Sunday, December 30, 2007

Global bioethics: selected highlights in 2007

The year's end is the traditional time to draw up lists. Below is a list of bioethics issues or events around the world that lingered on the desk during 2007. In the USA, probably the biggest bioethics news of 2007 revolved around new advances in stem cell technology that seem to undercut the scientific need to terminate human embryos, and the 'spare the embryo' story probably received more press than all of the following items combined.

1. Outsourcing health care and developing countries.
As health care gets more expensive or health resources become more scarce in the richer countries of the north, clinics offering access to cheaper health services are springing up like mushrooms in the poorer countries of the south. The patterns of global trade in organ translants is well known, but this is seemingly only the tip of the iceberg. Think of any possible health need or desire, and there is a company that offers a relatively inexpensive (fewer-questions-asked) service for it in Brazil, Malaysia or Turkey. Fertility problems? Need a surrogate mother for your child? Try India. The natural resources of developing countries may be starting to dwindle, but they still have bodies, body parts, clinics or physicians of interest to those with the ability to pay.

2. Global warming, health and global inequality.
In the future, Hurricane Katrina may be regarded as a harbinger of the connections between climate change and the health of those worse off in society. Individuals or countries with the wherewithal will be more able to adapt to rising coastlines or drought; poorer individuals or countries will be less able to prevent the untoward consequences of climate change or mount a significant response once they occur. Adverse health conditions -- in the form of disease outbreaks -- are not the only effects: there can be social disintegration and political turmoil. Vulnerability breeds vulnerability. In this light, New Orleans should adopt Dhaka, capital of Bangladesh, as a sister city. A low-lying and impoverished country, in one of the worst hurricane areas of the world, Bangladesh is recognized by experts as an inevitable victim of the effects of global climate change. Some have argued that the industrialized countries that have contributed most to greenhouse gases over the years have a moral responsibility to limit the future damage to Bangladesh -- an argument that currently has zero traction in international corridors of power. Bangladesh: New Orleans feels your pain.

3. Male circumcision and HIV prevention.
The year 2007 was largely disasterous for HIV prevention research. Important clinical trials on HIV vaccines not only showed no positive preventive effect, one important vaccine seemed to increase the likelihood of acquiring HIV. A similar setback occurred with microbicide research. Amazingly, two randomized controlled trials on male circumcision in Uganda and Kenya showed roughly a 60% related reduction in risk of men acquiring HIV. It is ironic that an ancient rite seemingly has a greater protective effect than highly sophisticated drugs. In the future, the trick will be to appropriately, safely and effectively implement this finding in the field, given the ethical, political and social baggage this practice bears in cultures around the world.

4. Multidrug resistant tuberculosis and the politics of epidemic control.
The chickens have come to roost in regard to tuberculosis. This infectious disease, typically afflicting the poor, was once a serious health threat in the developed world. Effective medicines, prevention and treatment programs led to a marked decline in TB prevalence in Europe and North America in the mid-twentieth century. In developing countries, tuberculosis control programs were only implemented half-heartedly, partly because of the sub-standard conditions of local public health institutions and clinics, partly because it is more interesting to fund research on new drugs for diseases affecting the affluent than to fund programs to provide old drugs for ancient maladies among the poor. However it came about, one thing is clear: multidrug resistant strains of TB are on the rise in the developing world, and they are coming back to haunt the richer northern nations, often by way of commercial aircraft. And with multidrug TB comes all the ethical problems associated with control of a potentially deadly infectious agent, including the use of quarantine.

5. The ongoing legal battle between Nigeria and Pfizer.
In 1996, the pharmaceutic company Pfizer conducted the controversial trials for the antibiotic Trovan involving 200 children during a meningitis epidemic were conducted in Kano, Nigeria. The state of Kano alleges Pfizer conducted the trials illegally, without the full knowledge and consent of the government and the parents, causing the death of 11 children and injury to some 118 others. Pfizer denies all allegations, stating that the children's death and adverse conditions were a result of the epidemic, and not their drug. In the case that is now before the Nigerian court, the government of Nigeria is seeking $7 billion in damages, and the state of Kano is seeking $2 billion. Over the holidays, arrest warrants were issued to three staff members of Pfizer for having failed to appear in court after having been subpoenaed. The story, increasingly complicated and partly obscure, goes on and on. It is a living symbol of the ethical challenges of doing biomedical research across stark differences in power and culture, but a symbol with real effects: the controversy has eroded public trust in Western medicine in some parts of Africa.

Thursday, December 20, 2007

The unbearable lightness of Helsinki

It is a mandatory quiz question for introductory research ethics courses: what is the Declaration of Helsinki?

  • Standard answer: the Declaration of Helsinki is a well-known international ethical guidance document for biomedical research involving human beings, first formulated in 1964 and revised 5 times since. Although propagated by the World Health Association, the document is meant to be the property of humanity, promoting responsible research wherever it takes place in the world.
  • Less than standard answer: the Declaration of Helsinki is a oft-cited document containing lofty moral aspirations but zero legal bite, a brief laundry list of problem areas in human subjects research rather than a resource for real-world solutions, produced by an obscure agency (the World Medical Association) whose main claim to fame is that ... it produces the Declaration of Helsinki, in a deliberative process that makes the Vatican look like a model of transparency. The Declaration joins the bewildering number of international guidance documents that bioethics workers/policy geeks pay far more attention to than researchers ever will or should.
Which answer would get -- or should get -- the higher grade?

There is certainly something to the less than standard answer. Ordinary mortals are apparently not even allowed to see, much less weigh in on, the newest draft version of the Declaration. We can glimpse some aspects of the draft revision in a recent article on the Bioethics Forum, written by those who have apparently visited the inner sanctum. How is the concealed debate of a 'universal' document to be explained? About ten years ago, after controversial prevention of mother-to-child HIV trials, people were sweating over the revisions of the Declaration as if life and death of vast populations were at stake with each word. Is the relative secrecy is meant to circumvent another round of endless debate and heated controversy?

They might not need to worry. There have been lessons learned over the last ten years, and according to some bioethics workers, the key lesson is that the Declaration is dead as a moral and regulatory force in international health research. Dead, because the Declaration's wording is always under pressure to align with the interests of powerful groups, especially regulatory bodies in the United States and their associates in the pharmaceutical industry. Dead, because however the Declaration is formulated, its general prescriptions can be reasonable to ignore and unwise to follow in particular cases. Dead, because it encourages an utterly wrongheaded idea of what is involved in trying to tackle ethical challenges as they messily emerge in the field of health research, i.e. the application of universal statements to particular circumstances. That's not how it goes. And if it doesn't help with that, what good is it?

Perhaps the best place of the Declaration of Helsinki really is the classroom, as a pedagogical device, as a possible teaching moment. It can usefully introduce students with an interest in international research ethics to some general areas of enduring debate, and some tasty value language, before moving on to explore issues in greater detail and nuance. Outside the classroom, however, Declaration's authority, scope, status and usefulness are getting increasingly obscure.

Wednesday, December 12, 2007

Corn and global ethics in Malawi

It has been some time since the last post. Two things have monopolized my time: (a) setting up a qualitative research project in Malawi on community attitudes towards male circumcision as a way of reducing risk of HIV and (b) writing an NIH Bioethics grant renewal -- in fact a renewal of the grant which is affiliated with this blog. This involved flying to Blantyre (Malawi) to help train interviewers on qualitative methods by day, while furiously grant-writing by night.

While I was in Malawi, there was a New York Times piece that caught my eye, and also the eye of the local population. Malawi is currently experiencing a food surplus, only two years after being on the brink of famine. The past food shortages were especially alarming in the light of the high HIV prevalence in the country, and the need for good nutrition to help manage the virus. The turnaround from famine is attributed to a change in governmental policy in regard to the subsidization of fertilizer. For years, under pressure of the World Bank and other donor agencies, the Malawian government were reluctant to subsize fertilizer so that local farmers could afford it. The theory, emanating from Washington, was that it would be better for Malawian farmers to grow cash crops (like tobacco) for export and use what they earned in foreign exchange to import food. In practice, many farmers stuck to corn, but without fertilizer, and they found themselves producing less and less. After the disasterous 2005 harvest, the Malawian president started subsidizing fertilizer, the farmers got their hands on it, and yields skyrocketed. The painful irony is that while Washington preaches free markets and lack of government intervention for the poorest countries of the world, it gives billions of dollars in subsidies to its own agricultural sector. You have to wonder: how many people died in Malawi as a direct or indirect result of these unjust policies? It is probably impossible to know. Will foreign policy-makers be held accountable? Of course not.

The irony is not lost on the Malawians. Driving back in the rain from the College of Medicine in Blantyre, my colleague Eric Umar said: 'These kinds of things have happened many times before. It is not new. So after awhile, you get the idea that these foreign agencies are not really trying to succeed. They want us to suffer, if is in their own interest that we suffer.'