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.


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