The dignity of stupidity

It seems that the biggest bioethics news of the week has to do with two concepts that look funny together: dignity and stupidity. Steven Pinker has written a rather brittle essay -- entitled 'The Stupidity of Dignity' -- in response to the recent publication of a report by the President's Council on Bioethics, Human Dignity and Bioethics. For those who keep track of such things, Ruth Macklin wrote an article about five years back with the catchy title 'Is dignity a useless concept?', and she answered her own question in the affirmative, arguing that the term is religious in origin, has no real place in bioethics and should be replaced without remainder by the secular concepts of autonomy and respect for persons. Human Dignity and Bioethics is a 555-page rejoinder to Macklin's challenge. According to Pinker, it is a lousy rejoinder: the report, by dredging up concepts of dignity that are fuzzy or contradictory, has failed to show that dignity is of much use to bioethics.

If Pinker just stuck to that, pointing out the lack of progress with conceptual clarity in regard to 'dignity', his essay would have raised few eyebrows. But Pinker goes on to argue, in effect, that while dignity is a useless concept for analysis of bioethical issues, over the last years it has proved a very useful tool for religious conservatives (including members of the President's Council on Bioethics) seeking to influence political leaders on matters concerning science, technology and human values. In fact, most of Pinker's essay is a kind of potted and impressionistic sociology of the conservative origins and tendencies of the Council, rather than a sustained analysis of what is actually said in their report, though he does pick out a few choice gems for comic relief. Leon Kass, the bioethicist in America closest to the ear of President Bush, comes off as someone whose intense concern for dignity casts doubt on his overall mental health: the man vigorously opposed to IVF turns out to be equally opposed to the (undignified) practice of eating ice cream in public. Imagine, if you will, a group of like-minded moral hypochondriacs imposing their religiously-fueled vision on the rest of society, beating down opponents with resonant (but actually empty) appeals to 'human dignity'. You get Pinker's drift: lovers of human dignity may end up being enemies of human freedom, and when push comes to shove, he will take freedom.

The best parts of Pinker's essay are not about the Council, but his views about the limitations of the concept of dignity: it is relative, it is fungible and it can be dangerous. Unfortunately, Pinker does not draw out more the profound implications, and make the chickens come to roost. Are the 'secular' notions of autonomy and respect for persons in any better conceptual shape than dignity is? What do we mean by autonomy, and how is it immune to being relative, fungible and potentially dangerous? (Those who think this concept is obvious or innocuous should read 2000 years worth of moral philosophy.) Ditto for 'respect for persons'. The bottom line is that when we look at the most fundamental concepts that we use in bioethics, we go from applied ethics to metaethics, and from slogans to philosophy, we reach a place where words can falter, and where everyone is vulnerable to looking a bit stupid.

How does this connect to bioethics in a global context? As discussions about bioethical issues become more frequent and explicit around the globe, there are likely to be conflicts between secularism and religion, modernity and tradition. Each culture will struggle to negotiate ways of reconciling new medical technologies and practices with deep-seated values and customs. This will be messy. But one hopes that these tricky negotiations will not replicate the style and tenor of contemporary American bioethics, marked as it often is (from all sides) with excursions into mudslinging, ad hominem arguments and heaping helpings of contempt. Always engage with others as if they are acting in good faith after serious reflection: a good working principle for bioethics, expressing humility and generosity of spirit, but very difficult to follow.

New global health exhibit at the National Library of Medicine

The National Library of Medicine -- the world's largest medical library -- has launched an exhibit on global health at the National Institutes of Health in Bethesda, Maryland. The exhibit, entitled Against the Odds: Making a Difference in Global Health, is devoted to raising awareness about challenges to human health and human rights in an increasingly interconnected (and in many ways, unstable) world. I have not seen the exhibit, but NLM has put out a very impressive exhibit website that provides a wealth of information about the history of the concept of 'global health', the myriad challenges posed to health around our planet, some of global health's (sung and unsung) heros, educational resources and opportunities for advocacy and commentary. If the website is any indication, it looks well worth a visit.

If you work in global health -- or 'global bioethics' for that matter -- you can lose your faith in its mission from time to time. Partly because the problems seem so overwhelming, too big to tackle in one short lifetime, as one small individual. Partly because when global health is made fashionable, strange things happen, such as students from rich universities streaming down to 'help' poorer countries in ways indistinguishable from global tourism. Partly because big funding institutions putting god-knows-how-much-money into god-knows-what-sort-of-project. Partly because trying improve health in an ethically responsible way, in contexts of gross inequality and injustice, can leave you with dirty hands and a bad taste in your mouth. Exhibits such as the one at NLM are largely aimed at the general public, but for those working in the field, it can have other functions: an opportunity to remember the original ethical vision of global health, transcend cynicism and renew old vows.

The FDA ditches the Declaration of Helsinki

As it has been threatening to do for years, the Food and Drug Administration in the United States has finally abandoned the Declaration of Helsinki as ethical standard to be used when evaluating data from clinical trials conducted abroad. But let us back up. Getting FDA-approval for a new tested drug is a big deal: you can make big money this way. But to do research in the United States on a new drug, you first have to submit an application for an investigational new drug (or IND). You can get around this by conducting your clinical trial outside US soil, and then seek FDA approval for the tested drug by submitting a new drug application (or NDA). Up to now, the FDA required that studies submitted in support for an NDA should have been conducted in a manner consistent with either with the Declaration of Helsinki or local laws, whichever is more protective of the participants in the trial. Now the FDA has changed that requirement: it is now enough that the foreign-based trial be conducted according to the Good Clinical Practices (GCP) of the International Conference on Harmonization.

So what is the difference? Someone with a stronger stomach than my own could go through the Declaration of Helsinki and GCP point by point, and try to discern every little ethical difference. Or look at the Federal Register, and evaluate the myriad justifications made by the FDA in favor of the change. For those unable, unwilling or uninterested in going through this regulatory potpourri, let me cut to the chase: the GCP overall is less ethically demanding than the Declaration of Helsinki, and thus encourages the outsourcing of clinical trials in developing countries in a regulatory atmosphere more supportive of pharmaceutical interests than protective of research participants or communities. As some commentators have pointed out, the FDA (and the pharmaceutical companies with whom it often shares beds) was never enamoured of the section in the Declaration of Helsinki that stated that a new drug should be 'tested against the best current prophylactic, diagnostic and therapeutic method', since that would limit the possibility for placebo-controlled trials. That is why GCP is apparently more attractive to them: it does not have any such requirement. Not only that: the GCP does not (unlike the Declaration of Helsinki) contain anything about conflicts of interest, the need to publish results, or post-trial availability of the tested drug to study participants or communities. In the end, GCP is ethics-lite.

The Declaration of Helsinki has its own problems, not the least of which are problems of ambiguity in its language and limited enforceability. But even its most uncharitable critic can see that the document has an ethical backbone. What impact the FDA's decision will have on clinical trials around the world remains to be seen, but the decision would seem to encourage pharmaceutical companies to cut ethical corners when working abroad.

Buying public health: World Bank's Tanzania experiment

And the girl behind the counter has a tattooed tear
One for every year he's away she said
Such a crumbling beauty,
Ach there's nothing wrong with her
That a hundred dollars won't fix

Those are lyrics from Tom Waits' song '9th and Hennepin'. They slipped involuntarily into my consciousness when I read about a World Bank study that is being planned in Tanzania. According to the report in the Financial Times, the study involves 'incentivizing' sexual behavior change by means of cold hard cash. Participants, if they do not pick up sexually transmitted infections during the study period, are told that they will receive $45 for their efforts. The study also will have a comparative control arm in which participants will also be tested for STIs, but will not receive any money. One of the researchers from the University of California-San Francisco is reported as saying: “We hope this ‘reverse prostitution’ will make people think hard about the long-term consequences of their short-term behaviour.” An intriguing statement, since it implies that the problem with Tanzanians, in regard to sexually transmitted infections, is that they are just not thinking hard enough. Nothing like 45 dollars to get you to think straight. If the question is -- as the accompanying Editorial puts it -- "Are the funders saying young Tanzanians cannot be trusted to do what is good for them without a bribe?", it looks like the answer is a resounding yes.

Now before you say that the World Bank is throwing money at a problem again -- because they in a sense are -- it is necessary to point out that a similar program has had some success. In Mexico's Progresa program, parents were paid educational grants if their children attended school and regularly visited medical clinics, and the program seems to have had positive educational outcomes and also favorable health results. Such 'conditional cash transfer' programs have become increasingly popular in development circles, and has even been imitated in New York. And if you can make it there, you can make it anywhere, even Tanzania.

Or perhaps not. Educational grants is one thing, cash-in-hand is another. Incentivizing the improvement your child's health and education is one thing, incentivizing your own sexual activities is another. Some might say that giving money to young women will empower them in negotiating sex with male partners, but others may suspect the women may be targets of violence on payday. Hard to say. And even if the study shows some association between getting money and lower sexually transmitted infections, what then? What are the policy implications? Is paying people off a sustainable way of tackling disease in a population? Should people be paid to prevent themselves developing chronic illnesses too? Where does it stop?

It is important to note that this 'bold initiative' comes at a time of diminished hopes regarding sexual behavior change. Over the last decades, a great many programs and interventions have been devised, studied and implemented to effect healthy sexual behavior, with only limited success. Millions of sexually transmitted infections continue to occur. Not long ago, the idea of using money to promote safe sex would have been considered simply crassly inappropriate. The current zeitgeist seems to be: hell, we have tried so many things to promote healthy sexual behavior among the poor, why not dangle money in front of them?

Trust and distrust in Kwazulu-Natal

Confucius apparently once said that three things are needed for government: weapons, food and trust. But not necessarily in that order. A government can still rule if weapons are scarce and food is rationed, but loss of trust is fatal. When people don't trust each other, when they treat each other as unreliable, cooperative projects falter. The more distrust, the more relationships and institutions start to unravel. On the other hand, a surplus of trust -- what is perhaps better described as reverence -- is not healthy either. Those that are trusted (particularly those in positions of authority) might well not be trustworthy, after all. Too much trust gives too much power, and too much power is often abused.

These loose thoughts about trust came from reading about the latest misadventure of the Kwazulu-Natal Department of Health in South Africa. Kwazulu-Natal is the epicenter of the HIV/AIDS epidemic in South Africa, with 16.5% of its population over the age of 2 being HIV positive. Over the past few years, there have been a number of ugly conflicts between the Department of Health and those in the field delivering HIV/AIDS prevention, care and treatment. Not long ago, Dr. Colin Pfaff at chief medical officer at Manguzi Hospital, was suspended by the Department of Health for raising money to provide dual therapy (neviripine and AZT) to prevent transmission of HIV from pregnant women to their children. Although sufficient evidence for the effectiveness of dual therapy existed, the Kwazulu-Natal Department of Health had been dragging its feet on the issue for years, citing budgetary constraints or lack of feasibility. It may well have been that Dr. Pfaff's initiative exposed the Department's responsibility for preventable transmission of HIV to children, i.e. that they were asleep at the wheel. In any case, after an massive outcry, the Department reinstated Dr. Pfaff.

Now it is the turn of Dr. Mark Blaylock. He is accused of something apparently trivial, but actually more profound. At a launch of dual therapy back in February, the head of the Department of Health (Peggy Nkonyeni) saw fit to attack the integrity of those who would implement the therapy and question their motivations for expanding HIV prevention options for pregnant women. More specifically, doctors who had pushed for dual therapy in the past were accused of wanton behavior, being opportunists, creating anarchy and caring more about money than about the health of rural populations; at the same meeting, she even managed to cast doubt on the benefits of the very therapy she was there to launch. Soon afterward, Dr. Mark Blaylock apparently reached his limit, and tossed a framed picture of Ms. Nkonyeni into a trash can. For which he received a letter formally charging him of misconduct, having acted in an 'improper, disgraceful and unacceptable manner' towards the head of the Department of Health. Dr. Blaylock was sentenced to a month's unpaid leave, but he is reportedly taking permanent leave. While Kwazulu-Natal cries out for doctors, he has had enough, and is apparently heading off to Canada.

The incident exposes the level of distrust among those involved in fighting the AIDS epidemic in South Africa. All the infighting is bound to make a bad situation worse. But part of the problem has to do not with trust, but with reverence. The Department of Health in Kwazulu-Natal seems to think that any criticism of its policies is an act of betrayal, and by implication, that its recommendations ought to be accepted on faith. Dr. Blaylock was ultimately punished for having desecrated Ms. Nkonyeni's image, but the question is why the image should be considered 'sacred' in the first place. As a holder of public office, Ms. Nkonyeni is a servant of the people and open to criticism by the people. She and her Department should be taken to task -- loudly and publicly -- when it undermines trust in effective HIV prevention and the commitment of the men and women who labor daily to implement it.

Dr. Blaylock created a potent image by sticking Ms. Nkonyeni's likeness in the garbage. Of course, the phony sanctity of Ms. Nkonyeni can be exposed in other ways: she is currently under investigation for the purchase of a mammogram machine at three times the normal price, and she is alleged to be having a relationship with the head of the company from which the machine was bought.

Biofuels: enemy of the world's poor?

Sitting in my room in Leslie Lodge in Blantrye (Malawi), I get the opportunity in the evenings to do something unusual: watch television. I don't have one at home. Besides the predictable trash, and some good football, I have been struck by the way that the current food crisis has been treated by most of the news channels. They have been milking the connections between biofuels, rising food prices, and imminent hunger for millions of persons for all they are worth. For some reason, Germans are being interviewed at gas stations that offer biofuels, apparently to show how good intentions can pave the autobahn to hell: the ethanol going into their tanks is pulling food out of the mouths of the poor. When the news channels are not probing the depths of German guilt, they produce an excellent soundbite from the UN Special Rapporteur for the Right to Food, Jean Ziegler, stating that the production of biofuels is "a crime against humanity" because of its impact on global food prices, and the effects of food insecurity on health and well-being. Add the remark of the UK Prime Minister of the food crisis as the 'new credit crunch', and stir. You get a big biofuels backlash.

Fortunately, some newspapers take a more skeptical and nuanced view, by asking the essential question: to what extent does increased biofuels production impact on food production and rises in global food prices? The answer seems to be: we don't really know yet. It may well contribute something, but it is not as if a couple years of biofuels promotion has undone an global situation which was otherwise in wonderful shape. In fact, the fingerpointing at biofuels might just be a (new) way of ignoring the weightier and longer-standing reasons for chronic food insecurity in developing countries. Might it have also to do with existing international trade policies and the subsidized-to-the-teeth agriculture industries in America and Western Europe? Lack of committment to (god forbid) family planning in developing countries? I am reminded of the story about Malawi, published in the New York Times the last time I was here: how the country went from the brink of famine to being able to export corn by ignoring the neo-liberal policies of the International Monetary Fund. Many developing countries, like Malawi, have been dealing with food insecurity for years. Biofuels production might be only delivering the coup de grace, while taking the rap for the whole ugly thing.

The global scramble for ready-to-consent populations

Last year, Jill Fisher at Arizona State University wrote a very interesting article on the concept of 'ready-to-recruit' populations for biomedical research for the journal Qualitative Inquiry (subscription required, goddammit). The term 'ready-to-recruit' is a concept used in the pharmaceutical industry to describe populations that do not really have an attractive alternative to joining a clinical trial, because they live in circumstances of poverty, where there are few doctors, where local medical care is sub-standard and so on. Fisher prefers the more ethically charged term 'ready to consent' to describe these populations, because they are not just easy to access, but gaining their consent is a piece of cake. Practically all you need to do is ask. Socio-economic forces do the rest. Which is to say: the whole consent process is a bit of a farce.

I was reminded of this when reading that India has surpassed China as Asia's most popular venue for clinical trials conducted by pharmaceutical companies. India currently has some 139 clinical trials going on (compared to China's 98), worth something upward of $300 million, and by 2010 this market is apparently going to be worth 1.5-2 billion dollars. India is attractive for pharmaceutical trials, according to the India Times, because of its diverse genetic pool, large patient numbers, drug naive population, competent medical professionals, high quality hospitals where trials can be undertaken at something like 20%-60% lower costs than in developed countries. What the India Times piece does not mention are some of the gaping regulatory holes in the Indian drug R&D world (though this one does), questions about the effects of the pharmaceutical industry (such as possible 'internal migration' of the best clinicians) on Indian primary health care services, or about the benefits (or lack of them) likely to accrue to local communities.

Should Africa steer clear or join the bandwagon? God knows there are enough ready-to-consent communities on the subcontinent. And it's cheap. Diverse genetic pool? Of course, it is the cradle of mankind. High patient numbers? Yes, if by 'patient' you mean anyone with lousy health, instead of someone who has been seen by a doctor. Drug naive? Hardly a problem. Now those other criteria, about the high quality medical institutions and health professionals, are a bit harder to meet. The health infrastructure in many places is in rough shape, and the physicians and nurses keep taking off to more attractive places like United States, Canada or ... India. Not to fear, the United Nations Economic Commission for Africa and the African Union recently organized a conference to promote increased clinical trial research in Africa, with a couple big pharmaceutical representatives in attendance. What was agreed on or planned is all a bit vague, though there seems to be a big stress on research ethics guidelines accompanying the promotion of clinical trials in Africa. Reams of guidelines. There is even a suggestion that the guidelines should have an 'African' character, in order for the latter to 'feel a sense of ownership'.

But scratch under the ethics, and you can read the economics. As Francis Crawley, executive director of Good Clinical Practice (GCP) Alliance puts it: "We need to have the pharmaceutical industry there in a really committed way because Africa—with the somewhat exception [sic] of South Africa—really lacks an industry presence and it needs that. We have seen the difference that this makes in places like India, Singapore, Korea, Thailand and China. And Africa needs to be there too." Do the ethics and the economics align? Is the pharmaceutical industry good for you? Just say yes. Sign here.