TAC Electronic Newsletter - Reporting on the Tara KLamp
1 November 2010
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 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 an author of the Orange Farm study 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 assistan ce 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 3 will be published tomorrow. Part 4 will be published on Wednesday.
1 Written by Nathan Geffen and Marcus Low with assistance from Catherine Tomlinson, Kiu Kim, Jonathan Berger, Ntombizonke Ndlovu, Richard Shandu and Lihle Dlamini. Several other people assisted but wish to remain anonymous.
2 The manufacturers of the Tara KLamp capitalise the L in KLamp.
3 Auvert et al. 2005. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005 Nov;2(11):e298. Epub Oct 25. http://www.ncbi.nlm.nih.gov/pubmed/16231970
6 Mthembu B. 2010, 19 January. KZN backs circumcision programme to combat HIV. Mail & Guardian. http://www.mg.co.za/article/2010-01-19-kzn-backs-circumcision-programme-to-combat-hiv
8 These studies were of questionable quality because neither were randomised and one did not have a control group, but they were sufficient basis for proceeding with a trial in adolescents and adults.
9 This trial was a separate one to the Orange Farm trial that showed that medical male circumcision reduces the risk of heterosexual men contracting HIV. Both trials were carried out by the same investigators.
10 All these differences were statistically significant.
11 Lagarde E et al. 2009. High rate of adverse events following circumcision of young male adults with the Tara KLamp technique: a randomised trial in South Africa. S Afr Med J. Mar;99(3):163-9. http://www.ncbi.nlm.nih.gov/pubmed/19563093
12 Cambell, W et al., ‘Be a hero: The battle for mercy and social justice.’ 2004. Pg. 204. http://books.google.co.za/books?id=mpG77eCDCREC&pg=PA203
14 The appendix to this series of articles explains the difference in cost between the two techniques.
15 Faull L. 2010. Tender details get the KLamp. Mail & Guardian. http://www.mg.co.za/article/2010-09-03-tender-details-get-the-klamp. Many of the details for the M&G article were discovered by TAC intern Kiu Kim.
16 Faull L. 2010. Cloud over clamp man. Mail & Guardian. http://www.mg.co.za/article/2010-10-01-cloud-over-clamp-man
17 Faull L. Tara KLamp director faces extradition. M&G October 23 to 28 2010.
This is part three in our four-part series on the Tara KLamp. Part one and two can be read here:
Part four will be published tomorrow.
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.1 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”.2 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.3 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.4 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 antibi otic 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."5
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:
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.6 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.7
Part four will be published tomorrow.
1 Hatzold K et al. 2010. Models to increase volumes and efficiency (MOVE) in Zimbabwe's male circumcision program. XVIII International AIDS Conference. http://pag.aids2010.org/Abstracts.aspx?SID=433&AID=11622
2 Faull L. 2010. Tender details get the KLamp. http://www.mg.co.za/article/2010-09-03-tender-details-get-the-klamp
3 National Assembly. Question No. 2523. http://www.tac.org.za/userfiles/QuestionsAndAnswersInParliamentAboutTaraKLamp20100913.doc See also National Assembly. Question No. 2461.
4 We have learned that approximately 7,000 forceps-guided circumcisions have been carried out since the programme was launched. The KZN Health Department released a statement claiming that a total of 10,229 circumcisions have been conducted since April 2010 and the target for 2010/11 is 372,754. http://www.info.gov.za/speech/DynamicAction?pageid=461&sid=13648&tid=22281
6 SAPA. 29 October 2010. KZN government to circumcise prisoners. http://www.timeslive.co.za/local/article733337.ece/KZN-government-to-circumcise-prisoners
7 In a statement published On 14 October a group of over 20 civil society organisations, including MSF, the World AIDS Campaign, Black Sash, SECTION27 and TAC demanded that the Deputy President and the Minister of Health intervene with utmost urgency to halt the use (and purchase) of the Tara KLamp until a Voluntary Medical Male Circumcision policy based on sound medically proven procedures can be adopted nationally. See http://www.section27.org.za/2010/10/14/meeting-the-challenges-of-hiv-treatment-and-prevention-through-independent-mobilisation-and-work-through-the-sa-national-aids-council-sanac/