Submission from Medical Whistleblower Advocacy Network



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Submission from Medical Whistleblower Advocacy Network (MWAN) to the United Nations Committee Against Torture

on the List of Issues for the U.S.A.
June 27, 2016
Reporting Cycle VI

Session 59 (2016)
Torture and Ill Treatment in Health Care Facilities
By

Dr. Janet Parker DVM
Medical Whistleblower Advocacy Network

P.O. Box 42700

Washington, D.C. 20015

MedicalWhistleblower@gmail.com
Introduction
Medical Whistleblower Advocacy Network (MWAN) acts as a grassroots advocate for human rights for disabled persons and other individuals within the U.S.A. and abroad. MWAN human rights cases often involve issues with medical implications, such as protection of mandated reporters, medical abuse, medical fraud, psychiatric abuse, prisoner mistreatment, sexual assault, domestic violence and stalking. MWAN provides information, referrals, and also direct human rights defender advocacy services. MWAN has allowed victims of human rights violations to directly tell their own stories, assisting them when necessary with their time lines, helping them access documents, and doing research and analysis of their situations. Some who experienced human rights violations chose to tell their stories in their own words on MWAN's internet radio program. MWAN also works with other NGO organizations to advocate for the rights of the disabled and promote the protection of human rights.
See the following Medical Whistleblower Advocacy Network reports:
Medical Whistleblower Advocacy Network, “Voiceless Victims: Wards of the Court”, CAT Reporting cycle V Session 53 (2014) MWAN - US Human Rights Network #5, 16 Oct 2014, 10 pages. INT_CAT_NHS_USA_18523_E
Medical Whistleblower Advocacy Network (MWAN) Voiceless Victims: Wards of the Court, CCPR IV Session 110 (2014) 48 pages, INT_CCPR_NGS_USA_19896_E also in Russian, Arabic, Chinese, French, and Spanish
Medical Whistleblower Advocacy Network, 2/16/16 Follow Up Report to the United Nations Human Rights Committee Concerning the implementation of obligations of The United States of America Pertaining to CAT, CAT/C/USA/CO/3-5, Nov. 28, 2014 (adoption of the Concluding Observations) Nov. 28, 2015 (Deadline for the State follow-up report)
Medical Whistleblower Advocacy Network, Statement for consideration by the Human Rights Committee for General Comment No. 36 - Article 6: Right to life of the International Covenant on Civil and Political Rights, at its 114th Session, Palais des Nations, Room XIX – 14 July 2015.
Medical Whistleblower Advocacy Network, Submission to the United Nations Universal Periodic Review of United States of America, Second Cycle, Twenty Second Session of the UPR, Human Rights Council April-May 2015, “Disability Rights” MWAN JS-8.
Medical Whistleblower Advocacy Network, Submission to the United Nations Universal Periodic Review of the United States of America, Nineth Session of the Working Group on the UPR, 22 November – 3 December 2010. (MWAN, JS-14) “Defenders of Human Rights” http://lib.ohchr.org/HRBodies/UPR/Documents/session9/US/JS14_JointSubmission14.pdf
Medical Whistleblower Advocacy Network, Statement to the President Obama and the White House In Conjunction with Public Citizen 7/4/15
Medical Whistleblower Advocacy Network, Written Testimony To The State of Civil and Human Rights in the United States, Hearing Before the Senate Judiciary Subcommittee on the Constitution, Civil Rights, and Human Rights, December 9, 2014 Testimony regarding Protection of Human Subjects and Guardian Abuse.
Medical Whistleblower Advocacy Network, Written Testimony of Dr. Janet Parker. DVM to the Hearing before the Senate Committee on the Judiciary, Subcommittee on the Constitution, Civil Rights and Human Rights, “Law Enforcement Responses to Disabled Americans: Promising Approaches for Protecting Public Safety," April 29, 2014, Provided to Chairman Durbin, Ranking Member Cruz, and distinguished members of the Subcommittee, “Do You Know What A Dragon Looks Like?”
Medical Whistleblower Advocacy Network, Dr. Janet Parker DVM, Written Comments for the Record to the Federal Election Commission, 1/8/15, REG 2014-01 Earmarking, Affiliation, Joint Fundraising, Disclosure, and Other Issues (McCutcheon).
Medical Whistleblower, Abuse and Neglect in U.S.A. Residential Treatment Centers A Systemic Problem by Dr. Janet L. Parker DVM, 8/14/2011.
District of Columbia - Constitutional Convention, Woodrow Wilson High School June 17, 2016, Written Statement for the Record Dr. Janet Parker DVM, Due to lack of equal suffrage to the U.S. Congress the residents of the District of Columbia— the nation’s capital—are prohibited from voting for and electing representatives to the United States Senate and the United States House of Representatives. It has long recognized by the international community that representative democracy and its associated political rights are essential to the effective realization and protection of human rights
Questions for the United States of America:


  1. Why are no professionals in the U.S.A. doing Istanbul protocol evaluations on suspected torture victims/survivors who are US citizens who reside in the U.S.A.?

  2. Why are there no rehabilitation programs for United States citizens who have been victims/survivors of torture within the U.S.A?

  3. Which US law enforcement agency is empowered to investigate torture and ill treatment of persons within health care settings and are those investigating officers training in human rights issues?

  4. What formal training in human rights as it pertains to health care settings is provided to medical professionals, social workers, legal advocates, attorneys and judges?

  5. How many persons in the U.S.A. are currently wards of the court?

  6. How many persons within the U.S.A. have had their own legal rights curtailed and have been assigned by the court to have substituted decision makers/surrogate decision makers for their health care decisions?

  7. Are these substituted decision makers/surrogate decision makers trained in their obligation to protect the human rights of the person under guardianship?

  8. What measures are being taken to oversee, supervise and monitor the decisions by these substituted decision makers/surrogate decision makers?

  9. What oversight and protections are there to prevent human subject experimentation on these vulnerable wards of the court?

  10. Why are off-label pharmaceutical products being used on wards of the court that have not met the Food and Drug Administration standard for approval and which have not met safety and efficacy standards?

  11. What measures does the U.S.A. employ to ensure that courts do not impose medical experimentation with off-label drugs on vulnerable patients that are wards of the court?

  12. Are substituted decision makers/surrogate decision makers, judges, and prescribing medical professionals informed by the FDA of product warnings and criminal prosecution of pharmaceutical companies for off label promotion of pharmaceutical products, so that they can discontinue the off-label use of these products on persons under guardianship?

  13. For wards of the court that have had their human rights violated, what avenue of legal redress do they have and is any rehabilitation provided?

  14. What programs are available to provide medical assistance to wards of the court who were forced to take and then addicted to off-label pharmaceutical products and who now wish to discontinue that medication?


Summary of the Issue:
There is a right to an adequate standard of health care (right to health). It is necessary to have accountability in order to prevent, prosecute and redress violations that occur in a health care setting. (See Juan E. Méndez, A/HRC/22/53 Human Rights Council, Twenty-second session, Report of the Special Rapporteur on torture and other cruel, inhuman or degrading treatment or punishment, 1 February 2013)
UN Special Rapporteur on Torture, Manfred Nowak stated in the Interim report A/63/150. 28. July 2008. “Torture, as the most serious violation of the human right to personal integrity and dignity, presupposes a situation of powerlessness, whereby the victim is under the total control of another person. Persons with disabilities often find themselves in such situations, for instance when they are deprived of their liberty in prisons or other places, or when they are under the control of their caregivers or legal guardians. In a given context, the particular disability of an individual may render him or her more likely to be in a dependent situation and make him or her an easier target of abuse. However, it is often circumstances external to the individual that render them “powerless” such as when one’s exercise of decision-making and legal capacity is taken away by discriminatory laws or practices and given to others.”
UN Special Rapporteur on Torture, Manfred Nowak stated: “Medical treatments of an intrusive and irreversible nature, when they aim at correcting or alleviating a disability, may constitute torture and ill-treatment if enforced or administered without the free and informed consent of the person concerned.” The administration in detention and psychiatric institutions of drugs, including neuroleptics that cause trembling, shivering and contractions and make the subject apathetic and dull his or her intelligence, has been recognized as a form of torture.” “The Special Rapporteur notes that forced and non-consensual administration of psychiatric drugs, and in particular of neuroleptics, for the treatment of a mental condition needs to be closely scrutinized. Depending on the circumstances of the case, the suffering inflicted and the effects upon the individual’s health may constitute a form of torture or ill-treatment.” SRT (2008) UN Special Rapporteur on Torture. Interim report A/63/150. 28. July 2008.
The number cases of torture and ill-treatment in health-care settings report in the U.S.A. represents a small fraction of this problem. Medical interventions can amount at least to inhuman and degrading treatment, often they arguably meet the criteria for torture, and thus they are always prohibited by international law. The prohibition of torture is one of the few absolute and non-derogable human rights,i a matter of jus cogens,ii a peremptory norm of customary international law. Examining abuses in health-care settings from a torture protection framework provides the opportunity to solidify an understanding of these violations and to highlight the positive obligations that the United States of America has to have to prevent, prosecute and redress such violations. The right to an adequate standard of health care (“right to health”) determines the U.S.A. obligations towards persons suffering from illness. In turn, the absolute and non-derogable nature of the right to protection from torture and ill-treatment establishes objective restrictions on certain therapies. In the context of health-related abuses, the focus on the prohibition of torture strengthens the call for accountability and strikes a proper balance between individual freedom and dignity and public health concerns. In that fashion, attention to the torture framework ensures that system inadequacies, lack of resources or services will not justify ill-treatment. Although resource constraints may justify only partial fulfilment of some aspects of the right to health, the U.S.A. cannot justify its non-compliance with core obligations, such as the absolute prohibition of torture, under any circumstances.iii By reframing violence and abuses in health-care settings as prohibited ill-treatment, victims and advocates are afforded stronger legal protection and redress for violations of human rights. In this respect, the recent general comment No. 3 (2012) of the Committee against Torture on the right to a remedy and reparation offers valuable guidance regarding proactive measures required to prevent forced interventions. Notably, the Committee considers that the duty to provide remedy and reparation extends to all acts of ill-treatment,iv so that it is immaterial for this purpose whether abuses in health-care settings meet the criteria for torture per se. This framework opens new possibilities for holistic social processes that foster appreciation of the lived experiences of persons, including measures of satisfaction and guarantees of non-repetition, and the repeal of inconsistent legal provisions.
Issue 1: Torture, Abuse and Ill Treatment in Healthcare Settings
Medical abuse can amount to inhuman and degrading treatment and sometimes meet the criteria for torture.v The prohibition of torture is one of the few absolute and non-derogable human rights. Abuses in health care must be examined from an understanding of the nature of these violations and be addressed from a torture protection framework. The doctor-patient and doctor-human subject relationship is a relationship in which the doctor has great power and authority. In this imbalance of power, ethical violations of human rights occur - including violations of the Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment. In addition, the medical community uses the concept of privacy protections to prevent transparency and accountability for their actions. Unequal relationships exist between health researchers and their patients. But health practitioners rarely acknowledge this conflict of interest in their dual roles as health practitioners who are also doing research on their own patients. Vulnerable patients who are used as research subjects within a therapeutic doctor-patient relationship are not afforded the same level of protection as other research subjects, such as persons participating in university or governmental agency research project. A large number of subjects are poor, disabled, children, racial minorities and/or prisoners. These unwitting human subjects have been subjected to deliberate infection with deadly or debilitating diseases, exposed to biological or chemical weapons, exposed to radiation or radioactive chemical, given mind-altering chemicals or toxins. Subjects were told that they were receiving “medical treatment” and reassured by the doctor who they believed would be acting in their “best interest.” Third party/surrogate decision makers do not question whether medical professionals are doing what is in the “best interest” of the patient and thus force patients to comply with treatment plans devised by biased persons with conflicts of interest and often vested financial and professional interests.
Some of these human rights issues related health care settings and CAT include:



  • Human Subjects Protections & Unethical Medical Experimentation

  • Compulsory Detention for Medical Conditions

  • Powerlessness and The Doctrine of “Medical Necessity”

  • Evaluations of Victims/Survivors of Torture and The Use of The Istanbul Protocol

  • Legal Capacity and Informed Consent

  • Refusal to Acknowledge The Right To Refusal (In Regards To Treatment)

  • Domestic Legislation Allowing Forced Interventions

  • Nonconsensual Psychiatric Interventions

  • Involuntary Commitment in Psychiatric Institutions

  • Compliance-Based Behavioral Interventions

  • Stigmatized Identities

  • Abuse of Persons with Disabilities

  • Absolute Ban On Restraints and Seclusion

  • Criminal “Off-Label” Promotion of Pharmaceutical Products

  • Torture, Ill-Treatment and People with Psychosocial and Intellectual Disabilities

  • Reproductive Rights Violations

  • Abuses in Drug Detention Centers

  • Denial of Pain Treatment

  • Abusive Treatment of Institutionalized Forensic Patients

  • Torture, Inhumane and Degrading Treatment In Non-Governmental Drug Rehabilitation Centers

  • Abusive Treatment of Persons Living with HIV/AIDS

  • Abusive Treatment of Persons Who Use Drugs

  • Abusive Treatment of Sex Workers

  • Legal Capacity, Informed Consent, And Stigmatized Identities

  • Abusive Practices Toward LGBTI


Issue 2: Need for Protection of Human Subjects
The Nuremberg Code and the related Declaration of Helsinki delineates what is considered ethical conduct for human subjects’ research and forms the basis for the US Code of Federal Regulations - Title 45 Volume 46 (The Common Rule). The United States Department of Health and Human Services (HHS) regulations 45 CFR part 46 governs all federally-funded research in the United States. The United States Constitution should constrain the use of individuals in non-consensual experimentation, including non-consensual medical treatment and experimentation. Specifically, the Fifth and Fourteenth Amendments proscribe deprivation of life, liberty or property without due process of law. The Fourth Amendment proscribes unreasonable searches and seizures (including of a person’s body), and the Eighth Amendment proscribes the infliction of cruel and unusual punishment. Federal law also prohibits non-consensual clinical investigations of medical products on human subjects in the U.S., and in foreign clinical investigations when the data are to be used to support drug or device approvals.
Human subject research includes experiments and observational studies in basic biology, clinical medicine, nursing, psychology, and all other social sciences. There are various codes for the proper and responsible conduct of human experimentation in medical research, the best known of these codes are the Nuremberg Code of 1947, the Helsinki Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued by the U.S. Department of Health, Education. The Belmont Report was written concerning the Ethical Principles and Guidelines for the protection of human subjects of research. The Nuremberg Code and the related Declaration of Helsinki delineates what is considered ethical conduct for human subjects’ research and forms the basis for the US Code of Federal Regulations - Title 45 Volume 46 (The Common Rule).
The Federal Policy for the Protection of Human Subjects or the “Common Rule” was codified in separate regulations by 15 Federal departments and agencies. The United States Department of Health and Human Services (HHS) regulations 45 CFR part 46 governs all federally-funded research in the United States. The right to informed consent is delineated in the federal regulation Protection of Human Subjects, 45 CFR 46 also known as the Common Rule under the authority granted by the U.S. Department of Health and Human Services. There are also Welfare Codes for the conduct of social and behavioral research such as that published by the American Psychological Association in 1973.
Control of pharmaceutical and device products is vested by statute in the Food and Drug Administration (FDA) within HHS. The involvement of human beings in such research is prohibited unless the subject or the subject’s legally authorized representative has provided prior informed consent, with only very limited exceptions. A waiver of informed consent by the Institutional Review Board is supposed to be granted only in circumstances where the research presents no more than minimal risk to subjects, and the waiver will not adversely affect subjects’ rights and welfare.
Yet the real promise of human subjects’ protections promised by the Belmont Report have not been fully realized in the U.S.A. In part, because although there was full discussion of the ethical principles involved, the US National Commission choose not to address the concerns regarding the practice of medical research within clinical therapeutic settings.
The Office of Human Research Protections (OHRP) has responsibility for oversight of compliance with the Health and Human Services (HHS) regulations for the protection of human research subjects. In carrying out this responsibility, OHRP reviews allegations of noncompliance involving human subject research projects conducted or supported by HHS or that are otherwise subject to the regulations, and determines whether to conduct a for-cause compliance evaluation. OHRP has jurisdiction only if the allegations involve human subject research (a) conducted or supported by HHS, or (b) conducted at an institution that voluntarily applies its Assurance of Compliance to all research regardless of source of support. In other words, research done by companies with their own money and not financed or conducted by HHS are not under OHRP jurisdiction, unless the research company “volunteers” to be under OHRP oversight.
Human experiments have been performed in the United States and also in other countries by US companies which have been considered unethical. These experiments were often performed illegally without the knowledge, consent, or informed consent of the test subjects. Vulnerable populations such as children, mentally disabled persons, prisoners, persons already suffering from disease or injury, financially disadvantaged, immigrants, or from a racial minority population were targeted for use by researchers. Vulnerable populations in other countries have been targeted to be used as human subjects and often less stringent standards of human rights protection were used to enroll them in clinical trials. (Medical Whistleblower Advocacy Network (MWAN) Voiceless Victims: Wards of the Court, CCPR IV Session 110 (2014) INT_CCPR_NGS_USA_19896_E)
Time and time again, since the original outcry against these atrocities, we are confronted with the reality that researchers, doctors and medical professionals have acted unethically and violated basic human rights of patients and human subjects. In spite of the Hippocratic Oath to “Do No Harm”, doctors and medical professionals have violated the human rights of vulnerable persons.

The following are just a few examples:


1932 -1972 U.S.A. - U.S. Public Health Service Tuskegee Study of Untreated Syphilis scientific researchers infected hundreds of mental patients with sexually transmitted diseases.
1946-1948 Guatemala - U.S. Public Health Service study on syphilis where researchers enrolled people in studies that involved intentional exposure to STD’s without informing them of risks or seeking their consent.
1900 - 1930’s U.S.A. - Indian Health Service doctors treated Native Americans for Trachoma, an infectious eye disease, by surgically removed the upper and lower eyelids of men, women and children. This was “a serious radical operation” called a tarsectomy and was done as a preventative measure on non-symptomatic individuals in several American Indian communities.
1950’s U.S.A. - U.S. Air Force’s former Arctic Aeromedical Laboratory attempted to identify the role of the thyroid gland in human acclimatization to cold weather gave radioactive iodine (Iodine131) to Alaska Natives and Eskimos. Many of the Alaskan subjects were non-English-speaking individuals and children, who were unable to provide proper consent at the time.
1970’s Zimbabwe - Depo-Provera was clinically tested on Zimbabwean women and then the women were pressured to use it once it was approved.
1989-1991 U.S.A. - Los Angeles study of experimental and unlicensed Measles vaccinations on African American and Latino children.
1996 Nigeria - Pfizer non-consensual administration of its experimental meningitis drug Trovan for meningitis in Kano. Pfizer eventually paid $75 million to settle claims that children were injured or killed by the drug Trovan.
1994 U.S.A. - The Medical University of South Carolina in Charleston was accused of enrolling poor black women into narcotic treatment research without their knowledge.
1990 – 2005 U.S.A. - The US Department of Defense obtained a waiver that allowed it to force 8.9 million ground troops to accept inoculation with experimental anthrax vaccines.
2001 U.S.A. - The Kennedy Krieger Institute in Baltimore encouraged black families to move into lead-contaminated housing as part of a study on lead levels in children.
2003 U.S.A. - Northfield Laboratories set up a nationwide trial of its blood substitute PolyHeme. Which was randomly administered by ambulance crews to unconscious victims of car accidents, shootings and cardiac arrests.
2008 Argentina - Santiago del Estero, seven babies died while taking part in trials for an experimental vaccine made by GlaxoSmithKline to prevent pneumonia and related diseases.
Research can be disguised as “treatment” but instead actually be a harmful or deadly experiment done without the patient’s knowledge or informed consent to treatment. Numerous court cases have been brought regarding psychiatric forced drugging and the lack of informed consent. (See Medical Whistleblower Advocacy Network, Statement for consideration by the Human Rights Committee for General Comment No. 36 - Article 6: Right to life of the International Covenant on Civil and Political Rights, at its 114th Session, Palais des Nations, Room XIX – 14 July 2015.)
In 1962 the US Congress enacted the Kefauver-Harris amendments to the Federal Food, Drug and Cosmetic Act. Because of these new amendments, manufacturers had to prove that a drug was not only safe, but also effective. Therefore, Food and Drug Administration (FDA) approvals need to be based on sound science. When the regulatory environment is one that protects human subjects and patients in the general public, the best drugs and treatments do rise to the top, not just those that are heavily marketed. The FDA should ensure that safety reports that emerge postmarket are aggressively monitored and that companies adhere to good manufacturing practices that would lead to consistently safe products. There must be adequate protections for patients, who are often forced by medical professionals into therapeutic clinical trials, often with drugs never approved or determined to be safe by the FDA (off-label). The design and implementation of controlled clinical trials should be very carefully monitored, even those done at the company’s expense, not just those publically funded. Major therapeutic breakthroughs can result, like the use of beta blockers in patients after a heart attack and angiotensin-converting enzyme inhibiters to improve survival in patients with heart failure. The Harris-Kefauver Amendments created a culture of quality and innovation that laid the foundation for the regulatory environment of the U.S.A. But the U.S.A. must incorporate human rights ethical standards in its training and regulatory oversight as well as criminal enforcement in order to respond to changing situations and challenges of the new scientific advances. The U.S.A. needs to not lose sight that clinical patients are vulnerable persons in need of human rights protections. Through the vigilance of FDA medical officer, Dr. Frances Kelsey, a public health tragedy of enormous proportion was prevented by ensuring that the sedative thalidomide was never approved in the United States. Thalidomide has once again come back on the U.S. market in 1998, after data showed it was safe and effective to treat a complication of leprosy. In an appropriate balancing of benefit and risk, FDA required strong safety monitoring and a strict dispensing plan before approving the drug.
Kataloq: Treaties

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