Saturday, September 13, 2014

The Foster Children in Medical Research Debate

Foster Children's Rights—Congressional Amnesia

With scant public notice Congress authorized the employment of foster children in medical research in 1989. This decision was based on HHS Secretary Bowen's recommendation 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).
Thus it came to be that foster children became exceptions to the informed consent rule and the research industry gained a valuable commodity. Supporters of the exception rule state that juvenile judges and welfare agencies are able to make consent decisions for their custodians but it can be argued under due process law that, excepting life-threatening situations, no wards of state may be enlisted in government-sponsored research experiments.

Lawmakers declare that they have established rules to protect children from clinical trial abuse but these assurances are suspect because Congress initiated and funds the foster children in medical research program. The Associated Press reported in 2005 that the majority of foster children utilized in AIDS research did not receive " basic legal protection ."

In 1974 Congress, by way of the National Research Act , mandated the creation of Institutional Review Boards to approve or decline medical research prospectuses based on the risk-benefit formula. The measure was passed to assuage public anger over the disclosed Tuskegee experiment.

A 2002 study found that fifty-eight percent of IRB chairpersons were fully knowledgeable of the child protection rules. Most importantly the inquiry showed that the evaluators could not agree on the risk levels of procedures common in clinical trial practices in healthy 11-year olds. There was no consensus on the part of the respondents on whether blood draws, MRIs, allergy skin tests, electromyography, pharmacokinetic studies and lumbar punctures were minimal risk, minor risk over minimal risk or more than minor risk over minimal risk. Results of the study may be found here .

There are more than 3,000 IRBs overseeing human clinical trials in 350,000 U.S. locations . Two-thirds of the research projects are privately-managed and 1% are reviewed by the FDA. HHS receives approximately 300 IRB registrations and 300 quality assurances each month. The GAO probe found that many of these filings are not reviewed. This is an unacceptable inspection record considering that Congress , the GAO and the DHHS inspector general have documented critical IRB operating deficiencies.

The 2009 GAO report determined that
The IRB system is vulnerable to unethical manipulation, which elevates the risk that experimental products are approved for human subject tests without full and appropriate review. Unfortunately the IRB system sometimes fails to protect research subjects. For example, in 2002, a 47-year-old man died after his heart stopped beating while participating in an experimental trial of antipsychotic medication at a Texas research center.
Daniel Dueber, Coast IRB Chief Executive Officer, testified during the INSTITUTIONAL REVIEW BOARDS THAT OVERSEE EXPERIMENTAL HUMAN TESTING FOR PROFIT hearing that he did not understand why his company was being investigated for approving the counterfeit Adhesiabloc clinical trial:
we have never at Coast ever had a fraudulent study submitted to us. There is no economic reason for anybody to do such a thing.
Mr. Dueber was equivocating because he certainly knows that money is the catalyst for misconduct.

The Fiddes faux research trials are another illustration of the ease of fraud within the IRB system. Family practitioner Fiddes, conductor of more than 170 clinical trials, deceived his pharmaceutical employers by substituting test samples. Dr. Fiddes' actions harmed test subjects and contaminated research results submitted to the FDA for new drug approvals. For these manipulations Dr. Fiddes was convicted of medical fraud and was sentenced to a fifteen-month prison term in 1998. The FDA did not initiate debarment proceedings against Dr. Fiddes and his accomplices until 2002.

More than seventy percent of clinical trials fail efficacy or safety markers by the close of phase II testing. The following two examples highlight the hazards of pharmacokinetic testing . In 2006 anti-inflammatory drug TGN1412 was tested on six volunteers. The experimental drug caused immediate organ failure in all drug recipients. A 1995 NIH-sponsored fialuridine phase II study caused the death of five participants. Post mortem investigation determined that fialuridine, a thymidine analog, caused mitochondrial injury.

The Taking of Justina Pelletier: A Sentinel Event

The Justina Pelletier case history, investigated by The Boston Globe, has brought unwelcome attention and perhaps congressional mitigation to the practice of using foster children in psychological and medical research. Justina Pelletier became a foster child as the result of an abuse complaint filed by Dr. Alice Newton of Boston Children's Hospital.

The Globe discovered that Justina was the sixth child whose parents were accused of medical abuse while their children were receiving treatment in BCH. In its successful state custody court petitions, Boston Children's Hospital was allowed to keep the children and proceed with parent-ectomy studies.

Dr. Newton and other professionals opine that taking questionably diagnosed children out of the parental sphere will improve their health. These severance studies were approved by the hospital's ethics committee. In a follow up article The Globe reported that some hospitals would cease these in-house decisions in view of the negative responses generated by Justina Pelletier's sixteen month psychiatric incarceration.

Parental medical child abuse complaints are profitable. BCH, for example, received more than $400,000 for Justina's confinement.

Some still believe that Dr. Newton's judgment in the Justina Pelletier affair was appropriate. The truth is Dr. Newton's medical child abuse allegations do not withstand scrutiny. The issue before Judge Joseph Johnston was whether Justina's entering mitochondrial diagnosis was valid and whether her Tufts cecostomy button surgery was a warranted procedure.

Dr. Newton, head of BCH's child protection team assured the court that she was certain that Justina's mitochondrial condition was induced by her parents' influence. Dr. Newton failed to advise the court that BCH treats mitochondrial conditions and performs cecostomy surgeries. Justina was referred to BCH to see her former gastroenterologist Dr. Alejandro Flores. Dr. Flores' opinion on the value of cecostomy surgery is positive .

Dr. Newton's court presentation was flawed but neither she nor her cohorts could not know that Justina's parents would violate the court's gag order and reveal the circumstances of their daughter's abduction.

Justina's Law, H.R. 4989, would reduce the use of foster children in medical research but the bill does not address the issue of consent.

Justina's Law as proposed:
Prohibits the use of federal funds to conduct or support treatment or research involving a ward of the state in which the individual's health is subjected to greater than minimal risk with no or minimal prospect of direct benefit.
Clinical trials involve unexplored terrain and they expose subjects to unquantifiable immediate and long term health risks. For this reason research volunteers have expressed safeguards: they are apprised of the potential impairments and may depart the clinical trial at any time.

Foster children became research captives by congressional fiat but this action violates equal protection laws. The exceptions to the consent rule is ripe for judicial review.

Thursday, August 21, 2014

Foster Children: Exceptions to the Informed Consent Rule

"Unless the law winks occasionally, you have no progress in medicine "

These telling words written by Dr. John C. Cutler , a high-ranking Public Health Service employee, are memorable because Dr. Cutler was intimately involved in the Tuskegee and Guatemala syphilis experiments. Without compunction, Dr. Cutler and his team deliberately harmed unwitting and conscripted subjects by withholding curative penicillin treatments or by infecting selected individuals with various pathogens.

The Tuskegee observational initiative spanned 30 years [1942-1972] and involved hundreds of black observees and their families who were told that they had bad blood. In Guatemala, U.S. medical researchers used children from the Sisters of Charity orphanage, prostitutes, mental patients, members of the U.S. Air Force stationed in-county and Guatemala service men as resources. There were 5,500 individuals in the Guatemala [1946-1948] STD offensive and Dr. Cutler continued follow up studies until 1953.

For a description of the Public Health Service project please read "Guatemala victims of US syphilis study still haunted by the 'devil's experiment.'" The secret Tuskegee operation was disclosed by a whistleblower; Guatemala, by an archivist. Dr. Cutler and other civil servant participants were not prosecuted for their malfeasance.

From Dr. Cutler's Guatemala research papers on the subject of Berta, a mental health patient:
She was first deliberately infected with syphilis and, months later, given penicillin. After that, Dr. John C. Cutler of the Public Health Service, who led the experiments, described her as so unwell that she ‘appeared she was going to die.’ Nonetheless, he inserted pus from a male gonorrhea victim into her eyes, urethra and rectum. Four days later, infected in both eyes and bleeding from the urethra, she died.
(NYT 4/30/2011 - “Panel Hears Grim Details of Venereal Disease Tests") and " Ethically Impossible " STD Research in Guatemala from 1946 to 1948—President's Commission September 2011

The Tuskegee and Guatemala experiments were not unusual enterprises. During the 20th century Congress funded numerous conscience-shocking medical procedures on U. S. citizens, some of them involved institutionalized children.

American jurists during the Nuremberg Doctors' Trial severely criticized German scientists for their conduct during WW II but U.S. practices during the Cold War—4,000 radiation experiments—were similarly egregious. Some examples are: unsuspecting hospital patients injected with either plutonium, uranium or polonium, mentally handicapped state custody children fed irradiated Quaker Oats cereal [Fernald School Experiment]  and 200,000 servicemen deliberately exposed to harmful radiation. 

There were no research boundaries on the part of the government as evidenced by the aforementioned and Operation Delirium, a psychochemical study involving 7,000 military personnel. For further information on the radiation experiments please refer to Congressman Ed Markey's " American Nuclear Guinea Pigs: Three Decades of Radiation Experiments on U.S. Citizens. "

The committees investigating these and other covert medical experiments inform that these activities will continue because national security and scientific interests supersede civil rights.
Human research can still be conducted in secret today, and under some conditions informed consent in secret research can be waived. ( The Advisory Committee Report on Human Radiation Experiments 1944-1974)
Furthermore the ACHRE Committee found that predicated on its review there are:
no subjects of biomedical experiments for whom there is a need to provide notification and medical follow-up for the purpose of protecting their health.

...the Committee does not recommend notification or medical follow-up for descendants of subjects of human radiation experiments. (page 807)
Foster Children as Test Subjects

Recognizing the shortage of volunteers, Congress authorized the use of state wards for research purposes in 1989. For the past twenty-five years millions of foster children from birth to age 18 have served as pharmaceutical/medical device test vessels. It was HHS Secretary Otis R. Bowen who recommended these practices:
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's proposal was adopted and as a result the scientific community gained a perpetual pool of non-consenting research subjects. Justina Pelletier was one of these children.

Foster Child Justina Pelletier

Justina Pelletier is an example of medical child abuse on the part of the state of Massachusetts. Without her consent this fourteen year old was enrolled in a psychiatric experiment initiated by Dr. Alice Newton of Boston Children's Hospital. In Dr. Newton's opinion Justina's condition would improve if she were separated from her parents.

Justina endured a sixteen-month psychiatric clinical study while a state ward. The adverse publicity surrounding her case has opened a congressional debate on current practices. If enacted as proposed the new law would constrain the employment of foster children in clinical trials deemed greater than minimal risk and that are not relevant to the enrollees' health.

H. R. 4989, also known as Justina's Law offers protection for some foster children but would leave the majority to the whim of Institutional Review Boards . There are more than 3,000 Institutional Review Boards overseeing government-funded human medical experiments. Members of Congress and the General Accounting Office have faulted IRB methodology but nevertheless these entities control the clinical trial environment. Janet Woodcock, director of CDER at the FDA, has reported that " the agency inspects at most 1 percent of all clinical trials ".

Unstated in the pending rule change is the reality that clinical trials are by and of themselves perilous propositions. This is true because more than 70% of the experiments fail to meet intended goals by the conclusion of Phase II. Clinical trial death and injury data are not published because this information would challenge long-established government practices.

Foster children are entitled to equal protection and that means no enrollment in superfluous clinical trials. This issue is ripe for Supreme Court review for many reasons but primarily because wards of state are non-consenting participants.

Saturday, August 2, 2014

Prayer for Relief from State Medical Child Abuse

Pharmaceutical Research on Foster Children is Medical Child Abuse

Department of Health and Human Services data shows that for the period 2003-2011, there were over 4 million foster children available for investigational studies. Since 1989 PhRMA has chosen foster children as test candidates because most parents decline to enroll their children in potentially harmful research projects. The testing of pharmaceutical products and medical devices is beneficial to science but the regimen can also be deadly . For informational purposes: more than 60% of the under-study drugs fail clinical trial Phases I and II examination. Clinical trials are suspended for two reasons: safety and efficacy. Foster children are the only class of citizen subjected to non-consensual clinical trials.

Justina Pelletier, a victim of state medical child abuse practices, recently appeared in the House of Representatives to support H. R. 4989. Nicknamed Justina's Law, the bill would limit but not stop the standard practice of using foster children in government-financed research endeavors. The Justina Pelletier/Boston's Children's Hospital psychiatric parentectomy study lasted 16 months. Here are the present and proposed rules governing foster children experimentation policies.

Current federal foster child regulations provide the following:
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...
Justina's Law 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 employment of foster children in medical research was initiated by 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).
These regulations and proposed refinements fail to recognize that wards of state have inviolable civil rights which include exemption from clinical trials, no matter the risk factor. Members of Congress have a duty to protect foster children from harm but a correction on their part will be difficult because they formulated the policy.

Congressional dictates sometimes conflict with Constitutional protections. The fact that millions of foster children have involuntarily served as test receptacles is a matter of judicial urgency because compulsory participation in research initiatives is a form of medical child abuse.

Recently the U.S. Court of Appeals for the First Circuit ruled [Case 3:10-cv-30073] that the Massachusetts Department of Children and Families absence of care "shocked the conscience" and deprived foster children of constitutional protections.

Although not listed in the 2010 complaint, the conscription of foster children for experimental purposes is relevant to the Appeals Court decision and deserves review. These at-risk children are not servants of the medical industry.

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.

Tuesday, June 17, 2014

Letter to Reverend Barber Regarding State Medical Child Abuse Practices

June 17, 2014

Rev. Dr. William J. Barber II
President NC NAACP
P.O. Box 335
Durham NC 27702

Dear Reverend Barber:

There are many abominable practices in our country but of singular import is the use of foster children in medical research.

The latest figure available from the Department of Health and Human Services indicates there were more than 400,500 minors available for pharmaceutical/medical test product studies in 2011.

NIH reports that there are 13,690 children's trials here and in other countries either completed, in progress or terminated. Many of the U.S. minors who are selected for research are under state protection but the government does not segregate this data.

Medicaid insures foster and poverty-designated children. The CDC confirmed last month that 10,000 Medicaid-covered toddlers had been placed on ADHD drugs. The Citizens Commission on Human Rights says these figures are not inclusive and state that 274,000 0-1 year olds and 370,000 toddlers are on psychotropic drug regimens .

Although not specified as such, these prescriptive practices are clinical trials and a form of medical child abuse because the psychotropic products are not FDA approved for these age groups.

For decades the National Institutes of Health and PhRMA have allowed third parties, e.g. Covance , to select children from state welfare agency rolls and situate them in clinical trials. This concept is condoned by the governing parties because most parents are not willing to subject their children to experimentation.

It is customary for drug development service companies to pay volunteers for participating in clinical trials. State welfare agencies are also reimbursed for the use of their captive children. For more on this subject and the AIDS drug research projects please refer to Harriet Washington's book: Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present.

Other than financial incentives, why would states conscript previously abused children for medical research? The expressed reason is to save lives and enhance knowledge.

To appease child protection groups, the government requires Institutional Review Board approval before children may be enrolled in these exploratory enterprises. These considered safeguard measures are meaningless because foster children's civil rights are being abridged.

New York City foster children suspected of AIDS infection were the recipients of toxic drugs in the late 80s and early 90s. The public become informed of these practices in 2004 with the publication of Liam Scheff's report, " The House That Aids Built ." His allegations prompted a federal investigation and criticism of Mr. Scheff's findings on the part of The New York Times. But there is no debate that these activities occurred or that children suffered during the course of the experiments.

NYC child welfare administration officials told The Times that 90% of the children labeled H.I.V. positive were enrolled in these drug programs over a 14-year period. The number of foster children involved in these trials is unknown because the documents were either missing or incomplete. Welfare spokespeople admitted that the safety and well being of these children were not carefully monitored. Absent paper work allowed supervising pediatricians to say that they do not remember deaths or serious side effect events in the almost decade and a half endeavor.

Most of the children in the AIDS research trials were held in medical institutions as are those in current pharmaceutical evaluative studies. Incarceration ensures that the test subjects receive the under-study drug and are available for bodily fluid extractions. Blood is acquired via venipuncture for 0-18 age groups; urine by catheterization in the youngest subjects.

These procedures often require restraints. Children unable to swallow pills or who are troublesome are fitted with gastric and or nasal feeding tubes. Dr. Katherine Painter, former director of the NYC Incarnation Children's Center verified Mr. Scheff's medical child abuse complaint.

In 1998 The Times advised that federal officials were investigating psychiatric experiments conducted over a three year period by the New York State Psychiatric Institute and the Mount Sinai School of Medicine.

The clinical trial study consisted of 100 mostly black and Hispanic youths, ages 6-10 who were intravenously-fed fenfluramine based on the supposition that violent or criminal behavior could be ascertained by certain brain chemicals. Fenfluramine was banned in 1997 because of its heart-damaging side effects.

With the imprimatur of the federal government, states are subjecting their wards to medical child abuse via clinical trials. Please censure these abhorrent practices.

For the children,

Lynne Vogel

Wednesday, June 11, 2014

Reflections on Misconduct in the Justina Pelletier Affair

Judge Joseph F. Johnston's Pelletier Family Gag Order

In a rare display of contempt, Lou and Linda Pelletier Justina's parents, chose to breach Judge Johnston's gag order and publicize that their daughter Justina had been imprisoned in Boston Children's Hospital for months. This was a perilous decision because exposure of confidential court matters can lead to prison and or fines.

The precipitate for judicial intervention was an allegation of medical child abuse. This charge was not levied against Justina's former medical providers but against her parents. The term, medical child abuse, is a contradiction.

Boston Children's Hospital Benefits from Medical Child Abuse Allegations

Justina Pelletier became a ward of the state in the now cause célèbre diagnostic dispute between Boston Children's Hospital and Tufts Medical. As reported by the The Globe Justina is one of six minors whose parents were charged with medical child abuse while their children were receiving care at Boston Children's Hospital in the past eighteen months. These accusations are a conflict of interest because the abuse complainant, if successful, keeps the child and receives remunerations for their efforts.

Justina's Boston Children's Hospital incarceration, most of which was in a psychiatric ward, lasted from February 2013 through December 2013. Costs are not revealed. After the December 2013 Boston Globe revelatory articles Judge Johnston ordered that Justina be transferred to an out patient psychiatric facility. Under Judge Johnson's direction, Justina was moved again in May.

There has been no explanation or follow-up investigation as to why Dr. Alice Newton , director of Boston Children's Hospital's child protection team and Judge Joseph Johnston , the presiding arbitrator, subjected Justina to these punitive environments and other harsh measures. Justina posed no risk to herself or others because she was incapacitated at her time of admit and remains in the same condition.

Doctor Alice Newton and Judge Joseph Johnston's Conduct in the Justina Pelletier Case

If the circumstances of the case had been presented to a jury it is unlikely that they would have allowed the state to take custody of Justina Pelletier.

A review of the Justina Pelletier case suggests misconduct on both the part of Dr. Alice Newton and Judge Johnston. Within a three day period Dr. Newton and her staff were able to determine that Justina Pelletier was suffering from a psychological condition called somatic system disorder . This is an unsupportable assertion because medical literature states that this mental illness requires months of observation to evaluate. There are no tests to ascertain SSD, judgment is purely subjective. Somatic system disorders, new psychiatric nomenclatures , are often alleged in medical child abuse custody petitions across the country.

To enhance her medical child abuse allegation, Dr. Newton told Judge Johnston that the cecostomy button procedure performed by Tufts as a result of Justina's diagnosed mitochondrial disease was a needless operation.

Dr. Newton did not tell Judge Johnston that Boston Children's Hospital treats mitochondrial disease and performs cecostomy button surgery. Justina had been referred to BCH to see Dr. Alejandro Flores, her former Tuft's gastroenterologist. All of this information was available to the court but it did not stay Judge Johnston's quick decision to revoke parental rights.

Opposing medical treatment opinions do not warrant the taking of a child so the question remains why did Dr. Alice Newton and Judge Joseph Johnston act to remove Justina from her parents' custody?

It is a disquieting consideration but children who become wards of the state due to physical and or medical abuse are valuable assets. They are used in medical research, prescribed experimental psychotropic drugs or as in the case of Justina Pelletier confined in psychiatric facilities.

Suggested Readings:

The Kids for Cash case of juvenile judges who violated children's civil rights.

2008 Testimony of Kimberly Castro regarding the death of her daughter Chelsey Cruz while she was under state protection and Boston Children's Hospital supervision.

Medical Child Abuse/MSBP 2004 Indictment of Kelly Savage — Ms. Savage was exonerated.

" UK firm tried HIV drug on orphans " in U.S. institutions. The Guardian —April 2004

The cruel methodology of children's clinical trials is detailed by Liam Scheff in " The House That AIDS Built ."

"Thousands of Toddlers Are Medicated for A.D.H.D., Report Finds, Raising Worries"—The New York Times—May 2014

Psychotropic Drugs: What Are They? "—ABC News—2011

"Atypical Antipsychotic Use Among Medicaid-Insured Children and Adolescents: Duration, Safety, and Monitoring Implications " —Journal of Child and Adolescent Psychopharmacology—April 2014

Psychotropic Meds for Georgia Youth in Foster Care: Who Decides ? — Georgia Supreme Court Committee on Justice for Children—January 2011

" Payment of clinical research subjects " — The Journal of Clinical Investigation—2005

" The Justina Pelletier Medical Experiment "— Daily Kos—April 2014

" What Killed Rebecca Riley ?"—60 Minutes—2007

Watchdog Says Report of 10,000 Toddlers on ADHD Drugs Tip of the Iceberg —274,000 0-1 Year Olds and 370,000 Toddlers Prescribed Psychiatric Drugs— Citizens Commission on Human Rights (CCHR)—May 2014

"A medical collision with a child in the middle"—The Boston Globe—December 2013

"Frustration on all fronts in struggle over child’s futureThe Boston Globe—December 2013