The future of global health: Navigating a complex ethical terrain

1. Office of Research Integrity & Assurance (ORIA) The future of global health:Navigating a complex ethical terrain Mary Simmerling, PhD Assistant Professor of Research Integrity in Medicine Office of Research Integrity

2. Global Health at Weill Cornell Medical College • Service, training, and research to address health problems that transcend national boundaries, disproportionately affect the resource poor, and are best addressed by multidisciplinary solutions.  • Goal is to create a sustainable and innovative research and training program that engage students and faculty at all levels and from multiple disciplines to solve problems of global health.

3. Major Global Health Initiatives at WCMC • Australia: University of Sydney Medical School • Brazil: UFBa and FIOCRUZ • India: Christian Medical College • India: Narayana Hrudayalaya and Mazumdar-Shaw Cancer Center • Peru: San Marcos Medical College • Qatar: Weill Cornell in Qatar • Tanzania: Weill Bugando • Haiti: GHESKIO Centers

4. GHESKIO (Groupe Haitien d’Etude du Sarcome de Kaposi et des Infection Opportunistes) Centers

7. * 'Managing Conflicts of Interest in Clinical Care: The 'Race to the Middle' at US Medical Schools' appeared in the October 2013 edition of Academic Medicine, Vol. 88, No. 10 – data based on September 2011 Policies

8. * 'Managing Conflicts of Interest in Clinical Care: The 'Race to the Middle' at US Medical Schools' appeared in the October 2013 edition of Academic Medicine, Vol. 88, No. 10 – data based on September 2011 Policies

9. * 'Managing Conflicts of Interest in Clinical Care: The 'Race to the Middle' at US Medical Schools' appeared in the October 2013 edition of Academic Medicine, Vol. 88, No. 10 – data based on September 2011 Policies

11. 1982 2014

12. How do we respond when things don’t go that well? What happens at the intersection of longstanding cultural norms and moral disagreements/disharmonies? What happens when we are faced with conflicting demands (internal or external)?

13. Philosophical considerations Principles based framework for establishing: • What is morally permissible/justifiable • What is morally required (eg, as a duty or obligation) • What is morally unjustifiable

14. Guiding/foundational moral principles Beneficence • Do good, don’t harm Respect for persons • Treat people as autonomous agents (with limitations) • Allow them to make their own decisions • Put them in a good position to make those decisions in a well-informed way (power differential, knowledge differential) Justice • Fairness (not necessarily equality, but consistency)

15. With hard questions….. • Do we need to respect everyone and everything? • What does it mean to do good? Towards what end? • How do we resolve competing moral – and practical - demands?

16. Beneficence • What maximizes benefits? • Whose benefits? • Who gets to decide?

17. Respect for Persons • Who gets to choose (be a chooser)? • Under what circumstances?

18. Justice • Fairly sharing benefits and burdens – should geographic lines matter? Are they morally relevant? • Defining the standard of care: is it where one stands at the time, or is it defined by the best (available) options? Does this mean the poor should get less, because they have less? (and if so, how could THAT be fair?)

19. Case for consideration/discussion Organ transplantation in China • January 2007 – Vice Minister of Health publicly admits that China uses organs from executed prisoners for transplantation

21. How should we respond?

22. US: SUPPLY: ~30,000 transplants in 2005 12,958 donors in 2011 (7,502 deceased) DEMAND: > 112,905 currently wait listed for transplant PRC: SUPPLY: ~10,000 transplants/year DEMAND: ~1.5 million in need of transplant Supply & Demand – US & PRC

23. HBV and HCV Prevalence

24. Worldwide Incidence of HCC • China • 120,000 deaths per year • Highest incidence in the world • Second leading cancer related cause of death

25. US Living donors (~50%) Biologically & emotionally related Stranger/”Good Samaritan” Deceased donors (~50%) Donation after cardiac death Donation after brain death (1968) PRC Living donors (~5%) Currently all living donors are genetically related to recipient – e.g., parents, children, siblings Deceased donors (~95%) Donation after cardiac death Small percentage (~2-3%) from traffic accident victims Majority of deceased donor organs from executed prisoners (Huang, 2007) Sources of Organs

26. US Prisoners are allowed to donate organs (while alive and at death), though deceased prisoner organs are rarely used – no use of organs from executed prisoners South Carolina passed legislation allowing the creation of a network for organ & tissue donation in prisons In 2007 legislation was under consideration in South Carolina that would have given prisoners the option to donate organs in exchange for 180 days off their sentence PRC Prisoners (and their families) are asked to give consent to allow their organs to be used for transplantation after execution Use of Organs from Prisoners

27. Executions in the US 1930-2006 U.S. Dept of Justice Office of Justice Programs Bureau of Justice Statistics

28. US - 2006 Population in US ~298,444,215 US DOJ states that 53 prisoners were executed in 2006 PRC - 2006 Population in PRC ~1,313,973,713 (~4x that of US) Amnesty International has estimated that ~1,700 prisoners were executed in PRC in 2006 (per capita ~32x that of US) Number of Executions/Population

29. Use of Organs from Prisoners • Separability between medical organ transplantation and the criminal justice system • Although the practice of organ transplantation is standardized globally, the systems and mechanisms for criminalization and punishment of citizens varies widely • Use of organs from executed prisoners in PRC has been widely criticized by international transplant community • US’s decision not to use organs from executed prisoners has been criticized as unethical by some who argue it is wasteful

30. US National recipient waiting list National allocation system - deceased donor organs “public” goods No national heath insurance Average cost of liver transplant in 2011 $557,100 US PRC No national recipient waiting list No national allocation system No national health insurance Average cost of liver transplant ~$30,000 US Access to Transplantation

31. Historical Challenges Feasibility Risks & Benefits Scarcity, Supply & Demand Access & Allocation Informed Consent Use of prisoner organs Organ sales Continuing/Emerging Challenges Risks & Benefits Scarcity, Supply & Demand Access & Allocation Informed Consent Use of prisoner organs Organ sales Transplant tourism Ethical Challenges

32. US Promote deceased donation Ensure validity of informed consent for donors & recipients (living & deceased donors) Ensure protection of vulnerable individuals Prevent organ trafficking & transplant tourism Standardization of evaluation & consent criteria for living donors Move towards greater equality of access to transplantation – address issue of poverty as a de facto contraindication for tx Address issue of compensation/organ sales PRC Promote deceased donation Ensure validity of informed consent for donors & recipients (living & deceased donors) Ensure protection of vulnerable individuals Prevent organ trafficking & transplant tourism Continuing & Emerging Ethical Challenges

33. US 1968 - Uniform Anatomical gift Act (UAGA) Establishes comprehensive & uniform laws regarding organ and tissue donations 1984 – National Organ Transplant Act (NOTA) Prohibits commercial dealings in organs for transplantation PRC 1995 – Ministry of Health enacts “The Human Organ Transplant Ordinance” Prohibits commercial dealings in organs for transplantation Regulates living donor transplantation November 2006 – Guangzhou meeting – established “entrance criteria” for programs – reducing the number from 600 to 125/150 2007 – Regulation of Human Organ Transplantation Legislation of Transplantation

34. Challenges • Abolishing & criminalizing transplant tourism • China has already taken a clear and strong position against this human rights abuse, however there is still a need to enforce it • Utilizing living organ donors without contributing to the organ trafficking problem • Establishing an ethical framework for transplantation that reflects China’s history, culture, and beliefs

35. Opportunities • Use of brain dead donors in PRC • Establishment of a national system for access and allocation of organs • Further improvement of procedures for informed consent for living & deceased donation

36. Support, and sanctions • The global transplant community has supported China’s efforts to establish an ethical framework for transplantation that reflects China’s history culture, beliefs, and values - simply imposing a distinctively Western ethic on China would be disrespectful & may be damaging to China’s efforts. • At the same time, initiated sanctions by barring publication of articles utilizing organs from executed prisoners

37. Moral engagement • Be humble, curious, and creative • Approach issues with humility, gravitas, and honesty • Recognize these are complex and serious issues that can’t be solved alone, and often are not completely solvable • Don’t be a moral bystander – take the opportunity to tune your moral compass