Dissenting Opinion: Against Waiving Parental Permission for Research July 25, 2001 To: Mary Faith Marshall, Ph.D, Chairperson, National Human Research Protections Advisory Committee Department of Health and Human Services Re: Specific Comment on FDA’s Decision to Adopt HHS 45 CFR 46 Subpart . . . Continue reading →
THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Abstract This paper argues that contrary to the claims made by the . . . Continue reading →
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 . . . Continue reading →
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 . . . Continue reading →
Drug Warnings: Are They Effective? USA Today Tue, 26 Apr 2005 How effective are drug warnings? USA Today reports that experts are unsure. For example, a study in the January issue of Pharmacoepidemiology and Drug Safety focused on Ohio Medicaid claims for . . . Continue reading →
Merck / Johnson & Johnson/ Lilly-Zyprexa: $690 Million settlement / a Flowering of Diabetes Drugs Fri, 10 Jun 2005 A cluster of news reports about three pillars of the pharmaceutical industry– Merck, Eli Lilly, and Johnson & Johnson–leave no doubt that this . . . Continue reading →
Mosholder Suppressed Report Posted/ Bush Moves to Block Medical Suits – NYT Mon, 26 Jul 2004 The New York Times reports that the Bush administration is actively blocking individual citizens who have been seriously harmed from drug-related hazards from suing drug manufacturers. . . . Continue reading →
The Senate Finance committee is cracking down on drug industry "educational grants" to physicians, medical associations and "patient advocacy" groups. Continue reading →
Abbott Seeks FDA approval for cancer drug despite failed trials – WSJ Mon, 12 Sep 2005 Abbott Laboratories is asking the FDA to approve a cancer drug even though it failed in clinical trials to demonstrate a benefit greater than placebo–which is . . . Continue reading →
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, Continue reading →
http://www.nytimes.com/2005/06/10/business/10drug.html?ei=5094&en=5475b3c17e50e692&hp =&ex=1118462400&partner=homepage&pagewanted=print THE NEW YORK TIMES June 10, 2005, front page Lucrative Drug, Danger Signals and the F.D.A. By GARDINER HARRIS and ERIC KOLI Dozens had died and more than 100 patients had suffered serious heart problems by March 1998 after taking . . . Continue reading →
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.