Medical whistleblower model letter informed consent


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Medical whistleblower model letter informed consent

  1. 1. Medical Whistleblower Advocacy Network P.O. Box C Lawrence, KS 66044The United States Declaration of Independence declared that all men are endowed with certain inalienable rights, and that "among these are life, liberty, and the pursuit of happiness".Dear Governmental Official:As an advocate for human rights of ___________________________ Iwish to bring to your attention the issue of informed consent which is ahuman right as delineated in international human rights law and indicatehow forced psychiatric drug treatment is viewed by the international humanrights bodies and by the jurisprudence of international human rights courts.The U.S.A. is party to the Universal Declaration of Human Rights (UHDR),the International Covenant on Civil and Political Rights (ICCPR), theConvention against Torture (CAT), and the International Convention on theElimination of Racial Discrimination (CERD), all of which must be appliedwithout discrimination based on disability. The U.S. has signed but not yetratified the Convention on the Rights of Persons with Disabilities (CRPD), aswell as the Convention on the Rights of the Child (CRC) and the InternationalCovenant on Economic, Social and Cultural Rights (ICESCR). The humanrights of patients are also delineated in the Universal Declaration onBioethics and Human Rights. In addition the US Americans with DisabilitiesAct (ADA) prohibits discrimination based on disability.International human rights law imposes a negative obligation on the a nation and also on all governmental officials to not to inflict torture,inhuman or degrading treatment or punishment on individuals. UnitedStates officials also have a positive obligation to take pro-active measures toprotect its citizens from ill-treatment – whether carried out by state officialsor private individuals or groups. The U.S.A. as a nation has a duty to takesteps to protect mental health patients from inhuman or degradingtreatment or any form of exploitation or abuse. So the U.S.A. should makesure that an effective investigation is carried out if inhuman or degradingtreatment, exploitation or abuse is alleged.The prohibition of torture and inhuman or degrading treatment orpunishment is absolute. The International Courts have emphasized that sucha fundamental right deserves no exceptions or limitations, nor anyderogations.
  2. 2. “All human beings are born free and equal in dignity and rights.” [Article 1 of the Universal Declaration of Human Rights (UDHR)]International human rights standards are delineated in the Principles for theProtection of Persons with Mental Illness and the Improvement of MentalHealth Care (MI Principles), which were adopted by the UN GeneralAssembly in 1991. All human rights are based on the basic principle ofdignity. “All persons with a mental illness, or who are being treated as such persons, shall be treated with humanity and respect for the inherent dignity of the human person.” [MI Principle 1(2)]Under the Convention on the Rights of Persons with Disabilities – GeneralPrinciples (CRPD Article 3) “(a) Respect for inherent dignity, individual autonomy including the freedom to make ones own choices, and independence of persons; (b) Non-discrimination; (c) Full and effective participation and inclusion in society; (d) Respect for difference and acceptance of persons with disabilities as part of human diversity and humanity; (e) Equality of opportunity; (f) Accessibility; (g) Equality between men and women; (h) Respect for the evolving capacities of children with disabilities and respect for the right of children with disabilities to preserve their identities.”Authorities are under an obligation to protect the health of persons deprivedof liberty. The position of inferiority and powerlessness which is typical ofpatients confined in psychiatric hospitals or under mental health care callsfor increased vigilance in reviewing whether accepted international humanrights standards have been complied with. Any invasion of a person’s bodyis an interference with private life. The Stroudsburg Court has said that“Mental health must also be regarded as a crucial part of private lifeassociated with the aspect of moral integrity”. (Bensaid v. United Kingdom,6 February 2001, paragraph 47).An essential part of the standard of care in medicine is the engaging in aninformed-consent process between a clinical doctor and a patient. TheNuremberg Code and the related Declaration of Helsinki are the basis for the
  3. 3. Code of Federal Regulations Title 45 Volume 46, which are the regulationsissued by the United States Department of Health and Human Servicesgoverning federally-funded research in the United States. In the UnitedStates governmental agencies which legally participate in humanexperimentation, like the Department of Health, Education and Welfare andits subsidiaries like the National Institute on Health (NIH) and the NationalInstitute on Drug Abuse (NIDA) must have legal policies and regulationswhich include standard "human consent forms" to be filled out byparticipants to acknowledge that they are participating in humanexperimentation, thus keeping the United States government in compliancewith the Nuremberg Code of International Law and other internationalhuman rights standards. Thus in clinical or research studies additionalinformed consent must be used to protect the human rights of the subjects.Informed consent is a requirement, not a courtesy. This is especially true ifthe human subject is going to undergo any evaluation, testing, treatment orprocedure that is not part of standard medical care. These standards ofinformed consent are applicable even when "no standard of treatment" fortheir condition is even available.The principle of Free, Prior and Informed Consent is an important humanright which has been addressed in many international and domestic laws andpractices. When treatment is initiated against the wishes of the patient andwithout informed consent then it must be determined that the treatmentitself does not constitute punishment and that the medical necessity hasbeen shown to convincingly exist. The lack of appropriate non-drug medicaltreatment of a person deprived of his/her liberty may amount to a humanrights violation under international human rights law. So in addition, inorder to validate the use of forced drugging, it also must be proven that atherapeutic means more acceptable to the patient and more in concert withthe wishes of the family is not applicable.Essentially, people have the right to make treatment decisions. Principle 19of the UN’s “Principles for the Protection of Persons with Mental Illness”mandates that: “Informed consent is consent obtained freely, without threats or improper inducements, after appropriate disclosure to the patient of adequate and understandable information in a form and language understood by the patient on: (a) The diagnostic assessment; (b) The purpose, method, likely duration and expected benefit of the proposed treatment; (c) Alternative modes of treatment, including those less intrusive; (d) Possible pain or discomfort, risks and side-effects of the proposed treatment.”
  4. 4. Many in the field of human rights believe that forced psychiatric treatmentcan be humiliating and degrading and leaves lifelong stigma and emotionaltrauma to the patient and can impact the patients’ life in a negative waypermanently. Thus when making medical decisions for the physical andmental health of patients who are entirely incapable of making decisions forthemselves, there still is an obligation under Convention Against Torture(CAT) - for freedom from torture, inhuman or degrading treatment orpunishment.It is crucial to recognize "the therapeutic value of antipsychotic medicationdepends upon the existence of a trusting relationship," (People v. Medina,705 P.2d at 970), and "if the patient is unwilling to accept it, the positiveeffects are greatly lessened." (Rennie v. Klein, 462 F. Supp. at 1141. Davisv. Hubbard, 506 F. Supp. at 936). In Canada patients with mentaldisabilities who have the mental capacity to make treatment decisions havea right to make those decisions, whether or not they are in hospital, andwhether or not they are subject to legal confinement. This has resulted inbetter outcomes and actually caused few practical problems inimplementation. Canadian medical professionals have indicated broadacceptance with these changes in policy because many believe thesechanges have caused medical practitioners to discuss treatment optionsmore closely with their patients, thus re-enforcing good medical practice.To give informed consent, the patient must receive information in a formand language he/she understands about: 1) His/her mental health, 2) thetreatment he/she will receive, 3) why he/she is receiving it and how long itwill take, 4) the expected benefit of the treatment, 5) other possibletreatments that might be suitable including less invasive (milder)treatments, and 6) possible pain and discomfort, risks and side effects of theproposed treatment. The patient must also have consented freely, that iswithout being threatened or wrongly talked into consenting.Some other human rights principles relevant to treatment are: 1) ThePrinciple of Least Intrusive Treatment [MI Principle 9(1)] states that patientsshould be treated with the least restrictive and intrusive treatmentappropriate in the circumstances. This means that patients should not begiven any form of treatment if a less invasive (milder) form of treatmentmight work just as well. 2) The Principle of Individualized Care Plans [MIPrinciple 9(2)] states that treatment and care should be based on a plan thatis designed only for the patient and in consultation with the patient. Thisplan should be reviewed regularly and changed as necessary to suit thepatient’s changing needs.
  5. 5. In addition it has been proven that chronic use of psychiatric medicationsshortens life expectancy by as much as 20 years in patients who have beendiagnosed early in life with mental illness and then given a lifelong treatmentwith psychiatric drugs. The US courts have recognized that psychotropicmedications are a "high-risk treatment" that "has potentially devastatingeffects." (In re Guardianship of Roe, 421 N.E.2d at 54) Thus "a personhas a constitutionally protected interest in being left free by the state todecide for himself whether to submit to the serious and potentially harmful... administration ,or antipsychotic drugs." [Rogers v. Olein, 634 F.2d 650,653 (1st Cir. 1980), vacated and remanded sub nom. Mills v. Rogers, 457U.S. 291 (1982).]Thus research has proven that psychiatric medications are not without riskof serious and life endangering effects and thus the Right to Life can also bea human rights concern.The Universal Declaration of Human Rights, adopted by the United NationsGeneral Assembly declared in Article 3 states: “Everyone has the right to life, liberty and security of person.”Convention on the Rights of Persons with Disabilities Article 10 Right to life -states: “States Parties reaffirm that every human being has the inherent right to life and shall take all necessary measures to ensure its effective enjoyment by persons with disabilities on an equal basis with others,”An automatic relationship between compulsory detention and compulsorytreatment is not consistent with human rights principles. There is nothingtheoretically inconsistent with confining someone in a psychiatric facility, butstill leaving them with the authority to decide treatment decisions. “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
  6. 6. strictly defined exceptional circumstances. “[The Committee for the Prevention of Torture (CPT) Standards, 2002, CPT/inf/E (2002) 1, para 41]Psychiatrists unfortunately have shown a consistent bias toward the use ofpsychotropic drugs to the exclusion of considering other options (counseling,group therapy, individual psychotherapy, or assignment to constructive,therapeutic activities). Psychologists who are expert in non-drug therapiesshould be consulted and alternative options considered. There must bethorough exploration of reasonable alternatives to forced drugging so as tonot abrogate a constitutional liberty interest.Thus I respectfully submit to you these legal concepts of internationalhuman rights for your consideration.Please feel free to contact me for further information if needed.Sincerely,Dr. Janet Parker DVMMedical WhistleblowerP.O. Box CLawrence, KS 66044For purposes of this communication I have used the followingdefinitions:Torture: Deliberate inhuman treatment causing very serious and cruelsuffering.Inhuman treatment or punishment: Intense physical or mental sufferingDegrading treatment or punishment: Treatment which arouses in thevictim feelings of fear, anguish and inferiority capable of humiliation anddebasement and possibly breaking physical or moral resistance.