Congress Subjects Wards of State to Medical Child Abuse
Justina Pelletier while under the care of the state of Massachusetts was confined in psychiatric facilities and treated for her alleged psychological condition. The Justina Pelletier medical experiment lasted sixteen months.
Justina was taken from her parents because Dr. Alice Newton , head of Boston Children's Hospital child protection team persuaded the juvenile court system that their just-admitted patient was a victim of parental medical child abuse. With Judge Joseph Johnston's permission , Dr. Newton sequestered Justina, initiated treatment for her claimed mental disorder and barred her former Tufts physicians from co-evaluating her newly-established diagnosis. News coverage of Justina Pelletier's Boston Children's Hospital medical mistreatment has ignited a legal challenge to the practice of using foster children in medical research.
"Justina's Law," [H.R.4989] introduced June 26, 2014, would:
prohibit Federal funding of any treatment or research in which a ward of the State is subjected to greater than minimal risk to the individual's health with no or minimal prospect of direct benefit.Current foster child medical research regulations stipulate :
Children who are Wards of the state may be included in research that presents minimal risk or greater than minimal risk with a prospect of direct benefit. Children who are Wards of the state may be included in research that presents greater than minimal risk with no prospect of direct benefit only if the IRB determines and documents that such research is related to their status as wards...Federal regulations state that minimum risks are those "ordinarily encountered in daily life or during routine physical or psychological examinations or tests." Advocates of children's clinical trials say these experimental regimens are no more a hazard than riding a bicycle, being a passenger in a car or participating in sports' activities. The significant difference is those actions are voluntary.
There are more than 3,000 Institutional Review Boards making decisions for state-custody children and other participants. When IRB investigations are initiated they often reveal deficiencies. Consider for example the 2007 congressionally-authorized sting operations and the Ketek probe that uncovered IRB improprieties. A copy of the government report may be found here .
Absent adequate public notice, PhRMA , physicians and government officials have been trafficking in foster children since 1989. It was HHS Secretary Otis R. Bowen who advised Congress that:
State and local child welfare agencies should create systems to manage the participation of children in foster care in special medical treatment and experimental trials” (HHS/ASPE, 1989, p. 60).Secretary Bowen was responding to the infant AIDS crisis and the need for extraordinary interventions but it is doubtful that he intended for foster children to be used in non-emergency research studies.
The Department of HHS has not updated its foster children web page since 2011 but in that year there were more than 400,000 children available for medical research projects. Because most parents decline to enroll their healthy children in clinical trials, the medical industry turned its sights on under-state-custody children.
There are currently 13,830 U.S. and foreign children's clinical trials in progress, completed, or suspended. The government does not provide data regarding the quantity of foster children offered for research but the figure is substantial because other resources are limited.
Clinical trial participants, whether conscripted or voluntary, face possible negative health consequences. This is true because marketplace drugs often present similar end results. The government is of the opinion that these risks are secondary concerns because of anticipated benefits.
Those overseeing these often perilous research endeavors fail to communicate that more than 60% of PhRMA's experimental drugs fail clinical trial Phases I and II investigation. Pharmaceutical test products are abandoned for two reasons: safety and efficacy.
Do the ends justify the means? The practice of using foster children as research vessels is a moral issue. Justina's Law would limit but not prevent future medical child abuse.
Sample Children's Clinical Trials
Cincinnati Children’s Hospital Medical Center along with five other medical centers is recruiting up to 400 healthy children, ages 6 months to 17, to test the safety and efficacy of a swine flu (H3N2v) vaccine. Additional information regarding this Phase II Open-Label Study can be found here .
Cincinnati Children’s Hospital Medical Center needs healthy subjects, ages 5-17, to test an experimental drug product to see if it might mitigate Fragile X Syndrome symptoms. This comparative study will utilize both healthy and FXS-impaired children. The study drug, acamprosate [Campral], is presently prescribed to control alcohol addiction.
New York State Psychiatric Institute, Mount Sinai School of Medicine and Queens College clinical trial protocols became the subject of a federal ethics investigation in 1998. The medical facilities' 100 trial subjects, mostly black and Hispanic youths, ages 6-10 were intravenously-fed fenfluramine on the supposition that violent or criminal behavior could be ascertained by certain brain chemicals. Fenfluramine was banned in 1997 due to its heart-damaging side effects.
In May 2006 the FDA asked Sanofi-Aventis to terminate pediatric Ketek trials because the '04 approved antibiotic had been linked to liver failure, unconsciousness, and blurred vision in adult patients. At the time of the request more than 5 million prescriptions had been written and Sanofi-Aventis was conducting 4 clinical trials on children ages 6 months to 13. For further information on the Ketek™ Clinical Trials and FDA Approval please visit the CIRCARE web site. Sanofi-Aventis was not required to notify trial participants or patients that they had received a potentially toxic medication.
Pemoline [Cylert], a 1975 approved ADHD/narcolepsy medication, was removed from the marketplace in 2005 due to liver toxicity. Numerous pemoline clinical trials were conducted on pediatric subjects prior to the drug's release.