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.