The Gilead Saga: A New Installment
In a previous post, I described how an effective anti-retroviral drug Viread, or tenofovir) developed by Gilead Sciences is currently being tested for safety and effectiveness as an HIV ‘prevention pill’. The trials are being held in various sites around the world, and are funded by the NIH, CDC and the Bill and Melinda Gates Foundation. The benefits of such a pill, if proven safe and sufficiently effective, would be substantial, particularly in low-income countries where HIV continues to be transmitted and women are often powerless to negotiate male condom use. But such HIV prevention studies must also wind their way through an ethical minefield, considering that the research participants must be both HIV-negative and exposed to the HIV virus if the studies are to be meaningful. As I put it last time:
All ethical hands on deck: do the trial participants really know they are not being guaranteed immunity from getting HIV? Are participants given sufficient resources and education about the use of condoms and other preventative means? Are the women, even if educated about prevention, really in a position to negotiate condom use? And what will be provided to those who become HIV-infected during the trial? If weaving an acceptable path through these issues is not difficult enough, keep in mind that the participants are often from non-Western cultures where the understanding of biomedical research may be less than ideal. And note that from a strictly scientific point of view, it is in the researcher’s interest that (at least some) participants fail to take the recommended precautions and expose themselves to HIV transmission. The study design is an ethical tinderbox waiting for a flame.In August 2004, the tenofovir trials in Cambodia were halted by the Minister of Health following concern by sex worker unionists about adequate compensation to sex workers infected during the study. The tenofovir trials in Cameroon were suspended in February 2005 after months of heated rumors about ethical violations, culminating in a demonstration against the study by ACT UP Paris in front of the Cameroonian embassy in Paris.
Now it seems to be Thailand’s turn. And this time it is before the trial even starts.
The study population in Thailand, unlike the case with Cambodia and Cameroon, are 1600 intravenous drug users. According to Thai Drug Users’ Network (TDN) and other AIDS organizations in Thailand, the main ethical issues are (a) failure to provide clean injecting equipment (b) potential coercion involved in recruiting participants from methadone clinics (c) post-trial access to costly tenofovir if the drug proves safe and effective (d) lack of guarantees about treatment and care for those who are found HIV positive during pre-trial screening or who become infected during the trial.
This last concern is especially sensitive, considering the, well, unhappy relationship between intravenous drug users and the Thai government. Since 2003, the Thai government has waged a war on human rights drugs that has allegedly involved the killing of more than 3000 drug users. (For the gruesome Human Rights Watch report, see this.) So the prospective participants probably shouldn’t expect their government to lose much sleep over their welfare. But then you wonder – if the researchers and research funders knew just how vulnerable Thai intravenous drug users are to abuse and neglect, why did they decide to hang their shingle over there in the first place? - Stuart Rennie, UNC
