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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Sunday, June 25, 2017

The case for an Indigenous Bioethics

Indigenous communities in the Americas experience a disproportionate incidence of illness and disease compared to the general population. They also possess sophisticated ethical traditions which diverge and not infrequently conflict with Western-oriented bioethics. This culture gap between patient, provider and ethicist is no small public health concern—it can foster feelings of alienation and distrust which compromise the relationship between those in need of care and those able to offer it. Research ethicists have already made considerable efforts to bring sensitivity for aboriginal cultural mores into their discipline, but bioethicists have been slower out of the gate.
This is the argument made by an article last year in the American Journal of Bioethics. The authors Jaro Kotalik and Gerry Martin are well-situated to make such claims—Kotalik is a bioethicist and Martin is an Elder of the Mattagami Nation. The pair attempt to draw parallels between classical systems of virtue ethics and the Ojibwa narrative of the Seven Grandfathers, a fable with the central aim of transmitting the community’s moral compass from one generation to the next. Kotalik & Martin hope this exercise will show that aboriginal and mainstream bioethical frameworks are indeed, to quote First Nations intellectual Leroy Little Bear, “jagged worldviews colliding”. They share parallels, but they are far from perfect complements. Real work must therefore be done to smooth the contact point between them.
Kotalik & Martin make a provocative argument, but they paint a hazy picture of what this work entails. They doubt the possibility of an “aboriginal bioethics”, but they do speak of an “ethical framework” for the provision of healthcare in indigenous communities along the lines of what has been achieved in human research.
What would this look like? Well, some of the groundwork might already have been laid. Narrative bioethics, which has gained increasing traction in recent years, finds common ground with the oral traditions of many indigenous peoples by framing clinical ethical dilemmas with the devices of story. Communitarianism has also grown in popularity amongst bioethicists, paralleling the unbroken continuum between individual and community important to many aboriginal societies.
With these intellectual currents in place, an indigenous bioethics may or may not be possible. However, one thing is certain: it is only with the leadership of aboriginal communities articulating their vision of ethical healing that we’ll find out.
Gaelen Snell 

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Tuesday, June 20, 2017

Guest Blogger: Introducing Gaelen Snell

It has been some time since my last posting. Of course, this is not due to their being a shortage of bioethics challenges related to developing countries. There is never a shortage of that. Rather, a number of research and training projects have pulled me away from my usual late night musings. I will get back to it. Fortunately, there is also some help on the way.

Gaelen Snell is currently finishing off his Bachelor of Science degree (History and Philosophy of Science plus pre-med studies) at the University of British Columbia, Vancouver, Canada. This comes on top of his Bachelor of Art in Political Science obtained at the L'Institut d'Etudes Politiques de Paris. Gaelen has long been interested in health promotion in resource poor settings (including those located within the ‘developed world’) and is planning a career in humanitarian medicine. Gaelen will be contributing posts to this blog from time to time, as the spirit moves him.  

Welcome Gaelen!

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Saturday, April 22, 2017

A more ethical form of HIV criminalization

HIV has been criminalized throughout the history of the epidemic, or to be more exact, people living with HIV and their behaviors have been a persistent focus of criminal law. This was undoubtedly due in part to the fact that HIV initially was untreatable and infection (for the vast majority) spelt death. It was terrifying. But it wasn't just an understandable public health reaction. Criminalization is not necessarily a wise way of controlling an epidemic, as it can be counterproductive, driving underground persons potentially subject to the laws. And there is no way of getting around that those disproportionately affected by HIV (especially in the USA), were considered 'undesirables' by many in the public and those leaders they voted for. Criminalization also reflected a moral panic against homosexuals and injection drug users. So, because it was not really based on solid public health principles or scientific evidence in the first place, it is unsurprising that states made laws covering actions highly unlikely to lead to transmission (like spitting or oral sex), fail to take the use of new prevention technologies (PreP, use of antiretrovirals) into account, and often don't take into consideration the intention to cause harm. What is perhaps more surprising (and depressing) is that many of these laws are still on the books.

I am thinking that HIV criminalization should not be abolished, but pointed in a better direction. Let me back up. For a few years now, I have been working on a NIH-funded project on the social and ethical dimensions of HIV cure research. In the context of that project, we have been confronted with numerous cases of people claiming they have found a cure for HIV. Such claims originate from all over the world, but Africa would likely be leading the pack, if anyone was counting. (Just set up a google alert with "HIV cure" and you will see what I mean) The President of the Gambia, Yahya Jammeh, claimed his home-brewed concoctions cured HIV, but his ex-patients (of those still living) aren't doing so well. But that is just one example. It is hard to keep up. This month, a Kenya politician, Harry Kombe, claimed that he can cure early-stage HIV with reflexology. And a whole bunch of other things, including helping a 60-year old woman give birth.

So here is where criminalization could come in. Anyone who, without any verifiable evidence, makes a claim of curing HIV, should be subject to prosecution, if serious harms can be reasonably shown to result from that claim being made. If, for instance, the claims of a cure involve or result in people going off their antiretroviral treatment, and the health of such people is seriously compromised, then the behavior of the 'cure claimer' should be criminalized. This could be expanded to cover the case of former South African President Thabo Mbeki and his HIV denialism, where a Harvard study indicated that his unfounded claims led to 300,000 deaths. An evidence-based criminalization of baseless HIV cure claims would vast improvement, in terms of justice, over the forms of HIV criminalization we have now. For one thing, Mbeki would be in a cell, rather than being the new chancellor of the University of South Africa.

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Tuesday, November 22, 2016

Global health porn: the case of Extreme Doctors

The last few years have seen a growing interest in the ethics of short-term medical missions in the developing world. Global health initiatives and programs in many universities often involve such missions, where medical students or faculty travel to a faraway lands (relatively resource-constrained, with high disease prevalence and fragile health infrastructure) and provide certain medical services, for awhile. These missions certainly enhance the prestige and attractiveness of Western medical institutions and schools of public health, and can improve the CV's of those who participate in them. But those working in the field know such missions, particularly when embedded in longstanding partnerships, can also do some good. They also know that such missions can raise a number of serious ethical challenges that need to be addressed in advance, carefully thought through and continuously managed.

These ethical challenges include: students or doctors practicing beyond their competence; inadequate follow-up care for interventions that are provided, particularly for chronic conditions; disruption of local health systems and patient expectations; lack of correspondence between services provided and local health priorities; cultural clashes between Western views of medical need and local conceptions of health and disease. And so on. Further, since medical care is being dispensed by wealthy individuals and organizations to patients and communities that are relatively poor, questions about exploitation are never far away: who really benefits, or benefits the most, from these 'exchanges'? How can such missions, however well-intentioned, avoid taking unfair advantage of the vulnerable? Efforts have been spent on developing ethical guidance, and while there are best practices for short-term global health missions out there, all this is clearly a work in progress. The background of massive health (and other) inequalities in the world makes the ethical conduct of short-term global health initiatives a complex, uphill battle.

There is another way of treating that background and viewing those challenges: as a basis for entertainment. Extreme Doctors is a show currently in production by the Lifetime TV Channel. As for the show's premise, I will let their website do the talking:

In season one our teams will converge on an underserved country in Central Africa that is known for its extreme contrasts from breath taking beauty to life threatening poverty. As soon as their boots hit the ground they assess needs and get to work. They only have 21 days to treat countless patients and try and make an impact. The long hours, frustrations, overwhelming need and third world conditions will test their skills and pull on their every emotion.

The show is presumably being shot in Zambia at this moment, and while no one can judge its content yet, the material posted on its website already runs the gamut from cringeworthy to appalling. The show's drama solidly centers on the medical professionals, plucked from their privileged American environments, and flown (likely premier class) to provide medical care to seriously messed up other-cultured remote people in adverse conditions (where, as one clip notes, access to a hair dryer is not guaranteed). They are interviewed before their medical mission, where they try to anticipate the magnitude and grandeur of their own personal sacrifices, and gird themselves for the mental toughness needed to 'get them through the sadness' of dealing with sick/poor Zambian people. (Suffering people can be such a downer.) One of the doctors even explicitly acknowledges that he is not prepared for the challenges ahead, apparently because that is part of the fun, though presumably will be less fun for his patients.

In typical 'reality television' style, the show plans to have medical professionals tell their own homespun personal stories, gossip about the other doctors and nurses, and express their 'fish-out-of-water' reactions. It's clearly all about them. The Zambians and their communities will seemingly play bit parts, as the suffering bodies to work 'medical miracles' on, and to provide occasions for foreigners to vent their emotions. But, as one of the doctors puts it, Africans accept death, so maybe the stakes are not that high, after all. Oh, and the flora and fauna of Africa is very photogenic, which helps to lighten things up a bit. But, you might ask, what happens after the medical mission is over? How is the impact of their 21-day intervention measured? What do locals make of these 'medical heros' helicoptering in, and whining about their feelings on camera, then heading back to their 6-figure incomes? From the entertainment perspective, those ethical questions are likely to be considered boring, and therefore irrelevant. For those concerned about the ethics of short-term medical missions, watching Extreme Doctors could be akin to watching a crime scene.

What are the likely effects of such a show? In the best case scenario, there are no grave effects, because the show is cancelled after viewers become horrified by this pretentious, neocolonial monstrosity. Or the show continues on, reinforcing the white savior complex. Or the show inadvertently manages to de-legitimize all short-term global health missions, including ethically sound ones. From an ethical point of view, it is hard to see a good case scenario. Raising awareness of global health inequality? Please.  

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Saturday, October 22, 2016

Bioethics in China: not wild, but not tame either

Here is a way to turn yourself into a hostage of fortune, in bioethics and elsewhere. It is to vigorously defend something against allegedly unfair accusations, while acknowledging you may not know all the relevant information about what you are defending. That position can, should inconvenient truths come to light, transform you into an advocate of the dubious.

Case in point: back in July of this year, Douglas Sipp and Duanqing Pei wrote a comment in Nature entitled Bioethics in China: No Wild East. In it, they defended Chinese research practices (particularly in regard to genomics research involving human embryos) against accusations of being morally cavalier, loosely regulated, and prey to corruption. According to the commentary, Chinese research has been given bad press about its practices that do not match up with regulatory and laboratory reality. Biomedical research, including highly sensitive studies, is being (or well on the road to being) conducted responsibly there, even to the extent that China has some lessons for the rest of the world in this respect. Probably some truth to it, but you know this will not end well.

Earlier this month, China's State Food and Drug Administration (SFDA) disclosed that after examining a year's worth of clinical trial (n = 1622) data, that up to a whopping 80% of said data was fabricated. According to the report, the fabrication in part took the form of deliberately underreporting harmful side effects and adverse events experienced by trial participants in order to gain the necessary safety approvals. The SFDA surmised that the motivation for the fabrication was financial: trying to get drugs to market faster than their competitors.

You could of course say this is a victory for Chinese regulators who at least looked for, found and reported the research fraud (though what penalties will be levied, if any, is unclear). And certainly every country has its own struggles keeping biotechnological advances on the straight and narrow, particularly in the private sector. But it does complicate attempts to defend the ethical climate of research in China against perceived 'bad press.'

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Saturday, September 03, 2016

Bioethics and its better self

Renee Fox is one of the most, if not the most, distinguished American sociologists alive. If anything, this makes the attention that she has devoted to bioethics and bioethics workers all the more surprising, because after all, how interesting or important ARE we as subjects? She clearly would not agree with my assessment. She has written a whole book on it (Observing Bioethics, with Judith Swazey), and recently published a talk entitled "Moving bioethics toward its better self: a sociologist's perspective", where she clearly and unapologetically has gone from observing bioethics to prescriptively stating what bioethicists ought to be doing. Of course, people telling bioethicists what to do is nothing new. Some make a career out of lumping all bioethicists together and lambasting them as a band of heartless utilitarians promoting a culture of death. Fox is a more astute and gentler critic. For one thing, she apparently thinks bioethics has a 'better self', and that it can be nudged in that direction.

So where does Fox think bioethics is now, such that it needs a good nudge? First, its focus is narrow, concentrating on a relatively limited set of phenomena in biology, medicine and medical technology, particularly as they relate to the beginning and end of life. In understanding the ethical issues related to these phenomenon, bioethics goes back to the well of one particular value (autonomy) over and over again, to the neglect of other values like the common good, solidarity and social justice. The comfort zone of bioethics is the individual or interpersonal level of analysis: it appeals strongly to moral imagination (because you can imagine 'what you would do' in a certain case) as well as resonating with traditional American individualism. Ascending to a more macro level of analysis -- social determinants of health and political forces impacting health but lying outside medicine -- pull bioethics more outside its comfort zone. For similar reasons, global health ethics, and appreciating other ways of how ethics is conducted around the world, are still marginalized interests within bioethics. Fox is also underwhelmed by talk of an 'empirical turn' in bioethics, arguing that the field has not yet seriously stepped outside its academic haven and embraced the lived experiences of patients, researchers, patients and their families. Worse still, what is supposed to be the bread and butter of bioethics, debate and argumentation, is shot through with timidity. In her experience, Doctors without Borders has more vigorous discussion and self-examination than your average bioethics center.

So what is the recipe for getting to a 'better self'? Fox does not spell it out, but you get the idea. Open up the range of topics as to what counts as a 'bioethics question'. Stop fixating on autonomy and make room for other values worth caring about. Get a passport, then use it. Don't skim a couple of articles from social science journals and think you now have a deep acquaintance with 'the facts'. And argue, dammit, rather than just pointing out problems and simply stating recommendations or 'points to consider'.

Fox is worried about the current state of bioethics, because she believes it has an important social function. She is not worried about bioethicists being 'evil'. She is worried that they are is self-absorbed, tepid, and ineffectual.

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