Right to health

From Wikipedia, the free encyclopedia

The right to health is the economic, social, and cultural right to a universal minimum standard of health to which all individuals are entitled. The concept of a right to health has been enumerated in international agreements which include the Universal Declaration of Human Rights, International Covenant on Economic, Social and Cultural Rights, and the Convention on the Rights of Persons with Disabilities. There is debate on the interpretation and application of the right to health due to considerations such as how health is defined, what minimum entitlements are encompassed in a right to health, and which institutions are responsible for ensuring a right to health.

Definition

Constitution of the World Health Organization (1946)

The preamble of the 1946 World Health Organization (WHO) Constitution defines health broadly as "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity." The Constitution defines the right to health as "the enjoyment of the highest attainable standard of health," and enumerates some principles of this right as healthy child development; equitable dissemination of medical knowledge and its benefits; and government-provided social measures to ensure adequate health.

Frank P. Grad credits the WHO Constitution as "claiming ... the full area of contemporary international public health," establishing the right to health as a "fundamental, inalienable human right" that governments cannot abridge, and are rather obligated to protect and uphold. The WHO Constitution, notably, marks the first formal demarcation of a right to health in international law.

Universal Declaration of Human Rights (1948)

Article 25 of the United Nations' 1948 Universal Declaration of Human Rights states that "Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services." The Universal Declaration makes additional accommodations for security in case of physical debilitation or disability, and makes special mention of care given to those in motherhood or childhood.

The Universal Declaration of Human Rights is noted as the first international declaration of fundamental human rights, both freedoms and entitlements alike. United Nations High Commissioner for Human Rights Navanethem Pillay writes that the Universal Declaration of Human Rights "enshrines a vision that requires taking all human rights—civil, political, economic, social, or cultural—as an indivisible and organic whole, inseparable and interdependent." Likewise, Gruskin et al. contend that the interrelated nature of the rights expressed in the Universal Declaration establishes a "responsibility [that] extends beyond the provision of essential health services to tackling the determinants of health such as, provision of adequate education, housing, food, and favourable working conditions," further stating that these provisions "are human rights themselves and are necessary for health."

International Convention on the Elimination of All Forms of Racial Discrimination (1965)

Health is briefly addressed in the United Nations' International Convention on the Elimination of All Forms of Racial Discrimination, which was adopted in 1965 and entered into effect in 1969. The Convention calls upon States to "Prohibit and to eliminate racial discrimination in all its forms and to guarantee the right of everyone, without distinction as to race, colour, or national or ethnic origin, to equality before the law," and references under this provision "The right to public health, medical care, social security and social services."

International Covenant on Economic, Social and Cultural Rights (1966)

The United Nations further defines the right to health in Article 12 of the 1966 International Covenant on Economic, Social and Cultural Rights, which states:

The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for:

The reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child;

The improvement of all aspects of environmental and industrial hygiene;

The prevention, treatment and control of epidemic, endemic, occupational and other diseases;

The creation of conditions which would assure to all medical service and medical attention in the event of sickness.

General Comment No. 14 (2000)

In 2000, the United Nations' Committee on Economic, Social and Cultural Rights issued General Comment No. 14, which addresses "substantive issues arising in the implementation of the International Covenant on Economic, Social and Cultural Rights" with respect to Article 12 and "the right to the highest attainable standard of health." The General Comment provides more explicit, operational language on the freedoms and entitlements included under a right to health. 

The General Comment makes the direct clarification that "the right to health is not to be understood as a right to be healthy." Instead, the right to health is articulated as a set of both freedoms and entitlements which accommodate the individual's biological and social conditions as well as the State's available resources, both of which may preclude a right to be healthy for reasons beyond the influence or control of the State. Article 12 tasks the State with recognizing that each individual holds an inherent right to the best feasible standard of health, and itemizes (at least in part) the 'freedoms from' and 'entitlements to' that accompany such a right; however, it does not charge the State with ensuring that all individuals, in fact, are fully healthy, nor that all individuals have made full recognition of the rights and opportunities enumerated in the right to health.

Relation to other rights

Like the Universal Declaration of Human Rights, the General Comment clarifies the interrelated nature of human rights, stating that, "the right to health is closely related to and dependent upon the realization of other human rights," and thereby underscoring the importance of advancements in other entitlements such as the rights to food, work, housing, life, non-discrimination, human dignity, and access to importance, among others, towards the recognition of the right to health. Similarly, the General Comment acknowledges that "the right to health embraces a wide range of socio-economic factors that promote conditions in which people can lead a healthy life, and extends to the underlying determinants of health." In this respect, the General Comment holds that the specific steps towards realizing the right to health enumerated in Article 12 are non-exhaustive and strictly illustrative in nature. 

The inextricable link between health and human rights

Jonathan Mann was a Francois-Xavier Bagnoud Professor of Health and Human Rights and Professor of Epidemiology and International Health at the Harvard T. H. Chan School of Public Health. He was known for being a powerful pioneer and advocate for the promotion of health, ethics, and human rights, championing the theory that health and human rights were inextricably interlinked in a dynamic relationship.

According to Mann, health and human rights are complementary approaches for defining and advancing human well-being. In 1994, Jonathan Mann and his colleagues started the “Health and Human Rights Journal” to underline the importance of this inextricable link between health and human rights.

In the first volume of the “Health and Human Rights Journal,” Jonathan Mann and his colleagues published a transformative article to explore the potential collaboration in health and human rights. In this article, Mann et al. describe a framework for connecting the two domains that are interlinked. This framework is broken into three broad relationships.

The first relationship between health and human rights is a political one. Mann and colleagues state that health policies, programs, and practices have an impact on human rights, especially when state power is considered in the realm of public health. 

Next, the article posits a reverse relationship: that human rights violations have health impacts. It also calls for health expertise to help understand how health and well-being can be impacted by human rights violations through measurement and assessment. 

The third segment of the framework linking health and human rights introduces the concept that the protection and promotion of human rights and health are linked fundamentally in a dynamic relationship. While literature has largely supported the first two relationships, this third hypothesis has not been explored as substantially. 

The article supports this concept by stating that this link suggests there are dramatic practical consequences in the independent operations of, but also in the interaction in activities of, the practice of public health and the practice of human rights. There is what is deemed an interdependence that cannot be negated. Mann and his colleagues further posit that research, education, experience, and advocacy are all required to understand this intersection, in order to understand and advance human well-being globally.

Ultimately, Mann and his colleague’s mission is to convey that, while individual health has been much of the focus for medical and other health provision services, especially concerning physical illness and disability, public health’s focus has more so evolved around how people can be healthy. According to this surprisingly simple definition, public health’s mission is to promote positive health and prevention of health problems – disease, disability, premature death. That is, the traditional sense of individual health as understood and processed by health care services is “one essential condition for health,” but does is not the sole qualifier or an exchangeable term with “health.” In other words, health care services are not sufficient for health, as public health practitioners understand it – there are external factors that have both nuanced as well as pronounced positive and negative impact on health and well-being of the global human population.

Health equity

The General Comment also makes additional reference to the question of health equity, a concept not addressed in the initial International Covenant. The document notes, "The Covenant proscribes any discrimination in access to health care and underlying determinants of health, as well as to means and entitlements for their procurement." Moreover, responsibility for ameliorating discrimination and its effects with regards to health is delegated to the State: "States have a special obligation to provide those who do not have sufficient means with the necessary health insurance and health-care facilities, and to prevent any discrimination on internationally prohibited grounds in the provision of health care and health services." Additional emphasis is placed upon non-discrimination on the basis of gender, age, disability, or membership in indigenous communities.

Responsibilities of states and international organizations

Subsequent sections of the General Comment detail the obligations of nations and international organizations towards a right to health. The obligations of nations are placed into three categories: obligations to respect, obligations to protect, and obligations to fulfill the right to health. Examples of these (in non-exhaustive fashion) include preventing discrimination in access or delivery of care; refraining from limitations to contraceptive access or family planning; restricting denial of access to health information; reducing environmental pollution; restricting coercive and/or harmful culturally-based medical practices; ensuring equitable access to social determinants of health; and providing proper guidelines for the accreditation of medical facilities, personnel, and equipment. International obligations include allowing for the enjoyment of health in other countries; preventing violations of health in other countries; cooperating in the provision of humanitarian aid for disasters and emergencies; and refraining from use of embargoes on medical goods or personnel as an act of political or economic influence.

Convention on the Elimination of All Forms of Discrimination Against Women

Article 12 of the 1979 United Nations Convention on the Elimination of All Forms of Discrimination against Women outlines women's protection from gender discrimination when receiving health services and women's entitlement to specific gender-related healthcare provisions. The full text of Article 12 states:

1. States Parties shall take all appropriate measures to eliminate discrimination against women in the field of health care in order to ensure, on a basis of equality of men and women, access to health care services, including those related to family planning.
2. Notwithstanding the provisions of paragraph I of this article, States Parties shall ensure to women appropriate services in connection with pregnancy, confinement and the post-natal period, granting free services where necessary, as well as adequate nutrition during pregnancy and lactation.

Convention on the Rights of the Child

Health is mentioned on several instances in the Convention on the Rights of the Child (1989). Article 3 calls upon parties to ensure that institutions and facilities for the care of children adhere to health standards. Article 17 recognizes the child's right to access information that is pertinent to his/her physical and mental health and well-being. Article 23 makes specific reference to the rights of disabled children, in which it includes health services, rehabilitation, preventive care. Article 24 outlines child health in detail, and states, "Parties recognize the right of the child to the enjoyment of the highest attainable standard of health and to facilities for the treatment of illness and rehabilitation of health. States shall strive to ensure that no child is deprived of his or her right of access to such health care services." Towards implementation of this provision, the Convention enumerates the following measures:

• To diminish infant and child mortality;
• To ensure the provision of necessary medical assistance and health care to all children with emphasis on the development of primary health care;
• To combat disease and malnutrition, including within the framework of primary health care, through, inter alia, the application of readily available technology and through the provision of adequate nutritious foods and clean drinking-water, taking into consideration the dangers and risks of environmental pollution;
• To ensure appropriate pre-natal and post-natal health care for mothers;
• To ensure that all segments of society, in particular parents and children, are informed, have access to education and are supported in the use of basic knowledge of child health and nutrition, the advantages of breastfeeding, hygiene and environmental sanitation and the prevention of accidents;
• To develop preventive health care, guidance for parents and family planning education and services.

The World Health Organization website comments, "The CRC is the normative and legal framework for WHO’s work across the broad spectrum of child and adolescent health." Goldhagen presents the CRC as a "template for child advocacy" and proposes its use as a framework for reducing disparities and improving outcomes in child health.

Convention on the Rights of Persons with Disabilities

Article 25 of the Convention on the Rights of Persons with Disabilities (2006) 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 sub-clauses of Article 25 state that States shall give the disabled the same "range, quality, and standard" of health care as it provides to other persons, as well as those services specifically required for prevention, identification, and management of disability. Further provisions specify that health care for the disabled should be made available in local communities and that care should be geographically equitable, with additional statements against the denial or unequal provision of health services (including "food and fluids" and "life insurance") on the basis of disability.

Hendriks criticizes the failure of the Convention to define specifically the term "disability"; he contends further that "the absence of a clear description [...] may prejudice the uniform interpretation, or at least place in jeopardy the consistent protection the Convention seeks to guarantee." He does, however, acknowledge that the lack of a clear definition for "disability" may benefit the disabled by limiting the State's ability to limit extension of the Convention's provisions to specific populations or those with certain conditions.

Definitions in academic literature

While most human rights are theoretically framed as negative rights, meaning that they are areas upon which society cannot interfere or restrict by political action, Mervyn Susser contends that the right to health is a particularly unique and challenging right because it is often expressed as a positive right, where society bears an obligation to provide certain resources and opportunities to the general population. 

Susser further sets out four provisions that he sees as covered under a right to health: equitable access to health and medical services; a "good-faith" social effort to promote equal health among different social groups; means to measure and assess health equity; and equal sociopolitical systems to give all parties a unique voice in health advocacy and promotion. He is careful to note here that, while this likely entails some minimum standard of access to health resources, it does not guarantee or necessitate an equitable state of health for each person due to inherent biological differences in health status. This distinction is an important one, as some common critiques of a "right to health" are that it establishes a right to an unreachable standard and that it aspires to a state of health that is too subjectively variable from person to person or from one society to the next.

While Susser's discussion centers on healthcare as a positive right, Paul Hunt refutes this view and makes the argument that the right to health also encompasses certain negative rights such as a protection from discrimination and the right to not receive medical treatment without the recipient's voluntary consent. However, Hunt does concede that some positive rights, such as the responsibility of society to pay special attention to the health needs of the underserved and vulnerable, are included in the right to health.

Paul Farmer addresses the issue of unequal access to health care in his article, "The Major Infectious Diseases in the World - To Treat or Not to Treat." He discusses the growing "outcome gap" between the populations receiving health interventions and the ones that are not. Poor people are not receiving the same treatment, if any at all, as the more financially fortunate. The high costs of medicine and treatment make it problematic for poor countries to receive equal care. He states, "Excellence without equity looms as the chief human-rights dilemma of health care in the 21st century."

Human right to health care

An alternative way to conceptualize one facet of the right to health is a “human right to health care.” Notably, this encompasses both patient and provider rights in the delivery of healthcare services, the latter being similarly open to frequent abuse by the states. Patient rights in health care delivery include: the right to privacy, information, life, and quality care, as well as freedom from discrimination, torture, and cruel, inhumane, or degrading treatment. Marginalized groups, such as migrants and persons who have been displaced, racial and ethnic minorities, women, sexual minorities, and those living with HIV, are particularly vulnerable to violations of human rights in healthcare settings. For instance, racial and ethnic minorities may be segregated into poorer quality wards, disabled persons may be contained and forcibly medicated, drug users may be denied addiction treatment, women may be forced into vaginal examinations and may be denied life-saving abortions, suspected homosexual men may be forced into anal examinations, and women of marginalized groups and transgender persons may be forcibly sterilized.

Provider rights include: the right to quality standards of working conditions, the right to associate freely, and the right to refuse to perform a procedure based on their morals. Healthcare providers often experience violations of their rights. For instance, particularly in countries with weak rule of law, healthcare providers are often forced to perform procedures which negate their morals, deny marginalized groups the best possible standards of care, breach patient confidentiality, and conceal crimes against humanity and torture. Furthermore, providers who do not oblige these pressures are often persecuted. Currently, especially in the United States, much debate surrounds the issue of “provider consciousness”, which retains the right of providers to abstain from performing procedures that do not align with their moral code, such as abortions.

Legal reform as a mechanism to combat and prevent violations of patient and provider rights presents a promising approach. However, in transitional countries (newly formed countries undergoing reform), and other settings with weak rule of law, may be limited. Resources and tools for lawyers, providers, and patients interested in improving human rights in patient care have been formulated.

Criticism

Philip Barlow writes that health care should not be considered a human right because of the difficulty of defining what it entails and where the 'minimum standard' of entitlements under the right ought to be established. Additionally, Barlow contends that rights establish duties upon others to protect or guarantee them, and that it is unclear who holds the social responsibility for the right to health. John Berkeley, in agreement with Barlow, critiques further that the right to health does not consider adequately the responsibility that an individual has to uphold his or her own health.

Richard D Lamm vehemently argues against making healthcare a right. He defines a right as one that is to be defended at all costs, and a concept that is defined and interpreted by the judicial system. Making healthcare a right would require governments to spend a large portion of its resources to provide its citizens with it. He asserts that the healthcare system is based on the erroneous assumption of unlimited resources. Limited resources inhibits governments from providing everyone with adequate healthcare, especially in the long term. Attempting to provide "beneficial" healthcare to all people utilizing limited resources could lead to economical collapse. Lamm asserts that access to healthcare but a small part in producing a healthy society, and to create a healthy society, resources should also be spent on social resources.

Another criticism of the right to health is that it is not feasible. Imre J.P. Loefler argues that the financial and logistical burdens of ensuring health care for all are unattainable, and that resource constraints make it unrealistic to justify a right towards prolonging life indefinitely. Instead, Loefler suggests that the goal of improving population health is better served through socioeconomic policy than a formal right to health.

Medical ethics

From Wikipedia, the free encyclopedia

A 12th-century Byzantine manuscript of the Hippocratic Oath

 

AMA Code of Medical Ethics

Medical ethics is a system of moral principles that apply values to the practice of clinical medicine and in scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal without any conflict. It is important to note that these four values are non-hierarchical, meaning no one principle routinely “trumps” another.

The term medical ethics first dates back to 1803, when English author and physician Thomas Percival published a document describing the requirements and expectations of medical professionals within medical facilities. The Code of Ethics was then adapted in 1847, relying heavily on Percival's words. Over the years in 1903, 1912, and 1947, revisions have been made to the original document. The practice of Medical Ethics is widely accepted and practiced throughout the world.

There are several other codes of conduct. The Hippocratic Oath discusses basic principles for medical professionals. This document dates back to the fifth century BCE. Both The Declaration of Helsinki (1964) and The Nuremberg Code (1947) are two well-known and well respected documents contributing to medical ethics. Other important markings in the history of Medical Ethics include Roe v. Wade in 1973 and the development of Hemodialysis in the 1960s. As this field continues to develop and change throughout history, the focus remains on fair, balanced, and moral thinking. Medical ethics encompasses a practical application in clinical settings as well as scholarly work on its history, philosophy, and sociology.

History

Historically, Western medical ethics may be traced to guidelines on the duty of physicians in antiquity, such as the Hippocratic Oath, and early Christian teachings. The first code of medical ethics, Formula Comitis Archiatrorum, was published in the 5th century, during the reign of the Ostrogothic king Theodoric the Great. In the medieval and early modern period, the field is indebted to Islamic scholarship such as Ishaq ibn Ali al-Ruhawi (who wrote the Conduct of a Physician, the first book dedicated to medical ethics), Avicenna's Canon of Medicine and Muhammad ibn Zakariya ar-Razi (known as Rhazes in the West), Jewish thinkers such as Maimonides, Roman Catholic scholastic thinkers such as Thomas Aquinas, and the case-oriented analysis (casuistry) of Catholic moral theology. These intellectual traditions continue in Catholic, Islamic and Jewish medical ethics.

By the 18th and 19th centuries, medical ethics emerged as a more self-conscious discourse. In England, Thomas Percival, a physician and author, crafted the first modern code of medical ethics. He drew up a pamphlet with the code in 1794 and wrote an expanded version in 1803, in which he coined the expressions "medical ethics" and "medical jurisprudence". However, there are some who see Percival's guidelines that relate to physician consultations as being excessively protective of the home physician's reputation. Jeffrey Berlant is one such critic who considers Percival's codes of physician consultations as being an early example of the anti-competitive, "guild"-like nature of the physician community.

In 1815, the Apothecaries Act was passed by the Parliament of the United Kingdom. It introduced compulsory apprenticeship and formal qualifications for the apothecaries of the day under the license of the Society of Apothecaries. This was the beginning of regulation of the medical profession in the UK. 

In 1847, the American Medical Association adopted its first code of ethics, with this being based in large part upon Percival's work. While the secularized field borrowed largely from Catholic medical ethics, in the 20th century a distinctively liberal Protestant approach was articulated by thinkers such as Joseph Fletcher. In the 1960s and 1970s, building upon liberal theory and procedural justice, much of the discourse of medical ethics went through a dramatic shift and largely reconfigured itself into bioethics.

Well-known medical ethics cases include:

• Albert Kligman's dermatology experiments
• Deep sleep therapy
• Doctors' Trial
• Greenberg v. Miami Children's Hospital Research Institute
• Henrietta Lacks
• Chester M. Southam's Cancer Injection Study
• Human radiation experiments
• Jesse Gelsinger
• Moore v. Regents of the University of California
• Surgical removal of body parts to try to improve mental health
• Medical Experimentation on Black Americans
• Milgram experiment
• Radioactive iodine experiments
• The Monster Study
• Plutonium injections
• The David Reimer case
• The Stanford Prison Experiment
• Tuskegee syphilis experiment
• Willowbrook State School
• Yanomami blood sample collection
  • Darkness in El Dorado

Since the 1970s, the growing influence of ethics in contemporary medicine can be seen in the increasing use of Institutional Review Boards to evaluate experiments on human subjects, the establishment of hospital ethics committees, the expansion of the role of clinician ethicists, and the integration of ethics into many medical school curricula.

Values

A common framework used in the analysis of medical ethics is the "four principles" approach postulated by Tom Beauchamp and James Childress in their textbook Principles of biomedical ethics. It recognizes four basic moral principles, which are to be judged and weighed against each other, with attention given to the scope of their application. The four principles are:

• Respect for autonomy – the patient has the right to refuse or choose their treatment.
• Beneficence – a practitioner should act in the best interest of the patient.
• Non-maleficence – to not be the cause of harm. Also, "Utility" - to promote more good than harm
• Justice – concerns the distribution of scarce health resources, and the decision of who gets what treatment.

Autonomy

The principle of autonomy views the rights of an individual to self-determination. This is rooted in society's respect for individuals' ability to make informed decisions about personal matters with freedom. Autonomy has become more important as social values have shifted to define medical quality in terms of outcomes that are important to the patient and their family rather than medical professionals. The increasing importance of autonomy can be seen as a social reaction against the "paternalistic" tradition within healthcare. Some have questioned whether the backlash against historically excessive paternalism in favor of patient autonomy has inhibited the proper use of soft paternalism to the detriment of outcomes for some patients.

The definition of autonomy is the ability of an individual to make a rational, un-influenced decision. Therefore, it can be said that autonomy is a general indicator of a healthy mind and body. The progression of many terminal diseases are characterized by loss of autonomy, in various manners and extents. For example, dementia almost always results in the loss of autonomy. Dementia is a chronic and progressive disease that attacks the brain and affects the ability to make judgments, can induce memory loss, cause a decrease in rational thinking and affect orientation.

Psychiatrists and clinical psychologists are often asked to evaluate a patient's capacity for making life-and-death decisions at the end of life. Persons with a psychiatric condition such as delirium or clinical depression may lack capacity to make end-of-life decisions. For these persons, a request to refuse treatment may be taken in the context of their condition. Unless there is a clear advance directive to the contrary, persons lacking mental capacity are treated according to their best interests. This will involve an assessment involving people who know the person best to what decisions the person would have made had they not lost capacity. Persons with the mental capacity to make end-of-life decisions may refuse treatment with the understanding that it may shorten their life. Psychiatrists and psychologists may be involved to support decision making.

Beneficence

The term beneficence refers to actions that promote the well being of others. In the medical context, this means taking actions that serve the best interests of patients and their families. However, uncertainty surrounds the precise definition of which practices do in fact help patients.

James Childress and Tom Beauchamp in Principle of Biomedical Ethics (1978) identify beneficence as one of the core values of healthcare ethics. Some scholars, such as Edmund Pellegrino, argue that beneficence is the only fundamental principle of medical ethics. They argue that healing should be the sole purpose of medicine, and that endeavors like cosmetic surgery and euthanasia are severely unethical and against the Hippocratic Oath.

Non-maleficence

The concept of non-maleficence is embodied by the phrase, "first, do no harm," or the Latin, primum non nocere. Many consider that should be the main or primary consideration (hence primum): that it is more important not to harm your patient, than to do them good, which is part of the hippocratic oath that doctors take. This is partly because enthusiastic practitioners are prone to using treatments that they believe will do good, without first having evaluated them adequately to ensure they do no harm to the patient. Much harm has been done to patients as a result, as in the saying, "The treatment was a success, but the patient died." It is not only more important to do no harm than to do good; it is also important to know how likely it is that your treatment will harm a patient. So a physician should go further than not prescribing medications they know to be harmful—he or she should not prescribe medications (or otherwise treat the patient) unless s/he knows that the treatment is unlikely to be harmful; or at the very least, that patient understands the risks and benefits, and that the likely benefits outweigh the likely risks.

In practice, however, many treatments carry some risk of harm. In some circumstances, e.g. in desperate situations where the outcome without treatment will be grave, risky treatments that stand a high chance of harming the patient will be justified, as the risk of not treating is also very likely to do harm. So the principle of non-maleficence is not absolute, and balances against the principle of beneficence (doing good), as the effects of the two principles together often give rise to a double effect (further described in next section). Even basic actions like taking a blood sample or an injection of a drug cause harm to the patient's body. Euthanasia also goes against the principle of beneficence because the patient dies as a result of the medical treatment by the doctor. 

Dr. Watts putting on gloves before surgery.

Double effect

Double effect refers to two types of consequences that may be produced by a single action, and in medical ethics it is usually regarded as the combined effect of beneficence and non-maleficence.

A commonly cited example of this phenomenon is the use of morphine or other analgesic in the dying patient. Such use of morphine can have the beneficial effect of easing the pain and suffering of the patient while simultaneously having the maleficent effect of shortening the life of the patient through the deactivation of the respiratory system.

Respect for human rights

The human rights era started with the formation of the United Nations in 1945, which was charged with the promotion of human rights. The Universal Declaration of Human Rights (1948) was the first major document to define human rights. Medical doctors have an ethical duty to protect the human rights and human dignity of the patient so the advent of a document that defines human rights has had its effect on medical ethics. Most codes of medical ethics now require respect for the human rights of the patient.

The Council of Europe promotes the rule of law and observance of human rights in Europe. The Council of Europe adopted the European Convention on Human Rights and Biomedicine (1997) to create a uniform code of medical ethics for its 47 member-states. The Convention applies international human rights law to medical ethics. It provides special protection of physical integrity for those who are unable to consent, which includes children.

No organ or tissue removal may be carried out on a person who does not have the capacity to consent under Article 5.

As of December 2013, the Convention had been ratified or acceded to by twenty-nine member-states of the Council of Europe.

The United Nations Educational, Scientific and Cultural Organization (UNESCO) also promotes the protection of human rights and human dignity. According to UNESCO, "Declarations are another means of defining norms, which are not subject to ratification. Like recommendations, they set forth universal principles to which the community of States wished to attribute the greatest possible authority and to afford the broadest possible support." UNESCO adopted the Universal Declaration on Human Rights and Biomedicine to advance the application of international human rights law in medical ethics. The Declaration provides special protection of human rights for incompetent persons.

In applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken into account. Individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected.

Conflicts

Between autonomy and beneficence/non-maleficence

Autonomy can come into conflict with beneficence when patients disagree with recommendations that healthcare professionals believe are in the patient's best interest. When the patient's interests conflict with the patient's welfare, different societies settle the conflict in a wide range of manners. In general, Western medicine defers to the wishes of a mentally competent patient to make their own decisions, even in cases where the medical team believes that they are not acting in their own best interests. However, many other societies prioritize beneficence over autonomy.

Examples include when a patient does not want a treatment because of, for example, religious or cultural views. In the case of euthanasia, the patient, or relatives of a patient, may want to end the life of the patient. Also, the patient may want an unnecessary treatment, as can be the case in hypochondria or with cosmetic surgery; here, the practitioner may be required to balance the desires of the patient for medically unnecessary potential risks against the patient's informed autonomy in the issue. A doctor may want to prefer autonomy because refusal to please the patient's self-determination would harm the doctor-patient relationship. 

Individuals' capacity for informed decision-making may come into question during resolution of conflicts between autonomy and beneficence. The role of surrogate medical decision makers is an extension of the principle of autonomy.

On the other hand, autonomy and beneficence/non-maleficence may also overlap. For example, a breach of patients' autonomy may cause decreased confidence for medical services in the population and subsequently less willingness to seek help, which in turn may cause inability to perform beneficence. 

The principles of autonomy and beneficence/non-maleficence may also be expanded to include effects on the relatives of patients or even the medical practitioners, the overall population and economic issues when making medical decisions.

Euthanasia

There is disagreement among American physicians as to whether the non-maleficence principle excludes the practice of euthanasia. Euthanasia is currently legal in the states of Washington DC, California, Colorado, Oregon, Vermont, and Washington. Around the world, there are different organizations that campaign to change legislation about the issue of physician-assisted death, or PAD. Examples of such organizations are the Hemlock Society of the United States and the Dignity in Dying campaign in the United Kingdom. These groups believe that doctors should be given the right to end a patient's life only if the patient is conscious enough to decide for themselves, is knowledgeable about the possibility of alternative care, and has willingly asked to end their life or requested access to the means to do so. 

This argument is disputed in other parts of the world. For example, in the state of Louisiana, giving advice or supplying the means to end a person's life is considered a criminal act and can be charged as a felony. In state courts, this crime is comparable to manslaughter. The same laws apply in the states of Mississippi and Nebraska.

Informed consent

Informed consent in ethics usually refers to the idea that a person must be fully informed about and understand the potential benefits and risks of their choice of treatment. A correlate to "informed consent" is the concept of informed refusal. An uninformed person is at risk of mistakenly making a choice not reflective of his or her values or wishes. It does not specifically mean the process of obtaining consent, or the specific legal requirements, which vary from place to place, for capacity to consent. Patients can elect to make their own medical decisions or can delegate decision-making authority to another party. If the patient is incapacitated, laws around the world designate different processes for obtaining informed consent, typically by having a person appointed by the patient or their next of kin make decisions for them. The value of informed consent is closely related to the values of autonomy and truth telling.

Confidentiality

Confidentiality is commonly applied to conversations between doctors and patients. This concept is commonly known as patient-physician privilege. Legal protections prevent physicians from revealing their discussions with patients, even under oath in court. 

Confidentiality is mandated in America by the Health Insurance Portability and Accountability Act of 1996 known as HIPAA , specifically the Privacy Rule, and various state laws, some more rigorous than HIPAA. However, numerous exceptions to the rules have been carved out over the years. For example, many states require physicians to report gunshot wounds to the police and impaired drivers to the Department of Motor Vehicles. Confidentiality is also challenged in cases involving the diagnosis of a sexually transmitted disease in a patient who refuses to reveal the diagnosis to a spouse, and in the termination of a pregnancy in an underage patient, without the knowledge of the patient's parents. Many states in the U.S. have laws governing parental notification in underage abortion.

Traditionally, medical ethics has viewed the duty of confidentiality as a relatively non-negotiable tenet of medical practice. More recently, critics like Jacob Appel have argued for a more nuanced approach to the duty that acknowledges the need for flexibility in many cases.

Confidentiality is an important issue in primary care ethics, where physicians care for many patients from the same family and community, and where third parties often request information from the considerable medical database typically gathered in primary health care.

Control and resolution

To ensure that appropriate ethical values are being applied within hospitals, effective hospital accreditation requires that ethical considerations are taken into account, for example with respect to physician integrity, conflict of interest, research ethics and organ transplantation ethics.

Guidelines

There is much documentation of the history and necessity of the Declaration of Helsinki. The first code of conduct for research including medical ethics was the Nuremberg Code. This document had large ties to Nazi war crimes, as it was introduced in 1947, so it didn't make much of a difference in terms of regulating practice. This issue called for the creation of the Declaration. There are some stark differences between the Nuremberg Code and the Declaration of Helsinki, including the way it is written. Nuremberg was written in a very concise manner, with a simple explanation. The Declaration of Helsinki is written with a thorough explanation in mind and including many specific commentaries.

In the United Kingdom, General Medical Council provides clear overall modern guidance in the form of its 'Good Medical Practice' statement. Other organizations, such as the Medical Protection Society and a number of university departments, are often consulted by British doctors regarding issues relating to ethics.

Ethics committees

Often, simple communication is not enough to resolve a conflict, and a hospital ethics committee must convene to decide a complex matter. 

These bodies are composed primarily of healthcare professionals, but may also include philosophers, lay people, and clergy – indeed, in many parts of the world their presence is considered mandatory in order to provide balance. 

With respect to the expected composition of such bodies in the US, Europe and Australia, the following applies.

U.S. recommendations suggest that Research and Ethical Boards (REBs) should have five or more members, including at least one scientist, one non-scientist, and one person not affiliated with the institution. The REB should include people knowledgeable in the law and standards of practice and professional conduct. Special memberships are advocated for handicapped or disabled concerns, if required by the protocol under review.


The European Forum for Good Clinical Practice (EFGCP) suggests that REBs include two practicing physicians who share experience in biomedical research and are independent from the institution where the research is conducted; one lay person; one lawyer; and one paramedical professional, e.g. nurse or pharmacist. They recommend that a quorum include both sexes from a wide age range and reflect the cultural make-up of the local community.

The 1996 Australian Health Ethics Committee recommendations were entitled, "Membership Generally of Institutional Ethics Committees". They suggest a chairperson be preferably someone not employed or otherwise connected with the institution. Members should include a person with knowledge and experience in professional care, counseling or treatment of humans; a minister of religion or equivalent, e.g. Aboriginal elder; a layman; a laywoman; a lawyer and, in the case of a hospital-based ethics committee, a nurse.

The assignment of philosophers or religious clerics will reflect the importance attached by the society to the basic values involved. An example from Sweden with Torbjörn Tännsjö on a couple of such committees indicates secular trends gaining influence.

Medical ethics in an online world

In increasing frequency, medical researchers are researching activities in online environments such as discussion boards and bulletin boards, and there is concern that the requirements of informed consent and privacy are not applied, although some guidelines do exist.

One issue that has arisen, however, is the disclosure of information. While researchers wish to quote from the original source in order to argue a point, this can have repercussions when the identity of the patient is not kept confidential. The quotations and other information about the site can be used to identify the patient, and researchers have reported cases where members of the site, bloggers and others have used this information as 'clues' in a game in an attempt to identify the site. Some researchers have employed various methods of "heavy disguise." including discussing a different condition from that under study.

Cultural concerns

Culture differences can create difficult medical ethics problems. Some cultures have spiritual or magical theories about the origins and cause of disease, for example, and reconciling these beliefs with the tenets of Western medicine can be very difficult.

Truth-telling

The WMA International Code of Medical Ethics explicitly states, "A physician shall...report to the appropriate authorities those physicians who practice unethically or incompetently or who engage in fraud or deception." There is also the conflict with physicians who are tempted to report made up incidents or make an incident worse than what it was for their own personal motives. In vice versa, a physician might be hesitant to report an incident because of personal friendship he or she may have with his or her colleague.

Online business practices and privacy

Healthcare websites have the responsibility to ensure that the private medical records of their online visitors are secure from being marketed and monetized into the hands of drug companies, occupation records, insurancers. The delivery of diagnosis online leads patients to believe that doctors in some parts of the country are at the direct service of drug companies, finding diagnosis as convenient as what drug still has patent rights on it. Physicians and drug companies are found to be competing for top ten search engine ranks to lower costs of selling these drugs with little to no patient involvement.

With the expansion of internet healthcare platforms, online practitioner legitimacy and privacy accountability face unique challenges such as e-paparazzi, online information brokers, industrial spies, unlicensed information providers that work outside of traditional medical codes for profit. The American Medical Association (AMA) states that medical websites have the responsibility to ensure the health care privacy of online visitors and protect patient records from being marketed and monetized into the hands of insurance companies, employers, and marketers. With the rapid unification of healthcare, business practices, computer science and e-commerce to create these online diagnostic websites, efforts to maintain health care system's ethical confidentiality standard need to keep up as well. Over the next few years, the Department of Health and Human Services have stated that they will be working towards lawfully protecting the online privacy and digital transfers of patient Electronic Medical Records (EMR) under The Health Insurance Portability and Accountability Act (HIPAA). 

Humanitarian medical volunteerism

One concern regarding the intersection of medical ethics and humanitarian medical aid is how such assistance can be as harmful as it is helpful to the community being served. One such example being how political forces may control how foreign humanitarian aid can be utilized in the region it is meant to be provided in. This would be congruous in situations where political strife could lead such aid being used in favor of one group over another. Another example of how foreign humanitarian aid can be misused in its intended community includes the possibility of dissonance forming between a foreign humanitarian aid group and the community being served. Examples of this could include the relationships being viewed between aid workers, style of dress, or the lack of education regarding local culture and customs.

Conflicts of interest

Physicians should not allow a conflict of interest to influence medical judgment. In some cases, conflicts are hard to avoid, and doctors have a responsibility to avoid entering such situations. Research has shown that conflicts of interests are very common among both academic physicians and physicians in practice.

Referral

Doctors who receive income from referring patients for medical tests have been shown to refer more patients for medical tests. This practice is proscribed by the American College of Physicians Ethics Manual. Fee splitting and the payments of commissions to attract referrals of patients is considered unethical and unacceptable in most parts of the world.

Vendor relationships

Studies show that doctors can be influenced by drug company inducements, including gifts and food. Industry-sponsored Continuing Medical Education (CME) programs influence prescribing patterns. Many patients surveyed in one study agreed that physician gifts from drug companies influence prescribing practices. A growing movement among physicians is attempting to diminish the influence of pharmaceutical industry marketing upon medical practice, as evidenced by Stanford University's ban on drug company-sponsored lunches and gifts. Other academic institutions that have banned pharmaceutical industry-sponsored gifts and food include the Johns Hopkins Medical Institutions, University of Michigan, University of Pennsylvania, and Yale University.

Treatment of family members

The American Medical Association (AMA) states that "Physicians generally should not treat themselves or members of their immediate family". This code seeks to protect patients and physicians because professional objectivity can be compromised when the physician is treating a loved one. Studies from multiple health organizations have illustrated that physician-family member relationships may cause an increase in diagnostic testing and costs. Many doctors still treat their family members. Doctors who do so must be vigilant not to create conflicts of interest or treat inappropriately. Physicians that treat family members need to be conscious of conflicting expectations and dilemmas when treating relatives, as established medical ethical principles may not be morally imperative when family members are confronted with serious illness.

Sexual relationships

Sexual relationships between doctors and patients can create ethical conflicts, since sexual consent may conflict with the fiduciary responsibility of the physician. Out of the many disciplines in current medicine, there are studies that have been conducted in order to ascertain the occurrence of Doctor-Patient sexual misconduct. Results from those studies appear to indicate that certain disciplines are more likely to be offenders than others. Psychiatrists and Obstetrician-Gynecologists for example, are two disciplines noted for having a higher rate of sexual misconduct. The violation of ethical conduct between doctors and patients also has an association with the age and sex of doctor and patient. Male physicians aged 40–49 and 50–59 years are two groups that have been found to be more likely to have been reported for sexual misconduct, while women aged 20–39 have been found to make up a significant portion of reported victims of sexual misconduct. Doctors who enter into sexual relationships with patients face the threats of losing their medical license and prosecution. In the early 1990s, it was estimated that 2-9% of doctors had violated this rule. Sexual relationships between physicians and patients' relatives may also be prohibited in some jurisdictions, although this prohibition is highly controversial.

Futility

The concept of medical futility has been an important topic in discussions of medical ethics. What should be done if there is no chance that a patient will survive but the family members insist on advanced care? Previously, some articles defined futility as the patient having less than a one percent chance of surviving. Some of these cases are examined in court.

Advance directives include living wills and durable powers of attorney for health care. In many cases, the "expressed wishes" of the patient are documented in these directives, and this provides a framework to guide family members and health care professionals in the decision-making process when the patient is incapacitated. Undocumented expressed wishes can also help guide decisions in the absence of advance directives, as in the Quinlan case in Missouri. 

"Substituted judgment" is the concept that a family member can give consent for treatment if the patient is unable (or unwilling) to give consent themselves. The key question for the decision-making surrogate is not, "What would you like to do?", but instead, "What do you think the patient would want in this situation?".

Courts have supported family's arbitrary definitions of futility to include simple biological survival, as in the Baby K case (in which the courts ordered a child born with only a brain stem instead of a complete brain to be kept on a ventilator based on the religious belief that all life must be preserved).

In some hospitals, medical futility is referred to as "non-beneficial care."

Baby Doe Law establishes state protection for a disabled child's right to life, ensuring that this right is protected even over the wishes of parents or guardians in cases where they want to withhold treatment.

Placebo-controlled study

From Wikipedia, the free encyclopedia

Prescription placebos used in research and practice.

Placebo-controlled studies are a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a sham "placebo" treatment which is specifically designed to have no real effect. Placebos are most commonly used in blinded trials, where subjects do not know whether they are receiving real or placebo treatment. Often, there is also a further "natural history" group that does not receive any treatment at all. 

The purpose of the placebo group is to account for the placebo effect, that is, effects from treatment that do not depend on the treatment itself. Such factors include knowing one is receiving a treatment, attention from health care professionals, and the expectations of a treatment's effectiveness by those running the research study. Without a placebo group to compare against, it is not possible to know whether the treatment itself had any effect. 

Patients frequently show improvement even when given a sham or "fake" treatment. Such intentionally inert placebo treatments can take many forms, such as a pill containing only sugar, a surgery where nothing efficacious is actually done (just an incision and sometimes some minor touching or handling of the underlying structures), or a medical device (such as an ultrasound machine) that is not actually turned on. Also, due to the body's natural healing ability and statistical effects such as regression to the mean, many patients will get better even when given no treatment at all. Thus, the relevant question when assessing a treatment is not "does the treatment work?" but "does the treatment work better than a placebo treatment, or no treatment at all?" As one early clinical trial researcher wrote, "the first object of a therapeutic trial is to discover whether the patients who receive the treatment under investigation are cured more rapidly, more completely or more frequently, than they would have been without it." More broadly, the aim of a clinical trial is to determine what treatments, delivered in what circumstances, to which patients, in what conditions, are the most effective.

Therefore, the use of placebos is a standard control component of most clinical trials, which attempt to make some sort of quantitative assessment of the efficacy of medicinal drugs or treatments. Such a test or clinical trial is called a placebo-controlled study, and its control is of the negative type. A study whose control is a previously tested treatment, rather than no treatment, is called a positive-control study, because its control is of the positive type. Government regulatory agencies approve new drugs only after tests establish not only that patients respond to them, but also that their effect is greater than that of a placebo (by way of affecting more patients, by affecting responders more strongly, or both).

Methodology

Single Blind trials

Things like sugar pills, that look like real treatments but in fact have no physical effect are used to create "blind" trials in which the participants do not know whether they are getting the active treatment or not, so that physical effects can be measured independently of the participants' expectations. Single Blind trials control all of these by making whatever expectations there are equal for all cases. 

Placebos are not the only possible technique for creating "blindness" (= unawareness of the treatment): to test the effectiveness of prayer by others, the participants are not told who has and has not had prayers said for them. To test the effect of changing the frequency of fluorescent lights on headaches, the light fittings are changed at night in the absence of the office workers (this is a real case). It has been shown that "mock" surgery can have similar effects, and so some surgical techniques must be studied with placebo controls (rarely double blind, due to the difficulty involved).

Double-blind trials

Because a doctor's belief in the value of a treatment can affect his or her behavior, and thus what his or her patient believes, clinical trials are usually conducted in "double-blind" manner: that is, not only are the patients made unaware when they are receiving a placebo, the doctors are made unaware too.

Nearly all studies conducted find benefit in the placebo group. For example, Khan published a meta-analysis of studies of investigational antidepressants and found a 30% reduction in suicide and attempted suicide in the placebo groups and a 40% reduction in the treated groups. However, studies generally do not include an untreated group, so determining the actual size of the placebo effect, compared to totally untreated patients, is difficult.

Natural history groups

The practice of using an additional natural history group as the trial's so-called "third arm" has emerged; and trials are conducted using three randomly selected, equally matched trial groups, David wrote: "... it is necessary to remember the adjective ‘random’ [in the term ‘random sample’] should apply to the method of drawing the sample and not to the sample itself.".

• The Active drug group (A): who receive the active test drug.
• The Placebo drug group (P): who receive a placebo drug that simulates the active drug.
• The Natural history group (NH): who receive no treatment of any kind (and whose condition, therefore, is allowed to run its natural course).

The outcomes within each group are observed, and compared with each other, allowing us to measure:

• The efficacy of the active drug's treatment: the difference between A and NH (i.e., A-NH).
• The efficacy of the active drug's active ingredient: the difference between A and P (i.e., A-P).
• The magnitude of the placebo response: the difference between P and NH (i.e., P-NH).

It is a matter of interpretation whether the value of P-NH indicates the efficacy of the entire treatment process or the magnitude of the "placebo response". The results of these comparisons then determine whether or not a particular drug is considered efficacious.

Indexing

In certain clinical trials of particular drugs, it may happen that the level of the "placebo responses" manifested by the trial's subjects are either considerably higher or lower (in relation to the "active" drug's effects) than one would expect from other trials of similar drugs. In these cases, with all other things being equal, it is reasonable to conclude that:

• the degree to which there is a considerably higher level of "placebo response" than one would expect is an index of the degree to which the drug's active ingredient is not efficacious.
• the degree to which there is a considerably lower level of "placebo response" than one would expect is an index of the degree to which, in some particular way, the placebo is not simulating the active drug in an appropriate way.

However, in particular cases such as the use of Cimetidine to treat ulcers, a significant level of placebo response can also prove to be an index of how much the treatment has been directed at a wrong target.

Implementation issues

Adherence

The Coronary Drug Project was intended to study the safety and effectiveness of drugs for long-term treatment of coronary heart disease in men. Those in the placebo group who adhered to the placebo treatment (took the placebo regularly as instructed) showed nearly half the mortality rate as those who were not adherent. A similar study of women similarly found survival was nearly 2.5 times greater for those who adhered to their placebo. This apparent placebo effect may have occurred because:

• Adhering to the protocol had a psychological effect, i.e. genuine placebo effect.
• People who were already healthier were more able or more inclined to follow the protocol.
• Compliant people were more diligent and health-conscious in all aspects of their lives.

Recognition

Appropriate use of a placebo in a clinical trial often requires or at least benefits from a double-blind study design, which means that neither the experimenters nor the subjects know which subjects are in the "test group" and which are in the "control group". This creates a problem in creating placebos that can be mistaken for active treatments. It therefore can be necessary to use a psychoactive placebo, a drug that produces physiological effects that encourage the belief in the control groups that they have received an active drug. 

A psychoactive placebo was used in the Marsh Chapel Experiment, a double-blind study in which the experimental group received the psychedelic substance psilocybin while the control group received a large dose of niacin, a substance that produces noticeable physical effects intended to lead the control subjects to believe they had received the psychoactive drug. The term "psychoactive placebo" is rare in the literature; but, when it is used, it always denotes a placebo of this type. For example, "Neither the experienced investigator nor the naive [subject] is easily fooled on the matter of whether he has received a psychedelic substance or merely a psychoactive placebo such as amphetamine."

History

James Lind and scurvy

A portrait of Scottish doctor James Lind (1716-1794)

 

In 1747, James Lind (1716–1794), the ship's doctor on HMS Salisbury, conducted the first clinical trial when he investigated the efficacy of citrus fruit in cases of scurvy. He randomly divided twelve scurvy patients, whose "cases were as similar as I could have them", into six pairs. Each pair was given a different remedy. According to Lind’s 1753 Treatise on the Scurvy in Three Parts Containing an Inquiry into the Nature, Causes, and Cure of the Disease, Together with a Critical and Chronological View of what has been Published of the Subject, the remedies were: one quart of cider per day, twenty-five drops of elixir vitriol (sulfuric acid) three times a day, two spoonfuls of vinegar three times a day, a course of sea-water (half a pint every day), two oranges and one lemon each day, and electuary, (a mixture containing garlic, mustard, balsam of Peru, and myrrh). He noted that the pair who had been given the oranges and lemons were so restored to health within six days of treatment that one of them returned to duty, and the other was well enough to attend the rest of the sick.

Animal magnetism

In 1784, the French Royal Commission looked into the existence of animal magnetism, comparing the effects of allegedly "magnetized" water with that of plain water. It did not examine the practices of Franz Mesmer, but examined the significantly different practices of his associate Charles d'Eslon (1739–1786).

Perkins tractors

In 1799, John Haygarth investigated the efficacy of medical instruments called "Perkins tractors", by comparing the results from dummy wooden tractors with a set of allegedly "active" metal tractors, and published his findings in a book On the Imagination as a Cause & as a Cure of Disorders of the Body.

Flint and placebo active treatment comparison

In 1863 Austin Flint (1812–1886) conducted the first-ever trial that directly compared the efficacy of a dummy simulator with that of an active treatment; although Flint's examination did not compare the two against each other in the same trial. Even so, this was a significant departure from the (then) customary practice of contrasting the consequences of an active treatment with what Flint described as "the natural history of [an untreated] disease".

Flint’s paper is the first time that he terms "placebo" or "placeboic remedy" were used to refer to a dummy simulator in a clinical trial.

… to secure the moral effect of a remedy given specially for the disease, the patients were placed on the use of a placebo which consisted, in nearly all of the cases, of the tincture of quassia, very largely diluted. This was given regularly, and became well known in my wards as the placeboic remedy for rheumatism.

Flint treated 13 hospital inmates who had rheumatic fever; 11 were "acute", and 2 were "sub-acute". He then compared the results of his dummy "placeboic remedy" with that of the active treatment’s already well-understood results. (Flint had previously tested, and reported on, the active treatment’s efficacy.) There was no significant difference between the results of the active treatment and his "placeboic remedy" in 12 of the cases in terms of disease duration, duration of convalescence, number of joints affected, and emergence of complications. In the thirteenth case, Flint expressed some doubt whether the particular complications that had emerged (namely, pericarditis, endocarditis, and pneumonia) would have been prevented if that subject had been immediately given the "active treatment".

Jellinek and headache remedy ingredients

Jellinek in 1946 was asked to test whether or not the headache drug's overall efficacy would be reduced if certain ingredients were removed. In post-World War II 1946, pharmaceutical chemicals were restricted, and one U.S. headache remedy manufacturer sold a drug composed of three ingredients: a, b, and c, and chemical b was in particular short supply.

Jellinek set up a complex trial involving 199 subjects, all of whom suffered from "frequent headaches". The subjects were randomly divided into four test groups. He prepared four test drugs, involving various permutations of the three drug constituents, with a placebo as a scientific control. The structure of this trial is significant because, in those days, the only time placebos were ever used "was to express the efficacy or non-efficacy of a drug in terms of "how much better" the drug was than the "placebo". (Note that the trial conducted by Austin Flint is an example of such a drug efficacy vs. placebo efficacy trial.) The four test drugs were identical in shape, size, color and taste:

• Drug A: contained a, b, and c.
• Drug B: contained a and c.
• Drug C: contained a and b.
• Drug D: a 'simulator', contained "ordinary lactate".

Each time a subject had a headache, they took their group’s designated test drug, and recorded whether their headache had been relieved (or not). Although "some subjects had only three headaches in the course of a two-week period while others had up to ten attacks in the same period", the data showed a "great consistency" across all subjects. Every two weeks the groups’ drugs were changed; so that by the end of eight weeks, all groups had tested all the drugs. The stipulated drug (i.e., A, B, C, or D) was taken as often as necessary over each two-week period, and the two-week sequences for each of the four groups were:

1. A, B, C, D
2. B, A, D, C
3. C, D, A, B
4. D, C, B, A.

Over the entire population of 199 subjects, there were 120 "subjects reacting to placebo" and 79 "subjects not reacting to placebo".

On initial analysis, there was no difference between the self-reported "success rates" of Drugs A, B, and C (84%, 80%, and 80% respectively) (the "success rate" of the simulating placebo Drug D was 52%); and, from this, it appeared that ingredient b was completely unnecessary. 

However, further analysis on the trial demonstrated that ingredient b made a significant contribution to the remedy’s efficacy. Examining his data, Jellinek discovered that there was a very significant difference in responses between the 120 placebo-responders and the 79 non-responders. The 79 non-responders' reports showed that if they were considered as an entirely separate group, there was a significant difference the "success rates" of Drugs A, B, and C: viz., 88%, 67%, and 77%, respectively. And because this significant difference in relief from the test drugs could only be attributed to the presence or absence of ingredient b, he concluded that ingredient b was essential. 

Two conclusions came from this trial:

• Jellinek, having identified 120 "placebo reactors", went on to suppose that all of them may have been suffering from either "psychological headaches" (with or without attendant "hypochondriasis") or "true physiological headaches [which were] accessible to suggestion". Thus, according to this view, the degree to which a "placebo response" is present tends to be an index of the psychogenic origins of the condition in question.
• It indicated that, whilst any given placebo was inert, a responder to that particular placebo may be responding for a wide number of reasons unconnected with the drug's active ingredients; and, from this, it could be important to pre-screen potential test populations, and treat those manifesting a placebo-response as a special group, or remove them altogether from the test population!

MRC and randomized trials

It used to be thought that the first-ever randomized clinical trial was the trial conducted by the Medical Research Council (MRC) in 1948 into the efficacy of streptomycin in the treatment of pulmonary tuberculosis. In this trial, there were two test groups:

1. those "treated by streptomycin and bed-rest", and
2. those "[treated] by bed-rest alone" (the control group).

What made this trial novel was that the subjects were randomly allocated to their test groups. The up-to-that-time practice was to allocate subjects alternately to each group, based on the order in which they presented for treatment. This practice could be biased, because those admitting each patient knew to which group that patient would be allocated (and so the decision to admit or not admit a specific patient might be influenced by the experimenter's knowledge of the nature of their illness, and their knowledge of the group to which they would occupy).

Recently, an earlier MRC trial on the antibiotic patulin on the course of common colds has been suggested to have been the first randomized trial. Another early and until recently overlooked randomized trial was published on strophanthin in a local Finnish journal in 1946.

Declaration of Helsinki

From the time of the Hippocratic Oath questions of the ethics of medical practice have been widely discussed, and codes of practice have been gradually developed as a response to advances in scientific medicine. The Nuremberg Code, which was issued in August 1947, as a consequence of the so-called Doctors' Trial which examined the human experimentation conducted by Nazi doctors during World War II, offers ten principles for legitimate medical research, including informed consent, absence of coercion, and beneficence towards experiment participants. 

In 1964, the World Medical Association issued the Declaration of Helsinki, which specifically limited its directives to health research by physicians, and emphasized a number of additional conditions in circumstances where "medical research is combined with medical care". The significant difference between the 1947 Nuremberg Code and the 1964 Declaration of Helsinki is that the first was a set of principles that was suggested to the medical profession by the "Doctors’ Trial" judges, whilst the second was imposed by the medical profession upon itself. Paragraph 29 of the Declaration makes specific mention of placebos:

29. The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.

In 2002, World Medical Association issued the following elaborative announcement:

Note of clarification on paragraph 29 of the WMA Declaration of Helsinki

The WMA hereby reaffirms its position that extreme care must be taken in making use of a placebo-controlled trial and that in general this methodology should only be used in the absence of existing proven therapy. However, a placebo-controlled trial may be ethically acceptable, even if proven therapy is available, under the following circumstances:

— Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or

— Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm.

All other provisions of the Declaration of Helsinki must be adhered to, especially the need for appropriate ethical and scientific review.

In addition to the requirement for informed consent from all drug-trial participants, it is also standard practice to inform all test subjects that they may receive the drug being tested or that they may receive the placebo.

Non-drug treatments

"Talking therapies" (such as hypnotherapy, psychotherapy, counseling, and non-drug psychiatry) are now required to have scientific validation by clinical trial. However, there is controversy over what might or might not be an appropriate placebo for such therapeutic treatments. In 2005, the Journal of Clinical Psychology, devoted an issue  to the issue of "The Placebo Concept in Psychotherapy" that contained a range of contributions to this question. As the abstract of one paper  noted:

Unlike within the domain of medicine, in which the logic of placebos is relatively straightforward, the concept of placebo as applied to psychotherapy is fraught with both conceptual and practical problems.