Urgent inquiry from Treatment Action Campaign

From:  Nakatani, Hiroki

 

To:      Nathan Geffen; Marcus Low
CC:     Hirnschall, Gottfried Otto; Dickson, Kim Eva Yaa
Date:  Wed, Jul 7, 2010 at 7:35 PM

subject:     RE: Urgent inquiry from Treatment Action Campaign

Dear Mr Nathan Geffen and Mr.Marcus Low,

From:  Nakatani, Hiroki

 

To:      Nathan Geffen; Marcus Low
CC:     Hirnschall, Gottfried Otto; Dickson, Kim Eva Yaa
Date:  Wed, Jul 7, 2010 at 7:35 PM

subject:     RE: Urgent inquiry from Treatment Action Campaign

Dear Mr Nathan Geffen and Mr.Marcus Low,

Further to my earlier correspondence on the Tara KLamp and its use in South Africa, WHO has taken your concerns very seriously.  I needed some time to review the issues you raise, hence, this delay of response.
 
WHO is committed to supporting the scale-up of male circumcision as a proven biomedical intervention and in this regard, policy and programme recommendations were issued in 2007. Since then WHO has shown leadership in supporting the scale-up of male circumcision programmes in southern and eastern African countries. WHO has developed a wide range of critical guidelines and tools to guide country programming, and has also provided technical support to governments for programme implementation.
 
WHO's contributions have significantly contributed to the progress that countries in southern and eastern Africa have made in scaling up male circumcision programmes over the past 3 years. While WHO is pleased with country progress to date, we acknowledge that much more needs to be done if the HIV epidemic is to be reversed and remain committed to supporting countries to implement male circumcision and other evidence-based interventions and strategies for HIV prevention.
 
In response to the specific issues you raise: 
 
WHO did not withdraw a Statement on the Tara KLamp, no such statement has been issued. WHO considered publishing a Statement on male circumcision devices but decided to prioritize   publishing a report on an expert consultation on male circumcision devices that was held in March 2009 with programme managers, representatives from national regulatory authorities, surgeons, product developers and scientists .  This meeting report gives important background and context to the status of male circumcision devices for adults and summarizes the expert group discussions and their recommendations. The objective of the meeting was to reach a consensus on appropriate clinical evaluation pathways for devices, balancing the requirements of safety with the importance of making devices available rapidly if their potential to enhance circumcision programme delivery is supported by evidence.
 
The report indicates that the expert group considered all available devices with a potential for male circumcisions and recommended a framework for their evaluation. Key recommendations from the meeting include the following:

  • While circumcision devices had been successfully used in other populations, experience with their use among adults in Africa had not been encouraging.  It was important to proceed in a cautious yet progressive fashion, ensuring that the safety, effectiveness and acceptability of the devices in populations with good access to care were established before proceeding to more widespread implementation.
  • Since male circumcision for HIV prevention was being implemented as a public health intervention among healthy men, it was important to proceed cautiously and avoid any major complications or adverse events.
  • Requirements outlined for evaluation of male circumcision devices were more stringent than requirements for registration of medical devices that presented minimal risks to the provider or patient.  However, the desired end result was to ensure that safe, effective and acceptable devices could be introduced rapidly into national programmes. This required more extensive data on clinical experience and acceptability than that required for a device to be authorized for distribution in the country.

The meeting therefore recommended to proceed with the cautious evaluation of male circumcisions devices for adults as they have the potential to support the acceleration of scale-up of national programmes.
 
WHO has a stringent process for issuing guidelines based on available evidence. At this stage, WHO does not have sufficient evidence to recommend the use of the Tara KLamp. However, while the one small study that was done on the Tara KLamp did not provide encouraging results, the adverse events were resolved with minimal intervention. The paper also highlights important limitations to this study which could have included provider inexperience with the Tara KLamp method. It is therefore important that further evaluation of the Tara KLamp is undertaken.
 
WHO has received information that the Tara KLamp is currently being used in South Africa and is holding high-level discussions with the National Department of Health on the use of the device in the country. 
 
In these discussions, WHO has strongly recommended to the Department of Health the need to further evaluate the performance of the Tara KLamp. WHO has offered technical support to conduct a randomized controlled trial of the Tara KLamp. In addition, WHO has offered technical support for an independent review of all cases that have already been performed using the Tara KLamp.
Furthermore, WHO has recommended that an adverse event surveillance system for all male circumcision-related adverse events is set up.
 
WHO will continue dialogue with the Department of Health on this issue and will provide technical support for the scale-up of safe and accessible male circumcision services.
 
I hope this addresses your concerns.
 
Regards
 
Dr. Hiroki Nakatani
Assistant Director General for HIV, TB,Malaria and NTD
WHO