Sunday, August 02, 2015

Pinker tells bioethics what its new moral imperative is, or not

Steven Pinker has written a provocative opinion piece today in the Boston Globe about bioethics. It was apparently sparked by a new technique for editing genomes, namely CRISPR-Cas9, and the social, political and ethical responses to this novel biotechnology. In a nutshell, Pinker states that promising new biotechnologies for improving human health like CRISPR-Cas9 should be aggressively pursued, and " ... the primary moral goal for today's bioethics can be summarized in a single sentence. Get out of the way." If bioethicists are not getting out of the way, they are, um, in the way. And if they are in the way, then they are blocking the bonanza of benefits that science could produce. With horrifying results.

My first reaction was: how is this new bioethics skill taught? Should there be classes that teach it in a stepwise manner, i.e. where you first learn not to butt in, then how to just step a bit aside, followed by somewhat getting out of the way, and culminating in totally screwing off? What would the syllabus look like? Wouldn't avoiding bioethics class altogether be a sign of success?

But seriously, how does Pinker get to this conclusion? Answer: a number of shaky assumptions. The first assumption is that health outcomes are primarily driven by biotechnological advances, rather than (say) non-biomedical driven changes in the social determinants of health. That first and controversial assumption is needed in combination with a second one about bioethics, i.e. thwarting important research is the primary goal of bioethics as it is currently practiced. That view of bioethics comes in the form of a massive, bloated straw man:

A truly ethical bioethics should not bog down research in red tape, moratoria, or threats of prosecution based on nebulous but sweeping principles such as 'dignity', 'sacredness', or 'social justice'. Nor should it thwart research that has likely benefits now or in the near future by sowing panic about speculative harms in the distant future. These include perverse analogies with nuclear weapons and Nazi atrocities, science-fiction dystopias like 'Brave New World' and 'Gattaca' and freak-show scenarios like armies of cloned Hitlers, people selling their eyeballs on eBay, or warehouses of zombies to supply people with spare organs. 

Well, yes, bioethics should not be insane. But maybe people just have less wacky short and long-term concerns about gene editing. Pinker brushes this aside too, saying that slowing down science even a little bit causes devastating harm (see first assumption), and since we can't reliably predict long-term implications of science anyway, why hold us back by discussing them? So old bioethics of constraint and caution to the side! Let biotechnological research be free of impediment, so we (in the better off countries, mostly) can feast on its benefits! But whoa, wait a minute. He also writes:

Of course, individuals must be protected from identifiable harm, but we already have ample safeguards for the safety and informed consent of patients and research subjects. 

Where do those protections come from? Old bioethics, the kind that does not step out of the way. And although those protections are (more or less) in place, it is not insane and irresponsible to discuss research on human subjects involving gene editing in order to get some grip on what the 'identifiable harms' might be, what informed consent should involve, and what safeguards would be appropriate. And it is not just silly bioethicists that worry these sorts of things: the call for a moratorium was made by the scientist that invented CRISPR-Cas9 in the first place.

On closer inspection, what is Pinker saying? Not a lot. Science is awesome, when it leads to good things; irrationality is irrational. So as far as this opinion piece goes, it might have been better to get out of the way.

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Saturday, August 01, 2015

Imperialism and access to bioethics journals

Let's say that bioethics is about understanding and managing conflicts of value related to health and care for health. Call them moral challenges. Let's also say that there is something at stake in these challenges, i.e. that they could be understood and managed for better or for worse, where the 'better' and the 'worse' could impact on human lives. Let's say too that these challenges are universal, i.e. that no society or community is immune from them, even if there are differences between what constitutes 'health', 'care for health', 'values', and how challenges are seen to be understood rightly (or wrongly) and managed well (or badly). In this generic sense, bioethics is universal. Now what if access to bioethics, as a tradition of thought, was largely limited to practitioners in the richer, industrialised countries of the world? It seems unjust that developing countries would be saddled with the moral challenges of health and medicine, without (presumably) also having resources to help make sense of and deal with them in reasonable ways.

This is the central complaint of Chattopadhyay, Myser and De Vries in a recent article in the Journal of Bioethics Inquiry, fetchingly entitled Imperialism in Bioethics: How Politics of Profit Negate Engagement of Developing World Bioethicists and Undermine Global Bioethics. The authors describe how policies by many publishers of bioethics journals making it extremely difficult for aspiring bioethicists in developing countries to engage with the existing (and past) literature. While there are initiatives to improve global access to existing bioethics journals (like HINARI), and there are some open access journals related to bioethics (like BMC Medical Ethics), and you could always write to authors and ask them for copies, these forms of access are inferior to the kind on offer in certain academic institutions in America and Europe. The great powers feast, the others get the crumbs.

The situation of inequality of access to bioethics literature is fairly well-known. What makes Imperialism in Bioethics especially interesting are the ethical implications it tries to draw. For example, the authors state that poor access to bioethics resources make training initiatives aiming at 'capacity building' in developing world countries (like Fogarty and Erasmus programs) illusory. How can capacity be developed if there is no ongoing, sustainable access to bioethics as a tradition of thought? Another implication is that, if there continues to be limited global access to bioethics resources, then bioethics will continue to reflect largely 'Western' assumptions, values, preoccupations and mindset. What will continue to be excluded are alternative forms of health and care for health, and alternative ways of conceiving and dealing with the conflicts related to them. For the authors, it is not just sad that this situation turns bioethics into a Western echo chamber, despite its global pretentions. They call it an intellectual, cultural and moral genocide of non-Western traditions, " ... varieties of sociocultural experience, theorizing, and moral visions of life and medicine that have evolved over eons."

I am not sure that all the implications stick at full strength. Access to bioethics literature certainly matters. But there are substantive obstacles to local bioethics practice in developing countries even if information access problems were to be overcome. One obvious one is that aspiring bioethicists often have nowhere to work in those countries, or at least, no where to work as bioethicists. Local institutions often do not value bioethics enough to fund it, probably because they are too busy tackling all the other fallouts of inequality. Convincing struggling educational institutions that some (or any) of the medical curriculum should be devoted to bioethics can be hair-raising.

As usual, global inequalities lead to uncomfortable ironies. It is painfully ironic that Developing World Bioethics, owned by Wiley-Blackwell -- is not accessable through PubMed Central or HINARI. It is somewhat ironic for the authors to complain about lack of access to a tradition of bioethics they otherwise describe as parochial, decontextualised and hence to some extent useless to the rest of the world. It is really ironic that the article is -- as the authors acknowledge -- published by Springer, whose policies are precisely those that they criticize. And to top it off, Springer seems to have made an exception to their policy for this particular article: everyone (with internet) can read it without paying the usual $39.95.      

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Thursday, July 23, 2015

Postmodernity and global polio eradication

Polio is getting closer to being eradicated. If it happens, it would join (along with smallpox among humans and rinderpest among cattle) that very rare class of pathogens that have been taken literally out of circulation by conscious human efforts.  That sounds good, but in the case of polio it also shows just how long it takes medical advances to deeply penetrate resource-limited and politically volatile settings: a safe and effective vaccine has already been around for half a century. In any case, due to the collective efforts by charitable organizations, civil society, government and religious leaders, Nigeria is getting nearer to being rid of polio, and tomorrow will mark a year since a case of polio has been diagnosed there. The remaining holdouts are Pakistan and Afghanistan. But potential threats to polio eradication may lie elsewhere, where you rationally would expect it less.

Like California. According to the California Department of Public Health, over 60% of children in the state have not received the full suite of vaccinations. This is partly a case of being victims of their own success: Americans have little experience of what it is like to be prey to infectious agents precisely because vaccines have worked so well on so many of them. It is a stance you have the luxury of taking from a position of relative privilege. But it is partly due also to a culture of gossip, suspicion and kneejerk mistrust of medical authority, and hence also from a position of ignorance. If vaccines are the product of Enlightenment faith in reason and science to improve society, rejection of vaccines -- when not itself based on sound reasoning and evidence -- is regression into a pre-scientific state where life was nasty, brutish and short. Privilege and ignorance is a toxic combination, and some people have to (re-)learn the hard way.

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Tuesday, July 21, 2015

The bioethics of austerity

One of the more depressing aspects of the crisis in Greece is the cartoonish way the plight of the Greek people has been portrayed. It is as if ordinary Greeks had all taken out massive and reckless loans, and when asked to pay them back, they stubbornly refused. The nerve of such people! Do they want money for nothing? Can't they pay off their debts like us, i.e. hard-working sensible people? How lazy and irresponsible of them.

Africans may view all this with a sense of dรจja vu. In the years after independence, the ruling class of African countries brought their economies into debt, while rulers enriched themselves from revenue generated by the selling off of their natural resources to the developed countries in the North. In the 1980's and 1990's, the collection agencies of the international creditor community (i.e. the World Bank and the IMF) imposed 'structural adjustment programs' that involved reducing expenditures by the public sectors -- especially education and health -- opening up markets to foreign investment and establishing debt repayment schemes. This was austerity avant la lettre, whose effects in Africa were largely catastrophic and are still felt right up to this day. In this way, Africa was a laboratory for a new, 'bloodless' way of dominating and exploiting other countries, not by armed conquest, but by debt. Debt in this geopolitical context is not like the debt you incur when you voluntarily take out a loan to buy (say) a car. No ordinary African citizen voluntarily asked for despots and kleptocrats to siphon off national resources, run their country deep into the red, and then agree to repayment terms and conditions that gut their schools and hospitals. Africans are familiar with European powers doing this to them, and accusing them of laziness in the process.  Europeans doing it to one of their own: now that is new.

Just like the African case, the Greeks are getting hit ... right in the health sector. Crumbling infrastructure, doctor and nurse burnout and brain drain, use of cheap but unsafe materials, shortages of medical supplies, increasing inability of patients to pay for services: all the classic symptoms of austerity health care. The imposition of austerity will be predictably associated with avoidable morbidity and mortality -- and it is avoidable because austerity is a political construct, not a natural event. If the more powerful countries want to bail out or provide debt relief to certain countries or institutions, they can and they have. So they are at least partly responsbility for those consequences when they decide not to, both in the old African case and the new Greek one.

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Friday, April 24, 2015

Penile transplants and ritual male circumcision in Africa

It should not be going to too far out on a limb to say that ritual male circumcision is not, and never has been meant to be, a medical intervention. Certainly in sub-Saharan Africa, where it has generally been understood as part of a larger rite of passage from boyhood to manhood, questions of safety, hygiene, pain relief or psychological trauma are typically not concerns central to the ritual. If they were, the use of unsterile instruments by non-surgeons on the un-anesthetized would have led to the disappearance of the practice long ago. The ritual is about risk, not safety; it is about testing an initiate's response to fear, not making the youth feel comfy. And what is more fearful that the threat of a sharp instrument being brought to bear on your private bits? One can be appalled by the practice, but you have to at least acknowledge that it is not an attempt to do the same thing as medical circumcision, except more primatively and with higher complication rates. It has unsafe practices partly because it serves a whole other purpose.

Nevertheless, it is hard to say that penile amputation or death are just the price you pay for ritual male circumcision, and those who think otherwise should just man up. Are you culturally ignorant if you care about and want to protect those who are harmed by traditional circumcision? Are you culturally insensitive if you want to change the practice to reduce harm to persons? One interesting development related to the issue has been the announcement of the first penis transplant. A nine-hour surgery by a South African surgical team late last year transplanted the penis of a dead donor to a young man who had lost his own member due to ritual circumcision complications. To barely-contained chuckles in news reports and the twitter-sphere, the patient enjoyed a rapid recovery, successfully putting his Johnson through its sexual paces only five weeks after surgery. Bad knifework corrected by better surgery, giving hope to all those harmed by ritual.

There are some puzzling and disquieting aspects to the story though. I suppose the first is that I never realized that you could donate your penis. Is this a checkbox on a form? The second is the question -- never answered in any news report that I saw -- whether the donated penis was itself circumcised. If it  wasn't, this could be a first: the first man to be circumcised twice. But most of all I wondered: how many of those who suffer from penile amputation via ritual circumcision are in a position to afford a nine-hour operation? And how will having another man's penis play itself out in their communities? Will it be considered more or less strange than not having one at all? And to what extent is this surgical achievement an adequate response to the deaths and dismemberments of ritual initiates occurring each year, rather than showcasing what powerful medical institutions are able to do?

Prevention rather than treatment is probably the only realistic way to cut down on the morbidity and mortality associated with ritual male circumcision. The problem is that it is unclear how to minimize the harm associated with the practice without significantly altering its meaning. Probably no headway will be made until the adherents themselves (and not just outsiders) regard the deaths and mutilations as matters of deep moral concern, rather than something that just comes with the ritual territory.

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Wednesday, March 04, 2015

Whose risk/benefit ratio is this, anyway?

It's a good question. An analysis of risks and benefits for study participants is considered central to the ethics of research, but how risks and benefits are determined remains tricky. Part of the job description of research ethics committees is to make such determinations, and the Belmont Report encourages use of quantitative risk data whenever possible, but it is unclear how often that actually happens. Anecdotally, there is a lot of eyeballing and back-of-the-envelope estimation of risks, if not outright speculation and magnification. And as for benefits, there is much disagreement as to what should count as a benefit in the risk/benefit assessment. Compensation and inducements are traditionally thought to be inadmissible; benefits that come with study participation ('inclusion benefits') are permitted in the mix by some, ruled out by others.

The problem of risk/benefit determination is not just a problem about how, but also about who. Traditionally, the work of making such judgments is something reserved for experts: bioethicists, researchers, research ethics committees, policy makers. This is one area in which the whiff of paternalism in research ethics is particularly strong. If anything, the perspectives of research participants and communities are regarded as ethically dangerous and problematic, particularly in cases where communities are poor and the prospective participants are hoping to gain medical benefits by joining research studies. An article in a recent edition of Tropical Medicine and International Health suggests that local communities make their own risk/benefit calculations about particular studies, which go far beyond whatever risks and benefits may be directly connected to study interventions. For example, the thought "How could my participation in this study possibly benefit my family?" is a consideration unlikely to appear in your standard risk/benefit discussions. What could be a benefit for participants may, from the perspective of an ethics committee, be literally invisible.

The authors state that much more research is needed into the complex links between socio-economic vulnerability, access to health care and the freedom to decide on participation in medical research. Seems reasonable. But whether such research will lead to a participant perspectives being more determinative of 'official' assessments of the risks and benefits of health research remains to be seen.

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Saturday, January 10, 2015

Big Pharma feeling misunderstood

The CEO of Bayer, Marijn Dekkers, was last month reported to have said the following:

"We did not develop this [cancer] drug for Indians. We developed it for Western patients who can afford it."

What Dekkers said was in response to a question about a decision by an Indian government official to grant a compulsory licence to patents on said cancer drug, on the grounds that Bayer's price for it ($65,000) was far too expensive for Indian patients. Dekkers added that he thought the move towards a compulsory licence -- permitting low-cost generic equivalents to be produced and sold by companies other than Bayer -- was "essentially theft."

A couple of websites condemned the comments as the usual 'profits before persons' standpoint of Big Pharma, albeit stated much more brutally than CEOs of major drug companies generally do.  It turns out that Bloomberg News, who originally ran the quote, actually manipulated it a bit. What Dekkers actually said was:

"Is this going to have a big effect on our business model? No, because we did not develop this product for the Indian market, let's be honest. We developed this product for Western patients who can afford this product, quite honestly. It is an expensive product, being an oncology product." 

Plus compulsory licensing is theft. Bloomberg News rightly corrected itself, although if anything the actual quote sounds even worse.

What is really ironic is that Dekkers' statement was made at a conference called Buffering the Pharma Brand: Restoring Reputation, Rebuilding Trust. It could alternatively been called: we make you sophisticated drugs, that you can't make yourself, so where is the love? The participants in the conference seem bewildered that the public trusts pharmaceutical companies less than producers of alcohol and tobacco. How is this possible? In this regard, Dekkers' statement may have inadvertently been the most insightful 'take home' message of that particular get-together.

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