From 29 September – 2 October 2005, Pugwash Meeting no. 310 was held in Ajaccio, Corsica, France.
3rd Pugwash Workshop on Science, Ethics and Society: Ethical Dimensions of HIV/AIDS
Workshop Report by Arthur Petersen
The HIV/AIDS pandemic confronts global society with stark, dreadful and inescapable ethical questions. These questions were identified in a series of workshops organised by the Pugwash Conferences on Science and World Affairs under the title ‘Threats without Enemies: The Security Aspects of HIV/AIDS’ (held in Betty’s Bay, near Cape Town, South Africa, 7–9 February 2004; Mabula Lodge, Limpopo, South Africa, 25-28 June 2004; and Villa Via, Gordon’s Bay, South Africa, 29 April–1 May 2005). Over the past two years, Pugwash has also convened a series of workshops on ‘Science, Ethics and Society’ (Paris, France, 27–29 June 2003; and Ajaccio, Corsica, France, 10–12 September 2004). Exploiting the area of overlap between the two workshop series, the decision was made to directly confront the ethical issues related to HIV/AIDS through a workshop ‘Ethical Dimensions of HIV/AIDS’ that brought together from all over the world 21 highly qualified participants from disciplines including virology, epidemiology, physiology, pathology, neuroscience, psychiatry, bioethics, medical research management, humanitarian assistance, political science, military and historical studies, geography, conflict and disaster studies, socially responsible business management, and uncertainty assessment.
The workshop was held Ajaccio, Corsica, France, from 29 September–2 October 2005. On 29 September 2005, during a public evening organised at the Palais des Congrés, Khadija Moalla delivered a speech on the ‘Role of religion and ethics in the prevention and control of the epidemics’ and Gilles Raguin spoke about ‘Le Sida en 2005: réalités et enjeux’, and this session was followed by a discussion with the public.
The organisation of the workshop was fully supported by the ‘Mouvement pour la Corse du 21ème siècle’ and benefited from grants from The Swiss Pugwash Group, the Ajaccio Chamber of Commerce and Industry, the Mayor of Ajaccio, the Territorial Organisation of Corsica, the Corsican Tourism Office and the General Council of South Corsica.
Five main topics were discussed: (1) social ethical problems of combating the long wave HIV/AIDS pandemic; (2) ethical issues in HIV/AIDS research in developing countries; (3) ethics and action of multinational companies against HIV/AIDS; (4) ethical implications of treatment versus prevention-led strategies; (5) role of religion and ethics in the prevention and control of the epidemics.
In this report, the presentations held at the workshop are outlined and the discussions are reflected. Subsequently, the most salient points of the workshop are summarised. Finally, future work for Pugwash is identified.
Introduction
The workshop was held within a month after the death of Sir Joseph Rotblat, co-founder of the Pugwash Conferences. At the opening of the workshop, Professor Marie Muller of the University of Pretoria, Chair of the Pugwash Council, gave a brief tribute to Sir Jo. With Sir Jo—who had dedicated his life to the abolition of nuclear weapons, who had always emphasised the social responsibility of scientists, and who shared the 1995 Nobel Peace Prize with the Pugwash movement—the members of Pugwash had lost a very dear friend. The best way now to pay him tribute is by continuing his lifework. The participants should keep in mind that in this workshop they were in a broad sense busy doing so.
Professor Gwyn Prins of the London School of Economics and Political Science (LSE) and Columbia University provided an introduction to the workshop. According to him, this is a Pugwash moment in science and world affairs. The key message of the Russell-Einstein Manifesto (1955) is that the world community is morally and intellectually challenged to learn to think in a new way. Among the characteristic of the current age are long wave events like HIV/AIDS, which is one of the central ill-understood problems confronting humanity. In our thinking and our action, it is necessary to stay ahead of the wave of the HIV/AIDS pandemic. One of the reasons that Pugwash became involved with the problem of HIV/AIDS is the link with global security. This link was acknowledged by the United Nations at the level of the Security Council with the passing of Resolution 1308 on 17 July 2000. The Security Council is responsible for the maintenance of international peace and security through international peacekeeping operations and HIV/AIDS poses a threat to these operations.
However, the evidence base on which action in the field of HIV/AIDS and security began was totally inadequate—and incorrect. This is understandable, since good scientific work on the social aspects of the epidemic is difficult to do. The problem of HIV/AIDS constitutes a toxic mix of sex, race and power. In the absence of good research, many interested advocacy groups could more easily push their views by commissioning ‘quick and dirty’ studies by consultants. The result was that one or two good facts started being blown up to produce ‘inverted pyramids’. The first ‘factoid’ (that is, a fact which has no existence before appearing in the media) was that soldiers are seven times more likely than others to be infected. The second factoid was that 45% of peacemakers in Cambodia had sex with the local population. Both these ‘factoids’ were misstatements of real facts. In the first case, for instance, the real fact is that the prevalence of sexually transmitted infections (STIs) in soldiers is generally seven times higher than in the general population. Whether this result also applies to HIV prevalence depends very much on the circumstances.
After it had been decided that there was potential for Pugwash to make a contribution in the area of HIV/AIDS and security, four workshops were convened. The reports and selected materials are available online. In the current workshop, the goal was to tackle the ethical issues directly. These issues broadly fall under four bundles of ethical problems: a) ethics of research (e.g., clinical trials); b) physicians’ problems in somatic treatment (e.g., what is the right thing to do for a patient?); c) ethics and its relation to epidemiology (e.g., how to deal with the development of multiple drug resistance?); and d) the ethics of the politics of action.
Social ethical problems of combating the long wave HIV/AIDS pandemic
In his presentation, Prins proposed five sets of moral and consequent dilemmas that are raised by the HIV/AIDS pandemic with special reference to South Africa. First, he called it ‘bad luck’ that HIV/AIDS had arrived simultaneously with ‘rights overload’ (a consequence of the rise of human rights over the last 60 years). Second, the problem is extremely persistent: HIV is an old type of virus, HIV/AIDS is a long wave social phenomenon (societies should prepare for 130 years of living with HIV/AIDS even assuming that better bio-medical interventions will be developed), and the available medical interventions range from imperfect to potentially dangerous. Third, there were doctors’ dilemmas. Which socio-medical context should be chosen here: the North American model (do all that one can for the sick patient lying before you, regardless of anything else) or battlefield medicine (where triage is practiced and the patient has no choice), for instance? Fourth, in the South African context, the first three dilemmas were compounded by the coincidence of President Mbeki’s Denialist agenda with a forceful constitutional promotion of a rights culture: how can organisations such as the Anglo-American Corporation or the South African National Defence Force manage the crisis if testing can only be done on a voluntary basis? Fifth, Prins claimed that fire-hosing money on Africa without strings attached, or without even setting terms and priorities or expressing preferences, gave rise to unintended consequences: corruption, crime and guns. Only major changes or interventions in behaviour offered any hope of controlling the crisis.
In the brief discussion that followed Prins’s presentation, his claim that human rights were hindering research was confirmed by one of the medical specialists. Other points were taken up in discussions later in the workshop. One participant later had problems with the triage analogy, for instance, since it supposes that there is only a fixed set of resources. This assumption should not be accepted, given the political prerogative to furnish additional resources if needed. Another participant found triage a dangerous way of going, since the people far away from functioning health systems would probably not receive treatment and care.
Dr. Clive Evian, HIV public health consultant and part-time clinician at the Johannesburg Hospital HIV Clinic, highlighted in his presentation some of the socio-economic determinants of HIV/AIDS in South Africa and shared the results of several pioneering anonymised prevalence studies, with elaborate social and other labelling, done under his supervision in workplaces in the sub-continent. The epidemic is very diverse and there is a close association between HIV infection and social dislocation. His own studies showed consistent patterns of higher HIV prevalence in the lower income categories, contract employees, seasonal workers, as well as economically disempowered women and employees living away from home or in unfavourable living conditions. Evian warned the participants that HIV was not the problem: it was the result of a problem, that of social disorder. The descriptions by Fredrich Engels of the poor of London in the 1840s were still closely appropriate: ‘The manner in which the great multitude of the poor is treated by society today is revolting. . . . As a result of this, they are deprived of all enjoyments except that of sexual indulgence and drunkenness.’ Socio-cultural transition is a major cause of this social disorder and the basis for the African and possibly Asian epidemics. The epidemiology of HIV is reflective of the social status and stability of communities in South Africa. The HIV transmission from older men to younger women (especially very young girls) may be a critical factor in propagating the epidemic. He concluded that socio-economic uplift and long term community stability were the most likely determinants of control of the HIV epidemic in developing countries. The world should prepare for the fact that the epidemic will be around for many years to come.
The participants were appreciative of the data offered by Evian, which gave a more broadly balanced picture than could be obtained from ante-natal clinic data and enabled the participants to crystallise their discussion. They provided a strong evidence base for the claim that the epidemic is socially produced. It was proposed that leadership and legislation were needed to prevent HIV transmission from older men to girls. It was asked whether it was sexual violence that made the difference. Evian responded that the problem was larger and a whole package of social disorder should be considered. A participant noted that for leaders in South Africa to discuss black sexuality was just too difficult, since it provides a stark and painful reminder of one of the ways some whites talked about black peoples’ sexuality in the days of apartheid.
Dr. Gilles Graguin, Infectious Diseases Specialist, Hôpital Saint-Antoine, University of Paris, provided the workshop with a brief comment on the present status of the health sector reform and its limitations. The cost-effectiveness approach to health-system reform in developing countries that was pushed by the international monetary institutions had resulted in major difficulties. The health sector was not delivering after 10 years of reforms. This was mainly due to the fact that the entire approach is money-driven and focused on privatisation. What was needed, however, was a value-driven approach to health systems, based on the concept of health equity. Another participant agreed that there were strong reasons to be sceptical of taking a capitalist approach for delivering public goods. It should therefore not come as a surprise that it had not worked. These positions were challenged by a third participant, however. When given the chance, there was no more capitalist place than rural Africa. A new model of capitalism was needed, which was going to look nothing like the late 19th century models. In this line of reasoning, the state was mainly needed to fulfil its ‘responsibility to protect’ (UN 2005 World Summit): you must have someone from whom to claim your right to be protected. Some participants were confused about what this ‘responsibility to protect’ precisely entailed. The UN 2005 World Summit refers to the responsibility to protect populations from genocide, war crimes, ethnic cleansing and crimes against humanity. The prime bearer of this responsibility is the state. If states do not fulfil this responsibility, the international community, through the United Nations, may step in to use appropriate diplomatic, humanitarian and other peaceful means. It could be argued that a similar principle should apply to the HIV/AIDS pandemic and the responsibility of states to protect their citizens from this pandemic. Still, the principle could be used in disastrous ways. Will the local community, or their leaders, be asked whether they want to be protected?
Dr. Michael Selgelid, bioethicist at the University of Sydney, pointed out in his presentation that infectious disease has in general been a neglected topic in the discipline of bioethics. He believed that the subject of infectious disease should be better recognized as a fruitful locus for ethical and philosophical reflection in virtue of the facts that (1) the historical and likely future consequences of infectious diseases are almost unrivalled, (2) infectious diseases raise difficult ethico-philosophical questions about how to weigh individual rights against the good of society, and (3) the issue of justice is raised by the fact that infectious diseases primarily affect the poor. With regard to (2), Selgelid advocated an Aristotelian approach: we should seek to balance the rights of individuals against the greater good of society rather than always giving priority to one or the other.
In his analysis of the issue of intellectual property right protection and HIV/AIDS drugs, Selgelid concluded that patent protection had not provided sufficient incentive for the pharmaceutical industry to develop technologies (such as an HIV/AIDS vaccine) most needed by the poor. If an alternative scheme would better promote currently lacking R&D and facilitate access to essential medications, then it should be put into place. For the solution of the health care situation in developing countries, political will and a substantial influx of funding from wealthy developed nations were needed. Motivating donor support was claimed to be key to any solution to the health care situation in developing countries. Activists and concerned academics should therefore put more energy into the generation of political will by emphasising cumulative—including self-interested—reasons for wealthy nations to do more to help improve the health of the poor.
In the discussion, the question was asked where the initiative should come from. According to Selgelid, NGOs, charity organisations, national governments and intergovernmental organisations all had a role to play. Subsequently, the funnelling of international aid to combat HIV/AIDS and build up health systems in developing countries was discussed. First, some participants diagnosed the United Nations as a bureaucratically constipated organisation. Although an initiative such as the Global Fund to combat AIDS, Malaria and TB was currently badly under-subscribed, with the USA being an early donor, it at least gave us one mechanism. The issue had to be attacked in many ways, however. New organisational models, with a large role for the NGO and business sectors, would have to be explored as well. Also the academic community had a responsibility here.
Ethical issues in HIV/AIDS research in developing countries
Dr. Joan Box, clinical research and ethics liaison manager of the UK Medical Research Council, indicated in her presentation that there was a need to build ethics review capacity for biomedical research in Africa. Ethics committees are needed in developing countries, both because it is important that the participants from local communities should understand and be able to consent (or refuse) to participate in biomedical research undertaken by donor countries and, since international guidelines require ethics approval of proposed research in host developing countries, for researchers to be eligible for international funding.. She gave an overview of a project funded by the European Commission which has this purpose. The project, titled ‘Networking for Ethics on Biomedical Research in Africa’ (NEBRA), involves four African and two European partners, coordinated by the Institut National de la Santé et de la Recherche Médicale (INSERM), and is currently gathering information about the existing ethics review framework and further needs in 15 West and Central African countries.
In the discussion, several participants stressed the importance of diversity in ethics, since ethics must deal with all aspects of culture.
The presentation by Professor Catherine Peckham, Professor of Paediatric Epidemiology of the Institute of Child Health and Deputy Chair of the Nuffield Council on Bioethics, dealt with the ethics of research related to healthcare in developing countries. She presented two publications by the Nuffield Council on this topic. Many developed countries sponsor healthcare-related research involving populations and patients in developing countries. Several of the ethical issues raised by such research tend to be exacerbated when only very limited resources are available, as may be the case in countries where basic healthcare is not widely available and research ethics committees are often underdeveloped or absent. The Council has set out an ethical framework for assessing the duties and responsibilities of those designing and conducting research and identifies the minimum requirements which must be met in all circumstances. The framework is based on four principles: the duty to (1) alleviate suffering, (2) show respect for persons, (3) be sensitive to cultural differences, and (4) not exploit the vulnerable. Key issues are consent, standards of care, ethical review of research, and what happens once research is over. Peckham referred to the international debate about the standard of care that should be provided to control groups in research. Should it be universal (the best treatment available anywhere in the world) or non-universal (the treatment available in a defined region)? The Council recommended that wherever appropriate, a universal standard of care should be offered to the control group and where this is not appropriate, the minimum that should be provided is the best treatment provided by the national public health system. The circumstances where a universal standard of care may not be appropriate are when it may not be possible to deliver a universal standard or when the use of a universal standard of care may not give research results which are relevant to the population in which the research is to be conducted. Furthermore, Peckham stressed that the question whether research is acceptable if benefits will not be made available to the community where it was undertaken, is complex. This is because the price of treatments may decrease and agreement may be reached to make treatments available at reduced costs. Existing guidelines are not equivocal on this issue. The Helsinki Declaration, for instance, requires that at the end of a study, ‘every patient in the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified in the study’. Some research institutes claim, however, that the cost of purchasing drugs to continue treatment provided in clinical trials after the trial has finished would severely restrict their research capacity and many research funders do not have the authority to use their funds for treatment rather than for research. A final aspect of the Nuffield Council report that Peckham emphasised was the responsibility of donors to build expertise in developing countries, in both healthcare and research. One should not only focus on trials, but also study the infrastructure needed to deliver. For that reason, she claimed, more research into health systems was needed.
In the ensuing discussion, differing points of view became visible within the group of participants. On the question of standards of care, several participants argued for not giving up the idea of applying a universal standard, which might drive the development of local health systems (often there is nothing of a health system in place). Others observed that insisting on the provision of a Western level of care in studies could deprive some developing communities of research that was applicable to—and could benefit—their people. Another topic on which opinions diverged was the question of who should benefit. Some considered it not fair to do research in communities that do not benefit. Others would be willing to accept that even if there is no local benefit, there could be a benefit at the epidemiological level: it must be acknowledged that there are huge areas of ignorance about AIDS, and it is important to perform as much research as possible to tackle the epidemic. The latter position might require HIV/AIDS to be considered an exceptional case. This in its turn led to the question of whether the interests of science and society would then take precedence over the well-being of the individuals studied, which is in conflict with many guidelines. It was countered, however, that even if you could not immediately provide treatment to the subjects studied, this should not be regarded as sacrificing them for the greater good, provided that the research was not against their interests. The fact that currently one cannot speak of crisis control, but rather should speak of damage control gives an argument for extraordinary interventions. Perhaps one should not get too dogmatic: something should be done and science should find out things that are important for society. The equity issue could not be reasoned away, however: if large populations do not have access to the results of the research, for whom is the research done? At the end of the discussion, it was observed that in other scientific domains, such as sociology and conflict studies, guarantees by researchers that a better future can be offered are never given. Apparently, in those domains it is accepted that the benefits accrue at a higher level.
Professor Olga Kubar, Chair of the Forum for Ethics Committees in the Commonwealth of Independent States (CIS) and Head of the Clinical Department at the Saint-Petersburg Pasteur Institute, described ethical aspects of clinical trials. In the CIS, there was no experience yet with inviting patients to be members of ethics committees. Besides legal issues, the ethical expert examination in the field of HIV/AIDS is determined by the vulnerability of HIV-infected persons and persons with high risk of HIV infection. This requires a strict observance of the ethical principles of confidentiality and fairness (balance between benefits and risk factors) during the organisation and performance of studies. Special attention should be given to the collection, keeping and preventing dissemination of the identifying information about participants in studies and the confidentiality of all information obtained during these studies. Patients participating in studies related to HIV, naturally, worry about confidentiality of the information they may give because when the confidentiality is ignored, this could result in serious negative consequences (loss of job, problems with relatives, and even criminal investigation).
In the discussion, participants commented that there was experience of involvement of consumers and patients in ethics committees which showed its importance and that it could be done successfully.
Ethics and action of multinational companies against HIV/AIDS
Dr. Arthur Petersen, expert in uncertainty assessment of the Netherlands Environmental Assessment Agency, gave a presentation on the Shell-sponsored project ‘AIDS in Africa: Three scenarios to 2025’ (carried out under the auspices of UNAIDS). The project was an instance of corporate social responsibility. Shell has extensive expertise in scenario building in the energy world and was willing to provide this expertise to UNAIDS. The key uncertainties about the future of the HIV/AIDS pandemic are: How is AIDS crisis perceived, and by whom? And: Will there be both the incentive and capacity to deal with it? In the report of the 3rd Pugwash Workshop on Threats Without Enemies (29 April–1 May 2005), it was stated that none of the African representatives supported any of the scenarios and that the project team could not incorporate African experience. To Petersen, who had not been involved in the process but had read the report and an insider’s account of the process, these statements seemed too strong. Still, from the experiences gained in the project, some ethical requirements for participatory scenario building could be distilled: the North-South divide should be bridged, all participants should be respected, one should be sensitive to normative agendas and reflexive (e.g., towards the institutional setting of UNAIDS). Even though some particular experiences in this project were negative, multinational corporations had a responsibility to contribute to analysis and solutions, and scientists had a responsibility to help decision-makers deal with uncertainty. The communication about uncertainty with a wider audience should be considered crucial.
In the discussion, one of the participants, who had been involved as an African participant in the scenario building project, pointed out that North Africa in particular was not adequately represented in the outcomes of the project. On the whole, it was judged that the project staff, based in London, was not able to incorporate into the scenarios the informal economy and Africans finding solutions themselves.
The issue of communication of uncertainty was considered to be a topic of general importance for this workshop. Therefore, Arthur Petersen briefly demonstrated the Guidance for Uncertainty Assessment and Communication that was developed for the Netherlands Environmental Assessment Agency, a web application that could be used as a tool for dealing with uncertainties much more widely than only in environmental assessments. The importance of effectively communicating uncertainty was also stressed in a presentation of the July 2005 Strategic Review of the International Council of Scientific Unions (ICSU) by Dr. Carthage Smith, ICSU’s Deputy Executive Director. The Strategic Review, titled ‘Science and Society: Rights and Responsibilities’, besides addressing risk and uncertainty, also addressed issues of equity, access and universality (changed mobility and global flows of science and scientists); the production of scientific knowledge (emergence of public-private contexts for research, raising concerns about the impartiality of science); accountability and governance of science; and expertise in science and society.
Patrice Lucas, Vice President of Social Policies at Lafarge, the world leader in building materials (Lafarge employs 77,000 people in 75 countries and posted sales of €14.4 billion in 2004), shared with the participants an ‘insider’ perspective on the way Lafarge deals with the problem of HIV/AIDS. He described why and how Lafarge decided to tackle this issue, and argued that the company culture made Lafarge’s commitment in the fight against HIV/AIDS possible. Lafarge has HIV/AIDS programmes and is active in the Global Business Coalition on HIV/AIDS. The company works with a set of basic principles: compliance with the national legislation, ban on HIV screening for job applicants, ban on discrimination, total confidentiality and adaptation of working conditions for sick employees. Additional principles in Africa are: education and prevention, anonymous and voluntary screening tests with counselling, treatment and support, and antiretroviral therapies. Lucas made clear how the non-discrimination principle was challenged by the fact that it is known who is receiving treatment. In implementing these policies, Lafarge manages everything as a business issue, the profitability for shareholders being the bottom line. Difficulties arose from the pressures to expand the scope of people who receive treatment: from the employees to their families to their multiple sexual partners to the wider community. Often, Lafarge is the only employer within a radius of 50 to 100 km. For that reason, partnerships with NGOs and governments were sought. All companies had the same questions here: Who should they treat? How long can they provide treatment? What happens when children grow old? What happens if employees leave the company? According to Lucas, Lafarge did not have the answers. In practice, the company decided on a case by case basis.
Olivier Vilaça, a social science researcher who had spent three years with the company, subsequently brought in a wider perspective on Lafarge and its battle against HIV/AIDS, focusing on the global context in which the company evolved. He argued that, in the global context, HIV/AIDS could give sense to the action of global players, such as transnational companies and big NGOs, and legitimise their global presence. The pandemic could be seen as a global public arena in which actions and interactions of global actors could be understood in a political framework. Vilaça characterised Lafarge’s commitment as ‘ethical’. Although the logic of economics is key for the private sector, not all companies have the same perception of their role within society. Companies typically defend particular models that characterise the way they organise their business, and the way they perceive the governance process. Lafarge could be called a ‘liberal’ (according to Henry Mintzberg’s typology) company with a certain idea of its social role, especially through revenue redistribution, and the belief that corporate governance should be led by executives instead of shareholders, the public sector or the labour force. Companies such as Lafarge had an interest in demonstrating that their model is the right one and, in a wider perspective, that capitalism is able to solve the problems that globalisation seems to cause. What made Lafarge’s commitment in the fight against HIV/AIDS possible were, locally, the urgency to treat employees living with HIV/AIDS for moral and economical reasons, and, globally, the awareness that the company was facing a global challenge, a common threat. By tackling this issue, Lafarge was giving sense to its global presence and legitimising its governance model.
In the discussion, the question was raised of how Lafarge dealt with the principle of compliance with national legislation in countries where the legislation goes against some of the other principles. Lucas responded that while Lafarge must respect local conditions, the company also had some degree of freedom at its own sites. For instance, Lafarge is free to respect the employees and to give them the right to express themselves. In this way, it may be possible to move progressively in the direction of guaranteeing human rights to all employees. Vilaça added that the Global Business Coalition has some leverage over governments. On the question of whether Lafarge’s activities were primarily a matter of its public image, providing a positive influence on Lafarge’s sales, Lucas answered that the company regarded this as more of a strategic than a marketing issue. The programmes are expected to continue, even in years that business may be going less well. It was proposed that Lafarge and similar companies should not be considered responsible for taking over the healthcare system in their localities of operation. Partnerships with governments and international donor agencies should enable dependents and others (and possibly even the employees themselves) to receive antiretroviral treatment, instead of having companies bear the full burden and having them have to decide on a case by case basis. Participants were generally impressed by what Lafarge had done; one participant stated that the initiatives taken by the company were valuable, but emphasised that in a general discussion on how to deal with the HIV/AIDS pandemic, these should be positioned in a larger framework of governance (including NGOs and the state). It was responded that strong states, NGOs and companies are all needed and should work together in networks, and that each actor, including companies, had a responsibility to contribute to building the state. One participant argued that it is not possible not to defend the state: although it is not necessary that state institutions deliver all health care, at least states should make sure by way of regulation that everyone has access to health care. Another participant was more sceptical about the role of states: African states could be considered to be patrimonial states, in which elites fight for control over resources. Most of Africa exists in the informal economy and the state is increasingly bypassed by the interventions coming from NGOs and business.
Ethical implications of treatment versus prevention-led strategies
Dr. Lynne Webber, Clinical Virologist and Consultant Pathologist at Lancet Laboratories and Lecturer at the Department of Medical Virology, University of Pretoria, gave a stimulating presentation on preventative strategies and vaccine developments, from a South African perspective. The history of HIV research is plagued with early optimism (‘We hope to have a vaccine ready for testing in two years’, was said in 1984). She stated that the reality was that a vaccine would certainly not be ready in 2006 and probably not even in 2016. Webber presented four big problems in vaccine development. First, there are no acceptable animal models that can be directly extrapolated to humans. Second, she claimed, it was ethically unacceptable to use ‘live attenuated’ HIV vaccines in trials. Third, science is confronted with a massive immunological challenge (many different vaccines will be needed for different people). Finally, a partially effective vaccine is not good enough. There are also problems in antiretroviral therapy. Since HIV is a rapidly mutating virus that is quickly developing multi drug resistance and is getting fitter as well, Webber stressed the importance of keeping track of exactly how the virus is changing everywhere across the globe, but especially in Africa (at geographic hotspots of extensive recombination). Generally, viral diversity is a growing feature of the HIV pandemic. Webber pointed out that not enough is known about this diversity yet, though there are strategies available to monitor: national serosurveys should therefore be put into place. Furthermore, since vaccines would not become available soon, more energy should be put into prevention. Knowledge of what has already happened in earlier waves of the epidemic should be used to prevent similar things from happening again, both at the same place and elsewhere. Webber emphasised that the world needs to act now. Several interventions are available, such as the prevention of mother-to-child transmission. It should be noted that the large-scale provision of antiretroviral therapy depends on the behaviour of the patients for its success. If patients do not take their drugs, the development of drug resistance is enhanced. If patients do not protect others from getting the virus, these mutated virus strains start spreading through the population. It should also be borne in mind that the drugs could have severe side effects. For doctors, it is considered ethically right to treat the individual patient. At the epidemiological level, however, the ethical issues are more complex. It may be better from the epidemiological perspective sometimes not to provide treatment, but doctors, like Webber herself, are not likely to follow that road.
In the discussion, a parallel was drawn with other infectious diseases and the question was raised of how different HIV is from tuberculosis, for instance, which is also developing multiple drug resistance. A plea was made that the public health system should tackle the issue of drug resistance, but that this resistance should not be used as a reason for not providing treatment to patients. Countering this claim, another participant argued that HIV is an exceptional virus and should be fought in exceptional ways. On a more positive note, it was remarked that HIV research had greatly increased international collaboration in a very short period and had resulted in spin-off (drugs developed for other diseases than HIV/AIDS). Webber replied that indeed scientists are living in exciting times and have done more than ever. They may even have a solution that works within a few years, but they cannot anticipate it yet. Participants asked several questions about live attenuated HIV vaccines: Who would be prepared to participate in trials? What are the research ethics questions that arise in such trials? Live attenuated virus vaccines may have a negative effect not only on the person treated, but also on the sexual partners of this person, and ultimately on the whole community. Vulnerable populations must be protected, so it is unacceptable to pressurise poor people without an understanding of the situation to participate.
The crucial question asked after Webber’s presentation was: Should antiretroviral therapy be scaled up in Africa, or not? The epidemiological data suggest a need for caution in scaling up. But also, if treatment were not provided, people could still get the treatment on the black market. What is at issue here is the completion of therapies. Non-completion is often a matter of ability rather than choice. From this, some participants concluded that the solution to the development of multi drug resistance is not to make access to the drugs harder. If treatment were provided on a large scale, the programme should be sustainable: will it be possible to keep everyone on treatment? However, one participant insisted that other medical interventions should be considered that could be applied on a large scale in a more cost-effective manner than large-scale antiretroviral therapy. Potential interventions that could be further investigated are male circumcision and the use of intra-vaginal microbicidal agents by women (starting with the cheapest and simplest of all, a little lemon juice). In addition to medical interventions, sexual behaviour needed to be changed, and the participants acknowledged that to change sexual behaviour one first needed to change people’s worldviews.
Role of religion and ethics in the prevention and control of the epidemics
The workshop participants received a presentation on ‘UNDP/HARPAS Religious Leaders Initiative on HIV/AIDS in The Arab Region: the Ethics of a Developmental approach’ by Dr. Khadija Moalla, Dr. Ehab El Kharrat MD, and Sayed EL Zenari MD of the UNDP HIV/AIDS Regional Programme in the Arab States (HARPAS), Cairo, Egypt. Any effective response to HIV/AIDS cannot stop at the health approach, but must involve many sectors of the society in a concerted effort. In the Arab world, like elsewhere, HIV/AIDS provokes deep ethical issues and dilemmas. Compassion, breaking the silence, overcoming denial and a proactive stance can be challenged by moral concerns about modesty, chastity, avoiding undue alarming of the public and a conviction that there are other priorities towards which the limited resources available should be directed. HARPAS identified religious leaders as key players in the region, who have an enormous impact on people’s values and attitudes. It was considered both possible and worthwhile to win their support to proven and human rights based responses to the HIV/AIDS epidemic. The Religious Leaders Initiative started in April 2004, and involved a technical meeting for key religious leaders, to prepare for the major Cairo Colloquium (11–13 December 2004) that involved 80 top Muslim and Christian leaders. They produced a progressive Declaration with a major change from their earlier stance. Since then, the Declaration had been endorsed by thousands of Muslim Imams and Christian Ministers in the region. It had been described as revolutionary by reporters covering the story. It emphasised the urgency of responding to the HIV/AIDS epidemic, calling for awareness campaigns, outreach to vulnerable groups, treatment and care for those infected and affected by the virus. It even explicitly supported womens’ right not to be infected, implying a possible review of the age-old power imbalance of gender in sexual relations in the region. Penal views explaining away the epidemic as an expression of God’s wrath upon the unrighteous are easily subscribed to in this region and elsewhere. But after the courageous stance of major religious leaders, the circumstances had been changing. The two HIV/AIDS manuals written by and for Muslim and Christian religious leaders had been well received by mid-level and grass root leaders all over the Arab world. They contained suggested material for sermons and religious lessons on HIV/AIDS-related issues, which integrate fact-based messages from not only the medical but also the broader development perspective, and a human rights based approach based on references from the Koran and Hadith, or the Bible and its scriptures. Sub-regional training workshops to promote the toolkits are currently being organised by UNDP’s HARPAS and national initiatives are mushrooming in almost every Arab country, creating a regional transformation. The change of heart individually among religious leaders takes place not only through sharing accurate information but also through religious leaders meeting face to face with People Living with HIV and AIDS. Participants also benefit from a package of leadership development exercises that encourage them to go beyond statistics and intellectual arguments, in order to develop an empathetic understanding of the issues that surround HIV/AIDS. The lessons learned from the promising results of this initiative included the value and methods of building trust, the importance of an empathetic and motivational approach, the effectiveness of religious leaders in either promoting or hindering developmental approaches, the gradual nature of the mechanisms of transformation and the possibility of discovering new meanings of virtue and spiritual values even among the most conservative circles. UNDP did not ‘tell’ the leaders what to do; rather it provided the platform for them to explore the issues in a safe and warm environment and trusted that they would find the right answers. Facing HIV/AIDS provokes either rigidity or open mindedness and compassion. Religious leaders in the Arab region are moving in the direction of the latter. This may have long-term repercussions in their reactions to many developmental issues including women’s rights, governance and access to knowledge. All of these aspects should be seen as essential components in any effective response to HIV/AIDS.
In the discussion, participants congratulated the UNDP HARPAS team upon the results already achieved. It was asked whether the approach would also work elsewhere: in Africa, for example. The general answer was positive: if you can find and influence the opinion leaders, who are often the religious leaders, you may be able to move the society. It does not go without martyrs and pioneers, however. But there are seeds of hope for a new understanding of religion. One participant expressed worries about the relation between science and religion. The freedom of the scientific community is at stake here: it may be dangerous to empower religion to get a foot into science and medicine. It was replied that in the Arab world there currently are gaps between government, academia and religious leaders. What the programme did was to start a dialogue between these three sectors of society. In fact, the scientists had nothing to lose in this interaction. If scientist were not doing anything, wrong things could happen, such as fatwas on the use of condoms. In the current situation, the programme is trying to convince religious leaders to talk to and learn from scientists. But there is a need for research on the role of religion in democratisation. The hope is that the acknowledgment of the existence of a pluralistic Arab society could act as a first step towards the freedom of thought and the freedom of science. Since scientists are much respected and listened to by progressive communities in the Arab world, they bear a responsibility to take up an advocacy role.
Summary of salient points
Social ethical problems of combating the long wave HIV/AIDS pandemic
- The epidemic reflects very powerful social forces (the socially deprived are more at risk, e.g., very young girls being infected by older men).
- Leadership and legislation are needed. Currently, some leaders are not willing to discuss it.
- States have a responsibility to protect all people. Do these people know about it? Do they want to be protected?
- Public support for dealing with HIV/AIDS in developing countries should be gained by presenting it as an ethical issue to the public and by referring to different kinds of reasons, including self interest.
- Whilst the provision of health care is the responsibility of the state, companies, NGOs, intergovernmental organisations and others may counterbalance the failure of public health systems.
- However, the lack of equitable access to health care remains a main problem. More can be done to improve health systems. There is a role for the global research community here.
- The cost-effectiveness approach to health system reform in developing countries that was driven by the international monetary institutions has resulted in major difficulties, since it is money-driven and not value-driven.
- Policymakers should better appreciate the position that Africans, through their informal economy, are findings some solutions themselves.
- There is an urgent need to use society’s knowledge of what has already happened to prevent similar things from happening again, both at the same place and elsewhere; it is vital to act now.
Ethical issues in HIV/AIDS research in developing countries
- The guidelines that are available for biomedical research in developing countries contain principles (e.g., human rights, benefit sharing) that should also guide HIV/AIDS research. If HIV/AIDS is considered to be an exceptional case, this could give rise to reasons to deviate from these guidelines. It is therefore vital that all research proposals are reviewed by ethics committees.
- It is very important to promote local involvement with clinical trials.
- It is necessary not only to focus on trials, but also to study the infrastructure needed to deliver effective care.
- It is vital to continue research on the virus, since there are huge areas of ignorance. Particularly, research is needed to follow the changes of the virus; for this, relatively cheap monitoring strategies exist.
- In testing live attenuated virus vaccines, the negative effects on communities—that are hard to restrict—must be taken into account.
Ethics and action of multinational companies against HIV/AIDS
- Companies providing treatment for their employees find it difficult to decide who else should receive it. The way forward is to form partnerships with NGOs and (inter-) governmental actors.
Ethical implications of treatment versus prevention-led strategies
- It is unwise to promise that a vaccine will be available within a couple of years.
- One can do good for individuals in the short term in a way that harms the public in the long term. Thus, in the battle against multiple drug resistant HIV, it is necessary to keep a critical look at the completion of treatments and to must ensure that treatment can be sustained for everyone involved.
Role of religion and ethics in the prevention and control of the epidemics
- It is of critical importance to use the current window of opportunity in areas where the epidemic is starting to take off, e.g. the Arab region.
- The sexual behaviour of those at risk could and should be changed by trying to influence their worldviews.
- Changing people’s worldviews can be done, in the Arab world and elsewhere, by starting a dialogue with religious leaders.
- Scientists can facilitate this process by undertaking research on topics like the effects of religion in HIV/AIDS and by playing an advocacy role.
Future work for Pugwash
At the end of the workshop, potential future work for Pugwash (and others) was discussed. Several proposals were put on the table.
First, it was proposed to broaden the scope from HIV/AIDS to infectious diseases. Not everyone was convinced that HIV/AIDS is special as compared with other infectious diseases. The health situation in developing countries is so bad that it does not make sense to be focused on HIV/AIDS alone. To make a special case of HIV/AIDS may even be considered unethical. It should be considered as one of the infectious diseases and attention should be drawn to the right of access to health care in the developing world. Too little research is being conducted on health systems. Other reasons to broaden the agenda to infectious diseases are that the same or similar sorts of social factors play a role (the poor are the most affected), that opportunistic diseases may increase (e.g., TB ‘piggybacking’ onto HIV/AIDS), that infectious diseases in general pose a global security threat, and that the security implications of other infectious diseases could be more serious than HIV/AIDS.
Second, the scientific community should speak truth to power. Pugwash is one of the vehicles that can facilitate this. The community should stress the importance of evidence-based decision making.
Third, Pugwash should further investigate new frameworks for partnering private companies, NGOs and governments. Maybe Pugwash could also work on the new global Medical Research and Development Treaty that the Consumer Project on Technology and others have recently proposed. The signatories of this treaty would take on obligations to fund a minimal amount of basic biomedical research as well as priority research for neglected diseases, pharmaceuticals, vaccine development, diagnostic tools, and so on.
Fourth, the results of the four Pugwash workshops now held on HIV/AIDS should be brought to other countries. Both the Muslim world and sub-Saharan Africa were mentioned as areas where follow-up work should be done on the HARPAS programme in the Arab world. Russia was also mentioned. But the most concrete proposal was to engage further with the Indians, who were present at the third Pugwash Workshop on HIV/AIDS. The plan is to organise a 5th workshop in New Delhi in 2006, where the insights that have been gained so far will be used to sound the alarm to India.
Fifth, there was a general consensus that ignorance about the nature and scale of sexual violence worldwide in the face of the HIV/AIDS pandemic, and ignorance about the underlying ‘social construction’ of sexuality, was a major block to effective prevention. The participants welcomed the suggestion of several that an independent collaborative research proposal to address these difficult but necessary issues be drafted as one of the outcomes of this workshop.
Six, a Pugwash Occasional Paper should be prepared, based on the work done in these four workshops.
Participant List
Dr. Joan Box, Clinical Research and Ethics Liaison Manager, Medical Research Council, London, UK
Col. (ret.) Pierre Canonne, Member, Pugwash Council [formerly: Senior Lecturer, Disarmament and Arms Control, Univ. Marne-la-Vallés/Paris, France; Head, Training and Staff Development Branch, OPCW; Senior Staff, Strategic Affairs Department, Ministry of Defence; Counsellor, Permanent Mission of France to the Conference on Disarmament, Geneva]
Prof. Nola Dippenaar, Professor, Dept. of Physiology, School of Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa; Vice-Chair, South African Pugwash Group
Dr. Ehab El Kharrat, MD, MSc Psychiatry, PhD, Consultant at UNDP- HIV/AIDS Programme in The Arab States; Founder and Executive Director of the Freedom, HIV/AIDS and Drugs Programme
Dr. Sayed El Zenari, MD, MPH, Consultant of UNDP- HIV/AIDS Programme in The Arab States; Director of Projects in the Arab Medical Union
Dr Clive Evian, Medical Officer, Johannesburg Hospital and freelance practice, South Africa; Director, AIDS Management and Support
Prof. Georg Frerks, Professor of Conflict Prevention and Conflict Management, Centre for Conflict Studies, Utrecht University, The Netherlands; Professor of Disaster Studies, Wageningen University; Chairman, Pugwash Nederland
Prof. Olga Kubar, Chair of the Forum for Ethics Committees in the Commonwealth of Independent States (FECCIS) and the Head of Clinical Department, Saint-Petersburg Pasteur Institute, Saint-Petersburg, Russia
Mr. Patrice Lucas, Vice President, Social Policies, Lafarge, Paris, France
Dr. Khadija T. Moalla (Tunisia), HIV/AIDS Policy Specialist, UNDP Regional Coordinator, HIV/AIDS Regional Program in the Arab States, Cairo, Egypt
Prof. Marie Muller, Chair of the Pugwash Council; Dean, Faculty of Humanities, University of Pretoria, South Africa
Prof. Catherine Peckham, Professor of Pediatric Epidemiology, Institute of Child Health, London, UK; Vice-Chair, Nuffield Council on Bioethics
Dr Arthur Petersen, Senior Policy Analyst and Director, Methodology & Modeling Program, Netherlands Environmental Assessment Agency (MNP), Bilthoven, The Netherlands; Treasurer, International Student/Young Pugwash; Treasurer, Pugwash Netherlands
Dr. Marie-Anne Phelouzat, Assistant, Association Suisse Pugwash, Geneva; High school teacher, Geneva [formerly: Maitre-assistante, Faculty of Medicine, Geneva, Switzerland]
Prof. Gwyn Prins, Alliance Research Professor, London School of Economics and Political Science, UK and Columbia University, New York.
Dr. Gilles Raguin, Infectious Diseases Specialist, Hôpital Saint-Antoine, University of Paris, France [formerly: Director, International Operations, Médecins du Monde]
Dr. Michael Selgelid, Sesquicentenary Lecturer in Bioethics, Centre for Values, Ethics and the Law in Medicine; and Unit for History and Philosophy of Science, University of Sydney, Australia
Dr. Carthage Smith, Deputy Executive Director, International Council for Science (ICSU), Paris, France; Ex-Officio Representative on the UNESCO World Commission on the Ethics of Scientific Knowledge & Technology (COMEST)
Prof. Jean-Pierre Stroot (Belgium/Switzerland), retired Physicist ; President of the Board of the Geneva International Peace Research Institute (GIPRI), Geneva; Association Suisse Pugwash, Geneva
Mr. Olivier Vilaca, PhD Candidate, Champagne-Ardenne University, Reims, France; Researcher, Lafarge HIV/AIDS Project Manager, Paris
Dr. Lynne Webber, Clinical Virologist and Consultant Pathologist, Lancet Laboratories; Lecturer, Department of Medical Virology, University of Pretoria
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