Bioethics, Thai style

PLoS Medicine this month has an interesting series on Social Medicine well worth checking out. Among the offerings is an article entitled 'Is there a Global Bioethics? End-of-Life in Thailand and the Case for Local Difference.' Using the case of a construction worker who is injured and placed on life-support, Stonington and Ratanakul argue that such situations as experienced in Thailand involve ethical conflicts that cannot be understood or dealt with by means of the 'Georgetown mantra', i.e. beneficience, non-maleficience, autonomy and justice. The only way to conceive and handle these bioethical dilemmas is to place them in a specifically Thai-based conceptual framework.

The article is a bit of a teaser, because it does not say how the case was resolved. When Lek, the construction workers brother, is advised by Dr. Nok to become ordained as a monk in order to help his brother achieve mental clarity and 'let go' of his attachment to life, there is no indication of whether or not this actually turned the trick. If it didn't, was Dr. Nok then forced to remove the ventilator, causing himself serious karmic damage in the process? Or is Gaew, the man in question, still languishing in a Thai hospital somewhere?

End-of-life issues involving medical technology take a culture's ethical framework and stretch it to the breaking point. That phenomenon, at least, is universal.

Jumping the gun with a knife

Anyone can make a mistake. Ask USAID, which according to a New York Times dispatch, mistakenly financed a program in Swaziland that promoted circumcision to prevent the spread of H.I.V. According to USAID spokeman David Snider, the agency gave Family Life Association of Swaziland (FLAS) about $150,000 in funds last year, and the latter went off and circumcised 328 men. That was a mistake. USAID, like WHO, has a policy of waiting for the results of two studies in Kenya and Uganda -- studies which are supposed to confirm that circumcision can reduce a man's risk of getting HIV from women -- before bringing scalpels to bear on foreskins.

On the other hand, the mistake may in fact have been overzealousness. It is not a secret that a USAID researcher and technical advisor was in Swaziland a few months ago, 'aggressively pushing news' among Swazi doctors of the recent South Africa study linking circumcision and reduced HIV transmission risk. It is also not a secret that doctors working at FLAS perform circumcisions: it's in the papers, and besides, FLAS doctors gave a refresher course in circumcision earlier this year, supported by USAID money. And it is not hard to find news reports that explicitly link USAID, FLAS and the performance of circumcisions either: try this one from the March 1st Swazi Observer. So the statement from USAID that it had only recently learned of the program sounds a bit farfetched. Perhaps this is why the New York Times piece is entitled, "Swaziland: U.S. Circumcision Funds Termed an Error."

(Thanks to Joseph Lee)

Funding with moral strings attached

In his 2003 State of the Union Address, US President Bush announced the President's Emergency Plan for AIDS Relief, often known as PEPFAR, a five year $15 billion global initiative to combat the HIV/AIDS epidemic. PEPFAR programs have proven effective in many areas, particularly in the scale-up of AIDS treatment in its 15 target countries. PEPFAR has also been dogged by controversy, particularly the amount of its funding allocated to abstinence HIV prevention programs, and the pledges that non-profit AIDS groups must sign before being eligible to recieve PEPFAR funds, i.e. pledges opposing prostitution or pledges that one will not give clients information about or referrals to reproductive services that also offer abortions.

As for the money alloted to abstinence programs, it is written into the 'United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003', and it is unlikely to be removed. The pledges, on the other hand, may be more negotiable. Last May, DKT International Inc. sued USAID, the agency in charge of PEPFAR, claiming that forcing them to sign a pledge opposing prostitution was a violation of the right to free speech. A US District Court judge sided with DKT, but this week the Justice Department has appealed the decision. According to the press report, the Justice Department claims that the pledge was "highly germane" to the overall goal of fighting the spread of AIDS and HIV, because:

Congress could reasonably determine that the government's efforts to stamp out prostitution and sex trafficking would be most successful if HIV/AIDS services are provided by organizations that affirmatively oppose two underlying causes of the disease.

But it is a very strange line of reasoning. There is no empirical evidence of the efficacy of signing these pieces of paper in the struggle against HIV/AIDS, and it is not as if organizations working with sex workers are 'in favor' of the trade. Nor are prostitution and sex trafficking 'two underlying causes of the disease'. They are ways that HIV/AIDS gets spread, but if you want to find underlying causes, it might be more wise to look at why women (and men) in developing countries enter into prostitution in the first place. DKT would surely sign a pledge against poverty, but the current US government seems more interested in using pledges to moralize about sexual behavior.

A tale of two policies

This week's Editorial in the Lancet is entitled "Should HPV vaccines be mandatory for all adolescents?". Those who expect an intelligent debate on the pros and cons of this type of mandatory vaccination are bound to be frustrated, because the editors just flatly state that, of course, it should be mandatory, and then go on to ponder whether HPV vaccines should be mandatory for boys too. Newspaper articles have covered the Lancet editorial, and parents have been bringing up the key ethical issue that the Lancet ignors: should the state have the power to enforce vaccination of adolescents, even against the will of parents or those adolescents themselves? It looks as if the Lancet's editorial team lapsed back into unreconstructed paternalism.

The Lancet editorial has even managed to misrepresent a recent ruling on HPV vaccination in the Michigan Senate.

Following earlier approval by the US Food and Drug Administration of the vaccine in girls and women, the Michigan Senate passed a bill on Sept 21, ruling that all girls entering the sixth grade of school (11–12 years old) should be immunised. This is the first legislation of its kind in the USA, and a decision from which the EU member states should take heed.

What this statement omits is the fact that the Michigan ruling allows for exceptions: parents who have medical, religious or philosophical objections to having their daughter vaccinated make opt them out of vaccination. Parents are not necessarily happy being told by their government that they must put drugs by big pharmaceutical companies like Merck into their daughters, no matter how effective those drugs may be. These days, governments, medical institutions and big pharma are not, to put it lightly, regarded as worthy of blind trust by the public. (It may be worth noting that the results of Merck's HPV vaccine Gardasil was first published in ... the Lancet Oncology). This relationship of compromised trust is perhaps something that EU member states, and the Lancet, should take more heed of in HPV vaccine promotion and policy-making.

Is the pursuit of evidence unethical?

Probably every undergraduate who endured a lecture about Karl Popper's philosophy of science got the point that science is not about attaining absolutely certain knowledge. There are no certainties. There are tentative theories which may be better than others if they have greater predictive power, can explain more, and survive current attempts to refute them. But they may also turn out to be wrong, and be replaced or absorbed by different (tentative) theories. So the humble march of science goes on.

In medicine and public health, this conception of science has important consequences. We want medical and public health interventions to be based on 'good science.' But since certainty about their effectiveness is unattainable, we are left with the tricky issue of deciding when the scientific evidence has reached a point that justifies stopping doing health research and starting to put our knowledge into health policy and practice.

In the current online issue of the British Medical Journal, Malcolm Potts et. al. have apparently had enough. They give vivid examples of where health authorities did not wait for randomized controlled trials before taking action (the use of oral hydration therapy for childhood diarrhoea), where we are still waiting for the results of two randomized controlled trials, despite decades of accumulated evidence, including an RCT (use of male circumcision to help protect against HIV infection); and where a low cost drug with an excellent safety profile and long shelf life, not being used in developing countries for fear of low effectiveness (the use of misoprostol for postpartum hemorraging).

According to Potts et. al., sometimes observational studies and clinical experience offer a good enough evidence base to justify health policy. Let us not, they argue, make the perfect the enemy of the good, and start making people healthier on the basis of what we know. This sounds like a fine 'let's-roll-up-our-sleeves-and-get-on-with-it' attitude, though it leaves open the issue of who decides what is good enough evidence, and the final paragraph may not be to everyone's liking:

Good science, we suggest, is taking the research to the problem rather than conducting the research in the tallest ivory tower the investigator can find. Randomised controlled trials are needed and, when appropriate, should be part of the empirical evidence necessary for decision making. The question is how much evidence is needed to move from research to practice, when the matter is life saving interventions in poor settings. The yardstick for decision making should take into account the risks and benefits in the local conditions, not those of an ideal situation.

What does the reference to 'poor settings' mean? Does it mean that there are double standards in what science counts as good enough to support health policies, one for the developed world, another for the developing world? The scientific bar is being set lower in order to provide immediate help to people suffering disproportionately in resource-poor countries. The assumption is that this will do more good than harm. But that, frankly, we can't be sure of. RCTs in the past have shown that some 'good enough' health policies and interventions have been not much good at all.

Potts et. al. are asking researchers and policy makers to take greater moral risks in regard to patients in the developing world -- but it is the latter who will pay if things turn out for the worst.

DDT, Malaria and Africa

This has been a heated controversy for some time, and it is not cooling down anytime soon. As many know, the use of DDT to control insects in agriculture has been highly restricted since the 1960's, due in no small part to Rachel Carson's Silent Spring, which connected DDT to cancer of the liver in humans and damage to bird reproduction. The successful restriction of DDT heralded the birth of the environmental movement in the United States as a political force, which means that any attempt to relax the restrictions is bound to spark a fierce ideological battle.

Now bring in Africa and the contemporary use of DDT in control of malaria. More than a million people die each year from malaria, mostly children under the age of 5, and 90% of the cases occur in sub-Saharan Africa. In the light of this public health catastrophe, observers over the years have argued that the benefits of using of DDT in small quantities for indoor spraying of walls and ceilings far outweigh the risks. Some have gone further, claiming that the restrictions on DDT have directly lead to millions of avoidable deaths, and thus crazy environmentalists (for some, read: eco-imperialists) have the blood of Africans on their hands. Worse still, the argument goes, while developed nations successfully eliminated malaria by using DDT in the 1940's and 1950's, those same nations now support a restriction on the use of DDT in poorer countries where where malaria is endemic, access to treatment is often limited, and economies are seriously impacted by the disease.

Two weeks ago, the World Health Organization officially announced its support of the use of DDT in indoor spraying, not only in epidemic areas (that was the old policy) but also 'in areas of constant and high malaria transmission, including throughout Africa.' The change in policy has strong backing from USAID and some US government officials, most notably Republican Senator Tom Coburn, who is quoted as saying:

“Finally, with WHO’s unambiguous leadership on the issue, we can put to rest the junk science and myths that have provided aid and comfort to the real enemy – mosquitoes – which threaten the lives of more than 300 million children each year.”

Republicans talking about health policy issues being resolved by a reference to scientific scholarship, of course, is heavy on irony, and naive to boot. The announcement by the WHO is unlikely to put the DDT issue to rest. While many (also in developing countries) have warmly welcomed the new policy, others remain unconvinced. At the recent Intergovernmental Forum on Chemical Safety conference in Budapest, delegates staged a protest over the new DDT policy, citing concerns about the potential effects of indoor spraying on reproductive health, neurological effects, effect on breast milk and increased risk of breast cancer, not to mention the possibility of resistance of mosquitoes to DDT. Inevitably, some raised the suspicion that dropping restrictions on DDT was ultimately driven by the financial interests of chemical industries in the US, rather than a concern for public health in Africa. A recent review article in the Lancet (2005) makes the usual song and dance, i.e. more research is needed:

Although DDT is generally not toxic to human beings and was banned mainly for ecological reasons, subsequent research has shown that exposure to DDT at amounts that would be needed in malaria control might cause preterm birth and early weaning, abrogating the benefit of reducing infant mortality from malaria. ... DDT might be useful in controlling malaria, but the evidence of its adverse effects on human health needs appropriate research on whether it achieves a favourable balance of risk versus benefit.

At the moment, how the risks relate to the benefits of using DDT in Africa still seem to be somewhat in the eye of the beholder. But given that the use of DDT in spraying is one of the few affordable and effective preventative interventions against malaria, and that hundreds of thousands die of the disease each year, the burden of proof seems to fall on those who focus on the risks.