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.
Today’s (6/30/04) editorial, “Missing Drug Data,” misses the point and argues with the pharmaceutical industry and its allies in the Congress, the NIH and the FDA that data can be selectively reported to satisfy commercial interests. This is a blatant attack on Karl Popper’s falsifiability principle on which empirical science depends to make progress. One needs all the data in order to verify the results of clinical or any other kind of research. Most academics and pundits know that any case can be made if allowed to manipulate the data and assumptions. The AMA, the medical journal editors, and Eliot Spitzer, all deserve applause from the Washington Post editor-not quibbling about the possible damage that somehow, somewhere might result from strict embrace of the principles and practice of scientific inquiry. It’s all about transparency.
John H. Noble, Jr.
To: Thomas Insel MD; Tommy Thompson Re: Published NIMH Prozac Trial Report Concealed Suicide Attempts by Teens ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Tel. 212-595-8974 Fax: 212-595-9086 142 West End Ave. Suite 28P New York, NY 10023 Related Link: NIMH Response to AHRP Letter Board of Directors: Vera Hassner Sharav,…
Recent revelations indicate that pharmaceutical companies have selectively reported partial (favorable) clinical trial results from pediatric antidepressant trials and concealed evidence of harm from physicians, other health care professionals, and the public. It is universally agreed in the literature that failure to disclose all trial results compromises physicians’ ability to provide professional care – thereby increasing the likelihood of causing preventable harm. More generally, failure to disclose trial results in scientific publications taints the scientific literature (by rendering it not credible) and, as New York State Attorney General Elliot Spitzer charged recently, constitutes plain and simple fraud.
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.
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…
On June 10, 2003, a panel of experts convened by the federal Office of Human Research Protections (OHRP) heard presentations by critics who had filed complaints about $37 million government sponsored, multi-site experiment conducted by major academic institutions participating in the ARDSNetwork, and by the ARDSNet investigators who defend the trial.
The experiment tested two extreme, rarely used methods of mechanical lung ventilation in 861 critically ill, vulnerable patients suffering from acute lung disease (ALD) or acute respiratory distress syndrome (ARDS).
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…
The April 3, 2003 New England Journal of Medicine (NEJM) issue contained an array of articles largely in support of a disputed multi-site, clinical trial sponsored by the National Heart, Lung, and Blood Institute (NHLBI), one of the National Institutes of Health (NIH), involving critically-ill, mentally incapacitated human beings with acute respiratory distress syndrome (ARDS) – who did not give their informed consent.
The accompanying editorial, "Controlling Research Trials," by Dr. J.M. Drazen, who serves on the NHLBI advisory committee that had approved the disputed trial, reveals much about the NIH attitude toward the rest of the world.
THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave. Suite 28P New York, NY 10023 April 4, 2003 Tommy Thompson, Secretary Department of Health and Human Services Dockets Management Branch (HFA–305), Docket Number 02N–0475, Food and Drug Administration, 5630 Fishers Lane, Room 1061 Rockville, MD 20852. Re: Docket…
