Monday, October 10, 2011

The Deadly Arrogance Behind Trials of HIV Prevention Interventions

In a review of randomized controlled trials for HIV/AIDS prevention interventions in Africa, Dr David Gisselquist finds the HIV community somewhat wanting when it comes to tracing the source of infections, asking questions about non-sexual as well as sexual risks and failing to report findings that don't support the prevailing orthodoxy.

As Gisselquist points out, HIV is transmitted through memorable events, be they sexual or skin-piercing. Despite all the reports of 'African' sexual behavior, most people remember a fair bit about their own sex lives, with whom they had sex, when, how often, what kind of sex, etc. Stigmatizing the whole issue of HIV by branding Africans as sex obsessed doesn't help collect information about sexual behavior, but data could be collected.

The problem is that researchers tend to disbelieve Africans when they list no or very few partners, no or very little sex, relatively low levels of risky sex, little sign of promiscuity, an adult attitude towards sex and reproduction and a humane attitude towards sexual partners, friends, family members and children, especially their own children.

Researchers tend not to ask at all about non-sexual risks, which often carry a far higher probability of transmitting HIV and other blood borne diseases; some of these risks are extremely common. For example, it is rare to find data on shaving other cosmetic practices, dental visits, hospital and clinic visits and various medical procedures that could involve the use of unsterile equipment. Or if they ask, they don't seem to report the responses.

Many HIV positive people would be able to remember most or all the events that could have led to their infection, if only they were asked. Many would be able to cite such events, even if not asked, if only they were taught to watch out for those risks as assiduously as they are taught to watch out for relatively low risk sexual experiences, such as penile-vaginal sex with their only sexual partner.

The review identifies 44 randomized controlled trials, following more than 120,000 adults in Africa which saw over 4,000 infections during the course of the trials. But interventions that assume almost all HIV transmission to be sexual, even where the intervention may reduce transmission, will likely fail to identify the circumstances that give rise to massive rates of transmission only found in some African countries. These interventions all failed in this respect.

In general, where people were said to have been infected sexually, no attempt was made to test their partner or to identify a sexual partner who was also HIV positive. No effort was made to identify non-sexual risks, either. So the UNAIDS advice to "know your epidemic" in order that you may "know your response" can not be followed, even by UNAIDS.

It is not even possible to carry out further analysis of data because it was either not collected or has not been made available by researchers. And the review raises a number of serious ethical issues in the RCTs. Six of the studies did not warn participants that their sexual partners were HIV positive, which meant they could have avoided a serious risk of being infected. It is not known how many people became infected in this way.

The review recommends that African governments should insist on trials being carried out ethically, particularly by following protocols that would be required in the countries funding the research. In addition to being carried out ethically, data that is relevant to risks should be collected and made available to the research community. And all data that is relevant to HIV risk should be collected, not just sexual risk behavior.

The findings of this review are truly shocking. That Western governments can carry out such research, knowing the effect they are having on innocent people, is sickening. The fact that African governments allow these trials to take place under such conditions is also horrifying, though it does not exonerate the Western governments involved.

But the most frightening thing of all is that these trials have taken place with the full participation of some of the most highly educated people, using the latest research and equipment, with some of the biggest health research funds ever awarded, over so many person years....

Far from reducing HIV transmission or finding out why transmission is so extraordinarily high in some countries, these randomised controlled trials appear to have allowed avoidable HIV transmission to occur, perhaps even hastened transmission in some instances. This is arrogance on an appalling scale, the consequences of which are deadly. And all done in the name of HIV prevention.

[Dr Gisselquist's review is available in various formats on the Don't Get Stuck website's download page.]


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