Ethics in Public Health, Health Care, Health Research and the Biomedical Sciences

1. Ethics in Public Health, Health Care, Health Research and the Biomedical Sciences TH Tulchinsky MD MPH Braun School Public Health 16 November 2010

2. Ancient Origins of PH Biblical Principals Pikuah nefesh - sanctity of human life Tikun olam – Biblical - repair the world Ancient India and China - sanitation Ancient Greece Hippocratic oath - do no harm Healthy body-healthy mind City states Religion – Charity, after-life

3. Medieval The Church - Religious institutions, relieve suffering, care of the poor Aristocracy – noblesse oblige Universities – royal charters Cities – royal charters, municipal government sanitation, hospitals Guilds – mutual benefit “friendly” societies Leprosy Pandemics - undefined The Plague

4. Modern Origins of Public Health Ethics Miasma and germ theories Social hygiene Scientific and PH advances during 19th-20th centuries Government responsibility –local, state and national Collective bargaining for health benefits Tragic distortions of social hygiene – eugenics, genocide Human rights – Nuremberg, Tuskegee, Helsinki Universal right to health care (Health for All) Self responsibility (lifestyle) in health Advancing technology and rising costs Public awareness and expectations Pragmatism and science

5. Ten Achievements of Public Health of the 20th Century • Control of infectious disease • Vaccination • Motor vehicle safety • Safer workplaces • Decline in deaths coronary heart disease, strokes • Safer and healthier foods • Healthier mothers and babies • Family planning • Fluoridation of drinking water • Recognition of tobacco as a health hazard MMWR, 1999

6. Ethics in Epidemiology Ethics is a branch of philosophy that deals with distinctions between right and wrong – with the moral consequences of human actions. The ethical principles that arise in epidemiologic practice and research include: Informed consent Confidentiality Respect for human rights Scientific integrity Last JM [ed]. A Dictionary of Epidemiology. Fourth Edition. 2000

7. Ethics, Values, and Mission Statements in Epidemiology • Core values - fundamental ethical and basic scientific values support mission and purpose of the profession • Epidemiologic mission is to acquire new scientific information needed to maintain, enhance, and promote the public's health • Different opinions about core values • Values in the profession may gradually evolve over time e.g. euthanasia • Core values in epidemiology are closely related to core values in the broader field of public health. • "Values define us as a group of public health professionals; values drew many of us into public health”. Coughlin SS. Epidemiologic Review. 2000;22:169-175

8. Moral Reasoning as Guide for Action • Mandatory and voluntary • Benefits – for society and individuals • Do no harm - balance potential good and harm • Action vs. non action • Autonomy - right of self determination • Justice and equity • Case based approach • Design and conduct of research • Application of knowledge • Conflict of interests – disclosure • Autonomy - informed consent, confidentiality • Screening Coughlin S. Emerging Themes in Epidemiology, 2006

9. Ethical Issues in PH Routinely in public health, scientific considerations blend with political and ethical conflicts, and questions of autonomy, individual rights, coercion, justice, community, the common good, the norms of research, and multi-cultural values are central. In public health today several different types of political and moral theory overlap, converge, and contend with one another, including libertarian liberalism, egalitarian liberalism, utilitarianism, human rights frameworks, and communitarianism. Ethics and Public Health: Model Curriculum, ASPH, 2003 http://www.asph.org/UserFiles/EthicsCurriculum.pdf

10. New Public Health:Individual and Population Health Population Health Public health = utilitarian, paternalistic, social and legal responsibility to protect the public health, community orientation, accountability, universal, governmental responsibility Individual Health Bioethics = human rights, civil liberties and individual autonomy approach, medicalized system, confidentiality, privacy, personalized

11. Ethics in PH • Moral imperative of PH to ensure and protect the health of the population and the individual • Ethical foundations traditionally implicit in PH • The right to health • Responsibility fro population health • Renewed awareness of and accountability • Conflict between individual and community rights • Effects of doing or not doing public health interventions or “best practices” • New issues all the time – diasters, genocide

12. When and When Not to Act • Public (community) right to protection and best available standards • Dangers/costs of not acting exceed those of acting • Judgment, experience, evidence, ethics • Experience of Good Public Health Practice (GPHP) • Threats of preventable mortality or risk factors • Public right to know • Individual rights • Balance of contradictions • Accountability, transparency

13. Why Study Ethics in PH • Many issues of conflict between good of the individual and good of society • Immunization, chlorination, fluoridation • Food fortification • HIV/AIDs, MDRTB, DOTs vs. DOTS Plus • Aging and chronic diseases • Genetically modified foods • Technology and resource allocation • Stem cell research • The Case-for-Action

14. Basic Questions • Does society’s responsibilities = paternalism? • Does freedom of individual = rejection of responsibility of the state in health? • Do we need informed consent for all PH interventions? • Do individual rights over-ride social responsibility? E.g. AIDS contact tracing • “Precautionary Principle” = must prove zero risk of an new medication or PH intervention? • Equity in health? • Adequacy of funding and its allocation?

15. Old-New Battles • UK Variolists oppose vaccination vs. smallpox C19th • US Opposition to public health departments in 1920s • UK GPs oppose immunization with pertussis (1980s) and MMR (2002+) • AMA opposes to national health insurance 1920s + • Civil rights vs. HIV control, 1980s US • Anti-fluoridation 1950s to present • Resistance to innovations e.g. MMR, Hib, Pap smear • Anti-food fortification in Europe • Anti-genetic engineering of food in Europe

16. PH Ethical Issues • Responsibility to protect society • Responsibility to the individual • Individual vs. community rights • Government responsibility • Corporate responsibility • Right to health care • Personal responsibility - self care • Quality of care • Freedom of choice • Acting on evidence vs. not acting

17. PH Law and Ethics • Gov’t obligation to protect health of the population • Power of government to legislate, tax, spend, regulate, punish • Restriction of personal and business liberties e.g. seat belt laws; smoking restrictions vs. human rights • Economic, social impact of intervention vs. non-intervention e.g. inequities of the poor and rural • Laws enacted by legislative bodies • Court decisions • Public scrutiny • Accountability

18. Individual Rights and PH Ethical Issues • Right to quality health services • Provider responsibility to act for benefit of client • Euthanasia - right to die • Confidentiality – right to privacy • Informed consent – right to know • Birth control – religion vs. individual rights • Supply and distribution of resources for health • Incentives - disincentives • Equity – social, ethnic, regional • Social solidarity

19. Groups at Special Risk • Women • Children • Civilians in war and terror situations • Disaster victims • Native peoples • Minority groups • Prisoners • Military • Refugees and internal migrants • Mentally ill • Rural vs. urban

20. Individual Personal hygiene Immunization Right to health care Self care Choice of provider Right to know Right to die Confidentiality Privacy Informed consent Patients Bill of Rights Community Sanitation Herd immunity Universal access Education Gatekeeper function Mandatory reporting Case follow-up Resources for health Cost containment Equity Minority and special groups High risk groups Individual and Community PH Ethics

21. Public Health: “the Slippery Slope” • 1920’s-1930’s: Eugenics movement • 1930’s-1940’s: Mass sterilization of "defectives" in United States and Sweden. • 1930-1940’s: Mass murder of “defectives” in Germany (750,000) • 1940’s: Quarantining as pretext for ghettos by Nazis • 1940s: Concentration camps, human experimentation • 1940s: The Holocaust (6 million Jews and others) • 1946 – Nuremberg Trials

22. Landmarks on Individual Rights: the Biomedical Model • Focus on individual informed consent • Concern of exploitation and abuse of the individual • Eugenics and forced sterilization • Concentration camp medical “experiments” - Nuremberg trials • Helsinki declaration • Tuskegee experiment • Declaration of human rights • Health for All

23. Nuremberg Code 1946 • Nazi experiments and industrialized murder • Doctors found guilty and executed • Set new conditions for research • Subjects must have: • Right to knowledge of purpose and effects of experiment • Right of voluntary consent • Right to end participation • Scientist in charge responsible for: • Scientific basis or validity of the hypothesis • To terminate experiments likely to cause injury, disability, death

24. Universal Declaration of Human Rights, 1948 Article 25. 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 etc.

25. Helsinki Declaration 1964 • World Medical Assembly 1964 to present • Privacy and integrity of individual protected • Adequate informed consent • Research for valid scientific benefits • Accepted scientific principles • Benefits outweigh risks • Publication • Protect control group • Individual well-being vs. needs of science and society

26. Tuskegee Experiment • Tuskegee, Mississippi • Duration 1932-1972 • Conducted by US Public Health Service • To observe the natural history of syphilis • Group of black men • Treatment with penicillin available (1942) • Failed to provide information to subjects • Unethical (possibly criminal) behavior • New standards resulted • Apology by President Clinton 1996 • Continues to influence sectors of US public in response to public health initiatives

27. Health for All • WHO definition of health, 1948 • Alma Ata, 1978 Health for All • Health care as a universal human right • Government responsibility • Wide acceptance • Important to help shift priorities • Still unfulfilled • Health targets • Priorities and cost-benefit decisions

28. Changing Concepts of Disease • 1960s – Ivan Illitch and McKeowan – medical care of little value; health gains result of sanitary and nutritional adavances • 1970s – Marc Lalonde Health Field Concept: genetic, environment (physical and social), lifestyle and medical factors in health • Evidence of risk factors for disease e.g. smoking, diet exercise e.g. smoking and Framingham studies • Blaming the victim vs. self responsibility? • Health targets US Surgeon General and WHO

29. Law Government Ethics New Public Health Public Opinion Inter national standards Individual Health Population Health

30. The New Public Health • Sanitation, environment, infectious disease control • Managing health systems and resources • National target e.g. reduce stroke mortality • Health promotion e.g. food fortification, smoking restriction • Health education e.g. nutrition, exercise, self care • Personal preventive services e.g. hypertension, MI, CHF, diabetes • Clinical standards, guidelines e.g. AMI, diabetes • Ambulatory and home care • Long term care

31. Tasks of the ASPHER Ethics Working Group • Develop overall ethical standards of ASPHER EUPHA and member organizations • Develop ethical standards for public health practice • Develop curricula for undergraduate, masters and PhD level studies of PH • Promote research and publication in ethical issues in PH

32. Summary • Government responsibility to legislate, tax, regulate and enforce for the public health • Protection and pro-active services for the weak, the needy, for equity and social solidarity • Ethical considerations • Rights of society • Rights of individuals • Responsibility of individuals • Informed consent for research • Precaution vs. inertia • Importance of New Public Health

33. Which is the Right Way? What would your mother tell you to do?