Wednesday, October 27, 2010

Unethical and Invalid Vaginal Microbicide Trial Receives Fast-Track Status

It was recently reported that the massively hyped microbicide gel that might reduce HIV transmission from men to women by 39% failed to attract enough funding to run further trials. They had only managed to raise $40 million of the $100 million they needed.

Well now it's back, they hype, that is. The funding is not mentioned, though I assume it has been raised. I wrote two posts about this issue a few months ago. The first was about how unconvincing the whole trial was, along with the media coverage it received. The second was about how the trial was likely to be both invalid and unethical.

None of the worries that I and others have expressed about the trial, known as CAPRISA, have been answered by any subsequent publications. But now the gel has been 'fast-tracked' by the FDA.

The most worrying statement in this article about the 'fast-tracking' is: "most new cases are among women infected during sex with men". Most new cases are among women, but there is little evidence that most of them result from sex with men.

The CAPRISA trial itself gives numerous indications that HIV is not spread solely by sex. Most of the participants didn't engage in much sex and most of them used condoms most of the time. In other words, the sex involved was not predominantly 'unsafe' sex. But, despite this, HIV transmission rates were appallingly high. Why? The trial did not attempt to establish why.

This trial was indifferent as to whether people were infected sexually or non-sexually. Data about how many male partners were HIV positive, and how many had the same viral strain as their female partner, were not collected.

The assumption that HIV is almost always transmitted sexually (in African countries, not in non-African countries) informs most HIV prevention programming. Evidence of non-sexually transmitted HIV is often ignored or even suppressed. It is never investigated.

But even though the CAPRISA trial demonstrated the irrelevance of sexual behavior in very high transmission scenarios, apparently trials are going to continue. Worse still, all sorts of plans are being made about commercial production of the gel, as if its effectiveness has been demonstrated!

Almost all the money currently being spent on HIV prevention (as opposed to treatment, which receives far more funding) goes to programs that assume that sex is the problem. The result is that hardly any money goes into preventing HIV transmission that doesn't result from sex. Yet, medical services in African countries are of such low quality that UNAIDS warns UN employees about the risk of being infected with HIV from medical treatment.

If there are risks of medical transmission of HIV for UN employees, there are medical risks for everyone. The refusal of the CAPRISA trial to warn participants about non-sexual risks renders the trial unethical. The failure to investigate how participants were infected renders it invalid. This vaginal gel is just one more travesty being committed by the HIV industry.

(For discussion of pre-exposure prophylaxis (PrEP), see my other blog.)


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