Tuesday, April 14, 2015

The trouble with international ethics guidelines

In nearly regular intervals arguments flare up among bioethicists as well as political activists about the substantive guidance proffered in international ethics guidance documents such as the World Medical Association’s (WMA’s) Declaration of Helsinki or the Council for International Organisation of Medical Sciences’ (CIOMS’) research ethics guidance documents. Who doesn’t recall the arguments about standards of care in clinical trials undertaken in developing countries, or the post-trial benefits debate?[1] Monographs, anthologies, as well as an endless stream of graduate student theses focused on particular aspects of these debates. There is nothing wrong with these efforts. As someone who spends significant amounts of time vetting other people’s content, as a journal editor, academic supervisor and external examiner of graduate students’ theses I have read a lot of content dedicated to these debates over the years.

What has always struck me as strange is that virtually nobody seems to question the relevance of these documents. They are usually taken as authoritative statements, not dissimilar to consensus statements clinicians might publish in medical journals. And yet, it is far from clear that anyone should accept these declarations and guidelines as relevant documents of that kind.[2] Take the WMA’s Declaration of Helsinki as a case in point: it is interesting in so far as it has been one of the most bitterly fought over international research ethics guidance documents just a few years ago. It is still being revised in fairly frequent intervals, alas the old battle axes in this dispute have by and large moved on to other issues. There is little professional interest in substantive changes to what once were highly sensitive provisions in the Declaration.

At least the WMA has some claim to represent the world’s doctors. Still, the Declaration offers no justifications for its guidance, so it is unclear why anyone who undertakes biomedical research and isn’t a medical doctor should bother about it. It is also doubtful that the national medical associations debated in any meaningful way proposed revisions to the Declaration and instructed their delegates to the WMA’s General Assembly to vote in particular ways that actually represent the views of the members of these national associations. You might also wonder why a local GP’s views and vote ought to matter a great deal in matters research ethics in the first place. CIOMS remains a fairly smallish operator with even less of a claim to represent meaningfully people involved in biomedical research.[3] Its initial claim to fame was that it put itself forward to interpret the WMA Declaration of Helsinki. Once that – kind of - established its legitimacy this interpretation morphed into its own guidance document. At least CIOMS has a habit of trying to justify its guidance, as opposed to engaging merely in ex cathedra declarations like the WMA is wont to do.

The situation doesn’t get any better when one looks at international institutions such as the World Health Organisation (WHO). While undoubtedly United Nations insiders are clued in with regard to the status of myriad WHO documents, the wider public, and indeed policy makers outside the corridors of WHO offices, almost certainly do not. A case in point: After spectacularly failing in its response to the Ebola outbreaks WHO engaged in what can best be described as wild activism to show that it is doing something. It issued eventually an ethical guidance document that declared that it is OK to use unregistered experimental interventions on Ebola virus disease patients.[4] The authors of this document, celebrated as they were as experts on the subject matter, had mostly never published a word on either Ebola virus disease or, indeed, on the difficult subject of emergency access to experimental drugs in case of patients with catastrophic illnesses. The latter topic has been a matter of intense debate over the last few decades in bioethics. I should know, I have been involved in these debates. The WHO’s experts may have been nice people interested in this topic, who were known somehow to WHO people in charge of inviting someone ‘expert’, alas very few of their experts had any demonstrable expertise when they willingly pontificated publicly on WHO letterhead on this subject matter. Much like CIOMS, the authors of this guidance document ought to be commended for having made the effort to provide justifications for their recommendations.

The results of the WHO meeting were eventually reported the world all over as the WHO ‘approving’ the use of experimental drugs in patients with Ebola virus disease.[5] It turns out that the WHO has no jurisdiction to approve anything of that sort, and, equally as importantly, WHO never actually did approve what it was reported to have approved. The WHO documents produced by the people it invited to pontificate on this subject, state actually in small print that they merely reflect the views of the people who wrote them down, and that they are not the official view of WHO. Their views, in other words, ought to carry no more weight than the views of any other groups of academics who hang out together at conferences and draft papers in their spare time. This hasn’t stopped academics writing about this subject to mention the WHO documents as if they carried any meaningful regulatory or other weight.[6]

WHO is at the time of writing in the process of developing procedures for the selection and use of such experimental agents in Ebola virus disease patients.[7]  I suspect the status of these documents won’t be of more significant regulatory weight than that of any of its other Ebola crisis triggered documents. That is not to say that they will be bad documents. It appears to be the case that these documents will be an amalgam of best practice guidelines from nations that have many decades of regulatory experience with emergency access to investigational agents in patients with catastrophic illnesses. However, if, for instance, Liberia and the USA decided to establish an emergency access program for a particular therapeutic experimental agent, and they chose to ignore WHO (who is apparently keen to inject itself into these bilateral processes) what exactly would WHO be able to do about that? Nothing that I can think of.

What is the value of these sorts of guidance documents then? I think they are valuable as documents that drive debate among interested parties about the substantive controversial issues that they address. They might also be of value to organisations such as the International Committee of the Red Cross, Doctors without Borders, and others, who want guidelines for their own emergency access plans without spending too much time thinking about ethically defensible operational frameworks themselves. Last but not least, they might be useful to developing nations without the capacity to develop their own regulatory frameworks and who decide to resort to WHO guidance documents and protocols.

However, given these questions about the status and the legitimacy of these documents, if the old adage caveat emptor ever applied anywhere, it should apply to these guidelines, declarations and policies. Anyone choosing to adopt them ought to adopt them because they consider them ethically defensible, and not because they happen to come from WMA, CIOMS or indeed the WHO.

[1] Schuklenk, U. 1998. Unethical Perinatal HIV Transmission Trials Establish Bad Precedent. Bioethics 12: 311-318.
[2] Schuklenk U. 2004. The Standard of Care Debate: Against the Myth of an ‘International Consensus Opinion’. Journal of Medical Ethics 30: 194-197.
[3] Schuklenk U. 2004. Ibid.
[4] WHO. 2014. Ethical considerations for use of unregistered interventions for Ebola virus disease (EVD) Geneva, August 12, 2014. http://www.who.int/mediacentre/news/statements/2014/ebola-ethical-review-summary/en/ [Accessed March 16, 2015.] See also WHO. 2014. Ethical considerations for use of unregistered interventions for Ebola virus disease (EVD) Geneva: Report of an advisory panel to WHO. Geneva, n.d. http://apps.who.int/iris/bitstream/10665/130997/1/WHO_HIS_KER_GHE_14.1_eng.pdf [Accessed March 17, 2015.]
[5] Eg Anonymous. 2015. WHO approves experimental treatment for Ebola. AlJazeera August 12, 2014. http://www.aljazeera.com/news/africa/2014/08/who-approves-experimental-treatment-ebola-2014812122023925143.html, McKay B, Loftus, P. 2014. Ebola Virus: Experimental Drugs Approved for Use in Fighting Outbreak in West Africa. Wall Street Journal August 13, 2014.   http://www.wsj.com/articles/experimental-drugs-are-approved-for-use-in-fighting-ebola-in-west-africa-1407884538 [Accessed March 17, 2015]
[6] Hayden EC, Reardon S. 2014. Should experimental drugs be used in the Ebola outbreak? Nature August 12 doi:10.1038/nature.2014.15698.
[7] WHO. 2015. Public consultation on emergency use assessment and listings procedures for medical products during public health emergencies. http://www.who.int/medicines/news/public_consult_med_prods/en/ [Accessed March 18, 2015.]

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