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.