How to stop a worldwide pandemic?

The quote is from the Danish philosopher Søren Kierkegaard and was borrowed by Anna Forbes, member of the Global Campaign for Microbicides, whose Advisory Committee, met last 30th and 31st of May in Sitges, near Barcelona, in Spain.

This quote set the line of debate that was raised in this meeting on the ethical responsibility of the promoters of clinical trials with new preventive technologies (microbicides, vaccines and pre-exposure prophylaxis) in regards to how participants can have access to basic care, especially those who get infected with HIV during those trials.

This is not a debate limited to the Global Campaign for Microbicides, but one of the entire international HIV community. The triggering of this debate was the suspension of trials on the use of tenofovir as pre-exposure prophylaxis -when people not living with HIV take the drug on a regularly basis in small doses in order to prevent the transmission of the virus in the case of an exposure to it-, which were being conducted in female sexual workers in Cambodia and Cameroon. Through the intervention of both local and international activist groups the trials were suspended. The activists expressed their disagreement on how the trials were being conducted, focusing on, among other aspects, some of which are seriously alarming, that there was no guarantee to treatment access for those who acquired HIV during the study.

The situation is not simple. Clinical trials on new preventive technologies are done, by definition, with people not living with HIV. Both at the moment of enrolment as well as all through the trial, the promoters, if they follow the norms of good practice, offer counseling and HIV tests as well as free preventive material. In spite of this, some participants will carry out risky practices in the course of their normal daily life, and in the end become infected with HIV.

Providing ART
The question is: Do the promoters of the study need to be obligated to provide antiretroviral treatment for those who are infected during the course of the study if this treatment is not available by other means?

The obvious answer is ”yes“, for the simple reason that anybody, in any part of the world should have access to treatment. However to answer ”yes“ to this question brings along gigantic consequences. First of all the promoters of these preventive trials tend to be public institutions such as the American National Institute of Health (NIH) or non-profit organizations like the International AIDS Vaccine Initiative (IAVI) or the International Partnership for Microbicides (IPM): if the cost alone for setting up and carrying out the trials is already very high, adding on to it the cost of treatment for people who end up getting infected drastically reduces the possibility of conducting such trials.

The heart of the matter from an ethical point of view is whether the promoter should take responsibility or not for those who acquire HIV during the trial when the viral transmission was not due to any direct or indirect factor of the trial. Even more so, it is possible that the participant has received the best support in terms of counseling and preventive material which they normally would not have received if they were not part of the trial.

Unfortunately our desires cannot always, or rarely, fit in with reality. It has been shown from both a community and political point of view that a clinical trial on new HIV preventive technologies cannot take place if the care of the participants who become infected is not guaranteed. At the same time it is disturbing to see how some African and Asian governments, which are doing nothing in the way of providing access to treatments or in worst case scenario are even slowing it down, suspend clinical trials on the basis that their citizens should not be treated as Guinea pigs.

Many difficult questions
In this situation, the questions on how to solve this problem are many, and difficult. Kate MacQueen, from the HIV Prevention Trial Network (HPTN) in the USA, listed in Sitges a number of them. Taking into account that before being enrolled all candidates for these trials need to take an HIV test in order to certify that they do not live with HIV, is it acceptable that treatment only be given to those who acquire HIV after they have started taking the experimental substance (or placebo), or shouldn't it also include those who are screened out of the trial because they are HIV-positive? On the other hand, in contexts where there is no access to treatment, wouldn't it create an incentive for people who are convinced they are HIV-positive to volunteer for these trials? Should treatments only be given to this particular population during the study or for a longer time? And for how long? For the rest of their lives? Should it be only the first treatment combination, or also the following ones? Will this delay the expansion of national health systems and relieve local governments of their responsibilities in the affected countries?

What about the rest of the needs which come with HIV infection, such as diagnostic techniques, care for side effects or opportunistic infections? What about other health necessities, especially sexual and reproductive health? What about other vital needs such as food, resources or protection against gender-related violence? What about people who do not take part in the study, family, friends, and the rest of the local community?

Trial participants’ needs
Jannecke van de Wijgert, a Dutch clinical epidemiologist with years of experience in Africa warned on the simplification of the concept of the ”trial participants' needs“ , and explained that if you ask a woman what she needs, the most likely response will be a job or that you talk to her husband so that he stops assaulting her.

It is surprising that the debate has come about because of trials with new preventive technologies, as is the case with microbicides, meanwhile the negative consequences of studies on new antiretroviral treatments in countries without universal access to treatments are hardly ever mentioned.

What the international community truly needs, and desperately, are new options in preventing HIV, because if it is important to achieve that millions of people have access to treatment it is also necessary that the number of people living with HIV stops increasing.

Joan Tallada

EATN - European AIDS Treatment News, Volume 14, II – Autumn 2005

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