Act Up-Paris and treatment activism

Act Up-Paris has been the target of repeated accusations by Gregg Gonsalves and Nathan Geffen on this subject. We first resolved not to inflame the debate, which would have been a disservice to both sides, and to respond seriously to the attacks put forth. But for there to be a debate and not just a trial there has to be mutual respect among the parties involved. In an article [1], which appeared last fall and has recently been re-circulated on international list serves Gregg Gonsalves and Nathan Geffen this time have taken extreme positions regarding Act Up-Paris of an intensity rarely seen between activists on the basis of unfounded accusations, some of which are simply outright lies. They also singled out a former Act Up-Paris activist as a target of their attacks.

Now a debate is no longer at issue but rather a deliberate attempt to discredit the work of many organizations recognized as having some expertise in the domain of science and particular Act Up-Paris. We have already responded to Gonsalves’ and Geffen’s criticisms several times over the past few years.

We point out also that in the analysis that they make of the criticisms formulated against certain trials, the authors of the article completely underestimate the pioneering role played by local activists, for example in the case of the DART trial or the tenofovir prevention trial. Worse yet, they imply that Act Up-Paris manipulated these activists— as if the sex workers in Cambodia, PLWAs in Uganda and civil society in Cameroon were so easily manipulated and incapable of taking the least initiative. In their attempts to disparage us, the authors of the article infantilize PLWAs, activists and organizations in developing countries. This is insulting and unacceptable.

Act Up-Paris and research

–  Our partnership with researchers

People Living With HIV/aids (PLWA) must be complete actors in research. Research has every interest in recognizing PLWAs’ expertise. If the fight against AIDS has allowed this collaboration, it did not happen without pain. The interests are not always the same, PLWAs are not always thanked/recognized especially if they do not agree with the scientists and the scientist/PLWA partnership is a hard one to establish on equal footing.

Being an actor in research doesn’t mean the absence of conflict. Between researchers, in the private or the public sector, administrators who represent them, politicians and PLWAs there are often divergences. This does not necessarily mean that there are the « the mean researchers » and the « nice PLWAs », but simply conflicts of interest, different ways of seeing the PLWAs’ futures etc.

It is in this context that the mediatic actions that we do can be explained: bring to the public arena the problems of research and reverse power relations that are most often not in the favor of PLWAs.

These actions don’t prevent us to work with the researchers. In 1992, Act Up-Paris created with other Aids organizations the TRT-5, whose goal was to represent and defend the interests and the needs of the PLWAs by every people involved in the research or the medical care. 8 organizations work in TRT-5. Act Up-Paris elaborates and defends most of its positions regarding treatment or research issues in this very structure.

Act Up-Paris is represented in the French Agency in the Research on AIDS (ANRS [2]), COREVIH [3] and additionally in the rapport of experts on the recommendations of care and treatment of HIV [4]. We work on a daily basis with doctors and researchers; while this work sometimes involves conflict it always productive. To accuse us of being anti-science shows a total ignorance of our work.

–  Ethics in clinical trials

Act Up-Paris puts forth the following principle: to guaranteeing the protection of people enrolled in a trial, helps to assure the trial’s results. If a person is trusting, even while she knows she is taking risks, she will tend to want to “play by the rules” and inform the investigators if she is not in conformity with the demands of the trial. This means that ethical rules, even if they impose on the research some constraints-time, money, means, material- also guarantees the quality, the scientific character of the results obtained in a trial.

By definition, clinical trials imply risk for the people who participate in them. One criteria of the ethical character of a trial consists of looking at these risks (how large they are, whether or not they are permanent, how to reduce them or to take them into consideration after the trial...) and to compare these risks with the expected benefits. However, the expected benefits are not the same depending on the point of view of the researchers (who tend to see long term benefits in relation to the purpose of their research) the funders, and those who are enrolled in the trial. The balance of benefit/risks has to take into account all of this.

–  Our Newsletter: Protocoles

Every two months Act Up-Paris publishes a newsletter on treatment information entitled Protocoles. We analyze in particular treatment trials offered to people living with HIV; both publicly sponsored and privately sponsored. We look at the protocols that have been submitted to us by the researchers and we do a critical reading of them which we then share with our readers. We give an opinion on the basis of our experience as People Living with HIV/AIDS and our knowledge of science that we update constantly. It is also a way of participating in research. Our reading of trial protocols is recognized by researchers, doctors, institutions and People Living with HIV/AIDS.
We are therefore capable of reading trial protocols: it is the work that we did with the protocol of the DART or that of the tenofovir trial.

Our work on diverse international trials

Act Up-Paris produces numerous documents on these issues where we argue our positions.
It is therefore misrepresenting to say that we have never provided evidence to the criticism that we formulated or responses to the issues that our analyses could have raised.

Trials always have presuppositions

Science is never neutral. Research is not isolated from political, social, economic, ideological context in which it is designed. The results that they bring can in part determine different policies in the fight against AIDS. Denouncing specific presuppositions or assumptions of clinical research is not being “anti-science. “ On the contrary, doing so brings an indispensable perspective to scientific debate. Here are two examples:

The role of women

For example, on the three trials where our work is being reproached, the circumcision trial, the N9 trial and the tenofovir trial, the issue of women’s role in the epidemic is particularly striking. This is a political and social issue from which science cannot abstract itself. For example, the ANRS circumcision trial which will directly and solely benefit men, raises a real question about the relevance of a tool which will not be controlled by women, from which they will not benefit, and in this way runs the risk of increasing gender inequalities in prevention. There is nothing anti-scientific there but rather legitimate concerns given the feminization of the epidemic.

Economic issues in DART

Another example of presuppositions of a trial: at the moment when the DART trial started, the entire scientific community knew and had know for a long time that biological monitoring is preferable to simply clinical monitoring for PWAs. Likewise, recommendations concerning treatment interruptions had already been issued and we already knew, for example, for the people recruited by the trial this strategy was not recommended. See our documents on DART

The issues posed by DART can therefore only find a justification in the context of a dramatic lack of means given to access to treatment in southern countries - because we already had the answer from the rich countries. The main issue of DART becomes then: how much money do we save if we do barebones follow up and interrupt treatment— and are these savings on an economic level tolerable on the human level ?

Beyond the fact that DART gives itself no criteria whatsoever to respond to this economic question and therefore puts people at risk to answer questions already asked, we are right to ask about political assumptions of a trial thus formulated that could provoke the leveling downwards of standards of care and give scientific rationales to decision makers in rich countries not to finance to as much as they can universal access to treatment.
Let’s imagine for example that in France in the current political context where social health system is being dismantled in the name of economics that researchers, one of whom works in the area of treatment recommendations for the ministry of health suggests to evaluate the interest of limiting biological monitoring of People Living with HIV/AIDS to cut down on costs? Who can imagine this? Who would dare say to those who criticize such a study that they are anti-scientific?

Doing treatment activism also means raising political issues. What is anti-scientific about that? Do you want us to think that science is ideologically pure and that researchers don’t have to society and those who they work for?

Final answers to false accusations

The half-truths or lies of our detractors lead us to make the following clarifications:

–  N-9

There was not simple « a trial involving 900 people» on this spermicide, not more than than an «unpardonable confusion » on the part of a former member of Act Up-Paris that Gonsalves and Geffen’s article incriminates, but more than ten trials on nonoxynol 9 (N-9). Since 1987, American research has focussed on this spermicide, the in vivo results of which were disppointing: in large doses N-9 irritates the vaginal lining and increases the risk of transmission; in low doese it is inactive against the virus. Not one of the products under study show the least efficacy against HIV but for years researchers have conducted trial upon trial trying to find the illusory ideal dosage. In 2000 we calculated that around 900 people had become infected throughout the course of all of the trials testing this product, the majority of whose whereabouts are unknown and who are not receiving care or treatment. In those days, activism had not imposed the now currently accepted notion of shared responsibility between research agencies and governments to guarantee treatment to those who get infected in the context of research.

With considerable difficulty we were able to find the trace a few of those trials, beginning with a multi-site cohort of 2 509 people from 1976 to 1978 in the US, then two studies by the University of Alabama on the same group of 818 people in 1988 and 1990, a first trial in Cameroon (273 people in 1993), and then a second trial in 2002 on 1 292 people, another in Kenya in 1992 on 138 people, an FHI study in Thailand on around 350 people then 492 in the 1990s, another in Bogotá, Colombia in 1996, one in Zambia in 1997 on 110 serodiscordant couples and, finally, the study that Gregg Gonsalves and Nathan Geffen refer to : on 892 women in 4 countries: Benin, Côte d’Ivoire, South Africa and Thailand. It was only in 2000 that UNAIDS and Columbia’s laboratories interrupted the last trial of the series, citing the needless risks run by women who participated. This trial was criticized at the time by a number of community organizations. This is the only one Gonsalves and Geffen have remembered. What evidence of rationality !
In 2004, a last attempt was aborted in Malawi and in Zimbabwe, after 180 people were enrolled. The history of nonoxynol 9 can be qualified as hazardous without this being considered an anti-science position, quite the opposite.

–  Circumcision

The role that TRT-5 and other organization had in consulting with the ANRS is not the one described by Gregg Gonsalves and Nathan Geffen. One can be convinced by reading the letter written to TAC by the director of the ANRS, which attempts to calm the troublemaking enthusiasm of these leaders.