Saturday, August 27, 2005

Reforming bioethics: a world of contrasts

In America, reflection on the limits of bioethics doesn’t seem to come naturally: it is typically induced by battle fatigue. After furiously debating stem cell research, cloning and end of life issues, some American bioethicists pause, reload and take their grievances to another level: the chasm between religious and secular conceptions of humanity and nature. The latter are frequently regarded as the ultimate, underlying basis of bioethical disagreement.

There are those who recognize that the culture of bioethics as a whole may be suffering to the extent that its practitioners are divided into feuding ‘religious’ and ‘secular’ camps. Recognizing that the culture war in bioethics may be a war of attrition, there are periodical calls for reform in terms of compromise, consensus, inclusion and tolerance. ‘Reforming bioethics’ in this context means finding ways in which religious and secular bioethicists can get along better.

It is sometimes refreshing to break free of the fishbowl of American bioethics to see how others reflect on the limits of the discipline as it is currently practiced. Take the recent article by Benatar and Singer, Global health ethics: the need for an expanded discourse on bioethics. Here the ‘religious versus secular’ debate hardly enters the picture. Reforming bioethics, according to Benatar and Singer, means bioethicists confronting the challenges to fundamental human values posed by inequalities between rich and poor, rapid population growth, emerging infectious diseases, wars and dislocation of communities, nuclear proliferation, ecological destruction, unfair international trade relations and more.

Extending the discourse in this way could promote the mindset that could improve health and deal with threats to health at a global level. That mindset requires that health, human rights, economic opportunities, good governance, peace and development are all intimately linked within a complex, interdependent world.

Many of the challenges mentioned are all-too-familiar to those living in developing countries, but it remains to be seen whether bioethicists in North America are willing, ready or able to promote a new ‘global mindset’ in bioethics.

Friday, August 19, 2005

Is your country attractive for clinical trials?

In an article recently published in Science, P.V. Padma examines the advantages of conducting clinical trials in India. It reads, initially, like a shiny tourist brochure: India-based trials are inexpensive, the country’s high population holds out the prospect of easy recruitment of subjects, many of the local health personnel speak English, and unlike Africa, Indians are increasingly suffering from the sorts of diseases afflicting Americans and Europeans, such as diabetes and heart disease. Potential study participants in India are also interesting to recruit given that they 'treatment naive' -- for reasons that should be obvious in the light of local per capital expenditures on health care. The list of attractions could be expanded. But why bother: many major drug companies are already sold on India, and have been scrambling to outsource their clinical trials there for the past few years.

Like any tourist brochure, the fine print lies buried somewhere under the glossy images. In this case, it is a lack of adequately trained staff, a regulatory bureaucracy which is slow and is (though the author delicately avoids the issue) prone to corruption, and a recent history of ethical scandals involving the use of unapproved drugs or the use of approved drugs for unapproved purposes. But nothing, the author suggests, that can't be smoothed over with a few IRB workshops, a few short-term benefits for study participants, and the "check is in the mail" notion of future general access to the tested medications.

Friday, August 12, 2005

The trouble with tenofovir

It just gets more twisted. In earlier posts on the American Journal of Bioethics Blog, I described research on an anti-retroviral drug produced by Gilead Science called Viread (or tenofovir) which is known to have been effective in boosting immune responses and lowering viral loads in persons living with HIV. It is currently being tested at various sites around the world to establish whether, and to what extent, the drug is safe and effective in preventing persons from getting HIV in the first place. The hope is that tenofovir might work as a ‘HIV prevention pill’ for those who believe they may be exposed to the virus. But the trials have been dogged by ethical disputes.

The tenofovir trials in Cambodia failed to start in August 2004 after the local sex workers union demanded decades of free health care as compensation for participants becoming HIV-positive during the study. The study in Cameroon was suspended in February this year following rumors about deceptive recruitment practices, and despite persistent claims from researchers that no serious wrongdoing took place, last week the site was shut down permanently. The CDC-funded study in Thailand, involving injection drug users, has recently been the target of criticism because there is no provision of sterile injection equipment to be given to the participants. In all cases, the media got involved, AIDS activists got involved, spokepersons for research agencies got involved, local politicians got involved, and it all got ugly.

In the meantime, talk about these problematic trials has filtered through to the commentary sections of learned scientific journals. Interestingly, some seek to shift responsibility for the problems with these studies squarely from researchers to AIDS activists, and the latter are depicted as having a vested interest in creating an atmosphere of sensation and scandal around AIDS clinical trials in the developing world. Joep Lange, former president of the International AIDS Society, can barely contain his outrage against a minority of activists, which he says have ‘taken us hostage’. According to Lange, they will apparently stop at nothing to derail the tenofovir trials:

The methods of these specific activist groups are uninformed demagogy, intimidation, and ‘AIDS exceptionalism’, the last in the sense that they exploit their HIV-positive status to get away with behavior that would not be accepted from others.

According to this perspective, the researchers (and their funders) should have a clear ethical conscience, for they did nothing wrong. It is simply a lunatic fringe of activists, in cahoots with medical journalists who increasingly want hot research ethics stories, which have undermined studies on a promising new form of HIV prevention and thereby betrayed the struggle against HIV/AIDS.

This is obviously not going to be the end of the saga. Expect a backlash against the backlash, especially as new trials are being planned for South Africa and Malawi.

Sunday, August 07, 2005

HIV/AIDS: too much focus on Africa?

According to some Brazilian AIDS activists, Africa has received an excessive amount of attention by the media and researchers, and has led to the neglect of HIV/AIDS concerns in other regions of the world, including Latin America. Speaking at last week's Third International AIDS Society (IAS) Conference on HIV Pathogenesis and Treatment in Rio, Katia Braga Edmundo, a coordinator with the Centre for the Promotion of Health (CEDAPS), said that more attention should be paid to issues such as lipodystrophy and the development of resistance to the drugs currently in use.

Perhaps it is distasteful to compare tragedies, but Brazil does have universal access to anti-retroviral drugs, whereas the situation in sub-Saharan Africa (with the exception of Botswana) is strikingly different. If a comparison is made between Brazil and sub-Saharan countries in terms of annual new HIV infections, annual HIV/AIDS-related mortality, estimated economic costs due to the pandemic, and percentage of the needy population with access to AIDS treatment, then the attention paid to Africa might be anything but excessive. Lipodystrophy in Africa is an affliction only few can afford.