The Tara KLamp Story: An update

Medical male circumcision reduces the risk of heterosexual men acquiring HIV infection but it must be carried out ethically using proven methods.

This story was first run on the Treatment Action Campaign website on 2 November 2010. If you have already read it you may prefer to skip to the brief update.

Money from Mutilation: The Tara KLamp Story

By Marcus Low and Nathan Geffen

A massive unethical medical intervention is unfolding in Kwazulu-Natal (KZN). It could harm many men. At the root of it is greed and also cowardice. We tell the story of the Tara KLamp in four parts.2 Beyond the details it is ultimately a simple story. The Kwazulu-Natal government is using an unsafe circumcision device that will injure thousands of men. The device has been sold to the state by unscrupulous business people with shady pasts. At the end of our story one question will remain unanswered, what motivated the KZN government to do this? Perhaps by following the money we will find out.

Part One: Introducing the Tara KLamp

Medical male circumcision reduces the risk of heterosexual men acquiring HIV infection. This has been shown in three clinical trials in sub-Saharan Africa.3,4,5 Circumcision also has other health benefits. It puts an end to the painful condition, suffered by some men, of swelling foreskin. It reduces the risk of men contracting human papilloma virus which can cause throat cancer as well as cervical cancer in women. There is some evidence that circumcised men also have a lower risk of penile cancer and urinary tract infections. On the other hand, the risks with having a medical circumcision are small. There is about a 1 to 3% complication rate and these resolve nearly 100% of the time.

So it was greeted with great excitement when after years of foot-dragging the Department of Health began backing voluntary medical male circumcision. The KZN government led the way following an announcement by King Goodwill Zwelithini that circumcision should be revived amongst Zulu men.6

Unfortunately, this initial enthusiasm has turned sour. Instead of using only standard surgical techniques, such as the forceps guided one, for all circumcisions conducted in the province's public sector facilities, the provincial government has also rolled out a dangerous plastic circumcision device called the Tara KLamp. It works by clamping shut on the foreskin so that the blood supply to it is cut off. Over a period of 7 to 10 days the foreskin is supposed to die and fall off with the clamp, but sometimes the clamp must be surgically removed.7

The device was invented by Dr. Gurcharan Singh and is manufactured by a Malaysian company, Taramedic Corporation. It is sold in South Africa by two companies, Intratrek Properties and Carpe Diem Enterprises.

Researchers at one of the circumcision trial sites, Orange Farm in Gauteng, invested great effort to find the optimal way to carry out circumcisions. As part of that effort, back in 2005, they decided to test the Tara KLamp. They were genuinely excited by it, hoping that it would be quicker than the standard forceps guided technique but without compromising safety. They had reason to believe it would be successful. Two previous Tara KLamp studies had been conducted in children without serious problems.8

Unfortunately, the Tara KLamp was a disaster. 166 men were asked to participate in the trial but 97 declined, of whom 94 gave the reason that they did not wish to use the clamp.9 The remaining participants were randomly selected (with their permission) to either receive clamp or forceps guided circumcision. On every important measure the clamp was worse.10

Here are the results of the TaraKLamp versus forceps-guided techniques:

Complication rate: 37% versus 3%.
Delayed wound healing: 21% versus 3%
Problems with penis appearance: 31% versus 3%.
Participants more likely to report bleeding: 21% versus 0%
Injury to the penis: 21% versus 0%
Infection: 32% versus 0%
Swelling: 83% versus 0%
Problems with urinating: 16% versus 0%

The participants were also asked to estimate pain using a standard well developed methodology. The clamp caused much greater pain. In fact, this is probably its biggest problem.

The doctors involved in the trial noticed these problems. They requested the trial to be interrupted. Medical trials should have a Data Safety Monitoring Board. One of this board's jobs is to stop a trial if it becomes unethical to continue it. And indeed, after reviewing the data and seeing the shockingly bad results of the clamp, this is exactly what the board did.

The results of this trial were published in the South African Medical Journal last year.11 That should have put an end to the Tara KLamp being used in adults. Unfortunately it was not to be. As we shall see, the sellers of the Tara KLamp and the KZN government were intent on using the clamp.

Part two: The dubious people selling the Tara KLamp

The Tara KLamp is being marketed in South Africa, Lesotho, Mozambique, Kenya, Botswana and perhaps elsewhere. The KZN government has purchased tens of thousands of Tara KLamps. Without aggressive marketing, the clamp would have been a forgotten failed adult circumcision device.

Much of the marketing is carried out by Tony Lawrence. It is Lawrence who is usually quoted defending the clamp in articles published in the South African media. Lawrence is a motivational speaker with various business interests. Together with Magda van der Walt, he runs a company that sells the clamp, Carpe Diem Enterprises.

Van der Walt is a former Miss United Nations South Africa runner up – something she claims opened many doors for her in the political world. She also claims to have invested large amounts of her own money in Carpe Diem. Both Van der Walt and Lawrence are listed as non-voting members of the Haggai Institute South Africa, the South African branch of an international evangelical organisation.

Evangelism is part of their marketing strategy. A book promoting the device and the work of Lawrence states, “Twice per year... young male initiates in South Africa alone take an important step toward manhood by undergoing circumcision during a time of initiation … But what should be a glorious occasion for these teenagers often turns out to be a nightmare. One out of five boys end up with their genitals partially or fully amputated.... The Seize the Day foundation is rescuing these children in a holistic way. Among other things, Tony Lawrence and the seize the day volunteers distribute a pack [containing a clamp and bible] to each initiate … The solution is to circumcise and evangelize.”12

It appears that as it became clear that South Africa would implement circumcision, Carpe Diem toned down the religious aspects of their messaging in the hope of selling the Tara KLamp to the public health system.

Their marketing strategy is now focussed on discrediting the safety concerns raised by the Orange Farm study. Their website states, “This invention enables circumcisions to be performed not only safely and easily but also --for the first time in surgical history-- enables circumcisions to be performed just as aseptically, … on the roadsides or out there in the bush ...”.13 This statement is contradicted by the available evidence from the Orange Farm trial and reports of penile injuries in some patients in KZN.

The device's marketers, as well as KZN health officials, have also claimed that the device had bad results in Orange Farm because the trial doctors were insufficiently trained to use it. This is false. The doctors on the Orange Farm trial were highly experienced circumcision surgeons. They were provided with training on how to use the clamp at the outset. When they experienced a high rate of adverse events, Lawrence went to Orange Farm with an expert to train the doctors further. But the adverse events continued and the trial was then stopped. That expert circumcision doctors experienced problems with it despite training is not compatible with the claim that the Tara KLamp enables circumcisions to be performed safely and easily and even in the bush.

The clamp, which must be disposed after a circumcision, is usually sold for about R160 by Carpe Diem, although the KZN government has paid much more for it. Carpe Diem claims that circumcisions are cheaper with the clamp than the standard forceps guided technique. However, we consulted circumcision experts and calculated that the cost of the standard forceps circumcision is cheaper than the Tara KLamp, even without taking into account the cost of the additional complications that the clamp causes.14

The device is also marketed as a faster method of performing circumcisions, as it can be carried out in less than 10 minutes. This is not much faster than it takes to do a forceps-guided circumcision and certainly does not outweigh safety concerns. It also does not take into account the additional time needed to surgically remove the device from some patients, or the time health workers have to spend on the additional complications caused by the Tara KLamp.

In a letter circulated to the media Lawrence writes, “A number of key professionals (including urologists) have confirmed the efficacy of Tara KLamp and amongst these, is Professor Segone, previous Head of Urology at MEDUNSA.” We spoke to Professor Segone and he denied ever endorsing the Tara KLamp.

The attitude of the company to research critical of its device is exemplified by Dr. Gurcharan Singh, the Tara KLamp inventor. In an email exchange with one of the authors of the Orange Farm study that showed the clamp was dangerous Singh wrote, “All it needs is a simple withdrawal of your manuscript and gracefully accept the reality. I am even not asking for an apology, for I am a very forgiving man..... but there is a limit!”

However it was not Carpe Diem, but Intratrek Properties, directed by Ibrahim Yusuf, that got the lucrative KZN contract for the device, amidst some controversy.15 The Mail and Guardian (M&G) published a story about Yusuf and his murky past, which quotes sources alleging that he was involved in Mandrax smuggling in Zambia in the 1980s. The M&G also described a 2002 newspaper report that alleged that the Zambian Drug Enforcement Commission (DEC) was looking for Yusuf to help with an investigation into US$29,000 obtained from the Zambian National Assembly. Yusuf denied all the allegations against him to the M&G.16 The M&G subsequently published a further story alleging that Zambia's Drug Enforcement Commission was seeking Interpol's assistance to find Yusuf to “answer criminal charges.” Yusuf denied this too.17

Intratrek is also registered in Mozambique. Yusuf has 49% of the company's shares. His co-directors are former ANC intelligence operative Lawrence Pietersen with 26% of the shares and ex-Mozambican general Joao Americo Mpfumo who holds 25%. We have learned that the general is promoting the clamp in Mozambique.

As far as we can tell, none of Lawrence, Van der Walt, Yusuf, Pietersen or Mpfumo has medical backgrounds or expertise in circumcision. The obvious question that surely follows is why has the KZN government bought their device?

Part three: Where's the money: The role of the KZN Government

The Tara Klamp is unsafe, more expensive, and only marginally faster to use than standard methods of circumcision. Also, standard surgical techniques work very well in mass circumcision programmes. For example, a Zimbabwean programme, with a team of two doctors and three nurses, has been optimised to do ten surgical circumcisions an hour.18 Why then did the Kwazulu-Natal (KZN) health department start using the clamp?

On 12 July 2010 the Treatment Action Campaign (TAC) sent a letter outlining our concerns to KZN MEC for Health Sibongiseni Dhlomo. His reply was astonishing, “What we have explained to the Minister and now indirectly to you is that we are committed to massive Medical Male Circumcision in KZN as directed by His Majesty our King. We will do it medically as the Majesty instructed us. The king has instructed us that no one should die as a result of our MMC intervention but he did not instruct us that no one should have pain.” This is the only response we have had from Dhlomo. Various attempts to meet with him and Premier Mkhize to discuss the Tara KLamp have so far failed to materialise.

On 3 August we asked the department for details on the contracts relating to the purchase of the Tara KLamp. We did not receive a reply. On 3 September the Mail & Guardian ran an article titled “Tender details get the klamp”.19 It outlined how they too failed to obtain financial details on the purchase of the clamp.

In October, in reply to questions asked in Parliament, the national Minister of Health wrote that the KZN government had purchased 22,500 Tara KLamps from Intratrek as of 30 September at a total of R4.4 million excluding VAT.20 KZN paid R188 (ex. VAT) per device for the first 2,500 but then started paying R195, much higher than the Carpe Diem price of R160. A KZN official explained in a telephone conversation with TAC that the province did not need to call for a tender for the clamp because there was only a single supplier. This is confirmed in the national Minister of Health's Parliamentary answer. Either Carpe Diem has been abandoned by the Malaysian manufacturer or the claim of a single-supplier is false. Even if Intratrek is the only supplier, a motivation for the purchase must still be made public.

As part of the circumcision drive in KZN, the province has held several circumcision camps, where young men gather at a hospital venue and are circumcised. Most of these camps have used forceps-guided circumcision, but the Tara KLamp is also being used.21 Apparently to compensate for the increased pain caused by the clamp, health workers in at least one of these camps were instructed to administer a higher dose of a strong pain killer, bupivacaine. Although this would relieve the worst pain experienced from the clamp, which usually occurs in the first 24 hours, it adds to the cost. The health workers were also instructed to prescribe antibiotics to offset the device's risk of infection. The KZN government intends to do millions of circumcisions over the next few years. If it gives antibiotics routinely to men circumcised with the clamp it will risk creating antibiotic resistance for no good reason.

Following a letter from TAC to Health Minister Aaron Motsoaledi describing our problems with the device, Motsoaledi met with TAC and the Southern African HIV Clinicians Society. In response to our concerns, he established the Medical Male Circumcision Steering Committee.

As a compromise, the committee, which includes people from the WHO, HIV Clinicians Society, KZN and national government, is trying to do a rapid assessment of the clinical outcomes of patients who were circumcised with the clamp in KZN. But this should have been a secondary objective; stopping the use of the device should have been the first priority. Even so, the committee, which has met a few times, has missed its deadlines for conducting the assessment. Furthermore, we have learned that the record keeping of the Tara KLamp circumcisions conducted in KZN over the last few months has been poor so it is unlikely that the rapid assessment can be done properly.

Sandile Tshabalala of the KZN Health Department was quoted by SAPA claiming that “More than 5000 people have been circumcised by this clamp and not even a single person has died. … No-one has complained that his penis has been cut."22

Meanwhile, TAC has received reports, including cell phone video clips, of people injured by the Tara KLamp. We also have a first-hand account of the immense pain a man experienced. We release photos of Tara KLamp caused injuries in KZN over the last few months. Please note these are very disturbing:

http://www.tac.org.za/userfiles/TaraKLampInjury1.png

http://www.tac.org.za/userfiles/TaraKLampInjury2.png

It has also been reported that the KZN Health MEC has committed to rolling out the Tara KLamp in prisons and that 148 such circumcisions have already been carried out in Qalakabusha Prison.23 But the reasoning behind this decision is difficult to understand. Medical male circumcision has been shown to reduce the risk of HIV-positive women transmitting the virus to men. No prevention benefit has been shown in populations of men who have sex with men.

This is a terrible situation. Companies selling the Tara KLamp are making money by inflicting injuries and suffering. The KZN government's adoption of the clamp is, in the best case scenario, deeply suspicious and unscientific.24

Part four: 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 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.”25

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.26

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).27

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.”28

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.

Update

By Nathan Geffen

After writing this piece a TAC delegation met with members of the KZN provincial government including Premier Zweli Mkhize. We were informed that the use of the device was proceeding and that data was being collected on its safety.

We therefore asked if the Tara Klamp was being implemented in the province as part an operational rollout. In that case, on what basis was a device that had failed a randomised controlled trial being used? Alternatively, if the device was being rolled out as part of a clinical trial, had ethical approval being given for such a trial? These questions went unanswered and we were promised a further meeting with a technical committee who would answer them.

Since then I've received conflicting 2nd-hand reports on how widely the device has been used and future plans for it. In one report I was told that despite tens of thousands of Tara KLamp circumcisions in the province, not a single adverse event occurred. This is implausible. TAC presented two people to the KZN government who had experienced adverse events. We have cell phone-taken video footage of people who were injured by the Tara KLamp in KZN. No circumcision procedure has a zero percent adverse event rate. This obviously nonsensical report and the lack of answers we received in our meeting with the KZN government do nothing to allay the suspicions and ethical problems Marcus Low and I described in our report. Instead they suggest poor record-keeping and a lack of implementation protocols.

The following questions remain unanswered:

Why is or was the Tara KLamp being used to circumcise people in Kwazulu-Natal when it had failed in a randomised clinical trial conducted by leading circumcision experts?

What tender procedures were followed in procuring these devices?

Why did the KZN government pay over R70 more per device for a bulk purchase than TAC did for a purchase of just two Tara KLamps?