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MEDICAL male circumcision reduces the risk of heterosexual men acquiring HIV infection. This has been shown in three clinical trials in sub-Saharan Africa. Circumcision also has other health benefits. The risks associated with having a medical circumcision are small.
So it was greeted with great excitement when after years of foot-dragging, the Department of Health began backing voluntary medical male circumcision. The KwaZulu-Natal government led the way following an announcement by King Goodwill Zwelithini that circumcision should be revived among Zulu men.
Unfortunately, this initial enthusiasm has turned sour. Instead of using only standard surgical techniques, 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 seven to 10 days the foreskin is supposed to die and fall off, along with the clamp, but sometimes the clamp must be surgically removed.
The Tara KLamp was invented by Dr Gurcharan Singh and it 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. In 2005 they decided to test the Tara KLamp. They were excited by it, hoping that it would be quicker than the standard surgical technique without compromising safety.
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. The remaining participants were randomly selected (with their permission) either to receive the clamp or surgical circumcision. On every important measure the clamp was worse (see table).
The doctors involved in the trial noticed these problems. They requested the trial to be interrupted.
Medical trials should be monitored by the Data Safety Monitoring Board. One of this board’s jobs is to stop a trial if it becomes unethical to continue it. After reviewing the data and seeing the bad results of the clamp, this is exactly what the board did.
The results of this trial were published in the 2009 South African Medical Journal. That should have put an end to the Tara KLamp being used in adults. Unfortunately it was not to be.
Standard surgical techniques work very well in mass circumcision programmes. For example, a Zimbabwean programme has been optimised to do 10 surgical circumcisions an hour. Why did the KZN Health Department start using an unsafe and more expensive device on young men?
On July 12, the Treatment Action Campaign (TAC) sent a letter outlining our concerns to the KZN Health MEC, Sibongiseni Dhlomo.
His reply was astonishing: “[W]e are committed to massive medical male circumcision in KZN as directed by his majesty our king. We will do it medically as his majesty instructed us. The king has instructed us that no one should die as a result of our … intervention but he did not instruct us that no one should have pain.”
This is the only response we have had from Dhlomo. Attempts to meet him and Premier Zweli Mkhize have failed. On August 3, we asked the department for details of its purchase of the Tara KLamp. We did not receive a reply. On September 3, the Mail & Guardian ran an article titled “Tender details get the klamp”. It described how they failed to obtain financial details on the purchase of the clamp. In October, in reply to questions asked in Parliament, the national Health Minister Aaron Motsoaledi wrote that the KZN government had purchased 22 500 Tara KLamps from Intratrek as of September 30, at a total of R4,4 million excluding VAT. KZN paid R188 (excluding VAT) per device for the first 2 500 but then started paying R195, much higher than the R160 quoted by Carpe Diem (see box).
A KZN official said in a telephone conversation with the TAC that the province did not need to call for a tender for the clamp because there was only one 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 is still required.
As part of the circumcision drive in KZN, the province has held circumcision camps. Most of these camps have used a surgical circumcision technique, but the Tara KLamp is also being used. Apparently to compensate for the increased pain caused by the clamp, health workers in at least one of the camps were instructed to administer a higher dose of a strong painkiller, bupivacaine. Although this would relieve the worst pain, 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 the TAC to Motsoaledi describing the problems with the device, he met with the TAC and the HIV Clinicians Society. In response to our concerns, he established the Medical Male Circumcision Steering Committee. The committee is now trying to do a rapid assessment of the clinical outcomes of patients circumcised with the clamp in KZN. But this should have been a secondary objective and stopping the use of the device should have been the first priority. Even so, the committee has missed its deadlines for conducting the assessment. We have also learnt that the record-keeping of the Tara KLamp circumcisions done in KZN has been poor so it is unlikely that the assessment can be done properly.
Meanwhile, the TAC has reports, including video clips, of people injured by the Tara KLamp. We also have a first-hand account of the immense pain a man experienced. Companies selling the Tara KLamp are making money by inflicting suffering. The KZN government’s adoption of the clamp is suspicious and unscientific.
RESULTS OF THE TARA KLAMP VERSUS A STANDARD SURGICAL TECHNIQUE
• The participants were also asked to estimate pain using a well-developed methodology. The clamp caused much greater pain.
MUCH of the marketing of the Tara KLamp is carried out by Tony Lawrence. Together with Magda van der Walt, he runs Carpe Diem. Initially, it appears evangelism was a central part of Carpe Diem’s marketing strategy.
Under the banner of “circumcise and evangelise” they presented the device as an alternative to traditional circumcision. Their marketing strategy is now focused on trying to discredit the concerns raised by the Orange Farm study. Their website states: “This invention enables circumcisions to be performed not only safely and easily but also … enables circumcisions to be performed just as aseptically, … on the roadsides or out there in the bush ...”.
This statement has been shown to be false. Carpe Diem also falsely claims that circumcisions are cheaper with the clamp than the standard forceps-guided technique. Carpe Diem is marketing the device 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 surgical circumcision and does not outweigh safety concerns. It also does not take into account the additional time needed to remove surgically the device from some patients, or the time health workers have to spend on the complications caused by it.
However, it was not Carpe Diem, but Intratrek Properties, directed by Ibrahim Yusuf, that got the lucrative KZN contract for the device. The Mail & Guardian (M&G) published a story about Yusuf and his past, which quotes sources alleging that he was involved in Mandrax smuggling in Zambia in the eighties. The M&G also described a 2002 newspaper report that alleged that the Zambian Drug Enforcement Commission was looking for Yusuf and was seeking Interpol’s assistance to find Yusuf to “answer criminal charges.” Yusuf denied all theallegations.
This table shows the difference in cost between Tara KLampcircumcisions and standard forceps-guided circumcision. The table excludes costs that are the same for both procedures.
THE KwaZulu-Natal government has defended the use of the controversial Tara KLamp for male circumcision in the province.
“To me the debates around the use of the clamp are peripheral,” Premier Zweli Mkhize said on Tuesday.
“To me it does not matter whether you use scissors or forceps as long as it will remove the foreskin safely: hallelujah.”
Mkhize was speaking in Durban at an Aids Foundation conference on culture in the context of Aids.
Defending the clamp, Mkhize said South Africans are prone to unending debates which delay the implementation of important projects. He said that male circumcisions would play a huge role in reducing HIV infections.
Dr Sandile Tshabalala of the KwaZulu-Natal Department of Health told the conference that he does not understand why people criticise the clamp.
“More than 5 000 people have been circumcised by this clamp and not even a single person has died,” he said. “No one has complained that his penis has been cut.”
He said 157 people were circumcised at the University of Zululand on Monday. Professor Nceba Gqaleni of the University of KwaZulu-Natal’s Nelson Mandela School of Medicine told the conference he would have preferred circumcisions to be done in a traditional way.