FDA: Regulatory Protections for Children. Comments by Sharav, Noble, & Fishman for AHRP

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,…

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Dissenting Opinion: Against waiving parental permission for research

Dissenting Opinion: Against Waiving Parental Permission for Research July 25, 2001 To: Mary Faith Marshall, Ph.D, Chairperson, National Human Research Protections Advisory Committee Department of Health and Human Services Re: Specific Comment on FDA’s Decision to Adopt HHS 45 CFR 46 Subpart D, EXCLUDING §46.408 (c) Dissenting opinion of Vera…

New Evidence Uncovered About AIDS Drug/Vaccine Experiments on Foster Care Infants & Children

New Evidence Uncovered About AIDS Drug/Vaccine Experiments on Foster Care Infants & Children Thu, 1 Sep 2005 A moral controversy is spiraling as additional evidence is uncovered about the use of infants and children in foster care as experimental subjects of Phase I and II trials of AIDS drugs, vaccines,…

Federal Study Finds No Benefit of New Antipsychotic Drugs – WashPost/Wall StreetJ/NY Times

Federal Study Finds No Benefit of New Antipsychotic Drugs – WashPost/Wall StreetJ/NY Times Tue, 20 Sep 2005 The findings of a $44 million government sponsored study, CATIE, published in The New England Journal of Medicine, comparing an older generic antipsychotic to four new atypical antipsychotics, undercut the legitimacy of psychiatry’s…

Lilly to Add Suicide Warning to Strattera – Medicaid May shrink $5.5 Billion spending on Schizophrenia Drug

Lilly to Add Suicide Warning to Strattera – Medicaid May shrink $5.5 Billion spending on Schizophrenia Drug Thu, 29 Sep 2005 Reuters reports that Eli Lilly is adding a Black Box suicide warning to the Strattera label. Strattera has been promoted as a “non stimulant” treatment for ADHD. Since ADHD…

Failed Drug Treatments for Schizophrenia–Letters to the Editor – NYT

Failed Drug Treatments for Schizophrenia–Letters to the Editor – NYT Fri, 23 Sep 2005 Letters to the NY Times editor (below) demonstrate the combative reaction of stakeholders in the psychotropic drug industry to the evidence-based overthrow of psychiatry’s treatment recommendations. Psychiatrists who have financial contracts with psychotropic drug manfuacturers, have…