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. *Reorganized in 2000 as OHRP Mar 30: AHRP…

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 to conceal the risks and deceive the public….

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 the companies whose drugs / devices they report…

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 executive at Pfizer, Arthur Kuebel, a salesman who…

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. 

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 safety data to back up what is common…

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 to $4 million a year might be wasted…

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.

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 attention-deficit/hyperactivity disorder: Summary, evidence Report / Technology assessment…