Ethics of TB prevention, care and control 1
Guidance on Ethics of Tuberculosis Prevention,
Care and Control
Guidance on Ethics of Tuberculosis Prevention,
Care and Control
Swiss Re – Pandemic Risk Talk
THE ATLANTA JOURNAL-CONSTITUTION : TB DIAGNOSIS DOES NOT REPEAL A PERSON'S RIGHTS
BYLINE: BOB BARR; For the Journal-ConstitutionWhen I was a young boy, growing up in the early 1950s before the Salk vaccine became widely available against polio, pictures of boys and girls lying in "iron lung" machines struck fear into our hearts.
Having to spend one's life captive to a body-sized metal cylinder in order to breathe was terrifying, and the risk of contracting polio was real. Thanks to the miracles of post-WWII medicines, however, the risk of diseases like polio has been largely, if not quite entirely, eradicated from life in these United States.
In the post-9/11 world, however, every incident involving a remotely serious possible problem becomes a headline story to be red-flagged and repeated endlessly, until it becomes all-consuming and takes on an aura of importance it may very well not deserve.
Why address ethical issues in TB?
Drug-proof TB strain poses ethical bind
Man locked up indefinitely, sparking civil liberties
debateThe Associated Pressupdated 6:01 p.m. ET April 2, 2007
PHOENIX - Behind the county hospital’s tall cinderblock walls, a 27-year-old
tuberculosis patient sits in a jail cell equipped with a ventilation system that
keeps germs from escaping.
Robert Daniels has been locked up indefinitely, perhaps for the rest of his
life, since last July. But he has not been charged with a crime. Instead, he
suffers from an extensively drug-resistant strain of tuberculosis, or XDR-TB. It
is considered virtually untreatable.
Is it ethical to provide TB treatment without quality counselling?
March 20th, 2009 - 11:00 pm ICT by admin By Bobby Ramakant (CNS)How ethical is it to providing treatment for anti-TB drug resistance without quality
counseling? The treatment literacy, infection control, toxicity and side-effects related to
the treatment, adherence and a range of other issues need to be addressed in
counseling sessions, believes the activist from the West Bengal Network of people
living with HIV (BNP+) in India. This indeed provides a food for thought for delegates of
the 3rd Stop TB Partners Forum (Brazil: 23-25 March 2009) and the high-level
ministerial meeting on drug-resistant TB (Beijing, China: 1-3 April 2009).
Detention and the Evolving Threat of Tuberculosis:
Evidence, Ethics, and Law
Richard Coker 1 , Marianna Thomas 2 , Karen Lock 3 , and Robyn Martin 4
1 Reader in Public Health in the Department of Public Health & Policy at the
London School of Hygiene and Tropical Medicine. 2 Honorary Research
Fellow in the Department of Public Health & Policy at the London School of
Hygiene and Tropical Medicine. 3 Lecturer in Public Health in the
Department of Public Health & Policy at the London School of Hygiene and
Tropical Medicine. 4 Professor of Public Health Law at the Centre for
Research in Primary and Community Care at the University of Hertfordshire,
U.K.
Copyright 2007 American Society of Law, Medicine & Ethics, Inc.
Ethics of TB prevention, care and control 3
Ethical guidance is needed to support countries solve existing problems
TB is primarily a disease of poverty and therefore raises issues of social and global justice and social determinants
Public health measures aimed at TB control can conflict with rights and liberties
Stigmatization and discrimination occur in the context of TB
TB has received comparatively little attention by bioethics and human rights
Ethical issues have been highlighted by the emergence and spread of MDR/XDR-TB
Why address ethical issues in TB ?
Ethics of TB prevention, care and control 4
Development of WHO guidance Development of WHO guidance
Recognising the need for ethical guidance on TB, WHO established a "Taskforce on Addressing Ethical Issues in TB Care and Control Programmes"
August 2008: Establishment of Task Force
08-10 December 2008: 1st Meeting of Task Force (Toronto)
26-28 August 2009: 2nd Meeting of Task Force (Geneva)
12-13 October 2009: Briefing at the MDR-TB and DOTS Expansion Working Groups
15 October 2009: Global Consultation (Geneva)
10 November 2009: Present draft guidance to STAG-TB Meeting
6 December 2009: Session at the Union Conference
Ethics of TB prevention, care and control 5
Development of WHO guidance (2)Development of WHO guidance (2)
May 2010: International conference and workshop, Athens, Greece
June 2010: Workshop of European TB managers, The Hague, Netherlands
December 2010: Publication of guidance document
Translation into 6 UN languages
May 2011: Regional workshop in Guatemala
June 2011: Country workshop in China
December 2012: Country workshop in Azerbaijan
WHO guidance on ethical issues in TB care and controlSTAG-TB, 9th Meeting, 9-11 November 2009
Paula Akugizibwe, ARASA
Ron Bayer, Columbia University, USA
Solomon Benatar, U. of Capetown, SA
Jeff Blackmer, Can. Med. Assoc.
Oscar Cabrera, Georgetown U.
Richard Coker, LSHTM, UK
Angus Dawson, U. of Toronto
Anne Fanning, U. of Alberta
Michel Gasana, NTP Rwanda
Case Gordon, World Care Council
Larry Gostin, Georgetown U.
Dirceu Greco, U. of Minas Gerais, Brazil
Members of the Ethics & TB Task Force
Przemyslaw Musialkowski, Council of Europe
Pr.R. Narayanan, TB Res. Center, India
John Porter, LSHTM, UK
Rajeswari Ramachandran, TB Center, India
Lee Reichmann, New Jersey Med. School
Michael Selgelid, Australian National U.
Julia Seyer, World Medical Association
Jerome Singh, U. of Kwa-Zulu Natal
Ross Upshur, Joint Center f. Bioethics, Toronto
Lyn Vianzon, NTB Philippines
Xie Xiu Wang, CDC China
Ethics of TB prevention, care and control 7
Important ethical values in TB prevention, care and control
Important ethical values in TB prevention, care and control
Ethical considerations can be seen as a complex web of different obligations. In TB care, many will be relevant, in particular:
Social justice/ equity, solidarity, the common good
Autonomy, reciprocity
Effectiveness, subsidiarity
Participation, transparency and accountability
Ethics of TB prevention, care and control 8
The obligation to provide access to TB servicesThe obligation to provide access to TB services
Governments have an ethical obligation to provide free and
universal access to TB services
This obligation extends to M/ XDR-TB, which is more costly to treat
Providing access to care not only benefits individuals, but also the broader community
Ethics of TB prevention, care and control 9
The obligation to provide access to TB services (2)The obligation to provide access to TB services (2)
Governments must ensure the availability of quality-ensured drugs, otherwise health care workers are put in an ethical dilemma
Many ethical considerations in providing TB care have been articulated in WHO's Stop TB Strategy, including a patient-centred approach, the promotion of community-based care, a focus on patients as part of their larger communities and the promotion of social justice
Ethics of TB prevention, care and control 10
Information, counselling and informed consentInformation, counselling and informed consent
Doctors have an obligation to fully inform patients about the risks, benefits and alternatives available to them.
HCW should enlist patients' cooperation to notify contacts.
Non-consensual disclosure of TB status should only be a last resort.
Like for any other medical intervention, the informed consent of the patient is necessary for TB treatment.
Ethics of TB prevention, care and control 11
Supporting adherence to TB treatmentSupporting adherence to TB treatment
There are effective and ethically sound strategies to increase adherence, such as directly-observed therapy and the use of "enablers"
Financial incentives can be useful, but should be managed carefully
People with TB have a duty to complete therapy; providers have an obligation to support the patient's ability to adhere to treatment
Ethics of TB prevention, care and control 12
Supporting adherence to TB treatment (2)Supporting adherence to TB treatment (2)
There is an obligation not to abandon patients: when curative treatment fails, there is still a right to palliative care
If non-adherence is a large- scale problem, this suggests that the system has failed and providers should increase efforts
Treatment should not be denied based on predictions of non-adherence
Ethics of TB prevention, care and control 13
Limited access to M/XDR TB treatmentLimited access to M/XDR TB treatment
All patients should undergo drug susceptibility testing to enable a tailored drug therapy, even though many countries are still in the process of scaling up treatment
When no appropriate drugs are available, drug susceptibility testing is still recommendable as an interim measure, since it provides evidence of prevalence of M/XDR-TB and guidance on how to treat affected individuals
Decisions on how to treat patients where no drug susceptibility testing is available have to be made on an individualized basis
Ethics of TB prevention, care and control 14
Health care workers' rights and obligationsHealth care workers' rights and obligations
Health care workers have an ethical obligation to care for patients, even if this involves some degree of risk
They should not be expected to assume risks that could be
avoided if health care institutions and governments fulfilled their obligations
HCW at heightened risk of infection, such as those who are HIV positive, may be exempted from their duty to care
Ethics of TB prevention, care and control 15
Involuntary isolation and detentionInvoluntary isolation and detention
In general, TB treatment should be provided on a voluntary basis, engaging the patient in the treatment process and respecting his/her autonomy
If support is provided, adherence to treatment should not be a problem
In rare cases, a patient may refuse treatment, leaving involuntary isolation as the only means of safeguarding the public
Ethics of TB prevention, care and control 16
Involuntary isolation and detention (2)Involuntary isolation and detention (2)
Detention should never be a routine component of TB
programmes
The manner in which isolation or detention is implemented
must comply with ethical and human rights principles
Isolated patients should be offered treatment, but their informed refusal should be respected
Ethics of TB prevention, care and control 17
Research in TB care and controlResearch in TB care and control
There is a need to advance research on TB to improve prevention, treatment and care
Guidelines for research on TB should draw on principles of research ethics already articulated in other documents, such as CIOMS, Declaration of Helsinki etc.
Epidemiological research might raise issues of informed consent (to be considered by a research ethics committee), yet this should be distinguished from public health surveillance activities
Ethics of TB prevention, care and control 18
Implementation activities (- Dec 2011)Implementation activities (- Dec 2011)Normative documents/thematic areas
Global, regional and national trainings (# of participants)
Other
Fact sheet on Ethics&TB TB Union meeting: Training for TB specialists on Ethics & TB, Mexico 2009
25 Global Summit of National Ethics Committees: Special session on Ethics&TB, Singapore 2010
Special issue of International Journal on TB and Lung Disease on Social Determinants and Ethics, with 5 papers on ethics;
European Regional Workshop, Athens 2010 European Regional Workshop, Wolfheze 2010; session on ethics
30
80
TB Union meeting: Special session on ethics and human rights, Berlin 2010
Chapter “Ethical considerations” in the WHO Tuberculosis prevalence surveys: a handbook
Inter-professional regional workshop on health-care worker safety, Benin, Sept 2010: session on ethics
40 Establishment of a WG of National Ethics Committees on Ethics & TB - Global Summit in Tunis, 2012
Section on ethics in the WHO Guidelines for drug resistance surveillance
WHO/PAHO regional training workshop on Ethics&TB, Guatemala, May 2011
25 Session on ethics at the Global Consultation on Xpert MTB/RIF, 2010
Development of a monitoring and evaluation tool for Ethics&TB in programmes
WHO-AFRO Regional training on Infection Control for TB in Francophone countries, 2-6 May 2011, Dakar, Senegal; session on ethics
25 Report on activities at UN-Interagency Committee on Bioethics, Paris, March 2011
Advanced TB Infection Control Training and Workshop for future consultants on TB IC; 10-13 May 2011, Addis Ababa, Ethiopia; session on ethics
12 International Childhood TB meeting, Stockholm, March 2011: Session on ethics
MDR-TB training course for Francophone Africa, Ruanda, June 2011
30 Steering Committee on Bioethics of the Council of Europe, 40th Plenary Session, Strasbourg, June 2011: Presentation of guidance and brief discussion
WHO/CDC-China workshop on Ethics&TB, June 2011
40 Session on ethics at the Expert meeting on WHO policy for introduction of new anti TB drugs, Geneva, July 2011
DR-TB workshop for WHO staff, July 2011, Geneva; ethics session
40
National Workshop on Ethics&TB, Azerbaijan, December 2011
30
Total 377
Ethics of TB prevention, care and control 19
Future activities:Future activities:
Development of case studies to give concrete examples of ethical dilemmas that TB programmes face (Moldova and Southern Africa)
Development of an online-course, jointly with Bioethics at Miami (WHO Collaborating Center)
TB & Human Rights work
Regional workshops in Asia and Eastern Mediterranean Region (2012)
Technical support missions to countries (2012)
Thank you!Thank you!
More information on WHO's activities on Ethics & TB:
http://www.who.int/tb/challenges/mdr/ethics/en/
WHO Ethics & TB Task Force
Ernesto Jaramillo, Diana Weil (STB, WHO)
Acknowledgements