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Evidence-based bioethics: delineating the connections between science, practice, and values in medicine. (CROSBI ID 233357)

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Orešković, Stjepan Evidence-based bioethics: delineating the connections between science, practice, and values in medicine. // Croatian medical journal, 57 (2016), 4; 307-310. doi: 10.3325/cmj.2016.57.307

Podaci o odgovornosti

Orešković, Stjepan

engleski

Evidence-based bioethics: delineating the connections between science, practice, and values in medicine.

The origins of the notion of bioethics, self- defined as "science of survival", are multiple (1). They can be traced back to The Code of Hammurabi (1754 B.C.), which was dedicated to establishing specific rules and drastic penalties for medical doctors in cases of therapeutic failure. The Code represents an early attempt to establish strict behavioral guidelines and via a connection between the responsibility for a medical intervention (rules 215-225) and measurable outcomes: "If a physician makes a large incision with the operating knife, and kill him, or open a tumor with the operating knife, and cut out the eye, his hands shall be cut off." There is a significant difference between the evidence collected to make a value judgment for a particular case and evidence that serves in the process of testing a certain hypothesis about the nature of things (3). The Judgment of Solomon represents the model and the case for a different bioethical method and approach in "life or death situation" decision making. When King Solomon of Israel was called to make a judgment regarding two women, both claiming to be the mother of a child, he decided to employ a wise and intuitive method. He was tricking the "mothers" into revealing their true feelings. From a bioethics point of view, his task was to distinguish the right outcome from the wrong outcome without any empirical evidence. The episode has become an example of a middle ground argument (argumentum ad temperantiam) where an impartial judge is displaying wisdom in making a decision. Solomon was collecting evidence with a non-standard, non-epidemiological method for informed decision making. The Case of Re A (Separation of Conjoined Twins and a decision of the Court of Appeal of England and Wales) likewise demonstrates the complexity of bioethical decision-making (4). The Hippocratic Oath (500 B.C.E.) marks the beginning of Western ethical reasoning and decision making in medicine. However, the well- known phrase (“primum non nocere”) that became the binding ethical rule of utmost importance is not in the Hippocratic Oath. It comes from The History of Epidemics, which is part of the Hippocratic corpus (5). The same applies to the well-known principles of non-maleficence and beneficence (“salus aegroti suprema lex”). From Hammurabi's Code to the moment when the German theologian Fritz Jahr published articles using the German term “Bio-Ethik” in 1927 (6) there were 3.681 years of non- interrupted efforts directed towards establishing the ground for decision making that would be ethical, objective and life- saving. Finally, an important academic and professional "boost" for bioethics came with van Ransselaer Potter's “Bioethics, the Science of Survival” (7) and Callahan’s “Bioethics as a Discipline” (8). What where the key drivers for increased professional, public and institutional interest in bioethics in late 1960s and early 1970s? Joint interests and parallel history of Evidence Based Medicine and Evidence Based Bioethics The first and most important argument was fostered by a series of important events in research and clinical medicine: the Harvard Definition of Brain Death (9), the Roe v. Wade case (10), the Karen Ann Quinlan case (11), and the Baby Doe case (12). The second important stimulus came from the institutional background. The Joint Commission for Accreditation of Healthcare Organizations that accredited hospitals in the USA was introducing clinical ethics consultation as a must-have method for the improvement of quality assurance through the newly established hospital ethics committees (13). David M. Eddy was the first one to use term "evidence-based medicine" in the course of his work on population-level policies. He was also the first one to link clinical practice guidelines and insurance coverage of new technologies with the idea of evidence-based bioethics. Two associations, The American College of Physicians and the American Heart Association, followed immediately in 1987 by publishing evidence-based guidelines. Another important step was made in the United Kingdom by Richard Smith's editorial in the British Medical Journal introducing the ideas of evidence- based policies (14). Finally, five years later, the Cochrane Collaboration initiated a network of experts aimed to produce systematic reviews and guidelines. A similar interest in the development of practice guidelines applies to evidence- based bioethics. A major difference is the level of specificity and a ten to fifteen year delay. However, there are two similar interests. One is the evaluation of ethical practices in the context of effectiveness when issuing clinical practice guidelines and public health and population- based policies. The other shared interest is the introduction of epidemiological methods into individual patient-level decision-making (15). The parallel history of evidence-based bioethics starts in 1979, when Tom Beauchamp and James Childress published Principles of Biomedical Ethics (16), connecting efforts to resolve ethical issues in clinical medicine with a development of defined and concrete ethical principles - defining it as principalism (17). Principles of respect for persons, beneficence, and justice were identified as guidelines for responsible research using human subjects in the Belmont Report (18). However, efforts to regulate physicians' behavior through codes of ethics as specific ethical guidelines started already in 1847, when the American Medical Association meeting in Philadelphia established uniform standards for professional education, training, and conduct. The Code was adapted from the ethical code of conduct published in 1794 by Thomas Percival (19). After WW2, numerous international organizations joined the practice of developing bioethical codes for specific bioethical problems. The World Medical Association (WMA) accepted The Declaration of Helsinki (20). The Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization (WHO), issued International Ethical Guidelines for Biomedical Research Involving Human Subjects (21). The Council of Europe (CoE) issued The Oviedo Convention - The Convention on Human Rights and Biomedicine (ETS No 164) (22). The European Council and The European Parliament (EU) issued Directive 2001/20/EC (23). At the clinical level, practical approaches to ethical problem solving developed, and new institutions specialized for operational research in bioethics were established. The National Institute for Health Care Excellence became a model institution for quality improvement in health care through the development of evidence-based guidance that increasingly considers bioethical aspects of clinical decision making (24). The Nuffield Council on Bioethics is systematically identifying ethical questions raised by recent advances in biological and medical research and publishing reports and guidance on specific bioethical topics such as biological and health data, mitochondrial DNA disorders, Zika ethical considerations, genome editing and public dialogue, dementia, invasive cosmetic procedures just to mention a few recent documents (25). A Case Example of Development of Utilitarian Bioethics: From Bentham's Felicific Calculus to World Happiness Report How do we define and measure good and bad ethical outcomes in medicine and healthcare? How to even measure the bioethics of happiness? The practice of pragmatic ethics John Stuart Mill called "experiments of living." Pragmatic ethics attempts to use philosophical methods to identify the morally correct course of action concerned with legal issues in the life sciences. Ethical pragmatists, such as John Dewey, thought that norms, principles, and moral criteria were likely to be improved as a result of the inquiry. Henry Sidgwick introduced the idea of motive or intent in morality, and Peter Singer was conceptualizing the idea of preference into moral decision- making. The idea of human happiness is a good example of the utilitarian theory approach. The "greatest happiness principle" or the principle of utility, forms the cornerstone of all Bentham's thought. Bentham was trying to develop an operational concept for the scientific approach to human happiness by proposing a technical instrument “Felicific Calculus”. By "happiness", he understood a predominance of "pleasure" over "pain." He wrote in The Principles of Morals and Legislation explaining that " The word utility does not so clearly point to the ideas of pleasure and pain as the words happiness, and felicity does.”(26). John Stuart Mill, being Bentham’s disciple, was trying to move step further while trying to develop the system to measure pain and pleasure. Mill distinguished between higher and lower pleasures understanding that certain human goods are irreducible to the calculation of the amount of pleasure or pain. Jeremy Bentham, or at least his auto-icon now on public display at University College London, would be delighted to know that less than two centuries after his death, The United Nations Sustainable Development Solutions Network published The World 2015 Happiness Report. The report outlined the state of world happiness, causes of happiness and misery, and policy implications highlighted by case studies (27). The Gallup World Poll database was utilized as a rich source of information. Each variable reveals a population-weighted average score on a scale running from 0 to 10 that is tracked over time and compared to more than 150 countries. These variables measured and compared are healthy life expectancy, GDP per capita expressed in Parity Purchasing Power (PPP), the freedom to make life choices, social support, generosity, and perceptions of corruption. Each country is compared to a hypothetical nation called Dystopia, which represents the imaginary nation with the lowest averages for key variables and is, along with the residual error, used as a regression benchmark (28). Psychologists, sociologists, economists, and statisticians analyze the feeling of happiness as related to general mental illness, the benefits of happiness, the relevance of bioethics and policy implications and links it to the Human Development Report (29). A Critique of Evidence Based Bioethics Empirical research in bioethics started at the end of XX century and was mostly influenced by developments in biological and clinical research, using methods from epidemiology and medical statistics. Writing during the first decade of the HIV/AIDS epidemic, Benjamin Freedman noted that "perception, rather than reality, controls the generation and resolution of ethical issues" (30). Freedman was referring to the debate on doctors' duties to provide care to AIDS patients and how they were perceiving the risk that patients might transmit the virus to them as vastly different from the actual risk involved. Halpern was trying to establish the argument for the development and implementation of evidence- based bioethics by asking a logical question "but what ought to guide ethical deliberations once evidence becomes available?" (31) Value conflicts may emerge not only in clinical care or the epidemiology of infectious diseases. Solomon, Gusmano, and Maschke all demonstrated how they regularly emerge in health care organizations, public health, regulation and among payers. Conflicting situations may be resolved with transparent public dialog about the evidence involving patients, as well as public engagement (32). Societies also need to develop strategies for managing values conflicts, as for any other complex behavioral and social situation related to healthcare. After two decades of development, there is a long list of studies in favor of evidence-based bioethics. However, the scope of scientific evidence behind bioethics should not be narrowed and limited exclusively to medical outcomes. "The qualitative, ethnographic, and phenomenological methods typically undertaken in empirical ethics are ranked low on the evidence-based hierarchy of knowledge…" (33). It is a consequence of the widespread practice and dominating convictions throughout the history of medicine that the primary goal “efficacy”. Such a reductionist approach is creating space for the healthcare policies that are frequently driven by ideologies and hidden agendas, rather than evidence. Influenced by ideology, many countries are enacting arbitrary healthcare, reproductive health or pharmaceutical policies. As the only real strategy that may oppose such arbitrary policies are evidence-based bioethics principles implemented in everyday practice. However, the limits that evidence-based approaches put on current research in empirical ethics deserves further attention and discussion regarding what kind of normative (34) background and evidence forms bioethical theory and informs bioethics.

Evidence Based Bioethics ; Science ; Practice ; Values

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Podaci o izdanju

57 (4)

2016.

307-310

objavljeno

0353-9504

10.3325/cmj.2016.57.307

Povezanost rada

Javno zdravstvo i zdravstvena zaštita

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