Subject(s)
Postpartum Hemorrhage , Venous Thromboembolism , Consensus , Female , Humans , Patient Safety , PregnancyABSTRACT
The implementation of a recommendation by the President's New Freedom Commission (NFC) to screen the entire United States population--children first--for presumed, undetected, mental illness is an ill-conceived policy destined for disastrous consequences. The "pseudoscientific" methods used to screen for mental and behavioral abnormalities are a legacy from the discredited ideology of eugenics. Both eugenics and psychiatry suffer from a common philosophical fallacy that undermines the validity of their theories and prescriptions. Both are wed to a faith-based ideological assumption that mental and behavioral manifestations are biologically determined, and are, therefore, ameliorated by biological interventions. NFC promoted the Texas Medication Algorithm Project (TMAP) as a "model" medication treatment plan. The impact of TMAP is evident in the skyrocketing increase in psychotropic drug prescriptions for children and adults, and in the disproportionate expenditure for psychotropic drugs. The New Freedom Commission's screening for mental illness initiative is, therefore, but the first step toward prescribing drugs. The escalating expenditure for psychotropic drugs since TMAP leaves little doubt about who the beneficiaries of TMAP are. Screening for mental illness will increase their use.
Subject(s)
Eugenics , Health Policy , Mass Screening , Mental Disorders/diagnosis , Psychotropic Drugs , Adult , Child , Drug Industry , Eugenics/history , Eugenics/legislation & jurisprudence , Federal Government , History of Medicine , History, 19th Century , History, 20th Century , Humans , Mass Screening/legislation & jurisprudence , Mental Health Services , Psychotropic Drugs/therapeutic use , Sterilization, Involuntary/history , Sterilization, Involuntary/legislation & jurisprudence , Texas , United StatesSubject(s)
Academic Medical Centers/economics , Academic Medical Centers/ethics , Conflict of Interest , Ethics, Research , Financing, Government , Morals , Nontherapeutic Human Experimentation/ethics , Research Support as Topic , Child , Ethics Committees, Research , Ganglionic Blockers/adverse effects , Hexamethonium/adverse effects , Humans , Intellectual Disability/etiology , Lead Poisoning/complications , Lead Poisoning/etiology , Maryland , Nontherapeutic Human Experimentation/legislation & jurisprudence , Research Subjects , Social Values , Value of LifeABSTRACT
This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have increasingly become the subject of experiments that offer them no potential direct benefit but expose them to risks of harm and pain. A wide range of such experiments will be examined, including a lethal heartburn drug test, the experimental insertion of a pacemaker, an invasive insulin infusion experiment, and a fenfluramine "violence prediction" experiment. Emphasis, however, is given to psychoactive drug tests because of the inherent ethical and diagnostic problems involved in the absence of any objective, verifiable diagnostic tool. Effort is made to provide readers comprehensive reference sources to evidence-based reports about the serious risks these drugs pose for adults and children so that the reader may judge whether the benefits (if any) outweigh the risks for children.
Subject(s)
Adolescent , Child , Clinical Trials as Topic/ethics , Government Regulation , Human Experimentation/ethics , United States Food and Drug Administration , Attention Deficit Disorder with Hyperactivity/drug therapy , Behavior Control , Biomedical Research , Conflict of Interest , Depression/drug therapy , Drug Industry , Ethics Committees, Research , Ethics, Research , Humans , Methylphenidate/adverse effects , Methylphenidate/therapeutic use , National Institutes of Health (U.S.) , Psychotropic Drugs/adverse effects , Psychotropic Drugs/therapeutic use , United StatesABSTRACT
This article argues that contrary to the claims made by research stakeholders in industry, academia and government, the shift in public policy since the enactment of the Food and Drug Administration Modernization Act (FDAMA) of 1997 and its financial incentives to industry to test drugs on children, has had a deleterious impact on children's dignity, health and welfare. Those lucrative incentives offered an opportunity to accelerate the pace of FDA approval for pediatric drug marketing. FDAMA resulted in a radical shift in federal policy to accommodate an expansion of pediatric trials. Children who are precluded from exercising a human adult's right to informed consent to research are increasingly sought as test subjects even when the trials offer no potential benefit for them. Prior to FDAMA children were protected under federal regulations that prohibited their recruitment for experiments that were not in their best interest. This article discusses eight cases and controversies demonstrating that children have been subjected to experiments that exposed them to pain, discomfort, and serious risks of harm. Babies have died testing a lethal heartburn drug; children have been subjected to "forced dose titration" in antidepressant drug trials that resulted in several suicide attempts. Toddlers are currently being subjected to methylphenidate dose tolerance tests without evidence of any pathological condition. Healthy teenagers are being exposed to antipsychotic drugs known to induce severe pathological side effects in speculative "schizophrenia prevention" experiments.
