Wednesday, October 15, 2014

Boston Children's Hospital Threatens Parents with Medical Child Abuse

The state practice of revoking parental rights based on medical child abuse [disparate medical opinions] is being legally challenged by the parents of a child who received treatment at Boston Children's Hospital in June 2012.

Nature of the Action:
The Massachusetts Department of Children & Families ("DCF") has violated and continues to violate the fundamental rights of parents under the Due Process Clause of the Fourteenth Amendment to the U.S. Constitution, to choose which healthcare providers will examine and treat their children. DCF has unconstitutionally expanded the concept of "medical child abuse" without sufficient and justifiable standards to intrude on sincere, vigilant and loving efforts by parents who face competing diagnoses and different views on the medical condition of their children.
This May 2014 civil complaint bears an uncanny resemblance to the case of Justina Pelletier. Both children entered Boston Children's Hospital with complex medical histories and both were reevaluated and subsequently diagnosed with undifferentiated somatoform disorders. The Boston Globe reported in December 2013 that Boston Children's Hospital has a history of alleging medical child abuse and then subjecting the taken children to psychological therapy.

Abuse allegations are self serving because when the hospital is successful in its claims, the state permits the institution to keep the children, dismiss previously established diagnoses and proceed with its own judgment. Elizabeth Wray was another child whose parents were charged with medical child abuse while their daughter was receiving care at BCH. In the cases referenced the new diagnoses are psychological in nature.

Rob Graham, Boston Children's Hospital spokesman has refuted claims that the hospital conducted research on Justina Pelletier. In a written response to the Hartford Courant, Graham said that the "allegations that research was conducted on the patient are baseless and patently false."

Undifferentiated somatoform disorders are difficult to identify and manage conditions. Research on the subject suggests that some patients may require psychiatric confinement and intensive cognitive behavioral therapy. Dr. Alice Newton , head of Boston Children's Hospital child protection team and orchestrator of the Justina Pelletier custody petition told The Boston Globe that these drastic measures were worthwhile. It is likely, but yet unproven, that Boston Children's psychiatric staff were engaged in somatoform clinical research.

According to the complaint Dr. Gary Gosselin, Boston Children's Hospital Inpatient Psychiatric Medical Director, advised the parents that their daughter would be placed under state jurisdiction if they failed to agree with the hospital's orders. With no suitable options the parents agreed to: accept the somatoform diagnosis, pursue no further second opinions and commit their daughter. The forced isolation worsened the child's condition, she was released but remained subject to DCF's supervision.

Intimidated by Boston Children's Hospital dictates and the institution's connection to the Department of Children and Families, the parents are asking for injunctive relief to continue to seek other medical advice without fear of losing their daughter to protective custody.

Tuesday, October 7, 2014

Justina Pelletier and the other Children Chosen for Nontherapeutic Research

No Entity may Utilize Children in Nontherapeutic Research—Maryland Court of Appeals

Medical researchers are generally required to obtain consent before selecting subjects for experimental studies but there are two vulnerable populations not covered by the The Federal Policy for the Protection of Human Subjects (Common Rule). The first consent-waiver group is foster children , the other, trauma patients . Wards of state have been clinical trial test vessels since 1989.

The most recent example of a foster child being used in ambiguous behavioral research is Justina Pelletier. She and other minors while patients at Boston Children's Hospital were placed under state custody on the premise that the parents were medically abusing their children. Once under state jurisdiction, these children were held by the hospital and treated for their newly-diagnosed psychosomatic disorders. These novel measures, instituted by Dr. Alice Newton , were expected to demonstrate that parental influence was the cause of the children's physical complaints. The circumstances of Justina's sixteen-month confinement as reported by The Boston Globe has precipitated a law to protect children from similar mistreatment. Titled, Justina's Law, H.R. 4989 would:
prohibit 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.
An example of the use of children, with parental consent, in nontherapeutic research is the Kennedy Krieger Institute/Johns Hopkins lead abatement clinical study conducted in the early nineties. In 2001 the Maryland Court of Appeals determined , along with other issues, that:
in Maryland a parent, appropriate relative, or other applicable surrogate, cannot consent to the participation of a child or other person under legal disability in nontherapeutic research or other studies in which there is any risk of injury or damage to the health of the subject.
The lead measurement blood study 1993-1999, deliberately exposed hundreds of children to a known toxic property on the basis of the principle of the greater good. Involved parties, outside the complaint, included the EPA and the Johns Hopkins Institutional Review Board.

Concerns expressed by the court:

The researchers and their Institutional Review Board apparently saw nothing wrong with the search protocols that anticipated the possible accumulation of lead in the blood of otherwise healthy children as a result of the experiment, or they believed that the consents of the parents of the children made the research appropriate.

Annotation: Of the more than three thousand Institutional Review Boards directing research, many have been censured for their conduct. Members of Congress and the General Accounting Office have found IRB standards lacking, 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 ." An AMA survey conducted in 2002 found that IRB chairpersons could not agree on risk parameters for routine procedures performed on a healthy eleven-year-old child. For instance there was no consensus on whether pharmacokinetic testing was a minimal risk, minor increase over minimal risk or more than a minor increase over minimal risk procedure.

Otherwise healthy children, in our view, should not be enticed into living in, or remaining in, potentially lead-tainted housing and intentionally subjected to a research program, which contemplates the probability, or even the possibility, of lead poisoning or even the accumulation of lower levels of lead in blood, in order for the extent of the contamination of the children's blood to be used by scientific researchers to assess the success of lead paint or lead dust abatement measures. Moreover, in our view, parents, whether improperly enticed by trinkets, food stamps, money or other items, have no more right to intentionally and unnecessarily place children in potentially hazardous nontherapeutic research surroundings, than do researchers. In such cases, parental consent, no matter how informed, is insufficient.
Here, the IRB, whose primary function was to insure safety and compliance with applicable regulations, encouraged the researchers to misrepresent the purpose of the research in order to bring the study under the label of "therapeutic" and thus under a lower safety standard of regulation. The IRB's purpose was ethically wrong, and its understanding of the experiment's benefit incorrect.
Children, it should be noted, are not in our society the equivalent of rats, hamsters, monkeys, and the like.

The Nuremberg Code , cited often by the Appeals Court, was written to guard the public from scientific abuses with the "essential" informed consent rule. In the court's opinion citizens are empowered with the freedom to choose their medical course of treatment both by the Nuremberg Code and the due process Amendments.

Those who disagree with the Appeals Court Nuremberg Code ruling argue that:
the failure to conduct such research causes greater harm because it deprives disadvantaged populations of the benefits of imminent improvement in their health conditions.
The question is, whose opinion is trustworthy?

Tuesday, September 23, 2014

Trauma Care Patients: Exceptions to the Informed Consent Rule

Informed consent, the heart of the Nuremberg Code, is no longer applicable to certain trauma care patients receiving treatment in the U.S. The Nuremberg Code states unequivocally that:
the voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him/her to make an understanding and enlightened decision.
Rules were changed in 1996 to allow emergency research physicians the option of intervening with experimental therapies. The following directives, under 21 CFR 50.24 , currently govern trauma care research:
  • The research study must involve participants suffering from a life-threatening disease process or injury for which the current standard of care is associated with a very high failure or mortality rate.
  • In addition, there must be reasonable evidence that the research has the potential to provide real and direct benefit to the patient.
  • Furthermore, studies must be held to the highest ethical standards. These clinical trials undergo multiple independent rigorous reviews to ensure that they meet these standards.
  • Before any patients are enrolled, communities are consulted about participation and made aware that informed consent will not be obtained for most study participants, as required by law.
  • Surviving patients and/or their authorized representatives need to be informed about the trial as soon as feasible after the intervention has been given.
Emasculating the Nuremberg Code to serve scientific agendas is significant for it is the only principle protecting citizens from predatory research practices .

It is acknowledged that clinical trial subjects are vital resources for the research industry. But is there a valid defense for testing experimental products and procedures on unconscious, non-consenting patients?

The following three examples illustrate the conflict between the Nuremberg Code and scientific interests in the matter of Exception from Informed Consent rules.

PolyHeme , an artificial blood substitute [ hemoglobin based oxygen carrier— HBOC ], was tested on an unknown number of emergency room entrants from 1991 to 2009. Phase III PolyHeme studies , involving 720 hemorrhagic shock victims in 32 trauma centers, were concluded in 2007. The FDA notified the manufacturer, Northfield Laboratories, after the close of Phase III that:
the administration of PolyHeme places the patients at a higher risk of significant adverse events, and therefore, in the absence of clinical benefit, the risk: benefit assessment of the product in trauma is unfavorable.
The Emergency Research Waiver granted to Northfield was controversial for many reasons but specifically because patients were denied whole blood transfusions, the standard course of treatment.

Hemopure, a HBOC product derived from bovine red blood cells, was tested both in the U.S. and South Africa. The Hemopure trials were halted due to high fatality rates. A 2008 analysis from the Journal of the American Medical Association found that HBOCs are potentially deadly and should not be tested in humans. The critical Journal study prompted a firestorm of complaints from the Naval Medical Research Center, other related parties and the manufacturer . One of the coauthors of the JAMA critique said the FDA's concerns are moot because the Navy will advance plans for using Hemopure in likely to die patients.

Patients entering the University of Pittsburgh Medical Center suffering from significant blood loss are being enrolled, also without consent, in a unique clinical trial. It is called emergency preservation and resuscitation [EPR]. If the presumed dying individual meets criteria, trauma surgeon Samuel Tisherman and his team will place the patient in a type of suspended animation. This is accomplished by exsanguinating the patient's remaining blood and replacing with freezing salt water. The researchers hope that this procedure will provide a window of opportunity to stabilize cardiac arrest patients. To test the theory, researchers will select ten subjects and apply EPR, another ten will receive conventional cardiopulmonary resuscitation treatment.

Terminally injured and diseased patients are subject to the Emergency Research Consent Waiver at any juncture during course of treatment because of the influence of the Declaration of Helsinki. The World Medical Association, an international research consortium, determined in 1964 under Helsinki that informed consent was not a mandatory code of conduct. Language was altered to secure consent "if at all possible" and by proxy consent was approved.

The World Medical Association was a favored U.S medical ethics trendsetter until 2000. The reasons for the schism are discussed here .

Modifications to the Helsinki guidance document in 1975 set the stage for the concept of independent medical research committees as overseers of clinical trials. Institutional Review Boards have managed clinical studies in the United States since 1981.

In the World Medical Association's opinion:
In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement, it offers hope of saving life, reestablishing health or alleviating suffering.
Contravening the Nuremberg Code and due process rights to achieve scientific prowess is necessary argue those who advocate for expedient clinical trials.

It should be remembered that it was Dr. John C. Cutler , director of the Guatemala syphilis trials and participant in the Tuskegee experiment who said , "Unless the law winks occasionally, you have no progress in medicine."

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.