Friday, February 6, 2015
The failure of the VOICE pre-exposure prophylaxis trial, daily treatment of HIV negative people with antiretroviral drugs via a vaginal gel, was guaranteed by the long and widely held assumption that almost all HIV transmission in African countries is a result of 'unsafe' sexual behavior.
Participants were deemed to be at risk of being infected with HIV by researchers who had no evidence for this risk. In fact, sexual risk was low, with only one fifth reporting more than one sex partner in the previous three months, low rates of sexual intercourse, very high rates of condom use and fairly low rates of anal sex (which may or may not have involved condoms).
During this trial HIV incidence was very high, 5.7 cases per 100 person years, although it went as high as 9.9 per 100 person years in Durban, a figure that is in urgent need of investigation. Yet, researchers made no effort to find out how the several hundred seroconverting women were infected. There were high rates of certain sexually transmitted infections (though low rates of others); could some women have been infected with HIV as a result of unsafe treatment at an STI clinic?
A whopping 71% of the participants use injectible Depo-provera (DMPA), which is known to significantly increase HIV transmission risk from women to men and from men to women. Two thirds of participants were from Durban, in South Africa's highest prevalence province, Kwa-Zulu Natal. To what extent could this have contributed to these high HIV transmission levels?
It is to be wondered if taking part in this trial could have exposed many women to the risk of being infected with HIV, given that they were selected on the basis that they were currently uninfected and had low sexual risk at baseline.
Whatever the answer to these questions, the unwarranted but ubiquitous assumption that HIV is almost always transmitted through heterosexual intercourse in African countries (but not elsewhere) remains in urgent need of revision. But where does it come from?
UNAIDS, effectively a UN funded lobby for the rich and powerful pharmaceutical industry, bandies the figure about at every opportunity. The claim had been made before this lobby was spawned, but it seems impossible now to identify any body of evidence to support it. Indeed, evidence claimed to support it often suggests the opposite, such as the baseline figures collected by the VOICE study.
Until the HIV industry establish how people are being infected with HIV and employ appropriate (and effective) prevention interventions, high rates of transmission will not stop in African countries. The continued recruitment of vulnerable people in high HIV prevalence areas for trials adminsitrated by researchers who are so entirely blinded by bigotry is inexcusable.
To make matters worse, some are calling for types of monitoring that no longer require them to rely on answers given by participants themselves. This is yet another instance of a 'veterinarian' approach to Africans, similar to the insistence on the utility of injectable Depo-provera (DMPA) in developing countries, despite evidence of harm that even those promoting the drug do not deny.
There is a supremely patronizing article on the trial in the New York Times which, like the researchers, can't accept the possibility that it failed for any other reason than the "elaborate deceptions employed by the women in it". Nothing is said about the elaborate deception of the HIV industry and the researchers eagerly looking for any way of giving pharmaceutical companies the green light to sell ever growing quantities of their grossly overpriced products.
Instead of admitting to any of their obvious failures, researchers are finding ways to get around trial conditions specifically designed to ensure that such trials do not depend entirely on lies and subterfuge in their efforts to find positive results for the various sub-sectors of the HIV industry that stand to benefit most.
Viewed from a different angle, the many rumors that the NY Times article refers to are not surprising, given the experiences of African people countries of unethical practices, harmful procedures, fudged figures for adverse events (or a failure to report them), outright lies told to participants and cover-ups of evident harm to people taking part in trials, and even to people taking various medications.
The issue of payments to participants is briefly discussed (after all, if there's sex there must also be money, right?). One 'global health specialist' says “I’ve never been concerned that money is the factor driving participation or is corrupting the results”. He may like to revise that view during future trials, rather than by further eroding the already weak protection from abuse that participants currently receive.
When a trial fails as miserably as the VOICE trial, researchers need to re-examine some of their most unsupported assumptions, particularly their most bigoted ones. Then they might think twice (or even once) before accusing participants of deception, in addition to promiscuity, lack of understanding, and indifference to the risk of transmitting a deadly disease to their partner and their children.
Posted by Simon at 2:53 PM