MAJOR SESSION 15

Title: TB ETHICS (The Ethics of Tuberculosis)

Scheduled : MS15 : TB Ethics
09 :40 – 12 :00, Wednesday, 9 August
Hall 12, Level 3, BICC

Organizer :
Anne FAGOT-LARGEAULT <anne.fagot-largeault@college-de-france.fr>

Speakers :
Mary EDGINTON <edgintonme@sph.wits.ac.za>,
Lourdes GARCIA-GARCIA et al. <garcigarml@gmail.com>
Brigitte GICQUEL <bgicquel@pasteur.fr>

Corresponding organizer’s address :
Prof. Anne FAGOT-LARGEAULT
Chair : Philosophy of Biology and Medicine
College de France
11 pl. Marcelin Berthelot
75005 PARIS, France
Telephone : 33 1 44 27 14 17
Fax : 33 1 44 27 13 30

General argument:
Effective drugs to treat and cure tuberculosis have been available for more than 50 years, but two million people in the world still die from it each year. « Two million deaths from a curable disease is unacceptable », said Lucy Chesire at the 36th World Conference (in Paris, October 2005) of the IUATLD (International Union against Tuberculosis and Lung Disease).
The object of this ‘TB Ethics’ special symposium is to contribute to a reflection (1) on the ethics of fundamental and clinical research (finding fast and accurate diagnostic tests, more effective vaccines, shorter treatment regimens) , (2) on the ethics of the evaluation of treatment strategies (DOTS is the name of the WHO-recommended treatment strategy, a combination of five elements).
Tuberculosis affects mostly « the poor and weak », that is, vulnerable people living in poverty, often co-infected with other severe diseases (such as AIDS), in areas of the world where health services may be defective. This makes the research for better TB care « a question, not only of public health, but also of human rights and social justice », and calls for wider social mobilisation and patient advocacy in the definition, coordination and evaluation of TB management . Abstracts of presentations :

Dr. Brigitte GICQUEL,
Institut Pasteur, Paris, France
<bgicquel@pasteur.fr>

“Enhancing ethical evaluation, review and monitoring in international collaborative research in tuberculosis: the TBETHICS project”
TBETHICS is a project funded by the European Commission to gather expertise in ethics, biomedical research and clinical trials with the aim to discuss ongoing and future clinical trials for testing new vaccines and new drugs against tuberculosis. This disease is still a major public health problem with two million deaths each year. New drugs shortening the standard treatment and new vaccines more efficient that BCG are warranted. Thanks to an enormous international effort new vaccine candidates showing promising results in preclinical studies are being tested in phase one clinical trials. New regimens with existing drugs and new drugs will be tested in a near future. International guidelines like the Helsinki declaration are existing. However implementation of clinical trials in different countries with socio-cultural and economic specificities require a careful consideration of the local situations with the different actors i.e. scientists, physicians, health workers, researchers in cultural anthropology, philosophers and representatives of society at large. The implementation of clinical trials will involve people from countries in which TB is endemic because they are the populations in need of new treatments and vaccines. Such trials should not interfere negatively with ongoing tuberculosis control programmes, but reinforce them and provide an opportunity for increasing capacity building to fight against tuberculosis and poverty.

Mary E. EDGINTON*, Donald ENARSON#
* School of Public Health, University of the Witwatersrand, Johannesburg, South Africa
# International Union against TB and Lung Disease, Paris (« The Union »)
<edgintonme@sph.wits.ac.za>, <denarson@iuatld.org>

“Treatment of Tuberculosis: Ethical and management issues”
The provision of a secure supply of anti-TB drugs is one of the components of the international DOTS strategy, which outlines the major needs of a comprehensive TB control programme. Systems for the procurement, ordering and availability of drugs at all levels of health services, according to standardised regimens, are the responsibility of programme managers of the public health services. If treatment is interrupted due to the unavailability of medications, this can lead to a lower probability of treatment success, continuing infectiousness and, if the interruptions are selective, the development of drug resistance. All these consequences are serious for the patient and for the community in which the patient lives. Thus, failure to ensure patients' access to the drugs reflects mismanagement and unethical practice. The presentation will give concrete examples of wise (or less wise) programme management in South Africa.

Lourdes GARCIA-GARCIA, Alfredo PONCE DE LEON, Jose SIFUENTES-OSORNIO
Instituto Nacional de Salud Publica, Cuernavaca, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirán, Mexico
<garcigarml@gmail.com>

“Needs for emerging ethical frameworks in tuberculosis public health research in developing countries”
Tuberculosis in Mexico continues to represent a public health problem. Although it has not reached the magnitude of other regions, estimated rates are of 50 cases per 100,000 inhabitants. Poor management of local programs, lack of treatment compliance, and drug resistance are the main obstacles to achieve adequate control. TB raises important ethical challenges for emerging frameworks that orient public health research in developing countries.
We will use the case of a study conducted in Southern Mexico to discuss relevant aspects in the field of ethics of tuberculosis public health research in developing countries. Some of the questions that will be raised are:
1. “How can we promote more dialogue and policy development on the issue of community protection?”
2. “How should standard of care be defined adequately?”
3. “What is the appropriate level of ancillary care that can or should be provided in research studies?”
We need new ethical and policy analytic frameworks that contribute to constructive policy making. These should be accompanied by indicators that help researchers communicate with decision takers in developing countries.

Anne FAGOT-LARGEAULT
College de France, Paris
<anne.fagot-largeault@college-de-france.fr>

“The specificity of TB Ethics”
The fact that tuberculosis in all countries is a disease « of the poor and weak » gives the ethics of TB research and management a political and social dimension, besides its medical dimension. Of course, it is essential that professionals in the field (researchers, physicians, health care providers) be aware of international guidelines for biomedical research (WMA Helsinki Declaration, last amended 2000 ; CIOMS-WHO Guidelines, last revised 2002 ; etc.). But is is also necessary that patients and communities be involved in the definition and evaluation of TB management programmes. This raises the difficulty of finding how to switch, at least partially, from the top-down approach (« do good science and apply the international rules ») to a bottom-up approach (let the growing patient advocacy movement propose strategies and take initiatives). Three aspects will be examined : the potential conflict between the effort to disseminate scientific knowledge and the moral duty to respect the beneficiaries’ point of view, the necessary cooperation between ‘hard’ and ‘soft’ sciences, the acquisition of medical and ethical expertise by patients and communities.