What’s a Patient to Think? Prescription for Confusion – NY Times Editorial

What’s a Patient to Think? Prescription for Confusion – NY Times Editorial Tue, 28 Dec 2004 At long last, The New York Times has validated the well-placed anger and frustration that patients feel at having their trust in medicine and the nation’s oversight agents betrayed: “Now I just don’t trust…

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.

“Precursors to Diabetes in Japanese American Youth”

Comments Re: DHHS Notice of Proposed Recommendation Regarding Support of Research Protocol: "Precursors to Diabetes in Japanese American Youth" Grant Number I R01 DK59234-01

The proposed experiment would involve 450 children healthy children, aged 8-10 years old, 300 of Japanese ancestry and 150 Caucasians. The experiment is not approvable under federal regulations, 45 CFR 46 Subpart D because it involves greater than minimal risk and no potential direct benefit to the children.

Infomail Archive

July 15, 2002 Short Drug Tests, Fatal Flaws. Thomas J. Moore. Op Ed. Boston Globe. FYI “We need new laws, a national scientific program, and money to assure that every important drug intended for long-term use receives the same long-term testing as was provided for hormone replacement therapy.” An Op-ed…

Dissenting Opinion – Proposed Children’s Workgroup Reinterpretation of Fed Regs 45 CFR 46 sects. 404 & 406

Dissenting Opinion (NHRPAC Children Workgroup) re: Proposed Reinterpretation of Fed. Regs Protecting Children (45 CFR 46, sections 404 and 406) May 14, 2002 To: Alan Fleischman, MD, Chair, Children’s Workgroup of NARPAC        Mary Faith Marshall, Ph.D., Chair, NARPAC From: Vera Hassner Sharav Re: Dissenting Opinion re: Report to NHRPAC, proposing…

InfoMail for April 9, 2002

  AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav April 9, 2002 Debate on Value of ScreeningTests for Cancer FYI Today’s Science section in The New York Timesprovides the kind of critical reporting that has not…

Seattle Times Series on Fred Hutchinson Cancer Center

Seattle Times Series on Fred Hutchinson Cancer Center 2001 Seattle Times Series, UNINFORMED CONSENT An in-depth, documented, 5-part investigative series, in The Seattle Times, beginning Sunday, March 11, 2001, turned the spotlight on cancer research at the world renowned Fred Hutchinson Cancer Center in Seattle — with supporting documents available…