Conflict of Interest: Profits vs Safety Congressional Investigations US Senators Pharmaceutical industry holdings, 2004: http://www.consumerwatchdog.org/resources/SenPharma.pdf Oct 12: How Did the Vioxx Debacle Happen? USA Today / Lancet Oct 4: Op Ed: Psychiatry on the Ropes–WP / Evidence-based Psychiatry Oct 3: BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical…
FDA Failed to Enforce Law Requiring Drugmakers to Disclose Test Data – WashPost Tue, 6 Jul 2004 A front page article in The Washington Post reports that the FDA failed to enforce the law that requires drug companies to disclose ALL clinical drug trials and ALL trial findings-whether they’re good…
Dr. Carl Elliott's insightful essay in SLATE:: Why do drug companies want to give money to bioethicists in the first place? In the public relations business, this approach is called "third-party strategy."
NIH Expert on Safe Drug Research Seeks Whistleblower Protection Tue, 14 Dec 2004 In the wake of the Associated Press investigative report about unethical NIH-sponsored AIDS research involving infants and pregranant women Africa, and charges of misconduct by high officials at the National Institutes of Health (NIH), Senate Finance Committee…
Researchers Caught Faking AIDS data in NIH funded research Fri, 5 Dec 2003 The Washington Times reports that three researchers from the University of Maryland, department of pediatrics admitted faking data that gave high marks to reduced incidence of HIV in teenagers counseled about “safe sex” in an enhanced widely…
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…
Rehnquist Warns Drug Makers _Marketing Actimune for Unapproved Use_NYT Mon, 28 Apr 2003 1. The New York Times reports that Janet Rehnquist, the Inspector General of the Department of Health and Human Services, has issued “a compliance guide for drug manufacturers” in which they are waned that many of their…
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…
