"Every year, drug companies spend $14 billion to test experimental substances on humans. Across the U.S., the centers that do the testing–and the regulators who watch them–allow scores of human test subjects to be injured or killed."
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,
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) www.ahrp.org Proposed Changes to Subpart D Regulations Increase Risks to Children in Non-Therapeutic Research Statement of the AHRP Opposing the SACHRP Children’s Committee Recommendations April 18, 2005 The Alliance for Human Research Protection (AHRP) welcomes the opportunity to respond to the question “What…
The Alliance for Human Research Protection (AHRP) welcomes the opportunity to respond to the question “What is the Best Way to Protect Children?”
Our recommendation – which is backed up by evidence that children have suffered harm in medical research – is to significantly limit the discretion of IRBs to approve greater than minimal risk research without direct benefit for the child-subjects under 46.406.
We recommend staying the course in requiring that any such proposed experiment undergo a transparent open evaluation with ample opportunity for public oversight and comment – as required under the provisions of 46.407.
Scientists Decode Secret of Getting NIH Grants – WSJ Mon, 28 Jun 2004 The Secret of Getting Grants: Marketing Helps University Win $350 Million a Year, by Bernard Wysocki, a front page article in The Wall Street Journal, provides insight into an iron triangle that controls medical research. This triumvirate…
Is it Cloning? U.S. experiment in China – Baltimore Sun Fri, 17 Oct 2003 Concern has been raised about unauthorized US initiated human experiments conducted offshore. One such experiment is said to come “perilously close to human cloning.” The debate prompted the chief scientist of a biotech company in Singapore…
10 monkeys killed in botched experiment at Johns Hopkins Sat, 6 Sep 2003 To err is human, but Johns Hopkins researchers have shown a tendency to cut corners on safety and ride roughshod with experimental subjects–human and animal. [See: https://ahrp.org/infomail/0701/19.php ] This time the victims are 10 monkeys and baboons…
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…
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.
Debate Resumes on the Safety of Depression’s Wonder Drugs – NYT Thu, 7 Aug 2003 After a decade of lies, deception, and cover-up of evidence linking antidepression drugs – such as, Prozac, Paxil, Zoloft – to acts of suicide in previously non-suicidal people – children and adults, some of who…
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:…
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…
