Tuesday, December 30, 2014

The FDA and Pharmaceuticals: False Sense of Security

Consumers conduct business in a global marketplace but, unlike most world citizens, Americans outside the state of Maine do not have the right to import pharmaceutical products for medical necessities. Although the government rarely prosecutes those purchasing from foreign suppliers, the policy restricts choice and is a form of intimidation. The government's rationale for banning out-of-country manufactured drugs is safety.

The patient protection claim is absurd for more than 80% of the active ingredients in U.S. drugs have been formulated in foreign, primarily Indian/Chinese, venues. Often these businesses are owned by American pharmaceutical companies who have found significant savings by using foreign labor. Most products, food/clothing etc. imported into the U.S. indicate country of origin. Pharmaceuticals products do not provide this advice.

According to the General Accounting Office, global pharmaceutical production sites are rarely, if ever, checked by U.S. regulators:
FDA’s foreign inspection program continues to be driven by new drug applications and the agency acknowledges that it may never inspect most foreign manufacturers exporting pharmaceutical products to the United States. (GAO 1998 Report: "FDA: Improvements Needed in Foreign Drug Inspection Program" pg. 33)
In 2011 the GOA found the same FDA inspection deficiencies.

The government knew or should have known that these infrequent inspection regimens would be the cause of nightmarish patient outcomes. Two notable examples are the contaminated heparin drug imported by Baxter in 2008 and the other is the 2012 New England Compounding polluted methylprednisolone acetate product.

In both instances deviant manufacturing practices and perfunctory regulations caused death and injury to hundreds of patients. As noted by the General Accounting Office Congress's failure to allocate adequate funding for regular inspections poses needless risks to consumers. To ensure product safety, foreign and domestic facilities should receive annual unannounced visits by the FDA and no pharmaceutical product should enter the US market without said inspection.

As long as pharmaceutical prices were reasonable, most Americans did not question the legitimacy of the federal foreign drug prohibition but the costs of drugs, especially generics has risen inexplicably in the last two years. In some cases over 500% report congressional researchers. For information on savings from foreign distributors please visit PharmacyChecker.com.

Last year, in violation of federal law, the Maine legislature decided to provide state residents with an option—Mainers can legally purchase pharmaceuticals from Canada, Great Britain, Australia and New Zealand. The Maine Drug Importation Law provides consumers with choice and savings. The state of Maine is being sued by PhRMA and other interested parties who claim unfair business practices among other issues.

In early December Bloomberg News published a timely article on foreign drug imports. It is titled " Drug Batch Tainted? Just Hit Delete and Ship It to the U.S ."

Contrary to the FDA's opinion, it makes little difference where Americans purchase their prescriptions.

Tuesday, December 2, 2014

Foster Children in Experimental Servitude

Gabriel Myers, a heavily-medicated seven-year old foster child, committed suicide in 2009. Gabriel's autopsy report indicated that he was taking psychotropic drugs known to trigger suicidal actions. Gabriel's psychiatrist, Dr.Sohail Punjwan , had prescribed Vyvanse 50 mg, Symbyax 3/25 mg and Lexapro 10 mg. Symbyax is a combination drug product consisting of olanzapine, an antipsychotic and fluoxetine, a selective serotonin reuptake inhibitor.

Gabriel was under state custody from June 29 2008 to April 16, 2009, the time of his death. Gabriel Myers' case history is available here .

Florida officials suspected that Dr. Punjwan had placed Gabriel in his psychotropic drug trial and asked the FDA to verify whether Gabriel and other state-protected children were involved in Dr. Punjwan's pharmaceutical research. This is a telling piece of information for it means that protection agencies are not apprised of foster children's enrollment in government-sponsored testing regimens.

Because the FDA refused to provide said information George Shelton, secretary of the department of Children and Families told the agency that Florida was banning the employment of wards of state in drug trials. The FDA's response : the benefits can outweigh the risks.

In early 2010 the FDA advised Dr.Punjwan via letter that he had neglected to:
adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations. Your failure to conduct the requisite safety measures contributed to the unnecessary exposure of pediatric subjects to significant overdoses, which jeopardized the subjects' rights, safety and welfare.
Children seized by state protection agencies have routinely been subjected to federally-financed experimentation since 1989. This practice was approved by Congress at the suggestion of HHS Secretary Otis R. Bowen who said:
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).
It is not known what the legislators were thinking when they adopted Secretary Bowen's proposal but their action clearly violated Article IV of the Bill of Rights which states:
The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no warrants shall issue, but upon probable cause, supported by oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized
Children are generally taken by juvenile courts to protect them from abuse and neglect. For the federal government to authorize state use of this population for experimental purposes is illegal under the law for it permits unreasonable searches.

Since 1989 millions of foster children have been forced to test pharmaceutical compounds for the benefit of the medical complex. Since this captive group has no voice in their medical servitude the U.S. is also breaching the Nuremberg Code mandate of informed consent.

To understand the plight of these state-controlled children one should consider the standard practices in clinical studies. The American Medical Association reports the following common procedures: blood draws, MRI's, allergy skin testing, electromyography, pharmacokinetic studies, testing of drugs believed to be safe in 500 adults and lumbar punctures with and without sedations. Upon occasion, researchers have surgeons fit children with gastronomy tubes to ensure drug delivery. Risks of harm to trial participants is high for more than 70% of the trials fail to meet safety/efficacy expectations.

Children believed to be suffering from somatoform [induced by parents] disorders are also often taken by the state and are then isolated in psychiatric facilities. Cases in point are Justina Pelletier and the other children who entered Boston Children's Hospital with difficult to define medical issues.

Course of action on the part of BCH staff: dispute the admitting diagnosis, claim parental medical child abuse [ Dr. Alice Newton ], have a judge agree [ Joseph F. Johnston ] and then take the child into experimental chambers. Researchers posit that isolation is beneficial to those believed to be suffering from somatoform disorders.

Dosing children's bodies with all manner of untested chemicals to market new drugs and incarcerating others in psychiatric wards to evaluate somatoform disorders is not acceptable.

U.S. policy—foster children as test vessels—abrogates provisions of the Bill of Rights, the Nuremberg Code and the Rome Statute of the International Criminal Court .

The International Criminal Court defines non consensual human experimentation as a crime against humanity.

Saturday, November 8, 2014

Brittany Maynard's Suicide: The Right to Choose Death

Brittany Maynard's reflections on why she was ending her life:
I made my decisions based on my wishes, clinical research, choices, discussions with physicians, and logic.  I am not depressed or suicidal or on a ‘slippery slope.’ I have been in charge of this choice, gaining control of a terrifying terminal disease through the application of my own humane logic.
Most religions, specifically Catholicism, condemn Ms. Maynard's action as a violation of the Fifth Commandment — "Thy Shall not Kill." Interpreters of the Bible have determined that the homicide dictate is also applicable to suicide.

When the Bill of Rights was added to the Constitution in 1791 the authors recognized the likelihood that religious leaders would attempt to influence legislative matters and so Article Three affirmed that Congress "shall make no law respecting an establishment of religion." The founding fathers knew from past experience that religious disputes cripple governments.

Be that as it may, Congress and state legislative bodies have frequently passed Christian-inspired laws. These controlling measures violate Article Three and civil rights. Most state laws, for instance, forbid physician-assisted suicides. Some other laws based on religious belief (Canon Law) include divorce , reproduction, and sexual preference prohibitions. From the Catholic Church's perspective homosexuality, birth control/abortion, divorce and suicide are not issues of choice.

President Reagan formalized relations with the Holy See in 1984. Those serving as Vatican ambassadors, if Catholic, must agree with the church's position on life issues.

As intended Brittany Maynard provoked a fiery discussion on the right to die while under medical supervision and as expected many dispute her course of action. For instance, Msgr. Ignacio Carrasco de Paula, president of the Pontifical Academy for Life, called Oregon's Death with Dignity Law reprehensible.

The Catholic Church is a misogynistic institution with unresolved pedophilia and forced labor issues.

If Msgr. Carrasco and his employer were in charge of American affairs, women would not be eligible for political office and personal choice laws would be abolished.

Tuesday, November 4, 2014

MSN's "No Choice News" Homepage

On September 30, 2014, Microsoft terminated its "My MSN" homepage service and substituted its own selected news feeds. The consequence: MSN now controls the source of news for its patrons.

Prior to the change MSN homepagers could choose their news outlets which might include The Washington Post, The New York Times, The Wall Street Journal, The Guardian, Fox News and Al Jazeera.  Comparing news reports on various issues was an easy endeavor.

MSN's new rolling photo format could be called the three stooges of news, lots of slapstick, little substance. Phooey!

Sunday, October 26, 2014

The Taking of Justina Pelletier by Judge Joseph F. Johnston

Juvenile judges in Massachusetts and other states routinely sever parental rights on the grounds of wrongful medical treatment. Suspicions of medical child abuse are generally brought to the courts' attention by research hospitals who upon occasion have pursuits outside the well-being of the child.

When the intervenors are successful the institutions are permitted to keep the children, proceed with divergent courses of medical treatment and bill Medicaid for the cost. If the now ward of state has a condition of interest to the research facility the child may be selected for experimental therapies such as psychiatric isolation. Parents, foster children and their former physicians have no voice in these decisions.

Circumstantial evidence suggests that Boston Children's Hospital was engaged in somatoform disorder research when the psychiatric staff filed a medical child abuse complaint against Justina Pelletier's parents. Justina was not the only child targeted by the hospital. The Boston Globe reported that at least five other children over an eighteen-month period preceded the path of Justina in Boston Children's Hospital medical child abuse complaints.

A lawsuit filed in May 2014 alleges that the parents of a child who was receiving treatment at Boston Children's Hospital in June 2012 were put on the state abuse watch list and were then threatened with loss of their daughter if they did not agree to her psychiatric confinement.

The taking of Justina Pelletier by Judge Joseph F. Johnston on the basis of a medical child abuse allegation is an example of the unchecked power of hospitals, the Department of Children and Families and the Massachusetts juvenile court system.

Although medical child abuse was not addressed by the U.S. Court of Appeals for the First Circuit in their ruling against the Department of Children and Families et al in March 2014 the court found that the Massachusetts child protection agency's practices were "conscience shocking" and were depriving foster children of constitutional protections.

The decision by Judge Johnston to allow the incarceration of Justina Pelletier, a fourteen-year-old foster child with no history of mental issues, meets the Supreme Court's test of "shocks the conscience."

The following is a brief recap of the Pelletier travesty as reported by The Boston Globe. Dr. Alice Newton and Judge Joseph F. Johnston were the parties responsible for Justina's sixteen-month captivity.

Dr. Alice Newton, head of Boston Children's Hospital child protection team, notified the state Department of Children and Families in February 2013 that their newly-admitted patient, Justina Pelletier, was a victim of medical child abuse. Swayed by Dr. Newton's certainty Judge Joseph Johnston held within days that Justina Pelletier had been harmed by her parents, Lou and Linda Pelletier. The rationale for taking Justina: the parents were permitting Dr. Mark Korson of Tuft's Medical Center to treat their daughter for a mitochondrial condition.

Dr. Newton conveniently neglected to tell Judge Johnston that Boston Children's Hospital treats mitochondrial disorders and performs the highly criticized cecostomy surgery.

If Lou Pelletier had obeyed Judge Johnston's gag order, Justina may have remained a ward of the state until her eighteen birthday.
Former rulings make it clear that Judge Johnston erred when he chose to separate Justina from her parents and place her under state custody for the reasons cited by the Supreme Judicial Court of Massachusetts in Sevigny’s Case, 337 Mass. 747 (1958). :
The courts are not to determine which side of a medical dispute is sound where each side is supported by reason and logic.
When Judge Johnston returned Justina to her parents on June 18, 2014 the contretemps became moot. But the question remains, was Judge Johnston conducting a kangaroo court ?

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.

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

Thursday, May 29, 2014

CDC Medical Child Abuse Report: Ten Thousand Plus Toddlers Prescribed Psychotropic Drugs

Psychotropic Drug Regimens are Medical Child Abuse

According to the Centers for Disease Control and Prevention an unreasonable number of children under the age of three are the recipients of psychotic medications. This information coupled with last month's New York Times report that 6 million children are under treatment for psychosomatic disorders raises the question of professional misconduct.

Because the FDA has no authority to regulate the practice of medicine, these subjective childhood mental illness determinations strongly indicate that some physicians have been abusing the country's carte blanche prescription delivery system.

This laissez-faire marketplace has been beneficial to pharmaceutical manufacturers and drug prescribers but not to the children who have no say in the matter.

The behavior-altering drugs under scrutiny are not FDA authorized for use in children under the age of six but physicians may recommend medications outside their intended use.  It has long been verified that these Class II substances pose significant risks to patients, especially children.

Although troubled by the data, the CDC offered no suggestions on how to dissuade physicians from approving dangerous substances for three-year olds and other children.

Doping minors, many of whom are state wards, for economic gain is an indefensible enterprise. The Department of Health and Human Services reports that in 2011 there were 400,500 children under state protection available for research projects.

Consideration: If physicians were charged with medical child abuse these predatory prescription practices would cease.

Medical Child Abuse References:

"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