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 research stakeholders in industry, academia and government, the…
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, &…
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…
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 Rezulin prescriptions – the diabetes drug had been…
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 industry has shown its disregard for the welfare…
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. The administration argues that “if a local judge…
FDA Underhanded Tactics Against Medical Officer Who Blew the Whistle Mon, 29 Nov 2004 The Food and Drug Administration is the epicenter of a collision between medical officers in the drug safety office and senior officials in managerial positions whose focus is on facilitating new drug approvals. Officials at the…
The Senate Finance committee is cracking down on drug industry "educational grants" to physicians, medical associations and "patient advocacy" groups.
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 a minimal FDA requirement. The Wall Street Journal…
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,
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 Propulsid, a popular medicine for heartburn. Infants, given…
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.
