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