The U.S. has Mandated Drug Research on Children*
War Crimes Tribunal at Nuremberg. Adolf Hitler’s personal physician, 43-year old Karl Brandt. Brandt was also Reich Commissar for Health and Sanitation, and was indicted by the U.S. prosecution with 22 other Nazi doctors. Brandt was found guilty of participating in and consenting to using concentration camp inmates as guinea pigs in horrible medical experiments, supposedly for the benefit of the armed forces. He was sentenced to death by hanging
By John P. Thomas
The U.S. federal government has mandated drug research with children. The need for children to participate in drug company research is high, and the temptation to overstep parental rights to force children to participate is great. Researchers publicly admit using money and other rewards to obtain participation of children in their drug trials.
Organizations that advocate for the rights of parents to make decisions regarding their children’s healthcare are finding that foster children in CPS custody are being enrolled in drug experiments without parental approval. State Child Protective Services are enrolling children in drug experiments without parental approval or court orders. However, those who conduct these drug experiments for pharmaceutical companies, and those who are charged with monitoring such research, do not see a problem with their recruitment methods.
Kayla and Hannah Diegel suffer from a rare form of mitochondrial disease, and were removed from the custody of their parents in 2014 for allegedly disagreeing with their doctors. Are they a subject of a drug trial?
In a 2011 article in the Journal Pediatrics, researchers discussed the problem of recruiting children for participation in clinical trials for drug testing. Researchers from Ohio State University (Columbus) and Case Western Reserve University, confirm that the US federal government is mandating that children be included in clinical research studies.
Dr. Tishler, PhD, and Dr. Staats Reiss, PhD stated:
Since 1994, federal guidelines have called for the inclusion of children in clinical studies. Related federal incentives and laws such as the “paediatric rule” (the Pediatric Research Equity Act) and the paediatric exclusivity provision have also been passed to increase the number of paediatric clinical trials launched by pharmaceutical companies. Despite these mandates, the allocations to paediatric clinical trials in federal and private research and development budgets have remained limited. In addition, paediatric researchers continue to experience difficulty locating children and families who are willing to enroll in clinical trials.
Recruitment for paediatric studies is hampered by several factors including ethical concerns with using children as subjects, regulatory oversight that is significantly more restrictive for child trials than for adult trials, a lack of research infrastructure, the need to obtain consent from parents, and the challenge of determining appropriate payments for participation that are not coercive
These researchers were struggling with ethical considerations concerning the use of money to entice parents to enroll their children in research studies. These researchers didn’t think that parents should see the enrollment of their children in drug experiments as a money-making proposition. On the other hand, they realized that money and gifts were very useful for bringing more children into pharmaceutical drug research.
They also noted that the number of paediatric research participants has been increasing. In 2006, they found that there were approximately 45,000 children participating in experiments. There has also been an increase in the number of Phase I studies with normal healthy children. In their review, only 9,817 of the 39,628 studies listed on ClinicalTrials.gov included children.
The researchers indicated that one of the most pressing challenges in doing paediatric clinical research is the limited number of participants. Researchers often must network across sites or countries to gain adequate numbers of participants. They often must expend significant energy and resources locating potential subjects.
Dr. Tishler, and Dr. Staats Reiss discussed how money is often given in exchange for voluntary participation. They stated:
One review of the Centerwatch.com clinical trials listing service published in 2002 revealed that nearly 25% of paediatric trials offered payments to participants that ranged from $25 for an investigation of influenza medications to $1500 for a psoriasis-medication study. In another study, [researchers] sent surveys to the IRB chairs [institutional review boards] at member institutions of the National Association of Children’s Hospitals and the Office for Protection From Research Risks.
Sixty-six percent of these institutions used paid participants, and there was wide variation in payment practices across the sites (ranging from $1 to $1000 in cash and $500 in savings bonds). Many of the institutions in the Weise et al study (42%) used a combination of incentives and/or payments for both the children and parents.
CPS Violates Parental Consent and Freedom of Speech
Isaiah Rider suffers from a rare condition called neurofibromatosis. When his mother took him to a hospital in Chicago that specializes in his condition, they ended up taking custody of him over the objections of his mother. Is Isaiah part of a drug trial?
There are two factors that normally limit child participation in medical and drug company research. The first is the requirement for parental consent. Children normally cannot participate unless a parent gives written consent. The second is the normal right that people have to publically speak out in situations where parents and their children are being coerced and compelled to participate in drug company experiments.
We would expect that these two constraining factors would keep children safe from becoming unwilling participants in drug research. However, there are situations in which state agencies are able to avoid both of these constraints and force children to become human guinea pigs.
The network of state operated child protective service agencies (CPS) routinely circumvent the rights of parents and children, and give permission for physicians/researchers to force children to participate in drug company experiments.
Children who are in the foster care system and who are under the control of Child Protective Services are easily targeted for involuntary inclusion in drug experimentation. Ideally, even if children are under CPS control, their natural parents should retain the right to give consent for medical treatment for their children whether it is routine or experimental.
In practice, however, once CPS steps into a family’s private life and takes children out of the home and places them in foster care, then parental oversight regarding the healthcare of their children is routinely violated. Because these cases are involved in State Juvenile or Family Courts (as opposed to Civil Courts), records are sealed and kept secret, supposedly to protect the children.
Tonya Brown with Adopted Son Christopher, who had a rare form of Leukaemia. Doctors and CPS took Christopher away when she disagreed with the doctors over his treatment
CPS Collects Federal Funds for Trafficking Children
There is money to be made and lots of it! Whenever a child enters state CPS control, federal funding flows into that state. It is in the best interest of state budgets to bring children into the CPS system and to keep them there as long as possible. States have a large incentive to take children and sever parental rights and put children up for adoption. Adoption brings even greater money into state budgets. The flow of money into CPS budgets helps maintain the jobs of CPS workers.
The Alliance for Human Research Protection testified to the U.S. Congress about the flow of money into state budgets. They reported:
In 2004, the Federal Government provided more than $7 billion in dedicated funds for child protection. The bulk of these funds (almost $5 billion) supported children who had been removed from their homes.
In 2007 Joseph Doyle, an economics professor at MIT’s Sloan School of Management, published a study which tracked at least 15,000 kids in foster care from 1990 to 2002. It was the largest study of its kind at that time.
Although foster care is meant to be a temporary arrangement, children stay in care for an average of two years, and there are currently over 500,000 children in care (US Department of Health and Human Services 2005). Roughly 60% of foster children return home; 15% are adopted; and the remainder “age out” of foster care (Fred C. Wulczyn, Kristen Brunner Hislop, and Robert M. Goerge 2000). Three quarters of these children live with substitute families, one-third of which are headed by relatives of the children. These families are paid a subsidy of approximately $400 per month per child (Child Welfare League of America 1999), and states spend over $20 billion each year to administer these child protective services (Roseana Bess et al. 2002).
Chaunell Smith was taken away from her family by CPS after her mother questioned her treatment. Was her custody battle an attempt to cover up medical malpractice?
CPS and Medical Kidnapping
CPS takes control over all aspects of the lives of children. CPS severs contact between parents and their children when parents don’t do what CPS demands, and will give permission for foster children to participate in drug experiments. This is done even when the drug trials may be life-threatening. This is done, so it is said, to protect the children, but such “protection” destroys the family unit, traumatizes children, and frequently results in permanent harm to children.
The process that results in CPS seizing children and placing them in foster care begins with allegations of parental neglect or harm against their children. It is not unusual to find that such allegations are without truth. Even so, CPS and the family court system may refuse to return children to their parents. Sometimes, after many months or even years, children are returned after the experimentation is complete. But in many other situations, children are simply put out for adoption. In these cases, unproven allegations against parents can result in permanent loss of children without any opportunity for future contact.
Parents, who have done nothing wrong, find themselves without their children, and they have no recourse to get them back once they are adopted by others.
CPS Does Not Help Families, But Destroys Them
The lofty goal that CPS once had many decades ago to strengthen dysfunctional families and restore children to a safe and loving environment with their biological parents or with close relatives is long gone. Today, CPS does not fix families, rather, it destroys families in order to provide paediatric subjects for clinical drug trials, to provide desirable children for adoption, and to keep federal dollars flowing into the state CPS budget.
Children are even more likely to be kidnapped by CPS workers for medical experiments when they have rare diseases. Such children are highly prized subjects for experimentation. This happened in a nationally publicized case that was exposed in 2013. Justina Pelletier was abducted by officials at Boston Children’s Hospital and subjected to disabling drug therapies.
As a result, 32 members of the US House of Representatives cosponsored legislation in 2014, which was entitled “Justina’s Law.” The proposed legislation was intended to End Experimental Medical Research on Children Seized by CPS. Unfortunately, the proposed law never even made it out of the House subcommittee. The proposed law languished and died without action by Congress. (See: “Justina’s Law” Seeks to End Experimental Medical Research on Children Seized by Child Protection Services.)
Justina Pelletier was just One of Many Children Abducted for Medical Research
Justina Pelletier was not an isolated example of CPS abuse. Similar abductions and medical experimentation have been taking place throughout the United States since the late 1980s.
Georgia Senator Nancy Schaefer. Crusader against CPS before her murder
The late state house senator from Georgia, Nancy Schaefer most likely gave her life in exchange for bringing CPS sponsored medical abuse to light. She publicly exposed many cases of medical kidnapping, which involved CPS workers in numerous states.
Congresswoman Schaefer lost her Senate seat in Georgia as a result of her speaking out, but states it was something “worth losing” for standing up for the rights of parents who were having their children kidnapped by CPS. She and her husband were found murdered in their home in 2010. You can read her report on CPS from 2007. (Senator Nancy Schaefer: Did her Fight Against CPS Child Kidnapping Cause her Murder?)
Nancy Schaefer describes the attack that is being waged against children for the purposes of drug experimentation and adoption. She points out how such state sponsored child abuse is ultimately an attack on the sovereignty of parents to make decisions for their family without coercion and manipulation from state agencies and the family court system. Neither of these organizations is operating to protect the family structure. They are operating under a new ethic, which is to do what is right for the child – and to ignore what is best for the entire family.
Children are now seen as autonomous individuals whom the state must protect from parents. The relationship between parents and their children is no longer valued and protected. Rather, parents are seen as potential offenders who are considered guilty of any charges that are brought against them. The wide range of parenting styles which was once permitted in our society is no longer valued. CPS workers, Family Court judges, and the authority of the state are now determining what is normal, and any parent who disagrees with them is subject to retaliation against their family and parental authority. Everything is based on what the state thinks is “best for children.”
Homeschool children being removed from their family by force by CPS and sheriff deputies.
Homeschool children being removed from their family by force by CPS and sheriff deputies.
Best for Whom?
As reported by Steven R. Isham M.A., L.B.S.W, in a recent article published by Health Impact News and MedicalKidnap.com, children who are seized by CPS and placed into long term foster care do very poorly when compared to other children. Foster care is not usually a safe refuge for damaged children, which allows them to heal. Rather, foster care perpetuates the abusive and neglectful patterns in the lives of many children, which sets them up for long-term failure as adults.
Steven Isham reveals that former foster children rarely become productive citizens who are able to take care of themselves. He indicated that by age 25, 61 out of 100 former foster children will be unemployed, 24 out of 100 will be homeless, 64 out of 100 males will be incarcerated 32 out of 100 females will be incarcerated, and only 3 out of 100 will have been able to complete a four year college degree.
U.S. House of Representatives Investigates Medical Trials of Foster Children
Phil Crane, right, meets with President George W. Bush and Representative Bill Thomas of Committee on Ways and Means
Phil Crane, right, meets with President George W. Bush and Representative Bill Thomas of Committee on Ways and Means
In 2005, a hearing with the title “Protections for Foster Children Enrolled in Clinical Trials” was held by the U.S. House of Representatives. The Subcommittee on Human Resources of the Committee on Ways and Means, investigated whether adequate safeguards were in place to protect foster children from being forced to participate in drug studies.
The allegation that they were investigating involved clinical drug trials on AIDS drugs that were conducted during the period from the late 1980s through 2001. In part they were looking back at the past and asking if there were abuses. They were also wondering whether there were any inappropriate actions taking place in more recent years.
The testimony could easily be divided into two camps.
The first camp could be called the professional camp. It consisted of U.S. Health and Human Services administrators, pediatricians, public health researchers, and CPS administrators. The second camp could be called advocates for injured children. This second camp consisted of representatives from various children’s advocacy groups, biological parents of foster children who were taken by CPS, and various other individuals who were concerned about exploitation and forced experimentation on children.
In short, the professional camp did not believe there was a problem. They believed the use of existing institutional review boards (IRBs), which reviewed all experiments involving human subjects, would prevent abuse of children in foster care. They also believed that other random reviews conducted by the federal government would keep researchers from behaving unethically.
On the other hand, the camp that was advocating for parental rights and the protection of foster children told a very different story. They described medical abuse. They described individual events, and systemic problems, and called for reform of the CPS system.
Members of the congress are very busy people. They do not schedule hearings on potentially controversial topics unless there is already sufficient evidence to warrant the investigation. Sometimes hearings are held to emphasize a problem to raise awareness in preparation for their action. In other situations, hearings are scheduled and witnesses are carefully selected to quiet a politically hot situation, which could bring embarrassment or lead to allegations of criminal wrong-doing.
The subcommittee invited certain witnesses to speak to them and to answer questions. All of the witnesses were from the professional camp of government administrators, physician researchers, and CPS administrative staff. Invited witnesses were all directly involved in regulating drug experiments or responsible for conducting those experiments. Advocates for parents and children were not invited to speak, but were permitted to submit written testimony.
Congress Knows Children are being Abused in the CPS System
When the Subcommittee on Human Resources of the Committee on Ways and Means, U.S. House of Representatives met to examine this problem, Chairman Wally Herger, Representative from California made this statement:
Over the last 18 months, this Subcommittee has heard hearings about a number of issues affecting kids in the Federal, State child welfare programs, and this issue is like many of them: It has the potential for being explosive. The child welfare program in the richest, most powerful country in the world is, and has been, often an abysmal failure.
Now, we don’t need proof of more of that. We can give you all kinds of examples of it. We know about kids losing their lives in the child welfare system. Practically every State legislature every year deals with one case or another, and everybody wrings their hands, and the problems go on. The kids are sometimes locked up and sometimes starved under the supervision of the agencies. We know the children have been used without proper supervision for drug testing.
The first witness to testify before the House subcommittee was Dr. Donald Young, M.D., U.S. Department of Health and Human Services, Principal Deputy Assistant Secretary for Planning and Evaluation. He provided extensive testimony regarding governmental oversight. Dr. Young concluded his remarks by stating:
We continue to address challenges posed by the threat of HIV/AIDS and are committed to basic and clinical research to strengthen the nation’s ability to cope with this infectious disease. The protection of human subjects, including children, in clinical trials has been and will remain a top priority for HHS. HHS is firmly committed to the protection of the rights and welfare of every individual who participates in human research consistent with sound ethical standards and regulatory requirements.
Later in the hearing, Dr. Young was asked if any changes were needed in regard to foster children and their participation in drug experimentation. Dr. Young stated:
We are not aware of any changes that we believe need to be made. If they are identified, we will be very happy to consider them and make a decision as how best to proceed. We share with you the concern about the adequate protection of foster children. At the same time, the opportunity to let them participate and get the advantage of clinical research, if that is theirs and their guardian’s decision.
Advocates for Parental Rights Blow the Whistle on Drug Trial Abuses
The testimony provided by advocacy organizations, parents, and concerned professionals told a very different story. Most were not interested in discussing the past AIDS drug trials, but were narrowing in on what they saw as current abuses in 2005.
Their testimony exposed a pattern of foster care abuse that has continued to worsen over the past ten years. The abuse now has to do mostly with forced experimentation on foster children with psychiatric drugs, or the treatment of children with very rare diseases.
Important testimony was given by representatives of Ablechild.org. Sheila Matthews stated:
I am the National Vice President and Co-founder of Ablechild.org, a non-profit national parent organization that works on educating the public on the issues of informed consent and the right to refuse psychiatric “treatment”. Our organization is very concerned with the outcome of this hearing because we hear directly from parents victimized by the trafficking of their children into clinical drug trials while in state custody.
Ablechild has documented cases of children who have been placed on drugs, completely unaware that they are participating in a clinical drug trial, and without knowing that they have the right to “opt out” of participating. The fact is, the State holds the responsibility of providing informed consent to parents and children, and lacks any procedure to protect and safeguard this right.
Our organization points out the problems that resulted from strategies designed to target and exploit these children. The Connecticut Advocate reported these resulting problems in its June 5th, 2001 article, “Study Calls for Review of Psychiatric Drugs Prescribed to Kids.” Within this news story, the authors of a new study questioned why 396 children under 4 years old covered by Medicaid were prescribed psychiatric drugs. Some of these children were less than 1 year old.
A clear conflict of interests exists between the pharmaceutical industry and the experimentation occurring on children within state custody. This fact is clearly demonstrated by workshops sponsored by the pharmaceutical and biotechnology industries designed to optimize strategies for drug development and trials in children.
Gloria Wright, also from Ablechild.org, added these comments to the subcommittee in a separate letter:
As a grandparent and a member and officer of Ablechild, a 501(C) 3 organization, I wish to bring to your attention our cry for the protection of human rights of foster children across America!
Our organization frequently hears from parents across the nation who implore us for assistance in the matter of the clinical trial/experimental drugging of their children while in state custody and in foster care. These children have been placed on clinical trial drugs without a legal advocate responsible for safeguarding their health, or their life. As minors these children are unable to opt out of these tests/experiments, the parents have been denied their right to dissent and there obviously are no procedures in place to safeguard the rights of the children.
Statement of Linn Asplund, a parent from Waterbury, Connecticut:
Thank you for considering my testimony. When my son was 10 years old, he was attending Washington School in Waterbury, CT. He started having problems in the beginning of third grade, September 1999. He was being picked on and bullied by the other children. His grades started suffering and he too started having discipline problems. This bullying was brought to the school’s attention, but it still went on. The principal suggested a PPT. I agreed and at the first PPT I agreed to have him tested. I was then told he was “LD” (Learning Disabled), but it was not that bad.
Next they told me they wanted him to see a psychologist for a psychological evaluation, I agreed. I obtained a copy of the evaluation. My son told the doctor that he had no friends at school. He liked it better at home and would wake up repeatedly at night with thoughts of how to quit school. By this time Dr. Abramavich said my son was psychotic and needed to be medicated. I refused. The next thing I knew, DCF (Department of Children and Families) was at my door telling me the school said my son has special needs that need to be taken care of. I still refused the psychiatric drugs. I brought him to “child guidance” and was told that he was a normal child.
After several visits from DCF I still refused to drug my son. On March 16th 2000, I found court papers on my doorstep. In them my husband and I were charged with abuse and neglect and were informed that DCF was going to take our son from us. Later that day a social worker and police officer arrived and took him away.
Two weeks later, DCF placed him in Waterbury Hospital where Dr. Edwards gave my son Haldol and Attavan–mind altering drugs not approved for use in children. A few days after this, Dr. Mennessen put him on 100 mg of Wellbutrin a day; also not FDA approved for use in children. When I asked Dr. Mennessen why he was giving my son this drug without my consent, his reply was “we need a number of cases to get it FDA approved.” (emphasis added)
Conclusion: CPS and Doctors are Kidnapping Children for Medical Research
Images from a few of the stories we have covered at Health Impact News and MedicalKidnap.com
It is hard to determine the exact number of clinical drug trials that are currently in process in the United States, or to determine how many children are in such trials. This problem was identified at the House of Representative hearing in 2005, and it still remains a problem ten years later.
If data from Europe can be used as a yardstick to compare the involvement of children in clinical studies, then the scope of drug testing on children has increased dramatically since the 2011 data, which was presented at the beginning of this article.
The European Union Clinical Trials Register currently displays 25,527 clinical trials, of which 3,662 are clinical trials conducted with subjects less than 18 years old.
The CPS system is setup in such a way that its activities with specific families are secret. They hide behind confidentiality laws to prevent public oversight. They threaten parents with permanent loss of their children if they speak publically. The family court system adds its authority to demand that parents remain silent. All the while, family after family is threatened and broken. Children are brought into drug experimentation programs, and others are provided for the adoption business, which brings even more money into state coffers.
CPS intentionally does not place children with family members, because the children bring in greater income to the state when they are placed in foster care home. CPS often acts quickly to put children up for adoption, because the cash payments that the state will receive are substantial. In short, the violation of parental rights is a money making proposition for state government. The money perpetuates the CPS system, and allows abuse to happen in the name of “protecting” children.
Physicians are required by law to report to CPS any situation that looks like child abuse or medical neglect. This is a ticket for CPS to investigate, seize children, meet their quotas, and start bringing money into the state budget. Since American culture has been trained to idolize and even worship the judgement of physicians, then most parents have little power to fight both the judgements of CPS and the medical establishment. The Family Court system works hand in hand with CPS and physician recommendations, and gives little respect to the desires of parents.
Children with rare diseases, especially rare genetic diseases, are very vulnerable to CPS medical kidnapping and abuse. If parents don’t agree with a doctor’s treatment plan, then the doctors can notify CPS that the parents are neglecting their children by not doing what the doctor recommends. Once this happens, parents lose the right to make independent decisions for their children.
Once control over a child’s life is taken by CPS and the medical care system, then parental rights are ignored. Parents are not usually contacted to obtain permission to allow their children to participate in drug trials. If they are contacted, and refuse to give permission, then they will be ignored and may have future contact with their children denied. The parent’s health insurance companies can be billed for treatments/services that parents did not approve. Payments can even be made for drugs given to children that have not been approved for use with children by the USFDA.
In a letter written by Sharon Schuldt to the House committee that examined clinical drug testing on foster children, she gave us a serious warning. She wrote:
There was horrific disregard for humanity that took place in World War II Germany, some of which started out being directed toward the weak and vulnerable, in orphanages and hospitals, but then was directed to millions who lost their lives in the concentration camps. A society does not just lose their regard for human life overnight. It is a step at a time downward and soon that society slips further and faster downward. Many vowed, “Never Again.” We in the U.S. cannot and should not be allowing access to our children for medical research. There is no argument that justifies it!
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