John J. Potterat has just published an article in Future Medicine (Jan 2010) delving into the shortcomings of the recent, prematurely concluded study on risk to women (or as the researcher's termed it, "benefit') from male circumcision. Said study found the search for any benefit to women "futile," but ignored any potential harm to be deduced therefrom. Mr. Potterat's article is particularly interesting because it is primarily concerned with factors not considered in the design of the study.
The researchers failed to factor into their design any concern for iatrogenic HIV infections, a mode of transmission that has been determined to make up a full 1 in 5 of all HIV infections in Africa. Potterat argues that a "singular focus on sexual HIV trasmission" has blinded researchers to broader modes of transmission. Many results focused on sexual transmission have been described as surprising and unexpected when in fact such outcomes can in fact be explained by this singular focus. He concludes:
Singular focus on sexual HIV transmission, lack of specificity in modes of sexual transmission, incomplete HIV sequencing on partner-linked pairs, not to mention possibly inappropriate termination of the RCT, undermine confidence in the validity of the trial’s outcomes. Yet, such unexpected and disappointing results fit within the long lineage of RCTs in sub-Saharan Africa that have, during the last two decades, monochromatically focused on sexual HIV transmission and failed to demonstrate anticipated outcomes. This lineage includes RCTs and population- based surveys to assess the efficacy of treating STI to reduce HIV incidence, the impact of sexual concurrency on rapid HIV propagation, the impact of sexual behavior interventions and the impact of vaginal microbicides or of providing pre-exposure prophylaxis (daily tenofovir). The words ‘paradox’, ‘surprising’ and ‘unexpected’ are commonly used in these reports. The real lesson from disappointing RCTs may be that sexualization of sub-Saharan Africa’s HIV epidemics has deterred researchers from exploring a broad range of blood exposures as contributing factors. Two decades of unexpected and disappointing results argue for a fundamental reassessment of what is being missed by the orthodox assumptions. Time to cut the Gordian Knot? [Internal citations omitted.]
Link: Randomized, controlled trials for HIV/AIDS prevention in Africa: learning from unexpected results
I would like to thank Mr. Potterat for referencing this website in his article. I'm never quite sure of the reach and influence of the posts herein. I'm gratified that perhaps the germ of an idea first disseminated on these pages has resulted in an intelligent, thoughtful academic article on the above issue.
