The Ebola clinical trials: a precedent for research ethics in disasters.

The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics panel convened in August 2014 by the WHO. By considering why and on what conditions the exceptional circumstances of the Ebola epidemic justified the use of unproven interventions, the panel's recommendations have challenged conventional thinking about therapeutic development and clinical research ethics. At the same time, unanswered ethical questions have emerged, in particular: (i) the specification of exceptional circumstances, (ii) the specification of unproven interventions, (iii) the goals of interventional research in terms of individual versus collective interests, (iv) the place of adaptive trial designs and (v) the exact meaning of compassionate use with unapproved interventions. Examination of these questions, in parallel with empirical data from research sites, will help build pragmatic foundations for disaster research ethics. Furthermore, the Ebola clinical trials signal an evolution in the current paradigms of therapeutic research, beyond the case of epidemic emergencies.

Reaching out to Ebola victims: Coercion, persuasion or an appeal for self-sacrifice?

The 2014-2015 Ebola crisis in West Africa has highlighted the practical limits of upholding human rights and common ethical principles when applying emergency public-health measures. The role of medical teams in the implementation of quarantine and isolation has been equivocal, particularly when such measures are opposed by communities who are coerced by the temporary suspension of civil liberties. In their encounters with Ebola victims, outreach teams face moral dilemmas, where the boundaries are unclear between coercion, persuasion and appeals for self-sacrifice. For those teams, we propose a set of practical recommendations aimed at respecting the autonomy of epidemic victims and easing tensions within communities. We recognize that some of these recommendations are progressively achievable, depending on the specific stage or setting of an outbreak. Yet with the increasing availability of experimental treatments and research interventions, weighing patients' autonomy against the common good will become an even more pressing ethical obligation.

Coincident polio and Ebola crises expose similar fault lines in the current global health regime.

BACKGROUND: In 2014, the World Health Organization (WHO) declared two "public health emergencies of international concern", in response to the worldwide polio situation and the Ebola epidemic in West Africa respectively. Both emergencies can be seen as testing moments, challenging the current model of epidemic governance, where two worldviews co-exist: global health security and humanitarian biomedicine. DISCUSSION: The resurgence of polio and the spread of Ebola in 2014 have not only exposed the weaknesses of national health systems, but also the shortcomings of the current global health regime in dealing with transnational epidemic threats. These shortcomings are of three sorts. Firstly, the global health regime is fragmented and dominated by the domestic security priorities of industrialised nations. Secondly, the WHO has been constrained by constitutional country allegiances, crippling reforms and the limited impact of the (2005) International Health Regulations (IHR) framework. Thirdly, the securitization of infectious diseases and the militarization of humanitarian aid undermine the establishment of credible public health surveillance networks and the capacity to control epidemic threats. SUMMARY: The securitization of communicable diseases has so far led foreign aid policies to sideline health systems. It has also been the source of ongoing misperceptions over the aims of global health initiatives. With its strict allegiance to Member States, the WHO mandate is problematic, particularly when it comes to controlling epidemic diseases. In this context, humanitarian medical organizations are expected to palliate the absence of public health services in the most destitute areas, particularly in conflict zones. The militarization of humanitarian aid itself threatens this fragile and imperfect equilibrium. None of the reforms announced by the WHO in the wake of the 68(th) World Health Assembly address these fundamental issues.

Ethics and images of suffering bodies in humanitarian medicine.

Media representations of suffering bodies from medical humanitarian organisations raise ethical questions, which deserve critical attention for at least three reasons. Firstly, there is a normative vacuum at the intersection of medical ethics, humanitarian ethics and the ethics of photojournalism. Secondly, the perpetuation of stereotypes of illness, famine or disasters, and their political derivations are a source of moral criticism, to which humanitarian medicine is not immune. Thirdly, accidental encounters between members of the health professions and members of the press in the humanitarian arena can result in misunderstandings and moral tension. From an ethics perspective the problem can be specified and better understood through two successive stages of reasoning. Firstly, by applying criteria of medical ethics to the concrete example of an advertising poster from a medical humanitarian organisation, I observe that media representations of suffering bodies would generally not meet ethical standards commonly applied in medical practice. Secondly, I try to identify what overriding humanitarian imperatives could outweigh such reservations. The possibility of action and the expression of moral outrage are two relevant humanitarian values which can further be spelt out through a semantic analysis of 'témoignage' (testimony). While the exact balance between the opposing sets of considerations (medical ethics and humanitarian perspectives) is difficult to appraise, awareness of all values at stake is an important initial standpoint for ethical deliberations of media representations of suffering bodies. Future pragmatic approaches to the issue should include: exploring ethical values endorsed by photojournalism, questioning current social norms about the display of suffering, collecting empirical data from past or potential victims of disasters in diverse cultural settings, and developing new canons with more creative or less problematic representations of suffering bodies than the currently accepted stereotypes.

What is the relationship of medical humanitarian organisations with mining and other extractive industries?

Philippe Calain discusses the health and environmental hazards of extractive industries like mining and explores the tensions that arise when medical humanitarian organizations are called to intervene in emergencies involving the extractive sector.

In Search of the 'New Informal Legitimacy' of Médecins Sans Frontières.

FOR MEDICAL HUMANITARIAN ORGANIZATIONS, MAKING THEIR SOURCES OF LEGITIMACY EXPLICIT IS A USEFUL EXERCISE, IN RESPONSE TO: misperceptions, concerns over the 'humanitarian space', controversies about specific humanitarian actions, challenges about resources allocation and moral suffering among humanitarian workers. This is also a difficult exercise, where normative criteria such as international law or humanitarian principles are often misrepresented as primary sources of legitimacy. This essay first argues for a morally principled definition of humanitarian medicine, based on the selfless intention of individual humanitarian actors. Taking Médecins Sans Frontières (MSF) as a case in point, a common source of moral legitimacy for medical humanitarian organizations is their cosmopolitan appeal to distributive justice and collective responsibility. More informally, their legitimacy is grounded in the rightfulness of specific actions and choices. This implies a constant commitment to publicity and accountability. Legitimacy is also generated by tangible support from the public to individual organizations, by commitments to professional integrity, and by academic alliances to support evidence-based practice and operational research.

High prevalence of multidrug-resistant tuberculosis, Swaziland, 2009-2010.

In Africa, although emergence of multidrug-resistant (MDR) tuberculosis (TB) represents a serious threat in countries severely affected by the HIV epidemic, most countries lack drug-resistant TB data. This finding was particularly true in the Kingdom of Swaziland, which has the world's highest HIV and TB prevalences. Therefore, we conducted a national survey in 2009-2010 to measure prevalence of drug-resistant TB. Of 988 patients screened, 420 new case-patients and 420 previously treated case-patients met the study criteria. Among culture-positive patients, 15.3% new case-patients and 49.5% previously treated case-patients harbored drug-resistant strains. MDR TB prevalence was 7.7% and 33.8% among new case-patients and previously treated case-patients, respectively. HIV infection and past TB treatment were independently associated with MDR TB. The findings assert the need for wide-scale intervention in resource-limited contexts such as Swaziland, where diagnostic and treatment facilities and health personnel are lacking.

Oil for health in sub-Saharan Africa: health systems in a 'resource curse' environment.

BACKGROUND: In a restricted sense, the resource curse is a theory that explains the inverse relationship classically seen between dependence on natural resources and economic growth. It defines a peculiar economic and political environment, epitomized by oil extraction in sub-Saharan Africa. METHODS: Based on secondary research and illustrations from four oil-rich geographical areas (the Niger Delta region of Nigeria, Angola, southern Chad, Southern Sudan), I propose a framework for analysing the effects of the resource curse on the structure of health systems at sub-national levels. Qualitative attributes are emphasised. The role of the corporate sector, the influence of conflicts, and the value of classical mitigation measures (such as health impact assessments) are further examined. RESULTS: Health systems in a resource curse environment are classically fractured into tripartite components, including governmental health agencies, non-profit non-governmental organisations, and the corporate extractive sector. The three components entertain a range of contractual relationships generally based on operational considerations which are withdrawn from social or community values. Characterisation of agencies in this system should also include: values, operating principles, legitimacy and operational spaces. From this approach, it appears that community health is at the same time marginalized and instrumentalized toward economic and corporate interests in resource curse settings. CONCLUSION: From a public health point of view, the resource curse represents a fundamental failure of dominant development theories, rather than a delay in creating the proper economy and governance environment for social progress. The scope of research on the resource curse should be broadened to include more accurate or comprehensive indicators of destitution (including health components) and more open perspectives on causal mechanisms.

Oil for health in sub-Saharan Africa: health systems in a 'resource curse' environment

Background In a restricted sense, the resource curse is a theory that explains the inverse relationship classically seen between dependence on natural resources and economic growth. It defines a peculiar economic and political environment, epitomised by oil extraction in sub-Saharan Africa. Methods Based on secondary research and illustrations from four oil-rich geographical areas (the Niger Delta region of Nigeria, Angola, southern Chad, Southern Sudan), I propose a framework for analysing the effects of the resource curse on the structure of health systems at sub-national levels. Qualitative attributes are emphasised. The role of the corporate sector, the influence of conflicts, and the value of classical mitigation measures (such as health impact assessments) are further examined. Results Health systems in a resource curse environment are classically fractured into tripartite components, including governmental health agencies, non-profit non-governmental organisations, and the corporate extractive sector. The three components entertain a range of contractual relationships generally based on operational considerations which are withdrawn from social or community values. Characterisation of agencies in this system should also include: values, operating principles, legitimacy and operational spaces. From this approach, it appears that community health is at the same time marginalised and instrumentalised toward economic and corporate interests in resource curse settings. Conclusion From a public health point of view, the resource curse represents a fundamental failure of dominant development theories, rather than a delay in creating the proper economy and governance environment for social progress. The scope of research on the resource curse should be broadened to include more accurate or comprehensive indicators of destitution (including health components) and more open perspectives on causal mechanisms.

Exploring the international arena of global public health surveillance.

Threats posed by new, emerging or re-emerging communicable diseases are taking a global dimension, to which the World Health Organization (WHO) Secretariat has been responding with determination since 1995. Key to the global strategy for tackling epidemics across borders is the concept of global public health surveillance, which has been expanded and formalized by WHO and its technical partners through a number of recently developed instruments and initiatives. The adoption by the 58th World Health Assembly of the revised (2005) International Health Regulations provides the legal framework for mandating countries to link and coordinate their action through a universal network of surveillance networks. While novel environmental threats and outbreak-prone diseases have been increasingly identified during the past three decades, new processes of influence have appeared more recently, driven by the real or perceived threats of bio-terrorism and disruption of the global economy. Accordingly, the global surveillance agenda is being endorsed, and to some extent seized upon by new actors representing security and economic interests. This paper explores external factors influencing political commitment to comply with international health regulations and it illustrates adverse effects generated by: perceived threats to sovereignty, blurred international health agendas, lack of internationally recognized codes of conduct for outbreak investigations, and erosion of the impartiality and independence of international agencies. A companion paper (published in this issue) addresses the intrinsic difficulties that health systems of low-income countries are facing when submitted to the ever-increasing pressure to upgrade their public health surveillance capacity.

From the field side of the binoculars: a different view on global public health surveillance.

It is generally assumed by the donor community that the targeted funding of global, regional or cross-border surveillance programmes is an efficient way to support resource-poor countries in developing their own national public health surveillance infrastructure, to encourage national authorities to share outbreak intelligence, and ultimately to ensure compliance of World Health Organization (WHO) Member States with the revised (2005) International Health Regulations. At country level, a number of factors and constraints appear to contradict this view. Global or regional surveillance initiatives, including syndromic surveillance and rumour surveillance projects, have been conceived in neglect of fragile health systems, from which they extract scarce human resources. In contradiction with a rightful stance promoting 'integrated surveillance' by WHO, the nurturing of donor-driven, poorly coordinated and redundant surveillance networks generally adds further fragmentation to national health priorities set up by developing countries. In their current categorical format, ignoring the overwhelming deficits in governance and health care capacity, global surveillance strategies seem bound to benefit mainly the most industrially developed nations through the provision of early warning information or scientific data. In lower-income countries, a focus of resources on strengthening the health system first would ultimately be a more efficient way to achieve proper detection and response to outbreaks at national or sub-national level. As documented in several pilot initiatives at sub-national level (India, South Africa, Tuvalu and Cambodia), the empowerment of frontline health workers and communities is a key element for an efficient surveillance system. Such simple measures centred on human resources and community values appear to be more beneficial than massive and conditional monetary inputs.

Can oral cholera vaccination play a role in controlling a cholera outbreak?

Control measures to limit the spread of a cholera outbreak in Pohnpei Island (Micronesia), included mass vaccination with the single-dose live-attenuated oral cholera vaccine CVD 103-HgR as a potential adjunct measure. The outbreak provided a unique opportunity to evaluate the practicality of use and effectiveness of this vaccine. Under field conditions encountered in Pohnpei, crude vaccine efficacy was estimated at 79.2% (95% CI: 71.9-84.6%) in the target population. Retrospective analysis suggests that mass vaccination with oral cholera vaccines can be a useful adjunct tool for controlling outbreaks, particularly if implemented early in association with other standard control measures.