Ethical Considerations in TB Mike Watson Frick November 20, 2015
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1 Ethical Considerations in TB Mike Watson Frick November 20, 2015 Tuberculosis Intensive November 17 20, 2015 San Antonio, TX EXCELLENCE EXPERTISE INNOVATION Mike Frick, MPH has the following disclosures to make: No conflict of interests No relevant financial relationships with any commercial companies pertaining to this educational activity 1
2 ETHICAL CONSIDERATIONS IN TB Mike Watson Frick TB/HIV Project Treatment Action Group Heartland TB Intensive November 2015 The plan Key concepts: ethics & human rights Key context: zero TB campaign & endtb strategy Ethics and the language of TB Ethics and patient-centered TB care Ethics and protection of healthcare workers Ethics and involuntary isolation and detention Ethics and TB research Update on revised TB ethics guidance from WHO Hearing from you 2
3 ETHICS simply part of our life with others Refers to the way we ought to live our lives, including our actions, intentions and habitual behavior Ordinary ethics when we talk about ethics, we re not leaping away from everyday life, but rather descending into it Ethical values best understood as a complex web of obligations sometimes in alignment, sometimes in conflict HUMAN RIGHTS timeless expressions of fundamental entitlements of the human person Universal, inalienable Defined by international law Primarily concerned with the relationship between individuals and their governments Governments are charged to respect, protect and fulfill Rights can be civil and political (e.g., freedom of movement, religion etc.) Rights can be economic, social or cultural (e.g., the right to health) 3
4 Ethics, meet human rights There s a lot of overlap especially in health Human rights are concrete legal expressions of ethical values (for example, non-discrimination, participation, accountability etc.) Not unwavering universal agreement on ethics Not all countries have ratified all the human rights treaties We have a lot of catching up to do when it comes to promoting ethics and human rights in the TB response. Until recently, unambitious global goals. A one size fits all approach (DOTS). A heavy emphasis on top-down, biomedical interventions. Infrequent discussions of patient education, empowerment and psychosocial support. Slow progress in research and development. Little political will mobilized to tackle the TB epidemic. 4
5 WHO s END TB Strategy 95% reduction in TB deaths by % reduction in TB incidence by 2035 Zero catastrophic spending due to TB Ethics and the language of TB As leaders in the TB community, NTCA urges that care be provided using the most compassionate and patientcentered approach possible. NTCA recognizes the need for non-stigmatizing language in TB services. We resolve to use non-stigmatizing language in our publications and discourse, and to promote the use of non-stigmatizing language with our partners. NTCA The Union fully acknowledges that some terms that have been used for many years to describe TB activities can stigmatize people affected by TB. The Union is committed to communicating in a manner that embodies respect for all people affected by TB. IUATLD 5
6 What does language have to do with ethics? Words and gestures uncover the nature of the world and the self hence language becomes much more than a system of communications, it expresses ethical commitments that have become embedded in everyday life. What is at stake in language is not only to communicate, but to do so in a manner that the self-respect, dignity and honor [of others] is not harmed. Veena Das Language and TB Stigma Stigma >>> contagion, defect, disability Treatment default Defaulter TB suspect Compliance Research subjects TB control Treatment non-completion Person lost to follow-up Person to be evaluated for TB Adherence Research participants TB prevention and care 6
7 Ethics and patient-centered TB care Patient-centered care is oriented toward addressing patients priorities, not in the sense of a menu of choices, but rather as a holistic model of health care delivery that considers the patient as the central figure in the process or continuum of care. Physician Patient Physician Patient Health System O Donnell MR, Daftary AD, Frick M, et al. Re-inventing adherence: toward a patientcentered model of care for drug-resistant TB and HIV. IJTLD [forthcoming]. Patient-centered care is a process, not an outcome Patient-centered approaches recognize that comprehensive care must be provided along a locally contextualized continuum of services. 7
8 Patient-centered care and human rights Requires overcoming mindset that people with TB are nonadherent, while medicine is always efficacious. Requires rethinking responsibilities. Patientcentered care does not mean re-centering all responsibility back on the person with TB. The obligation to provide care rests with governments. Ethics and protection of healthcare workers 8
9 The duty of care does not exist in a vacuum HCWs have an ethical obligation to provide care to patients, even if doing so involves risk; But there are limits to the degree of risk HCWs can be reasonably expected to take. The duty of care depends on the provision of goods and services by governments and healthcare institutions. HCWs have multiple obligations to families, coworkers, society. Coworkers Government Patients HCWs Society Families Ethics and involuntary isolation and detention Forced treatment = never ethically justifiable Involuntary isolation and detention = last resort measures Non-adherence is often the direct result of failure to engage the patient fully in the treatment process. Any program that experiences frequent refusals of care, or significant adherence problems, should take a hard look at whether it is doing everything it can to implement a patientcentered approach WHO TB Ethics Guidance 9
10 The Siracusa Principles There are limits to rights-limiting measures. When is it justified to limit human rights in the interest of public health or safety? Restrictions must be: 1) Necessary 2) Proportional to the potential harm 3) Non-discriminatory Restricting one right cannot be taken as a justification for limiting all rights. Photo by Maxim Dondyuk Ethics and TB Research (as opposed to the ethical conduct of TB research) Shortcomings in R&D have helped give rise to many of the ethical challenges that TB programs face. Research can transform the way a disease is culturally perceived (e.g., moving from fatal to curable). Research can galvanize advocacy and clarify social or legal petitions for redress of TB-related harms. The benefits of research are not always equitably or fairly distributed.without reflection, research may reinforce the disparities that drive the TB epidemic. 10
11 R&D shortcomings give rise to ethical challenges faced by TB programs Weak R&D environment leaves people with TB and health systems reliant on lengthy treatment regimens with pill burdens, side effects, dosing schedules that complicate adherence. Limitations to TB diagnosis and treatment still unresolved by research have changed the nature of TB disease itself. Limited funding limits the equity proposition of TB research from the outset and means compromise is woven into the fabric of TB research itself. 1 ex: not studying drugs in optimal combination; 2 ex: desire for clean studies producing data with little noise leads to studies focused on easiest-to-treat (i.e., adults with minor cavitation, no HIV or HIV with high CD4 count) 3 ex: little research that includes most vulnerable populations (children, pregnant women, people who use methadone etc.) 11
12 Thinking beyond informed consent Does research generate social value? = Evaluation of a treatment, intervention or theory stands to improve health and well being or increase knowledge. = Research responds to global and local needs and equitably alleviates the burden of TB disease. Update on revised TB ethics guidance from WHO WHO Experts Group on TB Ethics and Human Rights met in Geneva Nov
13 What s changed since the first guidance? Clinical trials New drugs for DR-TB (bedaquiline and delamanid) New regimen for TB infection (3HP: RPT + INH) New diagnostic test (GeneXpert MTB/RIF) Disappointing results (4-month DS-TB trials, TB vaccine trials) Epidemiology/surveillance Clearer picture of the size of the TB epidemic Greater recognition of the burden of pediatric TB Better understanding of DR-TB transmission Cross-cutting Funding for research has stagnated 3 pharmaceutical companies have left TB research Development of Good Participatory Practices as an ethical guidepost for TB research New considerations in the guidance A deeper focus on preventing and treating TB among special populations and in challenging contexts. Ethical issues related to pediatric TB Ethical issues of treating TB in prisons Ethical issues related to TB and migration Ethical issues related to suboptimal treatment of MDRand XDR-TB (i.e., functional monotherapy) 13
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