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Medical Whistleblower Advocacy Network

Human Rights Defenders

“All human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood.”

 Universal Declaration of Human Rights

Article 1

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"Oppression in the extreme appears terrible: but oppression on more refined appearances remains oppression; and where the smallest degree of it is cherished it grows stronger and more extensive."

From ‘A plea for the poor’ John Woolman (Quaker) 1720-1772

 

Medical Whistleblower

Medical Whistleblower was founded by Dr. Janet Parker, a Veterinarian who reported Fraud, Abuse and Neglect in the Medical Community.   The organization is dedicated to advocacy and the emotional support of all Medical Whistleblowers regardless of their professional background or licensing status.  A Medical Whistleblower is a person who has come forward to report Medical Fraud, Abuse or Neglect to State, Federal or International governmental authorities.   Medical Whistleblower provides advocacy for all regardless of national origin, religious faith, color, disability, sex, sexual orientation, or age.   Anyone with access to information related to medical fraud, abuse and neglect can be a Medical Whistleblower.   Medical Whistleblower advocates for those who have already made that choice and those still considering their future path.  There is no cost to request support from Medical Whistleblower.  Medical Whistleblower is not a counseling service and does not provide legal advice or representation. We are an advocate for change and provide meaningful information related to the Medical Whistleblower’s experience and networking contacts for further support. 

"The test of a democracy is not the magnificence of buildings or the speed of automobiles or the efficiency of air transportation, but rather the care given to the welfare of all the people."

Helen Adams Keller

 

 

Who are Medical Whistleblowers? 

Medical Whistleblowers come from all walks of life and many professional disciplines. Medical Whistleblowers can be Doctors, Pharmacists, Researchers, Police Officers,  Federal Law Enforcement Agents, Nurses, Medical Technicians, Certified Public Accountants, Attorneys, Judges, Therapists, Prosecutors, Hospital CEO’s, Academic Medical Instructors, Veterans, Emergency Medical Technicians, and even Patients and their families.   Medical Whistleblowers are themselves human rights defenders of others.   Medical Whistleblowers risk their livelihoods when they dissent in the name of transparency and openness, and in return often lose their cherished right to privacy and suffer severe personal loss.

"It is dangerous to be right
when the government is wrong."

VOLTAIRE

Human Rights Issues Addressed by Medical Whistleblower Advocacy Network

 

Medical Whistleblower Advocacy Network does human rights advocacy, investigation and analysis regarding human rights violations in medical settings. Medical Whistleblower Advocacy Network is a stakeholder in the Universal Periodic Review Process and a reporter to the UN and to the US Department of State in that process.

 

Some of the issues that Medical Whistleblower Advocacy Network works on are for example:

  • Human rights related to clinical patients in health care settings 

  • Human rights of sexual assault and crime victims 

  • Disability Rights

  • Medical professionals as mandated reporters of child sexual abuse, domestic violence and human trafficking

  • Treatment of PTSD of crime victims and veterans

  • Patients who are victims of medical fraud 

  • Abuse and mistreatment of developmentally disabled

  • Pharmaceutical product mis-branding and deceptive "off-label" marketing

  • Abuse and mistreatment of psychiatric patients in institutions 

  • Guardianship abuse

  • Abuse and neglect of the elderly either in the community or in nursing homes

  • Treatment neglect, psychological and physical abuse of prisoners 


Medical Whistleblower Advocacy Network focuses on US citizens on US soil.


Who is a Human Rights Defender?


A human rights defender (HRD) was defined as  a person who acceptances the universality of human rights, are defined and accepted according to the rights they are defending and according to their own right to do so, and whose actions are peaceful. 

HRD is an individual who promotes and protects human rights.

Human rights defenders must accept the universality of human rights as defined in the Universal Declaration of Human Rights.

A person cannot deny some human rights and yet claim to be a human rights defender because he or she is an advocate for others. For example, it would not be acceptable to defend the human rights of men but to deny that women have equal rights.

Human rights defenders must be defined and accepted according to the rights they are defending and according to their own right to do so. Whether or not they are legally correct is not relevant in determining whether they are genuine human rights defenders. The key issue is whether or not their concerns fall within the scope of human rights. Peaceful action i. e actions taken by human rights defenders must be peaceful in order to comply with the Declaration on human rights defenders.

There is no academic or professional requirement to ‘become‘ an human rights defender.

Neither preaches nor supports violence

Exposes corruption of state actors

Reports and documents human rights violations. 

Doesn’t have personal and political agenda

Reports and document human rights violations

Support government in protection of victims and their families and raise voice for remedies for them

Does constructive criticism on government policies, plan and legislation

Respects GOOD laws and oppose bad laws

No particular academic qualification or degree is required for being HRD. Any individual who is lawyer, doctor, teacher, businessman and journalist who promote and protects human rights can be human rights defender.

Support government in making pro human rights policies, strategies and plans.

HRDs consciously take on risk through their work, thus human rights work might by its definition be about giving up some security. A silenced human rights worker, through kidnapping, jailing or intimidation, means a human rights worker not doing their work. Protecting human rights defenders doesn’t always mean protecting them against physical violence. “slander, smear campaigns, stigmatisation, etc are all serious threats to defenders.”

Pharmaceutical Transnational Corporations' Impact on the Health of Patients

10/8/2017  Pharmaceutical transnational corporations have a vast and growing impact on the lives and health of human patients worldwide. There is a critical need to  promote global compliance with a uniform human rights standard to help protect the rights of human subjects and patients.  This is critically important with regard to non-consensual experimentation, or treatment without informed consent with off-label medications.  These medications are sold worldwide. National regulatory lapses and lack of criminal enforcement against pharmaceutical companies, has resulted in an atmosphere of impunity for expansive deceptive marketing programs.  These promotional marketing efforts are designed to disseminate false information in an effort to boost sales to vulnerable patients. Off-label promotion of pharmaceutical drugs is a serious crime, because it undermines the national regulatory agency's role in protecting the public through determination of a drug's safety and effectiveness for a particular use prior to marketing.  Illegal marketing, promotion and misbranding activity increases patients’ costs, threatens their safety, and negatively affects the delivery of healthcare services to patients. 
 
When the company is facing regulatory actions or criminal sanctions, they often seek to market in another country the medication they can no longer effectively market at home. Pharmaceutical companies frequently repackage medications for a different condition than the one for which the drugs had been tested in clinical trials.  This expands the market for drugs that don’t bring in enough profits when marketed for a particular condition.  When they do this they often do not provide the human consumers of their products with accurate information about the medication's side effects and adverse effects,  Pharmaceutical companies are often deceptive about the drug's effectiveness for the condition for which it was sold.  (for example Eli Lilly's marketing of Strattera in China) 
 
It is wise to consider why the regulation of pharmaceutical products and their marketing is so crucial to the Right to Health.  A terrible international human rights tragedy was caused by the promotion and sale of the drug, Thalidomide. It was marketed worldwide with little regard to the research findings that the drug could cause severe birth defects in children born to women taking the drug. Thalidomide was synthesized in West Germany in 1954 by the pharmaceutical company Chemie Grünenthal.  It was marketed (available to patients) from October 1, 1957 (West Germany) into the early 1960's. Thalidomide was present in at least 46 countries under many different brand names.  Thalidomide was a morning sickness drug taken by pregnant women. It continued to be sold and assertively marketed to pregnant women, even after it was known by both research findings and clinical experience, that it caused congenital defects. Thalidomide, was promoted and marketed by the pharmaceutical company as a "wonder drug" that provided a "safe, sound sleep".  Thalidomide was a sedative that was found to be effective when given to pregnant women to combat many of the symptoms associated with morning sickness.
 
Thalidomide was a catastrophic drug with tragic side effects. Initially, it was not realized that thalidomide molecules could cross the placental wall affecting the fetus.  But when the first reports of birth defects became known to the pharmaceutical company, the evidence was suppressed and the company continued to market the drug because it was extremely profitable.  A percentage of the affected patients experience the effects of peripheral neuritis, a devastating and sometimes irreversible side effect.  But thalidomide became notorious as the killer and disabler of thousands of babies. When thalidomide was taken during pregnancy (particularly during a specific window of time in the first trimester), it caused startling birth malformations, and death to babies. Any part of the fetus that was in development at the time of ingestion could be affected.  For those babies who survived, birth defects included: deafness, blindness, disfigurement, cleft palate, many other internal disabilities, and of course the disabilities most associated with thalidomide: phocomelia.  Phocomelia is a condition that involves malformations of the arms and legs. The birth defect results in hands and feet that are attached to abbreviated arms and legs.
 
The number of thalidomide victims has never been adequately quantified, but it has been estimated that there were between ten and twenty thousand babies born disabled.  Within a few years of the widespread use of thalidomide in Europe, Australia, and Japan, approximately 10,000-20,000 children were born with phocomelia, leading to the ban of thalidomide in most countries in 1961.  There are approximately 5,000 survivors alive today, around the world.  The number of babies miscarried, or stillborn, let alone the number of family members and parents who have suffered over the years will never be known. (Suffer the Children: The Story of Thalidomide, by the Insight team of The Sunday Times of London, The Viking Press, New York)

Around the world, in the late 1960's and into the early 1970's, the victims of the drug thalidomide and their families entered into class action legal suits, or threatened actions, against the various drug companies who manufactured and/or distributed the drug, and they were eventually awarded settlements. In most countries, these settlements included monthly or annual payments based on the level of disability of the individual.  But in some countries, victims of the drug were often forced to face the human tragedy and the legal and medical costs alone, family by family. The victims of this human rights tragedy did not receive adequate redress for their injuries. Often cases never received a trial verdict.  Rather, many families were forced to settle out-of-court with gag orders imposed on them not to discuss the amounts of their settlements. This resulted in wide disparity in the compensation amounts, with settlements for individuals with the same levels of disability varying by hundreds of thousands of dollars. The victims faced the extraordinary medical costs because of their disabilities and now, decades later, any settlement money is long gone. Survivors of the thalidomide tragedy, who are now in their fifties and sixties, are experiencing physical deterioration due to stress placed on their different body structures, further limiting their abilities.  This often results in new disabilities, thus compounding this human rights tragedy. There are many unaddressed needs and overwhelming problems of these victims of a pharmaceutical company. The long term social and medical costs are extensive and borne by the affected individuals themselves, their families, their communities and their home nations.

In the U.S.A. during the 1950's it was legal for U.S. companies to promote drugs for any use.  After the public outcry concerning the thalidomide tragedy, the U.S. Congress banned the practice in 1962.  After 1962, pharmaceutical companies in the U.S.A. were required to prove to the Food and Drug Administration that their drugs were safe and effective for specific uses.  Before that, a drug company could market an approved medicine for any illness.
 
Thus, the regulatory legislation which legally prohibits the misbranding and deceptive marketing of pharmaceutical products is extremely important in order to prevent another worldwide medical disaster such as thalidomide tragedy.  Nations have the essential need to protect their citizens from off-label promotion and marketing and deceitful misbranding and false and misleading claims about pharmaceutical drugs.
 
Investor-State Dispute Settlement (ISDS) systems are designed to grant new rights to thousands of multinational corporations to bypass domestic courts and their existing constitutional and human rights protections. The ISDS system enables foreign companies to challenge public health, environmental and social protection laws that harm their profits. The rules of such settlement systems contain conflicts of interest that would be deemed unethical under most legal systems. In the ISDS provisions there is no obligatory code of conduct for arbitrators, to tackle the problem of conflicts of interest or human rights issues. The ISDS system does not provide adequate legal requirements for transparency and accountability for human rights protections and public policy protections for safety and effectiveness of medications. The decisions are not bound by legal precedents or the opinions of governments.  There is no outside appeal to their rulings, even when those rulings may impact the human rights of hundreds of thousands of patients. The ISDS system was designed to give multinational firms the ability to challenge new policies of governments, including social public policy designed to protect the right to health for patients. The investor-state dispute settlement clause, within free trade agreements, is intended to protect foreign investors from discrimination by governments. In practice, it means that companies will have the right to sue foreign governments if they don't like the local legislation. There is little transparency to the process as the cases are heard in private. The nations who face ISDS stand to lose millions of pounds, dollars and euros to private companies when a secret panel of arbitrators decides the national government legislation is not conducive to free trade. In such settlement systems, the safety regulations necessary to promote safe and effective medications are not considered more important than “trade agreement” rights.   In cases involving national social policies regarding the regulation of pharmaceutical products, availability of generic drugs, or the restrictions on the marketing of tobacco to children, full consideration of human rights issues is necessary to protect the human Right to Health. 
 
The protection of patent rights as it pertains to pharmaceutical drugs is the first step toward off-label marketing of that drug within another nation.  Often with the harmonization of pharmaceutical regulations between countries, a drug legally sold within one nation - like the U.S.A. - gets reciprocal regulatory acceptance and licensing in another country without additional regulatory hurdles prior to marketing.  These reciprocal licensing agreements thus open the door to off-label and misbranded products to be sold in the other country through free trade agreements, as soon as the patent is approved.  Drugs with little evidence of the effectiveness or safety, are thus sold off-label in other countries with less regulatory control over pharmaceutical products.  When faced with public outcry, regulatory control or criminal prosecutions at home, pharmaceutical companies seek to market their products more aggressively in countries with reciprocal licensing agreements and less regulatory control.   In developing countries monitoring is not sufficient to identify all the side-effects and adverse medical events of such medications.  Thus problems with the off-label medications may not be detected immediately and adequate medical response may not be available to affected patients. These same countries have less resources to deal with massive numbers of patients suffering from iatrogenic or medically caused chronic conditions. 

The financial resources of huge transnational pharmaceutical companies sometimes dwarf the resources of developing countries that will be facing them legally in an ISDS dispute.  Faced with the prospect of a long drawn out legal dispute and extensive legal costs, countries are pressured into settlements which are not subject to human rights considerations. The ISDS system allows pharmaceutical companies to sue foreign governments if they try to stop off-label promotion of drugs in their countries.  In ISDS proceedings to calculate corporate losses, pharmaceutical companies can utilize marketing profit data from misbranded off-label promotion and marketing in the USA.  This can occur even if those pharmaceutical companies are currently under investigation or prosecution for criminal misbranding and off-label promotion in the U.S.A.

For example, the U.S. pharmaceutical company Pfizer repeatedly criminally marketed drugs for things they knew they couldn’t demonstrate efficacy for.  In 2004, Pfizer agreed to pay $430 million in criminal fines and civil penalties, and assured U.S. prosecutors that Pfizer and its units would stop promoting drugs for unauthorized purposes. But Pfizer managers were off-label marketing in another Pfizer unit, Pharmacia & Upjohn.  In 2009,  Pharmacia & Upjohn, agreed to plead guilty to the same crime. This time, Pfizer executives had been instructing more than 100 salespeople to promote Bextra, a drug approved only for the relief of arthritis and menstrual discomfort, for treatment of acute pains of all kinds.  For this new felony, Pfizer paid the largest criminal fine in U.S. history: $1.19 billion. On the same day, it paid $1 billion to settle civil cases involving the off-label promotion of Bextra and three other drugs with the U.S. and 49 states.  The FDA found Bextra to be so dangerous that Pfizer took it off the market for all uses in 2005.

Across the U.S.A., pharmaceutical companies have been pleading guilty to criminal charges or paying penalties in civil cases when the U.S. Department of Justice finds that they deceptively marketed drugs for unapproved uses, putting millions of people at risk of kidney and liver failure, diabetes, chest infections, heart attacks, suicidal impulses or death. Doctors influenced by the direct to doctors pharmaceutical promotions, write more than 10 million such prescriptions each year.  This high volume of off-label prescribing is done in the absence of good scientific evidence to support the use of these drugs - especially antidepressants, antipsychotics, and anxiolytic-sedatives. About 15 percent of all drug sales in the U.S. are for unapproved uses without adequate evidence the medicines work. (Randall Stafford, a medical professor at Stanford University in Palo Alto, California.) 

Pharmaceutical companies view the $7 billion paid in penalties for misbranding and off-label promotional marketing criminal fines as just the cost of doing business.  Since May 2004, Pfizer, Eli Lilly & Co., Bristol-Myers Squibb Co. and four other drug companies have paid a total of $7 billion in fines and penalties. Six of the companies admitted in court that they marketed medicines for unapproved uses.  In  2007, Bristol-Myers paid $515 million — without admitting or denying wrongdoing — to federal and state governments in a civil lawsuit brought by the Justice Department. The six other companies pleaded guilty in criminal cases. In  2009, Eli Lilly, the largest U.S. psychiatric drug maker, pleaded guilty and paid $1.42 billion in fines and penalties to settle charges that it had for at least four years illegally marketed Zyprexa, a drug approved for the treatment of schizophrenia, as a remedy for dementia in elderly patients.  In five company-sponsored clinical trials, 31 people out of 1,184 participants died after taking the drug for dementia — twice the death rate for those taking a placebo.  These findings were reported in the Journal of the American Medical Association in October 2005. The Pfizer and Lilly cases involved the illegal promotion of drugs that have been shown to cause substantial harm and death to patients.

In 2013 Eli Lilly Corporation used the NAFTA Foreign Investor Privileges to attack Canada's patent policy and demanded $100 million for invalidation of a patent for Strattera.  Eli Lilly sued Canada for violating the North American Free Trade Agreement because Canadian courts had found patents for two of its drugs to be invalid under Canadian law. The Canadian court decisions, Lilly claimed, violated minimum standards of treatment guaranteed to foreign investors under NAFTA and expropriated Lilly’s investment in Strattera, used in the treatment of ADHD, and Zyprexa, used to treat mood conditions including bipolar disorder and depression.  Eli Lilly was demanding to market Strattera in Canada for off-label uses, because sales in the U.S.A. had dropped due to many reports of adverse medical events for individuals using the drug and lack of evidence that it was safe or effective for the purpose it was marketed.  Canada had demanded that Eli Lilly prove that the medication was actually useful (had utility). Eli Lilly claimed that the patent protections in other countries did not need to prove that the drug have utility, therefore Canada was interfering with their right to free trade.  Canada was trying to protect their citizens from the sale of a medication with a proven history of medical problems and no greater effectiveness over generic medications already in use in Canada.   By allowing investors to sue governments for damages, trade agreements with ISDS provisions may be elevating the rights of foreign investors over domestic sovereignty.

The Eli Lilly case centered around the “promise doctrine,” which has played a prominent role in Canadian patent law since 2005. Canada is the sole developed nation that requires applicants to demonstrate the “utility” of an invention at the time of application.  Under this doctrine, Canadian courts have reviewed patent specifications to determine whether the inventor had made an express promise concerning the invention’s utility at the time the patent application was made, and whether the patent data fulfilled that promise. Canadian regulators realized the threat of unregulated off-label promotion of Eli Lilly's products.   Canada had the scientific and legal means to counter the legal challenge, but many developing countries do not have the scientific medical patent expertise or legal resources to effectively protect their home country from such legal challenges presented outside their own nation's court system.  In the final decision, the NAFTA tribunal  refused to question Canadian judicial interpretations of domestic patent law and Eli Lilly lost the case. 

But the ISDS clauses have been rewritten and redefined in newer trade agreements to better protect the profit interests of transnational corporations and businesses, with little consideration of the human rights issues involved.  The Trans-Pacific Partnership (TPP) – a trade agreement which was under negotiation between the United States and ten Pacific Rim countries – planned to expand on the ISDS provisions that provide the basis for such challenges to countries’ patent policies.  
 

Historically pharmaceutical companies have shown little willingness to abide by human rights principles and have done human rights abuses especially in regards to the use of human subjects for non-consensual experimentation in pharmaceutical research.  These corporations actively promote deceptive marketing practices that impede the patient's right to the knowledge necessary to give informed consent prior to treatment. There is a huge disparity between the political power and financial power of transnational pharmaceutical corporations and the victims of their business related human rights abuses. Through the global reach of these corporations, the violations of human rights by such entities disproportionately affect marginalized and impoverished groups and exacerbate existing human rights concerns.  It is essential to find effective means of preventing and redressing human rights abuses related to transnational pharmaceutical corporations and of ensuring greater accountability and access to remedy for victims.  Much more remains to be done to prevent abuses in connection with activities by transnational pharmaceutical corporations and other medical business enterprises and to enable victims to have meaningful  access to remedy when abuses occurred.   

The Australian Government is opposed to signing up to international agreements that would restrict Australia’s capacity to govern in the public interest — including in areas such as public health or the environment, especially in the wake of a complaint by Philip Morris about Canada's requirements for health warnings on cigarette packets. Brazil continues to receive lots of foreign investment, despite its long-standing refusal to sign any treaty with an ISDS mechanism.  South Africa, Indonesia, India and Ecuador are  terminating or renegotiating their treaties with ISDS provisions. Venezuela and Bolivia have already done so. 

 

La Experimentación no Consensual y la Promoción [de Medicamentos] Sin Etiqueta y Marcados Erróneamente [Off Label and Misbranded]

 

Presentación al
 

Grupo de Trabajo Intergubernamental de Composición Abierta de las Naciones Unidas sobre las empresas transnacionales y otras empresas comerciales en el ámbito de los derechos humanos

8/30/17
 

El tratamiento [medico] no Consensual y la Promoción [de Medicamentos] Sin Etiqueta y Marcados Erróneamente [Off-label Promotion and Misbranding]
 

La Experimentación no Consensual y la Promoción [de Medicamentos] Sin Etiqueta y Marcados Erróneamente

[Off Label and Misbranded]


 


 

Prohibición de la Tortura o de la Experimentación no Consensual


 

Uno de los derechos más fundamentales, absolutos y no derogables es el derecho a no ser sometido a tortura ni a tratos o penas crueles, inhumanos o degradantes ni a la experimentación médica o científica. Toda persona tiene el derecho al libre, previo y fundamentado consentimiento para recibir tratamiento médico, incluidas las personas con discapacidad de salud mental. El derecho a no ser sometido a experimentación médica o científica sin su consentimiento libre es absoluto, no derogable, ius cogens e erga omnes.


 

La experimentación médica humana no consentida, que viola los derechos de la persona a la vida, la salud y la integridad personal, es universalmente condenada como una violación del derecho internacional consuetudinario y codificado.


 

 La administración involuntaria de los medicamentos sin etiquetas [misbranded, o de marca, pero no marcados o marcados erróneamente] viola el artículo 5 (2) de la Convención Americana y el artículo 7 del PIDCP, así como las normas éticas establecidas por el Código de Nuremberg y la Declaración de Helsinki.
 

Los Estados Unidos y la Ley de Tratados
 

El derecho a no ser sometido a tortura ni a tratos o penas crueles, inhumanos o degradantes ni a la experimentación médica o científica es un principio de derechos humanos que tiene el carácter de jus cogens y, por lo tanto, está intrínsecamente enraizado en la enmienda o derogación del tratado.
 

El artículo 53 de la Convención de Viena sobre el Derecho de los Tratados (firmada en Viena el 23 de mayo de 1969), establece que “A los efectos de la presente Convención, una norma imperativa de derecho internacional general es una norma aceptada y reconocida por la comunidad internacional de los Estados en su conjunto como una norma a partir de la cual no se permite una excepción y que sólo puede modificarse mediante una norma ulterior de derecho internacional general que tenga el mismo carácter.”


Los Estados Unidos han firmado y ratificado el Pacto Internacional de Derechos Civiles y Políticos (PIDCP) y la Convención contra la Tortura y Otros Tratos o Penas Crueles, Inhumanos o Degradantes (Convención de las Naciones Unidas contra la Tortura). Ambos tratados delinean la prohibición de la tortura. El PIDCP especifica específicamente la experimentación no consensual dentro del Artículo 7 del PIDCP.


 

Nadie será sometido a torturas ni a penas o tratos crueles, inhumanos o degradantes. En particular, nadie será sometido sin su libre consentimiento a experimentos médicos o científicos.”


 

Art. 2 del PIDCP establece que "cada Estado Parte [...] se compromete a respetar y garantizar a todos los individuos que se encuentren en su territorio y estén sujetos a su jurisdicción los derechos reconocidos en el presente Pacto .... '


 

El PIDCP no contiene ninguna disposición sobre la terminación o el retiro, y el Comité de Derechos Humanos en la Observación General 26 de 1997 declaró que no había tal intención para que un Estado no pudiera retirarse de ella.


 

Por último, el artículo 103 de la Carta de las Naciones Unidas establece que “en caso de conflicto entre las obligaciones de los Miembros de las Naciones Unidas en virtud de la presente Carta y sus obligaciones en virtud de cualquier otro acuerdo internacional, prevalecer”.


 

El tratado PIDCP debe interpretarse de buena fe y con interpretación liberal para proteger los derechos humanos de las personas vulnerables. El canon de buena fe estipula que los tratados "deben ser mantenidos en la más escrupulosa buena fe", y que un tratado "debe ser interpretado... en una manera de llevar a cabo su propósito manifiesto.”

Si un tratado como el Pacto Internacional de Derechos Civiles y Políticos (PIDCP) tiene el carácter de ley federal suprema y crea o protege derechos individuales, entonces un individuo cuyos derechos, objeto del tratado, han sido violados tiene derecho a un recurso interno judicial. La Cláusula de Supremacía complementa los mecanismos de derecho internacional para hacer cumplir los tratados agregando mecanismos internos. La Cláusula de Supremacía hace que los tratados sean asimilados a los estatutos federales ya la Constitución (ordenamiento jurídico nacional), evitando así las diferencias en los mecanismos de aplicación que de otro modo existirían entre estas formas de derecho. Entre otras cosas, la Cláusula de Supremacía hace que los tratados sean ejecutados en las Cortes de Justicia a pedido de los individuos. Debido a que se refiere a "Jueces", la Cláusula de Supremacía claramente contempla que las Cortes de Justicia harán cumplir los tratados y, de hecho, "la jurisdicción de la Corte de Justicia es, únicamente, decidir sobre los derechos de los individuos.”


 

En el caso de Foster v. Neilson,Anchor el Jefe de Justicia Marshall reconoció que nuestra Constitución, específicamente la Cláusula de Supremacía, establece la regla general de que los tratados son ejecutables en las Cortes de Justicia de los Estados Unidos, al igual que la Constitución y los estatutos federales.


 

Propósitos y Objetivos del Congreso de los Estados Unidos sobre Derechos Humanos


 

Los Tratados Internacionales de Derechos Humanos firmados y ratificados por los Estados Unidos son claramente una declaración de los propósitos y objetivos del Congreso estadounidense en materia de derechos humanos.


 

Por lo tanto, una interpretación de las obligaciones de los Estados Unidos bajo el Pacto Internacional de Derechos Civiles y Políticos (PIDCP), junto con las normas éticas y legales de la Constitución de los Estados Unidos y la Declaración de Derechos de los Estados Unidos, persona natural y ciudadana de los Estados Unidos, tiene el derecho de presentar esta petición a la Comisión Interamericana de Derechos Humanos en apoyo de sus derechos humanos, tal como se definen en el derecho internacional de los derechos humanos y en las normas consuetudinarias de derechos humanos.


 

Algunos derechos, como el derecho a no ser sometido a torturas y no estar sujeto a la experimentación no consensual, son inderogables y, como tales, no pueden ser suspendidos incluso en tiempos de emergencia nacional. Los derechos humanos, como la prohibición de los crímenes contra la humanidad, la tortura y la experimentación científica o médica no consensual se consideran absolutos. Existen deberes erga omnes implícitos para que los Estados Unidos prohíban la experimentación y la tortura no consensuales.


 

El principio de la prohibición de la experimentación no consensual es fundamentalmente normativo y la práctica generalizada de proteger a los seres humanos se considera legal o moralmente obligatoria - Opinio Iuris.


 

El Congreso de los Estados Unidos ha indicado claramente mediante la ratificación del Pacto Internacional de Derechos Civiles y Políticos (artículo 7) que el propósito y la intención del Congreso es proteger a las personas de la experimentación no consensual.


 

El Congreso de los Estados Unidos también ha implementado el artículo 7 del PIDCP en la legislación nacional para proteger a los seres humanos de la experimentación no consensual - La Regla Común (45 CFR Part 46). El Congreso de los Estados Unidos ha hecho su intención claramente evidente por lo siguiente: 1) la ratificación del Pacto Internacional de Derechos Civiles y Políticos (incluido el artículo 7), 2) la celebración de amplias discusiones sobre la necesidad ética de la protección de los seres humanos, 3) la publicación del Informe Belmont y 4) codificación de la Regla Común.


 

La Regla Común (45 CFR Parte 46) es la legislación federal redactada y entró en vigor bajo los procedimientos constitucionales apropiados y por lo tanto es ejecutables por la Corte.


 

Al legislar La Regla Común a través de un proceso político minucioso y detallado, el gobierno federal de los Estados Unidos ha expresado la voluntad política del pueblo de proteger y defender los derechos de las personas contra la experimentación no consensual.


 

Legislación Nacional


 

El 12 de julio de 1974, se promulgó la Ley Nacional de Investigación de los Estados Unidos (L. 93-348), mediante la creación de la Comisión Nacional para la Protección de los Sujetos Humanos de la Investigación Biomédica y del Comportamiento. Uno de los cargos a la Comisión fue identificar los principios éticos básicos que deberían ser la base de la investigación biomédica y conductual en seres humanos y elaborar directrices que deben seguirse para asegurar que dicha investigación se lleve a cabo de conformidad con esos principios. Al llevar a cabo lo anterior, se solicitó a la Comisión que considerara: (I) los límites entre la investigación biomédica y conductual y la práctica aceptada y rutinaria de la medicina, (ii) el papel de la evaluación de los criterios riesgo-beneficio en la determinación de la idoneidad de la investigación en seres humanos, (iii) directrices apropiadas para la selección de sujetos humanos para participar en dicha investigación y (iv) la naturaleza y la definición del consentimiento informado en diversos contextos de investigación.


 

El Informe Belmont (1976)Anchor Es una declaración formal del gobierno de los Estados Unidos sobre los estándares éticos y las normas legales aceptadas con respecto al uso de sujetos humanos en la experimentación médica, conductual o científica. El Informe Belmont resume los principios éticos básicos identificados en cuatro días de deliberaciones complementados por las deliberaciones mensuales celebradas durante un período de casi cuatro años. Es una declaración de los principios éticos básicos y las pautas a considerar en el uso de sujetos humanos en la investigación. Se publicó en el Registro Federal para que pudiera convertirse en guía ética para los investigadores, científicos, empleados gubernamentales y Juntas de Revisión Institucional (IRB, por su sigla en inglés).


 

El Informe Belmont identifica tres principios éticos básicos que son particularmente relevantes para la ética de la investigación en seres humanos: los principios de respeto a las personas, la beneficencia y la justicia.


 

Investigación vs Práctica Médica


 

La práctica médica tiene por objeto mejorar el bienestar de un paciente o cliente individual y se espera que tenga una expectativa razonable de éxito. El propósito de la práctica médica, psicológica o psiquiátrica es proporcionar diagnóstico, tratamiento preventivo o terapia a individuos. Dentro de la práctica médica clínica, los médicos son éticamente obligados a obtener libre consentimiento informado previo para cualquier tratamiento.


 

El consentimiento libre, informado y previo para el tratamiento es especialmente importante cuando un clínico se aparta de manera significativa de la práctica estándar o aceptada, o utiliza un medicamento que la FDA no ha aprobado para ese uso. Aunque los profesionales médicos pueden utilizar un medicamento "experimental" (en el sentido de ser nuevo, no probado o diferente), esto no exime al médico de revelar al paciente los posibles riesgos y beneficios del tratamiento y obtener el consentimiento libre, informado y previo. Fracaso en obtener el consentimiento libre, previo e informado adecuado y legal se considera negligencia médica.


 

El proceso de obtención del consentimiento debe comprender tres elementos: información, comprensión y voluntariedad. El consentimiento obtenido por engaño, desinformación o coerción no es legalmente válido. La información suministrada en inglés a un paciente cuyo único idioma es el español no cumple con el aspecto de comprensión del consentimiento informado. Proporcionar información sólo en una terminología científica muy detallada que no es entendida por el laico, tampoco está cumpliendo con el aspecto de comprensión del consentimiento informado. Sin el consentimiento fundamentado, previo y libre, el tratamiento experimental sobre seres humanos está prohibido por la ley de los Estados Unidos. Los medicamentos radicalmente nuevos deben ser objeto de investigación formal en una etapa temprana a fin de determinar si son seguros y eficaces. Por lo tanto, es responsabilidad de los comités de práctica médica exigir que se apliquen los principios éticos del Informe Belmont y se protejan los derechos humanos de los pacientes.


 

Los Estados Unidos han aceptado como norma ética la prohibición de la experimentación científica o médica no consensuada mediante la promulgación de leyes federales que prohíben expresamente tales prácticas – La Regla Común - "La Política Federal para la Protección de los Sujetos Humanos". La Regla Común (45 CFR Part 46) fue adoptada en 1991.


 

La FDA, Promoción [de Medicamentos] Sin Etiqueta y Marcados Erróneamente [Off Label and Misbranded]


 

En los Estados Unidos, los nuevos medicamentos se prueban en ensayos clínicos (estudios de investigación) antes de que sean aprobados por la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) para su uso en el público en general.


 

Los ensayos clínicos se realizan para demostrar que el fármaco [droga o medicamento]:

  • Trabaja para tratar una cierta condición médica

  • Funciona como se espera

  • Es seguro cuando se usa según las indicaciones


 

Cuando la FDA está satisfecha de que el fármaco funciona y es seguro, y el fabricante del fármaco crea la etiqueta del fármaco. Esto no es una etiqueta real que se pega a una botella, sino un informe de información muy específica sobre el medicamento. La FDA debe aprobar este informe, que se pone a disposición de todos los profesionales de la salud que prescriben o venden el medicamento. La etiqueta del fármaco proporciona información sobre el medicamento, incluyendo la condición médica específica para la que ha sido aprobado (llamada la(s) indicación(es) de uso), las dosis que se utilizarán y cómo se administrará. Cuando se usa un fármaco de una manera diferente a la descrita en la etiqueta de fármaco aprobada por la FDA, se dice que es un uso "fuera de etiqueta" [off label use].


 

Esto puede significar que el medicamento es:

  • Utilizado para una enfermedad o condición médica diferente

  • Dado de una manera diferente (como por una ruta diferente)

  • Dado en una dosis diferente que en la etiqueta aprobada


 

El uso fuera de la etiqueta de medicamentos aprobados por la FDA [off label use] no está regulado, pero es legal en Estados Unidos y muchos otros países. Aunque es legal que los médicos usen drogas fuera de etiqueta [off label use], no es legal que las compañías farmacéuticas comercialicen (anuncien o promuevan) sus medicamentos para usos fuera de la etiqueta [off label use]. El marketing fuera de la etiqueta [off label marketing] es muy diferente del uso fuera de la etiqueta [off label use]. Algunos de los problemas del uso de drogas fuera de la etiqueta [off label drug use] es que a menudo no refleja el tratamiento de "estándar de atención". Esto podría causar que un paciente tenga un resultado no deseado o malo del tratamiento. La FDA no regula la práctica de la medicina. En general, una vez que la FDA aprueba un medicamento, los médicos licenciados pueden usarlo para cualquier propósito que consideren médicamente apropiado.


 

Uno de los mayores problemas relacionados con el uso generalizado fuera de la etiqueta [off label use] es la falta de información sobre cómo utilizar mejor la droga que no sea por lo que fue aprobado. La etiqueta del medicamento contiene la información que ha sido aprobada por la FDA, y no cubre los usos fuera de la etiqueta. La falta de información sobre el uso de drogas fuera de la etiqueta y los resultados pone a los pacientes en un mayor riesgo de errores de medicación, efectos secundarios y reacciones no deseadas. Para el uso médico apropiado de un medicamento no etiquetado, el médico debe informar adecuadamente al paciente sobre los posibles riesgos de usar el medicamento y sopesarlos en contra de los posibles beneficios. Cuando una Corte de Justica decide que un paciente deberá recibir tratamiento médico con medicamento sin etiqueta [off label drug], el proceso de obtención del consentimiento previo, libre e informado no ocurre. La promoción de medicamentos de prescripción sin etiqueta [misbranded] es muy común en la población vulnerable de las personas que estan bajo la protección de la Corte de Justicia debido al bajo riesgo de detección y bajo riesgo de responsabilidad por negligencia médica.Anchor


 

La promoción de medicamentos sin etiqueta [off label] puede implicar lo siguiente: 1) Pagar incentivos a representantes de ventas basados ​​en ventas para uso fuera de la etiqueta [off label use];Anchor 2) Pagar sobornos [kickbacks] a los médicos para recetar medicamentos para uso fuera de la etiqueta [off label use];Anchor 3) Difundir carteles engañosos promoviendo el uso fuera de la etiqueta [off label use];Anchor 4) Pagar médicos: (a) Pretender ser los autores de artículos sobre usos fuera de la etiqueta [off label uses] cuando los artículos fueron realmente escritos por agentes de los fabricantes; (b) Servir como miembros de "consejos consultivos" que promueven el uso fuera de la etiqueta [off label use]; (c) Viajar a lugares turísticos para escuchar promociones sobre el uso fuera de la etiqueta [off label use]; o (d) Dar conferencias promocionales en favor del uso fuera de la etiqueta [off label use] a compañeros practicantes.Anchor 5) Proporcionar asesoramiento a los prescriptores sobre cómo codificar sus reclamos y documentar sus registros médicos para apoyar el pago de usos fuera de la etiqueta [off label uses] no cubiertos por Medicaid;Anchor 6) Publicación de estudios que demuestren la eficacia de los usos fuera de la etiqueta [off label uses] mientras suprimen los estudios que no muestran eficacia ;Anchor and 7) Hacer representaciones falsas directamente a Medicaid para influir en las decisiones sobre el pago de medicamentos usados ​​fuera de la etiqueta [off label use].Anchor


 

Derecho a la Salud y a la Libertad de Información


 

En 2009, el Relator Especial sobre el derecho a la salud enfatizó que el derecho a la salud depende del derecho al acceso a la información. El Relator Especial declaró que el consentimiento informado es una "decisión voluntaria y suficientemente informada, que protege el derecho del paciente a participar en la toma de decisiones médicas y asigna deberes y obligaciones asociados a los proveedores de atención médica". La información es un elemento integral del derecho a la salud. La integridad de la información se encuentra entre los componentes necesarios del consentimiento informado.


 

Para obtener el consentimiento fundamentado previo se requiere la divulgación de los beneficios, riesgos y alternativas asociados a un procedimiento médico. La exactitud e integridad de la información es necesaria para el consentimiento informado válido para el tratamiento médico. Sin información científica verídica acerca de los beneficios asociados, los riesgos y alternativas a un procedimiento médico o tratamiento es necesario para que el consentimiento sea válido. La garantía del consentimiento informado es respetar la autonomía, la autodeterminación y la dignidad humana de los individuos. Constituye una violación del derecho del paciente a la salud a actuar, o no actuar, de tal manera que priva al paciente de la información que necesita para proporcionar su consentimiento informado.


 

Además, la retención de los hechos presentados en la evaluación de salud mental que se utilizó para certificar al Peticionario como incapacitado legalmente es también una violación del Artículo 13 de la Convención Americana. Sin los hechos es imposible montar una defensa legal para el paciente. La Comisión Interamericana de Derechos Humanos ha establecido el principio de que "toda persona tiene derecho a acceder a la información sobre sí mismo". Los Estados en el contexto de la Convención Americana deben garantizar el ejercicio de este derecho. La Corte Interamericana de Derechos Humanos estipuló el derecho a "buscar" y "recibir" "información", de conformidad con el Artículo 13 de la Convención, protege el derecho de todas las personas a solicitar acceso a información mantenida por el Estado. Esto incluye el derecho del individuo a recibir dicha información y la obligación positiva del Estado de proporcionarla.


 

En el caso emblemático de Claude-Reyes et al vs. Chile, [el derecho a] la libertad de pensamiento y expresión también está protegido por los Artículos IV de la Declaración Americana y 13 de la Convención Americana.


 

La Convención de las Naciones Unidas sobre los Derechos de las Personas con Discapacidad fue adoptada para promover, proteger y garantizar el pleno goce de los derechos humanos y las libertades fundamentales de todas las personas con discapacidad y promover el respeto de su dignidad inherente. Las Partes en la CDPD deben velar por que las personas con discapacidad puedan ejercer el derecho a la libertad de expresión e incluya "la libertad de buscar, recibir e impartir información e ideas en igualdad de condiciones con los demás y mediante todas las formas de comunicación de su elección."


 

El acceso a información médica científica verídica es esencial para el consentimiento informado del paciente. El acceso irrestricto a la información médica es necesario en la lucha contra la corrupción farmacéutica y el fraude médico, e impacta la salud pública. Alentando y creando un sistema más transparente para la distribución de información médica al público y exigiendo responsabilidad criminal por los esfuerzos engañosos de promoción de etiquetas por parte de la industria farmacéutica, los Estados Unidos podrían comenzar a eliminar la corrupción en la comercialización farmacéutica y los sistemas de salud.


 

En 1990, la Organización Panamericana de la Salud (OPS/OMS), la Oficina Regional de las Américas de la Organización Mundial de la Salud (OMS) y un organismo especializado de la Organización de los Estados Americanos (OEA), patrocinaron la Conferencia Regional sobre Reestructuración de la Atención Psiquiátrica en América Latina América, con la CIDH como copatrocinador. En esa conferencia se aprobó la Declaración de Caracas. La Declaración de Caracas establece normas sobre la protección de los derechos humanos y la salud mental. En cuanto a la atención psiquiátrica, indica que "los recursos, la atención y el tratamiento que se ponen a disposición deben salvaguardar la dignidad personal y los derechos humanos y civiles ... y esforzarse por asegurar que los pacientes permanezcan en sus comunidades". También recomienda que los países reformulen la legislación nacional para garantizar que se protejan los "derechos humanos y civiles de los pacientes mentales".


 

En abril de 1999, la Comisión Interamericana de Derechos Humanos aprobó el Informe N.º 63/99 en el caso de una persona con trastorno mental. Ese informe concluye que es "pertinente aplicar normas especiales para determinar si se han cumplido las disposiciones de la Convención en casos de personas que sufren de enfermedades mentales" o los detenidos en hospitales psiquiátricos que se consideran un grupo particularmente vulnerable. En ese informe, la CIDH interpretó las normas de la Convención Americana que prevén el derecho a la integridad física, el derecho a la vida y el derecho a la protección judicial a la luz de los Principios de Salud Mental. En ese informe, la CIDH interpretó las normas de la Convención Americana que prevén el derecho a la integridad física, el derecho a la vida y el derecho a la protección judicial a la luz de los Principios de Salud Mental. En ese informe, la CIDH también estuvo de acuerdo con la posición del Tribunal Europeo de Derechos Humanos, que ha establecido que el estado de salud de una víctima es un factor importante para determinar si han sido sometidos a castigos o tratos inhumanos o degradantes y por lo tanto concluyó que el encarcelamiento de una persona con discapacidad mental en condiciones deplorables y sin tratamiento médico puede considerarse como trato inhumano o degradante, prohibido por el artículo 5 (2) de la Convención Americana sobre Derechos Humanos.

AnchorAnchor

Marcas Erróneas Criminales y Promoción Fuera de Etiqueta [Off Label Marketing]


Las compañías farmacéuticas tienen una extensa historia criminosa de promoción sin etiqueta [off label marketing] de sus medicamentos psiquiátricos. La comercialización fuera de la etiqueta de medicamentos [off label marketing] es la promoción de estos fármacos para usos que nunca han sido aprobados por la Administración de Alimentos y Medicamentos [Food and Drug Administration - FDA] y para los que no se ha demostrado que sean seguros o eficaces. El uso fuera de la etiqueta [off label use] de estos medicamentos aumentó en los adolescentes, debido a un esfuerzo organizado por la industria farmacéutica para aumentar proactivamente el diagnóstico de la depresión en los adolescentes. Una manera de hacer esto fue a través del programa “Selección de Adolescentes” ["Teen Screen"] hecho a través del sistema de escuelas públicas.


 

El público no se dio cuenta de que estos usos fuera de etiqueta [off label uses] nunca habían sido aprobados por la FDA. La financiación de la investigación farmacéutica es una parte importante del plano de cuentas de las instalaciones de salud mental. Los pacientes están, sin su consentimiento informado previo, inscritos en ensayos clínicos experimentales financiados y controlados por las compañías farmacéuticas. Los médicos no pasan por los pasos necesarios para proteger los derechos del paciente para sujetos humanos en experimentación médica como se requiere en la Regla Común. A menudo, los pacientes no están informados del uso experimental del medicamento. Esto sigue siendo una práctica común en hospitales psiquiátricos y clínicas de salud mental donde hacen intervenciones de salud mental de emergencia. Incluso en la práctica privada, los profesionales de la salud mental no obtienen el consentimiento previo informado del paciente antes de inscribir al paciente en una experimentación clínica poco supervisada con medicamento sin etiqueta [off label clinical use]. Los pacientes no se dan cuenta de que estos medicamentos no habían demostrado ser seguros o eficaces y el uso de estos productos fue esencialmente el uso experimental clínico del producto por sus médicos personales.


 

Las compañías farmacéuticas están siendo penalmente condenadas por el Departamento de Justicia de los Estados Unidos de tergiversaciones flagrantes de la seguridad y la eficacia de sus fármacos y la identificación errónea de su producto [misbranding]. La FDA puede perseguir criminalmente los casos de identificación errónea de medicamentos [misbranding], y las consecuencias pueden ser graves, especialmente cuando la FDA cree que la violación fue cometida con la intención de defraudar o engañar.


 

El Derecho Federal en los Estados Unidos [codificado en el] 21 USC § 331 deja en claro que la ley federal prohíbe "la introducción o entrega para la introducción en el comercio Inter estadual de cualquier alimento, droga, dispositivo, producto de tabaco o cosmético adulterado o sin etiqueta [misbranded]" y "la adulteración o marcación errónea [misbranding] de cualquier alimento, droga, dispositivo, producto de tabaco o cosmético en el comercio interestatal ". Además, [la norma legal codificada en el] 21 USC § 352 (f) estipula que un medicamento se considerará sin etiqueta [misbranded] a menos que su etiquetamiento contenga instrucciones adecuadas para el uso, lo cual típicamente requiere las instrucciones para permitir que un laico use el fármaco con seguridad y para los propósitos para los cuales estaba destinado.


 

En un caso reciente datado de 2012, por ejemplo, Abbott Laboratories Inc. se declaró culpable y acordó pagar 1.500 millones de dólares para resolver su responsabilidad penal y civil por su promoción fuera de etiqueta [off label promotion] [del medicamento conocido como] Depakote. Abbott promovió Depakote para controlar comportamientos en pacientes mayores, con demencia y esquizofrenia, sin evidencia significativa de su efectividad para ese uso, e incluso después de que los datos clínicos establecieran que no era eficaz. La resolución incluye una multa penal y confiscación por un total de 700 millones de dólares y acuerdos civiles con el gobierno federal y los estados por un total de 800 millones de dólares. El CEO y la Junta Directiva de Abbott estan sujetos a la libertad condicionada y las actividades de Abbott están bajo la supervisión por la Corte de Justicia.


 

Separado del arreglo del DOJ, Abbott acordó pagar a 45 estados un total de $ 100 millones para resolver la responsabilidad bajo las leyes estaduales de protección del consumidor. Eso hace que este sea el segundo fraude más importante en una compañía farmacéutica, detrás de los 2.300 millones de dólares de Pfizer en 2010.


 

La empresa mantuvo una fuerza de ventas especializada para comercializar Depakote con fines no autorizados [off label purposes]; concentrándose en los pacientes de demencia ancianos en casas de reposo [hogares de ancianos]. Abbott se ha declarado culpable de marcar erróneamente [misbranding] a Depakote promoviendo el fármaco para controlar la agitación y la agresión en ancianos pacientes de demencia y para tratar la esquizofrenia cuando ninguno de estos usos estaba aprobado por la FDA. La FDA aprobó Depakote para sólo tres usos: convulsiones epilépticas, manía bipolar y la prevención de las migrañas. La FDA nunca aprobó el fármaco como seguro y eficaz para el uso fuera de la etiqueta [off label use] para controlar las alteraciones del comportamiento en pacientes con demencia.


 

En 1999, Abbott se vio obligado a interrumpir un ensayo clínico de Depakote en el tratamiento de la demencia debido a una mayor incidencia de eventos adversos, incluyendo somnolencia (somnolencia), deshidratación y anorexia (pérdida de apetito) experimentada por los participantes del estudio ancianos tratados con Depakote.


 

La promoción sin etiqueta [off-label marketing], del medicamento Depakote, por Abbott, fue multifacética. Abbott formó a su fuerza de ventas para promover Depakote a los proveedores de atención médica ya los empleados de hogares de ancianos como ventaja sobre los fármacos antipsicóticos para controlar la agitación y la agresión en pacientes ancianos de demencia debido a que Depakote no estaba sujeto a ciertas disposiciones de la Ley Omnibus de Reconciliación Presupuestaria de 1987 [the Omnibus Budget Reconciliation Act of 1987 (OBRA)]. Los reglamentos de implementación de la OBRA fueron diseñados para prevenir el uso de medicamentos innecesarios en hogares de ancianos [casas de reposo]. Aprovechando el hecho de que ciertas disposiciones de la OBRA aún no se aplicaban a Depakote, los representantes de ventas de Abbott declararon que al usar Depakote, las residencias podrían evitar las cargas administrativas y los costos de cumplir con OBRA.


 

La compañía firmó contratos que proporcionaban a los proveedores de farmacias de cuidado a largo plazo pagos de descuentos basados ​​en aumentos en el uso de Depakote en hogares de ancianos atendidos por los proveedores. La compañía terminó dando millones de dólares en descuentos a los farmacéuticos en las instalaciones de cuidado a largo plazo que se basaron en aumentos en el uso de la droga en los hogares de ancianos atendidos. Abbott creó programas y materiales para capacitar a los farmacéuticos consultores de los proveedores de farmacias sobre el uso no autorizado [off label use] de Depakote para alentarlos a recomendar el medicamento para este uso no aprobado. Abbott no sólo participó en la promoción fuera de la etiqueta [off label marketing], sino que se dirigió a los pacientes ancianos de demencia y minimizó los riesgos aparentes de sus propios estudios clínicos, poniendo las ganancias por delante de la seguridad del paciente. Abbott ofreció y pagó una remuneración ilegal a los profesionales de la salud ya los proveedores de farmacias de atención a largo plazo para influir indebidamente en el contenido de los programas de Educación Médica Continúa patrocinados por la compañía, en violación del Estatuto Federal Anti-Soborno [the Federal Anti-Kickback Statute].


 

En la declaración de hechos acordada, Abbott también admitió que desde 2001 hasta el 2006, la compañía comercializó la droga Depakote, sin etiqueta [off label], para tratar la esquizofrenia. Abbott financió dos estudios científicos sobre el uso de Depakote para tratar la esquizofrenia y ambos fracasaron en cumplir con los objetivos principales establecidos para el estudio. Cuando el segundo estudio no mostró una diferencia de tratamiento estadísticamente significativa entre los fármacos antipsicóticos usados ​​en combinación con Depakote y fármacos antipsicóticos solos, Abbott esperó casi dos años para notificar a su propia fuerza de ventas sobre los resultados del estudio y otros dos años para publicar esos resultados. Durante este tiempo, Abbott continuó promoviendo la utilización sin etiqueta de la droga Depakote [off-label use] para el tratamiento de la esquizofrenia.



En otro caso penal, Pfizer pagó $ 1.300 millones en multas criminales por [practicar el] "misbranding” (el término legal para la comercialización fuera de la etiqueta [off label]) de drogas. Y eso fue sólo la punta del iceberg, considerando que el paquete total del asentamiento fue de $ 2.3 mil millones al agregar los honorarios y costos del Departamento de Justicia (DOJ) [del Gobierno Federal de los Estados Unidos]. La multa fue tan alta porque Pfizer fue considerado un "delincuente reincidente" después de que siguió promoviendo Lipitor y Viagra para usos fuera de la etiqueta [off label use] después de una solicitud de cesar y desistir estas prácticas por la FDA.


 

Grandes multas criminales de miles de millones de dólares fueron otorgadas por las Cortes de Justicia, pero esto hizo poco para restringir efectivamente la comercialización directa de estos medicamentos para uso fuera de etiqueta [off label use] de los productos farmacéuticos a los consumidores ya los profesionales médicos. Los fabricantes de drogas consideran que las sanciones monetarias son sólo otro costo de hacer negocios. Por lo tanto, las compañías farmacéuticas siguen recaudando enormes sumas de beneficio de los presuntos actos ilegales e incluso después de las condenas penales. Los pacientes no son retirados de estos medicamentos peligrosos. En su lugar, Medicaid y Medicare continúan pagando estos medicamentos fuera de la etiqueta [off label drugs] para el tratamiento de las personal bajo la protección de la Corte de Justicia (incluso después de la persecución penal). Los jueces que dirigen las Cortes de Salud Mental no son advertidos por el Departamento de Justicia que los medicamentos que están forzando las personas bajo la protección de la Corte a tomar han demostrado ser peligrosos para los pacientes y la compañía farmacéutica condenados penalmente.


 

Debido a que las sanciones por sentencia y resolución resultaron ser un impedimento ineficaz de estas prácticas, la FDA y el DOJ comenzaron a encontrar otras formas de tratar de detener a los fabricantes de actividades ilegales en curso. Las agencias federales han comenzado a emplear dos nuevas estrategias: 1) presentar cargos criminales contra ejecutivos rebeldes y 2) impedir que los fabricantes ofensores hagan negocios con o para los varios y múltiples planes de beneficios de prescripción federal (por ejemplo, Medicare, Medicaid) . El gobierno federal de Estados Unidos es el mayor comprador único de drogas en el mundo.


 

La participación del sistema judicial para hacer cumplir estos nuevos medios de disuasión es absolutamente crucial. Por lo tanto, los jueces de familia e sucesiones deben hacer valer el derecho del paciente al consentimiento fundamentado previo libre y el derecho a estar libre de la experimentación no consensual.


 


 

Discriminación de los Discapacitados y Necesidad de Protección


 

Las personas con discapacidad mental son a menudo discriminadas por su condición. De acuerdo con la Convención Interamericana sobre la Eliminación de Todas las Formas de Discriminación contra las Personas con Discapacidad, los Estados están obligados a supervisar adecuadamente la atención y tomar las medidas necesarias para prevenir todo tipo de discriminación. Los pacientes que viven en instituciones psiquiátricas o están recibiendo tratamiento en ellas son particularmente vulnerables a la tortura y otros tipos de tratos crueles, inhumanos o degradantes. Estas personas son más susceptibles al maltrato cuando son hospitalizadas. La autonomía y el derecho a la autodeterminación de los pacientes se ve severamente restringido en las instituciones de salud que afecta la integridad personal. Los Estados tienen el deber de supervisar y garantizar que, en todas las instituciones psiquiátricas, públicas o privadas, se preserve el derecho de los pacientes a recibir un trato digno, humano y profesional y que dichos pacientes estén protegidos contra la explotación, el abuso y la degradación. Los Estados también están obligados a promover la plena integración de esas personas en la sociedad.Anchor Los derechos de los discapacitados están delineados en las políticas y leyes federales, especialmente en la Ley de los Ciudadanos Americanos Discapacitados [Americans with Disabilities Act (ADA)].


 

El tratado internacional de derechos humanos - La Convención sobre los Derechos de las Personas con Discapacidad (CRPD) fue firmado por el Presidente de Estados Unidos, Barack Obama.Anchor El artículo 12 de la CDPD afirma el reconocimiento igualitario ante la ley y la capacidad jurídica de las personas con discapacidad. El artículo 13 de la CDPD afirma el acceso efectivo a la justicia de las personas con discapacidad. El artículo 25 especifica que " las personas con discapacidad tienen derecho a gozar del más alto nivel posible de salud sin discriminación por motivos de discapacidad." La Convención sobre los Derechos de las Personas con Discapacidad (CRPD) también protege la integridad de la persona. El artículo 17 de la CDPD establece que toda persona con discapacidad tiene derecho al respeto de su integridad física y mental en igualdad de condiciones con los demás.


 

Con respeto a los individuos en tratamiento psiquiátrico, los Estados Unidos no puede absolverse por completo de sus responsabilidades bajo el derecho internacional de los tratados delegando la responsabilidad legal para las determinaciones de la capacidad legal y la tutela a la ley del estado más que por la ley federal. El gobierno federal de los Estados Unidos todavía tiene la obligación de garantizar y proteger los derechos humanos y garantizar un trato humano. Que la capacidad legal y la tutela se rijan por la ley de los Estados miembros de los Estados Unidos de América, y no por la ley federal, no exime al gobierno federal de su responsabilidad. Los Estados Unidos, como Estado-nación, todavía tiene el deber de ejercer la supervisión y el control sobre las instituciones psiquiátricas públicas y privadas. El sistema judicial o la rama judicial de las instituciones gubernamentales y administrativas de los Estados Unidos no sólo deben proporcionar una supervisión competente de forma periódica sobre el confinamiento y el tratamiento médico, sino también si está justificado.Anchor

Anchor Foster v. Neilson, 27 U.S. (1 Pet.) 253, 314 (1829)

Anchor El Informe Belmont se publicó en el Registro Federal, y las reimpresiones se proporcionan a petición de científicos, miembros de Juntas de Revisión Institucional y empleados federales. El Apéndice de dos volúmenes, que contiene los largos informes de expertos y especialistas que asistieron a la Comisión en el cumplimiento de esta parte de su cargo, está disponible como DHEW Publicación No. (OS) 78-0013 y No. (OS) 78-0014, para la venta por el Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

Anchor Overprescribed: The Human and Taxpayers’ Costs of Antipsychotics in Nursing Homes. (2011, November 30). Hearing Before the Senate Special Committee on Aging. [Testimony of Daniel R. Levinson, Inspector General of the Department of Health and Human Services] http://oig.hhs.gov/testimony/docs/2011/levinson_testimony_11302011.pdf

Anchor U.S. Department of Justice. (2013, July 30). Wyeth Pharmaceuticals Agrees to Pay $490.9 Million for Marketing the Prescription Drug Rapamune for Unapproved Uses. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2013/July/13-civ-860.html

Anchor U.S. Department of Justice. (2010, April 27). Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-Label Drug Marketing. [Para. 10]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2010/April/10-civ-487.html

Anchor U.S. Department of Justice. (2011, June 9). U.S. Subsidiary of Belgian Pharmaceutical Manufacturer Pleads Guilty to Off-Label Promotion; Company to Pay More Than $34 Million. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2011/June/11civ-751.html

Anchor U.S. Department of Justice. (2010, September 1). Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®. [Para. 6]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2010/September/10civ-988.html

Anchor U.S. Department of Justice. (2010, September 1). Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®. [Para. 6]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2010/September/10civ-988.html

Anchor U.S. Department of Justice. (2011, March 2). Forest Pharmaceuticals Sentenced to Pay $164 Million for Criminal Violations. [Para. 8]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2011/March/11-civ-270.html

Anchor U.S. Department of Justice. (2012, April 19). U.S. Pharmaceutical Company Merck Sharp & Dohme Sentenced in Connection with Unlawful Promotion of Vioxx. [Para. 5]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2012/April/12civ-497.html

Anchor Convención Interamericana para la Eliminación de Todas las Formas de Discriminación contra las Personas con Discapacidad, supra nota 35, Preámbulo y Artículo III (1).

Anchor El artículo 12 de la Convención afirma el reconocimiento igual ante la ley y la capacidad jurídica de las personas con discapacidad. Los Estados Partes deberían: 1) Reafirmar que las personas con discapacidad tienen derecho a ser reconocidas en todas partes como personas ante la ley. 2) Reconocer que las personas con discapacidad gozan de capacidad jurídica en igualdad de condiciones con los demás en todos los aspectos de la vida. 3) Tomar las medidas apropiadas para facilitar el acceso de las personas con discapacidad al apoyo que puedan necesitar en el ejercicio de su capacidad jurídica. 4) Velar por que todas las medidas relacionadas con el ejercicio de la capacidad jurídica establezcan salvaguardias apropiadas y eficaces para prevenir los abusos de conformidad con el derecho internacional de los derechos humanos. Dichas salvaguardias garantizarán que las medidas relativas al ejercicio de la capacidad jurídica respeten los derechos, la voluntad y las preferencias de la persona, están libres de conflicto de intereses e influencia indebida, son proporcionales y adaptados a las circunstancias de la persona, aplican por el menor tiempo posible y están sujetas a revisión periódica por parte de una autoridad

independiente y imparcial o órgano judicial. Las salvaguardias serán proporcionales a la medida en que tales medidas afecten los derechos e intereses de la persona.

Anchor Corte Europea de Derechos Humanos, en el caso de Storck v. Germany, Peticion No. 61603/00, Sentencia de 16 de junio de 2005, p. 103.

 

 

List of Issues for the UN to consider regarding the U.S.A. by Medical Whistleblower 2016

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
 

 


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 fulfillment 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 post-market 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.


Issue 3: Lack of Oversight and Transparency in Guardianship Cases– Wards of the Court


Wards of the court have surrogate decision makers for both legal and medical decisions, thus wards are prevented even from effective appeal to the Judge or even to their US Congressmen/Congresswomen. The U.S.A. mental health guardianship system offers few procedural protections, and has spawned a profit-driven professional guardianship industry that often enriches itself at the expense of society’s most vulnerable members—the disabled and the elderly especially the mentally ill.vi Yet despite numerous calls for reform, most states have done little to monitor professional guardians and prevent abuse and neglect. Secrecy, lack of transparency and lack of accountability makes a perfect environment for human rights violations of the mentally disabled.vii viii ix (See Medical Whistleblower Advocacy Network, Voiceless Victims: Wards of the Court, INT_CCPR_NGS_USA_19896)
In the U.S.A. there remains little accurate information of who is in guardianship and the quality and nature of their medical care. There are approximately 1.5 million active pending adult guardianship cases in the United States, according to the 2011 National Center for State Courts report- Adult Guardianships: A "Best Guess" National Estimate and the Momentum for Reform.


The U.S.A. states clearly that “Under U.S. law, officials of all government agencies are prohibited from engaging in torture, at all times, and in all places.” This would presume that vulnerable persons who are currently in court ordered guardianship would be protected from torture, cruel, inhuman or degrading treatment or punishment, but in reality there is little transparency or accountability for what actually happens to wards of the court – especially in mental health cases.x
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. Forcing wards of the court to take medications that are “off-label” (not approved for that use by the Food and Drug Administration), is tantamount to human experimentation on the vulnerable wards of the court. Such violations of human subject provisions are routine with many patients in locked state and federal institutions given psychiatric drugs for “off-label uses.” xi Problems of patient abuse occur including: excessive dosing for purposes of chemical restraint, poly-pharmacy with multiple medications, lack of informed consent and the use of medication with little or no direct doctor/patient contact. xii


In addition, the use of medication with no real oversight of the process of diagnosis, means that patients often cannot question the use of these medications. Because surrogate decision makers have been assigned by the court to make all medical decisions, wards in mental health care have often been stripped of their legal rights and thus cannot assert their objections to treatment decisions. Unbiased independent review of medical charts is almost non-existent. Patient human rights have been ignored and there is no direct process to bring guardianship abuse or doctor/proxy/decision maker abuse to the attention of the court.


Effective monitoring of complaints of torture, inhumane treatment and abuse is necessary to ensure accountability, yet there is no effective monitoring of guardianship cases and the treatment of wards of the court. Domestic mechanisms of accountability and redress, must be accessible, transparent and effective but in the U.S.A. the court system does not even know exactly how many persons are currently wards of the court and in guardianship. Wards of the court are clearly persons in detention who were deprived liberty by state action.


Issue 4: Deceptive Pharmaceutical Marketing Practices


Deceptive and coercive marketing practices by the pharmaceutical industry are common place.xiii The practice of marketing drugs for purposes not backed by science is called “off-label promotion.” In addition, the restrictions upon who can prescribe psychiatric drugs have been reduced, thus allowing persons with lesser medical credentials (such as nurses with prescription authority) to prescribe these mind altering drugs. The pharmaceutical industry has provided marketing and promotional educational training and materials for those wishing to gain prescription authority to prescribe these drugs. This training is biased to sell their product, not to maximize patient informed consent and medical safety for the public. In reality, pharmaceutical industry supported educational programs support coercive psychiatric drugging and the removal of civil rights of psychiatric patients, as well as life-long drugging with psychiatric drugs. These drugs are widely prescribed for unapproved uses, including other non-approved psychiatric conditions and insomnia, significantly boosting their sales. These off-label psychiatric drugs do not live up to their marketing promises but instead have been known to cause serious, even fatal side-effects, particularly in children and the elderly.xiv Lives of some our most vulnerable citizens have been irreparably damaged and many have been lost to fatal adverse effects and even to suicide.xv xvi (See Medical Whistleblower Advocacy Network (MWAN) Voiceless Victims: Wards of the Court, CCPR IV Session 110 (2014) pp. 48 INT_CCPR_NGS_USA_19896_E)


Issue 5: Questionable Prescribing Practices


In the U.S.A., doctors routinely prescribe medications based on little evidence of their benefit. This is because there are high profit incentives to prescribe newly patented medications and many inducements offered by the pharmaceutical companies for doctor to prescribe their products. In an examination of off-label prescribing of 160 common drugs, off-label use was also found to account for 21% of all prescriptions, and most off-label drug uses (73%) were shown to have little or no scientific support. The highest rates of off-label use were for anticonvulsants (74%), antipsychotics (60%), and antibiotics (41%).xvii Atypical antipsychotics and antidepressants were particularly likely to be used off-label without strong evidence. The very drugs which are most often prescribed off-label with little or no scientific support to indicate that the medication is truly beneficial to the patient, actually are the same drugs which commonly cause serious debilitating medical conditions and even death.


In the U.S.A. the rates of diagnosis of psychiatric disorders in children and the elderly has dramatically increased in recent years. Nearly 70 % of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) task force members report having ties to the pharmaceutical industry. These drugs are widely prescribed for unapproved uses, including other non-approved conditions significantly boosting their sales. These prescription drugs do not live up to their marketing promises but instead have been known to cause serious, even fatal side-effects, particularly in children and the elderly.


Currently in all 50 states and in the District of Columbia, nurse practitioners prescribe these very dangerous mind altering substances. Authorized professionals include, psychiatric nurse practitioners, clinical nurse specialists, and certified nurse anesthetists, even certified nurse midwives. These nursing professionals are supposed to be supervised by medical doctors, but there is no actual oversight to make sure that this direct supervision actually occurs. In New Mexico, psychologists, who do not have medical training, and who have only completed a pharmaceutical industry training and certification program, are now permitted to prescribe these powerful psychotropic medications. So behind the closed doors of psychiatric hospitals, mental health clinics, and nursing homes, persons without the credentials of a doctor are prescribing these newly patented psychiatric drugs “off-label” with little restriction on wards of the court.


Prescribing providers withhold critical evidence of adverse events from the Food and Drug Administration (FDA), thus interfering with the ability of the FDA to ensure patient and public safety. Judges are not educated by the Food and Drug Administration Regulators regarding what medications have black box warnings and what those warnings mean. Medical providers still switch wards of the court onto dangerous drugs in order to maximize profit, while at the same time claiming in court that the medication was still “in the patient’s best interest.” Judges are not informed that the FDA had issued a medical safety alert and the need to watch carefully for medication switching. Prescribing medical professionals and surrogate decision makers are swayed by illegal off label promotion of pharmaceutical products. Wards of the court, had no informed consent and no right of refusal for this deliberate color of official right abuse of the court’s power. This is medical experimentation using off-label drugs on wards of the court without informed consent. In addition, in the U.S.A. children in foster care are considered wards of the court and psychiatric medications are given to them without their informed consent. ( See Medical Whistleblower Advocacy Network (MWAN) Voiceless Victims: Wards of the Court, CCPR IV Session 110 (2014) pp. 48 INT_CCPR_NGS_USA_19896_E)


Issue 6: Substituted Decision Making Power


Fully respecting each person’s legal capacity is a first step in the prevention of torture and ill-treatment. Medical treatments of an intrusive and irreversible nature, when lacking a therapeutic purpose or when aimed at correcting or alleviating a disability, may constitute torture or ill-treatment when enforced or administered without the free and informed consent of the person concerned.


Medical Whistleblower Advocacy Network (MWAN) points out that the substituted decision makers, the “qualified health care providers,” or the guardian are not chosen by the patient, but instead assigned to the patient by those in a position of power and authority. Medical practitioners sometimes treat persons with disabilities as objects of treatment rather than rights-holders and do not always seek their free and informed consent when it comes to treatments. Legal guardians defer medical decisions to the “qualified health care providers” who are often directly chosen by those who are directly financially benefiting from the selected medical treatment and aligned with the abusers. The “qualified health care providers” are given quasi-governmental immunity for their health care decisions and protected under special insurance for medical malpractice liability.


In addition, since most current mental health treatment is considered the administration of psychiatric drugs, these “qualified health care providers” are often financially and politically protected by the pharmaceutical industry’s legal team and direct lobbying efforts to governmental officials including enforcement agencies. Qualified health care providers are often deceived by pharmaceutical marketing representatives into believing drug therapy is safer and more effective than it really is. Psychiatric drugs are often used off-label for uses that the FDA has not approved –essentially using the wards as scientific guinea pigs. The medical care by “qualified health care providers” is often profit driven, and is often done with little regard to human rights and civil liberties. The goal of such care is often coercion and control of the disabled person.


Wards of the court are forced into treatment against their wishes and without informed consent. Forced drugging can be considered a form of torture and yet it is widely practiced in the U.S.A. Psychiatric interventions can be enforced disappearances, often under the guise of emergency medical care where the victim is kept incognito from family and friends, while mental health staff force signatures on paperwork which effectively removes the right of others to legally intervene in what the medical establishment has planned. (See Medical Whistleblower Advocacy Network (MWAN) Voiceless Victims: Wards of the Court, CCPR IV Session 110 (2014) pp. 48 INT_CCPR_NGS_USA_19896_E)


Issue 7: Lack of Free, Prior and Informed Consent


The principle of Free, Prior and Informed Consent is an important human right which has been addressed in many international and domestic laws and practices. Guardianship keeps people in institutions and negates the right of people with disabilities to exercise legal capacity, an aspect of the right to recognition as persons before the law. Often guardianship and the use of surrogate decision-makers is used to circumvent informed consent rather than making an honest attempt to discern the wishes of the person. To refuse to recognize the individual patient's human right to informed consent is contrary to the recognition of the legal capacity of persons with disabilities on an equal basis with others. Civil commitment laws create a separate regime of detention and involuntary treatment applicable only to persons with psychosocial disabilities that is discriminatory in purpose and effect.

In situations of civil commitment and compulsory mental health treatment the U.S. Supreme Court recognizes infringements of the liberty interest (a Constitutional Right) but asserts that these infringements are justified by state interests.xviii xix These practices pose a serious violation of mental and physical integrity by their close connection with disability-based discrimination, as analyzed by UN Special Rapporteur on Torture Manfred Nowak. xx The imposition of solitary confinement of any duration on persons with mental disabilities is cruel, inhuman or degrading treatment. Non-consensual detention, seclusion and restraints can only be legitimate to prevent serious harm to the patient or to others, and with measures and for the time strictly necessary to avoid such harm. The State has the burden to legislate and enforce this narrow scope of non-consensual treatment.


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. xxi


Adequate informed-consent process is not just a risk management process; it is good medical practice. Informed consent should define risks and potential benefits, but also take into consideration alternative treatments. Informed consent is an agreement to do something or to allow something to happen, made with complete knowledge of all relevant facts, such as the risks involved. There is a general right for all human persons to be free of inhuman treatment and individuals also have the legal right to privacy under international human rights law.
International human rights case law supports the concept that individuals do have the legal right to decide whether a proposed medical treatment will be performed on them. The human right to decide one's own treatment does not disappear just because it is more convenient or financially more beneficial for the caregivers or for the family members of the individual to force treatment. This right to decide to refuse treatment is a human right we all enjoy. Mental health treatment under human rights law should be the same as other treatments in regards to consent to treatment. But it is a sad fact that this right has not necessarily been consistently protected and thus through our mental health systems extended to people with mental disabilities.


Patients need to have the intellectual capacity to understand basic information about their diagnosis and proposed treatment. Correspondingly doctors have a responsibility to communicate the information in terms the patient can understand and to make efforts to be available to answer questions the patient may have. Skepticism by the patient in such circumstances does not mean that the person does not have capacity to make treatment decisions. Even if the patient, due to their disability, cannot believe the doctor's diagnosis that doesn't mean that the patient does not have capacity to make treatment decisions. Essentially, people have the right to make treatment decisions under Principle 19 of the UN's "Principles for the Protection of Persons with Mental Illness."


Because those with mental health disabilities are often detained, this then often automatically leads to forced treatment. This does not necessarily need to happen. It is not theoretically inconsistent with confining someone in a psychiatric facility, but still leaving them with the authority to decide treatment decisions. No treatment should be provided except in emergency situations until a determination of capacity has been made through a judicial hearing for treatment decisions. The hearing must be by an independent arbiter, and be judicial in character. In addition, there must be a right of the patient to return for re-consideration of the situation at regular intervals. A hearing to determine incapacity is required. Persons, who are lacking capacity, are often institutionalized and over-medicated. (Medical Whistleblower Advocacy Network (MWAN) Voiceless Victims: Wards of the Court, CCPR IV Session 110 (2014) 48 pages INT_CCPR_NGS_USA_19896_E)


Issue 8: Lack of Understanding of Human Rights Issues in Health Care Settings


Medical Whistleblower Advocacy Network identified problems with enforcement of the human rights of vulnerable persons who were served by protection and advocacy programs. Attorneys asked to provide advocacy and protection to vulnerable persons were not trained in many of the human rights issues regarding torture and abusive treatment in health care settings and the application of international human rights law to those situations.


The human rights model position of disability affirms that all human beings irrespective of their disabilities have certain rights which are inalienable. This model builds upon the spirit of the Universal Declaration of Human Rights, according to which, ‘all human beings are born free and equal in rights and dignity.’ The principle of diversity provides the foundation to accept disability as part of human variation. “Nothing about us without us”.


In the U.S.A. advocates, attorneys, and even peer mentors are being trained to intervene in health care cases without the benefit of any human rights instruction. These governmental agencies and NGO’s are instead depending on training modules which are primarily based on the medical model of disability rather than a human rights model. Under the medical model, disabled people are defined by their illness or medical condition. They are disempowered on the basis of a medical diagnosis used to regulate and control their access to social benefits, housing, education, leisure and employment. This model promotes the view of a disabled person being a dependent and needing to be cured or cared for, and it justifies the way in which disabled people have been systematically excluded from society. Alternatively, agencies, use a charity model of disability, one in which disabled persons are helpless victims needing ‘care’ and ‘protection’. Third party decision makers are given authority to make medical decisions for the patient and the patient is stripped of their legal right to appeal these decisions. These captive, vulnerable patients are then subjected to what amounts to human subject medical experimentation with no possibility of legal intervention, redress or rehabilitation. They are totally in the control of the medical team which benefits financially and professionally from the provision of medical care, often being paid by the U.S. government. Law enforcement officials and officers are trained to return patients to their assigned medical team and to obey the substituted decision maker’s medical decisions concerning the ward of the court.
In the U.S.A. attorneys often bring civil cases in court related to rights of mental patients that are guaranteed under the Americans with Disabilities Act – in particular the provisions related to the Supreme Court’s Olmstead Decision. Because of limited legal resources, legal firms often choose to pursue a limited legal agenda of cases, those which impact the greatest number of individuals and which present discrete legal questions that can be proven and won in court. Civil rights attorneys have pursued many important cases in which mental patients needed to have integration into the community. Attorneys were also successful in advocating for housing opportunities for people with mental disabilities, many of whom were formerly homeless. But attorneys often supported the use of forced outpatient treatment with psychiatric medications as a means to achieve housing options for the homeless.


Medical Whistleblower Advocacy Network was concerned to find out that the protection and advocacy programs in the United States do not train their attorneys in human rights issues related to mental health. Attorneys and advocates were not educated in how to apply principles of the Nuremberg Code, the Declaration of Helsinki or even the US law - The Common Rule. All of these, are necessary ethical and moral guidelines to utilize in decision making regarding the rights of persons with mental illness.


Governmental programs designed to train Peer Mentors do not support the human rights model, but instead teach substituted decision making and forced medical treatment. Disability rights advocates and in particular those with lived experience are rarely engaged to provide policy input or be involved in curriculum development of peer mentors. There are several non-governmental peer mentoring programs [Intentional Peer Support in Bristol, VT, and the Western Mass Recovery Learning Community in Holyoke, MA] that do teach from a human rights perspective, but these peer mentoring models are utilized very infrequently.


Recommendations for the U.S.A.


1. Enforce the prohibition of torture in all health-care institutions, both public and private, by, inter alia, declaring that abuses committed in the context of health-care can amount to torture or cruel, inhuman or degrading treatment or punishment; regulating health-care practices with a view to preventing mistreatment under any pretext; and integrating the provisions of prevention of torture and ill-treatment into health-care policies;
2. Promote accountability for torture and ill-treatment in health-care settings by identifying laws, policies and practices that lead to abuse; and enable national preventive mechanisms to systematically monitor, receive complaints and initiate prosecutions;
3. Conduct prompt, impartial and thorough investigations into all allegations of torture and ill-treatment in health-care settings; where the evidence warrants it, prosecute and take action against perpetrators; and provide victims with effective remedy and redress, including measures of reparation, satisfaction and guarantees of non-repetition as well as restitution, compensation and rehabilitation;
4. Provide appropriate human rights education and information to health-care personnel on the prohibition of torture and ill-treatment and the existence, extent, severity and consequences of various situations amounting to torture and cruel, inhuman or degrading treatment or punishment; and promote a culture of respect for human integrity and dignity, respect for diversity and the elimination of attitudes of pathologizaton and homophobia. Train doctors, judges, prosecutors and police on the standards regarding free and informed consent;
5. Safeguard free and informed consent on an equal basis for all individuals without any exception, through legal framework and judicial and administrative mechanisms, including through policies and practices to protect against abuses. Any legal provisions to the contrary, such as provisions allowing confinement or compulsory treatment in mental health settings, including through guardianship and other substituted decision-making, must be revised. Adopt policies and protocols that uphold autonomy, self-determination and human dignity. Ensure that information on health is fully available, acceptable, accessible and of good quality; and that it is imparted and comprehended by means of supportive and protective measures such as a wide range of community-based services and supports (A/64/272, para. 93). Instances of treatment without informed consent should be investigated; redress to victims of such treatment should be provided.
6. Ensure special protection of minority and marginalized groups and individuals as a critical component of the obligation to prevent torture and ill-treatment xxii by, inter alia, investing in and offering marginalized individuals a wide range of voluntary supports that enable them to exercise their legal capacity and that fully respect their individual autonomy, will and preferences.
7. Adopt a human rights-based approach to drug control as a matter of priority to prevent the continuing violations of rights stemming from the current approaches to curtailing supply and demand (A/65/255, para. 48). Ensure that national drug control laws recognize the indispensible nature of narcotic and psychotropic drugs for the relief of pain and suffering; review national legislation and administrative procedures to guarantee adequate availability of those medicines for legitimate medical uses;
8. Ensure full access to palliative care and overcome current regulatory, educational and attitudinal obstacles that restrict availability to essential palliative care medications, especially oral morphine. States should devise and implement policies that promote widespread understanding about the therapeutic usefulness of controlled substances and their rational use;
9. Develop and integrate palliative care into the public health system by including it in all national health plans and policies, curricula and training programs and developing the necessary standards, guidelines and clinical protocols.
10. Close compulsory drug detention and “rehabilitation” centers without delay and implement voluntary, evidence-based and rights-based health and social services in the community. Undertake investigations to ensure that abuses, including torture or cruel, inhuman and degrading treatment, are not taking place in privately-run centers for the treatment of drug dependence;
11. Cease support for the operation of existing drug detention centers or the creation of new centers. Any decision to provide funding should be made only following careful risk assessment. If provided, any such funds should be clearly time-limited and provided only on the conditions that the authorities (a) commit to a rapid process for closing drug detention centers and reallocating said resources to scaling up voluntary, community-based, evidence-based services for treatment of drug dependence; and (b) replace punitive approaches and compulsory elements to drug treatment with other, evidence-based efforts to prevent HIV and other drug-related harms. Such centers, while still operating as the authorities move to close them, are subject to fully independent monitoring;
12. Establish an effective mechanism for monitoring dependence treatment practices and compliance with international norms;
13. Ensure that all harm-reduction measures and drug-dependence treatment services, particularly opioid substitution therapy, are available to people who use drugs, in particular those among incarcerated populations (A/65/255, para. 76).
14. The Special Rapporteur calls upon all States to repeal any law allowing intrusive and irreversible treatments, including forced genital-normalizing surgery, involuntary sterilization, unethical experimentation, medical display, “reparative therapies” or “conversion therapies”, when enforced or administered without the free and informed consent of the person concerned. He also calls upon them to outlaw forced or coerced sterilization in all circumstances and provide special protection to individuals belonging to marginalized groups.
15. Review the anti-torture framework in relation to persons with disabilities in line with the Convention on the Rights of Persons with Disabilities as authoritative guidance regarding their rights in the context of health-care;
16. Impose an absolute ban on all forced and non-consensual medical interventions against persons with disabilities, including the non-consensual administration of psychosurgery, electroshock and mind-altering drugs such as neuroleptics, the use of restraint and solitary confinement, for both long- and short-term application. The obligation to end forced psychiatric interventions based solely on grounds of disability is of immediate application and scarce financial resources cannot justify postponement of its implementation;xxiii
17. Replace forced treatment and commitment by services in the community. Such services must meet needs expressed by persons with disabilities and respect the autonomy, choices, dignity and privacy of the person concerned, with an emphasis on alternatives to the medical model of mental health, including peer support, awareness-raising and training of mental health-care and law enforcement personnel and others;
18. Revise the legal provisions that allow detention on mental health grounds or in mental health facilities, and any coercive interventions or treatments in the mental health setting without the free and informed consent by the person concerned. Legislation authorizing the institutionalization of persons with disabilities on the grounds of their disability without their free and informed consent must be abolished.
19. Ensure that women have access to emergency medical care, including post-abortion care, without fear of criminal penalties or reprisals. States whose domestic law authorizes abortions under various circumstances should ensure that services are effectively available without adverse consequences to the woman or the health professional.
i Convention against Torture, art. 2, para. 2, International Covenant on Civil and Political Rights, art. 7.

 

Footnotes: 


ii International Criminal Tribunal for the Former Yugoslavia, Prosecutor v. Furundzija, case No. IT-95- 17/1-T, judgement (1998).
iii Committee on Economic, Social and Cultural Rights, general comment No. 14.
iv General comment No. 3, para. 1
v Torture in Healthcare Settings: Reflections on the Special Rapporteur on Torture’s 2013 Thematic Report by the Center for Human Rights & Humanitarian Law, Anti-Torture Initiative
vi Fields, Robin; Larrubia, Evelyn and Leonard, Jack. (2005)“Guardians for Profit.” Los Angeles Times (November 13-16, 2005).
vii United States Government Accountability Office GAO Testimony Before the Special Committee on Aging, U.S. Senate, GUARDIANSHIPS, Little Progress in Ensuring Protection for Incapacitated Elderly People Statement of Barbara D. Bovbjerg, Director Education, Workforce, and Income Security, September 7, 2006, GAO-06- 1086T.
viii Wood, Erica F. (2006) “State-Level Adult Guardianship Data: An Exploratory Survey,” American Bar Association Commission on Law and Aging for the National Center on Elder Abuse, August 2006.
ix Yeoman, Barry. (2004) “Stolen Lives.” AARP: The Magazine (January-February 2004).
18
x Leonnig, Carol D., Lena H. Sun and Sarah Cohen. (2003) “Misplaced Trust: Special Report.” The Washington Post (June 15-16, 2003).
xi Jones, Allen. (2004) “TMAP Critique,” January 20, 2004, PschRights.org, (see: http://psychrights.org/Drugs/AllenJonesTMAPJanuary20.pdf).
xii United States ex rel Law Project for Psychiatric Rights v. Matsutani, et al. US District Court, District of Alaska, Case No. 3:09-cv-0080-TMB.
xiii Jones, Allen, (2004)“Introduction to the documents on Big Pharma Corruption in Research & Clinical Trials,” Revised January 20, 2004, The Law Project for Psychiatric Rights, (see http://psychrights.org/)
xiv Jackson, Grace E., MD, (2004) “What Doctors May Not Tell You About Psychiatric Drugs” Public Lecture, UCE Birmingham June 2004.
xv March 21, 2000 Report to the court by Dr. Loren R. Mosher M.D. regarding Eric Harris and Luvox use prior to the Columbine High School shooting, Scoteria Associates.
xvi Jackson, Grace E. (2005) “Rethinking Psychiatric Drugs: A Guide for Informed Consent.” Bloomington, IN: Author House. ISBN-13: 978-1420867428, ISBN-10: 1420867423.
xvii Stafford, Randall S., M.D. Ph.D., “Regulating Off-Label Drug Use — Rethinking the Role of the FDA”, New England Journal of Medicine, 358;14, April 3, 2008, pp. 1427-1429.
xviii Addington v. Texas, 441 U.S. 418 (1979) (civil commitment).
xix U.S. v. Sell, Riggins v. Nevada, 504 U.S. 97 (1992).
xx U.N. Doc. A/63/175 (2008), particularly paragraphs 40, 44, 47, 49, 50, 61-65, 73-74.
xxi Meador v. Stahler and Gheridian (Middlesex Superior Court C.A. No. 88-6450, Mass. 1993).
xxii Committee on Economic, Social and Cultural Rights, general comment No. 14, para. 43 (a)-(f).
xxiii Convention on the Rights of Persons with Disabilities, art. 4, para. 2.

Prohibition of Torture - Off-label Promotion and Misbranding, Non-Consensual Experimentation 8-30-17

 

 

 

 

Medical Whistleblower Advocacy Network

 

 

Submission to the

 

 

United Nations’ Open-ended Intergovernmental Working Group on

 

 

Transnational Corporations and Other Business Enterprises

 

 

with Respect to Human Rights

 

 

August 30, 2017 

 

 

Non-Consensual Treatment and Pharmaceutical

 

 

Off-label Promotion and Misbranding

 

 

One of the most fundamental, absolute and non-derogable rights is the Right to freedom from torture or cruel, inhuman or degrading treatment or punishment and from medical or scientific experimentation. Everyone has the right to free prior informed consent to medical treatment, including individuals with a mental health disability. The Right to not be subjected medical or scientific experimentation without one’s free consent is absolute, non-derogable, ius cognens and erga omnes.

 

Non-consensual human medical experimentation, which violates one's rights to life, health, and personal integrity, is universally condemned as a violation of customary and codified international law.

 

 

The Right to freedom from torture or cruel, inhuman or degrading treatment or punishment and freedom from medical or scientific experimentation is a human rights principle that has the status of jus cogens, and thus is ipso facto entrenched against treaty amendment or repeal.

 

Article 53 of Vienna Convention on The Law of Treaties (Signed at Vienna 23 May 1969), stated that “For the purposes of the present Convention, a peremptory norm of general international law is a norm accepted and recognized by the international community of States as a whole as a norm from which no derogation is permitted and which can be modified only by a subsequent norm of general international law having the same character.”

 

The United States has signed and ratified the International Covenant on Civil and Political Rights (ICCPR) and The Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment (the United Nations Convention against Torture or CAT).  Both treaties delineate the prohibition against torture.  The ICCPR specifically identifies non-consensual experimentation within Article 7 of the ICCPR.

 

“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.”

 

Art. 2 of the ICCPR states that ‘[e]ach State Party… undertakes to respect and to ensure to all individuals within its territory and subject to its jurisdiction the rights recognized in the present Covenant ...’ 

 

The ICCPR contains no provision on termination or withdrawal, and the Human Rights Committee in General Comment 26 of 1997 declared that there was no such intention so that a state may not withdraw from it.

 

Finally, Article 103 of the UN Charter provides that ‘[i]n the event of a conflict between the obligations of the Members of the United Nations under the present Charter and their obligations under any other international agreement, their obligations under the present Charter shall prevail’.

 

The ICCPR treaty should be interpreted in good faith and with liberal interpretation in order to protect the human rights of vulnerable persons.  The canon of good faith stipulates that treaties “are to be kept in most scrupulous good faith,” and that a treaty “should be interpreted . . . in a manner to carry out its manifest purpose.”

 

If a treaty such as the ICCPR has the status of supreme federal law, and it creates or protects individual rights, then an individual whose rights under the treaty have been violated is entitled to a domestic judicial remedy.   The Supremacy Clause supplements international law mechanisms for enforcing treaties by adding domestic mechanisms.  The Supremacy Clause causes treaties to be assimilated treaties to federal statutes and the Constitution (the national legal system), thus obviating the differences in enforcement mechanisms that would otherwise exist between these forms of law.  Among other things, the Supremacy Clause makes treaties enforceable in court at the request of individuals.  Because it refers to “Judges,” the Supremacy Clause clearly contemplates that courts will enforce treaties, and, indeed, “[t]he province of the court is, solely, to decide on the rights of individuals.”

 

Chief Justice Marshall in Foster v. Neilson  recognized that our Constitution, specifically the Supremacy Clause, establishes the general rule that treaties are enforceable in U.S. courts, just as the Constitution and federal statutes are. 

 

 

International Human Right Treaties signed and ratified by the United States clearly are a statement of the U.S. Congress’s purposes and objectives in regard to human rights.

 

Thus, an interpretation of the United States obligations under the International Covenant on Civil and Political Rights (ICCPR), in conjunction with the ethical and legal standards of the United States Constitution and the U.S. Bill of Rights a natural person and citizen of the U.S.A., has the right to bring a petition to the Inter-American Commission on Human Rights in support of his/her human rights as defined under International Human Rights law and the customary human rights norms.

 

Certain rights, such as the right to freedom from torture and freedom from non-consensual experimentation, are non-derogable, and as such, cannot be suspended even in times of national emergency.  Human rights such as the prohibition against crimes against humanity, torture and non-consensual scientific or medical experimentation are considered to be absolute.  There are implied erga omnes duties for the United States to prohibit non-consensual experimentation and torture.

 

The principle of the prohibition against non-consensual experimentation to be fundamentally norm-creating character and the widespread practice of protecting human subjects is considered legally or morally obligatory - Opinio Iuris.

 

The United States Congress has clearly indicated through the ratification of the ICCPR, (Article 7) that it is the purpose and the intent of Congress to protect persons from non-consensual experimentation.   

 

The United States Congress has also implemented Article 7 of the ICCPR in domestic legislation to protect human subjects from non-consensual experimentation – The Common Rule (45 CFR Part 46).   The United States Congress has made its intent clearly evident by 1) ratifying the ICCPR (including Article 7), 2) Holding extensive discussions regarding the ethical need for human subjects protections, 3) publishing The Belmont Report and 4) legislating The Common Rule.

 

The Common Rule (45 CFR Part 46) is federal legislation drafted and entered in force under proper constitutional procedures and thus it is enforceable by the Court.

 

By legislating The Common Rule through a thorough and detailed political process the United States federal government has expressed the political will of the people to protect and defend the rights of persons against non-consensual experimentation.

 

 

On July 12, 1974, the United States National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.

 

The Belmont Report (1976)  is a formal statement by the United States government regarding the ethical standards and accepted legal norms regarding the use of human subjects in medical, behavioral or scientific experimentation. The Belmont Report summarizes the basic ethical principles identified in 4 days of deliberations supplemented by the monthly deliberations held over a period of nearly four years. It is a statement of basic ethical principles and guidelines to consider in the use of human subjects in research. It was published in the Federal Register so it could become ethical guidance for U.S. researchers, scientists, governmental employees and Institutional Review Boards (IRB).

 

The Belmont Report identifies three basic ethical principles that are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice. 

 

 

 

Medical practice is meant to enhance the well-being of an individual patient or client and is expected to have a reasonable expectation of success. The purpose of medical, psychological or psychiatric practice is to provide diagnosis, preventive treatment or therapy to individuals. Within clinical medical practice, physicians are ethically required to obtain free prior informed consent for any treatment.  

 

Free prior informed consent for treatment is especially important when a clinician departs in any significant way from standard or accepted practice, or utilizes a medication that the FDA has not approved for that use.  Although medical professionals can use a medication that is "experimental," (in the sense of being new, untested or different), this does not absolve the physician from disclosing to the patient the possible risks and benefits of treatment and obtaining free prior informed consent.  Failure to obtain proper and legal free, prior and informed consent is considered medical malpractice.

 

The process of obtaining consent must involve three elements: information, comprehension and voluntariness. Consent obtained by deceit, misinformation, or coercion is not legally valid.  Information supplied in English to a patient whose only language is Spanish does not comply with the comprehension aspect of informed consent. Providing information only in very detailed scientific terminology that is not understood by lay person, is also not complying with the comprehension aspect of informed consent.  Without free prior informed consent, experimental treatment on human subjects is prohibited by U.S. law.  Radically new medications should be made the object of formal research at an early stage in order to determine whether they are safe and effective. Thus, it is the responsibility of medical practice committees to demand that the ethical principles of the Belmont Report are applied and human rights of patients are protected.

 

The United States has accepted as an ethical standard the prohibition of non-consensual scientific or medical experimentation by promulgating federal laws which expressly prohibit such practices – The Common Rule – “The Federal Policy for the Protection of Human Subjects.” The Common Rule (45 CFR Part 46) was adopted in 1991. 

 

 

In the United States new drugs are tested in clinical trials (research studies) before they are approved by the US Food and Drug Administration (FDA) for use in the general public.

 

The clinical trials are done to show that the drug:

  • Works to treat a certain medical condition
  • Works the way it’s expected to
  • Is safe when used as directed

 

When the FDA is satisfied that the drug works and is safe, it and the maker of the drug create the drug label. This is not an actual label that sticks to a bottle, but a report of very specific information about the drug. The FDA must approve this report, which is made available to all health professionals who prescribe or sell the drug. The drug label gives information about the drug, including the specific medical condition(s) it’s approved for (called the indication(s) for use), the doses to be used, and how it’s to be given. When a drug is used in a way that is different from that described in the FDA-approved drug label, it’s said to be an “off-label” use.

 

This can mean that the drug is:

  • Used for a different disease or medical condition
  • Given in a different way (such as by a different route)
  • Given in a different dose than in the approved label

 

The off-label use of FDA-approved drugs is not regulated, but it is legal in the United States and many other countries. While it’s legal for doctors to use drugs off label, it’s not legal for drug companies to market (advertise or promote) their drugs for off-label uses. Off-label marketing is very different from off-label use. Some of the problems of off-label drug use is that it often does not reflect “standard of care” treatment. This could cause a patient have an unwanted or bad outcome from the treatment. The FDA does not regulate the practice of medicine. In general, once the FDA approves a drug, licensed doctors can use it for any purpose they consider medically appropriate.

 

One of the biggest problems related to widespread off-label use is the lack of information about how to best use the drug other than for what it was approved. The drug label contains the information that’s been approved by the FDA, and it does not cover off-label uses. Lack of information on off-label drug use and outcomes puts patients at a higher risk for medication errors, side effects, and unwanted drug reactions. For proper medical use of an off labeled drug, the doctor should adequately inform the patient about the possible risks of using the drug and weigh them against the possible benefits. When a court of law decides that a patient should receive off-label drug medical treatment, the process of obtaining prior, free and informed consent does not occur. Off label promotion of misbranded prescription medications is very common in the vulnerable population of persons who are wards of the court because of the low risk of detection and low risk of medical malpractice liability. 

 

Off-label promotion can involve the following: 1) Paying incentives to sales representatives based on sales for off-label use;  2) Paying kickbacks to physicians to prescribe drugs for off-label use;   3) Disseminating misleading posters promoting off-label use;   4) Paying physicians: (a) To pretend to be the authors of articles about off-label uses when the articles were actually written by manufacturers’ agents; (b) To serve as members of “advisory boards” promoting off-label use; (c) To travel to resort locations to listen to promotions about off-label use; or (d) To give promotional lectures in favor of off-label use to fellow practitioners.  5) Providing advice to prescribers on how to code their claims and document their medical records to support payment for off-label uses not covered by Medicaid;  6) Publicizing studies showing efficacy of off-label uses while suppressing studies showing no efficacy;  and 7) Making false representations directly to Medicaid to influence decisions about payment for drugs used off-label.

 

 

In 2009 the Special Rapporteur on the Right to health stressed that the right to health is contingent on the right to access to information.  The Special Rapporteur stated that informed consent is a “voluntary and sufficiently informed decision, protecting the right of the patient to be involved in medical decision-making, and assigning associated duties and obligations to health-care providers.”  The right to receive and impart information is an integral element of the right to health. Completeness of information is among the required components of informed consent. 

 

To obtain prior informed consent requires disclosure of the associated benefits, risks and alternatives to a medical procedure.  The accuracy and completeness of information is necessary for valid informed consent for medical treatment.  Without truthful scientific information about the associated benefits, risks and alternatives to a medical procedure or treatment is required for consent to be valid.  The guarantee of informed consent is to respect the autonomy, self-determination and human dignity of individuals.   It constitutes a violation of a patient’s right to health to act, or fail to act, in a way that deprives that patient from the information he or she needs to provide informed consent.  

 

In addition, the withholding of the facts presented in the mental health evaluation which was used to certify the Petitioner as legally incapacitated, is also a violation of Article 13 of the American Convention. Without the facts it is impossible to mount a legal defense for the patient.  The Inter-American Commission on Human Rights has established the principle that “every person has the right to access to information about himself or herself.”     States within the context of the American Convention therefore must guarantee the exercise of this right.  The Inter-American Court of Human Rights stipulated the right to “seek” and “receive” “information”, as per Article 13 of the Convention protects the right of all individuals to request access to State-held information.  This includes the right of the individual to receive such information and the positive obligation of the State to provide it.  

 

In a landmark case Claude-Reyes et al v Chile, Freedom of thought and expression is also protected by Articles IV of the American Declaration and 13 of the American Convention.

 

The UN Convention on the Rights of Persons with Disabilities was adopted to promote, protect, and ensure the full and enjoyment of human rights and fundamental freedoms by all persons with disabilities and to promote respect for their inherent dignity.   Parties to the CRPD must ensure that persons with disabilities are able to exercise the right to freedom of expression and that includes “the freedom to seek, receive and impart information and ideas on an equal basis with others and through all forms of communication of their choice.”   

 

Access to truthful scientific medical information is essential to patient informed consent.  Unimpaired access to medical information is necessary in the fight against pharmaceutical corruption and medical fraud, and impacts the public health.  By encouraging and creating a more transparent system for the distribution of medical information to the public, and demanding criminal accountability for the deceptive off label promotion efforts by the pharmaceutical industry, the United States could start eliminating corruption in the pharmaceutical marketing and health care systems.

 

In 1990, the Pan American Health Organization (PAHO/WHO) – the World Health Organization’s (WHO) Regional Office of the Americas and a specialized agency of the Organization of American States (OAS)–sponsored the Regional Conference on Restructuring Psychiatric Care in Latin America, with the IACHR as a co-sponsor. At that conference, the Declaration of Caracas was adopted. The Declaration of Caracas establishes standards on protecting human rights and mental health.  Regarding psychiatric care, it indicates that the “resources, care and treatment that are made available must safeguard personal dignity and human and civil rights … and strive to ensure that patients remain in their communities”. It also recommends that countries redraft national legislation to ensure that the “human and civil rights of the mental patients are safeguarded.”

 

In April 1999, the Inter-American Commission on Human Rights approved Report No 63/99 in the case of a person with a mental disorder. That report finds that it is “pertinent to apply special standards to the determination of whether the provisions of the Convention have been complied with in cases involving persons suffering from mental illnesses” or detainees in psychiatric hospitals, who are considered to be a particularly vulnerable group. In that report, the IACHR interpreted the standards of the American Convention that provide for the right to physical integrity, the right to life, and the right to judicial protection in light of the Mental Health Principles. In that report, the IACHR also agreed with the position of the European Court of Human Rights, which has established that the state of health of a victim is an important factor in determining whether they have been subjected to inhumane or degrading punishment or treatment and therefore concluded that the incarceration of a mentally disabled person under deplorable conditions and without medical treatment may be considered as inhumane or degrading treatment, prohibited under Article 5(2) of the American Convention on Human Rights.  

 

The pharmaceutical companies have an extensive history of criminal off label promotion of their psychiatric medications. Off-label marketing of medications is the promotion of these drugs for uses that have never been approved by the Food and Drug Administration, and for which they had not been proven to be either safe or effective. The off-label use of these medications increased in adolescents, due to an organized effort by the pharmaceutical industry to proactively increase the diagnosis of depression in teenagers.  One way they did this was through the “Teen Screen” program done through the public school system.

The public did not realize that these off-label uses had never been approved by the FDA. Pharmaceutical research financing is an important part of the budget of mental health facilities. Patients are without their prior informed consent, enrolled in clinical experimental trials financed and controlled by the pharmaceutical companies.  Doctors do not go through the necessary steps required to protect the patient’s rights for human subjects in medical experimentation as required under The Common Rule. Patients are often not informed at all about the experimental use of the medication.  This continues to be common practice within psychiatric hospitals and mental health clinics where they do emergency mental health interventions. Even in private practice, mental health professionals do not get patient’s prior informed consent prior to enrolling the patient into poorly supervised experimental off-label clinical use. Patients do not realize that these medications had not been proven safe or effective and the use of these products was essentially clinical experimental use of the product by their personal physicians. 

Pharmaceutical companies are currently being criminally convicted by the U.S. Department of Justice of gross misrepresentations of their drug’s safety and efficacy and misbranding of their product. FDA can pursue misbranding cases criminally, and the consequences can be severe, especially when the FDA believes that the violation was committed with the intent to defraud or mislead.

Federal law in the United States - 21 USC § 331 makes clear that federal law prohibits “the introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded,” and “the adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.” Additionally, 21 USC § 352(f) provides that a drug will be deemed to be misbranded unless its labeling contains adequate directions for use, which typically requires the directions to allow a layperson to use the drug safely and for the purposes for which it was intended.

In one recent case in 2012 for example, Abbott Laboratories Inc. plead guilty and agreed to pay $1.5 billion to resolve its criminal and civil liability for their off label promotion of Depakote.  Abbott promoted Depakote to control behaviors in elderly dementia and schizophrenia patients without significant evidence of its effectiveness for that use, and even after clinical data established that it was not effective.  The resolution includes a criminal fine and forfeiture totaling $700 million and civil settlements with the federal government and the states totaling $800 million. Abbott also will be subject to court-supervised probation and reporting obligations for Abbott’s CEO and Board of Directors.

Separate from the DOJ settlement, Abbott agreed to pay 45 states a total of $100 million to resolve liability under the state consumer-protection laws. That makes this the second-largest fraud settlement involving a drug company, behind only the $2.3 billion Pfizer settlement in 2010.

The company maintained a specialized sales force to market Depakote for off label purposes; targeting elderly dementia patients in nursing homes. Abbott has pleaded guilty to misbranding Depakote by promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of these uses was FDA approved. The FDA approved Depakote for only three uses: epileptic seizures, bipolar mania and the prevention of migraines. The FDA never approved the drug as safe and effective for the off-label use of controlling behavioral disturbances in dementia patients.

In 1999, Abbott was forced to discontinue a clinical trial of Depakote in the treatment of dementia due to an increased incidence of adverse events, including somnolence (sleepiness), dehydration and anorexia (loss of appetite) experienced by the elderly study participants administered Depakote.

Abbott’s off-label promotion of Depakote was multifaceted. Abbott trained its sales force to promote Depakote to health care providers and employees of nursing homes as advantageous over antipsychotic drugs for controlling agitation and aggression in elderly dementia patients because Depakote was not subject to certain provisions of the Omnibus Budget Reconciliation Act of 1987 (OBRA).  OBRA’s implementing regulations were designed to prevent the use of unnecessary medications in nursing homes. Exploiting the fact that certain OBRA provisions did not yet apply to Depakote, Abbott sales representatives stated that by using Depakote, nursing homes could avoid the administrative burdens and costs of complying with OBRA.

The company entered into contracts that provided long-term care pharmacy providers with payments of rebates based on increases in the use of Depakote in nursing homes serviced by the providers.  The company wound up giving millions of dollars in rebates to pharmacists at long-term-care facilities that were based on increases in the use of the drug in nursing homes they serviced.  Abbott created programs and materials to train the pharmacy providers' consultant pharmacists about the off-label use of Depakote to encourage them to recommend the drug for this unapproved use. Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies, putting profits ahead of patient safety.  Abbott offered and paid illegal remuneration to health care professionals and long term care pharmacy providers to unduly influence the content of company sponsored Continuing Medical Education programs, in violation of the Federal Anti-Kickback Statute.

In the agreed statement of facts, Abbott also admitted that from 2001 through 2006, the Company misbranded Depakote by marketing the drug to treat schizophrenia. Abbott funded two scientific studies of the use of Depakote to treat schizophrenia, and both failed to meet the main goals established for the study. When the second study failed to show a statistically significant treatment difference between antipsychotic drugs used in combination with Depakote and antipsychotic drugs alone, Abbott waited nearly two years to notify its own sales force about the study results and another two years to publish those results. During this time, Abbott continued to promote Depakote off-label to treat schizophrenia. 

In another criminal case, Pfizer paid $1.3 billion in criminal fines for “misbranding” (the legal term for off-label marketing) drugs. And that was just the tip of the iceberg, considering the total package of the settlement was $2.3 billion when adding in Department of Justice (DOJ) fees and costs. The fine was so high because Pfizer was considered a “repeat offender” after it continued to promote Lipitor and Viagra for off-label uses following a request to cease and desist these practices by the FDA.

Large criminal fines of billions of dollars were awarded by the courts, but this did little to effectively curtail the direct marketing of these off-label uses of pharmaceutical products to consumers and to medical professionals.  Drug manufacturers consider the monetary penalties as just another cost of doing business.  So pharmaceutical companies continue to collect huge sums of profit from the allegedly illegal acts and even after the criminal convictions. Patients are not withdrawn from these dangerous medications. Instead, Medicaid and Medicare continue to pay for these off label medications for treatment of wards of the court (even after criminal prosecution). Judges who run mental health courts are not warned by the Department of Justice that the drugs they are forcing on wards of the court have been proven to be dangerous to patients and the pharmaceutical company criminally convicted.

Because the judgment and settlement penalties proved to be ineffective deterrents of these practices, the FDA and DOJ started to find other ways to try to stop the manufacturers from on-going unlawful activities. The federal agencies have begun to employ two new strategies: 1) bringing criminal charges against wayward company executives, and 2) barring the offending manufacturers from doing any business with or for the various and multiple federal prescription benefit plans (e.g., Medicare, Medicaid). The U.S. federal government is the largest single purchaser of drugs in the world.

The involvement of the court system to enforce these new deterrents is absolutely crucial.  Thus the probate judges should enforce the patient’s right to free prior informed consent and the right to be free from non-consensual experimentation.

 

 

Persons with mental disabilities are often discriminated by reason of their condition. According to the Inter-American Convention on the Elimination of All Forms of Discrimination against Persons with Disabilities, States are obligated to properly supervise care and take actions necessary prevent all types of discrimination. Patients who live in psychiatric institutions or are undergoing treatment therein, are particularly vulnerable to torture and other types of cruel, inhuman or degrading treatment. These persons are more susceptible to mistreatment when hospitalized. The autonomy and right to self-determination of patients is severely curtailed in healthcare institutions which impinges on personal integrity. The States have the duty to supervise and guarantee that in all psychiatric institutions, either public or private, the patients´ right to receive a worthy, humane, and professional treatment be preserved and that said patients be protected against exploitation, abuse, and degradation.   States are also obligated to promote the full integration of such persons in society.   The rights of the disabled are delineated in federal policy and law most notably in the Americans with Disabilities Act (ADA). 

 

The international human rights treaty – The Convention on the Rights of Persons with Disabilities (CRPD) was signed by the President of the United States, Barack Obama.  Article 12 of the CRPD affirms the equal recognition before the law and legal capacity of the persons with disabilities. Article 13 of the CRPD affirms the effective access to justice for persons with disabilities. Article 25 specifies that "persons with disabilities have the right to the enjoyment of the highest attainable standard of health without discrimination on the basis of disability."  The Convention on the Rights of Persons with Disabilities (CRPD) also protects the integrity of the person.  Article 17 of the CRPD states that every person with disabilities has a right to respect for his or her physical and mental integrity on an equal basis with others.

 

Regarding individuals in psychiatric treatment, the United States cannot completely absolve itself of its responsibilities under international treaty law by delegating legal responsibility for determinations of legal capacity and guardianship to the law of the state rather than by federal law.  The federal government of the United States still has the obligation to guarantee and protect human rights and to ensure humane treatment. That legal capacity and guardianship are governed by the law of the state members of the United States of America, and not by federal law, does not absolve the federal government of its responsibilityThe United States, as a nation state, still retains a duty to exercise supervision and control over public and private psychiatric institutions. The judicial system or judicial branch of government and administrative institutions of the United States must not only provide competent supervision on a regular basis of the confinement and medical treatment, but also whether it is justified. 

 

 

 Foster v. Neilson, 27 U.S. (1 Pet.) 253, 314 (1829)

 The Belmont Report was published in the Federal Register, and reprints are provided upon request to scientists, members of Institutional Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

  Overprescribed: The Human and Taxpayers’ Costs of Antipsychotics in Nursing Homes. (2011, November 30). Hearing Before the Senate Special Committee on Aging. [Testimony of Daniel R. Levinson, Inspector General of the Department of Health and Human Services] http://oig.hhs.gov/testimony/docs/2011/levinson_testimony_11302011.pdf

  U.S. Department of Justice. (2013, July 30). Wyeth Pharmaceuticals Agrees to Pay $490.9 Million for Marketing the Prescription Drug Rapamune for Unapproved Uses. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2013/July/13-civ-860.html

  U.S. Department of Justice. (2010, April 27). Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-Label Drug Marketing. [Para. 10]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2010/April/10-civ-487.html

  U.S. Department of Justice. (2011, June 9). U.S. Subsidiary of Belgian Pharmaceutical Manufacturer Pleads Guilty to Off-Label Promotion; Company to Pay More Than $34 Million. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2011/June/11civ-751.html

  U.S. Department of Justice. (2010, September 1). Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®. [Para. 6]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2010/September/10civ-988.html

  U.S. Department of Justice. (2010, September 1). Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®. [Para. 6]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2010/September/10civ-988.html

  U.S. Department of Justice. (2011, March 2). Forest Pharmaceuticals Sentenced to Pay $164 Million for Criminal Violations. [Para. 8]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2011/March/11-civ-270.html

  U.S. Department of Justice. (2012, April 19). U.S. Pharmaceutical Company Merck Sharp & Dohme Sentenced in Connection with Unlawful Promotion of Vioxx. [Para. 5]. Retrieved August 24, 2015, from http://www.justice.gov/opa/pr/2012/April/12civ-497.html

 Inter-American Convention on the Elimination of All Forms of Discrimination against Persons with Disabilities, supra note 35, Preamble and Article III (1). 

 Article 12 of the Convention affirms the equal recognition before the law and legal capacity of the persons with disabilities. States Parties should: 1) Reaffirm that persons with disabilities have the right to recognition everywhere as a person before the law. 2) Recognize that persons with disabilities enjoy legal capacity on an equal basis with others in all aspects of life. 3) Take appropriate measures to provide access by persons with disabilities to the support they may require in exercising their legal capacity. 4) Ensure that all measures that relate to the exercise of legal capacity provide for appropriate and effective safeguards to prevent abuse in accordance with international human rights law.  Such safeguards shall ensure that measures relating to the exercise of legal capacity respect the rights, will and preferences of the person, are free of conflict of interest and undue influence, are proportional and tailored to the person's circumstance, apply for the shortest time possible and are subject to regular review by a competent, independent and impartial authority or judicial body. The safeguards shall be proportional to the degree to which such measures affect the person's rights and interests. 

 

European Court of Human Rights, Case of Storck v. Germany, Application No. 61603/00, judgment of June 16, 2005, p. 103.

 

Medical Whistleblower Statement Regarding DC Statehood 6-17-16

Written Statement for the Record


Dr. Janet Parker DVM


District of Columbia - Constitutional Convention

June 17, 2016


I am a resident of the District of Columbia and a citizen of the U.S.A. I am also a person with a disability. I, as Executive Director of Medical Whistleblower Advocacy Network, advocate for human rights and am a regular reporter to the United Nations and stakeholder in the United Nations Universal Periodic Review Process. I am a human rights advocate for persons who are disabled.


The United States government has systematically denied the residents of the District of Columbia the right to enjoy equal political participation in their own national legislature. The residents of the District of Columbia— the nation’s capital—are denied the fundamental right to equal suffrage in the U.S. Congress. They’re prohibited from voting for and electing representatives to the United States Senate and the United States House of Representatives. The residents of the District of Columbia are the only U.S. taxpaying citizens denied the right to universal and equal suffrage.


According the 2015 US Census there is an estimated population of 672,228 persons living in D.C. Because approximately 8.2% of the US population are persons with a disability, there are an estimated 55,122 disabled persons living in the District of Columbia. President Barack Obama signed the Convention on the Rights of Persons with Disabilities (CRPD) treaty in 2009 and sent it to the U.S. Senate for treaty ratification. Former Senator Bob Dole lead a bipartisan effort of support to secure the 2/3 Senate vote needed for ratification. There was strong bipartisan support for the ratification of the CRPD. Medical Whistleblower Advocacy Network (MWAN), The National Council on Independent Living (NCIL), The U.S. International Council on Disabilities (USICD) and many other disability advocates rallied for CRPD ratification by the Senate. When the disability advocates gathered in Washington D.C. to ask their U.S. Senator from their home states to vote for the ratification of the Convention on the Rights of Persons with Disabilities, I, as a citizen of D.C. had no U.S. Senator to express my view or vote for me in the CRPD treaty ratification process. Unfortunately, on December 4, 2012 the super-majority needed to ratify the CRPD was not reached, but we only lost by a few votes. I, and the other 55,122 disabled persons living in the District of Columbia, had no one representing our human rights in the CRPD treaty deliberation discussions.


Because of the lack of voting rights for persons who live in the District of Columbia, no disabled person living within the District could actually have direct input into the Senate CRPD ratification process. There is no elected person who serves in the Senate for the District. I, as a US citizen, went to US Senate Majority Leader Senator Harry Reid’s office the day of the 2014 USICD CRPD rally to express the wholehearted support for the treaty by the disabled community in Washington, DC. I had spoken to Representative Eleanor Holmes Norton to encourage her to advocate in any way possible for the human rights of all disabled persons in the District of Columbia. Because this US Senate vote was on a human rights treaty and not regarding domestic legislation, I requested that the District's only elected Congressional representative, Eleanor Holmes Norton be allowed to vote in favor of ratification of the CRPD. But Representative Eleanor Holmes Norton is a non-voting member of the United States House of Representatives. She is only allowed to vote on procedural matters and in congressional committees. Thus D.C. Residents have no representation in the U.S. Senate.


Thus, by denying citizens of the District of Columbia the right to fully participate in the national government, the United States of America is not in compliance with international human rights treaties. This fundamental human right is guaranteed under Article 25 of the International Covenant on Civil and Political Rights (ICCPR).


Article 25: Every citizen shall have the right and the opportunity, without any of the distinctions mentioned in article 2 and without unreasonable restrictions:
(a) To take part in the conduct of public affairs, directly or through freely chosen representatives;
(b) To vote and to be elected at genuine periodic elections which shall be by universal and equal suffrage and shall be held by secret ballot, guaranteeing the free expression of the will of the electors;
(c) To have access, on general terms of equality, to public service in his country.
In addition, the lack of representation for the citizens of D.C. in national government is also not in compliance with Articles II and XX of the American Declaration of the Rights and Duties of Man.
Article II. All persons are equal before the law and have the rights and duties established in this Declaration, without distinction as to race, sex, language, creed or any other factor.
Article XX. Every person having legal capacity is entitled to participate in the government of his country, directly or through his representatives, and to take part in popular elections, which shall be by secret ballot, and shall be honest, periodic and free.
The citizens of the District of Columbia should have the effective right to participate, directly or through freely chosen representatives and in general conditions of equality, in their national legislature. 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. It is the participation of citizens in their government which forms the basis and the true support of a democracy. Democracy cannot exist without it, for the title to government rests with the people, the only body empowered to decide its own immediate and future destiny and to designate its legitimate representatives. Neither political life, nor institutional change, nor development planning or the control of those who exercise public power can be made without representative government.


I, as a citizen of the District of Columbia and as a U.S. citizen, support statehood for the citizens of the District of Columbia.


Sincerely,


Dr. Janet Parker DVM


Medical Whistleblower Advocacy Network

Is Peer Review a Broken System?

Commitment to Non-Violence

Medical Whistleblower has a commitment to improving the protection of all civil, political, economic, social and cultural rights as defined in, among others, the following regional and international legal instruments:

•             UN legal instruments pertaining to human rights, including: the Universal Declaration of Human Rights; the international covenants on civil and political rights and on economic, social and cultural rights; the conventions providing for monitoring mechanisms (torture, racial discrimination, discrimination against women, the rights of the child, rights of migrant workers and their families); and the conventions and standards of the International Labor Organization;

•             Special procedures and non-treaty mechanisms of the United Nations;

•             The Declaration on Human Rights Defenders;

•             The UN resolution establishing the mandate of the Special Representative of the Secretary General on human rights defenders;

•             The United Nations guidelines on human rights defenders;

In addition, Medical Whistleblower upholds the principle of  a code of ethical and moral conduct that all means used by Medical Whistleblower will not include violence -  We exclude the use of violence to advance political aims.  We work with and in collaboration with existing governmental structures and systems but put pressure on governments in a non-violent manner to achieve human rights protections and goals. 

MWAN remarks to the Federal Election Commission and Dark Pharmaceutical Money in PACs

                               Medical Whistleblower Advocacy Network


                                                       by


                                        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)
Our democracy is dependent on the ability of the will of the people to affect the actions of our elected
officials. Only when we know to whom elected officials are beholden, can we hold our elected
officials accountable. We have an obligation to ensure that our legislation, administrative policies and
practices are consistent with protections for Constitutional Rights and also Human Rights under
International Human Rights Treaties. Because of Supreme Court decisions like Citizens United, many
political spenders, such as the pharmaceutical industry are effectively allowed to hide their true
identities and to greatly influence legislation and administrative policies. When we as a nation do not
have transparency or accountability regarding political lobbying efforts of huge corporate interests, we
can not draft legislation that protects the human rights of patients to safe and effective health care. We
can also not protect vulnerable patients from being human subjects of research without their informed
consent, as medicine is a profit driven business and patients are very vulnerable and trusting of their
medical providers.


Medical Whistleblower Advocacy Network (MWAN) acts as a grassroots advocate for human rights for
disabled persons and other individuals. MWAN provides information, referrals, and also direct human
rights defender advocacy services. I am a participating human rights advocate to the 2nd cycle of the
United Nations UPR Process reviewing the record of the United States of America.


Medical Whistleblower Advocacy Network is extremely concerned that the political power of the
pharmaceutical industry has furthered a profit making agenda which has overshadowed the rights of
patients and has led to the loss of human rights protections for vulnerable populations. The pursuit of
the almighty dollar often overshadows corporate responsibility to the public. We ask you to please
update and strengthen the FEC’s disclosure rules to protect our democracy.


The Pharmaceutical Industry lobby has mounted a sophisticated grassroots campaign to provide
political support for its position on key issues that affect its profit making enterprise – including
expanded Medicare/Medicaid funding for off-label drugs. The industry has funded various groups to
champion its positions, sponsored studies tilted to industry goals and hired public relations firms to
spearhead campaigns to soften up public opinion and government policies.


The Pharmaceutical Research and Manufacturers of America spent $12,650,000 on lobbying in 2014
according to OpenSecrets.org. Pfizer Inc. spent $6,910,000, Amgen Inc. spent $6,590,00, Eli Lilly &
Co. spent $5,776,000 and Novartis AG spent $5,435,000 and this is only what they actually disclosed,
not what they funneled through other 501 C 4 non-profit organizations. No health professional activity
is safe from the $200 billion pharmaceutical industry financial and political influence. The largest
growing portion of that market is now psychiatric medications which are highly profitable products but
of dubious benefit. Pharmaceutical companies spend a majority of their funds in marketing rather than
research and development. Financial and political power allows the pharmaceutical industry to push
their legislative agenda through Congress, influence regulatory actions of the FDA, and to control
research at academic medical centers. Public research institutions funded by tax dollars are doing the
basic research for the drugs, but the actual clinical trials are funded privately by the drug companies.
Off-label drug use clinical data is used to expand FDA approval to additional diagnoses. In order to
make patented drugs look better than they really are, clinical research trials are rigged. Government
granted exclusive marketing rights are extended for years by protective and aggressive industry
lawyers. The pharmaceutical industry has found that clinical safety trials are costly to perform. Instead
they have sifted their emphasis to political pressure on targeted government officials to sway public
policy decision making and thus be able to use federal tax dollars to pay for “off-label” use of welfare
recipients as their human subjects. Controlling the decisions of the medical proxy decision makers is
therefore their focus rather than making sure that medications are approved by the FDA as safe and
effective. Annually, the pharmaceuticals industry spends nearly twice as much on marketing as it
spends on research and development. According to the Center for Public Integrity the pharmaceutical
and health products industry has spent more than $800 million in federal lobbying and campaign
donations at both federal and state levels in the past seven years. (PublicIntegrity.org) The Supreme
Court Decision, Citizens United v. Federal Election Commission has now even further extended the
pharmaceutical companies influence over policy makers through unbridled secret contributions to 501 c
4 organizations which then can lobby legislators on behalf of the pharmaceutical industry. Individual
citizens of the U.S.A., especially persons with mental disabilities, cannot compete with equal lobbying
actions to the pharmaceutical industry. Indeed, many with mental health diagnosis are actually stripped
of their right to vote and even their right to petition their elected representatives for issues crucial to
their human rights. Surrogate decision makers often controlled by the medical proxies make voting
decisions for the wards and thus vote pro-pharmaceutical interventions. The human rights of wards of
the court are lost in this political exercise of power.


The pharmaceutical industry gives millions to public advocacy non-profit organizations with a variety
of missions, many of which then support the political agenda of the pharmaceutical firms. These nonprofit
organizations are under no legal obligation to reveal their donors, and thus provide an avenue for
support for positions favorable to the industry. Some of the groups that receive the industry funds are
independent, but many are just a front for the pharmaceutical lobby such as The Institute for Policy
Innovation (IPI). IPI does not disclose its funders, but according to the Foundation Center – Eli Lilly
and Company Foundation is among the group's supporters. The Eli Lilly Foundation is funded by Eli
Lilly and has the mission of providing financial support for non-profit organizations. With the support
of Eli Lilly funding the IPI has published reports opposing drug re-importation and price controls and
defending the industry's lavish spending on advertising, especially the direct-to-consumer advertising.
Other known pharmaceutical industry grassroots political lobbying groups are Seniors Coalition and
The United Seniors Association. The lobbying efforts by these so-called grassroots organizations can
be very deceptive, such as the Consumer Alliance 2002 campaign against legislation that would have
capped prices for prescription drugs. The Consumer Alliance faxed petitions to community leaders that
warned the poor and disabled were in danger of losing access to affordable prescription drugs. It was
revealed later by the Baltimore Sun, that Consumer Alliance was a front group used by Bonner and
Associates on behalf of PhRMA. PhRMA spent more than $60 million on television and newspaper
ads through a group called Citizens for Better Medicare. Citizens for Better Medicare claimed to be a
grassroots organization consisting of numerous organizations and more than 300,000 individual
members and had a mission to get passage of the Medicare prescription drug benefit in 2003. This
legislation has dramatically increased the amount of federal funding through Medicare to pay for off-label
psychiatric prescription drugs.


Off-label use is using a drug for a use that it has not been scientifically proven to be safe or effective –
in other words the drug has not met the requirements to be approved by the federal regulatory agency
the Food and Drug Administration. The pharmaceutical industry politically pushed for legislation
which would permit them to sell their patented drugs off-label (drugs without Food and Drug
Administration approval for that use). There is no need for the pharmaceutical industry to pay for
costly pharmaceutical clinical research trials when they can sell the drug off-label and get the US tax
payer to pay for it even if it is not even FDA proven to be safe or effective. The drug companies
promote these patented off-label drugs by deceptive direct-to-consumer and direct-to-doctor marketing
efforts. The practice of marketing drugs for purposes not backed by science is called “off-label
promotion.” Off-label drug promotion undercuts expectations that drug safety and efficacy have been
fully evaluated. The National Alliance for the Mentally Ill (NAMI) is a 501 C 3 which is funded by
pharmaceutical companies such as Eli Lilly to provide educational materials to both doctors and
patients touting the great benefits of the newly patented medications. Off-label promotion is illegal,
but the pharmaceutical industry pays their attorneys well to fight the FDA in court and when they are
finally criminally convicted the criminal penalties are not high enough to really prevent re-occurrence.
The pharmaceutical industry's political agenda is profit making – not provision of affordable, safe,
health care for all. When the government becomes a third party payer for off-label drug use and the
Medicare/Medicaid legislation mandates payment of any cost of psychiatric drugs then administrators
can not place reasonable cost-saving measures in place. When newer, more expensive drugs are used
off-label, it increases health care costs. The pharmaceutical industry has effectively turned welfare
recipients into human subjects for the testing of their patented drugs off-label and lobbied for the
federal government Medicare program to pay for this off-label use. Deceptive marketing through
contract with prescribing doctors and other medical professionals has expanded the off-label drug use
in this country and has increased health care costs. Highly profitable and expensive patented
medications are over-used and our population is over-medicated. Off-label drugs such as gabapentin
for chronic pain and olanzapine (Zyprexa) for dementia have shown that off-label use has potentially
very negative consequences. The highest rates of off-label use were for anticonvulsants (74%),
antipsychotics (60%), and antibiotics (41%). In an examination of off-label prescribing of 160
common drugs, off-label use was also found to account for 21% of all prescriptions, and most off-label
drug uses (73%) were shown to have little or no scientific support. Atypical antipsychotics and
antidepressants were particularly likely to be used off-label without strong evidence. ( Radley DC,
Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med
2006;166: 1021-6.)


Getting informed consent from a patient is a process, not just a formality, and engaging in that process
is of the essence of good medical care. But informed consent can not happen when research data is
suppressed and safety information is with held from prescribing doctors and patients. Informed
consent to use a medication 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 is an essential part of the standard of care in medicine. 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. Wards of the court have surrogate decision makers for both legal and medical decisions,
thus wards are prevented even from effective appeal to the Judge or even to their US
Congressmen/Congresswomen. Thus the pharmaceutical industry's influence on surrogate decision
makers such as doctors can effectively control what medical care is given. In the U.S.A. the
guardianship system offers few procedural protections, and has spawned a profit-driven professional
guardianship industry that often enriches itself at the expense of society’s most vulnerable members—
the mentally ill.


We must support the right of federal regulatory agencies to do their job in researching what is safe and
what is not. The Food and Drug Administration's restrictions on off-label promotion serve two
substantial interests: ensuring that both doctors and consumers receive accurate, scientifically based
information, and assuring that drugs have been proven safe and effective. Right now Jazz
Pharmaceuticals is off-label marketing Xyrem which is the sodium salt of GHB – a well known date
rape drug. Xyrem is a Schedule III drug, but when diverted to illegal use it is a Schedule I DEA
Controlled Substance. In the December 2012 case US v Caronia, the company appealed its conviction
for off-label promotion claiming constitutional free speech. The ruling US v Caronia removes the
liability for drug sales representatives which are left unsupervised 99 % of the time, yet control much
of the industry's communication with physicians.


We need to hold elected officials accountable for the public health and safety and therefore we need to
know who is giving them campaign contributions in order to influence their decisions. The
pharmaceutical industry is currently influencing our elected officials so effectively that we are actually
force drugging wards of the court with off-label psychiatric drugs that have no proven efficacy or
safety. Pharmaceutical lobbying is hidden within so many countless NGO's that we have no idea which
elected official is being influenced. This money from secret sources has lead to wide spread corruption
within the health care industry and has undermined the protections for human subjects, patients and has
forced the US taxpayer to pay for expensive off-label drugs which are not only ineffective but in many
cases dangerous.


Please update and strengthen the FEC’s disclosure rules to protect our democracy.


Today the pharmaceutical industry has unprecedented ability to spread money to influence thinking,
mental health practice, and policy making. We need to impose reasonable restrictions on those who
can exercise such immense financial and political power.


For additional information please see my written statement for the record, The State of Civil and
Human Rights in the United States, Senate Judiciary Subcommittee on the Constitution, Civil Rights
and Human Rights, December 9, 2014 or visit my website:
http://MedicalWhistleblowerNetwork.Jigsy.com

Part 2 - Testimony of Gerald Rogan, MD, before California Senate Committee

"When even one American -who has done nothing wrong - is forced by fear to shut his mind and close his mouth, then all Americans are in peril."

                                                                                            ~ Harry S. Truman ~

Medical Whistleblower United Nations UPR Report 2010

"The universal rights of assembly and free speech must be protected, and the United States stands with all who seek to exercise those rights."

-- President Barack Obama.

An Example of a Medical Whistleblower

One of these essential Medical Whistleblowers was Allen Jones who was an investigator for the Pennsylvania Office of Inspector General of the Food and Drug Administration.  He wrote an excellent report about a criminal corruption of our governmental processes for the approval of pharmaceutical drugs and their use on vulnerable populations such as the elderly,  prisoners,  welfare recipients,  the homeless,  children, teenagers in rehab and the mentally ill.  His report as well as other supporting evidence can be seen at this link from the Psychiatric Law Project in Anchorage Alaska - Attorney Jim Gottstein.

Allen Jones Report

International Convention on the Elimination of All Forms of Racial Discrimination 8-29-15 (CERD)

MEDICAL WHISTLEBLOWER ADVOCACY NETWORK


Follow Up Report to the


United Nations Human Rights Committee


Concerning the implementation of obligations of
The United States of America


Pertaining to the


International Convention on the Elimination of All Forms of Racial Discrimination (CERD)
As of August 29, 2015

 


NGO ASSESSMENT OF ACTIONS GOVERNMENT HAS TAKEN ON ISSUE SINCE REVIEW
CERD/C/USA/CO/7-9


August 29, 2014 (adoption of the Concluding Observations)
August 29, 2015 (Deadline for the State follow-up report)


Current Status: Report of the State still pending REPORTING ORGANIZATION


Medical Whistleblower Advocacy Network


Contact Information: Dr. Janet Parker DVM, Executive Director
 

FOLLOW-UP RECOMMENDATION REPORT WILL ASSESS
CERD articles: 5(b) and 6 ASSESSMENT GRADE
Reply/Action of the State party not satisfactory


C1: Response received but actions taken do not implement the recommendation

RELATED REPORTS BY MEDICAL WHISTLEBLOWER ADVOCACY NETWORK (MWAN)


1) Medical Whistleblower Advocacy Network CAT report, Voiceless Victims: Wards of the Court, 9/22/14 to the 53rd Session in Geneva on November 12 and 13, 2014.
2) Medical Whistleblower Advocacy Network (MWAN), Voiceless Victims: Wards of the Court, Report March 16, 2015. ISSUE 1 PARAGRAPH 17 EXCESSIVE USE OF FORCE BY LAW ENFORCEMENT OFFICIALS


“While recognizing the efforts made by the State party to intensify the enforcement of relevant laws, the Committee reiterates its previous concern at the brutality and excessive use of force by law enforcement officials against members of racial and ethnic minorities, including against unarmed individuals, which has a disparate impact on African Americans and on undocumented migrants crossing the United States-Mexico border (CERD/C/USA/CO/6, para.25). It also remains concerned that despite the measures taken by the State party to prosecute law enforcement officials for criminal misconduct, impunity for abuses, in particular those committed by the Customs and Border Protection (CBP) against Hispanic/Latino Americans and undocumented migrants, remains a widespread problem (arts. 5(b) and 6).”

RECOMMENDATION BY COMMITTEE
“The State party should: (a) “Ensure that each allegation of excessive use of force by law enforcement officials is promptly and effectively investigated; that the alleged perpetrators are prosecuted and, if convicted, punished with appropriate sanctions; that investigations are re-opened when new evidence becomes available; and that victims or their families are provided with adequate compensation;”

RECOMMENDATION BY THE COMMITTEE
“(The State party should) also (b) “Intensify its efforts to prevent the excessive use of force by law enforcement officials by ensuring compliance with the 1990 Basic Principles on the Use of Force and Firearms by Law Enforcement Officials, and ensure that the new CBP directive on the use of force is applied and enforced in practice;” CURRENT SITUATION/UPDATE: EXECESSIVE FORCE, ON DISABLED PERSONS OF COLOR


Racial profiling - the targeting of people by law enforcement officers based on their race or some other aspect of their identity - is a widespread and growing problem in our country. Thus being a person of color and also disabled increases the risk of excessive force by police. More than 60% of the people in prison are now racial and ethnic minorities. For Black males in their thirties, 1 in every 10 is in prison or jail on any given day. These trends have been intensified by the disproportionate impact of the "war on drugs," in which two-thirds of all persons in prison for drug offenses are people of color. i Many killed by the police were disabled persons who were also persons of color.ii These disabled victims of police force were often shot and killed by police after there was a request for police assistance to get the person to mental health care.iii Nationally half of the people killed by police officers had psychiatric disabilities.iv In many cases, police were responding to requests for assistance to get the person mental health care. Police are much more prone to consider subjects dangerous and use lethal force against those subjects who are African American men, even when their disability is known to police. The responding police officers knew at the time of the lethal incidents that the subjects were unstable psychiatric patients and yet police interaction escalated to lethal force. This calls into question whether police officers should have instead respected the comfort zone of the subject, engaged him/her in nonthreatening communications and used the passage of time to defuse the situation rather than precipitating a deadly confrontation.

Recent Police Excessive Force to Disabled Persons of Color:


 August 2015 San Francisco California, a black homeless man with prosthetic leg was violently restrained by a group 14 police officers for 30 minutes. The police were responding to a call about a black man who was waving his sticks in the air. The “weapons” turned out to be nothing but his crutches. “These are my crutches. I use these to walk,” the man said in the video as the cops took them away from him. At one point, one of the officers was clearly seen kneeling on the victim’s prosthetic leg to contain him and the subject was crying out in pain. The disabled man was later released without being charged with anything.v
 March 2015 An unarmed, homeless, disabled African-American, named Africa, was shot by Los Angeles Police Department (LAPD) officers.
 January 2015 Tanisha Anderson, a 37 year old black woman suffering from heart disease and mental illness died in police custody as a result of being physically restrained in a prone position by Cleveland police.
 March 16, 2014 James Matthew Boyd, 38 years old homeless man suffering from schizophrenia was fatally shot by Albuquerque Police Department officers.
 August 2014 Ezell Ford, a 25-year-old African-American man, diagnosed with depression, bipolar disorder and schizophrenia, died from multiple gunshot wounds after being shot by Los Angeles Police Department (LAPD) officers.
 August 2014 Kajieme Powell, a 25-year-old black man mentally disturbed man, was shot to death by St. Louis law-enforcement officers after walking toward them with a knife.
 2012 Milton Hall, 49 year old mentally ill black man-carrying pen knife, shot by police.vi
Mental illness is commonly diagnosed in minority groups with greater frequency– possibly because of personal bias and cultural differences. Minorities receive less care and poorer quality of care and 20% of African Americans are uninsured. Thus African Americans are least likely to have a long-term continuous doctor-patient relationship with a medical doctor they trust. African Americans were less likely than others to have received treatment that conformed to recommended practices. The numbers of mentally ill in the state prison population is five times greater than in the general adult population. The number of individuals with serious mental illness in prisons and jails is now estimated to exceed the number in state psychiatric hospitals tenfold. There has been an increase in the use of antipsychotics and antidepressants increased dramatically over the last 5 years with the largest cost going for off-label patented medications. Prisons distribute psychotropic medications to their inmates at an estimated cost to taxpayers of about $9 billion annually. Inmates who received some psychotropic medication, showed a greater ratio of aggressive incidents per days on medication than when off medication.vii These psychiatric drugs have a FDA black box warning labels that indicate that these drugs increase violent thoughts and suicidal ideation.
Common issues in law enforcement and disabled persons:
 Unexpected actions taken by some people with disabilities might be misconstrued by officers or deputies as, 'suspicious,' or, 'illegal,' activity or uncooperative behavior.
 People who are deaf or hearing impaired, or who have speech disabilities, or intellectual disabilities, or who are blind or visually impaired may not recognize or be able to respond to directions from police officers. These people with disabilities might erroneously be perceived as being, 'uncooperative.'
 Some people with disabilities may have a staggering gait, or slurred speech as a result of the disabilities they experience, or the medications they take. The characteristics, which may be associated with neurological forms of disabilities, mental or emotional disturbances or conditions, or medical conditions such as hypoglycemia, might be perceived by police officers as intoxication.

ACTIONS TAKEN BY THE STATE PARTY IN REGARDS TO EXCESSIVE FORCE ON PERSONS WITH DISABILITIES:


Numerous studies by public policy experts and the Department of Justice have documented concerns regarding the use of excessive force against persons of color, migrants, immigrants, asylum seekers and other minorities. Policy recommendations were are not really implemented. Currently collaboration and joint planning of educational outreach by police departments to include these protection and advocacy experts to provide human rights training for field law enforcement officers is limited. Many police departments are instead depending on training modules which are primarily based on the medical model of disability rather than a human rights model. Under the medical model, disabled people are defined by their illness or medical condition. They are dis-empowered on the basis of a medical diagnosis used to regulate and control their access to social benefits, housing, education, leisure and employment. This model promotes the view of a disabled person being a dependent and needing to be cured or cared for, and it justifies the way in which disabled people have been systematically excluded from society. Alternatively, police agencies, use a charity model of disability, one in which disabled persons are helpless victims needing ‘care’ and ‘protection’. The following federally funded agencies and non-profits are able to provide guidance and training on human rights issues related to use of police force but are currently underfunded, under resourced, and often not consulted.


 Protection and Advocacy for Individuals with Mental Illness (PAIMI) program was established by Congress in 1986.
 Protection and Advocacy for Individuals with Developmental Disabilities (PADD) was established under the Developmental Disabilities Assistance and Bill of Rights Act, 42. U.S.C. Section 6000 et. seq.
 The Protection and Advocacy of Individual Rights (PAIR) operates in each state under the Rehabilitation Act of 1973 as amended in 1992.
 The Protection and Advocacy for Beneficiaries of Social Security (PABSS), was established pursuant to the Ticket to Work Incentives Improvement Act of 1999.
 Protection & Advocacy for Individuals with Traumatic Brain Injury (PATBI) Program was created by the Traumatic Brain Injury (TBI) Act of 1996 (Public Law 104-166).


May 18, 2015 San Francisco v Sheehan appeal to Supreme Court was decided. Police officers who forcibly entered the room of a woman with a mental disability and shot her are entitled to qualified immunity from a lawsuit seeking redress for the woman’s injuries, because there was no clearly established law requiring them to accommodate her mental illness. The case involved a 2008 police shooting of a black woman in her mid-50s with a history of psychiatric disability who is in crisis. Instead of waiting for back-up from properly trained officers, two police officers entered Sheehan's room with guns drawn and proceeded to shoot her five times.

 

IMPACT OF THE ACTION OF THE STATE PARTY (IF ANY)


There has been very little decrease of incidents of excessive police force to minorities and persons of color who are disabled.
The Helping Families In Mental Health Crisis Act, the Murphy bill HR 3717 would slash funding by over 85% and impose severe restrictions on the minimal program remaining. HR 3717 is an attack on the recovery model of mental health care that empowers consumers to take an active role in their care planning and decision making. HR 3717 will make it easier to discriminate against people with disabilities in housing, education and employment, and lead to fewer individuals receiving the treatment they need. The bill would eliminate evidence-based, peer-run services and supports that have a proven record of reducing health care costs and helping people stay out of the hospital and live successfully in their communities. The Protection and Advocacy for Individuals with Mental Illness (PAIMI) program is a critical program that protects the lives of those with mental health needs.viii If not for the funding and authority of the federal PAIMI program, persons with psychiatric disabilities would continue to be abused, neglected and warehoused in atrocious conditions without access to an effective advocate or legal remedy. With PAIMI funds, there is monitoring of conditions in state psychiatric hospitals significant progress in advocating to eliminate deadly restraint practices, promote trauma-informed care that allows people to recover, and protect individuals from sexual harassment and assault. PAIMI is also successful in advocating for housing opportunities for people with mental health disabilities, many of whom were formerly homeless.ix HR 3717 also threatens federal block grant monies going to the states by making the funding contingent on the enactment of Involuntary Outpatient Commitment. PAIMI believes that it is the availability of appropriate services and not the court order that keeps people engaged in mental health care. Many mental health providers believe that coercive treatment is detrimental and makes individuals reluctant to seek treatment or identify as having a mental health issues.

 

COMMENTS


The human rights model positions disability affirms that all human beings irrespective of their disabilities have certain rights which are inalienable. This model builds upon the spirit of the Universal Declaration of Human Rights, according to which, ‘all human beings are born free and equal in rights and dignity.’ The principle of diversity provides the foundation to accept disability as part of human variation. “Nothing about us without us”. Disability rights advocates and in particular those with lived experience are not engaged to provide policy input or be involved in curriculum development of police training. Examples of peer support groups for those with mental disabilities include examples such as Intentional Peer Support (Bristol, VT),x Western Mass Recovery Learning Community (Holyoke, MA),xi and The Veterans Listening Project (Syracuse, NY).xii It is quite unfortunate that National Alliance on Mental Illness (NAMI) has increasingly been looked to by law enforcement departments for providing information about community integration based on outpatient commitment orders. NAMI has been in strong support of the Murphy Bill HR 3717 which would slash funding to the Protection and Advocacy for Individuals with Mental Illness (PAIMI) program.


i The Sentencing Project, http://www.sentencingproject.org/
ii David Perry, “To assess LAPD shooting, look past the moment of gunfire.” CNN.com, 3/2/15, http://www.cnn.com/2015/03/02/opinion/perry-lapd-police-shooting/index.html
iii David Perry, “Psychiatric Disability & the Police: The search for reasonable accommodations”CNN.com, 8/26/14 http://www.cnn.com/2014/08/26/opinion/perry-police-shooting/index.html?hpt=op_t1
iv Deadly Force, Police and the Mentally Ill, 4 part series Portland Herald Press, http://www.pressherald.com/interactive/maine_police_deadly_force_series_day_1/
v http://www.presstv.ir/Detail/2015/08/18/425299/Black-Handicapped-Police-Brutality
vi http://www.huffingtonpost.com/2014/10/27/milton-hall-shooting-video_n_6057402.html
vii Workman, D. G., & Cunningham, D. G. (1975). Effect of Psychotropic Drugs on Aggression In a Prison Setting. Canadian Family Physician, 21(11), 63–66.
viii American Bar Association, 3/31/14 Letter to The Honorable Joe Pitts, Chairman of the Committee on Energy and Commerce, Subcommittee on Health, U.S. House of Representatives http://www.ndrn.org/images/Documents/Media/ABA_letter_on_hr_3717.pdf
ix Submitted Testimony of the National Disability Rights Network, On a Legislative Hearing on H.R. 3717
The Helping Families in Mental Health Crisis Act. April 3, 2014
x Intentional Peer Support, Sherry Mead, 187 Jerusalem Rd. Bristol, VT 05443, info@intentionalpeersupport.org, 802-453-6786.
xi Western Mass Recovery Learning Community, 187 High St., Suite 303, Holyoke, MA 01040, 413-539-5941, info@westernmassrlc.org
xii The Veterans Listening Project, Syracuse, New York, www.veteranslisteningproject.org

“The Constitution is not an instrument for the government to restrain the people, it is an instrument for the people to restrain the government - lest it come to dominate our lives and interests”.
- Patrick Henry -

Abduction of Children - WWASPS Escort to torture

"This is a very powerful truth. All human beings are born free and equal in dignity and rights. This is the first article of the 1948 Universal Declaration of Human Rights. The Declaration represents the first time that universal human rights were spelled out for all people in a civil and individual context. But many of our faiths and holy books have words of wisdom and assertions of human rights in various forms. They all assert the equality and freedom of people; we are all born into freedom and other people can only make us slaves if we accept and succumb. All faiths declare the unity of human beings and the freedom of all."

—UNFPA Executive Director Thoraya A. Obaid

Health Professionals have a Duty to Report Human Rights Violations

Health professionals also have a duty to support colleagues who speak out against human rights violations. Failure to do so risks not only an infringement of patient rights and a contravention of the declarations listed above but also brings the health professions into disrepute.

The World Medical Association’s Declaration of Tokyo reiterates the prohibition of any form of medical participation or medical presence in torture or ill-treatment.  World Psychiatric Association’s Declaration of Hawaii, prohibits the misuse of psychiatric skills to violate the human rights of any individual or group. The International Conference on Islamic Medicine made a similar point in its Declaration of Kuwait, which bans doctors from allowing their special knowledge to be used “to harm, destroy or inflict damage on the body, mind or spirit, whatever the military or political reason”.   Similar provisions are made for nurses in the directive on the Nurse’s Role in the Care of Detainees and Prisoners.

The World Medical Association’s resolution on human rights calls on all national medical associations to review the human rights situation in their own countries and ensure that doctors do not conceal evidence of abuse even where they fear reprisal.  It also requires that they support individual doctors who call attention to human rights abuses.  The World Medical Association’s subsequent Declaration of Hamburg reaffirms the responsibility of individuals and organized medical groups worldwide to encourage doctors to resist torture or any pressure to act contrary to ethical principles. It calls upon individual doctors to speak out against maltreatment and urges national and international medical organizations to support doctors who resist such pressure.

An absolutely fundamental precept of modern medical ethics is that patients themselves are the best judge of their own interests. This requires health professionals to give normal precedence to a competent adult patient’s wishes rather than to the views of any person in authority about what would be best for that individual.

The World Medical Association’s Declaration of Lisbon specifies the duty for doctors to obtain voluntary and informed consent from mentally competent patients to any examination or procedure. This means that individuals need to know the implications of agreeing and the consequences of refusing. Before examining patients, health professionals must, therefore, explain frankly the purpose of the examination and treatment. Consent obtained under duress or as a result of false information being given to the patient is invalid, and doctors acting on it are likely to be in breach of medical ethics. The graver the implications of the procedure for the patient, the greater the moral imperative to obtain properly informed consent. (Istanbul Protocol -  UN 2004)

Three safeguards advocated by the Committee for persons held in police custody are:

 

(a) The right of a person deprived of liberty, if he or she so desires, to inform immediately a third party (family member) of the arrest;
(b) The right of a person deprived of liberty to have immediate access to a lawyer;
(c) The right of a person deprived of liberty to have access to a physician, including, if he or she so wishes, a physician of his or her own choice.

Even when doctors are appointed and paid by a third party, they retain a clear duty of care to any patient whom they examine or treat. They must refuse to comply with any procedures that may harm patients or leave them physically or psychologically vulnerable to harm. They must ensure that their contractual terms allow them professional independence to make clinical judgments.  Doctors must ensure that any person in custody has access to any medical examination and treatment needed.

The State is responsible for protecting alleged victims, witnesses and their families from violence, threats of violence or any other form of intimidation that may arise pursuant to the investigation. Those potentially implicated in torture should be removed from any position of control or power, whether direct or indirect over complainants, witnesses and their families as well as those conducting investigations. Investigators must give constant consideration to the effect of the investigation on the safety of the person alleging torture and other witnesses.

In his autobiography, You Can’t be Neutral on a Moving Train, Howard Zinn wrote:

“To be hopeful in bad times is not foolishly romantic. It is based on the fact that human history is a history of not only cruelty, but also of compassion, sacrifice, courage, kindness. What we choose to emphasize in this complex history will determine our lives. If we see only the worst, it destroys our capacity to do something. If we remember those times and places – and there are so many – where people have behaved magnificently, this gives us the energy to act, and at least the possibility of sending this spinning top of a world in a different direction. And if we do act, in however small a way, we don’t have to wait for some grand utopian future. The future is an infinite succession of presents, and to live now as we think human beings should live, in defiance of all that is bad around us, is itself a marvelous victory.”

Right to Life - MWAN statement regarding Non-Consensual Medical Experimentation

Medical Whistleblower Advocacy Network


Statement for consideration by the Human Rights Committee during the half-day general discussion in preparation 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.


Presented by


Dr. Janet Parker DVM


Medical Whistleblower Advocacy Network greatly appreciates the opportunity to be able to provide our input to the Half Day of General Discussion commencing the Committee's process of developing its General Comment No. 36 on the "Right to Life" with regard to article 6 of the International Covenant on Civil and Political Rights (ICCPR).


This general comment offers the Committee an opportunity to more fully examine the right to life, including the consideration of the principles of equality and non-discrimination regarding persons within a medical context. Human Subjects of medical experimentation are placed at risk when investigating unconfirmed hypotheses about treatments. Research subjects can experience serious adverse health effects as a result of participation in trials including death, shortened life expectancy, or significant decrease in the quality of the person’s life. Patients/Human Subjects can also be placed at risk by patterns of investigative medical practices that are premature and based on an inadequate understanding of a new technique or new drug – or because of direct deceit or fraud by drug or medical device manufacturers about their products.


A person’s equal enjoyment of the right to life is clearly placed at risk by state’s failures to take positive measures to address human subject’s protections in biomedical research whether it takes place in a university or governmental agency setting or whether it takes place in a clinical therapeutic setting. 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, Roma, children, people with disabilities, racial and ethnic minorities are more likely to be targeted by researchers. It is important to put in place international programs, policies and strategies to address global systemic violations of human subject’s protections.


At the end of the Second World War, at the Nuremberg Trials, 23 doctors including Dr. Joseph Mengele were placed before the international court for atrocities they committed under the guise and pretense of medical science. The Nazi doctors had conducted medical experiments on numerous prisoners – especially persons who were Jewish, Roma, other minorities and disabled children and adults.

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 "Right to Life" with regard to article 6 of the International Covenant on Civil and Political Rights (ICCPR). 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.”


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 in Guatemala infected hundreds of mental patients with sexually transmitted diseases.


1944-1945 Japan - Doctor Akira Makino performed surgery and amputations on condemned prisoners, mostly Moro Muslims, including women and children, while he was stationed on Mindano.


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.


1945-1955 Sweden- The Vipeholm dental experiments patients of Vipeholm Mental Hospital


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.


1950’s United Kingdom - human experimentation at Porton Down and death of Ronald Maddison.


1966 UK -British anesthesiologist Henry K. Beecher published 22 medical studies in which patients had been subjects with no expected benefit to the patient of the experiment including infusing patients with live cancer cells.


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.


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.


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. Because of a change in U.S. law in 1996, allowed non-consensual research on trauma victims on the pretext that they were unconscious and thus unable to give consent. It was later concluded that there were more deaths and heart attacks in the individuals who had received PolyHeme than those who had not. The blood substitute was therefore not licensed.

Present – U.S.A. and globally - Use of non-FDA approved psychiatric drugs “off-label” on wards of the court, elderly, foster children and school children, prisoners, and other minorities.


Medical research and the approval of prescription drugs is a global concern. 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 also 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).


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


Adequate informed-consent process is not just a risk management process, it is good medical practice. Informed consent should define risks and potential benefits, but also take into consideration alternative treatments. Informed consent is an agreement to do something or to allow something to happen, made with complete knowledge of all relevant facts, such as the risks involved. There is a general right for all human persons to be free of inhuman treatment and individuals also have the legal right to privacy under international human rights law.
International human rights case law supports the concept that individuals do have the legal right to decide whether a proposed medical treatment will be performed on them. The human right to decide one's own treatment does not disappear just because it is more convenient or financially more beneficial for the caregivers or for the family members of the individual to force treatment. This right to decide to refuse treatment is a human right we all enjoy. Mental health treatment under human rights law should be the same as other treatments in regards to consent to treatment. But it is a sad fact that this right has not necessarily been consistently protected and thus through our mental health systems extended to people with mental disabilities. Patients need to have the intellectual capacity to understand basic information about their diagnosis and proposed treatment. Correspondingly doctors have a responsibility to communicate the information in terms the patient can understand and to make efforts to be available to answer questions the patient may have.


Informed consent, with specific reliance on the Nuremberg Code, is also the basis of the International Ethical Guidelines for Biomedical Research Involving Human Subjects, the most recent guidelines promulgated by the World Health Organization and the Council for International Organizations of Medical Sciences (1993). The Nuremberg Code focuses on the human rights of research subjects, the Declaration of Helsinki focuses on the obligations of physician-investigators to research subjects, and the federal regulations emphasize the obligations of research institutions that receive federal funds.


In 1974, the U.S.A. signed a law empowering the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter called the National Commission or Commission) was charged by the U.S. Congress to identify the basic ethical principles that should underlie the conduct of research involving human subjects. In response to this charge, the National Commission published the Belmont Report in the Federal Register on 18 April 1979.

The Belmont Report iv concerning the Ethical Principles and Guidelines for the protection of human subjects of research

The Belmont Report admits that research involving human subjects always inherently includes ethical issues and raises moral problems. The Belmont report delineates 3 major principles: Respect for persons, Beneficence and Justice. The Belmont report explains ethics in a manner which is understandable to a diverse group of professionals and is reflective of a common morality. It provides a strong protection regarding informed consent and also discusses justice and injustice in regards to vulnerable populations. Belmont was then adopted in its entirety as a policy statement by U.S. Department of Health, Education, and Welfare (DHEW) - now called the Department for Health and Human Services (DHHS). Its principles of respect for persons, beneficence, and justice are regarded as the three quintessential requirements for the ethical conduct of research involving human subjects by the National Institutes of Health (NIH) Office for Protection from Research Risks (OPRR). In the US, most research involving human participants funded by federal government agencies is subject to the Common Rule — a set of regulations delineating the requirements for review by an institutional review board. Similar rules apply to research regulated by the Food and Drug Administration (FDA). Although US institutions could decline to apply the Common Rule to research that does not receive federal funding, relatively few do so.


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 true lessons of the past do need to be revisited. Take for example, the Tuskegee study which was highly publicized in at least 16 research articles which appeared in reputable medical journals, such as the Journal of the American Medical Association, the New England Journal of Medicine and the American Journal of Public Health. The Nuremberg Code had been adopted in 1947 and the ethical principle of informed consent was widely accepted by the medical community, yet the National Medical Association and its members remained silent to the abuse of human subjects at Tuskegee. In spite of the fact that this abuse of human subjects was not hidden from view and that the lessons from the Nuremberg trials should have been fresh in people’s minds – for 40 years no medical professional or medical association stood up to complain about the violations of the human rights of the human subjects. The white coat of silence that shields medical professionals meant that if anyone did object, they were certainly not going to make their concerns public. So during the Nazi era, doctors stood silent while atrocities occurred and then again years later, in the U.S.A., doctors were silent for 40 years about the abuses of the African American men in the Tuskegee syphilis trials. Racial bias against these poor black men made their abuse at the hands of the researchers almost unnoticed.


Concerns for the honesty and integrity of the medical profession are not new. But what is different is how complex the provision of medical care has become and the worldwide nature of today’s medical community. And thus how difficult it is for the average patient, a lay person, to understand whether they are getting safe and effective medical care. Even more difficult to comprehend, is the complex environment of medical research, which now often uses clinical doctors in their therapeutic settings to research the effects of newer drugs and treatments – often before these medications or procedures have been fully reviewed by the state’s regulatory agency (in the U.S.A. this is the F.D.A.).

There is a global distribution of pharmaceutical products. Medical research done in one nation will be used to obtain regulatory approval in another country. A drug approved for use in one country will rapidly acquire acceptance in other countries often through reciprocity. Thus if one nation has poor regulatory control over medical products or prescription medications, it will affect other nation states as well. A recent report of the US Department of Health and Human Services inspector general, indicated that “federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.” v In the U.S.A. there is an increased use of prescription drugs “off-label” or without the approval for that use by the Food and Drug Administration (FDA). This essentially means that these drugs have not been proven by scientific evidence to be safe or effective. These “off-label” medications are quickly marketed in other countries “off-label” as well as in the U.S.A.


Deceptive and coercive marketing practices by the pharmaceutical industry are common place. The practice of marketing drugs for purposes not backed by science is called “off-label promotion.” In addition, the restrictions upon who can prescribe psychiatric drugs have been reduced, thus allowing persons with lesser medical credentials (such as nurses with prescription authority) to prescribe these mind altering drugs. The pharmaceutical industry has provided marketing and promotional educational training and materials for those wishing to gain prescription authority to prescribe these drugs. This training is biased to sell their product, not to maximize patient informed consent and medical safety for the public.


In the U.S.A., doctors routinely prescribe medications based on little evidence of their benefit. This is because there are high profit incentives to prescribe newly patented medications and many inducements offered by the pharmaceutical companies for doctor to prescribe their products. In an examination of off-label prescribing of 160 common drugs, off-label use was also found to account for 21% of all prescriptions, and most off-label drug uses (73%) were shown to have little or no scientific support. The highest rates of off-label use were for anticonvulsants (74%), antipsychotics (60%), and antibiotics (41%). Atypical antipsychotics and antidepressants were particularly likely to be used off-label without strong evidence. vi The very drugs which are most often prescribed off-label with little or no scientific support to indicate that the medication is truly beneficial to the patient, actually are the same drugs which commonly cause serious debilitating medical conditions and even death.


In the U.S.A. the rates of diagnosis of psychiatric disorders in children and the elderly has dramatically increased in recent years. Nearly 70 % of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) task force members report having ties to the pharmaceutical industry. These drugs are widely prescribed for unapproved uses, including other non-approved conditions significantly boosting their sales. These prescription drugs do not live up to their marketing promises but instead have been known to cause serious, even fatal side-effects, particularly in children and the elderly.

Lives of some our most vulnerable citizens have been irreparably damaged and many have been lost to fatal adverse effects and even to suicide.


All subjects or their representatives who consent to participate in medical research should be enabled 1) to freely choose whether or not to become enrolled, 2) to comprehend what is being told to them, and 3) to understand essential information about what the research entails, what their options are, and so on.


So when a doctor prescribes an “off-label” drug for a patient in a therapeutic setting but is a cooperating doctor in a research protocol to expand the use of that still not yet approved medication – how is that not medical research? If that physician received a kickback, or research funding, or free educational programs, is that physician still acting in the patient’s best interest? If that doctor removes the FDA mandated patient information insert from the medication bottle and instead gives the patient a glossy brochure printed by the pharmaceutical marketing agency – is that still getting true informed consent? If that doctor answers all the patient’s questions based on a script and training he got from the pharmaceutical sales representative – is he still actually doing medicine or acting as a marketing sales person himself? And if it is medical research, doesn’t the patient have the right to know that that medication was never found by scientific evidence to be safe or effective and that in reality the patient is actually a guinea pig for the pharmaceutical company’s research.


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. In the U.S.A. many medical institutions are allowed to include wards of the State in research that presents greater than minimal risk to the subject with no prospect of direct benefit for the research subject. Forcing wards of the court to take medications that are “off-label” (not approved for that use by the Food and Drug Administration), is tantamount to human experimentation on the vulnerable wards of the court. Such violations of human subject provisions are routine with many patients in locked state and federal institutions given psychiatric drugs for “off-label uses.” Problems of patient abuse occur including: excessive dosing for purposes of chemical restraint, poly-pharmacy with multiple medications, lack of informed consent and the use of medication with little or no direct doctor/patient contact. According to the drug data firm IMS Health, the 2009 worldwide sales of antipsychotic drugs was $23.25 billion, and the largest market for these products is in the U.S.A. Antipsychotics (neuroleptics) are a controversial class of drugs, examples include: Risperdal (approved in 1993), Zyprexa (1994), Seroquel (1997), Abilify (2002), and Saphris (2009).


All psychotropic medications have the potential to induce serious adverse effects and these psychiatric drugs are not of small risk because they cause massive changes in the way the brain functions. Long term studies have indicated that there are severe debilitating and sometimes fatal effects of these drugs. Possible negative effects are minimized or not even discussed at all. There are risks of long term psychological harm, physical harm, social harm and economic harm. Many of these drugs cause symptoms that can themselves be construed as mental illness. The probability of developing Parkinson’s like symptoms is also great. These powerful mind-altering psychotropic
medications do cause potentially disabling and life-threatening side effects such as: suicide and violence toward others, increased risks of stroke, cardiovascular disease, metabolic syndrome, diabetes, acute closed angle glaucoma, seizures, fainting, and decreased infection-fighting white blood cells. One adverse effect of these medications is neuroleptic malignant syndrome (NMS), a drug induced, toxic, potentially fatal condition resulting in renal failure (10% to 38% of NMS patients die). Early recognition and immediate emergency medical treatment of NMS is necessary to prevent death. It is estimated that that over 50% of individuals with mental illnesses who are prescribed psychotropic drugs also have other serious medical conditions requiring other medications. It takes medical expertise and experience to properly prescribe and monitor these complex medical interactions. Side effects of these drugs include somnolence, obesity, and impaired cognition. These psychiatric medications may adversely affect the individual's quality of life and even shorten the person's life expectancy.vii Thus it is important that over-medication minimized, the views of the patient are considered and the quality of life issues explored. So an effective means of reviewing the treatment plans is important.


So can we really trust doctors to do what is always in their patient’s best interest? Clearly the history of violations of the rights of human subjects would teach us that we cannot and therefore some supervision and ethical guidance is necessary. Yet how do we know whether physicians and medical professionals are abusing their power in their private relationships with their patients and using the therapeutic relationship to coerce patients to submit to medical research?


In the U.S.A. the authors of the Belmont Report were aware that monitoring a doctor’s actions within the therapeutic relationship with his patient would be very difficult. The US Federal Regulations governing scientific research and the protection of human subjects does not address many of the difficult ethical questions and the kinds of situations that now occur. The Belmont Report can be used to supplement and augment the US Federal Regulations in order to provide a source of additional ethical guidance for essential protections for human subjects. In addition the US Food and Drug Administration could embrace both the Belmont Report and the Nuremberg Code.


The protection of Human Subjects in biomedical research is clearly a matter of life or death and relates to Article 6: Right to life of the International Covenant on Civil and Political Rights.


Dr. Janet Parker DVM


MedicalWhistleblower@gmail.com

 


i Nuremberg Code Directives for Human Experimentation
ii World Medical Association Declaration Of Helsinki
iii Meador v. Stahler and Gheridian (Middlesex Superior Court C.A. No. 88-6450, Mass. 1993)
iv The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research
v Harris G. Report assails FDA oversight of clinical trials. New York Times 28 Sept 2007. www.nytimes.com/2004/11/19/business/19fda.html
vi Radley DC, Finkelstein SN, Stafford RS. (2006) “Off-label prescribing among office-based physicians.” Arch Intern Med 2006;166: 1021-6.
vii Jackson, G.R., (2005). Rethinking psychiatric drugs: A guide to informed consent. Bloomington, IN: Author House

Part 1 - Testimony of Ian Grady, MD, before California Senate Committee

Part 2 - Testimony of Ian Grady, MD, before California Senate Committee

Human Subjects Protections

Directives for Human Experimentation

NUREMBERG CODE

  1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.

    The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
  2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
  3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
  4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
  5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
  6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
  7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
  8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
  9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
  10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182.. Washington, D.C.: U.S. Government Printing Office, 1949.

45 CFR 46 Protection Of Human Subjects

Guidelines for Conduct of Research Involving Human Subjects at NIH (Gray Booklet) (pdf file)

The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research

Nuremberg Code Directives for Human Experimentation

World Medical Association Declaration Of Helsinki

List of all Institutions Holding Assurances
Note: You must perform a search on “Assurances (FWAs)” from that page

 

Victim’s Rights and Needs: Requirements for a Victim’s Rights System

  • Compensation
  • Redress
  • Testimony
  • Truth
  • Acknowledgment
  • Memory
  • Reparation
  • Justice
  • Prevention (Never Again!)

JUSTICE

“As I've gotten older, I've had more of a tendency to look for people who live by kindness, tolerance, compassion, a gentler way of looking at things.“

~ Martin Scorsese

Senator Whitehouse called on all Americans to remember that the Constitution provides not just basic rights, but a mechanism to make sure that those rights cannot be trampled by wealthy and powerful interests:

"The jury serves as our last sanctuary, as Americans, when the forces of society may be arrayed against us: when the governor’s mansion has been bought by special interests; when lobbyists have the legislature tied in knots; when the newspaper owners have steered public opinion against you – the hard square corners of the jury box stand firm against the influence and money of special interests."

The Seven Social Sins - By Mahatma Gandhi

1. Politics without principles
2. Wealth without work
3. Pleasure without conscience
4. Knowledge without character
5. Commerce without morality
6. Science without humanity
7. Worship without sacrifice.

"Ours is not the task of fixing the entire world at once, but of stretching out to mend the part of the world that is within our reach."

-- Clarissa Pinolla Estes

Toxic Airlines

Gwen Olsen Former Pharmaceutical Sales Representative Speaks Out

Medical Whistleblower - Who We Are

"For every complex problem there is a simple solution that is wrong."

G.B. Shaw 1856-1950,

Irish critic and poet, famous for his 'verbal wit'

CPRD - UPR Town Hall on Treaties, International Mechanisms and Domestic Implementation

Medical Whistleblower Advocacy Network
Disability Rights


Written Testimony regarding
Treaties, International Mechanisms and Domestic Implementation


UPR Town hall July 20, 2015


Marshall Center, U.S Department of State, Washington DC


Regarding: MWAN Submission to the
United Nations Universal Periodic Review of
United States of America


Second Cycle, Twenty Second Session of the UPR
Human Rights Council


Medical Whistleblower Advocacy Network


Contact Name: Dr. Janet Parker DVM


 


Medical Whistleblower Advocacy Network (MWAN) acts as a grassroots advocate for human rights for disabled persons and other individuals. MWAN provides information, referrals, and also direct human rights defender advocacy services.


The United States of America has affirmed to the UN General Assembly that all are created equal and endowed with inalienable rights. The Americans with Disabilities Act (1990) was passed by the US legislature to prohibit discrimination against persons with disabilities. Medical Whistleblower Advocacy Network asks that the USA now ratify the Convention on the Rights of Persons with Disabilities. The Medical Whistleblower Advocacy Network reported in the MWAN 2015 UPR report that:


"President Barack Obama signed the Convention on the Rights of Persons with Disabilities treaty in 2009 and sent it to the U.S. Senate for ratification. Medical Whistleblower Advocacy Network (MWAN), The National Council on Independent Living (NCIL) along with many other disability advocates rallied the Senate alongside the U.S. International Council on Disabilities (USICD). Former Senator Bob Dole lead a bipartisan effort of support to secure the 2/3 Senate vote needed for ratification. Unfortunately on December 4, 2012 the super-majority needed was not reached. Again in 2013 Foreign Relations Committee Chairman, Robert Mendez held two successful hearings on CRPD ratification, but because of opposition the CRPD was not passed. Committee Chairman Mendez brought the matter again forward in 2014, supported again strongly by former Senator Bob Dole and many organizations for the disabled and veterans."


Medical Whistleblower Advocacy Network recommends immediate ratification of the CRPD as stated in our 2015 UPR report. (UN Summary, Office of the United Nations High Commissioner for Human Rights, Human Rights Council, Working Group on the Universal Periodic Review, Twenty-second session, 4–15 May 2015, A/HRC/WG.6/22/USA/3, JS8 paragraph 4). Medical Whistleblower Advocacy Network is concerned that violations, including denial of legal capacity and discrimination against persons with disabilities, are still occurring. (A/HRC/WG.6/22/USA/3, JS8 paragraph 85).


The following countries endorsed the specific recommendation that the USA ratify the Convention on the Rights of Persons with Disabilities (CRPD) (Draft report of the Working Group on the Universal Periodic Review United States of America, May 15, 2015, ( /HRC/WG.6/22/L.10):
 

Nepal 5.18
Sierra Leone 5.19
Kazakhstan 5.20
Australia 5.21
Indonesia 5.24
Ghana 5.32
New Zealand 5.32
Hungary 5.35
Czech Republic 5.38
Chile 5.55
Islamic Republic of Iran 5.57
Guatemala 5.59
Canada 5.59
Bosnia and Herzegovina 5.59
China 5.59


The following countries wrote in support of the recommendation that the US ratify the international human rights instruments from which the US is still not a party (this includes the ratification of the CRPD):


Peru 5.1
Nicaragua 5.2
Purinational State of Bolivia 5.3
Germany 5.4
Viet Nam 5.5
Israel 5.6
Panama 5.7
Tunisia 5.8
Russian Federation 5.9
Gabon 5.14
Bolivarian Republic of Venezuela 5.72
Uruguay 5.74


The United States does not have a national human rights institution accredited by the International Coordinating Committee of National Institutions for the Promotion and Protection of Human Rights. Medical Whistleblower Advocacy Network recommends that the United States (U.S.A.) establish a national human rights institution in accordance with the Paris Principles. Medical Whistleblower Advocacy Network recommends also that the U.S.A. review laws at the federal and state levels with a view of bringing them in line with US’s international human rights obligations. (A/HRC/WG.6/22/USA/3, JS8 paragraph 12) Medical Whistleblower Advocacy Network also recommends the establishment of a human rights institution at the federal level in accordance with the Paris Principles. Medical Whistleblower Advocacy Network supports the recommendation by Cyprus that the USA “Take concrete steps towards ratifying the Rome Statute of the International Criminal Court as early as possible.” (Cyprus 5.70)


Medical Whistleblower Advocacy Network recommended incorporating human rights training and education strategies in public policies. (A/HRC/WG.6/22/USA/3, JS8 paragraph 16)


The recommendation by MWAN to create a Federal Human Rights Institution was mirrored in multiple recommendations by the following countries:


Senegal 5.77
Congo 5.78
Tunisia 5.78
Paraguay 5.78
Chile 5.79
Bolivarian Republic of Venezuela 5.80
Poland 5.81
Sierra Leone 5.83
Republic of Korea 5.84
Sudan 5.85
India 5.86
Nepal 5.86
Panama 5.86
Ukraine 5.86
Democratic Republic of the Congo 5.86
Indonesia 5.86
Kenya 5.87
Kazakhstan 5.88
Gabon 5.89
Morocco 5.90
Hungary 5.90
Nepal 5.92
Philippines 5.93
Russian Federation 5.286


Medical Whistleblower Advocacy Network had in its first cycle UPR report (2010) recommended the following:


"Medical Whistleblower recommends that the U.S.A. should ratify United Nations Convention on the Rights of Disabled Persons (CRDP), the Convention on the Rights of the Child (CRC), the Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW), the International Covenant on Economic, Social and Cultural Rights, The International Convention for the Protection of All Persons from Enforced Disappearance, the International Convention on the Protection of the Rights of All Migrant Workers and Members of Their Families (ICRMW)."


Many nations also echoed these recommendations by Medical Whistleblower Advocacy Network (MWAN) to ratify the Convention on the Rights of the Child (CRC), the Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW), the International Covenant on Economic, Social and Cultural Rights (ICESCR), The International Convention for the Protection of All Persons from Enforced Disappearance (ICCPED), the International Convention on the Protection of the Rights of All Migrant Workers and Members of Their Families (ICRMW).


These nations included:


Uzbekistan 5.15
Philippines 5.15
Trinidad and Tobago 5.15
Mauritius 5.16
Luxembourg 5.17
Nepal 5.18
Sierra Leone 5.19
Kazakhstan 5.20
Australia 5.21
Bulgaria 5.22
India 5.23
Indonesia 5.24
Egypt 5.25
Romania 5.26
Cabo Verde 5.27
Togo 5.28
Paraguay 5.29
Botswana 5.30
Iceland 5.31
Ghana 5.32
Democratic Republic of the Congo 5.33
New Zealand 5.34
Hungary 5.35
Republic of Korea 5.36
The Former Yugoslav Republic of Macedonia 5.37
Czech Republic 5.38
Turkey 5.39
Iraq 5.39
Slovenia 5.39
Bosnia and Herzegovina 5.39
France 5.39
Canada 5.39
China 5.39
Trinidad and Tobago 5.39
Estonia 5.39
Lebanon 5.39
Philippines 5.39
Austria 5.46
Mali 5.47
Sweden 5.48
Timor-Leste 5.48
Algeria 5.48
Maldives 5.48
France 5.48
Portugal 5.48
Slovenia 5.48
China 5.48
Japan 5.48
Canada 5.48
Philippines 5.49
Estonia 5.50
Libya 5.51
Fiji 5.52
Czech Republic 5.53
Honduras 5.54
Chile 5.55
Burkina Faso 5.56
Islamic Republic of Iran 5.57
Slovakia 5.58


The US Summary of Stakeholder Reports has been posted to the OHCHR website as the UN General Assembly Report dated 16 February 2015 of the Human Rights Council, Working Group on the Universal Periodic Review, Twenty-second session 4–15 May 2015. (A/HRC/WG.6/22/USA/3) Medical Whistleblower Advocacy Network is listed as a UN stakeholder JS8.

 

 

“Too often we underestimate the power of a touch, a smile, a kind word, a listening ear, an honest compliment, or the smallest act of caring, all of which have the potential to turn a life around.”
 
― Leo Buscaglia

Medical Whistleblower Advocacy Network

MEDICAL WHISTLEBLOWER ADVOCACY NETWORK

P.O. 42700 

Washington, DC 20015

MedicalWhistleblowers (at) gmail.com

CONTACT

"Never impose on others what you would not choose for yourself."  Confucius

"It is not the critic who counts; not the man who points out how the strong man stumbles, or where the doer of deeds could have done them better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and blood; who strives valiantly; who errs, who comes short again and again, because there is no effort without error and shortcoming; but who does actually strive to do the deeds; who knows great enthusiasms, the great devotions; who spends himself in a worthy cause; who at the best knows in the end the triumph of high achievement, and who at the worst, if he fails, at least fails while daring greatly, so that his place shall never be with those cold and timid souls who neither know victory nor defeat."

Theodore Roosevelt- Excerpt from the speech "Citizenship In A Republic", delivered at the Sorbonne, in Paris, France on 23 April, 1910