Calling it a day on proceduralism in bioethics

It is unusual that an influential approach within our field is called ‘fundamentally wrong’ by its creator. Reidar Lie, a staff member of the US government’s NIH Department of Clinical Bioethics, and a leading expert on research ethics did just that in reference to the fair benefits approach that he substantially helped bring into being. In a recent commentary Lie conceded that there is ‘something fundamentally wrong’ with the approach.¹ Lie proposed a procedural account of justice in international health research instead of a substantive approach. This approach reduces ethics in international health research to a market-like transaction, whereby what is fair is what is negotiated between international pharmaceutical multinationals and their – frequently impoverished, undereducated - local prospective trial participants. There is much talk about partnerships and collaboration among fair benefits proponents, but really market norms reign supreme. Fair benefits proponents amassed – to some extent meaningless – surveys of prospective trial participants’ wish lists in terms of what they would like to receive in return for their trial participation. These laundry lists are indicative of how desperate some trial participants really are (some asked for food and soap, for instance). However, unlike what the NIH staff wanted us to believe, these surveys never told us anything of significance with regard to what benefits, if any, should reasonably be made available to such trial participants.

What triggered Lie’s change of mind? His reaction was informed by an excellent paper in the US journal Hastings Center Report.² Alex London and Kevin J.S. Zollman tried to put the fair benefits approach into action. Amongst their most significant findings was that the approach would likely result into a race to the bottom, whereby pharmaceutical companies would use their bargaining power to search across the globe for the cheapest possible deal to undertake their research. London and Zollman rightly concluded that the approach would produce results that would not even meet standards of fairness endorsed by its own proponents. Other aspects of the procedural approach to fair benefits have been sharply criticized by other bioethicists.³

It is time to move beyond this approach to fair benefits in international health research, and it is time to stop propagating it in developing countries under the guise of capacity building efforts. Alternative concepts aimed at addressing the normative problem at hand have been proposed. I am looking forward to how this debate will unfold.

1 RK Lie. 2010. The Fair Benefits Approach Revisited. Hastings Cent Rep 40(4):

2 AJ London, KJS Zollman. 2010. Research at the Auction Block. Hastings Cent Rep 40(4): 34-45.

3 RE Ashcroft. 2008. Fair Process and the Redundancy of Bioethics. Public Health Ethics 1: 3-9. U Schuklenk. 2010. For-Profit Clinical Trials in Developing Countries — Those Troublesome Patient Benefits. AJOB 10(6): 52-54.

WHO wastes scarce health funds on fashionable diseases

It is probably no secret to regular visitors of this blog that I tend to speak in the most scathing terms about the UN system and its associated freeloading agencies and staff. My favorite target tends to be UNESCO, because its overpaid Paris based staff is more often than not particularly incompetent and useless, certainly in my area of expertise.

I have, in the past held my fire when it came to WHO, even though I knew from personal experience with that outfit, that they're not much better. By and large bioethicists (such as Alex Capron) have performed pretty well there, hence the ethics unit seems to have been more or less closed down (ie exists only on paper or its website). The leading medical journal THE LANCET published this week an analysis of the budget allocations WHO has decided upon, and correlated those with the (mostly developing) world's disease burdens. (LANCET 2008; 372: 1563-9)

It turns out, in the words of the authors, "Three-fifths of WHO funds were spent on communicable diseases excluding HIV, tuberculosis, and malaria, which accounted for roughly 11% of global mortality. Conversely, non-communicable disease accounted for more than half of global mortality and almost half of global DALYs, but received roughly a tenth of all WHO funds. We recorded a similar disparity with injuries, which claimed 9% of global mortality and 12% of global DALYs, but received less than 1% of global funds. Further inspection of the WHO budget showed that the resources used for communicable diseases excluding HIV, tuberculosis, and malaria were mainly driven by WHO extra-budgetary funds for immunisation and vaccine development. WHO’s regular budget allocated US$14·3 million to this area of work, corresponding to 6% of WHO’s regular budget. By contrast, WHO’s extra-budgetary funds allocated $512·4 million, roughly 36 times as much as in the regular budget, corresponding to about 30% of WHO’s extra-budgetary allocations for infectious disease control."

The upshot of this is that WHO is clearly setting its eyes on fashionable diseases such as AIDS (much like Greenpeace is in the habit of rescuing cuties like wales but not gazillions of pigs in mass breedings factories), despite objectively more important disease targets. The maximisation of QALYs and DALYs per invested health care dollar should be the only criterion for deciding how to spend scarce resources. It is unethical to waste funds available for health care delivery and research on outcomes that are foreseeably suboptimal in terms of QALYs and DALYs. The criticism leveled here against WHO can arguably be made against private funders such as the Gates Foundation.

This all reminds me of the insanely wasteful NIH Fogarty International ethics programs in my own field. There's endless research ethics training in developing countries the world all over, as if these countries did not have substantially bigger fish to fry in terms of health issues.