Friday, July 25, 2014

Justina's Law: Protecting Foster Children from Medical Child Abuse

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.

Friday, July 11, 2014

PhRMA and Physicians Engaged in Medical Child Abuse

The medical child abuse concept, as defined by Drs. Carole Jenny and Thomas Roesler, states that parents are the sole perpetrators in these injurious pursuits. Medical child abuse is rampant in the U.S. but not by the usual suspects.

Medical Child Abuse Perpetrators

All aspects of medical treatment are controlled by physicians but inexplicably these professionals are never indicted, prosecuted or penalized when their malpractice is exposed in medical child abuse trials or custody hearings. When medical child abuse allegations are raised in criminal hearings the surgeon and the prescription provider should be facing the jury along with the child's parents or custodian. The American Medical Association has been silent on the subject of physicians preying on children.

Rebecca Riley Medical Child Abuse Case History

The Rebecca Riley medical child abuse trial covered by 60 Minutes is just one case reference. Rebecca's 2006 death was caused by a drug overdose. This four-year old was on physician-recommended multi-psychotropic medications. Her parents were convicted of murder, her physician, psychiatrist Dr. Kayoko Kifuji of Tufts-New England Medical Center, was not on the indictment.

Through her lawyer, Dr. Kifuji said that she was following standard medical protocol. The drugs given to Rebecca were prescribed off label. This means that Rebecca was subjected to potentially harmful experimental products. Dr. Kifuji ordered the drugs but it is not known whether she explained to the parents that Rebecca's medications were not authorized for use in children.

Joshua Parker et al Medical Child Abuse Case History

An another example is the Kate Parker criminal indictment. The mother has been with charged with medical child abuse yet her son's surgeon, Monica Wehby of Legacy Health is not listed as a defendant in the upcoming trial. According to Kate Parker's November 12, '09 diary post, Dr. Wehby had performed tethered cord surgery on Joshua, one of Ms. Parker's children, five times. The cost of this procedure is reported to be $23,000. Dr. Wehby is one of fifteen physicians mentioned in Mrs. Parker's journals. The list of medical providers can be found here and the indictment here . Mrs. Parker's journals provide details regarding Joshua, Bethany and Hannah's surgeries and prescription regimens.

Justina Pelletier Medical Child Abuse Case History

Allegations of medical child abuse outside criminal proceedings are reviewed by juvenile judges and normally their dispositions are confidential. This court-mandated secrecy policy allows juvenile judges to generally avoid scrutiny, shields physicians' reputations but does nothing to protect the alleged victim's interests.

The Justina Pelletier custody dispute is an illustration of untoward behavior on the part of Dr. Alice Newton and Judge Joseph Johnston . Justina Pelletier was a captive of the Massachusetts Department of Children and Families from February 2013 to June 2014. Boston Children's Hospital according to The Boston Globe received more than $400,000 for its medical child abuse intervention.

Once Justina became a ward of the state, her medical care was provided by Boston Children's Hospital. Justina's BCH physicians were allowed to change her diagnosis from physical to mental and treat her accordingly. Justina's ordeal has prompted four members of the House of Representatives to introduce legislation that would end the practice of using foster children in clinical trials that offer no benefit to the enrollee. If enacted Justina's Law [H.R.4989] 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.
The proposed bill, although a positive step, avoids the question of the propriety of using foster children in medical research.

Children's Psychotropic Drug Research

For decades news outlets, child advocacy organizations, some mental health care professionals, and the Government Accountability Office have criticized the extensive use of psychotropic medications in children but the number of minors under the influence continue to increase, especially for those under state custody. Congressional investigators and other concerned parties cannot explain why foster children are far more likely to receive psychotropic drugs than children in the general population.

One possible explanation: Foster children are the primary resource for PhRMA's medical experiments. Because the conscripted minors do not react positively in clinical trial environments clinicians may apply psychotropic drugs to help control behavior during the course of the project.

Children's clinical trials are punitive: the test subjects, generally held in medical facilities, are forced to ingest under-study drugs and undergo blood/urine extraction procedures. Sometimes the children are fitted with gastrostomy tubes to facilitate the drug delivery system.

Harold S. Koplewicz, MD, Editor-in-Chief of the Journal of Child and Adolescent Psychopharmacology, stated in reference to the April 2014 paper, " Atypical Antipsychotic Use Among Medicaid-Insured Children and Adolescents: Duration, Safety, and Monitoring Implications ," the following:
This study adds critical hard data to our understanding of a persistent and unacceptable trend in pediatric psychiatry. Our poorest, most vulnerable children, lacking access to evidence-based care, are receiving potentially harmful treatment with little oversight.
GAO officials testified in late 2011 that physicians treating foster children were placing their patients on concomitant prescriptions of five or more drugs, were exceeding dosage guidelines and were authorizing psychotic products in children under the age of one. [p. 2 of the GAO Report]

In May 2014 the CDC advised that more than 10,000 Medicaid-insured toddlers had been prescribed ADHD medications FY 2013. Attention deficient drugs are just one of many psychotropic agents recommended by PhRMA for use in the juvenile population.

The CDC figures are incomprehensible but they are just a minuscule representation of the numbers of children being abused by their physicians. Prescribing data collected by IMS Health’s Vector One: National and Total Patient Tracker Database for 2013 shows that 8,389,034 children, 0-17 were taking some type or combination of ADHD, antidepressant, anti-anxiety, antipsychotic drug.

The latest proposed behavioral disorder requiring prescription therapy is called Sluggish Cognitive Tempo Disorder .

PhRMA formulated the country's mental health epidemic— physicians provided the key.