On February 10, 2017, Medical Whistleblower Advocacy Network provided to the Organization of American States--InterAmerican Commission on Human Rights information about human subjects and medical experimentation in the U.S.A. The human-rights issues presented by Dr. Janet Parker DVM were about the use of human subjects in medical experimentation and the prescription of off-label medications and unapproved medical devices. The human-rights issue is the patient's right to free prior informed consent for medical treatment. The OAS-IACHR has not previously explored the subject of human rights as it pertains individuals in the U.S.A. who are subjects of medical experimentation and the use of non-FDA approved medical treatments. These non-FDA approved medications and medical devices have not met the standards of safety or efficacy set by the Food and Drug Administration. This issue potentially impacts every patient in health care in the U.S.A. and impacts the human rights of every patient worldwide who is prescribed medications and devices developed by US corporations.
The Inter-American Commission on the Elimination of All Forms of Discrimination against Persons with Disabilities states in Article II that "The objectives of this convention are to prevent and eliminate all forms of discrimination against persons with disabilities and to promote their full integration into society."The Inter-American Convention to Prevent and Punish Torture pertains to this issue. The Committee for the Prevention of Torture (CPT) has stated: "Patients should, as a matter of principle, be placed in a position to give their free and informed consent to treatment. The admission of a person to a psychiatric establishment on an involuntary basis should not be construed as authorizing treatment without his consent. It follows that every competent patient, whether voluntary or involuntary, should be given the opportunity to refuse treatment or any other medical intervention. Any derogation from this fundamental principle should be based upon law and only relate to clearly and strictly defined exceptional circumstances."
The prohibition of torture is one of the few absolute and nondisputable human rights. Medical interventions can become inhuman and degrading treatment. They might arguably meet the criteria for torture, which is prohibited by international law. The United States of America has a duty to have to prevent, prosecute and redress abuses in health care. (Inter-American Convention to Prevent and Punish Torture.)
There are many more cases of torture and ill-treatment in health-care settings than are officially reported to US authorities. Victims/survivors of this kind of abuse often are unable or unwilling to report what has happened to them. Thus, official reports represent only a small fraction of this problem. Ill treatment is not justified by health-care system inadequacies or lack of medical resources. Individuals have the right to an adequate standard of health care ("right to health"). The right to be protected from torture and ill treatment also provides objective restrictions on certain kinds of therapies.
Crucial to the protection of the human rights of vulnerable patients are:
1) Right to Legal Capacity (right of recognition of juridical personality and civil rights)
2) Right to Free, Prior and Informed Consent
3) Right for an individual to choose a surrogate decision maker or Guardian that will best represent his/her wishes
4) Protection for Human Subjects in medical, social and behavioral research
These rights have been delineated in multiple international human rights documents and in the relevant case law, but unfortunately color of law, and color of official right violations of these rights routinely happen within mental health institutions, prison and correctional institutions, long term care facilities and in the provision of health care to financially disadvantaged populations such as foster children.
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 can and do occur. The persons most vulnerable to exploitation as human subjects of medical research are those who are already marginalized and disadvantaged. Groups such as migrants, prisoners, children, people with disabilities, Native Americans, racial and ethnic minorities are more likely to be targeted by researchers.
Medical research and the approval of prescription drugs are global concerns. Much of the research done by U.S. pharmaceutical companies is happening worldwide. Africa and other nations who are economically disadvantaged have been targeted by large international pharmaceutical companies to be sites of clinical testing. However, as human-rights violations of corporations become known, people in the developing world are less willing to become guinea pigs -- and for good reason. This fundamental distrust lies in the paradox of Hobson's choice "Experimental medicine or no medicine at all". Often the medical research offered does not fully protect human rights nor provide to those participating in the research the full benefits of the findings. This leads to another concern regarding the "Right to Life". In that persons in the developing world are often denied innovative therapies and important research developments regarding diseases and conditions important to their communities. Even within the U.S.A., there are impacts of the withholding of the potential benefits of research while at the same time exploiting those same vulnerable populations as research subjects. This leads to unequal access to treatment modalities as well as treatment that is not inclusive of the specific needs of those vulnerable populations.
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, [i] and the World Medical Organization's Helsinki Declaration of 1964 (revised in 1975). [ii]
In the U.S.A., 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 Nuremberg Code's influence on global human-rights law and medical ethics has been profound. Its basic requirement of informed consent, for example, has been universally accepted and is articulated in international law in Article 7 of the United Nations International Covenant on Civil and Political Rights (1966). ICCPR Article 7 states "No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation."
The US 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.
Informed consent is consent obtained freely, without threats or improper inducements, and after appropriate disclosure to the patient of adequate and understandable information in a form and language understood by the patient. Engaging in an informed-consent process between a clinical doctor and a patient should be an essential part of the standard of care in medicine. Informed consent is a process, not just a formality, and engaging in that process is of the essence of good medical care. Information must be provided to the patient in a timely manner and in accordance with the accepted standard of practice among members of the profession with similar training and experience. A health-care professional may be legally liable if a patient does not give "informed consent" to a medical procedure and it results in harm to patient even if the procedure is properly performed. [iii]
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