Lawsuits, Just the Cost of Criminal Marketing of Antipsychotic Drugs
"When you’re selling $1 billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”
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Child’s Ordeal Shows Risks of Antipsychotic Drugs for Young
The prescribed drugs transformed Kyle Warren from a rambunctious healthy child into a drooling, sedated, obese, “shell.”
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AHRP Letter to Harvard Re: Dr. Biederman’s Research
AHRP proposes a multi-disciplinary team of independent scientists to review ALL of Dr. Joseph Biederman’s publications and supporting documents, including: research protocols, consent forms, and the original (of course, anonymized) data sets with associated code books for all pediatric studies.
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Florida Antipsychotic Pre-Approval Requirement Protects PreschoolChildren
The State of Florida has established a pre-approval requirement to protect preschool children on Medicaid from being exposed to the hazardous effects of antipsychotic drugs. That step has prompted "a seismic change" in doctors’ inappropriate prescribing of antipsychotics for preschool children: the number of prescriptions for this age group has…
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Sen. Grassley Letter to Harvard: Biederman Research Protocol Breaches
The most shocking disclosure is that Dr. Biederman’s study testing powerful antipsychotics in PRESCHOOL CHILDREN "was beset by breaches of research protocol,"
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Grassley to Harvard & Mass General: Biederman Protocol Breach
The most shocking disclosure: a Biederman study testing the use of powerful antipsychotics in PRESCHOOL CHILDREN "was beset by breaches of research protocol."
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Letter of Complaint to FDA Commissioner, 2007
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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The Impact of the FDA Modernization Act on the Recruitment of Children for Research
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 Abstract This paper argues that contrary to the claims made by the research stakeholders in industry, academia and government, the…
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Protecting Human Subjects in Research: Are Current Safeguards Adequate?
Protecting Human Subjects in Research: Are Current Safeguards Adequate? AHRP Testimony submitted to Congressional Committee April 23, 2002 Vera Hassner Sharav, President, and John H. Noble, Jr., Ph.D., steering committee member, The Alliance for Human Research Protection (AHRP), before the Subcommittee on Public Health, Committee on Health, Education, Labor, &…
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Researcher To Be Sacked After Reporting High Rates of ADHD – BMJ
Researcher To Be Sacked After Reporting High Rates of ADHD – BMJ Sun, 10 Apr 2005 The BMJ reports that Dr. Gretchen LeFever, a clinical psychologist and professor at Eastern Virginia Medical School, whose published reports (since 1995) have raised the alarm about a spiraling increase in elementary school children…
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Psychopharmacology in Turmoil: David Healy, MD Presentation Columbia + Debate Dr. Joseph Coyne, Ph.D
Psychopharmacology in Turmoil: David Healy, MD Presentation Columbia + Debate Dr. Joseph Coyne, Ph.D Fri, 9 Dec 2005 Recent reports describing a determined effort to pathologize US infants and toddlers who are being declared to suffer from “severe mental disorders”–the latest, most aggressively marketed diagnosis for children is Bipolar disorder,…
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AHRP Position Statement on Mental Health Screening – FDA Hearing Re: Drug Advertising
AHRP Position Statement on Mental Health Screening – FDA Hearing Re: Drug Advertising Wed, 02 Nov 2005 FDA is holding public hearings (Nov 1, 2) Re: Direct-to-Consumer Promotion of Medical Products at: National Transportation Safety Board Boardroom and Conference Center 429 L’Enfant Plaza, SW., Washington, DC 2 Time: 9:00 –5:00….
