Abstract
On 11th August 2014, the World Health Organisation (WHO) convened a special meeting to consider the ethics of using unregistered, experimental treatments in the rapidly evolving outbreak of Ebola in Western Africa. The meeting reviewed WHO’s previous practice of relying solely on containing the spread of Ebola by restricting travel between affected villages (and now between affected countries) and by communicating health messages to promote everyday personal hygiene in the community. This ‘tested’ practice of the past is clearly failing this time. The numbers of patients contracting Ebola have increased like never before and the fatality rate is as high as was originally feared. Contributing to difficulties faced by public health professionals, there seems to be a level of distrust in Western medicine, and behavioural traits and cultural rituals, involving touching those with Ebola, seem to be entrenched despite concerted public information campaigns. The need for cooperative community based health facilities cannot be under-estimated. A minimum standard of services is urgently needed on the ground to implement a more effective policy of containment as well as to host any pharmaceutical research to ensure patients (or research subjects) can be monitored closely, their condition managed carefully, and their data shared efficiently with others. Even if we could not bring general health facilities up to such a minimum standard quickly, or if the message to observe extra levels of hygiene does not get through, we would nevertheless wish now to pursue the possibilities pharmaceuticals might offer for reasons of helping those who still might contract it during this outbreak, now officially an international emergency, as well as during any future ones, whether naturally occurring in Africa or as a result of a terrorist attack on Western shores.
The WHO meeting resulted in a report, “Ethical considerations for the use of unregistered interventions for Ebola viral disease: report of the advisory panel”, 1 appealed to the “exceptional circumstances” of the outbreak and its threat to public and to global health, to justify widening therapeutic access to experimental treatments, precipitating the usual series of clinical trials under vastly more restrictive and highly controlled conditions to gain evidence of safety and efficacy.
Interesting, the report singles out “compassionate access” which, by definition, provides a well-established regulatory exception to the standard rules of research ethics.
We might better frame the problem of therapeutic access to experimental treatments in terms of a wider review of regulation which is increasing seen as adaptive to circumstance and the perceived social value of the research in question (although an adaptive outlook is more usually implemented by regulators in an evolving and sometimes discretionary way). If coherent, such an adaptive regulatory framework would remove the need for the “exceptional” and would instead be ready prepared with a suitable development pathway. 2 We can more clearly see that any case for justifying restrictive and paternalistic regulation on public health grounds cannot reasonably be upheld under circumstances of a public health crisis. 3 In other words, governments have a negative duty to refrain from interfering with individual liberty to try a new treatment should one be developed and donated. There is also a positive duty to respond efficiently and reasonably in a crisis, which could include facilitating access to what are currently very scare drugs, if made available, and promoting (or maybe even enforcing) certain choices. So far, the US and Canadian governments have donated supplies of experimental drugs being developed with support from the Defence programme.
The report also emphasises fairness, yet sheds little light on the problem of deciding on who should get the experimental treatments first, especially as current supplies are extremely scarce. Apparently consistent with other emergency response protocols, the report considers the possibility of treating health professionals first with experimental vaccines on grounds of reciprocity and of expected social usefulness (in addition wearing to full protective suits).
The language of priority seems to presuppose, however, that the experimental drugs already constitute a public good to which all patients have a claim. While there seems to be good evidence, from theory and from animal studies, that the experimental treatments have promise, we have a long way to go before establishing them as safe and effective. In dire straits, any claim rests on hope, albeit understandable and rational. In reality, two US citizens have already received a new drug derived from natural antibodies, once flown back to Emory hospital in the US, who were wholly funded by the charity, Samaritan’s Purse, which had supported their original work in Liberia. Priority, as far as it applies to claims regarding experimental treatments, is sometimes thought to be owed to those who are worst off. If it were possible to differentiate according to need, patients who are worst off seem to live in areas where the disease is most prevalent, in the most densely populated areas, where the spread is at its highest rate and with the highest fatality rates. These factors combined, however, present us with the least viable areas for undertaking robust science. There is, therefore, no escaping hard decisions, but any progress would seem to be welcome, here, no matter how pragmatically driven.
Editor’s Choice
This issue offers four papers carrying a fascinating mix of topics, starting with what we mean by research in journalism and why we should be concerned about its ethics, following popular discussion in previous issues on the oft perceived need to preserve free speech in the social sciences against the ‘medical model’ of ethics review by drawing analogies with journalism. Carolyn Beasley and Lyndon Walker skilfully extend this debate in her article, “Research Ethics and Journalism in the Academy”.
In an immensely useful review, Barbara Redman discussed in detail the range of ‘instruments’ researchers have used in their empirical studies in an attempt to measure those factors which affect the ethics of research. As well as the more well-known measures of understanding for valid consent, Redman’s article, “Review of measurement instruments in research ethics in the biomedical sciences, 2008-2012”, analyses the progress of the less well known measures such as trust in researchers and perceived control in decision making. Advancing research integrity measures, Alireza Ahmadi reports, in “Plagiarism in the academic context: a survey of Iranian EFL learners”, worrying results of a survey exploring attitudes to plagiarism amongst Iranian language students.
Finally, Malin Masterton and colleagues present a survey of patients and members of the public showing that they would sometimes prioritise different projects which respond to different aspects of chronic inflammatory disease and conclude that, at least in Sweden, there should be greater concern for the patients’ perspective on ethics review committees. The problem of prioritising research is not always part of the remit of ethics review committees, although funders must grapple with the issue of how different stakeholders value health states differently. Rather than to use an objective measure, e.g. Quality Adjusted Life Year, which compares how members of the public judge how they would feel in hypothetical situations, it is possible to create scores through deliberation and consensus discussion between the different stakeholders concerned. In fact, the Disability Adjusted Life Year was developed by the World Health Organisation for the purpose of prioritising research funding with a view to minimising the global burden of disease.