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Thursday, June 23, 2011
Farah Launches Overblown, Misleading Attack on Anti-HIV Trial
Topic: WorldNetDaily

Joseph Farah's June 21 WorldNetDaily column was a massive tirade about a field trial of an anti-HIV-transmission gel in South Africa -- "a joint project of the British government, the U.S. government and population-reduction advocate Bill Gates" -- which he portrayed as a modern-day Tuskegee experiment. He rants:

Last year, the experts were boasting about the gel showing a 39 percent effectiveness rate. I want you to think about what that means.

A 39 percent effectiveness rate when you are dealing with the transmission of a deadly virus means a 61 percent failure rate. Worse yet, the control victims received a placebo gel – one that could not protect them from HIV at all, just like the Tuskegee victims, meaning 100 percent were told to have sex with their HIV-infected partners with no chance of protection.

Is an experiment a success when 61 percent of the healthy patients die as a result of following the advice of doctors funded by the U.S. government, the British government and Bill Gates? Should experiments like that even be permitted, let alone tax funded? Shouldn't people be going to jail for participating in experiments that would make Josef Mengele proud?

Knowing all we know about past efforts to use human beings as guinea pigs, how is it that experiments like this are once again receiving taxpayer funds, accolades from the scientific community and no scrutiny or criticism whatsoever – until the publication of this column?

Farah offered no evidence he read anything about this study beyond a newspaper article about it. They're not hard to find -- they're all right here, at the website for Caprisa, the Centre for the AIDS Programme of Research in South Africa. If he had, he might have educated himself a bit more.

The study itself explains the population among which the field trial was conducted:

CAPRISA 004, a two-arm, double-blind, randomized, placebo-controlled trial, was conducted from May 2007 to March 2010. Women were enrolled at an urban and a rural clinic in KwaZulu-Natal, South Africa, but the study was not designed to assess the effectiveness of tenofovir in each clinic separately. Urban women were enrolled at the CAPRISA eThekwini Research Clinic, adjacent to an STI clinic located in the Durban city centre. Rural women were enrolled at the CAPRISA Vulindlela Research Clinic, adjacent to a comprehensive primary health care clinic in Vulindlela, a rural community of approximately 90,000 people, about 150km north-west of Durban. Prior to the CAPRISA 004 trial, feasibility studies were conducted to assess HIV incidence and sexual behavior at both sites. Extrapolated HIV incidence rates from prevalence studies in the urban (19) and rural (20) sites were 15.6% and 11.2% respectively. Reported anal sex rates were substantially lower at these two sites than we had observed in previous microbicide trials (21) in female sex workers in this region. Data from these feasibility studies were used as the basis for selecting these sites for the trial as well as for the design and sample size calculations for the CAPRISA 004 trial.


A coitally-related dosing strategy was selected to achieve high adherence, based on in-depth consultations with the communities involved. Sexual behavior data showed that women in the key study population had infrequent high-risk sex with migrant partners. 

The study also stated:

The trial (NCT00441298) was approved by the University of KwaZulu-Natal’s Biomedical Research Ethics Committee (E111/06), Family Health International’s Protection of Human Subjects Committee (#9946) and the South African Medicines Control Council (#20060835)

An accompanying Q&A explained more about the ethics and the subjects:

What approvals were required for this trial to get underway?

The trial underwent extensive and rigorous review, by South African regulatory authorities, the Medicines Control Council, and the ethics committees of the University of KwaZulu-Natal and FHI. In addition, both sites that conducted the trial had a local community advisory board to facilitate community involvement in the trial.
Did all women in the study provide informed consent?

Each woman was provided with detailed information on the study. The informed consent process ensured that the women understood (1) the study’s procedures as well as the risks and benefits of the study; (2) the need to practice safer sex behaviors regardless of which study group they were assigned to; (3) the importance of adherence to the study’s treatment regimen; and (4) the potential medical risks associated with participation. The women were under no obligation to participate and could leave the study, without consequence, at any time. Once a woman completed the study information session, she was asked to answer a comprehensive quiz about the key concepts of the trial. Women who answered all questions correctly were then asked to provide written informed consent prior to both screening and enrollment, using forms translated into isiZulu, where necessary.

Farah's ranting to the contrary, this field trial is nothing like the Tuskegee experiment. Unlike the Tuskegee victims -- who were never told they had syphillis and were allowed to die from it without receiving treatment, with the purported goal of finding out if syphillis affected blacks differently than whites -- those who took part in the Caprisa trial were fully informed about the study's risks and were instructed on the need to practice safe sex in addition to using the gel, with the goal of seeing if a gel designed to prevent HIV transmission works in real-world conditions. Farah doesn't mention that to his readers -- again, because he seems more interested in ranting than researching what he's ranting about.

The study also states that those who contracted HIV, whether on gel or placebo, engaged in more risky behavior such has not using condoms or sex with "migrant men" in a community that the study describes as the epicenter of South Africa's HIV epidemic. Farah didn't mention that, either.

Farah also claims that study participants "were told to have sex with their HIV-infected partners" by those who conducted the study -- something for which he has no evidence for, and something the study itself never claims. Does Farah really think that people in South Africa -- which HIV is spread mostly by heterosexual contact -- is knowingly having sex with HIV-positive people?

Farah offers no evidence that he attempted to contact anyone who took part in conducting the study to address his concerns. He's just hurling accusations without bothering to verify anything he wrote. That's the height of laziness.

Posted by Terry K. at 9:37 AM EDT

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