Monday, October 3, 2011

Male Circumcision, HIV, and the Media: My Perspective on Device Approval

On Monday, 26 September 2011, the New York Times' "Fixes Blog" published an article on male circumcision in Africa and regulatory barriers to its implementation in Africa. Below is my response to the article: 

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Dear Editor,


Surprisingly, your article “Obstacles Slow an Easy Way to Prevent H.I.V. in Men” (Sept 26) about Africa offers no perspective from Africans.


You state that "devices are game changers”, yet the process for their approval by external authorities is impossibly slow and is handicapping Africa from saving lives. This is by far the biggest obstacle. African governments cannot responsibly buy-in to a surgical procedure that could collapse the national health system given the shortage of surgeons in our region.


We have tested the PrePex device in over 1,000 cases in national public clinical studies (ClinicalTrials.gov: ID NCT01434628), with over 50% of procedures conducted by low-cadre nurses.  The procedure is safe, fast, bloodless, virtually painless, and requires no injected anesthesia. The demand is enormous and men leave smiling, without losing work days.


With innovation, we can achieve the goal of 20 million men circumcised in Africa by 2015. Rapid male circumcision is a reality today, if approval is granted.

Sincerely,

Agnes Binagwaho, MD, PhD
Minister of Health of the Republic of Rwanda