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Complaint about a surge of FDA administrative approvals for expanded use of highly toxic antipsychotic drugs for children. Approvals were determined by Dr. Thomas Laughren after secret deliberations–without disclosure of scientific data, without  an advisory panel or open public discussion. 

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Ethical Violations / Investigations Today Congressional Investigations Office of Human Research Protections (OHRP) Letters of Determination: http://ohrp.osophs.dhhs.gov/detrm_letrs/lindex.htm Office of Protection from Research Risks* (OPRR) List of Compliance Oversight Investigations Resulting in Restrictions or Actions to federally licensed Institutions between 1990 – 2000. *Reorganized in 2000 as OHRP Mar 30: AHRP Ethical and Scientific Objections to…

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Statin-Cholesterol Guidelines–Industry influenced? Wed, 14 Jul 2004 Scientific journal editors are scrambling about how to react to bad publicity emanating from public disclosure that the scientific reports they have published are likely to be biased because the authors’ had financial ties to the companies whose drugs / devices they report on favorably-and that information was…

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Prescription Drug Industfry: The Insiders – AARP Bulletin Wed, 10 Nov 2004 Three pharmaceutical industry insiders blow the whistle in one of the most important articles you’ll ever read about the unethical marketing of prescription drugs. Peter Rost, M.D, a top marketing executive at Pfizer, Arthur Kuebel, a salesman who promotes products to doctors, Kurt…

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An analysis published in the current issue of the British J of Psychiatry (BJP)  of the suicide rate among schizophrenia patients treated at the same hospital in North Wales (UK) before psychotropic drugs and patients treated (in and out of hospital) with neuroleptics and /or atypical antipsychotics, found a 20-fold increase in the suicide rate since use of psychotropic drugs. 

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Russian Roulette Medicine: More kids get multiple psychiatric drugs Wed, 3 Aug 2005 Stop the madness! Child psychiatrist, Joseph Penn, advises: “Parents shouldn’t passively accept whatever doctors recommend for children with behavior or psychiatric problems.” “We just don’t have the efficacy or safety data to back up what is common clinical practice.” US physicians’  dependence…

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Comments submitted by The Alliance for Human Research Protection
to The National Academy of Sciences
Committee of the Institute of Medicine on Clinical Research Involving Children

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.

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References for THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Agency for Health Care Research & Quality. (1999). Treatment of attention-deficit/hyperactivity disorder: Summary, evidence Report / Technology assessment number 11. AHQR Publication No.…

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