Global bioethics blog

Foreskins, clamps, and stabbings

2012-02-01T22:21:00.003-05:00

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

2012-01-13T00:43:00.004-05:00

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

2012-01-10T23:33:00.005-05:00

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

2012-01-03T23:27:00.004-05:00

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.

Ethically dubious business practices at Boingo

2011-12-19T23:19:00.007-05:00

This is a post about ethics, but not bioethics.

On my recent trip to Madagascar, I needed to get online at airports in order to do email and surf the web, in preparation for the planned bioethics and public health ethics workshop at the Institut National de Sante Publique and Communautaire in Antananarivo. So I signed on for a 'pay as you go' plan with Boingo, a company that enables you to gain access to internet hotspots at a price. You can find Boingo hotspots in airports from Malawi to Moscow to Jakarta. But the company, as I later found out, charges you outrageous prices for every access; has an app that facilitates without mentioning the precise financial implications of doing so (basically draining your bank card); intentionally makes unsubscribing to the service an ordeal, i.e. in my case a greater-than-one-hour wait on the customer service line. I was finally able to cancel my account, after the customer service representative offered that I pay 'only' about half of the bill that I was smacked with. So they made a juicy profit out of services I hardly used, and I am not alone in this. I wonder how those in lower-income countries, with undoubtedly less resources to extract themselves from the practices of dodgy companies, fare in such cases.

Amazingly, the company is celebrating its 10 year anniversary. If a research institution was found to treat research participants as Boingo treats its customers, heads would likely roll. I guess this is a difference between research ethics and business ethics: the former still clings to old-fashioned ideals like respect for persons, transparency and accountability. The latter is happier with 'buyer beware.'

Well, I feel somewhat better now. Back to global bioethics issues soon ...

Unhealthy ethical signals in India's clinical trial world

2011-11-13T21:59:00.005-05:00

Maybe I have been in this business a bit too long: I am starting to regard journalistic exposes about exploitive global health research in developing countries with (at least initially) with a jaded eye. This week The Independent newspaper is featuring a piece entitled Without consent: how drug companies exploit Indian 'guinea pigs'. The title itself is pushing all sorts of buttons: big Pharma + bad ethics + the vulnerable poor. But, as it stands, the content of the article only partially lives up to its vivid title. For those who read the original, consider the following:

The authors accuse researchers in India of not obtaining proper informed consent; participants are said to be not fully understanding what they sign up for. But full understanding is ever achieved in clinical trials conducted anywhere, including those with well-off, literate participants. There is more than a decade of bioethics literature on this.

A number of times, the authors state that there have been a number of deaths in clinical trials in India, and then later state that there has been no confirmed link between the deaths and study participation (including the use of the investigational drug). Unless a link is empirically proven, this is guilt by innuendo.

A number of persons provide soundbites about the Indian regulations of clinical trials being violated 'at every level' and on a regular basis. But concrete examples demonstrating grievous and widespread abuse -- or even detail on precisely what guidelines are being violated -- are not really on offer.

On the other hand, the journalists may have unearthed a couple of unethical nuggets. The Gates Foundation permitted local health authorities to empower headmasters to consent for their teenage girl students, i.e. the students were vaccine research participants without their or their parent's knowledge. If true, this is wrong. Since early this year, there have been accusations of 'enrolling' former victims of the Bhopal disaster into clinical trials without their knowledge. Again, if true, this is wrong. The editor of the Indian Journal of Medical Ethics states that he encountered fellow research ethics committee members unfamiliar with the practice of reading the protocol of the study they were reviewing. The practice of researcher/doctors investigating serious (fatal) adverse events in their own studies -- rather than having an independent body do so -- is cause for alarm. The concern about drugs being tested on those least capable of affording them is not new, but is still worth pointing out. And there have been numerous articles about the ethics of the clinical trial culture in India over the past five years: all this accumulative 'noise in the system' may reflect some serious and systematic wrongdoing. But you need verified and detailed facts to make it all stick.

There is an ethical tension in journalism between the pursuit of truth and the marketing of a compelling story. The whole narrative of global health research as a form of neo-colonialism, where the bodies of the poor are used and abused to make medicines for the bodies of the rich ... this story may be too attractive to pass up. The dodgy relationship between big Pharma and developing countries should be continually investigated, but we also need journalists who rake up some real dirt.

A struggle over samples in Taiwan

2011-11-08T22:11:00.003-05:00

Taiwan is experiencing an interesting confrontation about biorepositories. In some cases, it appears that, in the past, biospecimens were obtained and stored for research purposes without gaining consent for their use. In other cases, people consented to have their samples studied for some specific use, but researchers went on to use the samples to explore something else without informing them. Both practices run afoul of a rather conservative law has newly come into force, and that requires written informed consent of all biospecimens. In order to be compliant with the law, researchers must go back and locate the persons whose specimens were collected, and 'reconsent' them in order to use their samples for specific purposes. If they do not or cannot do so, they must destroy the specimens, and here we are talking about millions of specimens. Researchers are understandably concerned about the loss of a valuable scientific resource; advocacy groups are worried about exploitation and violations of human rights, given recent scandals of unconsented use of biological samples from indigenous populations in Taiwan.

Globally, issues about consent and biorepositories are still a work in progress: should there be consent for all specimens, including blood leftover from routine clinical examinations? When there is consent, should it specify certain limited uses of the specimen for research, or leave it unspecific and open to any kind of future research? The Taiwan example shows that the ethical and policy issues are best thought carefully through before biorepositories are created, and not when the horse has already left the stable.

Where the cheap babies are

2011-10-06T00:22:00.007-04:00

The New York Times has an interesting short piece about surrogate mothers in India. Apparently surrogate motherhood is becoming big business over there, big enough for the government to start regulating it. Or apparently, big enough for the government to draft laws to provide some measure of protection for impoverished women who rent out their wombs, but not so much legal protection that the lucrative surrogacy business climate would feel the pinch. The assisted reproductive industry in India brings in some $450 million dollars annually.

It is interesting how proponents of the industry regard the transaction between surrogate mother and clients as a 'win-win' situation. The mother gets money -- more than an annual income -- from the deal, and clinics supporting commercial surrogacy have every good reason to take good care of her, probably much better care than she would receive if she was having a baby of the old-fashioned (non-income generating) kind. But in order to see this as a win-win, there are large chunks of reality you need to forget: the poverty that motivates having a child for someone else (often from abroad) and the lousy standard of health care that typically goes with it.

The transaction is a 'win' that is quite compatible with losing, seeing as someone else gets the baby, and the life circumstances of the surrogate mother are unlikely to change dramatically. And it seems the legislation proposed is not going to help her much if something goes wrong: the law is silent on what happens in the case of miscarriage or other complications, for instance. As it stands, the regulations seem to send the message that everyone other than the surrogate mother -- the private clinic, the local government, the clients -- ought to be the real beneficiaries of this form of global baby trade.

Research ethics committees and the power of complaint

2011-09-17T23:54:00.004-04:00

Research ethics committees have had a bit of a rough summer. The Advanced Notice of Proposed Rulemaking (ANPRM) mentioned below implies that US research ethics committees working with the current version of the Common Rule are somewhat wrongheaded. When you are told that you need 'streamlining' in order to 'increase efficiency', it is hard not to conclude that you are bloated, misguided and ineffectual. It is noteworthy that the ANPRM is the first major revision of an influential research ethic regulation that is driven more by (researcher) criticism than by scandals (involving participants). The recent report by the Presidential Commission for the Study of Bioethical Issues -- centered on abusive US-funded research in Guatemala from 1946-48 -- does not seem to have motivated or made much of a mark on the proposed changes to the Common Rule.

That the ANPRM is complaint-driven, rather than scandal-driven, shows: there seems to be more emphasis overall about making ethical review of research more user-friendly for researchers than enhancing research participant protections. It remains to be seen where this 'deregulation' of ethical review is headed, and whether deregulation in this domain will have more positive effects than deregulation in financial circles.

The complaints and doubts about research ethics committees also seem to be going global. The current issue of the Indian Journal of Medical Ethics is largely devoted to the ethics of research ethics committees. How democratic are they? What gives them legitimacy? How should their roles be defined and their power monitored? These are all valid and fundamental questions. Such committees are hardly beyond criticism. But there should also be skepticism about the skepticism towards research ethics committees, or at least we should not only evaluate the reasons for the criticisms, but also where the criticisms are coming from and where they might be leading us.

Global implications of proposed revisions to the Common Rule

2011-08-10T00:53:00.006-04:00

For decades, criticism have been directed at Institutional Review Boards (IRBs) and the federal regulations they apply for the protection of human participants in scientific research. The procedures are thought to be too cumbersome, too bureaucratic, and too inconsistently applied. Studies that are low-risk are treated almost on a part with those of higher risk by the regulatory system, and in this way attention can get distracted from the main event, i.e. research studies in which participants really could get harmed. The IRBs were seen to be either losing their mission (with procedures that did not seem to help protect research participants) or expanding their mission in illegitimate ways (examining research methodology, tracking down potential conflicts of interest, etc.). Some researchers, of course, mostly railed at IRBs for being too damned slow, and impeding the progress of their (brilliant, earth-shattering) research.

But some of the more serious criticisms must have hit the mark, because the US government's Office of Management and Budget convened a working group to brainstorm revisions to federal regulations ('Common Rule'), and the group drafted an Advance Notice of Proposed Rulemaking (ANPRM) for public comment. The ANPRM appears in dense type for 20 pages in the Federal Register, and contains a daunting 74 questions for comment. For those not yet ready to dive headlong into the regulatory depths, Emanuel and Menikoff have published a useful summary of highlights in the New England Journal of Medicine.

Personally, I was wondering what the impact the proposed new revisions would have on international research. Changing the US Common Rule is no purely domestic matter; much research covered by the US federal regulations takes place abroad, and its provisions influence the regulations of other countries -- in this way the Common Rule has tremendous global reach. On the face of it, the proposed revisions don't have much of an international flavor to them, but I have been reflecting on possible implications.

Changes to annual review. The ANPRM floats the idea that there be no annual ethical review for studies involving minimal risk, unless an ethics reviewer can justify the need for continuing review. One would generally take it on faith that the research is proceeding as planned, with no modifications that could impact on the well-being of research participants. In my experiences in developing world settings, this is already happening in many cases: once a study is approved, it is approved pretty much forever. This is at least partly because continuing review requires infrastructure and monitoring (and file cabinets) that ethics committees in some settings just don't have. So some parts of the world are ahead of the curve on this one. What ANPRM might call streamlining, others might call poverty.

The new category of 'excused' studies. The ANPRM proposes a new category of review: studies that are excused from being reviewed by IRBs. These are studies in which the risks are 'informational', i.e. the risks are mainly from leaked disclosure of information rather than research interventions. Again, research ethics committees in developing countries might be ahead of the game here. The majority of social and behavioral studies have mainly 'informational' risks, and in many resource-poor countries, such studies are not reviewed at all. The whole category of non-biomedical research has been 'excused.' So if the revision goes through, this will be a confirmation of what is already happening, or rather, what is not happening.

Centralizing multi-site studies. Some studies have very many sites, and having the study reviewed by different IRBs at the different sites has often been a nightmarish experience. The ANPRM sensibly proposes that multi-site studies should have one IRB of record. What does this mean for international research? The ANPRM does not propose that a US IRB be the sole IRB of record when research is taking place at a foreign site. Local ethics committee review still makes sense '... because it might be difficult for an IRB in the US to adequately evaluate local conditions in a foreign country that could play an important role in the ethical evaluation of the study.' Why this could not also be true within a country as vast and diverse as the United States is not clear, but at least it means that past efforts to establish ethics committees abroad have not been in vain.

Control of biospecimens. The ANPRM is basically proposing one-time, general and 'open' consent processes in which participants agree to all their samples to be used by researchers in the future (for as yet unknown purposes) without reconsenting them. Here one might have some pushback from developing countries: the ownership of samples is still very much up in the air, and when samples are collected in many developing countries, they tend to end up in refrigerators in Maryland.

There is much more to be thought about -- this is just a first stab of what this wind of change in research protections may be bringing about.

Combatting and creating vaccine distrust

2011-07-27T14:57:00.005-04:00

NPR has an interesting piece on distrust of vaccines this week in developing countries. Apparently there are a growing number of anti-vaccine groups in resource-poor countries, with links to like-minded folks in more affluent nations. This development is alarming and depressing, because suspicions towards effective vaccines are more likely to have negative effects where health indicators are poor, infectious agents are prevalent and health infrastructure is fragile. The risk of negative consequences of a child not being vaccinated depends where the child happens to be; a parent's decision to forgo a child's polio or MMR vaccine is not the same in Baltimore and Lagos. Such parental decisions are less ethically controversial if the parent is working from a reasonable assessment of the risks and benefits of vaccination, rather than distrust based on hearsay, rumors or shoddy science. Researchers at the London School of Tropical Medicine are apparently studying the social determinants of vaccine distrust, and what is even more tricky, developing practical ways to combat distrust when unreasonable. If successful, this sort of applied social science could assist in the prevention of much morbidity and mortality in developing countries. As with other health interventions, it is not enough that a vaccination is efficient, even life-saving: to be integrated into practice, it has to be accepted in the hearts and minds of communities.

The piece includes a quite amazing, related story: that the CIA used a hepatitis vaccination program in Pakistan as a front in an effort to obtain DNA from bin Laden's family. The effort seems to have been double failure: failure to obtain the DNA and failure to vaccinate children sufficiently. It may well have succeeded in undermining the legitimacy of humanitarian organizations in the region, particularly those funded by the US. Is the potential exacerbation of vaccine distrust in developing countries justified by the (eventually successful) goal of assassinating the world's top terrorist?

Update: the New York Times has printed an editorial on the fake vaccination ploy by a former US Ambassador for HIV/AIDS and Assistant Director-General of the WHO on HIV/AIDS, tuberculosis and malaria. And, coincidentally, a piece in on the BBC news website has appeared about the global struggle to prevent and treat hepatitis.

Doing what is right when the result of research is death

2011-06-10T01:34:00.003-04:00

There is something intrinsically sacrificial about participating in biomedical research. Research exposes participants to some risks and often offer little no individual benefits. In some rare and extreme cases, research participants make the ultimate sacrifice: they die as a result of the intervention being tested. When this happens, there is a strong intuition that the participant's family should receive compensation for their loss. The intuition is also embedded in influential ethics guidance that researchers and their funders are supposed to adhere to: those conducting clinical trials are required to have insurance to cover such eventualities.

A column in the Times of India suggests a serious gap between regulations and reality. The records of the Drug Controller General of India (DCGI) indicate that 25 people died in clinical trials as direct result of study participation, but only the five families received any compensation. Of the minority who received compensation, the financial compensation for research-related death was quite low: between 3400 and 6700 US Dollars. The DCGI is apparently ready to take the major pharmaceutical companies on, having organized a meeting on June 6 to discuss lack of adherence to regulations. It will be interesting to see who wins this clash between for-profit and regulatory powers in India, where rapidly increasing numbers of clinical trials are taking place.

Avoiding the missionary position

2011-05-26T23:48:00.004-04:00

An intriguing book has just been published by Oxford University Press, edited by Catherine Myser, and entitled Bioethics around the Globe. The book examines, from loosely anthropological or sociological perspectives, variations in how bioethics is conceived and practiced in different parts of the world, as well as attempts to spread 'Western-style' bioethics globally. In regard to the latter, Raymond de Vries and Leslie Rott have written a provocative essay in which bioethics training programs (in the United States, continental Europe and the UK) are compared with old-style missionary work in developing countries. Either bioethics experts are flown into developing countries to spread the 'good word' of bioethics, or the natives are flown to Western centers of bioethics excellence, where they gather and return home with the 'right' bioethics notions and approaches.

If there was only one true way of doing bioethics, that those in the more affluent countries of the north just happened to latch onto, this would be less problematic. But as the rest of the book makes plain, bioethics wherever it is practiced tends to be heavily flavored by local morality, social conditions, and cultural norms. This means that attempts (however well-intentioned) to transfer Western bioethics into non-Western settings is going to be a bit weird at best, and harmful at worst. De Vries and Rott speak of various ills: blindness of Western bioethicists to the shortcomings of their own culture and to the cultural assumptions embedded in conceptions of informed consent and autonomy; the lack of cultural fit between what budding non-Western bioethicists get taught and what is relevant in their own culture. And what might be seen as relevant may arguably be relevant for the wrong sort of reasons. Learning how to set up an IRB might be interesting for those in the developing world hoping to attract funding and resources from research agencies, but that seems to miss the ethical point about protection of human participants in research. In these post-colonial exchanges, much is lost in translation.

How can the missionary trap be avoided? It is no simple thing. The dominant bioethics culture in the world is Anglophone, European-American, and secular with Christian overtones. Developing countries who want to expand their understanding and skills in this area are confronted with that particular world in the 'classic' texts, the most prestigious programs, and high-impact journals. Those interested in bioethics in the developing world need to be encouraged to (critically) tap into the 'Western' style of bioethics while also (critically) engaging with their own local moral traditions for guidance and inspiration. Only in this way will alternative bioethics traditions emerge. Those -- like the author of this blog -- involved in bioethics capacity-building projects in developing countries may still have a delicate role to play as facilitator or catalyst. In any case, the bioethics missionary has to be phased out, and replaced by those willing to listen as much as lecture.

Globalization of health research: old story, new twists

2011-05-16T18:05:00.003-04:00

When a story comes out called Big Pharma's Global Guinea Pigs, you can be sure of a number of things. There will be talk about the Tuskagee syphilis study, and if the author has been getting out lately, reference to the recent revelations about abusive US-led research in Guatamala during the 1940's. There will be mention of pharmaceutical companies outsourcing their research to cut costs, avoid red tape (read: institutional review boards) and gain access to research participants who are 'drug naive' (read: do not have regular access to adequate health care). The fact that FDA makes overseas site inspections as frequently as solar eclipses is brought in, giving the impression that when trials take place abroad, no one is really at the regulatory wheel. There is a good deal of truth to all of this, and perhaps it needs to be said repeatedly, given the challenges that the 24-hour news cycle poses to human retention. But it does get pretty tedious, so at this point I tend to scan these sorts of texts in search of a new twist.

The new twist in this particular news item is this:

In the United States, the Justice Department has mounted an investigation under the Foreign Corrupt Practices Act to see if drugmakers are offering overseas bribes, and clinical trials are firmly in the spotlight. That's because doctors in many countries are government employees and therefore any payments to them deemed above fair market value might be viewed as bribes. Britain, too, is introducing a strict new Bribery Act in July that also covers such overseas payments.

This is new, because most news items about global health research are focused on the possibility of research participants being exploited. Here, it is about alleged harm caused to medical institutions and patients by paying health care workers too much. Because just paying persons too much is not in itself a bribe: it is a bribe when the person starts bending rules for money, like a policeman on the take. And the rules being bent might come down to harm to research participants in the end, such as when overseas physicians in the pocket of Big Pharma 'massage' inclusion criteria for studies in order to satisfy the need for large sample sizes. As the global health research market grows, gets more diverse and complex, and the usual suspects get increasingly aware of the usual criticisms, the emergent ethical problems appear as new wrinkles in the old story.

The globalization of research ethics committees: paternalism, ethical imperialism or partnership

2011-04-16T00:26:00.004-04:00

Research, the story goes, has become increasing global: there is more clinical and behavioral research involving human participants in more places in the world now than ever before in human history. These things don't just happen, so it is interesting to reflect on the meaning of the march of research to all points of the compass. Is it because there is an overwhelming humanitarian concern about those who are sick in the most impoverished areas of the world? Or is it because far-flung (at least, from North America and Europe) countries are a friendly business environment as health-related research becomes more and more about developing profitable interventions and devices?

As research projects and institutions are rapidly springing up around the world like mushrooms, the development of ethics committees to review such research globally is moving at a much more leisurely pace. In many places in Africa, for instance, there is no local body with the authority or expertise to conduct an adequate ethical review of a scientific protocol. In this month's issue of Tropical Medicine and International Health (subscribers only, alas) Ravinetto et. al. argue that there always ought to be a double ethics review of research conducted/sponsored by foreign institutions in developing countries. The requirement for 'local' review -- in addition to review in the sponsor's institution -- appears in some ethics guidelines, and it does happen a good percentage of the time. But why ought it to happen? According to Ravinetto et. al., it ought to happen in order to produce a more comprehensive and balanced review process, which in turn better fulfills the central mission of ethics committees, i.e. to protect research participants and benefit communities affected by the research. A collaborative double review can avoid ethical imperialism (imposition of ethical standards of the richer countries on the poorer ones) and paternalism (in the assumption that only ethics committees in richer countries can really review research adequately). The current problem with double review (according to Ravinetto et. al.) is not just the unpleasant fact that some ethics committees in developing countries may be operating at a low standard. The problem is that ethics committees involved in the review of research often do not correspond with one another at all, and the possible benefits of collaboration are missed.

The points are well taken, but the paper seems to underrepresent some of the ethical challenges of ethical review in a context of global inequality. It should be remembered, for example, that sponsoring countries hold the purse-strings, including the portion of the budget that is supposed to go to the local institutions for administrative support (including financial support for the local ethics committee). When there are conflicts between foreign and local ethics committees, which one is more likely to have the greatest say? The ethical playing field, parallel to the political and socio-economic playing fields, is very uneven. What might help, besides greater collaboration between ethics committees, is greater investment in local scientific institutions in order to prevent the vast majority of research being funded and conducted by developed world institutions.

The unbearable fragility of HIV treatment access

2011-04-09T22:14:00.004-04:00

It has taken a tremendous effort, over the course of many years, to give HIV-positive persons in sub-Saharan Africa access to antiretroviral treatment. On the World Health Organization's latest reckoning, over five million persons are now on treatment worldwide. However, the success is partial: another ten million persons in need of treatment currently do not receive it, and the pool of those who will need treatment in the future is expanding furiously -- over 7000 new HIV infections take place globally every day.

Even the partial success in access to treatment is very, very fragile. The global HIV treatment initiatives are generally bankrolled by the developed world's financial heavyweights who (after debilitating their own economies) are calling for austerity and belt-tightening, and programs supporting the lives of distant others are looking vulnerable.

But the challenges to maintaining and expanding HIV treatment programs apparently come from all angles. AllAfrica, that great warehouse of online African news, gives two recent examples. Kenya has been hit by a rise in food prices and a drought. Nearly two and a half million Kenyans are regarded as food-insecure, as prices have risen 15 percent; herders are losing their livestock in the dry north-east of the country, and some are fleeing to Uganda. For those who are food-insecure, HIV-positive and in need of antiretroviral treatment, the situation is grim: even for those who can access treatment, the pills are very hard to tolerate (and less effective) on an empty stomach. Some people would rather go off treatment than deal with the side-effects, though this could lead to resistant strains of HIV; others are reluctant to start treatment, which is likely to lead to poor clinical outcomes. In Tanzania, another twist: a sizable patients taking antiretroviral treatment may fail to adhere to treatment in their quest for the latest miraculous herbal cure. A former Lutheran pastor in the village of Loliondo has concocted something which has stirred a great deal of excitement, as would any substance promising to cure diabetes, tuberculosis and HIV. The ingredients are unknown, but the Tanzanian Drugs and Food Authority, the National Institute for Medical Research and the Muhimbili National Hospital endorse the herb as fit for human consumption. But there is no proof of its efficacy. No matter: people with HIV are flocking there by the thousands, some persons literally dying to get there. The Tanzanian authorities are struggling to convince people to continue taking their drugs, and not succumb to the siren song of an HIV/AIDS cure. (It is always more pleasant to imagine an indigenous cure than deal with the reality of depending on products of foreign multinational pharmaceutical companies.) With all these pressures -- economic crises, natural disasters, rising new infections, strange cultural manifestations -- is it reasonable to expect the pool of those accessing HIV treatment to continue to expand? What is the plan B if the bubble bursts?

New report on a forgotten non-pandemic

2011-03-13T19:26:00.007-04:00

There are certain things we know about the avian flu scare back in 2009. First, that the initial fears, amplified tremendously by the media, culminated in a non-pandemic. When the World Health Organization (WHO) announced that H1N1 was no longer a global health threat, the news appeared somewhere deep in the back pages of newspapers. Second, pharmaceutical companies made a massive amount of money by producing and distributing Tamiflu in vast quantities. Third, critics suspected the World Health Organization of being in the pockets of pharmaceutical interests by whipping up fears of mass infection and death on the one hand, and fully integrating private for-profit companies into the global response on the other. The fact that advisors to WHO's Emergency Committee had undeclared potential conflicts of interest with pharmaceutical firms did not help matters.

Last year, an International Health Regulations (IHR) Review Committee was convened, consisting of an independent panel of 25 experts, to examine the WHO's response to the avian flu threat. The draft report is now available online, and it seems somewhat unsatisfying to conspiracy theorists and defenders of the WHO alike. The Committee contends that while the WHO could have done a better job in managing apparent conflicts of interest among its advisors, there is no evidence that the advisors' judgments were adversely influenced by their drug company connections (though one wonders what would count as evidence). There is also no hard evidence that the WHO 'sexed up' the data on avian flu in order to make the epidemic appear more threatening; there was no way of knowing at the beginning that the rate of new infections would fizzle out rather than explode. The report is less about ethically criticizing the relationship between the WHO and big pharma, and more about practicalities of improving global pandemic response in the future. The avian flu scare exposed serious weaknesses in systems of global pandemic control. In other words, the IHR report seems to mimic the pattern of the 2009 avian flu scare: the prospect looks urgent and compelling at first, but on closer inspection, there seems to be less to meet the eye, at least from an ethical perspective.

The President's Commission ponders global safeguards in research

2011-03-07T22:18:00.007-05:00

An article by Mike Stobbe on global research ethics is doing the rounds: my Google Alert has been sending me its many incarnations, as the piece seems to have been sold and resold to various news outlets. Titles vary from 'Ugly US medical experiments uncovered' to 'Shameful past of medical trials prompts new US investigations' and all sorts of other permutations. The first line of the article, though, is not promising:

Shocking as it may seem, US government doctors once thought it was fine to experiment on disabled people and prison inmates.

It should not be too shocking, because the National Institutes of Health sponsor and conduct research studies involving the disabled and prisoners right now. It was not just the populations that were the problem with those experiments, of course. It were the procedures, and more specifically, studies in the past that involved deliberate infection of healthy (but vulnerable) persons. Stobbe has himself sniffed around in the archives to find some more skeletons in the US research closet, and adds them to the scandals we already know: Tuskegee, Willowbrook, the Jewish Chronic Disease Hospital, the AZT trials, the Trovan study. He leavens his account with an indication of how health research has gone global: drug studies, once almost exclusively conducted in the US on prison populations, has been redirected to developing countries in order to evade stricter regulations at home and to hold down study costs.

This potted history is a lead-in to last week's meeting of the Presidential Commission for the Study of Bioethics Issues. The Commission devoted an afternoon to comments and discussion about global health research ethics, Commission having been given two tasks by President Obama: to investigate dubious US government funded studies in Guatemala in the 1940's, and to see what system of protections and safeguards exist to ensure that similarly abusive research does not happen. This is an enormous task, and the Commission has little time to complete its mission. They did invite an amazing array of experts for the session on March 1st that is well worth watching. What struck me, however, was the public comment session: a fair number of people stood up to give personal testimony of how they were subjected to secret government experiments, involving electroshock treatments, mind control, torture and so on, followed by way too much information about physical and psychological symptoms. Either mentally unbalanced persons are drawn to commissions about abusive research like moths to a flame, or there is much more abusive research taking place in the United States than we know about.

UPDATE (March 10th): I was amazed by the testimonies during the public comment session of the Presidential Commission. Those over at Are You Targetted? are not amazed at all by the content of the testimonies, where citizens claimed to be victims of abusive and covert state-sponsored research, but are amazed by the fact that the news outlets did not seem to cover this part of the proceedings at all. It is strange that the high drama and vividness of these testimonies was not considered newsworthy.

Pneumoccal vaccine in Africa: one step forward, one step back?

2011-03-04T23:20:00.003-05:00

It is pretty well known that many routine medical interventions in the world's more affluent countries make infrequent appearances -- or sometimes none at all -- in the world's poorer ones. The publicly-financed health care systems in some sub-Saharan Africa look to be decades behind the United States, Canada or the United Kingdom when it comes to devices, drugs and procedures. For that reason, initiatives that seek to close the gap are, in principle, to be welcomed. Oftentimes, however, these initiatives are accompanied by moral baggage.

Take for instance the launch of a new pneumoccal vaccine among children in Africa. Considering the number of childhood deaths attributable to pneumonia in this part of the world, the effort has an initial air of nobility. Many lives will be saved, many illnesses avoided. But if one looks more closely, serious ethical problems seem to emerge. There are two multinational pharmaceutical companies involved in the campaign -- GlaxoSmithKline and Pfizer/Wyeth -- who have agreed to sell 30 million doses every year for ten years at $10.30 per child vaccinated. These companies also stand to each gain $225 million in subsidies through their involvement in this scheme. Doctors Without Borders worries that this price for vaccination is very high for many countries, and that the lock on the market exercised by GSK and Pfizer/Wyeth will strongly discourage local companies from developing cheaper generic equivalents. The companies are establishing their brand under favorable circumstances to themselves; after that, all bets are off.

Some people argue that pharmaceutical companies should be given incentives to focus greater attention on developing countries, otherwise they will simply develop whatever is likely to sell to richer consumers elsewhere. But the pneumoccal vaccine example can make you think twice about the wisdom of 'incentivizing'. In the short term, many children will be vaccinated. But in the long term, unless prices are made to go down, children of wealthy elites within developed countries are most likely to benefit. The usual pattern threatens to repeat itself: big business wins, the higher classes win, and the rest struggle on.

A novel approach to fighting HIV infection among drug addicts: acceptance

2011-02-07T22:54:00.008-05:00

The New York Times has an interesting article this week on HIV and drug addiction. As has been known since early in the epidemic, intravenous drug use is a pretty efficient way of transmitting HIV. Addiction also leads to behaviors -- like trading sex for money and drugs -- that further multiplies risk. For those working in public health, intravenous drug users are a challenge; they are often called a 'hard to reach community' for good reason, because what they do is illegal, and they have to duck and cover for fear of being turned into the authorities. The group is also deeply stigmatized by the wider community: as trash, car crashes, disease-vectors, worst case scenarios. Those in bioethics who talk about protection of the vulnerable are usually not thinking about drug users: the preferred vulnerable are typically the non-addicted poor, the non-addled disabled, or innocent children and fetuses. (Bioethicists steer clear of that part of town, mentally as well as physically.) There is always the spoken or unspoken accusation of addicts being responsible for their predicament, and there is no way around it: a lot of drug addicts are in rough shape and live in rough circumstances. Some of the photos accompanying the New York Times piece are cringe-evoking, and leave no room for romanticizing drug use.

That should not take away from the point of the article, however. St. Paul's Hospital in Vancouver has set up Insite, a place downtown where injection drug users can get clean needles, and get tested and treated for HIV. A package of medical services is offered by staff nurses: basic care for needle infections, gynecological exams and tests for sexually transmitted diseases, and referrals for drug treatment. The strategy of aggressively testing for and treating HIV seems to be working: HIV incidence in Vancouver has apparently fallen by half. Up to now, Insite has managed to get an exemption from Canada's narcotic laws, so drug users can shoot up inside the premises without the risk of being arrested or robbed, and stand less chance of dying of an overdose.

The program is unusual in its acceptance of the grim reality of addiction. Most often, public health approaches with this community are strongly mediated (or hampered) by common sense morality, the law, and politics. For example, a number of studies worldwide have shown that clean needle exchange programs can play an important role in lowering HIV transmission, but such programs run headlong into stigmatizing attitudes about addicts and have only rarely been fully embraced. The Insite initiative gives a glimpse of what public health interventions with this population could be like when they are provided with funding, legal immunity, and minimal political pushback and moralizing. It looks like such programs could do some good on individual and population levels. While this approach might catch on, at least in Canada, other affluent countries (like the United States) are far away from having the social and political conditions to emulate this model, and others in developing countries are even further still.

On flogging concepts that refuse to die

2011-01-27T15:29:00.006-05:00

Cultural reproduction is a strange thing. It is normal and often desirable to transfer cultural artifacts to future generations. We want to instill certain values in own children. We want to ensure that our mother tongue survives and retains its integrity. We want to keep scientific progress going, and we want to perpetuate valuable institutions like the law and modern medicine. There is much good in this. However, it is easy to get the mistaken impression that cultural reproduction is under our control. Culture also has a life and momentum of its own, and some aspects are reproduced even if we think they have worn out their welcome. Racism, homophobia and sexism live on, and a whole host of other dubious inheritances besides. And efforts to discredit these inheritances from a rational point of view seem to have less effect than we sometimes suppose. An artifact can exist, even thrive, despite being pretty much debunked.

These were my reflections while reading a recent article in the journal Bioethics by Heather Widdows, entitled "Localized Past, Globalized Future: Towards an Effective Bioethical Framework Using Examples from Population Genetics and Medical Tourism." Widdows takes dead aim at the concept of individual autonomy, claiming that (a) the individual autonomy is conceived as a crucial or foundational value in bioethics and (b) the concept is inadequate to make sense of (or help resolve) bioethics issues. It is like turning up to a gunfight with a plastic spoon. She uses the issues of population genetics and medical tourism to make her point, but the point has far wider applicability. The thing is, though, this has all been said before, in a variety of ways: it would not be hard to draw up a long list of bioethics articles devoted to debunking the oversold status of individual autonomy.

I am not criticizing Widdows for flogging a dead horse. Yes, debunking autonomy is practically a cottage industry, but I am guilty of contributing to it as well. What I am saying is that the horse has been flogged for ages, it is still not dead, and the current zombie-like state of the concept requires an explanation. Why is it, say, that people still find it attractive to say that organ trade between the rich and the poor could be reasonably conceived as a fair and unproblematic trade if conducted between consenting adults? Or that exploitation in international health research is morally acceptable if the 'exploited' party in the transaction adequately consented and might be worse off if he or she did not join a certain study? When a notion seems to be debunked but somehow survives, it is tempting to look past its content and look at the social function it may continue to serve. What does the use of the concept of autonomy 'do' for (some) people when deployed in bioethics arguments? Who gains and who loses when these issues are viewed and defended within frameworks that see individual choice as paramount?

Shocking discovery: poverty messes up your head

2011-01-23T00:01:00.003-05:00

According to legend (and it's only a legend), the novelists F. Scott Fitzgerald and Ernest Hemingway were in a bar when the former remarked to the latter: "The rich are different from you and me." To which Hemingway dryly answered: "Yes, they have more money." It is safe to say that the poor have less money, by definition, but the way it makes a difference ... er, differs. According to researchers at the University of Texas at Austin, relatively impoverished socio-economic circumstances have a negative effect on the rate at which small children start to realize their genetic potential, as this is manifest in their cognitive development. The environment created by wealth unlocks the genetic contribution to mental capacities; poverty seems to suppress it. As the news items about the study are quick to point out, one in five children in the US lives in poverty, and the country is undergoing a massive economic crisis.

It might be better to pull out a few other wider implications of the research, even if it is only one study. The study is basically saying that poverty strikes human beings at their core: if your mind is not at your core, it is hard to say what is. Poverty appears to literally incapacitate, making us relatively less capable of developing the features that make us persons; the idea that poverty dehumanizes us seems as frightening as the disintegration of personhood involved in late-stage Alzheimer's disease. The problem is, while one in five American children lives in poverty (and this is troubling), the poverty of the majority of children in many countries is far worse. Except for a lucky few, their genetic inheritance gets pretty much laid to waste. How much it is laid to waste has yet to be fully studied. But if the study in Texas is any indication, the impact starts much earlier than previously thought.

Global health research ethics in Vanity Fair

2011-01-12T00:10:00.006-05:00

Vanity Fair, normally associated with glossy celebrity photo shoots next to swimming pools, is running something this month on ethics and the globalization of clinical trials. It really is. The basic thrust of the dramatically entitled article ('Deadly Medicine') is that pharmaceutical companies are guilty of a whole range of shady practices, from suppression of negative testing results to knowingly promoting products with serious side-effects or unknown efficacy, and there is little effective regulation to prevent or punish their irregularities and abuses. Furthermore, when pharmaceutical research takes place abroad in low- and middle- income countries, as it increasely does to cut costs, what goes on becomes even more obscure; when particular wrongdoings emerge from the global shadows, you can only guess how much exploitation, manipulation and harm is taking place on a regular basis.

What struck me reading the Vanity Fair article was a strong sense of deja vu. How essentially different is its content from those seminal Washington Post articles, the 'Body Hunters' series, written back a decade ago? Those were the exposes that blew the lid on the practices of global pharma and kick-started all manners of initiatives to raise consciousness about the ethics of global health research. So what happened in the meantime? A lot of activity in the public sector: the NIH consolidated its clinical ethics center, other bioethics centers popped up at universities around the country, new ethics journals were established, research ethics committees were established in developing countries, grants for research ethics projects were established, and so on. And yet, what did all this do in regard to the practices of for-profit multinational pharmaceutical companies as they scour the world for sites and populations favorable to their own economic interests? Did all this have any sort of impact?

From the looks of the Vanity Fair article, not much. The same sorts of 'irregularities' go on; what has changed through globalization is the quantity of institutions, investigators and researchers involved. Paradoxically, the bigger global health research becomes, the less visible its operations and effects seem to get.

The God Committee, Africa-style

2011-01-02T22:50:00.004-05:00

Who knows when bioethics started? Like other annoying questions (When did philosophy start? When did romantic love start? When did rock and roll start?) there is probably no way to definitively answer it, but that does not stop people from trying. For some, bioethics started in the United States with the so-called 'Seattle God committee', the body of health care professionals and laypersons that was formed to decide who among patients with kidney failure should receive (then new, and very scarce) dialysis treatment. The situation in Seattle seemed to open a new field of inquiry: while the question 'who should get dialysis?' was partly a medical question, it went beyond that. It was not enough for doctors to invoke medical criteria alone, since many patients were medically needy -- the fundamental question was how to choose among them, if there are not enough machines for everyone. If not using medical criteria, what other criteria should be used, and how should we best come to reach such decisions? And so, the story goes, the idea was born of non-physicians assisting in resolving ethical problems within medicine.

This is an old tale. To read about it, you have to go back to a yellowed Life Magazine article from 1962. I was reminded of this piece of history when reading a recent article in BBC news about the rationing of dialysis machines in South Africa. It is striking that Tygerberg Hospital in Cape Town is wrestling with the same problems faced fifty years ago in Seattle, and from the reports, is not fairing much better. More specifically: just as the 'God committee' brought in controversial subjective criteria to decide who should gain access to dialysis, the committee in Tygerberg apparently cannot avoid doing the same. Part of the criteria are having 'good home circumstances' (i.e. running water, electricity, toilet, etc.), the motivation of the patient to adhere to the treatment plan and improve his/her health, and having a good social support network. It is fairly obvious that this criteria does not favor the poor. All other things being equal among needy dialysis patients, those who are better off socially and economically are more likely to gain access to dialysis. One could argue that these non-medical criteria have a medical justification: if a patient does not have good social circumstances, dialysis will not produce a favorable outcome for that patient. Probably. But the upshot is brutal. If you are really poor in Africa, and suffer from renal failure, you are seriously screwed.

In the United States, the federal government in 1972 made the unprecedented decision to extend Medicare provisions to enable the vast majority of patients with chronic renal failure to gain access to dialysis. Basically, faced with a very public rationing problem, they threw money at it. This is not an option in Africa. As chronic diseases become more and more prevalent in the region -- certainly more prevalent than new clinics, new technology and new medical professionals -- there are going to be a lot more stories like this.

Wikileaks, Nigeria and Pfizer

2010-12-11T23:00:00.006-05:00

Wikileaks and its founder, Julian Assange, have been all over the news since the release of previously confidential US embassy cables. Media pundits and academics have been debating whether the actions of Wikileaks are an expression of freedom of information, and therefore ethically justified, or could be dangerously destabilizing to international politics, and are therefore unjustified (and perhaps criminal). It is interesting that the news focus has been largely on information leaked about individual political personalities, rather than other items of potentially greater interest.

For example: one of the cables, dated April 20th 2009, contains the following interesting tidbit. According to Enrico Liggeri, Country Manager for Pfizer, his pharmaceutical company was not happy about the prospect of defending itself in Nigeria's federal court in relation to the infamous Trovan study. Pfizer had already agreed to pay out a settlement of $75 million to the state of Kano in relation to the case. In an attempt to squash federal lawsuits, Pfizer (according to Liggeri) hired investigators to uncover corruption links to the Nigerian Federal Attorney Michael Aondoakaa. The strategy apparently was: gather dirt on Aondoakaa, pass this on to local newspapers, and then have Aondoakaa's cronies put pressure on him to stop the lawsuit in order to stifle the negative press. Those negative items did go into the Nigerian press, and soon enough Aondoakaa found himself suddenly and inexplicably demoted.

Liggeri goes on to say that it is imperative for Pfizer to control the fallout from the Trovan study and clean up its public image, because Nigeria is considered to be a major growth market for Pfizer's products. In the cable, Liggeri also expresses concerns about how to pay out the $75 million to the state of Kano: Nigerian representatives want the money in the form of lump sum checks, and Pfizer is worried about 'potential transparency issues.' In other words: that might be unethical. It is hard not to laugh.

Now that the cable is out, Pfizer denies its content. It released a statement last Thursday that said: "Although Pfizer has not seen any documents from the US Embassy in Nigeria regarding the federal government cases, any notion that the Company hired investigators in connection to the former Attorney is preposterous." To translate into plain English: we haven't looked into the facts, but they can't be true.

Perhaps this is why the latest round of leaked diplomatic cables is creating a bigger stink than the earlier ones about Iraq: these ones also contain information about how business corporations actually operate, and how governments, despite having intimate knowledge of their darker activities, does nothing or provides cover. Say what you will, but ordinary news agencies (themselves often beholden to corporate entities) do not get this sort of information out.

Ambiguous bioethics messages from high places

2010-11-29T22:06:00.006-05:00

The two of the biggest bioethics news items in the media this past week have formal similarities: they first raise interest, and end in puzzlement. First, the words of the Pope. The Catholic church, as is well known, is against the use of contraception, because it is said to sever the natural connection between sexuality and procreation. However, condoms -- when used and used properly -- are very effective at preventing the spread of HIV infection. This is why the Church's principled prohibition against condoms looks sinister in the context of the HIV/AIDS epidemic. It makes the Church look indifferent to (if not complicit in) the spread of HIV infection and the sickness, suffering and death that often accompanies it. Last week, the Pope floated a few ideas around that suggested that the use of condoms could be morally permissible in exceptional circumstances. And his example of such an exceptional circumstance was quite striking:

There may be a basis in the case of some individuals, as perhaps when a male prostitute uses a condom, where this can be a first step in the direction of a moralization, a first assumption of responsibility, on the way toward recovering an awareness that not everything is allowed and that one cannot do whatever one wants.

If the male prostitute is a gay sex worker, then the condom is not being used anti-procreatively, for obvious reasons. Hence, male prostitute condom use is not against Church doctrine -- not that this particular topic has been a rich source of doctrinal debate, to my knowledge. So the exception is not particularly helpful for regions like, say, sub-Saharan Africa, where male prostitutes are not the drivers of the HIV epidemic, God-fearing (and often married) heterosexuals are. And here is where it gets murkier: a Vatican spokesman claimed that the Pope was not talking about the use of condoms among male sex workers alone, but also with any "man, woman or transexual." (Gay sex workers and transexuals: since when did the Vatican get so racy?) The use of condoms could be regarded as a moral act if the intention is to prevent grave risk happening to another person. But is the spokesman really speaking for the Pope? Why were the Pope's comments part of some obscure interview? Is the Pope seriously considering a U-turn on condoms, or just floating something out there, testing the conservative waters?

The secular state has its own ways of being obscure. President Obama ordered a review of the ethics of research sponsored by the US government involving human participants. According to the press release, the review was provoked by the recent revelations that the US government funded and helped to conduct dubious syphilis research in Guatemala in the 1940's. The new (and newly renamed) Presidential Commission for the Study of Bioethics Issues is to lead the review. But, on reflection, this does not make much sense. The scandal in Guatemala happened sixty years ago. In the meantime, we had the infamous Tuskegee syphilis studies, the Belmont Report, the creation of the Common Rule, the proliferation of IRBs, the rise of bioethics centers, programs and scholarly journals, and much more besides. Why would an event which pre-dated all this trigger a review of all this? The only reason I can see is ... that there must have been calls to review the system of ethics protections already, and the news of the Guatemala scandal came at an opportune time for reformers. What sort of reforms are being contemplated, what is really driving the changes, and who is leading the charge? For the moment, the answers are shrouded in mystery, and the huddled masses have no way of telling.

The tobacco wars go global

2010-11-15T22:18:00.004-05:00

Smoking isn't good for you. Of course, there are a lot of things that aren't good for you, but we are starting to get more and more data about what habitual smoking does to the human body, both to the user and to bystanders, and it is not at all pretty. Although there are strong ethical arguments against the practice (including its contribution to health care costs for smokers and non-smokers alike), smoking would be impractical to outlaw outright. In developed countries, smoking is increasingly frowned upon socially and curtailed legally: it is getting more and more difficult to smoke in public space, smokers are regarded insurance risks, direct tobacco advertising pretty much a thing of the past, and only last week tobacco companies were required by the US Food and Drug Administration to put rather graphic warning labels on their cigarette packs. Not exactly a friendly business climate for marketing and sales.

Which is why developing countries have become so attractive for multinational cigarette companies over the last decade. The regulations -- for instance on tobacco advertising -- in some developing countries are less restrictive than those in the United States or Europe, and so companies search the world for regions marked by weak legislation and a strong consumer base, such as Indonesia. In this struggle between global big tobacco and global health agencies, the gloves are apparently off. Philip Morris has sued the country of Uruguay for loss of profits due to 'excessively restrictive' advertising policies. The World Health Organization, for its part, is advocating for stronger tobacco policies and laws globally, and encouraging individuals and governments to sue tobacco companies for harms to health. The WHO has even chosen to sponsor a summit in Uruguay this week, attended by representatives of over 170 nations, to analyze and support policies that reduce the prevalence of smoking on this planet.

The struggle against smoking that started in the United States and Europe is now to be played out around the globe, on very many fronts. A complicating factor in the debate is that tobacco is also grown in some developing countries (such as Malawi), and curtailing tobacco sales could in the short term have a negative impact (health and otherwise) on poor tobacco farmers, pickers and processors. These considerations are not without merit, but they are ultimately outweighed by the damage (long and short term) smoking causes, particularly in developing countries that do not have the health care systems to adequately cope with the effects tobacco has on its users.

The ethics of global trade in human flesh and bone

2010-11-02T19:00:00.004-04:00

The Bulletin of the World Health Organization has an interesting article out in its November issue, entitled 'Human cells and tissues: the need for a global ethical framework.' The authors describe the technological advances and growing interest in the field of tissue transplantation, and predictably, the rise of private, profit-seeking companies engaged in the procurement, processing and sales of human tissues. The biggest tissue corporations with the most aggressive and questionable practices, from the looks of the article, appear to be American. Medical and public health uses are only one possibility among others. Private companies have an obvious bottom-line interest in trading tissues for expensive cosmetic purposes such as penis widening or lip enhancement, if not more mundane uses, such as those we normally associate with the flesh of horses or fish: paste, glue, powder and suspensions. As far as current practices of informed consent go, those who donate or trade tissue on behalf of family members may or may not know where the tissue ends up, with the unfortunate possibility that your skin from your Granny's forearm unknowingly ends up on some stranger's foreskin. In addition,

there is the usual ethical concern about flesh and bones from the poor being harvested for the bodies of the rich, similar to concerns about the organ trade, only here there are more body parts in stock: heart values, corneas, patellas, powdered bone, hip sockets, you name it.

The authors call for regulation of the global trade in human tissues through the development of a binding ethical framework from the World Health Organization. However, it is clear that their proposal would be labelled 'socialist' by corporate interests in the United States, seeing as the authors call for 'reasonable profits' to be channelled into improvements in quality, safety, accessibility and R&D, and they insist that the ethical framework should 'prohibit financial gain on the human body and its parts.' If formulated this way, the framework would join the list of international guidelines that the United States would not sign onto. Which might not be so bad, if the US was not already such a dominant player in the human flesh and bone market.

Scale up and follow up: the struggle to stay on AIDS treatment in Africa

2010-10-27T21:42:00.005-04:00

Not so long ago, the number of HIV-positive persons in Africa who had access to antiretroviral drugs was painfully low. Through important initiatives such as the US President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis and Malaria, millions have been put on AIDS treatment in the past few years. Available graphs on treatment access show a healthy upward trajectory, flatter in some parts of the developing world, and steeper in others, but nevertheless going up. And up is good.

A recent report in the New York Times shows another side of the story. Getting people started on antiretroviral drugs is one thing, keeping them on the treatment is another. HIV treatment, as it currently stands, is lifelong. Once you start, there is no stopping: or rather, there is stopping, but with disasterous consequences for the health of individuals and potentially for the community (if expensive to treat resistant strains of HIV thereby emerge). But keeping people -- increasingly vast numbers of them -- from defaulting on their treatment is a tremendous challenge with many obstacles. It is hard to know how many are 'lost to follow up', but if it is as the report states (between 15-40%), then we are talking about millions.

The agencies that are to be praised for efforts to increase treatment access may also shoulder some of the blame for the current situation. For years, 'numbers of persons on treatment' were the stuff of progress reports, the ultimate marker of program success, and where efforts and funding were to be largely concentrated. The focus was not on keeping people on their treatment regimes. If hell is not to be paved with good intentions, attention is going to have to subtly shift, the causes of loss to follow-up will have to be thoroughly explored, and support will have to provide to those tracing treatment defaulters and coaxing them to take their drugs.

Final day, ASBH conference

2010-10-25T22:21:00.003-04:00

A thick mist hangs over the buildings and it is lightly drizzling. San Diego, since the beginning of the conference on Friday, has been doing a pretty good imitation of Belgium. Today is only a half-day, and a good number of conference attendees come with their carry-on bags, enabling them to bolt towards the taxi stand at a moment's notice. They have already entered into liminal space, neither here nor there.

One of the early morning sessions is rather bruising, though the topic lent itself to this: whistleblowing in bioethics, what to do when we discover unethical practices. Carl Elliott spoke about the suicide in 2004 of 26-year old Dan Markingson, who was enrolled in a University of Minnesota led, industry-funded, clinical trial of the antipsychotic drug Seroquel. The tale he told appears in the September issue of Mother Jones, and the case reveals not just faulty informed consent but a broader, systematic rot: clinical trials are increasingly becoming a plaything for pharmaceutical companies, which function not so much science as marketing tools, where the data gets massaged and researchers are lining their pockets. The participants get the short end of the stick, and when things go south, the pharmaceutical companies call their legal department and limit whatever recourse wronged participants or their family members may have. The IRBs stand idly by, either unwilling or powerless to intervene, despite their central mission. A compelling tale, but I almost needed anti-depressants myself afterwards. Alice Dreger and Ellen Feder discussed two controversial research studies they have brought to public attention lately: clitoroplasty studies and the experimental (but not IRB approved) use of dexamethasone, a risky Class C steroid aimed at female fetuses that may have a form of congenital adrenal hyperplasia (CAH). It got heated: an audience member accused Dreger of presenting falsehoods, which she denied, and Dreger accused the audience member of bullying those who criticized the dexamethasone studies, which he denied. Those (like me) who had no independent information may have felt that they were witnessing an obscure family dispute. The whole session reminded me: despite appearances sometimes, bioethics questions are not merely 'academic'. When there is a real conflict, it is a political conflict, with money and reputations and well-being at stake.

Ethics consultation services. If there is one area in bioethics that stands a chance of being professionalized, this is it. At this conference, I got the impression that no one wanted to enter into the old fashioned (philosophical) discussions about the possibility and meaning of 'ethical expertise'. We have moved on, apparently, and now the question is how to best operationalize the expertise we possess. In an affinity meeting on Saturday, there was much talk (but little discussion) about a proposal to develop certification procedures for clinical ethics consultants. What is needed, it was said, was non-negotiable standards for clinical ethics consultation, have current practitioners take some sort of examination, and get officially certified in a way that will (it is hoped) enhance their professional status and authority. How this is to be funded, and how to make medical institutions care about this, was unclear. The value of research ethics consultation, independent of sticky certification questions, was made clear in the last session on Sunday. Members of the NIH's research ethics consultation service provided a peek at their internal activities, challenges and lessons learned. From the looks of it, the decisions made were very likely more sensitive and better informed than they would have been otherwise, and that is probably all you can really ask for.

A four-beer lunch with the delightful Marin Gillis (fellow graduate from the University of Leuven, and currently at the University of Nevada), and I headed towards the hotel, towards the laptop, and home.

ASBH, Day Two

2010-10-24T19:48:00.010-04:00

How long it takes me to get to the conference hotel in the morning amazes me. It is not the distance: a short way through the Gaslamp Quarter, and I am there. It is not the time spent on the treadmill up in the Indigo Hotel fitness center, overlooking the early morning mist from the ninth floor. Whatever it is, I get to the Hilton Bayshore just as breakfast is wrapping up, and bury a couple of greasy french toasts and two cups of black coffee before the plenary starts. In a mood of haste and impatience.

The plenary was on creative engagement with persons suffering from Alzheimer's. Not something I had thought about before, but it makes perfect sense. Everyone knows the horror stories of older men and women being plunked down all day in front of television sets, and much worse forms of neglect or abuse. So engaging Alzheimer's patients in theatre, painting, songwriting and dance is in stark contrast with other tendencies in Alzheimer care, including early diagnosis and initiation for medication: with the old in general becoming a rapidly growing target market for the pharmaceutical industry, medicalizing approaches tend to predominate. A strength of the presentation was reference to empirical research indicating positive outcomes in 'non-medical' or cultural approaches, and a highlight was the speaker's call for pharmaceutical companies to devote 1% of their operating budgets to programs enhancing a 'sense of purpose' among Alzheimer's patients. Wishful thinking, but a nice thought.

Highlight of the day: a piece of good old fashioned philosophy. In a session on cognitive enhancement, we had two presentations of surveys conducted on attitudes of various populations towards cognitive enhancement, particularly medications for school performance. They were solid presentations, revealing the predictable, i.e. we are in two minds about using drugs to stimulate our minds. This was followed by a talk like a gust of fresh San Diego sea air: Tom Buller from the University of Alaska started asking some fundamental questions about the very idea of cognitive enhancement. Can we make people smarter with 'smart drugs' anyway? Improved memory and concentration is not equivalent to improved intellect. Even if drugs (somehow) improved intellect or knowledge, how valuable is that? Would it make us better people or better societies? Is there such thing possible as moral enhancement through medications? Muller offered skepticism of the best sort: patient, rational questioning of (inflated) claims about what enhancement is supposed to do for us or to us.

A panel discussion about ethics and quality improvement (QI) studies does not sound particularly riveting, but Saturday's session proved otherwise. Quality improvement studies, because they are so closely entangled with ordinary health care delivery, can pose problems for IRBs because it is not always clear whether they fit the definition of 'research' according to the Common Rule. According to the panel members, some IRBs treat QI as health research interventions like any other, requiring at least expedited review, consent forms and all the rest, even when they are very low risk. There was much grumbling about expedited reviews taking too long, and this unleashed a string of negative comments about IRBs, raising the impression of a groundswell of criticism against the Common Rule. There was even talk (gasp) of research institutions opting out of adhering to the Common Rule for all their research activities. However, an official from OHRP in the audience was having none of it: the official argued that there were already provisions in the Common Rule that could handle QI studies, and no overhaul of the regulations was necessary or desirable. If IRBs fail to implement the provisions or if they are not reviewing applications fast enough, that is their problem, and not problems with the Common Rule itself. I had to admire someone willing to stand up for their organization's mission in a room chock full of discontent.

ASBH, Day One

2010-10-24T02:26:00.010-04:00

One thing about the American Society for Bioethics and the Humanities conference was clear after just one session: don't expect a very deep discussion about anything. Not that there is a lack of quality speakers. To the contrary. It is just that within a 15-20 minute time-frame, there is only so much room for maneuver, and in fact the abbreviated time slots inspire speakers to race through their talks at a manic pace -- this conference comes but once a year, and they are going to get all the information out, come hell or high water. Ideas can get blurred or hollowed out this way. So it is best to let intellectual expectations drop somewhat and regard the sessions as 'samplers', where you are offered tastes of a diversity of themes and directions in bioethics.

Choosing what to taste is always difficult. Do you go to sessions on topics you already know something about? Or on something that you are clueless about? Both have potential pitfalls and benefits. A session on vaccines offered little information beyond the usual puzzlement (on the part of scientists) about why there are people who refuse to have their children vaccinated; I quickly took off to a large, thinly populated and appropriately spooky hall where the discussion focused on the ethics of using human remains. The idea was floated of a market in cadavers, and I involuntarily recalled what is said to happen in South Africa, the stealing of body parts from cadavers to be sold and used for muti, a sort of witchcraft. The session was rounded off by an interesting talk on the images of (and fascination with) the vampire in popular culture, and what vampire fiction could mean for bioethics. I thought of the persistent image, in Africa, of foreign researchers as vampires, coming to literally suck blood of locals.

The exhibit hall had an impressive display of well-stocked book stalls, conveniently located at a short distance from the coffee. My browsing experience, however, was somewhat disrupted by a couple of booksellers who were both selling what you might call 'other-help' books (as opposed to 'self-help') about clinical ethics decision-making. They both were aggressive, in their own ways: one was quite literally in my face, smiling and waving brochures, while the other was greasing the wheels of trade by offering free sunglasses and hand sanitizers. And both merchants featured books with algorithms and flow-charts, their own preferred paths to successful ethics conflict resolution. All very cheerily practical, like those who sell vegetable cutters in supermarkets. There really is a market for everything.

Low point of the day: a talk on international health research that was all over the map, conceptually muddy and in places, factually wrong. The cringe factor was high, and it was a pity, given that there is no little international bioethics on offer here. Fortunately, the session had two redeeming and stimulating talks after that, on the challenges faced by those wishing to provide compensation for research-related injuries (Jonathan Jay) and another on the parallels between moral responsibilities of photojournalists and international health researchers towards their respective 'subjects' (Valarie Blake). I was thus cheered up by presentations which were, on the face of them, pretty depressing.

Highlight of the day: the session on ethics and pain treatment. The general consensus among the speakers was that pain is undertreated in the US, at least partly due to the inability to visualize any physical source of pain by medical devices. A question of out of sight, out of practice and policy. The affable Daniel Goldberg (who writes his own excellent Medical Humanities blog) stormed merrily through his talk, making a strong case for a need to cultivate (political, socially and policy-wise) a greater receptivity to the subjectivity of pain, rather than merely tweaking current opiate policy. I couldn't help but think if pain is undervalued and undertreated in the US, what must the situation be in the developing world, where there are less diagnostics and less availability of opiates. A new twist on the phrase: a world of pain.

Field trip: the ASBH Annual Meeting in San Diego

2010-10-20T21:46:00.004-04:00

Normally I don't do this sort of thing. When I am not off to the DR Congo, Malawi, South Africa, Burundi, Madagascar or some other far-flung place, I am pretty much parked on my perch in North Carolina. Travel within the United States over the last decade has been very limited, and travel to domestic bioethics conferences pretty much absent. When you are already jetlagged, and poisoned by (increasingly) small bags of salted peanuts, why drag your sorry self to Cleveland or Nashville?

This week marks an exception. The annual meeting of the American Society for Bioethics and Humanities is being held in San Diego from October 21st-24th. My decision to go was not due to Glenn McGee's vigorous but somewhat unbalanced call last week for bioethicists to attend the event on the American Journal of Bioethics Blog. I had already signed on. And it is not due to the location, though I heard that it is sweet. For me, it is more about learning what practitioners of this odd activity in the United States are up to, think and care about, and believe others should think and care about. Connecting names and reputations with faces and fashion choices.

So, in the next few days, this outsider and first-timer will be posting reflections on the ASBH conference. How objective it will get depends on who mixes the cocktails.

The 'Guatamalan Tuskegee'

2010-10-14T22:31:00.007-04:00

When news broke about unethical syphilis studies being conducted by US government agencies in Guatamala back in the 1940's, I was not sure how to take it. My first (well, questionable) reaction was that some research ethics modules and textbooks would need an upgrade, and maybe some lectures on the infamous Tuskegee study might become less tedious, now that the well-worn scandal had both a precursor and an international twist. My second reaction was that I would have no choice but to write something about it, because it got so much press, and because the Guatamalan government received apologies from the US Secretary of State Hilary Clinton and President Barach Obama in a very big hurry. But reading the paper by the historian who broke the story, Susan Reverby, gave rise to deeper reflection on the moral landscape of health research between developed and developing countries, and how in some ways that landscape has not radically changed over the last sixty-some years.

As usual, the ethical problem was not so much with the research question itself. Trying to find a way of preventing men from acquiring syphilis after exposure by using penicillin had some merits. The use of captive and highly vulnerable populations -- prisoners, orphans, soldiers, and mental patients -- without gaining much semblance of informed consent is another story. As were some of the methods. Attempting to infect prisoners by means of deliberately selecting syphilitic prostitutes to visit them in prison, and conducting what sounds like a quite uncomfortable procedure of inoculating the penises of mentally ill patients: this is morally out of bounds. Sweetening the deal by offering the Guatamalan authorities supplies and infrastructure, as well as handing out cigarettes (yes, this was a public health study) to the prisoners, sounds like crossing the line between providing 'research benefits' and greasing the local wheels. There are important ethical differences the Guatamalan studies and Tuskegee: in the former, you had healthy participants being deliberately infected, whereas in the latter, the participants were already infected prior to being recruited. However, in the Guatamala case, those who became infected were all treated with pencillin (albeit without follow up), whereas treatment was infamously withheld from Tuskegee participants for decades.

What is striking in Reverby's paper is how the researchers know what they are doing is -- from a perspective they try to downplay and discredit -- ethically wrong. Reverby quotes a letter written in 1948 by the Public Health Service physician R.C. Arnold to a researcher involved in the Guatamala studies:

I am a bit, in fact more than a bit, leery of the experiment with the insane people. They can not give consent, do not know what is going on, and if some goody organization got wind of the work, they would raise a lot of smoke. I think the soldiers would be best or the prisoners for they can give consent. Maybe I’m too conservative....Also, how many knew what was going on. I realize that a pt [patient] or a dozen could be infected, develop the disease and be cured before anything could be suspected...In the report, I see no reason to say where they work was done and the type of volunteer.

The recipient of the letter, Dr. John C. Cutler, would go on to take a lead role in the Tuskegee syphilis studies and defend them to the end against accusations of wrongdoing.

At the end of her paper, Reverby muses about why this new addition to the history of research scandals matters. She raises two important points. First, US researchers in the Guatamala studies did things that they would not dare to do back home, not even in Tuskegee. In such studies, there is an implicit distinction between (as Reverby puts it) what is morally thinkable in the metropole and what is morally thinkable in the periphery. That distinction between what may be acceptable abroad -- but not at home -- is still very much with us in global health research. Second, we have to be wary about what is done with the case of the Guatamalan syphilis studies. Tuskegee gave rise to the Belmont Report, which strongly informed the Common Rule, arguably the most influential research ethics regulations worldwide. It gave birth to the IRB system. Many take issue with the provisions (and predominance) of US research regulations, and Reverby suggests the scandal in Guatamala -- particularly if it is misrepresented -- could give rise to Frankensteinian effects. But in truth, it is too early to know what this newly revealed scandal will come to mean.

Two cheers for microbicides

2010-09-29T22:10:00.003-04:00

This year's biggest success in HIV prevention research was undoubtedly the CAPRISA 004 study on pre-exposure prophylaxis (PrEP) microbicides gel for women. The unveiling of the study results at the recent International AIDS conference in Vienna made it the toast of the town and raised the spirits of HIV/AIDS researchers, policy-makers and advocates everywhere, given the sad string of serious pitfalls and setbacks -- scientific, economic, and political -- endured over the last years. Against that dismal backdrop, a gel that over a 30-month period, used before and after sex, protected women from getting HIV by 39% sounds like manna from heaven. Colleen Farrell over at the Bioethics Forum has a good brief description of the CAPRISA study and some of its implications and limitations.

However, even one assumes that the study results will be replicated and confirmed, it is still hard not to be somewhat pessimistic about the challenges of implementing this HIV prevention strategy in the field. On paper, it has fine feminist credentials: it is female-controlled way of preventing women from getting HIV from (all-too-often-wayward) men. In reality, there are bound to be challenges to adherence, when women are not repeatedly reminded to use the gel, and particularly if men dictate when sex occurs (not an hour from now, but now). This blogger does not personally have a vagina, but can imagine that inserting gel into it before and after sex is not a particularly erotic or pleasant experience, even if doing so might be lifesaving, particularly in high HIV-prevalence settings. (Fortunately pill and other forms of PrEP are currently being tested.) In addition, I am not sure anyone knows what the long-term health effects of intermittent use of antiretroviral drugs for HIV prevention purposes are, since this is (as Ferrell puts it) a new frontier. And we are not even talking yet about the usual problems of distributive justice in developing countries -- universal access to PrEP for safe sex purposes will be a long time coming, in countries where there is still no universal access for drugs for prevention of mother-to-child transmission or for antiretroviral treatment.

Of course, we already have a pretty vivid idea of what doing nothing in the face of the HIV/AIDS epidemic amounts to. Pessimism can and only should go so far. So researchers have to soldier on, even if they come up with interventions that provide spotty protection and whose implementation raises ethical problems right, left and center. CAPRISA 004 seems to have provided an important weapon for the long and ugly battle ahead.

The SAPIT trial on trial

2010-09-21T23:58:00.002-04:00

HIV and TB, tragically, to go well together. TB is the most common opportunistic infection to arrive when HIV has compromised the body’s immune system. Especially in sub-Saharan Africa, patients who are diagnosed with TB are routinely tested for HIV, and often are found HIV-positive. To compound the misfortune, current effective treatments for TB and HIV are not entirely compatible: starting HIV-positive patients with tuberculosis on antiretroviral treatment can lead to a number of complications, both in terms of toxicities and in terms of adherence (i.e. dual treatment involves taking different drugs daily for a long time). It is important, therefore, to have a clear understanding of the optimal time at which to start antiretroviral treatment with TB patients.

This is what the SAPIT study (South African Starting Antiretroviral Therapy at Three Points in Tuberculosis Therapy) in South Africa attempted to do, and their results were recently published in the prestigious New England Journal of Medicine. But the means taken to answer this important question – the study design – has been a topic of heated debate inside and outside South Africa since March. The design of the study included a sequential arm in which HIV-positive patients would start antiretroviral therapy only after they completed TB treatment or retreatment, a period of six or eight months respectively. This is a long time without antiretroviral therapy, particularly for those patients with advanced disease and low CD4 counts. The results of the study indicate significantly higher mortality in the sequential arm in the study than other arms where antiretroviral treatment was initiated earlier.

The burning ethical question is: was it predictable that those in the sequential arm of the study would experience greater mortality than those in the other arms that started antiretroviral treatment earlier? If the answer is no, the SAPIT study generated new and useful information about late initiation of antiretroviral treatment in this population. If the answer is yes, then the study violated the principle of equipoise, as enshrined in numerous ethical guidelines and regulations.

The SAPIT researchers and their defenders argue that at the time the study took place, little was known about mortality rates for HIV-positive, TB patients who were not on antiretroviral therapy. Accusations about violating equipoise are, from this perspective, criticisms based on hindsight. But a recent article in the South African Medical Journal, authored by some 20 scientists and activists, is having none of it. The authors present the evidence on mortality among patients similar to those in the sequential arm of the SAPIT trial, as was available when the trial was being conducted, as well as (generally underwhelming) evidence about complications of combining TB and HIV treatment. Their findings strongly suggest that those in the sequential arm of the SAPIT trial were given less than the clinical ‘standard of care’.

It is not easy to predict the fallout of the study, now that it is a large blip on the ethics radar. Certainly the South African ethics committees that approved the study are feeling awkward, and the relationship between (some) AIDS researchers and advocates may be strained. The fact that US investigators seemed to be involved in the study (enough to be considered authors) without the study having been reviewed in the US, raises questions about either the regulation of global health research, or the ethics of authorship, or both. The SAMJ article suggests (diplomatically) that the South African ethics committees are simply overwhelmed, but it may more simply a matter of committees inadequately judging a complicated case.

HIV testing policy revisited

2010-09-05T23:48:00.007-04:00

A few years ago, a colleague and I wrote a paper on some of the ethical issues surrounding proposed changes in HIV testing policy. Traditionally, HIV testing depended strongly on personal choice: if you felt you had been at risk of infection, you could (in theory) go to whatever available clinic offered HIV testing. The policy of voluntary testing and counseling (or VCT) was meant to do just that: support those who wanted to know their own HIV status. The policy change -- pursued by the World Health Organization and the Centers for Disease Control and Prevention -- involved putting greater pressure on individuals to get tested for HIV, given that (a) relatively few persons in high HIV-prevalent countries made use of VCT services and (b) antiretroviral treatment has become more available for those who test positive for HIV. 'Putting more pressure' took the form of an opt-out HIV testing policy, i.e. telling patients in clinics that they would be tested for HIV unless they choose not to be. While a more aggressive HIV testing policy could have some obvious benefits, my colleague and I were worried about possible negative repercussions that the policy might have. More precisely, the concern was less about the policy in the abstract, but what implementation of the policy might produce in settings marked by poverty, stigma, gender inequality and weak health care infrastructure.

This month's issue of the World Health Organization has a well-argued defense of 'opt-out' HIV testing policy. Michael April rests the argument on two philosophical foundations: consequentialism and what he calls 'libertarian paternalism.' On the consequentialist front, he basically argues that the positive consequences of having an opt-out testing policy outweigh the potential negative consequences. In regard to libertarian paternalism, April argues that there is nothing wrong with influencing persons to get tested for HIV by means of health policy as long as the influence does not constitute coercion and persons are thereby directed towards more health-promoting behavior than they might have otherwise.

Does the argument defuse the worries surrounding opt-out testing in poor countries in sub-Saharan Africa? Perhaps I should let the reader decide, but it is tempting to make a couple remarks. First, the consequentialist argument depends on the idea of 'weighing' potential positive consequences of opt-out testing against negative ones. Such weighing exercises in ethics are always slippery and elusive. On an individual level, it is not necessarily clear that getting tested for HIV has the best consequences, especially considering that health is not the only value at stake. (The astonishing book Three Letter Plague was centered around this theme.) If we go to a population level, and say that having opt-out testing will have overall better consequences than VCT, the consequences should (at least) be expressed in terms of lower HIV incidence. Maybe the policy will help to lower incidence, or rather, it may make a contribution as long as some other ducks are rowed up with it: presence of decent medical services (including HIV/AIDS care and availability of health care professionals), food and political security, opportunities for employment, and so on. As far libertarian paternalism goes, it seems plausible enough to say that people sometimes make decisions against their own interests, and that it can be justified sometimes to channel their behavior in more beneficial directions. But in an individual case, HIV testing conceivably might not be in a person's own interest, and hence libertarian paternalism would not be justified there. Though it sometimes makes appeals to individual self-interest, the whole argument works best at public health or population level: putting this policy in place, it is argued, will (likely) have positive overall consequences for many even if it might have negative consequences for some.

Perhaps so. On paper, the opt-out HIV testing policy has always looked promising. Our main concern was about such policies being implemented wisely and sensitively in the field, with a thorough knowledge of the cultures, communities and institutions involved, in order to avoid the best public health intentions going seriously astray.

On the move across South Africa

2010-07-09T10:28:00.003-04:00

Just a quick note to explain the relatively few posts over the last while. My term at the University of Cape Town philosophy department ended a couple of weeks ago, and since then we have packed up and moved out of Cape Town, on a month long working holiday (more work than holiday) that involves travelling from guest house to campground to borrowed apartment as we drift eastward across South Africa. Gansbaai. George. Jeffery's Bay. And points eastward, finally up to Joberg. My internet connections are somewhat Africanized: not very fast, when available, and finding wireless access in the places I am going is as rare as sighting a caracal. In short, don't expect much from this end, even though there has been no shortage of juicy bioethical issues, including here in South Africa: I am thinking of the SAPIT study on TB and HIV that was recently criticized in the Bioethics Forum. Until I fall back onto the radar, this will have to wait.

Ethical and unethical use of biological samples

2010-06-19T17:55:00.005-04:00

Researchers have had reasons -- generally good scientific reasons -- to gather, store or ship human tissues and blood for research purposes. But communities and individuals may be wary of such activities nevertheless: what will be done with my biological sample? For what reasons? How long will it be stored? Will it be shared with others? Which others? Will they be put to currently unforeseen uses? Who owns my sample, particularly if something commercially interesting results in its use? What if the researchers discover something medically important about me, through the analysis of my sample? Will I come to know about it? Given traditional deference to those more educated, more wealthy and with more social power, these concerns about the destiny of human biological samples have been muffled in the past. But they were probably always there. Developing World Bioethics this month published a fascinating paper by Melissa Graboye about research done in East Africa a half century ago, where it is clear that traditional villagers being studied wanted to know more (and have more say) about what was being done with their blood.

Concerns about use of samples -- as well as informed consent for their use -- are being voiced increasingly louder by communities and their advocates. Last week, Science Magazine ran a piece about the return of blood samples (collected in the 1960's) from the United States to the Yanomano tribe in Brazil. The stored blood samples were a center of controversy since the publication of Darkness in El Dorado: How Scientists and Journalists Devastated the Amazon, in which journalist Patrick Tierney accused anthropologists of exacerbating a measles epidemic in the region, among other abuses. Another recent controversy involves the Havasupai tribe in Arizona: the University of Arizona in April agreed to settle with members of the tribe to the tune of $700,000 for misusing their samples. By 'misuse', tribal representatives claimed that researchers used samples originally for diabetes research to evaluate the genetic basis of schizophrenia, which could stigmatize the tribe; another study used the samples to examine inbreeding, which raised concerns about stigmatization, given a cultural belief that inbreeding brings harm to one's family; another study used the samples for evolutionary genetics, which indicated that contrary to the tribe's origin story, its ancestors had migrated across the Bering Sea. Then, of course, there is the recently publicized and strange tale of Hendrietta Lacks, a poor Southern tobacco farmer whose cancer cells, taken without her knowledge, became one of the most important tools in medicine.

These controversies are an invitation to rethink the ethics of using human biological samples. We have all gained in many ways from the study of such samples in the past, and the collection of such samples is not inherently dubious or necessarily involves exploitation, even when the research is focused on traditional, relatively isolated or minority communities. Ethical use does require delicate balancing of the interests of researchers (and public health) and those of the studied community, and underlines the importance of community engagement in research. Some researchers shy away from the latter, arguing that it is too time-consuming and difficult. But the recent cases indicate that when it comes to tissues and blood, getting into ethical hot water is getting all too easy.

Global research ethics lecture series

2010-05-29T17:07:00.003-04:00

For a few months now, the kindly editor of Yourprof (Michael Valerio) has been asking me to check out his website. Yourprof is in the business of commissioning learned folks to talk about their fields of expertise. Michael asked some of the most experienced people in research ethics to explain some of the challenges of conducting health-related research around the world, particularly in resource-poor settings. They go beyond the standard questions about informed consent to issues about community engagement, the impact of culture, priority setting in health research and the growth of private health research institutions.

Being still neck-deep in work for the moment, I have not been able to watch them all yet. I have promised Michael to write a review when I finally do. But you don't have to wait for me to get my act together. The link to the list of all talks on Yourprof is here; just scroll down to the global research ethics talks.

Obama and the ethics of reining in global AIDS treatment programs

2010-05-12T16:51:00.006-04:00

Tomorrow, May 13th, President Obama will be at a fundraiser for the Democratic Congressional Committee at St. Regis Hotel in New York. Outside the building, AIDS activists from around the world will be gathering to protest the Obama's administration's approach to the funding of global HIV/AIDS treatment programs. These same groups most likely celebrated Obama's election in 2009: so how did this happen?

On the face of it, one can see the protests as a reaction to broken promises: the Obama administration promised, during the election campaign, to add one billion US dollars per year to the funding of the President's Emergency Plan for AIDS Relief (PEPFAR). But this year he asked Congress for only $366 million, the lowest increase in funding since PEPFAR began, citing the recession as justification. But this is part of a general pattern. The US government has also reduced its contribution to the Global Fund to Fight AIDS, Tuberculosis and Malaria by $50 million. There are memos from major US funders circulating around, instructing clinics and programs abroad not to enrol new patients unless they are replacing others who have left or died. The general slowdown in funding is bound to have the concrete consequence of excluding HIV-positive persons from accessing needed treatment. Sick persons will be turned away. No wonder the activists are up in arms.

On the other hand, there is something Frankensteinian about PEPFAR and similar HIV/AIDS treatment programs. The first decade of the twentieth century saw calls for aggressively increasing access to AIDS treatment in the developing world: ambitious targets were set, and programs strove to meet them. Clinics and labs were built. Persons were hired and trained. There were (partial) successes, measured in numbers of persons on treatment. But oftentimes the infrastructure and manpower developed by these foreign-funded programs sat uneasily beside (chronically underfunded) local health care systems. Local governments did not 'take ownership of them' (as the public health jargon goes), for the simple reason that they did not really own them. In the recent past, foreign funders have simply kept on increasing funding to AIDS treatment programs, but there are good reasons to doubt the wisdom of this approach: treatment for AIDS is lifelong, and more and more persons are in need of AIDS treatment each year. Are these global AIDS programs to be bankrolled by foreign institutions, at increasing rates, forever -- or at least until a cure for AIDS is found? Of course, stopping or severely reducing funding is not an ethically palatable option either: it condemns very poor and sick persons to death. Stopping treatment risks creating resistant strains of the virus. Once you start up with these programs, lives literally depend on them.

The Obama administration seems to acknowledge that increasing funding ad infinitum to non-sustainable AIDS treatment programs is untenable, recession or no recession. The administration is banking on smarter ways of using available funds, including treating the sickest patients first, shifting attention and resources to HIV prevention, and (importantly) working towards the goal of local governments supporting and delivering HIV/AIDS-related services themselves. The chance of this pragmatic approach appealing to AIDS treatment advocates is next to nil, so expect a lot of heated speeches outside the St. Regis tomorrow night.

Getting the ethical ideals right in international health research

2010-04-03T10:02:00.004-04:00

The free, open access Editor's Choice at the Journal of Medical Ethics this month is "Responsibilities in international research: a new look revisited" by Solomon Benatar and Peter A. Singer. Back a decade ago, Benatar and Singer advocated for vision of international research ethics less focused on risks and benefits for individual research participants. They wanted to see more attention directed towards the 'big picture' issues, i.e. the background of global (social, political, economic, gender) inequalities in which international health is embedded, and which gives rise to most of the ethical problems in any particular study. Looking back, Benatar and Singer see that some of the ideas they alluded to (such as ancilliary care obligations of researchers, community engagement in research and strategic partnerships among stakeholders) have been taken up in mainstream theoretical discussions about the ethics of global health research, and, to a much more limited extent, put into practice in the field. Meeting ideals of conducting 'responsible health research' in a global context, they suggest, still has a very long way to go.

To stimulate further ethical progress, Benatar and Singer offer some (fairly obvious) ethical principles, and suggest (less obviously) that these principles are based on the ethical value of solidarity. Benatar and Singer write that, first, research undertaken in poor countries should contribute to improved health care in the community in which the research is undertaken. Second, research should enable, or empower, host country researchers to solve their own research problems in the future. Behind these principles stands solidarity, a value they see expressed in:

[A]ttitudes and determination to work for the common good across the globe in an era when interdependence is greater than ever and in which progress should be defined as enhancing capabilities and social justice rather than sustaining dependency.

It is refreshing to see this attempt to put solidarity back into currency among those involved in bioethics. On the other hand, it is somewhat sad to be reminded, in 2010, of ethical principles that should not even require a reminder, and to become conscious of the relative disuse into which the notion of solidarity has fallen. But maybe getting the ideals right is the first step to getting the practices right.

Back in business, sort of

2010-03-29T17:48:00.005-04:00

Awhile ago, I wondered out loud how my posts might change now that I am living in (South) Africa. As it turns out, at least in the short term, the answer is undesired and unexpected: I am too consumed by work to blog. Until mid-May, it looks like my hands (and brains) are mostly tied. Bigger bioethics blogs may have research assistants that can step in, but not this one. Not that I am complaining. OK, I am.

Which does not stop me from acting as an occasional conduit of information. Luis Justo at the Blog Bioetica Latinamericana asked me to post a call for papers from the journal Revista Redbioetica/UNESCO. They are looking for original papers of theoretical or field research in bioethics, commentaries on books and papers, interviews and letters to the editor. They are also keen on commentaries on news in bioethics that can be published on the journal's blog. The journal has a wide focus, including both ethical issues arising from biotech and genetic developments as well as bioethics problems connected to political and social inequality. Paper and other proposals can be sent to the journal's editor at revistaredbioetica@unesco.org.uy.

Depoliticizing bioethics?

2010-02-14T17:05:00.007-05:00

Book reviewers always work between two extremes. One says more about the book and its author, the other says more about the worldview of the reviewer. Some reviews more or less describe what the book is about and add a bit of commentary. Others make use the book's content as a point of departure for reviewer's own opinions. Most reviews lie somewhere in-between. But one thing is clear: whichever direction they take, book reviews in general don't generate a lot of excitement.

The same cannot be said, however, about Sally Satel's review of Observing Bioethics (by Renee C. Fox and Judith P. Swazey), at least in the small world of bioethics. Observing Bioethics is a sociology of bioethics as practiced in North America, and like any decent sociology of any social practice, it is a 'warts and all' view documenting strengths, pitfalls, successes and failures. The activity called 'bioethics' has become an important force in some (mainly North American and European) societies, on the one hand, while there have always been lingering doubts about the expertise and legitimacy of its practitioners. Fox and Swazey's research describes these doubts, while depicting bioethics as narrowly focused on individuals (more than groups and communities) and rationality (more than traditions and shared values), and being somewhat allergic to cultural diversity.

This is where Satel, the reviewer, takes the ball and starts to run with it. She takes the doubts about the expertise of those working in bioethics to answer ethical issues in medicine and research, and offers her own conception of the bioethicist's mission and social role:

Bioethicists can be great educators of students and physicians and policy-makers. When an expert in bioethics approaches a problem, such as an end-of-life decision, he brings a deep knowledge of the cultural history of that controversy and the relevant legal decisions. This allows him to draw analogies to current situations. He is skilled at deliniating conflicts, laying out assumptions behind different positions, evaluating the soundness of arguments, and reflecting on potential consequences.

According to Satel, what people working in bioethics should not do is something that Fox and Swazey in fact recommend: getting involved more centrally in issues of global suffering and social justice. Moving bioethics in that direction, according to Satel, would be a mistake. Bioethics should not be moving outward to engage with global issues, but stay closer to home: bioethics workers as educators, not advocates. And when they educate, they apparently should not be taking or promoting any firm position on the issues they are discussing. They should simply lay out the issues for those who will make the decisions in the 'real world'.

Those antithetical to bioethics have delighted in Satel's review. For them, she has taken bioethicists down a peg. Bioethicists claim in a sense to tell us how we ought to live, and Satel has reduced them from 'Wizards of Oughts' to masters-of-nought. It is easy to see the appeal Satel's view could have for those who wish bioethicists would not only disappear into the relative obscurity of academia, but vanish from the face of the earth. The only problem is that Satel does not argue for her position, but merely states it. And the view is not without its shortcomings.

The first problem concerns neutrality. Above all else, people working in bioethics formulate normative arguments in favor (or against) certain ethical positions, and not just offer a panorama of possibilities. They will, on the basis of those arguments, judge (by presenting reasons and evidence for) ethical positions as being better or worse than others. When they have reason to judge some positions as being better or worse than others, it would be irresponsible of them not to mention this, not only to those they educate, but also to the larger community, since the issues that bioethics deal with are social issues of common concern. Bioethicists do not have to possess some magical expertise, capable of producing definitive answers to complex ethical questions, to have something worth contributing to these debates. The activity of conducting normative analysis and argument about (bio)ethical topics is already political.

Second, the idea of a 'de-politicized' bioethics looks like a developed world fantasy, or luxury. Bioethics in other contexts has sometimes been a way of speaking truth to power in the domain of medicine, public health and health research, particularly against the background of corrupt Ministries of Health, dodgy pharmaceutical studies, and skyrocketing numbers of deaths from preventable and treatable diseases. When things get this ugly, a purely educative role for bioethics does not look like a mission worth having. It starts to look like a parlor game. As long as activism and advocacy is rooted in open, honest analysis and argument -- and not simple ideology from the right or the left -- there is nothing wrong with bioethics workers trying to help make the world a better place, or at least control the damage.

Ethics, Zuma and the shield of culture

2010-02-04T17:01:00.006-05:00

The controversy regarding President Zuma and his extramarital (and unprotected) sexual capers heated up significantly today. I was greeted this morning with the Cape Times headline: ZUMA DEFENDS LOVE CHILD. The growing media coverage, some speculative, provoked the President to react in the form of a press release. In the press release, the President decries the invasion of his privacy while admitting that he fathered a baby with Ms. Sonomo Khoza. Then he says something very strange:

I said during World AIDS Day that we must all take personal responsibility for our actions. I have done the necessary cultural imperatives in a situation of this nature, for example the formal acknowledgment of paternity and responsibility, including the payment of inhlawulo to the family.

That is certainly a new twist on the concept of personal responsibility. Translated into a new HIV prevention message, it runs something like this: when you have unprotected extramarital sex, and your sexual partner then has your child, do remember to pay compensation to the family. It's the right thing to do! This slogan should be all the rage on the international AIDS conference scene this year. Though perhaps a catchier version would be: clean up your fuck up. In a culturally appropriate way, of course.

Then the press release goes in an even murkier direction:

The media is also in essence questioning the right of the child to exist and fundamentally, her right to life. It is unfortunate that the matter has been handled in this way. I sincerely hope that the media will protect the rights of children.

When I read this, I couldn't get the image out of my mind of Arnold Schwarzenegger in Total Recall, in the scene where he picks up people and uses them as shields to protect himself from gunfire. In Zuma's case, he picks up a child (and its associated rights) in an attempt to shield himself from criticism: don't shoot the baby! In any case, the media has not focused on the right of the child to exist, if only because that boring issue does not sell papers. How the child came to exist is far more interesting.

The press release includes a statement about the possible impact of this revelation to HIV prevention efforts. The President assures us that intensified efforts in prevention, treatment and research will continue. The idea that his personal behavior could act as a template of rationalization for sexual waywardness in local communities ... that does not come into play. Nor his obvious personal dislike of condoms that he and his government promotes. Now you could argue that President Clinton had his affairs, so why shouldn't Zuma be allowed his Presidential flings? One answer is: that Clinton was not allowed, he was nearly impeached, besides being roasted in the press. But the better answer is: Clinton's actions did not take place during a heterosexually-driven HIV epidemic responsible for hundreds of lives every single day.

South African presidents and HIV prevention: the madness never stops

2010-02-02T17:02:00.007-05:00

Former South African president Thabo Mbeki famously denied that HIV causes AIDS, and affirmed that the HIV/AIDS epidemic was really just a ploy by pharmaceutical companies to squeeze money out of African countries. He supported 'rogue scientists' who tried to support this unorthodox view with scientific evidence, though the larger scientific community was profoundly unimpressed. When it became obvious that his position on the subject was untenable, he kept hush on the whole epidemic, while sending out his minions to discretely and not-so-discretely enact his viewpoint in health policy. It led to lukewarm HIV prevention efforts, right when a real show of force and determination was needed to save lives. There are still calls, in some quarters of South African society, for Mbeki to stand trial for this episode.

When Jacob Zuma came to power, there were misgivings. Here was a man who was accused (and eventually acquitted) of rape, and who during the trial affirmed that he had unprotected extramarital sex with a HIV-positive woman, and in addition, believed that a post-coital shower was sufficient to protect himself from the virus. It was not looking good. However, President Zuma did seem to take a more progressive stance on HIV/AIDS than his predecessor in the first year of office. There seemed to be more committment in regard to provision of anti-retroviral treatment and HIV prevention campaigns.

And now this. The news this week is that President Zuma has recently fathered a 'love child' with the daughter of the owner of the Orlando Pirates, a local professional soccer team. From which one can reasonably gather, another case of unprotected extramarital sex -- from a man with three wives, one fiance and 20 children already.

I was listening on the radio today to various condemnations and defenses of the president. The condemnations were predictable, and so were some of the defenses (especially opportunistic appeals to cultural relativism). But one defense struck me: that the sexual behavior of the president will not have an effect on HIV prevention in the country, because studies have shown that a person's sexual behavior is more likely to be influenced by his or her own peers than by his or her president. No need to worry.

Perhaps that is true, though more research is needed. What seems true is that South Africa is back to failed leadership again, in the most personal way: the president apparently cannot restrict himself to only five sexual partners, and when he breaks out, he can't locate a condom dispenser. And when he is sitting there at the next World Aids conference, with his red ribbon on, promoting the use of condoms, what are we supposed to think?

Wrong and right in Haiti

2010-01-22T17:14:00.004-05:00

It is an old saying that disasters bring out the best and the worst in people. The idea makes sense: extreme events provoke extreme reactions. As far as 'the worst' goes, a disaster makes a country vulnerable, and creates opportunities for exploitation of the vulnerable. Take the news coverage of the earthquake's aftermath. A number of news agencies (notably, CNN) have sent in doctors who give emergency medical care and act as reporters while doing so. Bioethics experts throughout the US have been appalled by what they see as the lack of medical ethics on the part of these doctor/celebrities. The complaint is not about the classic themes, i.e. lack of informed consent or breaches of patient confidentiality. It is about exploitation of those that are poor, injured and dying. Since when is it acceptable for doctors, of all people, to help serve up the Haitian people as entertainment for those safely lounging on their sofas? That sort of behavior -- facilitating the consumation of the poor by the rich -- is what one expects of ... journalists. And it follows that the doctors involved invoke the usual journalistic justification: no, it is not at all about raising TV ratings, it is all about raising global awareness of the needs of the Haitian people.

On the bright side is the outpouring of donations to humanitarian organizations. There are organizations who are willing and able to help those in Haiti, even when a camera is not pointed in their direction. I would like to give a shout-out to one of them, International Medical Corps, a global non-profit organization of volunteer doctors and nurse who have boots on the ground in Haiti now.

Send something their way. Donating $10 is as easy as texting the word 'Haiti' to 85944. Click on this link to find out more.

WHO and accusations of a 'false pandemic'

2010-01-21T17:13:00.003-05:00

This does not look like it will be pretty. The World Health Organization (WHO) announced this week that it plans to launch an investigation into the global response to the H1N1 pandemic. The organization interest in such an investigation is not neutral . The WHO has been accused in many quarters of overestimating the scope and impact of the pandemic, i.e. overselling the threat. The rhetoric of urgency emanating from the WHO was in counterpoint to relatively modest statistics in terms of mortality and morbidity. It does not help that major pharmaceutical companies are the chief beneficiaries of the rapid production and distribution of H1N1, since this obviously makes delicious fodder for conspiracy theorists. You can imagine how it goes: credulous populations living in fear of death, a fear whipped up by a respected international health body, a fear that can only be managed by purchasing pharmaceutical products in vast quantities.

For the moment, the WHO is sanguine on the subject. It has not said when they will start their investigation, suggesting this would be premature given that the pandemic is not over yet. According to one WHO spokesperson, the investigation is not meant as a (self-)criticism, but rather a means of (self-) improvement: if that tepid language is anything to go by, a hard-hitting report is not in the works. That sort of report, if appropriate, is likely to come from somewhere else. The Parlementary Assembly of the Council of Europe is making 'false pandemics' a major issue in its next plenary session. And if they don't turn over some interesting rocks, someone else surely will.

Starting the new year with dignity -- or not

2010-01-07T07:27:00.006-05:00

The corks from the New Year's celebrations have hardly even been swept up, and already we have the first ugly bioethics conflict of the new decade. It about the concept of dignity, and more specifically whether the concept is coherent and useful in tackling bioethical problems. In 2003, Ruth Macklin wrote a paper in the British Medical Journal with the unambiguous title, "Dignity is a useless concept." But the concept of dignity has not made a dignified exit from the bioethics scene in the meantime. To the contrary, there have been a number of scholarly attempts to demonstrate its importance and usefulness, UNESCO's contribution to bioethics (Universal Declaration of Bioethics and Human Rights) in 2005 gave the concept of dignity a pride of place, and there are a number of bioethics-related blogs that clutch onto the concept of dignity as though their lives (and ours) literally depended on it.

A new article in the journal Bioethics takes aim once again at the concept of dignity. The author, Alasdair Cochrane, analyzes four ways of understanding the concept of dignity, and finds them all wanting. Dignity could be understood as a person's bearing or demeanor, particularly under stress or adversity; or it could mean the inherent moral worth (a kind of property) that each of us has by simply being human; or it could mean dignity in a Kantian sense, a property derived from being a person and the forms of treatment appropriate to persons; or it could signify the kind of flourishing we as humans are capable of having as a species. Cochrane rejects all four meanings as being useful concepts for bioethics, for different reasons.

The most important of them, I think, are the arguments against the second meaning of dignity: inherent moral worth. This is probably the most popular of the four meanings that Cochrane discusses, with the Kantian concept of dignity running a close second, at least in philosophical circles. One problem with the idea of 'inherent moral worth' is that it is very difficult to articulate what this means independently of descriptions of how we think that persons ought to be treated. This means that the analysis tends to be circular, and leads to the question: why bother talking about inherent moral worth, why not concentrate on the ways people ought to be treated, and why they should be treated that way? If you say "They ought to be treated that way, because they have intrinsic moral worth", you have gotten nowhere. As Cochrane points out, one way out of the circularity is to say that humans have intrinsic moral worth -- not just because we are apt to regard them in certain ways -- but because God has given us dignity/inherent moral worth. It is an objective, inalienable property of us, written in by the Creator. Of course, if you don't believe in God, or the kind of God who does this sort of thing, then this concept falls flat. But even if you do believe in that sort of God, it may fall flat anyway: dignity in this sense can be invoked to, for example, ethically defend or object to cases of assisted suicide.

What is the reaction to Cochrane's article on the blogosphere? So far, it is not pretty. It has taken no time flat for Cochrane to be accused of Nazism and eugenics, of rejecting the Universal Declaration of Human Rights and the US Declaration of Independence, and advocating (or 'promoting') the use of human beings -- particularly the most vulnerable among them -- as mere means to experimental and other ends.

These are very damning conclusions, so you would think that they would be arrived at by rationally evaluating and countering Cochrane's arguments point by point. But they aren't. What you get instead, are mere restatements of positions ("But humans have intrinsic moral worth, dammit") and a lot of heat and rhetoric about the evils and horrors that not using the concept of dignity would inevitably lead to. It is as if all of our ethical resources were invested in that one single concept, such that if we lose it (or even just dare to criticize it), we start a slide straight into barbarism. But if the concept is that important, you would think it would have stronger and better intellectual defenders, not those who stoop to insinuation, name-calling, false attribution, and the usual muck of bad reasoning.

Perhaps those who think that the concept of dignity is useless, and the opponents of that view, should make some New Year's Resolutions. The former should promise not just to criticize dignity, but also to demonstrate that the concept of dignity could be jettisoned without loss, i.e. that the kinds of concerns expressed by their opponents could be met adequately with alternative moral concepts. Those who want to retain the concept of dignity as a important bioethical notion should promise to argue rather than ventilate, both when they approach those they disagree with as well as articulating their own, positive positions. Otherwise, the whole dignity debate will remain, well, undignified.

Forced trials of drug users in Cambodia?

2009-12-28T16:32:00.005-05:00

This is one of these stories in ethical flux. Human Rights Watch (HRW) has claimed that earlier this month the Cambodian police rounded up at least 17 drug users and brought them to a government-run drug detention center on the outskirts of Phnom Penh, where they were forced to participate in a drug study. The drug being tested is 'Bong Sen', a herbal substance that is alleged (by the company that makes it) to detoxify heroin/opiate users in 4-5 days. HRW lays out the ethical problems with the experiment: coercive recruitment and lack of informed consent; lack of review of the study by the ethical committee of the Ministry of Health; unknown (and possibly shoddy) study methodology, including apparent lack of follow-up of research participants.

The British Medical Journal put out a small piece on this story last week, providing some interesting details. Bong Sen is produced by a private Vietmanese company, with a very strange looking (and long) name: Ben Tre Fataco General Import-Export Trading Service Company (kor Ben Tre Fataco, for short). According to NGOs in Cambodia, Ben Tre Fataco has formed a group with four Vietmanese doctors, a company in Cambodia marketing Bong Sen, staff from Cambodia's National Authority for Combatting Drugs (NACD) and its Secretariat-General, the Ministry of Health and the Orkas Knhom drug treatment center, which is run by the Phnom Pehn municipality's Department of Social Affairs.

Just to show how deep the government is involved in the Bong Sen trial, the Cambodian prime minister is said to have given the Vietnamese doctors written permission to administer Bong Sen to drug users. When the Orkas Knhom drug treatment center could not come up with sufficient 'volunteers', staff from the NACD are said to have demanded that clients at local NGOs take the medicine. The NGOs hesitated, given that the herbal medicine being pushed did not seem to go through routine drug trial procedures. Staff from the NACD then threatened the NGOs with closures and withholding their licences for needle-exchange programs. That is apparently what went on before the police arrested drug users and had them enter the Bong Sen study. For its part, the NACD has denied everything: the drug users were volunteers; the herbal treatment is not really a drug, and does not have to go through drug approval procedures; there is no real trial at all. Just giving out medicine.

One thing is certain: the relationship between the Cambodian government and Cambodian citizens who happen to be drug users is not very warm and friendly. Earlier this year, the Soros Institute put out a report entitled At What Cost? HIV and Human Rights Consequences of the Global 'War on Drugs'. One chapter of the Soros report is dedicated to the arbitrary detention and police abuse of drug users in Cambodia. But this is nothing new. There have been reports about government abuse of Cambodian drug users (many of whom are HIV-positive) for at least a decade. If the allegations are true, the question is why the Cambodian government would be so interested in corralling drug users for this particular trial. Is it just because Bong Sen is a non-opiate treatment? What interests does the government have in the success of Bong Sen treatment that they are deeply involved promoting as effective despite there being no evidence of its efficacy? As the BMJ piece notes, no one is talking: Ben Tre Facaco is not answering its phone or email, and the Cambodian Ministry of Health has nothing to say.

Hand-me-down vaccines?

2009-12-17T12:11:00.004-05:00

There have been months of fear and trembling (especially in the United States) about shortages of H1N1 vaccine. The idea of shortage -- in this one context at least -- in the land of plenty has motivated a rapid increase vaccine production and distribution, on the one hand, while the number of new cases of H1N1 has in fact decreased on the other. In little time, everyone in the United States who wants (and can afford) to have the vaccine, can get it. In fact, there will most probably be way too much of the stuff.

What should be done with the surplus? In a recent editorial in the San Francisco Chronicle, immunology and bioethics experts argue that the surplus should be donated to the world's poorer countries. These countries have health systems under tremendous stress, unhealthy populations at risk for H1N1, and have very limited access to the vaccine despite promises made by powerful governments and pharmaceutical companies. The argument for giving is especially pertinent at time of year. It is, as they point out, Christmas season.

It is hard to know what to make of this. First, the public health issue. The burden of disease that H1N1 constitutes is paltry in comparison to the diseases and conditions faced in developing countries. (It was already not very significant in terms of mortality and morbidity in developed countries themselves.) Sure, H1N1 will exacerbate pneumonia, one of the great killers in these nations. But we don't see significant donations of antibiotics which could save many more lives.

And then there is the symbolic issue. When the richer nations have had their fill of vaccines, and are getting out of danger, then we can think about the poor. The image is that of hand-me-downs, leftovers. Things we no longer need or want and can afford without sacrifice to give away as charity. Of course, it is not that it would be better if such donations were withheld. Some lives could be saved. But what do such acts of charity express about the relationship between richer and poorer countries? Should either party feel good about such a donation initiative? Perhaps some will find the spirit of Christmas in it somewhere, but the whole thing strikes me as deeply, deeply sad.

Ugandan government takes dead aim at HIV positive gays

2009-12-08T15:40:00.006-05:00

Many Africans seem to believe that men having sex with men, or women having sex with women, is unAfrican. It is as if such sexual behavior never took place on the continent during its very long history, and if it has appeared recently, this is due to external, non-African influences -- as if it were a new fashion craze helicoptered in from San Francisco. In this way, gays in Africa are doubly marginalized: they not only deviate from heterosexual norms, they aren't 'real Africans.' And being stripped of cultural identity is often a prelude to (and justification for) exclusion, humiliation or physical violence. Not everyone in Africa sees things this way, of course, but it is a real and strong tendency.

The tendency is strongly manifest in a provisional bill ("The Anti-Homosexuality Bill") currently being proposed and discussed by the Ugandan government. There already are anti-homosexual laws in Uganda, harking back to colonial times, but members of the government are seeking to beef them up, and how. Among its provisions, single gay sex acts could be punished by life sentences; repeated gay sex acts could lead to the death penalty; gays who test HIV positive could be executed; members of organizations who engage in the 'promotion of homosexuality' (i.e. gay rights groups) would be outlawed; even an attempt to commit a homosexual act would be considered a felony and a conviction would lead to a seven year prison sentence.

The proposal bill is worth reading in the original. It starts off with a number of unargued assertions: that homosexuality is not innate (hence mutable, or 'curable'), and that the bill aims to protect the traditional family values of Ugandans, apparently under serious threat by sexual rights activists hell bent on imposing their agenda of promiscuity and adoption of children by gay couples. One of the last provisions in the proposed bill is aimed to deflect any and all criticism from a human rights point of view: "Any International legal instrument whose provisions are contradictory to the spirit and provisions enshrined in this Act, are null and void to the extent of their inconsistency." A lot like saying: this is the way we intend to treat our gay Ugandan citizens, and outsiders, if they don't like it, can go to straight to hell. Highly reminiscent of Zimbabwean president Robert Mugabe's old trick: use a lot of nationalist and anti-colonial rhetoric against outsiders to justify abuses on the enemies within.

Ugandan government officials generally don't mind listening to right-wing religious groups from the United States (or taking their money) as long as the latter says what the former wants to hear or already believes in. But US anti-gay groups are pulling back (a bit) from this one publicly, even if they are happy with its spirit of the proposed laws. The Ugandans, it seems, are on their own. Or maybe not. Given the extent of gay hatred on the continent, the bill if approved could function as a template for similar legislation in neighboring countries. So it is important to see how this situation evolves.

It is also important from the perspective of HIV prevention. Plenty of men have sex with men in Africa, if you bother to look closely enough, and these men have a disproportionally higher incidence of HIV. Reaching this population with HIV prevention messages and strategies is already difficult enough, without laws that treat them as sub-human.

Condoms, Marriage, Catholicism and HIV

2009-12-01T17:10:00.005-05:00

Today is World AIDS Day and I can think of nothing better than recommending a paper on HIV, sex and religion. The current Editor's Choice in the Journal of Medical Ethics is an article with the self-explanatory title, 'Can the Catholic Church agree to condom use by HIV-discordant couples?' by Luc Bovens. There are many married couples, particularly in sub-Saharan Africa, who are Catholic or deeply influenced by Catholic teachings. Some of these couples are HIV-discordant, i.e. one in the marriage is HIV-positive, and the other HIV-negative. The Catholic church is opposed to pre-marital sex using condoms, but what about condom use among HIV-discordant married couples? Would the Church accept the use of condoms to prevent transmission of HIV during marital sex? Or would the Church's position be that such married couples should simply abstain from sex altogether?

Bovens argues that the Church should permit the use of condoms in such cases. I will not give away the argument, which is well-constructed and attempts to take Catholic objections to condom use as much into account as possible. One way to celebrate World AIDS Day: thinking of how Catholics -- including HIV-positive ones -- can experience the pleasures of (safe) sex in good conscience.

The rich using the poor as beauty products? (with update)

2009-11-28T15:07:00.005-05:00

This one falls into the 'obviously wrong if true category.' According to reports last week, police in Peru have arrested members of a gang who murdered a string of peasant farmers, drained the fat from their dead bodies, and then attempted to sell it to European cosmetics manufacturers. How the fat was extracted from the corpses is gruesome enough to gain the attention of bad horror film producers, and I will spare you the details. What is interesting, though sick, is the very idea of an international black market in human body fat for cosmetic purposes. The rich have long had (or have been sold) some strange notions about special concoctions allegedly capable of turning back the hands of time, or at least the signs of wear and tear on the human face. But using body fat is a new one, and harvesting it among Peru's poor (rather than more corpulent and frequently liposuctioned populations elsewhere) just seems gratuitous -- not that there is some part of the world where this should pass as acceptable behavior.

As the Independent points out, the gangsters oddly discarded more lucrative items in the form of livers, kidneys or lungs. My instinctive response: don't give them any ideas.

UPDATE (Dec 1, 2009): it seems to be false, after all. Since the story broke, no evidence has been uncovered to support the gruesome tale of murder and body fat sales, and the anti-kidnapping investigator at the origin of the story has been suspended. The story seems to have been a recycled version of the old Peruvian myth about Pichtacos -- a kind of South American vampire/cannibal. Rumor has it that the police authorities told the story just to distract the Peruvian public from real social problems. But who knows if we will ever get to the bottom of this one.

National Health Insurance in South Africa put on hold

2009-11-19T16:34:00.005-05:00

South African president Jacob Zuma and American president Barack Obama do not seem to have much in common. Obama went to college, and not just any college: Yale University. Whereas Zuma only attended school until Standard 3 (or Grade 5). Zuma has been tried in court on charges of rape and corruption, and during questioning stated that risk of HIV transmission could be minimized by taking a shower after sex. Whereas Obama used to smoke. Zuma has 4 wives, Obama has Michelle. Despite these and other differences, the two presidents have one thing in common: they are both currently involved in controversial national health care reforms. In the case of Zuma, it is the proposed National Health Insurance (NHI), which has been planned since the African National Congress first took office in 1994.

Social, political and economic inequality, as many studies have indicated, are bad for your health. It would seem to follow that decades of Apartheid would be generally bad for the health of those at the lower end of the ladder in South Africa. And it is. I spent the early part of this week marking medical ethics exams from budding doctors at Groote Schuur Hospital in Cape Town, and some of the case studies they presented were positively hair-raising. So it makes ethical sense, in principle, to increase access to health care for South African citizens.

While everyone seems to agree on the basic principle, the details of the NHI are vexing, and the discussions bring out the old social tensions and wounds. One large question is where the massive amount of money in support of the scheme is to be drawn from. If it is through taxation, this causes concern among those better off in South Africa, who are already been taxed to support the existing public health care system -- though many of them go to private health services when they are sick themselves. There is also a worry that private health institutions would be 'de-skilled' and overwhelmed if subjected to government demands to focus on primary care services. Requiring well-off South Africans to use public health care might also, it is feared, lead to people leaving the country: both patients who fear a drop in their standard of care as well as doctors who do not want to work in sub-standard conditions for less pay. There seems to be a general feeling that if the NHI might lead to the generalization of the health care standards currently provided in the public sector. It depends who you ask, and where you ask, but generally speaking opinions about the health care on offer in public hospitals and clinics are not positive. This is an understatement. The problems the government has had in doing just one thing -- providing antiretroviral therapy for those who need it -- draws serious doubt on its ability to provide a broad spectrum of services at an adequate and affordable standard. For the poorest of the poor, on the other hand, the promise of some (perhaps not great) services may look better than none.

Olive Shisana, head of the Human Sciences Research Council (which is responsible for drafting versions of the NHI) likes to say that opposition to the NHI is based on myths. But this week the Health Minister put the NHI on hold, perhaps for as long as five years. Reason? The public health sector is said to be in shocking shape, so shocking that bringing in the NHI wouldn't help matters. So back to the drawing board.

Delivering vaccines in Africa: some unethical obstacles

2009-11-08T15:02:00.006-05:00

The attention and money thrown at the H1N1 virus seems to grow by the day, even if the numbers of H1N1 related deaths, relative to other causes of mortality (including plain old seasonal flu), are still very modest. People actually die from H1N1, so it is not nice to make light of it, and because it is contagious, the death toll will rise, though we don't know how high or for how long. Nevertheless, there is no way of getting around the impression that the world's media is drawn to the latest viral threat to the richer developed nations, where the knight in shining armour is played by multinational pharmaceutical companies, whose cutting-edge research thankfully produces the latest vaccine, while the media makes rapid and widespread vaccination seem like the only rational response, and governments and local health agencies stand to be criticized for not getting vaccines into bodies fast enough. The significance of the H1N1 virus as a threat to humanity? Only time will tell. But that a great deal of money is being made: that is already certain.

Elsewhere in the world, other fish are frying. Forget new cutting-edge research for new diseases: in many countries, it is hard enough just to get the old vaccines administered, for the boring old diseases, the ones that people in developed nations hardly get anymore because they are routinely vaccinated against them. Take measles. Two troubling stories about measles vaccination in Africa came in this week.

First, here in South Africa, some media sources managed to revive the discredited measles-autism link, i.e. that the measles vaccine causes autism in children. A little media ethics for journalists working on public health issues could go a long way, and hopefully these incidents will not cause setbacks for measles eradication in South Africa, similar to the problems with polio vaccination in Nigeria some years back. The recent decline in measles mortality in Africa is a success story, but only conserted and sustained efforts (including communication of accurate health information) will keep those numbers going down.

Second, in the Democratic Republic of Congo, measles vaccination efforts face an unusual adversary: government troops. Medecins Sans Frontieres (Doctors without Borders) has accused the Congolese government of using their vaccination sites as bait. Due to a measles epidemic, MSF was vaccinating thousands of children in sites locations that are controlled by the Forces Democratique de Liberation du Rwanda (FDLR) . Knowing that people in the area would gravitate to the opportunity for measles vaccination, Congolese government troops apparently attacked all seven sites with deadly force, scattering populations (including children) into the bush. It remains to be seen if people in the area will trust going back to MSF sites for medical care, and in this troubled part of the world, that is about the only decent medical care around.

Let us compare epidemics

2009-11-02T16:27:00.004-05:00

There is always something a bit distasteful about comparing human tragedies, but it is also inevitable. The tsunami in 2004 was terrible, but was it as bad as the ongoing HIV/AIDS epidemic in Africa, which has taken millions of lives over the last decades? Darfur is bad, but has it really reached Rwandan genocidal proportions? We inevitably make these sorts of comparisons in order to get some sort of grip on what people ought to care about, and what nations ought to respond to with their finite resources. And we often lose our way.

The H1N1 virus has captured media attention, as well as substantial funding for task forces, response plans and research, particularly as increasingly more deaths have been linked to it. As has been observed many times, the 'media life' of a virus depends in large part on the extent to which citizens (especially ordinary citizens) of North America and Europe are affected by it, or are likely to be affected by it. When the centers of the world's power is under viral threat, vast resources may be mobilized, even if the numbers in terms of morbidity and mortality are, relatively speaking, small. Worse epidemics, elsewhere, receive much less press and support.

The point was not lost on those aware that today was World Pneumonia Day. Pneumonia is the greater killer of children worldwide. It is responsible for more deaths in children (2 million a year) than HIV/AIDS, measles and malaria combined. The tragedy is that we long ago developed effective vaccines to prevent it, and antibiotics to treat it, but it generally affects children away from the centers of the world's power, particularly in sub-Saharan Africa and South-East Asia. While many lives could be saved in delivering known effective medicines to these populations, there is not much money to be made in the endeavor, so rallying support for pneumonia initiatives tends to be an uphill battle. But it is a matter of fighting the good fight, a matter of trying to regain some sense of proportion, and a matter of not being entirely distracted by the latest virus on the 24-hour news cycle.

I pay thy poverty, and not thy will

2009-10-25T16:00:00.004-04:00

In Romeo and Juliet, there is the scene where Romeo goes to an Apothecary to obtain a poison. Juliet is presumed dead; Romeo wishes to go to the Capulet's family tomb, take the poison and join her in a deadly embrace. The Apothecary hesitates: distribution of such poisons is against local law. The two have the following exchange:

ROMEO: Art thou so bare and full of wretchedness, and fear'st to die? Famine is in thy cheeks, need and oppression starveth in thine eyes, contempt and beggary hangs upon thy back. The world is not thy friend nor the world's law. The world affords no law to make thee rich; then be not poor, but break it, and take this.

APOTHECARY: My poverty, but not my will, consents.

ROMEO: I pay thy poverty, and not thy will.

I was reminded of this exchange while reading a blog post on the Washington Post website, entitled 'In Praise of Human Organ Sales.' The author, Gary S. Becker (a Nobel prize-winning economist) argues that allowing people to buy and sell their organs would help solve the problem of shortages in organs for transplant, while countering possible objections to this idea. Neither the proposition nor the objection are particularly new; people working in bioethics have made this proposal before and objected to it before. The novelty lies in how quickly and brutally Becker states his case. His response to issues of social justice is succinct:

Another set of critics fears that the organ supply would be likely to come mainly from the poor, who would be induced to sell their organs to the rich. It is hard to see any reasons to complain if organs of poor persons were sold with their permission after they died, and the proceeds went as bequests to their parents or children. The complaints would be louder if, for example, mainly poor persons sold one of their kidneys for live kidney transplants, but why would poor donors be better off if this option were taken away from them?

It is true, the poor who sell their organs, either when they are alive or posthumously, would get their cut -- like the Apothecary. The rich would get their organs, and the middlemen, well, they would get richer. The poor would be mined -- with their agreement, of course -- for organs, without this sacrifice of body parts being likely to improve their lot very much. They would not be in a position, for instance, to buy organs for themselves if they needed them. For their part, the rich would have no (economic) motivation to put up their own organs for sale. Hard to see any reasons to complain here? Depends where you are looking. Romeo was unbalanced, and desperate, but at least he was honest: I pay thy poverty, and not thy will.

Thanks to Steve Levingston at Washington Post, who sent me the link to Becker's piece, and thereby informed me about the Post's excellent Book World blog.

HIV treatment: the good news and the bad

2009-10-20T17:12:00.003-04:00

First, the good news: more people worldwide living with HIV/AIDS are receiving treatment than ever before. Over the last 5 years, there seems to have been a 10-fold increase, and now some four million people are taking antiretroviral drugs. Traditionally, UNAIDS 'epidemic updates' on treatment access in Africa made for depressing reading, with only tiny percentages of HIV-positive persons within African countries being treated. For the vast majority of Africans, HIV/AIDS remained what it was in the beginning, a death sentence, even if had obtained the status of a chronic disease in far-off (and better-off) countries. Now there are three million Africans taking AIDS drugs. This impressive achievement has taken more than a decade of advocacy, negotiations with pharmaceutical companies, creation of cheaper generic drugs, lobbying, program development, investments in local capacity ... blood, sweat and tears, in other words.

The bad news. The numbers of persons 'on treatment' cannot be trusted altogether. The statistics are developed by governments in a vested interest in stating the highest possible estimates. To do otherwise might show incompetence in the use of (mainly external) funding. The numbers also tend to reflect the number of those who were placed on treatment, and not those who later stopped treatment for one reason on another.

But even if the numbers were more trustworthy, there are other concerns. AIDS treatment and care is lifelong. To keep these millions of persons on treatment in the future requires a vast and ongoing investment. The World Health Organization is considering revising its treatment guidelines on account of studies that indicate earlier initiation of treatment increases life-expectancy. More HIV-positive persons will fall into the category of those in need of treatment, and meeting this new demand will add to the already soaring costs. In addition, some of those currently on first-line treatment will develop drug resistance and need to switch to (more expensive) second-line drugs. And last but not at all least, millions of persons continue to be infected by HIV, meaning that the 'treatment pool' will grow larger and larger in the coming years.

The old questions keep coming back: is this magnitude of spending on HIV/AIDS treatment ethically justified? Is it justified when there are other diseases and conditions, causing greater numbers of deaths, but which do not attract nearly the same level of political and financial support? Why not devote greater attention to HIV prevention research or prevention strategies that may help reduce the rate of new infections?

This is becoming a dramatic example of 'hell being paved by good intentions.' Back a few years ago, we had the unacceptable situation of Africans routinely dying of untreated AIDS, while North Americans and Europeans accessed antiretrovirals and went on with their lives. It was a striking case of global health inequality, and no one with any sense of solidarity could fail to be moved by it. But in the process of trying to improve the situation, something else, vaguely Frankensteinian, has emerged. Billions of dollars will need to be spent to keep the (growing) millions of HIV-infected on treatment. This might not be sustainable, and all the spending might not be proportional or fair, but it would also be unwise to stop financing global AIDS treatment programs now that they have been started. Halting treatment would not only spell death for those living with HIV/AIDS, it could also mean creation of new drug-resistant strains of HIV, making prevention efforts more difficult than ever.

Ethics and the global registry of clinical trials

2009-09-30T16:45:00.004-04:00

We do not really know how many clinical trials are taking place in Africa. In fact, we don't know -- and have not known ever -- how many clinical trials are taking place around the globe. And, a fortiori, we don't have much of a grip on what kinds of research questions are being tackled in such trials, and when such trials are concluded, there is often (at best) only piecemeal and partial reporting of their outcomes. The spread of clinical trials around the world has not made information about them much more available.

Why does this information matter? Knowing about what trials are already ongoing would prevent duplication and waste, and would let patients and doctors know what is in the pipeline. It would help Ministries of Health and scientific institutions define research priorities, and would assist in focusing the efforts of regulators, including those charged with the protection of human participants in trials. Those thinking of participating in trials would also be better informed about 'what is out there'. It would also allow us to learn about negative results, which tend to be underreported or selectively reported. And it would be interesting to know how much (or how little) of the global research endeavor is devoted to diseases and conditions that disproportionally affect developing countries. However, the pharmaceutical industry for their part has traditionally been reluctant to share information about their activities, not necessarily because they have skeletons in their closets (though they might), but because they feel that greater transparency might reveal too much to their competitors, and result in the sacrifice of their competitive edge.

The World Health Organization, back in 2004, launched an initiative to create a global database of clinical trials, called the International Clinical Trials Registry Platform, ICTRP. The moral philosophy behind the initiative is that information generated by clinical trials conducted worldwide constitutes a 'public good' that must be shared to improve health. But if the carrot of 'doing good' is not enough to motivate agencies to register their trials, there is always the stick: the International Committee of Medical Journal Editors (ICMJE) has a policy that if there is an intention to publish trial results in any of its 11 member journals, the trial (including Phase 1 trials) must be registered with the ICTRP. And these are real journals like the Lancet or the New England Journal of Medicine, the kind that get you tenure or help you market your drug.

This week the global registry grew an African wing. The Pan-African Clinical Trials Registry (or PACTR) has been accepted as the first World Health Organization (WHO) endorsed trials registry in Africa. This registry will channel data into the ICTRP, and therefore we will come to know more about Africa-based clinical trial activities. It will be interesting to see what's cooking once the lid is taken off and we are allowed to peer in.

Research data from developing countries as 'the new gold'

2009-09-24T16:13:00.004-04:00

The ethical complexities involved in outsourcing of clinical trials in developing countries have been discussed over the last few years, and by the looks of things, this discussion will continue. For different reasons. First, and probably foremost, because the practice itself is lucrative: there are millions of dollars to be saved by holding your trial in Mumbai rather than Miami, and success in a clinical trial, especially when translated into a well-marketed pharmaceutical drug, can reap billions of dollars in profit. Second, no one to my knowledge has ever said that the practice was morally impermissible or that it should be prohibited. It has always been a matter of how to ethically conduct such studies in impoverished communities whose members may have little to no understanding of the nature of the research and will probably not benefit much directly from their involvement. Making research ethical in such contexts has always been a matter of adding protections and safeguards. Perhaps being ethical in a deeper sense would involve chipping away at the gaping inequalities in power and wealth between the researchers and the researched, but almost no one wants to touch that one: not researchers, not their funders, and (sadly) not governments.

The Guardian in the United Kingdom has a short piece on this issue. Frankly, the article itself adds little to the debate, but some of the comments on the article are worth looking at. Some depict outsourced trials in terms of exploitation, others as opportunity; and opportunity for local communities and trial participants, not just those trying to make a profit. For example, in poor countries, getting into a drug trial might be synonymous with gaining entry to a higher standard of medical care than one would otherwise get, and prohibiting this opportunity in the name of ethics, to some observers, sounds perverse. Communities might also gain some ancillary benefits in terms of facilities or training. And yet the possibilities for exploitation are still there, and these benefits (sometimes real, sometimes not) do not silence the concerns. So outsourced trials come across as a kind of mixed blessing, a partly dirty business, but not all bad.

A detailed and nuanced understanding of global drug research and outsourcing can be found in a new book by Adriana Petryna, When Experiments Travel: Clinical Trials and the Global Search for Human Subjects. The book makes clear that reliable data in support of new investigational drug applications to the FDA is a rare and highly lucrative commodity, like gold or diamonds. But to get the data, you need humans. And not just any humans: you need humans with this or that disease or condition, preferably who have not taken many other drugs before (drug interactions may influence the data), and many other specific inclusion criteria besides. And you want the study to run in places where you can get more for your dollar (or Euro), and where the regulatory climate is still immature. Contract research organizations (CROs) are paid by pharmaceutical companies to find the right humans in the right places, recruit them, run the study, deliver the data. Petryna's book shines a light on an obscure global industry, peopled with not so much with heros and villains, but with ordinary actors engaged in a partly dirty business across national boundaries.

The regulation of desperation

2009-09-13T04:50:00.002-04:00

We think sometimes that, when we are terribly sick, medical science must have progressed to a point where there is an effective treatment. That belief (or faith) sometimes turns to be true, and sometimes not. In the latter case, there is a terrible feeling of fear and powerlessness on the part of the patient, family members and friends. Science turns out not offer salvation. So if there is a chance that some new experimental treatment, being tested or offered somewhere, could provide some benefit, this can be a wildly attractive prospect. And the idea that access to a 'last chance therapy' could be prohibited by regulations can seem like unjustified paternalism. It is a bit like the scene in Monty Python's Life of Brian, where a man is about to be stoned to death for saying the holy name 'Jehovah'. As he is lined up to be stoned, he yells 'Jehovah! Jehovah! Jehovah!', and the priest presiding over the stoning exclaims: "You are only making it worse for yourself!" And the condemned man understandably replies: "But how can I make it worse for myself?" Those seeking last chance therapies might ask the same thing: even if the therapy is risky, even if it may not help, how can I make it worse for myself?

A couple of years ago, some of the people working at the National Institutes of Health clinical bioethics program wrote about different periods and paradigms in clinical research and research ethics. According to Emanuel et. al. (2007), there have been four periods and paradigms: researcher paternalism (1940's to early 1970's), regulatory protectionism (early 1970's to mid-1980's), participant access (mid-1980's to mid-1990's) and community partnership (mid-1990's onward). The AIDS crisis in the United States drove the paradigm of participant access, with patient rights groups increasingly demanding that people with terminal illnesses (and not just AIDS) should have the choice to join experimental trials. As Emanuel et. al. write, the desperate search for treatment tends to blur the distinction between experiment and therapy. A clinic offering a new intervention may be part of a clinical trial or it may be simply be offering 'experimental treatment'. Either might help the patient, either might push our medical knowledge further: but both could be dead-ends in any particular case.

Those trying to regulate this new paradigm have their work cut out for them. Not unrelated to the fact that much clinical research is being outsourced around the world, and the rise of medical tourism, people (who can pay for it) are seeking potential therapeutic benefits from cutting edge stem-cell research or clinical practice taking place in countries like China. This research may well not be taking place in the home country of the beneficiary, due to cost or regulatory/legal prohibitions. There is the possibility that such trials or practices may not be in the best ethical shape, for instance involving unnecessary risks and promising to desperate patients more than they can keep. The underlying ethical principle behind the patient access paradigm -- patient autonomy -- is unlikely to capture all of the ethical concerns associated with globalizing experimental therapy.

Gender, sport and race in South Africa

2009-08-31T18:21:00.004-04:00

The case of Caster Semenya is fascinating from what you might want to call a 'purely bioethics' point of view. Semenya blew away the field in the women's 800 meters at the world athletics championship in Berlin. In fact, the margin of victory was so great, and the improvements in her recent race times have been so radical, that it makes you suspect some kind of artificial enhancement. But that is not it. Along with these achievements, Semenya's outward appearance (body shape, facial hair, deep voice) have raised the possibility that Semenya is not an enhanced woman, but simply a man. No, that is not right: 'simply' is the wrong choice of words. She may be biologically too much like a man to fairly compete against other women. Which leaves us (as well as the International Association of Athletics Federations or IAAF) with the unsimple question: where do you draw the line for biologically 'man-ish' women in competitive sport?

In South Africa, the question is even more fascinating, or more depressing, depending on your perspective. Caster, after all, is South African, and the debate here, reflecting local realities, turned instanteously to questions of race. The whole sticky biological question was sidelined in favor of another question: is the questioning of Caster's gender racist? A number of prominent government officials were ready to answer in the affirmative, and ventilate their righteous indignation in front of press and cameras. The idea was that Caster's gender would not be in question if she were white; she is being unfairly discriminated against. When it was pointed out that gender tests were applied also to white athletes in the past, some took a new line of argument: that the South African media did not rally sufficiently behind Caster, too easily giving in to suspicions about her gender, and this proving that the media continues to be controlled by whites. According to this view, the Caster Semanya story exposed the South African media as racist, and if you don't want to deemed a racist yourself, it is best to regard Caster as a woman. (A woman, a whole woman, and nothing but a woman.) It is unfortunate that, at least in South Africa, strange new dilemmas about gender and sport have taken a backseat to posturing about race.

Forced circumcision case in South Africa

2009-08-13T17:02:00.009-04:00

The ancient practice of circumcision never fails to stir things up. Neonatal circumcision, whose popularity has steadily declined in Europe and is on the wane in the United States, is a reliable flashpoint for ethical debate. The debate over the costs and benefits of circumcision has been stimulated by research indicating that being circumcised significantly reduces a man's chances of getting HIV via hetrosexual intercourse. In South Africa, there has been much discussion about the state of traditional circumcision rituals, given that a significant number of young men die from circumcision-related causes each year.

An ongoing case in South Africa adds some new wrinkles to ethical and legal debates about circumcision in Africa. Bonani Yamani claims that when he was 19, he was abducted from his home, taken into the bush, circumcised against his will and forced to eat his own foreskin. His father apparently arranged or otherwise had knowledge that the abduction/circumcision was to take place, and it is his father that Yamani is suing. As it turns out, Yamani had undergone a (partial?) medical circumcision some months before. So Yamani is not against circumcision per se; he is opposed to traditional (Xhosa) circumcision, which he believes is contrary to his own Christian faith. And he is naturally opposed to having had it forced upon him.

The case brings out conflicts in a number of directions. There is the conflict between the father and son. The conflict between different views of circumcision: medical, traditional and (adopted) religion. But there is also a conflict between traditional leaders (in particular, the Congress of Traditional Leaders of South Africa or Contralesa) and the South African constitution: according to traditional norms, a male Xhosa who refuses to be circumcised is to be ostracised from his community. Traditional circumcision is not a matter of informed consent. It is just simply done, as part of being a Xhosa man, and refusal is not accepted. On this view, non-traditional circumcision and community membership are mutually exclusive. Yamani's legal defense will be arguing that not being able to live as a non-traditionally circumcised Xhosa should be regarded as discrimination under the South African constitution. Members of Contralesa have publicly stated that the constitution really has no grip on this area of South African life. This should be one to watch.

Ethics, research and Medecins sans Frontieres

2009-07-31T18:23:00.008-04:00

Medecins sans Frontieres (MSF) is a humanitarian organization whose Nobel Prize winning work barely needs an introduction. They are well-known for their efforts in providing health care (among other services) to those in severe social crises and emergencies worldwide. What is less known is that MSF is increasingly conducting its own research among vulnerable communities where it does its humanitarian work. This week, PLoS Medicine published an editorial and an article about the ethical challenges faced by research conducted by humanitarian organizations and the establishment of a research ethics committee within MSF.

It makes for fascinating reading. The ethical challenges abound: what does community engagement -- a recent 'must' for ethical research -- come to when the 'community' is being unraveled by war or a natural disaster? How can consent of participants be voluntary if MSF is doing clinical research and acting as the sole provider of medical care in a certain locale? How can consent be informed when there is a blurring of lines between MSF care and MSF research? How can MSF adhere to the ethical requirement of providing research benefits to local communities, when its field sites are subject to being moved elsewhere, due to severe political unrest or larger organizational priorities? The article is invaluable in carving out a relatively new area of study, i.e. 'humanitarian crisis research ethics.'

At the same time, though, some sentences in the article left me with the impression that the marriage between MSF and its ethics committee has been unhappy at times. The paper states that the ethical review board is "not accountable for any research which is carried out against its advice," suggesting that there were cases of non-approved research. It also states that " ... not all research is submitted to the IRB for review", giving the impression that MSF researchers or other MSF staff (rather than the ethics board) have been empowered with the decision of what constitutes reviewable research. At other points, the authors (themselves members of MSF's ethics review board) indicate that their recommendations have only partly been taken into consideration in MSF's research policies or procedures. A bit strange, when you think about it: wouldn't you expect a humanitarian organization, having decided to do research on vulnerable populations, to be the most aggressively concerned about the protection of research participants?

Postscriptum: since I am still in the Democratic Republic of Congo, my eye alighted on the video posted on MSF's homepage. It is a depressing piece, but gives an impression of the situation in the east of this country, and the activities of MSF there.

Rwandan mandatory sterilization kerfuffel

2009-07-11T15:53:00.003-04:00

The impact of the internet on the processes of determining health policy, anywhere in the world, is worth studying in its own right. Case in point: last week, Human Rights Watch (HRW) came out with a press report condemning a draft human reproductive rights law proposed to the Rwandan parlement. The draft, HRW alleged, contained a provision stating that individuals with intellectual disabilities were not to be allowed to reproduce. The Rwandan draft bill contained a whole lot of controversial material besides, especially pertaining to HIV/AIDS: compulsory premaritial HIV testing; requirement of a married individual to be tested for HIV if their spouse requests it; permission of doctors to test children or incapacitated persons for HIV without consent and then disclose the result to parents, guardians or other care providers. But it was the forced sterilization that really hit the internet, here and here and here.

Rwandan government officials scrambled to do what politicians (first) do when faced with a public relations nightmare: deny everything. Damascene Ntawukuriryayo, deputy speaker of the Rwandan parliament, denied the claims of HRW, said that there was never a proposal for forced sterilization, and that plans for HIV testing before couples get married were always to be strictly voluntary, not compulsory. Apparently thinking that a good offense is the best defence, Mr Ntawukuriryayo stated that HRW should check its facts before releasing reports into the wilds of the internet.

It does not take much effort to find views that contradict Mr. Ntawukuriryayo's statements. Back on June 23rd, before the HRW report hit the web, Focus Media in Kigali published a fairly detailed article by Sam Ruburika on the shortcomings of the draft legislation, including quotations of the original text. The proposed legislation on forced sterilization appears as Article 22: "The Government shall have the obligation to suspend fertility for mentally handicapped people as long as the handicap is still persistent and upon decision by a medical team comprising at least three medical doctors. An order of the Minister in charge of health shall specify the list and implementation modalities for diseases accounted for by this article." According to Ruburika, the Chamber of Deputies approved of the draft legislation, including its articles on sterilization and compulsory HIV testing, and it was only when it reached the level of the Senate that red flags started flying.

How are we to understand this? It goes without say that pregnancy and sexual relationships involving mentally handicapped persons is a very difficult and important issue. Why the hamfisted approach? One possibility is that there are members of the Rwandan government whose views on reproductive policy, while they might express certain draconian community sentiments, are at odds with the Rwandan constitution. Fortunately there are checks and balances enough to stop these sorts of unreconstructed proposals from becoming law, but it is striking that the draft survived in that form as long as it did. It survived long enough to be detected by the internet radar -- spelling its immediate demise.

This blog has moved to Cape Town

2009-07-05T15:02:00.006-04:00

From the beginning, this blog has explored emerging bioethics, research ethics and public health ethics issues in developing world contexts. But much of it has been, unapologically, about sub-Saharan Africa. Unapologically, because these fields have been -- and continue to be -- disproportionately orientated towards what goes on in more affluent, industrialized nations of the north.

Within this sub-Saharan focus, South Africa has had a prominent place in this blog. There are probably many sources for this. South Africa is a comparatively better-off country than (some of) its sub-Saharan counterparts, and therefore there is greater exposure of bioethical issues in the press and on the web. HIV/AIDS always brings with it dilemmas for researchers, clinicians and public health policymakers, and South Africa has a devastating HIV?AIDS epidemic, coupled with standard-fare tuberculosis, multidrug-resistant tuberculosis, and as if that was not enough, extremely drug resistant tuberculosis. The country has also had a spectacularly strange Minister of Health, some of whose pronouncements and policies about HIV/AIDS could have been written by Monty Python, but of course the unfunny part was that she really meant it. And an ex-President who denied HIV causes AIDS, and a bevy of medical charlatans running about. Plus conflicts between modern medicine and traditional healers, rising up (for example) in cases where young men die by the dozen in blotched ritual circumcisions. The country also has -- a legacy from the Apartheid era, no doubt -- a strong research infrastructure capable of conducting clinical trials and therefore dredging up all the research ethics issues of doing such trials with vulnerable populations. In short, a little bit of everything.

I accepted a sort of one-year visiting professor position in Cape Town awhile ago, and arrived here last week. It is not the first time I've been in the Cape: I completed my philosophy Ph.D. while living in nearby Stellenbosch some years ago, and left the country in 2001. Some things have changed, much has stayed the same. It remains to be seen whether this blog changes, now that it is being written out of Africa.

An epidemic of health care worker strikes

2009-06-27T15:45:00.002-04:00

This seems to be a summer of strikes among health care workers, raising again the ethical issues surrounding hospital strikes, particularly in resource-poor countries. On the one hand, state-paid doctors often work in abysmal conditions for relatively meagre wages, and when a strike breaks out, it is often a matter of doctors and nurses finally reaching the end of their tether. On the other hand, patients suffer when health care workers strike. They must wait longer or seek alternative care -- if such care is available and affordable. In many poor countries, the alternatives to health care in state hospitals are few. Traditional healing is one. No care at all is another. The impact of such strikes on patients are rarely the object of scientific study, but surely long and lingering strikes, where only the bare minimum health services remain in place, must be a source of avoidable morbidity and mortality. In the middle of all this you have the Ministries of Health: sometimes acting as mediators, and sometimes (because they are arms of government) the origin of the dispute and an obstacle to its resolution.

The provinces of Kwazulu-Natal and the Eastern Cape in South Africa are in the midst of a prolonged strike. State health care workers in Zambia are facing dismissal by the government if they do not show up to work by next Monday. In Adamawa state in Nigeria, health workers have started an indefinite strike and patients seem to be leaving the abandoned wards of clinics and hospitals in droves. And in the Democratic Republic of Congo, a health care workers strike has been going on for ages, though generally unreported in the press. Our sister blog, The Francophone African Bioethics Blog had a piece about this (in French) back in May, and the strike is still unresolved.

Each strike has to be judged, from an ethical point of view, on a detailed and (ideally) balanced account of the relevant facts. But some basic principles should be followed. Urgent medical services should always continue to be provided during a strike, and those providing them should not be regarded as 'scabs' or strike-breakers. Health care strikes should be regarded as qualitatively different than strikes in other labor sectors, due to the special value of health. For that reason, a as-swift-as-possible resolution of the strike should be the top priority of the health ministries involved, because of the impact that every day of the strike has on the ethical core of the issue: patient health.

Mandatory male circumcision in the Zambian police force

2009-06-24T18:32:00.006-04:00

In the last couple of years, there have been a number of high-profile studies exploring the relationship between male circumcision and HIV acquisition. Three randomized clinical trials in Africa confirmed an association suggested by less rigorously designed studies, i.e. that men who are circumcised are significantly less likely to acquire HIV from infected women during vaginal intercourse. But what to do about these findings in terms of public health policy? The professional views and lay public opinions are highly diverse and sometimes highly emotive. Some in public health circles consider male circumcision as effective as a vaccine and the promotion of male circumcision in regions of high HIV prevalence as an ethical imperative. Others, who have ethical objections to (especially neo-natal) male circumcision in general, criticize the methodology of the clinical trials, question their conclusions, and view the promotion of male circumcision as deeply misguided and harmful.

Whatever side one takes on this issue, the approach of the Zambian police force is bound to raise eyebrows. According to the Lusaka Times, the national police force is planning to make male circumcision a requirement for all new recruits. The police force has apparently been losing male police officers to HIV/AIDS. Male circumcision is being strongly promoted in other professional contexts in sub-Saharan Africa, such as Rwanda, which has included it as part of an HIV prevention strategy within its army.

Of course, the Zambian approach is not 'mandatory male circumcision' in the strict sense: it is only mandatory among those who have chosen to join the police force. At the same time, the idea of mandatory irreversible preventative genital surgery on healthy males bound to be controversial. Making the practice obligatory, rather than a matter of choice, raises the ethical stakes: you need a very strong justification to move from voluntary to mandatory. Is the HIV incidence among policemen in Zambia very high? If so, what explains that incidence? Is male circumcision likely to counteract whatever forces are driving the high incidence? To pull off a utilitarian justification of the policy, you need to clearly show that the overall benefits of the policy will outweigh the overall costs. And even if you do, not everyone will be impressed: not everyone is a utilitarian.

For a flavor of the online debate this sort of story inspires, have a look over at the Universal Circumcision blog.

Hat tip: Daniel Westreich.

Are countries that ratify human rights treatises more healthy than others?

2009-06-09T15:30:00.006-04:00

One might think that a country which has ratified human rights treaties, and thus has made them to some extent law, will have better health outcomes than countries where this is not the case, all things being equal or at least controlled for. A study just published in The Lancet indicates otherwise. The researchers looked at some key and often-measured health and social indicators, and sought correlations between number of treatises ratified and changes in health/social indicators before and after ratification of health-related human rights treatises, as well as making comparisons between health/social indicators in a total of 170 countries that did or did not ratify certain treatises.

The results are sobering, or perhaps predictable, depending on one's pre-existing opinions about the power of human rights approaches to health. Ratification of human rights treatises does not seem to have any significant effect on maternal mortality, infant/child mortality and life expectancy. The researchers try to put a brave face on the data, by adding that ratification of human rights treatises can have some indirect (but hard to pin down) effect on health by strengthening legal arguments aiming to ensure access to health care. But in the end, money trumps law: there is much greater evidence of an association between economic conditions and health than there is between the ratification of human rights and health.

One might object by saying that ratification is the mere promise of action, just the signing of a paper, and we should only expect an effect in terms of health outcomes in countries that rigorously monitor, enforce and make its human rights commitments real. In other words, in finding no significant association, what the researchers have actually done is study the global absence of political will in regard to human rights relevant to health.

Bioethics and democracy in developing countries

2009-05-26T23:05:00.005-04:00

The fields of bioethics in many developing countries -- despite some important 'capacity-building' initiatives -- have a very limited impact. There are a few people trained in bioethics here and there, some (underfunded) centers and attenuated networks, a few scattered publications. But why should that be the case? Bioethics is decades old by now, and research and medical practice among vulnerable populations in such settings raise a great many ethical challenges. So you would think there would be more activity, more interest.

In BMC Medical Ethics (free online access here), Ghaiath Hussein takes a shot at an answer. And his answer is: politics. The flourishing of bioethics, according to Hussein, depends on a number of political factors that are not present, or only faintly present, in developing countries. The first is an 'atmosphere of freedom' where people can engage in moral reasoning without fear of censorship of or punishment for their beliefs. That atmosphere of freedom in turn depends on a socio-legal framework in which the rights, duties and responsibilities of individual citizens -- both in regard to health and other important values -- are spelled out, understood by the populace, and protected by legislative and judiciary systems. Of course, the development of bioethics is aided to some extent by economic factors, in particular the progress in health systems development and creation of medical technologies. But these would not give rise to bioethics debates they did not engage with public expectations of receiving decent medical care, and citizens having some say in health policy decisions.

It is easier to see what Hussein is saying by reflecting on the place of bioethics within totalitarian or politically oppressive regimes. Where there is little press freedom, there will be less (and less diverse) public debate about controversial issues in medical research and practice. Where those working in bioethics are regarded as 'human rights activists' and subject to special state scrutiny, it will be difficult to motivate people to pursue these interests. Where people think of health care as a 'gift', and death as a common (and mostly unavoidable) event, the provision of sub-standard medical services will not be regarded as a failure of government and a moral outrage. Where Ministries of Health have historically acted (or currently act) as an arm of an oppressive state, and are as corrupt as any other branch of government, there will be little public trust in ethical codes, regulations, licencing boards, or ethics committees that are attached to these ministries or have received their seal of approval. All of these factors, according to Hussein, have diminished the impact of bioethics in many developing countries, and have reduced it to a mere academic pursuit, tolerated by the powers that be because it is poses no threat to them.

Hussein suggests that bioethics, in some places, is a deeply subversive activity. If real bioethical activity took place in some developing countries (he includes his own Sudan), there would be an ugly and dangerous clash with the established political order. So he suggests a softer approach: depict bioethics as a mere aid to decision-making (rather than embodying important rights and values); couch bioethics in religious or religious-friendly terms; adapt bioethics to local contexts rather than depict it as a fancy 'Western' import. Once it is conceptualized this way, it becomes clearer how long and difficult the road will be before bioethics becomes a social force in developing countries.

Motherhood as danger

2009-05-18T23:50:00.002-04:00

Nicholas Kristoff, columnist for the New York Times, has an interesting piece (and accompanying video) on maternal mortality in Africa. Women in many places in Africa, die during childbirth at a depressingly high rate: 1 in 10 births in some areas. What Kristoff piece does well is give a succinct impression of the different, and often avoidable, causes of maternal mortality during childbirth: poverty and lack of education; gender inequality and the associated low priority for women's health issues; brain drain of medical personnel to richer countries; overworked health staff and abusive attitudes towards (especially female) patients; sub-standard medical facilities; transport barriers to reaching health care centers, particularly for pre-natal services. The avoidability of death in such cases -- sometimes a mother's life could be saved with a few dollars -- makes this an ethical issue, and not just a medical one.

The unbearable lightness of international research law

2009-05-14T19:08:00.007-04:00

I am on a number of bioethics and research ethics listservs, mailing lists and have set up a couple of google alerts. This means that I tend to get news of everything bioethical that has been freshly posted on the web at least three times. When something comes out in a major journal, then this number increases. So when George Annas' piece on the globalization of clinical trials and informed consent appeared in the New England Journal of Medicine this week, I had my hands full: even friends had sent copies or links.

The title of Annas' piece was inviting, but after reading it (twice) I felt a bit deflated. Annas starts by remarking that the situation of a decade ago, well-publicized concerns were raised about the ethics of medical research in developing countries, and these concerns have not gone away. However, he goes on to write the controversial case of pharmaceutical giant Pfizer in Nigeria has dredged up some legal opinions that might, in the future, have enough bite to provide protections for participants in international research.

To be more specific, Pfizer is accused of conducting medical research in 1996 in Nigeria involving children, where informed consent was not properly (or at all) obtained from the parents, and according to families involved, some of the children were rendered blind, deaf, paralyzed, brain-damaged or dead. In January 2009, the US Court of Appeals for the Second Circuit reversed a prior trial decision that dismissed a lawsuit against Pfizer. What matters, according to Annas, is the basis of the Second Circuit's reversal: the court's arguments implied that getting informed consent from research participants (or proxy decision-makers) constitutes a norm of customary international law, and on this point the court relied on the Nuremberg Code, the International Covenant on Civil and Political Rights, the Declaration of Helsinki and CIOMS. Moral of the story: if you conduct medical experiments without consent (anywhere and including in developing countries), then you stand a chance of being sued in courts around the world for violating an international human rights norm.

Maybe. The Pfizer court case has not been tried, so it is not clear yet whether the Second Circuit will actually decide the case in terms of international human rights law -- so far, they have only created the possibility for making such a judgment. And this comes at a time when international (human rights) laws are not exactly striking fear in the hearts of the ruthless. There is the torture question. There is the illegal invasion question. Since World War II, many international codes have been floating around, some have been made law in some countries and used in some international tribunals, but the question is open whether these developments have made a real dent in the abuse of the weak by the powerful. Someone should research the track record. Because if unconsented medical research can only be deterred by means of a (new) international human rights norm that might (more than a decade later) be applied, and that is supposed to provide substantial protections for research participants in developing countries, then the world is in far worse shape than I thought.

Drugs for neglected diseases: an immodest proposal

2009-05-08T17:03:00.019-04:00

People working in bioethics have sometimes been criticized (often by social scientists) for not being radical or critical enough. Instead of speaking truth to power, we have been regarded as purveyors of watered-down or sanitized versions of the truth, hoping that by being 'pragmatic' or 'realistic', the powers that be will actually listen to the arguments and take appropriate actions. The powers in question can be powerful research institutions, international health agencies, pharmaceutical companies, medical insurance companies or Ministries of Health. The problem: the more palatable bioethics arguments are to these powers, the more likely they are to listen, but any changes based on those arguments will therefore be small, incremental, piecemeal. On the other hand, the more adversarial the arguments, the less likely they are to listen at all. And, of course, bioethics institutions are very often closely aligned with some of these very same powers: that is where bioethics acquires much of the authority it has, not to mention much of its funding.

So in this intellectual climate, it is refreshing to read an article laying out a policy that attempts to seriously rock the boat. In the current Journal of Medical Ethics, an article entitled 'Ethical issues in funding research and development of drugs for neglected tropical diseases' (free access) has an argument which basically runs as follows. Research and development on neglected diseases, particularly those affecting developing countries, has been very limited in the last decades, despite these diseases being responsible for vast numbers in mortality and morbidity. Between 1975 and 1999, only 16 new drugs for these diseases were produced out of the 1393 chemical entities developed during that period. One explanation for this situation is the current drug patenting system. Pharmaceutical companies are primarily driven by profit motives, and the patent system gives companies years of market exclusivity for their products. Market exclusivity allows companies to charge whatever prices the market can bear. The most profitable drugs are those which don't demand large research investments, provide some small health improvement for a large population, and respond to health conditions in industrialized countries where many people can and are willing to pay the price for the drug. For these reasons, drugs for neglected diseases affecting the world's poor is simply not interesting from a profit-seeking pharmaceutical company perspective.

The alternative? Scrapping the patent system enjoyed by pharmaceutical companies altogether. Reward the development of new pharmaceuticals from public funds based on the actual impact that they will have in terms of global morbidity and mortality. This would recast the focus from profit margins of private companies (and economic interests of more affluent nations) to global health, a seismic shift particularly important for resource-poor settings with the greatest need for improvement in health and well-being.

Will pharmaceutical companies and national governments buy into this? Not likely. The historical trend is toward short-term self-interest, not long-term public goods. There are very deeply entrenched vested interests who would be strongly opposed to this idea. The public funds probably would not be anywhere equivalent to the kinds of money pharmaceutical companies are making right now. But at the very least, the immodest proposal throws a spotlight on the ethically dismal regime of global drug research and production that we current have.

H1N1 flu vaccine and the developing world

2009-05-05T23:42:00.004-04:00

Up to a few months ago, the media was almost singularly focused on the election of President Obama. Seemingly from his first day in office, the attention switched to the feeble state of the US and global economy and what the new US president was going to do about it. Now the media has had to turn to something else: the 2009 H1N1 flu. Besides dubious Hollywood films, disease outbreaks have always made for good copy, particularly if the disease is potentially fatal and easily transmissible. Virtually every aspect of the flu has been reported and discussed in gruesome detail, from the effects of the epidemic on pork production to the (overly?) strict public health measures taken by the Mexican government.

There is one issue that has garnered significantly less attention, however. If the H1N1 virus comes in a more virulent form in a second wave during the fall or winter, there will be calls to produce a vaccine against the virus. Vaccines are generally made in a handful of European or American countries. Mostly vaccines are developed in these countries by pharmaceutical companies who patent their products -- and seek a healthy return on investments -- when they go from research to marketing and sales. The question then becomes whether those in the developing world will be able to access any new H1N1 vaccine, or will we see the usual disparity of epidemic impact as already we do with HIV/AIDS and tuberculosis: the poor will be hit the hardest.

As a pair of recent articles in SciDev point out, there is no shortage of expressions of goodwill by pharmaceutical companies who say they will give out H1N1 vaccines if it comes to that. Whether that will happen in reality is yet to be seen. For when an epidemic hits, there is immediate demand for vast quantities of vaccine, and when pharmaceutical companies are on the supply side, they are sitting in a very powerful negotiating position.

UPDATE or related link: the Third World Network has put out a press release on this subject, and the link is available here.

Same but different: inequities in international collaborative research

2009-04-16T21:35:00.008-04:00

When it comes to international health research and inequality, the ethical focus is usually on the relationship between the (generally well-off) researchers and the (generally poor) participants. And rightly so. But there is another relationship which has received far less attention, even though the associated ethical problems have the same basic roots. There are, namely, vast differences in socio-economic status, political power and (oftentimes) skills among researchers from industrialized nations and researchers from in resource-poor ones. The big funders of health research -- and those that set the research agenda -- are located in Atlanta, Washington, Geneva or London, and researchers from developed nations are generally in far better positions to negotate and gain research support from them. They are also likely to have received education at well-equiped, prestigious universities, to have gained mentorship in regard to publishing in the better peer-reviewed journals, and hence to have much more impressive-looking CVs. No wonder researchers in developing countries sometimes feel they are bit players in someone else's game.

This degree of inequality can lead to tensions between researchers from abroad and local researchers in developing countries. The two live in strikingly different contexts, but they have to work closely together. To bring out the contrasts and the tensions these contrasts can raise, I have sometimes asked international researchers whether they share the global budget of their research projects with local scientists. Some do, some don't. Some don't like to disclose that they are making 400% more money than their partners. Some are embarrassed by how much of the budget goes to overhead for an institution which is already quite well off.

SciDev reports that last month a conference was held in Germany focusing on North-South research partnerships and equity. A framework was proposed whose goal is to help ensure that developing country scientists have an equal role to those of developed countries in any collaborative research partnership. Capacity-building of individuals and institutions involved in health research in developing countries plays a prominent role within the framework. But then again, similar talk was aired at least a decade ago, and it is not clear how much progress has been made in the meantime. As long as the broader inequalities between countries in the 'North' and 'South' remain in place, and there is little serious commitment to combat them, the most well-meaning initiative to create equitable research partnerships faces very considerable challenges.

Economic downturn and global health

2009-04-10T22:51:00.004-04:00

Economic crises and economic recovery plans are dominating the news. There is news about macroeconomic indicators (such as unemployment rates) as well as how the economic downturn/recession is affecting the lives of ordinary people. Or at least, the macro- and micro effects of the crisis in America, Europe and better-off nations in Asia. With rare exceptions, there is little talk or concern about how the breakdown of the world's dominant economies is playing out in the world's poorer countries, despite estimates that the numbers of persons living on less than $2 per day will soon swell by the tens of millions.

Last week, the New York Times published an editorial about the situation that many developing countries find themselves. Currency rates are falling as is demand for whatever products those countries export in the global market. Unlike the United States and Europe, these countries don't have a few trillion dollars on hand to stimulate their own economies; they are struggling to pay back the loans taken out in years past to ... stimulate their economies. The NYT editorial claims that affluent nations should give more money to the International Monetary Fund, who in turn can extend more lines of credit to developing countries. The assumption seems to be: we need to maintain the longstanding debt and dependency relationship between developed and developing countries, i.e. prop it up with more cash injections. The editorial is silent about the very spotted history of IMF loan practices and developing countries, and about who is responsible for the culture of toxic financial products that created the global financial crisis in the first place. It has a real 'rearranging deskchairs on the Titanic' feel to it.

Another publication, quite another angle: the British Medical Journal has published a thoughtful piece on the potential effects of the financial crisis on health in developing countries, and how the crisis could be an opportunity to positively change the global financial landscape. Although there is no firm data yet, the consequences of the financial crisis on health in developing countries look very dire: if you take the 'social determinants of health' model, and reasonably assume that the economy (in terms of income) partly determines health, then people in already resource-poor countries are going to get sicker, and more are going to die of preventable and treatable conditions than before. The way out, according to the authors, is not to refill the coffers of the IMF. It would be better to first ditch the idea that the more unregulated a market is, the better off the economy will be, and the better off the health of nations will be. The de-regulation of markets seems to have faciliated the growing inequalities between the health and wealth of nations over the last decades. Moreover, at crucial points where the global market was regulated -- through trade laws and regulations -- the conditions of trade were largely set by and to the advantage of more affluent nations. We therefore need to draw radical lessons from our current predicament, by reflecting on just how we got here. As the authors write, "The financial crisis gives us the opportunity to bring social justice and environmental concerns to bear on the kind of new global economic order that must be put in place." Amazing that health professionals in the BMJ are now giving voice to these views, once the mainstay of activists at global economic forums.

Exciting new bioethics research topic: the Pope

2009-03-17T15:07:00.004-04:00

Former South African president Thabo Mbeki and his fellow ideological travellers in the South African Ministry of Health encountered much domestic and international criticism for their positions on HIV/AIDS. Mbeki once claimed that he 'knew no one who died of AIDS' (it was poverty that did them in) and was cosy for awhile with a fringe group of researchers who deny that HIV exists, or if it exists, that it causes AIDS. The former president was soon clever enough to realize that these positions were very unpopular in a country with a raging HIV/AIDS epidemic, and so left it to various health authorities in the country to express similar beliefs. The former Minister of Health, Manto Tshabalala-Msimang, famously suggested that HIV virus could be treated with lemons and garlic, and that anti-retrovirals were poison, and only benefitted the pharmaceutical companies that produced them. But these were only the most flamboyant characters in the tale. The less-known story is how this absence of leadership, or just plain obstructionism, immobilized the South African health system in regard to HIV prevention and treatment for years, or what the true cost of that paralysis really was in terms of human morbidity and mortality.

Recently, however, two studies have put numbers where there was only speculation and accusation. A mathematical modelling study at Harvard University estimates that Mbeki and company's stance was responsible for the deaths of 330,000 people. A paper by Nicoli Nattrass at the University of Cape Town comes to roughly the same figures: 343,000 lives would have been saved over 9 years if the South African government was not engaged in 'genocide by sloth.'

Which brings us to ... the Pope. The Pope is visiting Africa this week, where he has declared that the use of condoms is not the answer in the fight against HIV/AIDS, and the answer is abstinence. Of course, Pope Benedict is not the first Pope to talk to Africans about how to have (or not have) sex, or the first to say that the distribution of condoms 'can even increase the problem.' As usual, these statements will infuriate many in the HIV prevention community who regard abstinence as a largely failed approach and regular condom use as a crucially important element in the struggle against HIV/AIDS.

But instead of getting angry, researchers should do with the Pope what was done with Mbeki: devise rigorous studies to quantify the number of deaths and new HIV infections that have resulted from the Vatican's position. How many new HIV infections and AIDS-related deaths might have been averted due to the Papal condemnation of condom use, particularly in Christianized African communities? And how does the resultant carnage of preventable deaths square with Christian values? It is not enough to complain: we must study the Pope and his effects, just as we would any other global health hazard.

Bioethics and the stimulus package

2009-03-10T15:55:00.006-04:00

Last week, the National Institutes of Health (NIH) announced to great fanfare its new Challenge Grants program. The grant program is funded, to the tune of 200 million dollars , by the Obama administration's American Recovery and Reinvestment Act -- part of the 'stimulus package' we have been hearing so much about. This new grants mechanism will support studies on what are called 'challenge topics', i.e. specific high impact biomedical, social and public health research areas.

Shockingly, bioethics is considered one of those areas. Applications are requested for proposals about informed consent and data access policies; ethical issues of emerging technologies; ethical issues in health disparities and access to participation in research; ethics of sharing of electronic health information; ethics of translating genetic information into clinical practice; the ethical issues involved in the blurring of research and treatment; and research on recontact issues in genotype and genome-wide association studies. Those of us working in international bioethics and research ethics were especially excited by the sentence " ... studies are needed to assess the impact and ethical considerations of conducting biomedical and clinical research internationally in resource-limited countries." This is certainly a challenge topic, and no doubt relevant, given the increasing amount of US-funded or facilitated research taking place around the world, especially in the world's poorer countries.

And then came the fine print. A couple of days ago, the NIH added a notice to the request for applications. It reads:

Funding for this program is provided under the American Recovery and Reinvestment Act of 2009 (Recovery Act). The purposes of the Recovery Act are to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health. Consistent with these goals, domestic (United States) institutions/organizations (i.e., those located in the 50 states, territories and possessions of the United States, Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia) who are planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 (aggregate total for all subcontracts and subawards), whichever is less.

This does not mean that you cannot propose an international research ethics project involving foreign collaborators and institutions. It just means that you have to find collaborators and institutions willing to swallow the fact that, even if the topic is about health disparities and research in low-income settings, 90% of the grant money must stay in the United States. Dealing with that painful irony may be a challenge in itself.

How friendly can Big Pharma be to developing countries in a down economy?

2009-03-09T22:24:00.005-04:00

Pharmaceutical companies are easy targets of ethical criticism, and it is easy to see why. They invest vast amounts of capital to develop drugs that can be crucial for health, and seek a profitable return on their investment through consumption of the drugs by patients. Profitable returns are only likely when significant numbers of consumers suffer from the condition the drug aims to treat, and when those consumers have sufficient buying power. From a profit-seeking pharmaceutical perspective, there is little incentive to develop drugs for conditions that are prevalent in countries where few people have the wherewithal to purchase the drugs. There may be an urgent health need for such medicines, but if there is no market for them, no return on investment, then it is unlikely that pharmaceutical companies will develop such drugs or faciliate access to them. Unless, of course, developing such drugs and increasing access to them is part of a public relations ploy, meant to enhance the company's brand.

The head of GlaxoSmithKlein (GSK), Andrew Witty, apparently caused a stir at Harvard Medical School last month by promising that his company would make essential medicines accessible to developing countries and commit more resources to research on neglected diseases. More precisely, GSK will take 20% of its profits from sales in developing countries and reinvest back in local health care infrastructure, and patented medicines produced by GSK will be sold at 25% of their market value in the 50 poorest countries of the world. In addition, there was talk of a 'patent pool' for neglected diseases, i.e. an agreement between various patent-holders to share (for some fee) those patents with each other and with third parties.

These promises may make GSK look saintly, but the impression largely fades on reflection. 20% of GSK's profits in developing countries does not amount to much; an editorial in the Lancet calculates it as less than 0.1% of GSK's total profits, and the folks at Policy Innovations see this as boiling down to about $50,000 per country, hardly a generous investment in local health infrastructure. Selling patented medicines at a quarter of the usual (bloated) price may not be of much help either to those who live on a few dollars per day. And while giving access to patents sounds nice, the road from possession of patent information to research to marketing is a long and winding road paved by a great deal of money. Who has that kind of money? The big pharmaceutical companies, like GSK. But they won't really invest to create drugs for conditions affecting developing countries because the profit margin would be meagre. We come full circle.

Gestures of philanthropy towards the world's poorer nations, on the part of aggressively profit- seeking pharmaceutical companies, is to be taken with a grain of salt at the best of times. In a down economy, when pharmaceutical companies are merging for their own survival, full-blown skepticism is in order.

The ethics of outsourcing clinical trials, one more time

2009-03-01T10:39:00.007-05:00

Since the mid-1990's, and clinical trials on drugs to prevent mother-to-child transmission of HIV in Africa, there has been a growing academic literature on the ethics of clinical research in developing countries. Of course, this is an academic literature, which means that only a vanishingly small number of the world's population has actually read any of it. But the general popularization of the economic practice of 'outscorcing' has raised public awareness of the debate somewhat, together with the steady stream of scandals and suspicions emerging out of India, which seems to be a lightning rod of ethical concern about clinical trials lately. The global clinical trial outsourcing phenomenon is a wild and woolly affair: it is not known precisely how much of it is going on, precisely what sorts of studies are taking place, how regulatory oversight works (or doesn't) in actual practice, and what to think -- from an ethical point of view -- about the whole messy business. And it is important to get some clarity on this subject: given the vast health and other inequalities between the agencies funding and institutions largely conducting clinical trials in developing countries, how can such studies avoid plunging into one or another ethical pitfall? So it is timely that the New England Journal of Medicine published a commentary entitled 'Ethical and scientific implications of the globalization of clinical research' a couple weeks ago.

However, a piece in the New York Times on the NEJM commentary was not very positive, and it is not hard to see why. The authors breezily trot out the usual ethical problems in clinical trials: relative lack of understanding of research procedures by research participants; possible undue inducement by financial compensation offered to the poor; large differences in standards of care and possibility of ethical double standards, i.e. study designs in developing countries that would be allowed in more affluent ones; uneven research oversight by local ethics committees; drugs tested on participants not being responsive to local health needs; drugs developed from the research not being accessible to the communities who participated in the research. All of these are legitimate concerns, or at least can be, in particular clinical trials. But the NEJM article does not add anything here to current debates engaging with more fundamental questions: how much understanding is 'enough' for informed consent, in any research study, with any population? What makes an inducement undue? Are all cases of double standards wrong? What does it mean for a study to be 'responsive' (or not)? Are all cases of communities not having (immediate?) access to study drugs necessarily ethically wrong?

Whenever the commentary departs from old concerns, it seems to glide into hot water, particularly when it offers recommendations to address the ethical problems raised by the globalization of research. The authors suggest that clinical trials are outsourced largely because of bureaucratic regulations in developed countries, which adds to research costs, and therefore these regulations should be 'streamlined' in order to de-incentivize doing clinical trials abroad. It is a charming idea that ethics committees would be responsible for stimulating the globalization of research (and indirectly, the ethical problems that go with it), but it seems more likely that streamlining the processes at home will simply increase the number of trials abroad, as long as the economic disparities between countries remain in place. You will simply get your IRB approval faster. Besides, if you want to 'de-incentivize' clinical trials abroad, why not build up ethical review in developing countries, or force pharmaceutical companies to pay to build local health infrastructure and capacity as a cost of doing business, rather than scaling down IRB processes at home?

There is a sneaking sense in the NEJM commentary that the ethical problems raised by the globalization of clinical research is 'our' problem -- i.e. that of the more affluent countries -- and that it our responsibility to fix it:

Industry sponsors, contract research organizations, and the academic community can meet the challenges of globalization by accepting full responsibility for the ethical conduct and quality oversight of these trials.

There is little hint that such responsibility needs to be -- for ethical and practical reasons -- shared with local communities in which research takes place, as well as national governments, ethics committees, research institutions, NGOs, and other stakeholders. Developing world researchers enter the picture indirectly, and mostly passively, as the recipients of training in conduct of clinical trials. True, there is talk of 'reaching international consensus' on the ethics of global clinical research, perhaps in conferences held by the WHO or Institute of Medicine, and folks from the developing world could come too. But in the end, with this sort of top-down (and North-South) approach, the chances that the recommendations will be taken up, put much of a dent in the ethical issues surrounding outsourcing of clinical research, seems pretty dim. And the fact that this commentary about ethics and the globalization of research seems to have been penned exclusively by US researchers is not necessarily damning, but also not very encouraging either.

Fascinating research ethics case from Malawi

2009-02-03T12:40:00.004-05:00

Sci.Dev broke a story back in November about a research ethics scandal in Malawi. You have to be careful with this sort of juicy information: now there is a legal case in progress, and the information leaked to the press up to this point is threadbare. Let's go over what, according to the press, is known.

The suspect is a Mr. Thadeo Mac'osano is described as a 'medic' who received medical technician training at the Malamulo College of Health Science in the town of Makwasa for four years, and has a diploma in palliative care from Makerere University in Uganda. What he is not is a doctor, nor is there evidence so far to indicate that he has training in biomedical research.

Mac'osano is accused of conducting biomedical research on patients with HIV/AIDS and kaposi sarcoma without gaining regulatory approval from scientific and ethical boards in Malawi. His trial involved 20 patients (Mac'osano himself says 15), six of whom died, but it is not known whether they died from the study drugs or from late-stage AIDS and/or cancer. The study drugs included the antibiotic bleomycin, vincristine and the intravenous drug doxorubicin, and possibly also actinomycin and cyclophosphamide.

The charge against Mac'osana is contravening the Pharmacy Medicine and Poison Board regulations controlling the conduct of medical tests on humans. The penalties range from seven years to life imprisonment.

According to Aaron Sosola, acting registrar of the country's Pharmacy Medicine and Poison Board (PMPB), Mac'osano submitted an application to the PMPB to conduct palliative care studies in 2006, but this was rejected because it failed to provide adequate protections for research participants. In another news article, however, it states that the submission was 'ignored', neither rejected nor approved.

Back in October, PMPB and National Health Science Research Committee officials visited St. Luke's Hospital in southern Malawi where the study was conducted. They halted the trials, saying the original 20 patients did not give their written informed consent, the drugs used were not approved for use on patients with Kaposi's sarcoma, and that Mac'osano should not have been carrying out such tests.

Officials at St. Luke's Hospital did not seem to know that Mac'osano had applied to PMPB to conduct research at their facility. The PMPB seems to have simply let his file gather dust without contacting St. Luke's to find out what was going on.

For Mac'osano's part, he seems to be playing the immigrant card: The whole issue is simply internal politics, and that management is jealous of me as a foreigner." Mac'osano is Tanzanian.

The whole situation seems fairly murky, but a few remarks on how this looks at first glance. First, this seems to be a homebrewed research ethics scandal, not a Constant Gardener sort of affair involving foreign pharaceutical companies and their minions. Second, the lines of communication between institutions that are supposed to ensure the scientific validity and ethical quality of clinical trials look to be in pretty rough shape. If a regulatory board sits on submissions instead of seriously reviewing them and providing a judgment, then such a board is pointless. That does not justify Mac'osano going ahead without ethics approval. The fact that he could do that points to something else: a general lack of appreciation for research ethics on his part and on the part of those involved in or affected by his research. Because that's the thing: a clinical trial on 20 terminally ill patients in a clinic is not something that you do alone or something that can be kept completely secret. Maybe it is only when Mac'osano was crazy enough to present findings that his unapproved research became too obvious (and self-incriminating) for hospital administration to ignore.

But we will have to wait and see. The court may produce a reasonable facsimile of the truth.

Global health inequality gets personal

2009-01-30T14:26:00.004-05:00

There are many ways global health inequalities can be expressed. The usual one is statistics, expressed in graphs, comparing countries using some health indicator or other. Haiti and Canada on child mortality. Sweden versus Senegal on life expectancy. You can see the Powerpoint presentation in your mind's eye. And you might also anticipate that, despite the massive human suffering that lies behind these statistics, you would probably be bored watching it.

I have a personal anecdote about global health inequality, acquired the hard way. On my trip to the Democratic Republic of Congo last week, I felt an unusual bump under my neck on Day 2. I thought, well, it is probably just a swollen gland, some temporary reaction. After all, just being in Kinshasa -- with the dirt, the car exhaust, some of the food, the humidity -- probably compromises your immune system no matter what. Maybe it is the start of a cold from the air-conditioning. So I continued with my bioethics activities.

Except the lump started getting bigger. I started developing two competing amateur self-diagnoses: some sort of a glandual infection or a tooth abscess. I continued to work. Anyway, what doctor could I see about this, and even if I could get a correct diagnosis, would there be available medicine for whatever I had? It was all very doubtful. Eventually I stuck it out, got on the Air France flight to Paris with a massive lump under my chin, and flew back from Paris to Chapel Hill. By that time, the lump increased in size again, my head was aching and I started feeling chills. After a trip to UNC's Infectious Disease clinic, a diagnosis of lymphadenitis was established, and I was put on antibiotics. A few more days in the Congo, and I might have developed septicema.

I could have, using my privileged position and if I had worked hard at it, eventually found a suitable doctor, a correct diagnosis and the right drugs. And in the end, I could count on a flight out, a high-quality clinic and medication inexpensive relative to income. Which made me think: what happens to the Congolese who develop lymphadenitis? My guess is that some (most?) are powerless to do anything but watch the infection grow and eventually die from it. A horrible, unnecessary and unjust death.

AIDS, gay men and Africa

2009-01-14T22:21:00.005-05:00

Authorities in many African nations are deeply troubled by the prospect of having men who have sex with men in their midst. While living in South Africa a few years ago, I remember a heated debate in the letters to editor section of the Mail and Guardian about whether homosexuality was a purely imported phenomenon, something alien and originating from the fleshpots of (say) southern California, and dropped recently into Africa. The idea was that if it was something new and foreign, it could hopefully be returned to sender, like an unwanted package. But it eventually appeared that the phenomenon wasn't really new or entirely foreign to Africa. So what couldn't be denied would have to be repressed; while not unAfrican, the behavior was nevertheless an abomination. Many African churches have joined with political authorities over the years in their attempts to condemn and marginalize the sexual behavior of gay African men. In most African countries, homosexuality is still illegal.

Last week, the New York Times reported the sentencing of nine men in Senegal to eight years in prison for 'unnatural acts.' The men were arrested in the house of a leading gay HIV/AIDS activist in Dakar. The events in Senegal join a long list of repressive political actions against gay men in African countries, including Nigeria, Gambia, Burundi and Uganda. Now there is a lot that one could say, from a human rights or social justice perspective, about the political treatment of men who have sex with men in Africa. But there is also a public health ethics perspective: demonization of homosexuality is counterproductive in the fight against HIV/AIDS in Africa, just as it was in America during the early days of the epidemic. Condemnation and criminalization simply drives the behavior underground, away from prevention and treatment services, increasing risks of HIV transmission. The conclusion is hard to avoid: the HIV/AIDS epidemic has forced African countries to deal with homosexuality in their communities, but many have failed to develop responses that are justified from a public health point of view or even reflect basic human decency.

Resuscitating undue inducement

2008-12-19T00:14:00.008-05:00

There seems to be such a thing as ethical habit and routine. It goes something like this: someone finds a certain aspect of moral life that perhaps went unnoticed before, and under the light of new attention, it blossoms into an explicit moral concern. One thinks: yes, that is something we ought to care (more) about. This rediscovered concern then gets put into public circulation, and it passes through many hands. It gets standard definitions. It gets slipped into regulations and policies, and repeated. A lot. At a certain point, it becomes something you feel you have to take into account, in certain contexts, even if you are not quite sure what it means anymore.

The notion of 'undue inducement' in international research seems to have gone this route. Researchers commonly induce participants to join their studies by offering them something attractive, something that makes the burdens of research worth their while: the image of themselves as benefitting society perhaps, a key chain, maybe a T-shirt, or cold hard cash. However, the argument goes, what looks like a minor inducement in Chicago may be a whopping big inducement in Kampala, given the socio-economic differences between the two cities. Would the participant in Kampala be free to choose to be in the study, or would he or she automatically agree to join, in order to get whatever was on offer? In that case, aren't the researchers taking unfair advantage of -- i.e. exploiting -- global inequalities to get the poor into their studies? Thus the concern about undue inducements was born. And the concept, which has its legitimate uses, has become a knee-jerk reaction in no time. I have personally experienced discussions in ethics committees where members, in all seriousness, debate about whether $5 in some far-flung land will unravel somebody's agency, and that giving $2 would be better. (I have also heard investigators in central African countries murmuring that 'ethical concerns' about undue inducement are just a con: it is all about saving research money.)

There have initiatives to counteract the fall of 'undue inducement' into ethical habit. Emanuel reasonably proposed that if a study does not pose any great risk, then size does not really matter: give any inducement you want, you won't be making (poor) people act against their better judgment, which is the underlying issue. A researcher who offers a Mercedes to a poor farmer in Zimbabwe if he would join a highly risky phase I tolerance study is unethically manipulative; a researcher who offers a Mercedes to a poor farmer in Zimbabwe to take a simple household survey is just stupid (or a kind of Robin Hood). What makes inducement 'undue' is whether it motivates people take dangerous risks. Being worried about inducements that actually benefit people seems a bit strange.

In this month's issue of Developing World Bioethics, Angela Ballantyne tries to discern what is living and what is dead in regard to undue inducement. The conclusion of the argument is that (a) there is little empirical support for claims that payments distort research participants' assessments of risk in research and (b) that if research sponsors in the developed world are worried about exploitation, they should offer more benefits to research participants (and their communities), not less. It deserves to be read in full, and read widely. Hopefully the paper will help the concept of undue inducement awake from its slumber.

A yellow light for male circumcision

2008-12-09T21:54:00.003-05:00

In the past few years, a series of randomized controlled trials indicated that male circumcision reduced the risk of men acquiring HIV from women during hetrosexual intercourse. This finding seemed to confirm two decades of less rigorously controlled studies, and has turned out to be a rare success in the world of HIV prevention research, a world still reeling from failed HIV vaccine, diaphragm and microbicide trials. Male circumcision has always been a contested practice, so findings of the randomized controlled trials on male circumcision predictably sparked a great deal of debate. Some critics have argued that the findings were untrustworthy for a variety of reasons: because the trials were stopped prematurely or because not all possible confounders had been controlled for. Some of these criticisms were motivated by sincere concerns about scientific standards, but many times it seemed that criticisms of the trials were driven by a priori ethical views about the irrationality and harmfulness of male circumcision as such. In the meantime, emerging news items about male circumcision and HIV prevention are invariably accompanied by verbal battles among pro- and anti-circumcisionists in their comments sections.

The world has moved on. Or, at least, the biomedical research establishment in developed countries -- and in some developing ones -- seem to have moved on. The methods and findings from the randomized controlled trials are no longer the main event. The focus now is on how to implement male circumcision as an HIV prevention strategy in high HIV-prevalence countries with low-circumcision rates, mainly in sub-Saharan Africa. And the wallets are starting to open. To use a traffic metaphor, the strategy is getting a 'yellow light': proceed, but with caution. Caution for surgical risks in resource-poor clinics. Caution for diversion of scarce resources from other important health needs to circumcision initiatives. Caution for risky sex behavioral change among the recently circumcised. And a variety of other vexing and challenging hurdles. But there is the overwhelming sense of rolling up one's sleeves, that this is a fight worth fighting.

In the interests of full disclosure, my colleagues and I published a 'proceed with caution' piece about HIV and male circumcision last year in the Journal of Medical Ethics. But that piece does not have the same sort of authority or significance as last week's commentary article in Journal of the American Medical Association or the perspective piece in the New England Journal of Medicine: these are prestigious journals with a large and influential readership, and these are some well-known authors. Initiatives to promote male circumcision seem to have gotten the official yellow light, and join the increasingly crowded and messy world of HIV prevention.

Governing unto death in Zimbabwe

2008-12-04T23:13:00.006-05:00

If you were ever wondering if politics is a 'social determinant of health', well, just take a hard look at Zimbabwe. A few decades ago, the country was the breadbasket of the sub-Saharan region, and it is now heavily dependent on food aid and imports, with an economy crippled by massive debt and astronomical levels of inflation. In fact, its chief export in the coming months, besides Zimbabweans, could be infectious disease. This week, the Zimbabwean health minister, David Parirenyatwa, has declared the nation’s recent cholera outbreak a national emergency, and has asked for outside help in bringing the epidemic under control. But to bring the epidemic under control, you would need more than just oral rehydration therapy and truckloads of antibiotics. You would need a functional health care system. But that would require a government actually devoted to the welfare of its own people, rather than lining the pockets of some of its own people, and blaming foreign powers (while also asking them for stuff) whenever things go wrong. So what to do?

The Kenyan Prime Minister Raila Odinga -- in a rare display of backbone by an African leader -- has called for the isolation and ousting of Zimbabwean president Robert Mugabe. In the grander scheme of things, this could be as effective a public health intervention as any. Epidemiologist John Snow is said to have removed the handle on the water pump on Broad Street in London in 1854, once he discovered that contaminated water from the pump was responsible for the city's deadly cholera epidemic. The outbreak dissipated soon afterward. In Zimbabwe, Mugabe is the pump handle.

UPDATE: I was premature in calling President Mugabe the 'pump handle.' Today in a news conference he declared that there is no cholera epidemic in Zimbabwe. So it would be better to characterize him as a public health version of Jesus Christ the Savior, healing sick populations with his miraculous powers.

Making HIV transmission a crime

2008-11-28T01:07:00.010-05:00

There was a time when persons living with HIV were treated in somewhat peculiar ways, considering that they had a transmissible, incurable and (before the advent of antiretroviral treatment) invariably fatal disease. Some of the virus' chief modes of transmission -- injection drug use and anal sex -- led swiftly to stigmatization and discrimination towards carrying HIV, and therefore public health agencies, governmental organizations, and advocacy groups stressed the need to protect HIV-positive persons. Initially, when there was no effective treatment, there was no great push to have members of 'at-risk' populations tested: testing (it was argued) would increase stigmatization without real compensating benefits. Whenever testing was done, there was elaborate concern about preserving the confidentiality of the tested person, given the possible social consequences of being outed as HIV-positive. The ethical hand-wringing around HIV testing only started to decline, after two significant biomedical innovations: the development of means to prevent mother-to-child transmission of HIV, and the discovery of effective anti-retroviral treatment. It is only recently that public health agencies have used somewhat more aggressive means to get people HIV tested, such as 'opt-out' testing of pregnant women in hospitals. What makes all this peculiar is that transmissible, incurable and fatal diseases generally have not been handled with such delicacy and restraint in the past. Even epidemics of transmissible and curable diseases -- like tuberculosis and syphilis -- led past governments to invoke laws and ordinances strongly limiting personal autonomy for the good of society. From a public health perspective, HIV/AIDS has been treated exceptionally, i.e. there has been a greater stress on personal autonomy and human rights when tackling it than has been typical for diseases of this type and magnitude.

Against this background, an opinion piece and a recent news item caught my eye this week. In the Bioethics Forum, Udo Schuklenk argues that some HIV transmissions ought to be criminalized. The kinds of transmissions he is thinking of are clear-cut cases where a person, who knows he or she is HIV-positive, engages in unsafe sex with his or her partner, and the latter becomes HIV-infected as a direct result. Schuklenk is not worried (rightly) that criminalizing this sort of HIV transmission is stigmatizing or discriminatory to the perpetrator: knowingly exposing another person to HIV infection is just plain wrong, and the general concern about the human rights of HIV-positive persons shouldn't obscure the fact. HIV-positive persons need certain kinds of protection as well as access to prevention, care and treatment -- but they are not above the law.

Compare with this: in the small province of Papua in Indonesia, a bylaw has been proposed to involuntarily implant microchips under the skin of certain HIV-positive persons. Which HIV-positive persons? Those which are deemed 'sexually aggressive', i.e. those who are suspected of knowingly having the disease and actively spreading it intentionally to others. The microchip -- in some science fiction twist -- is supposed to track and identify the suspected person's sexual behavior. The proposed legislation stipulates that those found guilty of infecting others would be liable to a $5000 fine or six months in prison. This approach, of course, is a radical departure from 'AIDS exceptionalism'. The kid gloves are off: Indonesia has a growing HIV/AIDS epidemic, so let privacy be damned.

In some way, these two stories are related. One could say that the Indonesian proposal is merely a matter of being proactive: if intentionally infecting people with HIV is wrong, then we should have accurate tracking systems for 'suspect individuals' in order to control their behavior and prevent infections, as well as faciliate evidence-based judgments of criminal guilt when an infection occurs. But it seems ethically desireable to distinguish (a) criminal punishment of those who knowingly infect others with HIV from (b) invasive surveillance of individuals who allegedly might knowingly infect others with HIV. (a) is an expression of common sense and basic justice, whereas (b) has no clear public health or legal justification, and seems a step towards an Orwellian nightmare.

Singapore and compensation for organs and eggs

2008-11-24T19:14:00.005-05:00

The National Bioethics Committee in Singapore has been pretty busy lately. At the start of November, the Singapore Ministry of Health announced a change to the Human Organs Transplant Act (HOTA), and the National Bioethics Committee publicly endorsed the revised law soon afterward. Just days later, the Committee released guidelines on the donation of female eggs for research. And one of the central ethical issues in both cases concerns compensation and inducement in the context of exchanging human biological materials.

Should donors of organs or eggs receive some sort of compensation for their act of giving, or should it be a pure act of altruism? Should organ or egg exchange be a market-force driven transaction like any other -- like the buying and selling of cars -- or should these exchanges have a special, non-commercial status in keeping with the dignity of human beings? Positions in this domain often get polarized into the kinds of extremes that the media love: on the one hand, libertarians and utilitarians who think people ought to be able to do what they want with their body parts (including selling them), and that this sort of freedom is the ultimate solution to demands for organs and eggs. On the other hand, some believe that only the most restrictive laws are in keeping with the special status of our species, even if this comes with the cost of diminishing the supply of useable organs and eggs (for some members of that same species). For those unconvinced by the concept of 'dignity', there is also the consideration that wherever paid organ exchange takes place, the exchange from donor to recipient tends to channel along the lines of social injustice, i.e. from the poor to the rich, from women to men, and from non-Caucasian to Caucasian.

The Singapore approach involves a tricky distinction between compensation and (undue) inducement. The National Bioethics Committee is of the opinion that organ and egg donors should compensated for the costs to themselves involved in the act of donation, including loss of time and earnings, the burden of physical and psychological risks, transport and medical costs, including follow-up medical expenses and (in the case of organ donors) possible higher insurance premiums. Determining a fair level of compensation in general would seem to be very difficult, given that there will be diversity in (among other things) economic status between recipients and donors. The Committee wants to discourage people from seeing the donation of their organ and eggs as a for-profit activity -- even if third-parties do make money out of it -- while also avoiding placing an unfair burden on donors. The result will probably displease those on both ends of the bioethics extremes, but that is usually a sign of health when it comes to regulations.

Medical tourism and global health inequality

2008-11-12T23:21:00.003-05:00

By many accounts, the numbers of patients from industrialized countries seeking medical treatment in countries like India, Thailand or Cuba are increasing rapidly. Last year, the New York Times issued a piece whose basic theme was that medical tourism is becoming 'normalized', i.e. it is no longer just an option for a small minority seeking cheap nosejobs or teeth-whitening. North Americans and Europeans are now looking to developing countries for highly-invasive and life-extending operations, like heart-valve and hip replacements. That medical tourism is becoming regarded as a solution to the problems of high medical costs and insurance premiums is exemplified by the fact that insurance companies in the US are starting to provide plans that encourage clients to seek some medical interventions abroad. And governments in developing countries are encouraging the trend, for the same reasons they promote more familar forms of tourism.

On the face of it, one could see this as a mutually beneficial transaction: patients from industrialized countries receive medical services at bargain prices, while medical institutions and individuals in developing countries receive much needed revenue. But, as a recent piece in Asia Times emphasizes, the picture is much more complicated. Creating pockets of 'first-world' medical care in developing countries also has a number of ethically untoward effects: internal brain drain of health care professionals from public hospitals to state-of-the-art clinics catering to foreigners, and the creation (or reinforcement) of a strongly two-tiered health care system, with a superior level of care for the rich and an inferior one for the poor. Besides being a source of injustice, medical tourism is also unrealistic as a solution to problems of health care systems in more affluent nations. Even if the numbers of medical tourism has increased, the numbers are still relatively small compared to those staying at home. But the increasing amounts of money spent abroad by medical tourists might have a positive effect, i.e. encourage what should have been a priority in the United States long ago: affordable and high-quality health care.

Dilemmas of testing and treatment

2008-11-10T22:54:00.003-05:00

An editorial in a Pakistani newspaper offers this seemingly commonsensical ethical directive: do not give patients treatment until they have been correctly diagnosed (via testing procedures) to have the condition the treatment is meant for. Following this train of thought, a contrast is worked up between what the author calls 'speculation-based' and 'evidence-based' medicine. The former -- typically represented by 'quacks' -- can lead to all sorts of bad consequences, such as the potential harm caused when patients are given treatment for conditions they do not actually have.

In contexts of poverty, however, the connection between testing and treatment often gets complicated. Sometimes the access to treatment is better than the access to testing; sometimes it is the reverse. When diagnostics are scarce, sometimes all you have to go on are clinical symptoms and educated guesses. You don't have to be a 'quack' to find yourself in this position: just being a doctor in an under-resourced area of one of the world's poorer countries is enough. While this sort of guesswork can put patients at risk, doing nothing while waiting for reliable diagnostic tools to arrive is not risk-free either. Are doctors who make medical decisions about patients without testing them first to confirm their condition acting ethically? The World Health Organization has taken a pragmatic position on this issue, and for years it has recommended administering antiretroviral treatment for HIV/AIDS based on clinical criteria when no reliable diagnostic tools are available. As for testing without treatment, this -- a situation faced by many thousands in the developing world -- might be worse in some ways than treatment without testing: the latter at least involves the chance of receiving appropriate treatment.

Weaning Africa off health aid

2008-11-03T18:20:00.005-05:00

There are often complaints that the richer countries of the North -- particularly some of them -- do not devote a sufficient percentage of their GDP to international aid. The thought is basically that a small sacrifice, say a few dollars or Euros from each citizen, could save the lives of many people in poorer nations. There is something right about this, but also something quite wrong.

To increase in international aid -- especially health aid -- shouldn't be considered something good in itself. International health aid can be valuable in cases of catastrophic health emergencies, but over the long haul, countries should not become more dependent on external funders to provide a decent level of health care for their own citizens. It is not just the indignity of dependence on others as such; it is also the instability and unreliability that goes hand in hand with such dependence, as the levels and priorities of international health aid are subject to the political and economic fortunes of the developed world. And they generally come with strings attached, hidden agendas and unnegotiated preconditions. The ultimate goal should be to reduce the need for such disempowering dependence to the greatest extent possible.

A recent article in the Bulletin of the World Health Organization, by Joses Mithuri Kirigia and Alimata J Diarra-Nama, give some good general ideas about how to wean Africa off of international health aid. Reducing inefficiencies, changing priorities in public expenditures, expanding the tax base, increasing involvement of private sectors, and fighting corruption: attempting to do all this will raise many practical and ethical problems, but at least it holds the promise of minimizing a dependence too long regarded as 'natural' and 'inevitable.'

Declaration of Helsinki redux

2008-10-25T21:19:00.006-04:00

The Declaration of Helsinki was revised last week, apparently not to much fanfare. In fact, I could only find two news articles on the web about it (here and here), and Science published a piece about the lingering controversies surrounding the Declaration and its revisions. But other than that, the revised Declaration seems to have generated little interest, excitement or opposition. For those unfamiliar with this document, or the organization that acts as its custodian, the Declaration of Helsinki is a statement of principles concerning medical research with human participants developed by the World Medical Association (WMA). There is nothing particularly Finnish about the Declaration, only the name -- it happened to be where the WMA General Assembly first adopted it in 1964 -- but the name lends the document a certain austere, Nordic and 'internationalist' feel. This is only fitting for a document that is regarded by some as a cornerstone of research ethics with global reach.

Careful and prolonged attention is bestowed to the precise wording of the Declaration, as though the lives of millions depended on each word. So what is new about the revision? Three main changes seem to stand out:

Registering clinical trials. Paragraph 19 of the revised Declaration states: "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject." Apparently representatives of pharmaceutical companies are unhappy with this new paragraph, because it implies that all phases of clinical trials must be registered, even phase 1 trials. They argue that such registration drives up research costs and because it involves disclosure of what research projects are doing, it could violate intellectual property rights. On the other hand, it is predictable that something would be added to the Declaration about registering clinical trials (without being specific about any phase) after the high-profile injuries to humans involved in the Northwick Park TGN1412 Phase I trial. Nevermind: the pharmaceutical industry will probably just ignor this paragraph anyway.

The use of placebos in clinical trials. When is it ethically acceptable to have a placebo arm in a clinical trial? Paragraph 32 is meant to deal with this sticky issue, and the answer (to paraphrase) is that a new experimental intervention should be tested against the 'best current proven intervention', except when (a) no current proven intervention exists, or (b) where there are really good scientific reasons to use a placebo and where those who receive the placebo will not be subject to any risk of serious or irreverible harm. The paragraph adds: "Extreme care must be taken to avoid abuse of this option." Reports on the revision suggest that this Paragraph is really restrictive of placebo use -- which some find troubling because it could hamper the progress of science, and others find noble because it protects research participants and does not bow down to pharmaceutical industry interests. Nevermind: FDA recently implemented rules allowing applicants for new drug approvals bypass the Declaration ofHelsinki when conducting certain trials overseas.

Post-trial benefits. The concern that research participants (particularly those in impoverished countries) ought to get something back from their participation has been growing in reserach ethics circles in recent years. There is a feeling that it is unjust for drugs to be tested on the world's poor, while the benefits of the research mostly accrue to the richer nations -- in short, the poor are good enough to be tested on, but not good enough to have access to the finished product. The new Paragraph 33 reads: "At the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care and benefits." For better or for worse, this leaves the question what counts as an 'appropriate benefit' wide open. A research team could say that there were things in a study that the participants got that non-participants didn't get, and that is 'benefit' enough to fulfill the requirements of the Declaration of Helsinki. Nevermind.

We're just here to help: disaster research in developing countries

2008-10-20T23:16:00.002-04:00

Disasters are in the first place tragedies: persons are killed, injured and traumatized, and their ways of life may be irrevocably changed. But disasters are not necessarily tragedies for everybody: can also be manipulated to promote someone's interests. This is the central thesis of Naomi Klein's The Shock Doctrine -- natural and non-natural disasters are moments of collective weakness that the rich and powerful exploit to enact dubious policies that they might not otherwise get away with.

A recent opinion in SciDev warns against the potential for disaster research in the developing world to become an example of The Shock Doctrine. While there is obviously nothing intrinsically wrong about doing research in the midst of a disaster -- such research is needed to improve future disaster responses -- there are ways to doing it that threaten to increase the vulnerability of disaster victims. Author Athula Sumathipala speaks from experience:

Because natural disasters are often sudden (like cyclones) research can sometimes start without proper scientific rigour or ethical consideration. Researchers may rush to collect data, without adequate planning.

This can lead to undue pressure to participate, particularly when research is combined with humanitarian aid or clinical care. Some survivors may not even realise they are taking part in research.

In my home country of Sri Lanka, for example, the 2004 tsunami was followed by a huge influx of foreign organisations and individuals offering humanitarian aid, including counselling. Some advocated compulsory counselling for survivors, though this runs against recommendations from the WHO and the Cochrane Collaboration — a not-for-profit organisation that provides information on the effects of health care.

In parallel to these 'services', doctoral students from developed countries acquired data to finish their theses, harassed survivors with numerous questionnaires and even collected blood to research neurobiological stress markers. In the rush to provide assistance, a lack of familiarity with local customs caused cultural insensitivities. For example, many people would prefer to seek help from a temple rather than a therapist.

To counteract the feeding frenzy of 'help' from disaster researchers, Sumathipala promotes the usual sort of things: consultation on the needs and priorities of affected communities, the involvement of ethics review committees, and development of international guidelines specific to this type of research.

The conscientious objector argument in Thailand

2008-10-17T22:12:00.005-04:00

A couple of months ago, the 'conscientious objector' argument in medicine made headlines when the US Department of Health and Human Services proposed regulations that aim to protect health professionals who, for reasons of moral or religious conscience, are unwilling to provide certain medical services to patients. As everybody knows, 'certain medical services' is code for abortion, and no topic divides Americans ideologically more effectively than abortion does. 'Pro-choice' advocates argue that the head of Health and Human Services, Mike Leavitt, not so much concerned about 'discrimination' towards health professionals or freedom of conscience. The real concern is on the embryos and fetuses. But between talk about the conscience of the physician and talk about the fetus, something gets left out: namely the woman who is seeking abortion as a (legal) medical service. Proponents of the proposed regulation point out that it does not prohibit women from seeking abortion services; it merely prohibits women requiring the procedure from physicians who have religious or moral objections to it. Among other things, opponents of the regulation say that once you allow for the conscientious objection argument, you will soon have pharmacists refusing to dispense contraception or nurses refusing to recommend the 'morning after' pill. Women's reproductive rights get increasingly hemmed in by the values of social conservatives.

In a paper a couple of years ago, Julian Savulescu wrote a paper about conscientious objectors, in which he looked to make a reductio ad absurdum argument. Imagine, he writes, if a doctor said that he refused to treat patients over the age of 70, because on moral grounds, scarce medical resources could be better invested in the younger population. People would find such an 'act of conscience' appalling. The example suggests that once you allow for the conscientious objector argument, health professionals will be empowered to refuse to treat patients for all sorts of reasons. A weakness of Savulescu's argument, of course, is that it makes use of a thought experiment. There probably is no doctor who actually thinks this way. But there are doctors (nurses, pharmacists) in the world who do think this way about the provision of abortion services.

A better, real-world example of the conscientious objector argument gone awry surfaced last week. Thailand is currently embroiled in serious civil conflict, the culmination of three years of strife between forces for or against ousted Prime Minister Thaksin Shinawatra. The People's Alliance of Democracy (PAD) launched a street campaign in May against the government of Samak Sundaravej that they claim to be a puppet of Thaksin. There have been violent clashes between protesters and the government police, and in solidarity with the protesters, doctors in some hospitals have refused (or threatened to refuse) to treat injured police officers. The police have been using excessive force against protesters, and the physicians are basically claiming that treating injured policemen would be acting against their own moral conscience. Human rights groups have rightly condemned the doctors' action, saying that it is a violation of medical ethics and international humanitarian law, reaffirming that the doctor's primary task is to heal, not to judge.

Bioethics angle to the 'financial downturn'

2008-10-12T23:05:00.004-04:00

All major news outlets, as well as the US Presidential candidates, have been focused for the last ten days on the credit crisis that has rocked financial institutions worldwide, and rightly so: it looks as though the world is facing a deep economic recession, if not a full-blown depression. Experts are baffled by the exact causes of the upheaval, and the effectiveness of radical remedies (in the form of multi-billion dollar cash injections to banks) is not yet known.

From a developing world perspective, there is a terrible irony to all this. For decades, developed countries and international financial institutions (like the International Monetary Fund) have preached financial responsibility and restraint to low-resource countries, and complained bitterly about local corruption and mismanagement. Now the shoe is on the other foot, as an unregulated culture of excessive risk-taking and speculation in the world's more affluent countries leads global financial markets to implode.

Unfortunately, those living in low-income countries will probably not have much time to take pleasure in this vivid display of hypocrisy. The financial crisis could very well spread to low-income countries, and affect them disproportionately, since many of such countries were economically fragile already and most are dependent on international loans. Given the known links between economic indicators and health, it seems likely that if the economic crisis spreads, some developing countries may experience greater morbidity and mortality as a result of the irresponsible actions of far-away people from the 'richer North.' That kind of potential harm is rendered invisible by the media, which generally sees 'bad consequences' of the financial meltdown in terms of potential rises in unemployment in North America and Europe, not increased disease and death elsewhere.

Follow up on the ethics of nurse recruitment from developing countries

2008-10-03T00:04:00.003-04:00

A couple of posts back, the topic was the launching of a new ethics code, namely the Voluntary Code for the Ethical Recruitment of Foreign-Educated Nurses to the United States. The code is a response to the well-documented 'brain drain' of nurses from developing countries. In that post, I expressed some skepticism in regard to the code's enforceability and potential impact. Given that recruiting foreign-educated is interesting for powerful agencies in the United States from a cost-benefit perspective, why would they sign onto to Code and hold to its guidelines?

In a letter last Sunday to the Washington Post, Samuel Witten, Acting Assistant Secretary of the
Bureau of Population, Refugees and Migration within the US Department of State gives a flavor of the government's view of the Voluntary Code. Witten states that the Voluntary Code has noble ideals and makes some good points. But the point of the letter is to express one basic complaint: according to Witten, the Code " ... discourages U.S. companies from hiring nurses from countries with severe shortages of health workers, implying that a qualified nurse from a developing country has less right to apply for migration than a counterpart in a developed country."

In my reading, the Voluntary Code does not at all deny the right to migration. What it does is embed that right as one consideration among others in a larger context, which also includes the devastating social and health impact of the loss of nurses for developing countries. Its guidelines are the product of careful balancing of divergent concerns and interests. Apparently the US Department of State sees things quite differently: the individual's right to migration is taken to be the chief, overriding consideration in such cases, even when it comes to the poorest countries with the worst nurse/patient ratios.

That standpoint about 'individual rights' is convenient: it maintains the status quo in regard to the brain drain of medical human resources from developing countries to more affluent ones. The US Department of State is apparently much more concerned with US capacity to cheaply meet nursing care demands for its aging population than it is for the fate of health care and health in general in some of the poorest countries in the world. I suppose this is to be expected, but it is depressing nevertheless.

***Many thanks to Kristen Rosengren at AcademyHealth, who alerted me to Witten's letter in the Washington Post. AcademyHealth was one of the agencies involved in the writing of the Voluntary Code and is, as it describes itself, ". . . the professional home for health services researchers, policy analysts, and practitioners, and a leading, non-partisan resource for the best in health research and policy."