Saturday, April 04, 2020

Bioethics blog as plague journal

I have not been active on this blog for quite some time. The causes are multiple, but one comes to my mind first: do people still read blogs, anyway? The doubt is de-motivational. Over the last years, it seems that more and more bloggers have switched over to Twitter, which is to say that they have stopped posting longer pieces beyond 'threads' on that platform. You can see Twitter's attraction: less of an investment in time and greater likelihood of immediate feedback or impact. It fits better in our life-work imbalence. This blog too has been associated with a Twitter account since 2012 (@BioethicsGlobal), but over the years I have found that the elements that make Twitter attractive can also make it repulsive. I think Twitter ought to be renamed 'Oversharing', or more to the point, 'Hostility'. I am there for the retweeted news items and pet videos, mostly.

So why back to the blog, if blogging has been culturally sidelined? The answer, like the (unhappy) answer to a lot of questions these days, is COVID-19. It is not a matter of getting likes or being retweeted, anymore than it was for Daniel Defoe when he wrote A Journal of a Plague Year in 1722. It is more a matter of trying to bear witness, in a medium somewhat more accommodating than Twitter, though without the detachment and hindsight that the coming tsunami of bioethics books on COVID-19 are likely to have. Right now, we really don't know where all this is going.

In the last two months, bioethics has been reacting to the COVID-19 epidemic in all sorts of different ways. One way to look at the bioethics response is by categorizing it (very roughly) in terms of medicine, science, politics and art.

Medicine: the speed at which recommendations have been formulated to guide the allocation of scarce medical resources has been amazing. It is almost an epidemic in itself. True, questions about fair allocation has always been in the American bioethics wheelhouse, even if talk of rationing health care there is also somehow taboo. It makes sense that bioethicists would want to be useful in this particular area, though you can wonder how much the schemes will really come into play in the terrible rough and tumble of ICU units.

Science: when a pandemic strikes the richer nations, there seems to be a rise in epidemiology talk in the general public. This could be a good thing, if it means entrenching a public health mindset. But sometimes it also means that a lot of people are talking out of their their hats. The more epistemological bioethicists find themselves combatting rumor and questioning the assumptions of mathematical models. And in addition, there is the question of what kinds of scientific studies should be conducted (and how) in pandemic circumstances, something much closer to home for European and American bioethicists this time around, when the mayhem is happening in Los Angeles and not just Liberia.

Politics: the virus is apolitical, but the responses to it by countries, communities and individuals are political through and through. As has been remarked before many times, and forgotten many times, an epidemic magnifies whatever problems were pre-existing in the body politic. And apparently we have a lot of problems, worldwide. Politicians may put re-election interests before scientific facts and public health imperatives. Instead of social distancing out of social solidarity, people may go out shopping for guns. In a horrible calculus, the value of the economy is weighed against massive numbers of the dead. Not to mention the geopolitics.

Art: there are a number of websites devoted to the COVID-19 pandemic from a statistical perspective. Deaths and confirmed infections per country are continuously updated. Like obscene things in general, the numbers are hard to look at and hard to look away from. But every death is terrible, for the person concerned and the fabric of relations from which they were torn. The human face of the pandemic, from the perspective of the infected, their families, health care workers, and others -- in this case to some extent literally everyone, even the billionaires -- also should inform how people in bioethics respond. This is a world of suffering and human drama, not a trolly problem, and bioethicists need to bring out their ethnologist, novelist, poet.

In the weeks (months?) that come, this blog will focus on the COVID-19 response in low- and middle-income countries, especially in sub-Saharan Africa. The pandemic is only just starting to pick up there. Different countries face different challenges, and context matters, but there are some overarching issues. The health care infrastructure in many places is weak. In most if not all countries, there is severe poverty. Social distancing or 'stay in place' may be unrealistic where people have challenges accessing running water, live in crowded townships, or rely on face-to-face contacts to survive. Unlike elsewhere, only a small minority have the luxury of continuing their livelihoods online. What ethical issues will this confluence of circumstances engender and expose? There is already concern that the global supply chain of medical resources is being diverted towards richer and more powerful northern countries, from whom Africa can seemingly expect little humanitarian aid this time around. What will 'allocation of scarce medical resources' look like when (as is feared) fragile health care systems are rapidly overwhelmed?


Friday, May 17, 2019

Francophone Africa: bioethics terra incognita?

My colleagues and I have written about this before: stimulating bioethics in Francophone African countries involves a number of significant hurdles. First, there is language. Bioethics is predominantly expressed in English: the journals are in English, the majority of degree programs in bioethics are conducted in English, as are the vast majority of books, conferences, scholarship opportunities and so on. Designing a bioethics course makes this crystal clear: what readings are you going to assign? The second hurdle is that French-language bioethics (mainly from France and Quebec) is generally not focused on the kinds of social/economic/political circumstances that researchers, clinicians and public health practitioners in Africa have to wrestle with. 'Developing world bioethics' has been getting more airplay over the last decade, but as far as Africa is concerned, the focus is predominantly on ex-British colonies.

It is not just in bioethics, apparently. At the moment I have been reading about the history of research during the colonial period in Africa. Africa as a Living Laboratory by Helen Tilley is a fascinating read about how scientific research in Africa mixed and mingled with the interest and exercise of colonial powers. I picked up a copy of Randal M. Packard's A History of Global Health, which starts with colonial health initiatives and runs right up to HIV and PEPFAR. Melissa Graboyes' The Experiment Must Continue: Medical Research and Ethics in East Africa is also an engaging and informative read. But here too the focus is almost exclusively on Anglophone Africa. So whereas you can get at least some sense from these books of what kinds of health research with humans was taking place in Africa long before research ethics committees and 'bioethics' came onto the scene, what was going on in Francophone Africa during this period seems to be much harder to discern. To me at least.

This is unfortunate if you want to discuss historical events and patterns that have shaped relationships between (say) researchers and the larger community. Why should anyone in Francophone Africa, wanting to study bioethics, have to care about what happened in the Tuskegee Syphilis study? Bioethics education in this part of the world should include the local history of experimentation, at least as far back as the colonial period. The search continues.

Wednesday, March 28, 2018

Comparing trust-based and information-based consent

I remember watching people in the Democratic Republic of Congo consenting to biomedical research, a few years back. As the process of explaining the research study wore on, you often got the sense that prospective participants (by this time rolling their eyes) really just wanted to sign the form and get the whole consent thing over with. That attitude towards consenting -- not at all specific to resource-constrained settings -- can be explained in a variety of ways. People carry the burden of their own lives and might just be fatigued. Or they may just be more interested in whatever benefits or incentives the study might offer than what the study is about or involves. Yet another possibility is that those who are not really taking in the consent information are basing their decision to join the study on trust: trust in the researcher taking the consent and/or trust in the institution the researcher represents. Some social science studies of participant decision-making processes bear this out: people sometimes agree because they trust that the researchers will act responsibly.

The standard view is that decisions based primarily on trust do not constitute valid informed consent. Such consent is regarded as morally inferior to information-based consent, where prospective participants digest relevant information and make rational decisions in accordance with their own values. An interesting article in Bioethics challenges the standard view, arguing that trust-based consent is not inferior to information-based consent in the key ways that consent is morally supposed to matter: as an expression of autonomy and as a safeguard against coercion, manipulation and exploitation. Of course, consent based on trust is not protective against abuse if researchers or research institutions are not trustworthy, but (the authors argue) information-based consent is equally powerless in that regard.

Will this reasoned advocacy for trust-based consent have legs? Hard to say. There is a lot of confidence (trust?) in the more information-based approach to consent, perhaps because it makes us look more cognitive and rational, or because it can be associated with all sorts of procedures, and we are fond of procedures, even if we also know that people often don't understand much of what they consent to. In any case, the article is well worth a read.

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Tuesday, October 10, 2017

Beware of pharmaceutical companies bearing cheap drugs

Pharmaceutical companies are for-profit enterprises that make their money by selling medicinal drugs. This might seem stupefyingly obvious, but it can get (briefly) obscured when these companies distribute shiny pamphlets suggesting that the promotion of human well-being is their ultimate mission or when they act in seemingly philanthropic ways. Scratch the surface, or just wait until the smoke clears, and the profit motive comes back into view. This is partly why bioethics workers find pharmaceutical companies fascinating and appalling: sometimes they offer a glimpse of what it would be like if powerful multinationals really threw their weight behind public health goals, but only a glimpse, because they inevitably veer off to make money and please their stockholders, sometimes in ways at odds with the ethics of research and health care. They are a kind of ethical rogue element. We need them -- who can whip up their own Klonopin? -- but don't expect them to join your health and social justice parade.

The New York Times published a piece last week about two multinational drug companies, Pfizer and Cipla, who have made an agreement to charge low prices for 16 common chemotherapy drugs. In addition, specialists from American cancer hospitals are helping to set up a digital repository of clinical oncology guidelines (to be incorporated by IRB into their Watson program) to help doctors hone in on the right medical approach. This initiative is welcome news to health systems and patients in the developing world, because of the gradual epidemiological transition taking place there from infectious disease (HIV, tuberculosis ...) to non-communicable disease (especially cancer). In sub-Saharan Africa, current access to cancer drugs and adequate cancer care is, with some exceptions, flat-out terrible. Any improvement in cancer care could be lifesaving. Just as the lowering of HIV drug prices by big pharma, back in the 1990's, was lifesaving for many.

Here come the caveats. Prices for HIV drugs were lowered by the work of advocates, which the pharmaceutical industry initially opposed tooth and nail. (They have reaped profits from antiretrovirals in the meantime.) While lowering drug prices did make a significant difference for patient care, only 50% of those in sub-Saharan Africa currently in need of HIV drugs are on treatment, two decades later. Much more is needed than lowered drug prices to improve patient and population health. More too than the establishment of an oncology database, particularly if what the guidelines recommend implies human or material resources that are not locally available -- the guidelines could be a grim reminder of what you don't have. And the use of IBM's Watson for clinical care has not been a rousing success so far even in the best of circumstances.

Most likely, this initiative will help some people, but less than the early hopes and the hype might indicate. The pharmaceutical companies involved will gain from product visibility and may have a competitive advantage as the African population grows older, cancer prevalence rises and if the economies (and consumer buying power) of African countries strengthen. This may be the long game for them, and could help explain why -- long after these chemotherapy drugs were developed -- they are being offered more cheaply to African countries now.

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Saturday, September 30, 2017

Breaking the link between colonialism and global medical missions

Rudyard Kipling spoke to the spirit of the age at the turn of the 20th century when he called on newly minted imperial powers to go send your sons to exile to serve your captivesneed. Then, the Western popular imagination was captivated by the myth of the intrepid white civilizer setting off to tame the savage wilds. Unfortunately, this fascination did not die out with the empires it justified. We still see ample evidence of it today, medical volontourismbeing a prime example.
            Healthcare professionals from Europe and North America are traveling in increasing number to developing countries for short-term assignments. The effects of most of these assignments range from the benign to the outright harmful; rarely do they offer real benefit to local communities. Volontourists may arrive poorly equipped to deal with their new cultural, linguistic, and even medical milieu. They can end up providing redundant care that undermines nearby healthcare systems and diverts trained in-country personnel to their activities in an internal brain drain. There is a constant risk that the lions share of the benefits will be reaped by the foreign health workers (and their institutions) who carry back the experience they acquired to their far-flung home countries to decorate their résumés.
            This inequity is a painful reminder of open wounds from a recent colonial past. To the credit of the Western healthcare community, awareness has become firmly established of how problematic medical volontourism can be. Unfortunately, it has yet to devise a solution. The push to professionalize global healthhas hit upon the snag that no one can really agree what the field constitutes. As such, there is no widely-accepted means of weeding out those with a true passion for global health issues from those with only a superficial interest.
            Physician and global health advocate Timothy Laux thinks this role might be played by existing Institutional Review Boards (IRBs). Lauxs case is that, as the only true contender for authority in health science ethics enforcement, IRBs are best-positioned to crack down on medical volontourism.
            Laux acknowledges that, at first glance, IRBs are imperfect candidates for the job. Institutional ethics panels typically confine themselves to review of research proposals and projects in accordance with research-specific regulations and the capacities of the environments they find themselves in. Moreover, theyre frequently overburdened by and understaffed for their workload. Taking the step towards passing ethical judgement on the suitability of individual applicants for volunteer placementsoften clinical in nature and on the other side of the worldwould therefore be massive. But, Laux asks, if not IRBs, who else?
Well, ethics authorities in the regions where volunteers propose to operate for one. Admittedly, this is easier said than done. Knowledge of bioethical principles, let alone the review boards to enforce them, are likely lacking in many of these environments. A possible solution could be to integrate bioethics into existing health institutions, like local Ministries of Health, who are ultimately responsible for permitting short-term medical missions to take place in developing countries. This would be challenging, as it would require buy-infrom those institutions, and the cultivation of a cadre of health and other professionals so that they are in a position to inform ministry decisions. But it is not impossible, and local Ministries of Health have a self-interested motivation in maximizing local benefits from these international volunteer initiatives. Or, to be more realistic, they have an interest to at least be in negotiations with initiatives coming from more powerful countries, to minimize the potential for exploitation.     
            All of this is not to say that IRBs have no place in this discussion. They might still be able to take a lead in assessing the merits of studentsproposed projects, a job more in line with their existing competences. But at the end of the day, the final decision makers should always be the communities who themselves stand to gainor to sufferat the hands of sons sent to exile.

Gaelen Snell 



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Wednesday, September 27, 2017

Trying to look on the bright side of colonialism

There has been a big flap this week about an article published in Third World Quarterly entitled 'The Case for Colonialism' by Bruce Gilley at Portland State University. The controversy seemingly revolves around how the article was published by the journal's editor despite having been rejected by its reviewers, i.e. a violation of the peer review process. But, of course, the complaints are not purely about the process of the paper coming to light: after all, the author is arguing that colonialism was largely a good thing, and we should have more of it. There would be much less political buzz if the journal's editor had, over the objections of reviewers, approved a paper called 'The Case Against Colonialism.'

As for the paper itself, it is something of a train wreck, and there is a strong case for thinking the reviewers (whose reviews are apparently under lock and key) were right. Gilley maps out a series of epistemic virtues (non-biased data and case selection, internal coherence, falsifiability of claims), which he uses to criticize those opposed to colonialism. In the course of building his own argument, however, he violates all of them, and how. You could base a drinking game on how many times he hoists himself on his own petard. Just one example: Gilley claims that colonialism had 'subjective legitimacy' because, he writes, the colonized populations generally approved of colonial powers and governance. His 'data' for this sweeping claim throughout the paper largely comes in the form of journalistic impressions and anecdotal remarks. This is not the worst of it. As others have pointed out, the most damning problem with the article is his relentless cherry-picking of benefits from colonial rule together with a complete disregard for the long-term and widespread damage colonial rule caused or the self-serving and usually racist motivations behind it. It does not take much effort to see the piece, particularly in the current US political climate, as historical revisionism in the service of white supremacy. No doubt defenders of such views will object that academia should be open to 'alternative voices' in the name of the First Amendment. But academic journals have no obligation to be open to crappy papers.

What could have been more interesting, instead of making a case for colonialism, is a critical analysis of the myriad ways former colonies grapple with the legacies of colonialism, since they are typically unable to fully embrace or reject them. Whatever 'benefits' might be attributed to colonialism cannot be disentangled from harms and violations; there are no real concepts to faithfully describe this. Tainted benefits? Abuses with an upside? When you drive the N1 out of Cape Town in South Africa, you are enjoying one of the best highways in Africa. You are also 'enjoying' the fruits of the Apartheid system, built by cheap labor, and as you drive, you can see townships where populations of non-whites were dumped and continue to experience the effects of political oppression. Reading Gilley is like hearing someone say: "Get over it. Don't you see you have a highway? So blind, so ungrateful."

Is there a link here to bioethics? I think so. Bioethics workers in developing countries are in a similarly uncomfortable position of being unable to fully reject assumptions, preoccupations and frameworks originating from the richer countries of the north, but also unable to fully embrace them without losing touch with (and being useful for) their own local context. The decolonization of bioethics in Africa, whose shape is hard to discern, will be a long work in progress.

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Saturday, August 19, 2017

Lessons from the West African Ebola epidemic

Conventional wisdom—and an article in the Journal of Medical Ethics reviewed on this blog two years ago—advise that health research should not be conducted during times of crisis. Yes, such conditions compromise the controlled environments that studies typically require to produce reliable results, but they can also threaten the ethical integrity of research. Without institutional mechanisms to hold them accountable, investigators may cut corners, violate standards of privacy and informed consent, and even endanger participants. Disruption in the normal function of medical services can also apply pressure on individuals unable to access care by traditional means to seek it out by participating in risky research. And even if one assumes that researchers display honesty beyond reproach, it is still unreasonable to expect that they would be able to keep their cool in the midst of widespread panic and social collapse. But there is a fly in the ointment, at least when it comes to crises caused by epidemics. Public health organizations are first-responders at these moments, but they would be dead in the water without relevant data collected under real-world conditions to guide their actions. In this situation, the precautionary principle alone is not enough to stop a study altogether. In fact, it could be argued that an absolute prohibition against biomedical research in such situations may itself be unethical. The question then becomes, not whether, but how to guarantee ethical research during outbreaks?
The Ethics Review Board (ERB) of Médecins Sans Frontières (MSF) had to contend with this question during the 2014 Ebola epidemic. They recently chronicled their experience in the April issue of Public Health Ethics. Beyond the herculean task of evaluating 27 research proposals in the space 12 months—40% of which required review by the entire board—, they had to take into account the extremely vulnerable environment in which investigators intended to operate.
They noted critical ethical shortcomings in many of the studies they reviewed. Perhaps the most significant was the failure of many researchers to engage substantively with local ethical review committees. As a result, several studies did not develop adequate protocols to deal with the collection and storage of blood samples. This was particularly troubling in light of the importance many local communities attach to human blood.  While the MSF ERB is to be commended for its remarkable performance under considerable pressure, the authors’ account suggests areas for improvement. The article does not mention whether the MSF ERB considered that the studies under review could implicitly coerce participation in exchange for care. This is a tricky ethical dilemma to work through. Normal medical systems were entirely overwhelmed in West Africa; many in need of treatment had no other recourse to access care. Those who had contracted the virus might feel that involvement in research—even if it was risky or poorly understood—was their only option. Can participants grant true informed consent under such pressure? However, there is a counter argument to consider. These studies could offer some semblance of medical services, perhaps even life-saving ones, in places where there previously were none. Is it really ethical to deny this opportunity simply because a study fell short of perfection? Is no choice better than a forced choice? These questions have no easy answers, but they certainly are ones that ERBs should grapple with. In the words of the authors, “ethics corner-cutting is neither justified nor necessary even in an emergency.” Public health research during times of crisis or disruption may be a necessity. However, this is no excuse for slipshod consideration of ethical consequences, whether by researchers or review boards alike.
Gaelen Snell 

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