Tuesday, May 26, 2009

Bioethics and democracy in developing countries

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.

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Monday, May 18, 2009

Motherhood as danger

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.

Thursday, May 14, 2009

The unbearable lightness of international research law

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.

Friday, May 08, 2009

Drugs for neglected diseases: an immodest proposal

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.

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Tuesday, May 05, 2009

H1N1 flu vaccine and the developing world

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.