FYI
1 November 2010 Today we publish the first two parts of this story. Part 3 will be published tomorrow and part 4 on Wednesday. Money from mutilation: The Tara KLamp Story1<#12c06d24cc9b8b4f_sdfootnote1sym> Part one: Introducing the Tara KLamp Part two: The dubious people selling the Tara KLamp Part three: Where's the money: The role of the Kwazulu-Natal Government Part four: How not to be brave: The World Health Organisation Appendix: Cost of Tara KLamp versus forceps-guided circumcision techniques *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<#12c06d24cc9b8b4f_sdfootnote2sym>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 <#12c06d24cc9b8b4f_sdfootnote3sym>,4<#12c06d24cc9b8b4f_sdfootnote4sym> ,5 <#12c06d24cc9b8b4f_sdfootnote5sym> 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<#12c06d24cc9b8b4f_sdfootnote6sym> 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 <#12c06d24cc9b8b4f_sdfootnote7sym> 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<#12c06d24cc9b8b4f_sdfootnote8sym> 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 <#12c06d24cc9b8b4f_sdfootnote9sym> 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 <#12c06d24cc9b8b4f_sdfootnote10sym> 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 <#12c06d24cc9b8b4f_sdfootnote11sym> 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<#12c06d24cc9b8b4f_sdfootnote12sym> 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 <#12c06d24cc9b8b4f_sdfootnote13sym> 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<#12c06d24cc9b8b4f_sdfootnote14sym> 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 <#12c06d24cc9b8b4f_sdfootnote15sym> 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<#12c06d24cc9b8b4f_sdfootnote16sym> 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<#12c06d24cc9b8b4f_sdfootnote17sym> 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 <#12c06d24cc9b8b4f_sdfootnote1anc> 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 <#12c06d24cc9b8b4f_sdfootnote2anc> The manufacturers of the Tara KLamp capitalise the L in KLamp. 3 <#12c06d24cc9b8b4f_sdfootnote3anc> 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* 4 <#12c06d24cc9b8b4f_sdfootnote4anc> Bailey et al. 2007. Lancet. Feb 24;369(9562):643-56. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. * http://www.ncbi.nlm.nih.gov/pubmed/17321310* 5 <#12c06d24cc9b8b4f_sdfootnote5anc> Gray et al. 2007. Lancet. Feb 24;369(9562):657-66. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. *http://www.ncbi.nlm.nih.gov/pubmed/17321311* 6 <#12c06d24cc9b8b4f_sdfootnote6anc> 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 * 7 <#12c06d24cc9b8b4f_sdfootnote7anc> See also: TAC and Southern African HIV Clinicians Society. 2010. Voluntary Medical Male Circumcision is Safe and Effective: But beware of unsafe devices. * http://www.tac.org.za/community/node/2905* 8 <#12c06d24cc9b8b4f_sdfootnote8anc> 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 <#12c06d24cc9b8b4f_sdfootnote9anc> 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 <#12c06d24cc9b8b4f_sdfootnote10anc> All these differences were statistically significant. 11 <#12c06d24cc9b8b4f_sdfootnote11anc> 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 <#12c06d24cc9b8b4f_sdfootnote12anc> 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* 13 <#12c06d24cc9b8b4f_sdfootnote13anc> Tara KLamp marketing brochure. * www.taraklampsa.co.za/Tara%20KLamp%20Booklet.doc* 14 <#12c06d24cc9b8b4f_sdfootnote14anc> The appendix to this series of articles explains the difference in cost between the two techniques. 15 <#12c06d24cc9b8b4f_sdfootnote15anc> 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 <#12c06d24cc9b8b4f_sdfootnote16anc> Faull L. 2010. Cloud over clamp man. Mail & Guardian. http://www.mg.co.za/article/2010-10-01-cloud-over-clamp-man 17 <#12c06d24cc9b8b4f_sdfootnote17anc> Faull L. 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