Johns Hopkins University Experiment on Lead Paint Puts Children in Danger August 24, 2001 FYI Additional details are emerging about the lead-paint study conducted on infants and children by researchers at the Kenney Krieger institute which is affiliated with Johns Hopkins University. Today’s New York Times reports (below) that the…
FDA: regulatory protections for children. Comments submitted by Vera Hassner Sharav, John H. Noble, Jr., Ph.D and Howard Fishman, MEd, MSW for AHRP August 6, 2001 To: Dr. Bernard Schwetz Acting Commissioner Food and Drug Administration Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville,…
What to do about the ADHD epidemic William B. Carey, M.D. American Academy of Pediatrics Section on Developmental and Behavioral Pediatrics Newsletter, Autumn 2003, Pages 6-7 In the last two decades the United States has experienced a great increase in the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) and…
October 1, 2001 Text of AHRP Amicus Brief filed with the Maryland Court of Appeals in support of the Court’s ruling against Kennedy Krieger Institute for exposing children to lead poison in an experiment. The Court of Appeals Decision Validates AHRP’s Stand Against Using Children in Harmful Research Experiments. ___________________________________________________…
OHRP Investigation of experimental treatment for Acute Respiratory Distress Syndrome. ARDSNet studies: ARMA, FACCT, and ALVEOLI Table of Contents to Fax from OHRP page 1 Oct. 7, 2002 OHRP letter to: Ronald S. Newvbower, Ph.D(Mass. General Hospital), Lee E. Limbird, Ph.D. (Vanderbilt University), and Robert Kay, MD) (Cleveland Clinic Foundation)…
http://hedwig.mgh.harvard.edu/ardsnet/faq.html#3 The individuals participating in the ARDS Network are listed below: Steering Committee Chair: Gordon Bernard, M.D., Vanderbilt University Clinical Coordinating Center: Massachusetts General Hospital: David Schoenfeld, Ph.D. B. Taylor Thompson, M.D. Nancy Ringwood, R.N., CCRA Cathryn Oldmixon, R.N. NHLBI Project Office: Andrea Harabin, Ph.D. Myron…
THE ALIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Avenue, Suite 28P New York, NY 10023 www.ahrp.org FDA Docket Number 02N-0466 Comments re: Proposed smallpox vaccine trial to test the safety of Dryvax administration to children 2 to 5 years of age Recent public and professional debate about smallpox…
AHRP Opposes Drug Implants for Psychiatric Patients Those promoting the implants focus on its delivery of continuous sustained drug action to ensure that patients take the drugs they’re prescribed, presumably to prevent relapse. But critics who are familiar with widespread psychotropic drug prescribing abuses recognize the serious potential for harm…
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) August 21, 2002 Comments Re: DHHS Notice of Proposed Recommendation Regarding Support of Research Protocol: "Precursors to Diabetes in Japanese American Youth" Grant Number I R01 DK59234-01 The proposed experiment would involve 450 children healthy children, aged 8-10 years old, 300 of Japanese ancestry…
Cover Letter – AHRP Ethical and Scientific Objections to FDA’s Proposed Licensure of Anthrax Vaccine related links: Comments Submitted to FDA re Anthrax Vaccine (312K pdf) Who Is Protecting The Public Health? By Meryl Nass, Z Magazine March 29, 2005 Lester Crawford, Ph.D., D.V.M. Acting FDA Commissioner U. S. Food…
Who is a Human Subject? Who has the Right to Informed Consent? March 11, 2002 "The voluntary consent of the human subject is absolutely essential." [Nuremberg Code, 1947] "Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or…
Linguistic Tinkering with Regulatory Terminology Increases Risk of Harm for Children: "minimal risk" "minor increment of minimal risk" and "disorder or condition" January 28, 2001 A cornerstone of the Declaration of Helsinki (adopted by the World Medical Association in 1964, and reaffirmed on Oct. 2000) is the distinction between research…
