Globally embarrassing bioethics

February continues to be a trying month in bioethics circles. This week we have a firestorm concerning an article published a couple of days ago in the Journal of Medical Ethics, entitled After-Birth Abortion: Why Should the Baby Live? The authors Alberto Giubilini and Francesca Minerva argue that as a matter of consistency, if we accept that fetuses can be aborted for certain reasons (severe abnormality, psychological or financial burden on the family) then we must rationally accept that newborns can be put to death for the same reasons, because both fetuses and newborns have the same moral status as non-persons. Reactions from non-fans of infanticide have been swift and ugly, with the usual accusations of Nazism and dire assessments of where the world is headed when intellectual life is not constrained by religious faith. Editors at the JME, laughably, act as if shocked by all the fuss, as if they seriously expected all readers to receive the paper in a spirit of cool, robotic detachment.

What I found surprising about the paper was how old the main arguments are. Check the references: the philosophical papers cited are all between 20 and 30 years old. Peter Singer and Michael Tooley made the same basic arguments with the same basic premises and with the same rationalistic mindset. So it is not clear why what makes this paper especially publishable, unless the publishers were thinking the time was ripe for stirring up the culture wars (yet again) with a big, fat stick.

But the editors at JME are right that it would be good, ultimately, have a reasoned debate about the article's content. There is plenty in the article to question, including the key premises that our attitudes towards persons is based on their possession of mental capacities (especially their ability to plan for the future) and the idea that our moral sentiments (including our feelings towards newborns) ought or can as a general rule be governed solely by logic and consistency. Those outraged by the Giubilini and Minerva article should take some consolation in the fact that those old arguments by Singer and Tooley did not exactly popularize infanticide, even among other academics. To the extent that the new article has a shock value, the old article has had little effect on common morality.

There is another concern, though: how this all looks to those outside North America and Western Europe, the traditional bastions of bioethics. High-minded arguments in favor of dispatching unwanted babies (and other non-persons) setting off a torrent of mud-slinging and breast-beating. Bioethics: so that's how you do it.

Update: the Journal of Medical Ethics Blog has published some further responses to the paper by Giubilini and Minerva in an apparent effort to open reasoned dialogue on the subject. Giubilini and Minerva have published an open letter to clarify their position, interestingly claiming that they only meant their audience to be other bioethicists familiar with abortion/infanticide debates, emphasizing that they were only making an academic argument, without any practical implications for policy, law, or for what people ought to do.

Research ethics committees in developing countries: something old, something new

February has been a rough month for bioethics in the USA. Alleged conflicts of interest at the American Journal of Bioethics -- the top ranked bioethics journal -- has lead to a kind of feeding frenzy of accusation, distain and soul-searching in regard to the whole idea of bioethics and how it is practiced in it's most powerful home. Is bioethics a lousy kind of philosophy? Does it just consist in rationalizing the newest biotechnology that comes along, and running intellectual roughshod over whatever traditional values (often religious) might be threatened by that technology? Is that why bioethicists are lured to agencies and institutions that are part of one might call the military-industrial-university-biotech-pharma complex? Is bioethics losing ability to speak truth to power, because they are part of (or eating hors d'oeuvres with) the 1%?

Perhaps on another occasion there will be room for reflection about whether all this should be a cautionary tale for bioethics in other countries in the world, how much of it is true, and how much of it is overblown to serve the interests of other agendas. For my part, I have been lying low, staying away from bioethics news, and looking at what other journals have been putting out. A recent research ethics article in the Journal of Medical Ethics caught my eye, called 'Ethical Approval in Developing Countries is not an Option' (Online First, requiring subscription, goddammit).

What struck me initially was the obviousness of the title: how is that news? It is like having an article called 'Eating people: some arguments against'. And in a certain way, the point of the article is obvious: when there is an appropriate body in developing countries to review human subjects research conducted by anyone (local or from abroad), then it should be reviewed. The authors cite a published article about research conducted in Nepal, which did not have local Nepalese research ethics committee approval. It doesn't sound like a very risky study, but that is not the point. Nepal has an ethics committee that could have reviewed it, and it was not even submitted.

What makes the article publication-worthy are the underlying issues. Central among them is who should have ensured that the study was submitted to local review. Ethics committees are not detective agencies, who scour the community to find out who is doing research on what. Researchers have to volunteer this information; they also have to know that there is a committee to submit their research to. In many developing countries, this is not straightforward: in some settings, research ethics committees may not exist; where they exist, they may only review certain kinds of (biomedical) studies; and even if they do exist and they could review a certain study, getting information about them and their procedures can be unreasonably taxing for scientists. Compounding the problems, some committees may be dysfunctional and intolerably slow, undermining motivations to bother looking for them.

Perhaps if a study is conducted by a developed world institution, their own research ethics committee should ensure that scientists make good faith efforts to get their research reviewed where it will be conducted, or help them get it reviewed. Or journals should not publish articles in which researchers failed to get their research reviewed where it really is human subjects research, and there really is an adequate body that can appropriately assess its ethics. The authors rightly point out that if researchers from Nepal were to do a research study in the UK or USA, but only sought ethics approval for it in Nepal, and published it, this would be considered scandalous -- but when developed world institutions do the same in the developing world, there is far less concern, even when committee members do not know much more about Nepal than Everest expeditions.

So it is not news that local ethics committee review in developing world ought to be reviewed; the news is how this requirement continues to fall through the gaps.

Foreskins, clamps, and stabbings

Part of the interest in getting Google Alerts, at least as far as I am concerned, is that they provide diverse (if not surreally clashing) news items about the same topic. This week, I received a couple of links about male circumcision as HIV prevention strategy in low-resource, high HIV prevalence countries. A few years ago, three randomized controlled trials in Africa indicated that being circumcised significantly reduced risk of female-to-male HIV transmission. Male circumcision was then all the rage for awhile, but soon slipped off the front pages as it passed from 'research innovation' to 'yet another intervention to be implemented.'

Some countries in Africa are making male circumcision part of their HIV prevention strategy, though informing/convincing men to have their foreskins removed for this purpose, and actually getting it done, has proven slow going. There is some movement to change this. The New York Times has an article about new methods to speed the process of circumcision, complete with pictures of what to the untrained eye look (predictably?) like cock rings of a fairly utilitarian sort. The most promising of these devices seems to be the PrePex, which basically involves putting a ring around your Johnson, and cutting off blood circulation to the foreskin, until the latter comes off 'like a fingernail' as one proponent so sensitively put it. Apparently the clinical trials on male circumcision and HIV gave birth to a growing industry in foreskin removing clamps, from China's somewhat sinister sounding Shang Ring to the exoticism of the Turkish Ali's Klamp, to the device that terrorized many a South African penis a few short years ago, the infamous Malaysian Tara KLamp. That is the new story: which plastic gadget most cost-effectively whips off the African foreskin?

The other story on my Google Alert really goes in another direction. The Citizen, a Tanzanian newspaper has an item entitled 'One Hacked to Death in Male Circumcision Confrontation'. Apparently traditionalists in Tanzania are (very) opposed to the idea of medicalizing male circumcision and treating it similarly to an appendectomy; after all, circumcision in Africa is commonly viewed as a rite of passage for males, where the pain of circumcision is part of its meaning, and the act is part of a ritual performed by traditional practitioners. A crowd of those who have this 'old school' view of male circumcision confronted someone who was treating it more as a medical, disease prevention intervention, and things got ugly. Modernity meets tradition. So the clinical trials on HIV and male circumcision have not only given rise to plastic gadgets, but also some measure of inter-tribal conflict.

Failing to treat TB, until TB treatment fails

There are reports coming out of India of patients who have tuberculosis that responds to none of the existing drug regimes. When you have MDR (multidrug resistant) TB, the first-line drugs will not work on it, and your physician has to resort to second-line drugs that tend to be more expensive, less effective, have more side effects, and take longer to cure you from TB. When you have XDR (extensively drug resistant) TB, there is no point in you taking the first-line drugs as well as several of those in the second-line. Your clinical options and prognosis dwindle. Now there is the concept of TDR (totally drug resistant) TB, where patients are cast back into medical history, back to the time of the sanitorium and folk remedies.

TB is curable and, as is well recognized, failure to cure has to do with non-adherence to lengthy TB treatment, poor diagnostics, weak health care systems, and lack of political will. TB, in principle, could have been as prevalent today worldwide as polio. Instead, primary TB continues to kill millions every year, and if that is not bad enough, we now apparently have pockets of TDR in the world to control and contain. It is striking that a recent letter to Clinical Infectious Diseases states that systematically poor clinical management -- lack of medical ethics at the most basic level -- is helping to fuel TB drug resistance:

The vast majority of these unfortunate patients seek care from private physicians in a desperate attempt to find a cure for their tuberculosis. This sector of private-sector physicians in India is among the largest in the world and these physicians are unregulated both in terms of prescribing practice and qualifications. A study that we conducted in Mumbai showed that only 5 of 106 private practitioners practicing in a crowded area called Dharavi could prescribe a correct prescription for a hypothetical patient with MDR tuberculosis. The majority of prescriptions were inappropriate and would only have served to further amplify resistance, converting MDR tuberculosis to XDR tuberculosis and TDR tuberculosis.

Playing good cop/bad cop with Guatemala

Last year, the discovery that abusive sexually transmitted disease (STD) research was funded and conducted by the US government in Guatemala in the 1940's was headline news. This week, we are hearing two quite different responses to those events in the press. The US Department of Health and Human Services announced that it will commit roughly 1.8 million to strengthen public health activities on HIV and STDs in Guatemala as well as help bolster ethical protections for research participants in that country. It is hard to see this newfound interest in Guatemala, STDs and ethics as a coincidence, and also hard not to see it as partly driven by public relations interests. But if it does good, it does good.

Then there is the other voice. Hundreds of Guatemalans who were participants (or family members of participants) are suing the American government for compensation. The US Department of Justice is apparently having none of it. The DOJ is quite willing to state that the research in Guatemala was shameful, unethical and downright wrong, but also quite happy to draw a very firm line between morality and legality: what is immoral is not necessarily grounds for a legal claim. So the DOJ is asking a federal judge to throw out the lawsuit. You can see the reasoning: President Obama and Secretary of State Clinton already formally apologized for the US government's role. President Obama set up a commission to express, to the countries in the world where the US does research as well as the American electorate, that those abuses are being taken seriously and steps are being taken to ensure no repeat performances. Isn't this enough?

Not everyone is comfortable about sticking purely with moral outrage and disapprobation when it comes to serious abuses of persons in biomedical research. Doesn't the whole pious talk about 'respect for persons' just blow hot air around if there is no place for punishment and compensation, at least in the most egregious cases? Obama's Commission itself seems to think that compensation for harm -- which governments and private companies have historically shied away from for obvious reasons -- needs to be rethought. We will see in the coming years which voice about Guatemala makes itself heard.

Bioethics of food in the DR Congo

An article in the New York Times about the Democratic Republic of Congo had me thinking about bioethics on a very basic level. As organisms, humans need food to survive. This is clear. So if a society has become incapable of providing conditions where its citizens -- even formally employed ones -- can reasonably gain access to food for themselves and their families, something has gone really terribly wrong. This situation is not something that gains much attention in bioethics, despite the known impacts of undernutrition on health. For sure, nutrition makes an appearance once in awhile, say when discussing laws to ban trans fats in restaurants or sweetened beverages in schools. And the obesity epidemic will raise the profile ethical questions surrounding food production and consumption in the coming years. But the New York Times piece is not about how to regulate the consumption certain kinds of foods in order to promote health; it is about people being forced to chose who can get anything to eat at all. Choosing which of your children can eat today: that is a bioethical dilemma in a very raw sense.

Tracking the bioethics of food in the Democratic Republic of Congo would require a truckload of philosophy, history, anthropology, and most of all, economics and geopolitics. The well-known irony of the DR Congo is that it is one of the world's worst-off countries with one of the greatest reserves of precious natural resources. But it is not really an irony: it is closer to a causal relationship. Since colonial times, the Congo's lucrative natural resources (cobalt, coltan, gold, uranium) have drawn the attention of local and foreign governments away from the Congolese people and towards their own gain. The end result at this point in history is a kind of reductio ad absurdum of libertarianism: a country where the average citizen does not pay taxes, and is subsequently free not to receive much help from the government at all, in terms of roads, sanitation, education, health care, agriculture or food security. The recent farcical election in the DR Congo and the shameful near-silence about it in the aftermath indicates that it is not in the interest of any major power to change the status quo. So there will be food dilemmas and empty stomachs in Kinshasa households for the foreseeable future.

Top 10 HIV and ethics stories for 2011

I was looking on the web today hoping to find a top-10 list of bioethics stories for 2011. It is time of the year for such lists, and you would think that someone would be busy compiling bioethics stories of global significance, like whether extremely obese kids should be removed from their parents, the identity issues raised by face transplants or those pesky animal-human hybrids. Alas, I can't seem to find anything. There is always the Top 10 Evil Human Experiments, but beside the question of how these are determined (is there an Academy of Evil?), this is not specific to 2011. Of all places, IRIN/PlusNews, the humanitarian news and analysis service of the United Nation's Office for the Coordination of Humanitarian Affairs, has put out a top 10 list of the HIV/AIDS stories of 2011. And we can go with that, since the global significance of HIV/AIDS, and it only takes a certain degree of tweaking to turn it into an ethics list. It is in no order of importance:

1. HIV/AIDS turns 30. In June 1981, the CDC published a report in its Morbidity and Mortality Weekly Report (MMWR) about cases of what would later be called AIDS. Despite three decades of research and program implementation, both often hindered by politics and alternative public and private priorities, millions continue to be infected by HIV and die of HIV-related causes each year, particularly in low-resource settings like sub-Saharan Africa. How many died who could have been saved during this period, were it not for stigma associated with the condition and the stubborn preference among the world's wealthiest nations for military rather than health-related expenditures?

2. ARVs as prevention. Prior to 2011, there was already some evidence that being on antiretroviral treatment reduced the risk of a HIV-positive person transmitting the virus to others. The HPTN 052 study, a randomized controlled trial with sero-discordant (i.e. one partner HIV-positive, the other not) couples sealed the deal in 2011, indicating a 95% reduction of risk. The real ethical challenge now is implementation: should we target antiretrovirals for prevention purposes at those most likely to transmit the virus? How is this fair to those (such as children) who need such treatment but are unlike to pass it on to others?

3. AIDS funding. Research breakthroughs like the HPTN 052 study come at a painfully ironic time: just when real progress is made with HIV prevention research, we have an economic downturn that seriously threatens funding for studies and initiatives. The Global Fund for HIV/AIDS, Tuberculosis and Malaria just ditched its round of funding for 2011-2013, citing lack of sufficient contributions from supporting countries. What does this mean, ethically? Over the last decade, there has been a tremendous increase in the numbers of persons gaining access to anti-retroviral treatment. Cutting into programs could mean cessation of treatment, with serious potential impact on individuals and public health (in terms of rise of drug-resistant HIV strains).

4. Disappointing HIV prevention trials. The idea of giving antiretroviral drugs to HIV negative persons in order to prevent them from acquiring HIV has been kicked around for awhile, but 2011 has been an awful year for this line of research. Last year, the CAPRISA microbicide study looked very promising. But this year saw the crash and burn of two important studies (FEM-PREP and VOICE), tossing the whole pre-exposure prophylaxis approach to HIV prevention into serious disarray. Besides, if you want to (ethically) do a study with those exposed to HIV infection, doesn't HPTN 052 now imply that you ought to provide antiretroviral treatment to their partners? The mind boggles.

5. Gaffe prone politicians. Yes, this was on last year's list. It is still allowed, as long as you come up with fresh gaffes, and politicians are all too happy to help. Helen Zille, premier of the Western Cape (South Africa) apparently aimed for the title of most gaffe-prone this year. After stating that all HIV positive persons who knowingly infect others should be charged with attempted murder, she came up with a spectacular encore: the creation of an HIV lottery of sorts, where you get a chance of a cash prize if you get tested for HIV. For those not ready to regard these as gaffes, there is always Christine Ondoa, Uganda's new Minister of Health, who claimed in August to have known three persons cured from HIV by prayer. Top that one.

6. Anti-gay legislation. Anyone can make a gaffe. But attempting to make laws that discriminate against persons at heightened risk for HIV on the basis of sexual orientation is another matter. In sub-Saharan Africa, there is a perception that being gay is 'anti-African', as if same-sex orientation would be a Western import along with Volvos, Ipads and hot yoga. Mindless prejudice tarted up as defense of traditional values is nothing new or especially African, but the ferocity of the denial, as well as its negative public health consequences in the midst of an epidemic, might end up having a special African character. But not in a good way.

7. Threats to generic ARVs. HIV is tricky, and it takes a great deal of research investment to create drugs to control it. Those with the deepest pockets -- Big Pharma -- are most likely to develop antiretroviral drugs. While having cheaper generic versions of these drugs are in the interest of poor individuals and nations, it is not in the financial interest of the multinational corporations concerned. 2011 saw conflicts between generic ARV manufacturers in India and European Union, where the EU is widely seen as not being on the side of the angels. In 2012, mathematical modelers should examine the 'persons vs. patents' consequences of whatever policies come to pass.

8. Contraception and HIV risk. Some philosophers wonder if our urge to have children has any rational or ethical basis, but most take this conception as an unquestionable value. But in regions where HIV is highly prevalent, how to conceive without the mother and child risking HIV infection? A condom reduces risk of both HIV and conception. In 2011, a study suggested that a popular contraception drug (Depo-provera) increased risk of HIV acquisition and transmission. Back to the drawing board for researchers perhaps, but in the real world, couples continue to be torn between conception and HIV risk.

9. Medicines Patent Pool. As the IRIN/PlusNews report puts it, 'The patent pool was established in 2010 by the international health financing mechanism, UNITAID, and aims to stimulate innovation and improve access to HIV medicines through the negotiation of voluntary licenses on medicine patents that enable generic competition and facilitate the development of new formulations.' Quite a mouthful, but the point (see #7) is the impact this initiative has on patient access to HIV medicines in actual practice. Gilead should be commended for dipping its toe into this new pool in 2011. We will see if other big pharmaceutical companies follow suit.

10. New HIV targets. Yes, it is easy to get cynical about ambitious targets set by international health agencies, when you consider they rarely if ever get met. In June, the United Nations came out with the language: 'Zero new infections, zero stigma and zero AIDS-related deaths." On the face of it, a bit ridiculous: really, zero? Can we believe that any more than zero-teenage pregnancies, zero-drug abuse, or zero-drinking and driving? In reality, it is more a rallying cry or slogan than a goal. Goals have numbers on them, and the numbers are generally not 'zero'. Doubling the numbers of those on ARV treatment, halving TB-related deaths among HIV positive persons, bringing mother to child transmission of HIV down towards zero, and increasing prevention options among the vulnerable are valuable goals. This may be deja-vu for resource poor countries in Africa, and in an economic downturn the probabilities are altered. But it is better to have targets than none at all, as long as there is some commitment to pursuing them. Something like New Year's resolutions?