tenofovir : inethical trial

publié en ligne : 14 July 2004

 

Faced with an epidemic that is continually growing, the importance and urgency of effective, global and diversified prevention is one of the fundamental issues involved, on the same level as treatment access for all.

a nucleotide in prévention

In this context of prevention, where only the condom has proved its efficacy, it is essential, given the lack of short-term prospects for the discovery of a preventive vaccine and a relaxing of preventive practices, to develop research on effective products that are also well tolerated, easy to use and inexpensive. In this area, there are several leads and trials have already been initiated... Microbicides raised great hopes but their results remain inadequate, to the point that their use, especially in countries of the South raises serious ethical questions. As for vaccines, their production remains problematic and complex.

Since the end of the 1990s, laboratories have had anti-HIV molecules. Animal trials show that they could prevent transmission of the virus and encourage researchers to set up human trials.

placebo versus tenofovir a trial to make you sick

This is the case of Gilead Sciences Inc. with its nucleotide analog tenofovir DF, for which in vitro and animal trial results are promising. An in vivo trial is being prepared and is planned to include 1200 seronegative prostitutes in three countries (Cameroon, Nigeria and Ghana). Half of the subjects will receive tenofovir (one pill a day), and the other half will be given a placebo with the same appearance as tenofovir but lacking the active substance. At the end of the 12- month trial period, a comparison will be made of the number of prostitutes having become seropositive in each of the two groups, in order to determine whether tenofovir is effective in preventing HIV infection. Based on the preliminary results of in vivo animal trials, there is already a parallel market in the United States for tenofovir used in prevention.

The Bill and Belinda Gates (BBG) Foundation offered a grant of 6.5 million dollars to Family Health International (FHI) to launch this clinical research project. For its part, Gilead will supply the product and placebo free of charge. A preventive trial of the same type obtained a subsidy of 3.5 million dollars from the Center for Disease Control (CDC) to test tenofovir in the gay communities of San Francisco and Atlanta.

the end justifies the means?

The trial conducted by FHI in Cameroon, Nigeria and Ghana, financed by BBG with the logistic support of Gilead does not seem to us to provide a satisfactory response to all our questions. Provision for psychosocial support and the means implemented to promote condom use are clearly insufficient, even ridiculous: only 5 counselors and one doctor for 400 prostitutes, no access to the female condom, despite it being much easier for the prostitutes to use in negotiating with their clients. However, scientifically speaking, cases of contamination are “needed” for the trial results to be “interesting”.

If all precautions were taken with regard to prevention and supervision, it is certain that the trial would have to recruit a much larger study population so that a difference in contamination rates between the placebo and tenofovir groups would be statistically significant. From the viewpoint of this same concern for people’s safety, the human benefit/ scientific benefit conflict is extreme: is it not possible to test this product on a less vulnerable population than prostitutes who suffer the combined disadvantages of living in a country where access to healthcare and treatment is limited, even non-existent, and practicing a risky profession, all of which is compounded by the poverty of Cameroon and the other countries involved in the trial?

The heart of the dossier is not so much an ethical/scientific conflict, as an n ethical/economic duel. In this sense also, if recruitment for the trial did not target a population already “forced” to take risks, it would be necessary to considerably increase the number of participants and consequently the cost of the trial... By holding this trial in Africa, Gilead and the BBG Foundation know that they will find a population that is vulnerable both materially and in terms of practices, women willing to let them carry out a trial at minimal cost. It is then, really a question of money and therefore, of the value of life. For Gilead and the BBG Foundation, the life of an African has less value than that of a Westerner.

when hypocrisy rhyme with economy

The tenofovir DF trial expects to provide follow-up and access to treatment for sexually transmitted diseases (STD). This plan may appear generous. In fact, it is nothing more than a means of building the prostitutes’ loyalty and minimizing the risks of their dropping out. Moreover, it so happens that follow-up tests are required for the scientific validation of the trial. Setting the amount allowed for expenses at 2,750 Fcfa shows an extraordinary level of cynicism. In fact, a rapid calculation shows us that this amount was figured to cover transportation expenses on the one hand (500 F for the taxi) and the prostitutes’ lost income on the other hand (2,150 F for two tricks, minimal fee in Douala).

What will happen to prostitutes who are found to HIV-positive during pre-enrolment testing? We don’t know, but we can imagine. In Cameroon, the promoter plans to refer women who become HIV-positive during the trial to the system of access to care and treatments set up in this country by NGOs and the government. While it is true that in Cameroon, treatment access is less difficult than in other African countries, it remains uncertain. It is estimated that one million people are infected with HIV, i.e. a prevalence of 15% (according to all of our interlocutors, this figure is an underestimate), and that 40,000 people are in urgent need of antiretrovirals (currently only 10, 000 are under treatment). It is therefore particularly shameful that Gilead; which is donating the tenofovir and placebo for the trial has not also arranged to provide free antiretrovirals to participants who need them.

the cost of rumour

If, because of the unethical nature of this trial, a lead for finding a molecule capable of preventing HIV transmission is abandoned, Gilead and the BBG Foundation will be responsible for having destroyed this chance. If the information diffused when the trial is launched is not more transparent, the implications for prevention are likely to become apparent in the form of other victims. Notably those who will become contaminated while taking tenofovir as a preventive agent on the basis of rumors. For all these reasons; we ask that the trial stop immediately, that the people already selected and found to be seropositive or who have become so since June 15 (start date of the trial in Cameroon) be offered comprehensive health care with medical follow-up, treatments for opportunistic infections and antiretrovirals if necessary. In the future; the design of this type of trial must be discussed with the patient associations in the host country. We hold Gilead and the BBG Foundation responsible for the lives of the women included in the trial.

 

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