Letter of Complaint to FDA Commissioner, 2007

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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.  Continue reading →

Ethical Violations and Investigations Today

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. . . . Continue reading →

Merck Baby Vaccines Not Pure – LAT/ FDA Advisory-Crestor / Zyprexa Lawsuit charges Lilly concealed Diabetes risk

Merck Baby Vaccines Not Pure – LAT/ FDA Advisory-Crestor / Zyprexa Lawsuit charges Lilly concealed Diabetes risk Fri, 11 Mar 2005 The FDA’s failure to carry out its watchdog responsibility to protect the public from unsafe drugs, has encouraged the pharmaceutical industry . . . Continue reading →

Statin-Cholesterol Guidelines–Industry influenced?

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 . . . Continue reading →

Prescription Drug Industfry: The Insiders – AARP Bulletin

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 . . . Continue reading →

Disease Mongering_Conference / PLoS Special Issue

"Are we becoming patients for profit? That is the question knowledgeable observers are asking. Continue reading →

Comparison of Suicide Rates in Treated Schizophrenia Patients Found 20-Fold Increase

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

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 . . . Continue reading →

Texas Foster Care Investigation – Children as young as 3 are drugged with antipsychotics

Texas Foster Care Investigation – Children as young as 3 are drugged with antipsychotics Sat, 13 Nov 2004 The Dallas Morning News reports that Texas comptroller, Carole Keeton Strayhorn, who hade conducted an investigation of the foster care system, concluded that up . . . Continue reading →

Best Pharmaceuticals for Children Act of 2002


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: Impact of FDA inclusion of children as test subjects

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 . . . Continue reading →