule would redefine whistle-blower as “complainant” and would limit the role of the complainant. Under the old rule, the whistle-blower participated in the process helping investigators by leading them to the evidence, etc.

AHRP Comments Re: Best Pharmaceuticals for Children’s Act of 2002

Comments submitted by The Alliance for Human Research Protection Re: Best Pharmaceuticals for Children’s Act of 2002 The National Academy of Sciences Committee of the Institute of Medicine on Clinical Research Involving Children August 18, 2003 Vera Hassner Sharav, President John H. Noble, Jr., Ph.D, Treasurer David Cohen, Ph.D, Secretary…

Best Pharmaceuticals for Children Act of 2002


Comments submitted by The Alliance for Human Research Protection
to The National Academy of Sciences
Committee of the Institute of Medicine on Clinical Research Involving Children

AHRP has been closely monitoring pediatric research trends since passage of the FDA Modernization Act of 1997. We believe that medications used in children should be thoroughly tested for safety, effectiveness and appropriate dose. But unlike adults who can exercise their autonomous right to informed consent, children who are enrolled in clinical trials are non-consensual human subjects. They should not, therefore, be made to assume the burden of testing possibly toxic drugs whose safety is unknown.

Infomail Archive 2003

Infomail Archive 2003 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 19, 2003: Eli Lilly Prozac UK Fact Sheet: “Not Recommended” for Children – PMDD Withdrawn in UK Dec 19, 2003: Not-So-Public-Relations: Drug Industry & Bioethics – is it casuistry or sophistry? Dec 18, 2003:…

AHRP Letter to the editor re: editorial ARDS trial

AHRP Letter to the editor re: editorial ARDS trial July 10, 2003. The New England Journal of Medicine. Volume 349:188-192 Number 2 http://content.nejm.org/cgi/content/extract/349/2/188 Note: The April 3, 2003 the NEJM contained an editorial in support of a controversial multi-site, clinical trial sponsored by the National Heart, Lung, and Blood Institute…

Hopkins Asks Patients to Waive Privacy Rights to Facilitate Research Recruiting – AP/ ABC

Hopkins Asks Patients to Waive Privacy Rights to Facilitate Research Recruiting – AP/ ABC Tue, 8 Jul 2003 In the 19th century doctors robbed graves to obtain cadavers for medical training purposes. Today, medical researchers are far more ambitious– they seek backdoor access to living patients for medical experiments. A…

Article

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…