How not to be brave: The World Health Organisation (WHO)

The World Health Organisation (WHO) is a respected multilateral body dedicated to protecting public health globally. In many matters their expert advice and high standing inform health interventions across the planet. Their HIV treatment guidelines set a standard for developing countries to try to achieve, including South Africa. When Severe Acute Respiratory Syndrome broke out in November 2002, the swift decisive action of the WHO helped contain this potential epidemic.

However, the WHO's handling of the Tara KLamp has been marked by serious ethical lapses.

First, a statement on dangerous circumcision devices, drafted by the organisation's officials, was quashed and never released. Second, instead of voicing opposition to the use of the clamp in Kwazulu-Natal (KZN), the organisation proposed a study to monitor its use.

Medical interventions should be tested before being introduced for general use. Medicines may not be marketed before they have undergone clinical trials. Medical devices that modify the human body also need to be tested. Amendments to the South African Medicines Act, not yet in force, will require devices to be registered, just as medicines are.

The highest form of evidence in medicine is the randomised controlled clinical trial. And indeed, the Tara KLamp has been tested in a trial in Orange Farm. But it failed the test. If the Tara KLamp is ever to have a place in circumcision programmes, a trial similar to Orange Farm would have to be repeated. To be ethical, this hypothetical trial would have to counsel participants that the previous trial showed that the clamp had more complications and caused greater pain than a standard surgical method of circumcision.

It is unlikely that such a trial will ever get off the ground. It is rare for failed medical interventions to get a second life. For one thing, it is unethical to repeat experiments that gave negative results without taking additional safety precautions. But also, there are other circumcision devices that need to be tested that are likely to do better than the Tara KLamp.

In March 2009, the WHO held a consultation of experts to review circumcision devices. It released a 28 page technical report of the meeting. The report considered several circumcision devices, but its conclusions are mealy-mouthed when it comes to the Tara KLamp. The strongest thing it says is, "the low acceptability and high complication rates illustrate the difficulties of introducing a device in a new population and the need for careful evaluation by clinicians independent of the device manufacturers."¹

WHO officials also drafted a one-page statement expressing caution about medical male circumcision devices. Policy makers and non-circumcision experts would have been more likely to notice and read this. We have obtained a copy of it which we are releasing upon publication of this article (see next footnote).

The statement does not mention the Tara KLamp by name. It does however state that the WHO does not recommend any circumcision devices although it suggested further research on them. It says that "experience with their use among adults in Africa had not been encouraging." It emphasised the need for more extensive data and clinical experience before these devices were authorised for distribution.²

Had this statement been published, it would have been a blow to the marketing plans for the Tara KLamp across the continent. But it was never released. Two sources, both wishing to remain anonymous, informed TAC that South African officials pressured the organisation into blocking its release. WHO officials deny this. We also wrote to the WHO expressing our concerns.

Dr. Hiroki Nakatani, an assistant director-general at the organisation, and the person responsible for circumcision, replied to us, "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."

We also release the full contents of this letter with the publication of this article (see footnote).³

The WHO's problematic approach to the clamp continued. A WHO official drafted a protocol for an observational study to monitor the safety of the device in KZN. He emailed it to the Human Sciences Research Council for consideration, copying dozens of people, essentially making the protocol public. What this meant is that the WHO had accepted that the Tara KLamp would be rolled out in the province.

The WHO call for safety monitoring had the effect of legitimising the continued use of the clamp in KZN. When pushed by Health-e news service, KZN MEC for Health Sibongiseni Dhlomo cited the WHO to justify the continued use of the Tara KLamp. Referring to the continued use of the clamp, he told Health-e, "the World Health Organisation will also be observing the process."⁴

It is unethical to proceed to implement a medical intervention when a properly conducted randomised controlled clinical trial has shown it to be more painful and riskier than another intervention that achieves the same results.

The WHO technical report on circumcision devices states, "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." Unfortunately, the WHO's actions have ignored this common sense and the consequence is that many men will suffer.

Appendix: Cost of Tara KLamp versus forceps-guided circumcision

The marketers of the Tara KLamp claim it is cheaper than a standard surgical circumcision, such as the forceps-guided technique.

We spoke to circumcision experts in order to estimate the costs of the two techniques. At least one site has done a detailed analysis of the cost of surgical circumcision. On a busy day, the total cost of a circumcision (including health worker time, counselling, preparation etc) is approximately R400. But this rises to about R1,000 on quiet days. Many of the components of this cost remain fixed irrespective of the technique used.

The following table gives the costs specific to a forceps-guided circumcision where they vary from the Tara KLamp technique. It excludes fixed costs that would be the same irrespective of the method used. It also only includes costs for the day the circumcision takes place and excludes the cost of the return visit. From the table, it can be seen that the costs specific to the forceps-guided technique are approximately R221.

Table 1:

Costs of forceps-guided circumcision that vary from the Tara KLamp technique. Note: The cost of the surgical circumcision kit can come down if bought in bulk. All numbers are estimates based on discussions with circumcision experts. These prices include 14% VAT.

The following table gives the costs specific to a Tara KLamp circumcision at first visit, where these costs vary from the forceps-guided technique. Additional costs for this technique include higher dose anaesthesia, to nullify the pain in the first 24 hours, and antibiotics.

Table 2:

Costs of Tara KLamp guided circumcision that vary from the forceps-guided technique. Note: The cost of the Tara KLamp might come down if bought in bulk or from a different supplier to the one the KZN government is using. All numbers are estimates based on discussions with circumcision experts. These prices include 14% VAT.

It can be seen therefore that the Tara KLamp is more expensive for the visit at which the circumcision is carried out. The costs of the forceps-guided technique that vary from the Tara KLamp are R221 per first visit circumcision. The costs of the Tara KLamp that vary from the forceps-guided technique are R324 per first visit.

Even if the Tara KLamp is purchased for R160 from Carpe Diem Enterprises, the antibiotics are not used and the bupivacaine dose is the same as with forceps-guided, the cost is still marginally higher at the first visit for the clamp. The one cost advantage of the clamp is reduced doctor time, but here even our assumption of 5 minutes versus 10 minutes for the two different techniques errs, if at all, in favour of the clamp.

When the follow-up visit is considered, the cost of the clamp increases. Usually, a forceps-guided circumcision requires only a change of bandage at the follow-up visit which involves a short amount of time with a nurse. But with the Tara KLamp, the device usually has to be removed, a technically challenging activity, often requiring local anaesthesia. This is without considering the additional costs due to the much higher adverse event rate with the clamp.

1 WHO. 2009. Consultation to Review Manufacturing, Clinical and Regulatory Requirements for Male Circumcision Devices to Support Programme Expansion in High HIV Incidence Settings in Africa 11-12 March 2009, Nairobi, Kenya Meeting Report. http://www.who.int/hiv/topics/malecircumcision/MCDevicesMeetingReportfinal.pdf

2 It can be downloaded here: http://www.tac.org.za/userfiles/WHOStatementMCdevices2010.pdf

3 The response by the WHO to our letter can be read here: http://www.tac.org.za/community/node/2953

4 Cullinan, K. KZN to go ahead with controversial circumcision clamp. 19 July 2010. http://www.health-e.org.za/news/article.php?uid=20032864

Issued by the Treatment Action Campaign, November 3 2010

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