Thursday December 26, 2002

Circumcision study lands into problems

By ARTHUR OKWEMBA

The Kenyatta National Hospital Ethical and Research board is uncomfortable with a study just months after it authorised a local researcher to circumcise adult males at Kisumu to establish whether there is a correlation between circumcision and HIV transmission.

Sources say the researcher ran into trouble when the board began thinking he was betraying some of the agreed aspects of the research.

It immediately - last October - named a committee to investigate. The team finished its work early the next month, according to board secretary Prof A. Quantai.

But Prof Quantai would not reveal the findings, saying the board must first meet to discuss them.

She said: "We are going to take a position on the matter by the second week of January. What people need to know is that corrective measures are being taken for the mistakes made."

However, informed sources claimed the board's concern was that those involved in the research had altered an approved questionnaire without its knowledge.

There is also some worry about the number of people already circumcised and about exporting volunteers' specimens abroad for further analysis.

Although local scientists have been known to do such exportation in good faith, it is said their foreign counterparts take advantage of such specimen to carry out unauthorised research.

And, in the event, they often make medical breakthroughs that benefit only their countries and, through patents, only themselves.

Asked for comment, Prof Ndinya Achola, principal investigator in the study, says he cannot comment since the matter is confidential and under consideration by the board.

Prof Achola says: "I have explained the science of the study clearly to the board and they were comfortable. For the ethics of the study is something we left to them to decide and I cannot comment on it when they are still looking into the matter."

This revelation is the latest in a study that has generated a lot of interest and debate among researchers. Many have questioned its whole safety and ethics.

What preoccupies some of them is that, if circumcision is not hygienic, it can cause complications, which have killed some men.

Prof Achola has since argued that, in their study, they use doctors and clinical officers to carry out the circumcision. Besides, their activities are being supervised by Kenyan and American Data Safety Monitoring (DSM) experts.

The study, which began six months ago, seeks to find out whether circumcised men are less likely than otherwise to be infected with the HIV.

More than 300 young males have been circumcised since it began. The study requires them to be sexually active, aged between 18 and 25 and be HIV-negative. They will be monitored for two years immediately after being circumcised.

More than 600 young men out of the expected 2,000 have volunteered since the study began. Interest has been beyond the researchers' expectations.

A number of scientists, however, claim that people are being given incentives to take part and being made to believe they are HIV-proof once circumcised.

According to Prof Achola, although volunteers get free medical attention whenever ill, no incentives are given to lure them into participating.

He insists the issue of the volunteers thinking they are insulated from HIV infection has been thoroughly tackled. He is aware, says he, that, after circumcision, some young men may engage in unsafe sex thinking they are safe.

"Our approach is to educate them on HIV/Aids and we emphasise to them that no authoritative evidence has been produced to indicate circumcision reduces HIV infection, he stresses.

The study, funded by America's National Institutes of Health, is said to be the first in the world that attempts to come up with hard data on correlations between HIV infections and circumcision.

South Africa initiated its own a few weeks ago and Uganda plans to launch one soon. HIV experts think that, if the studies prove the hypothesis, then they will provide evidence for circumcision to be added to a list of public interventions in preventing HIV/Aids.

A few weeks ago, in an interview, Prof Achola insisted that all he wants is to verify earlier studies, which just compare HIV infection rates between communities circumcising men and those that do not.

He says: "We want to provide evidence based on practical results to justify or refute what other studies involving the comparison of untested phenomenon say."

HIV experts have also demanded that studies be done to produce hard data showing a relationship between circumcision and HIV infection, especially in Africa, where three quarters of the world's victims are claimed to live.

What has spurred interest in the whole issue are indications of circumcised males with low viral loads showing less likelihood of transmitting the virus to their female partners.

However, the same scientists have been confronted with cost and ethical issues, raising a lot of reservations about the whole approach to managing HIV/Aids.

James Ntozi, a Makerere University lecturer, has warned of money being diverted from other social needs to meet circumcision costs. Or, if the exercise is donor-dependent, then the programmes might not work.

In one its issues, The Horizons, a research organ of the Population Council, has raised fears that, in that case, "men may use their circumcision status as a reason for not using condoms, while women may be less inclined to insist on condom use if their male partners are circumcised."

"In this scenario," it adds, "women are in increased risk of contracting the virus and this may reduce the potential benefits of male circumcision on HIV transmission."

Another fear is that the rate of female genital mutilation (FGM) in areas where the practice exists may shoot up if men's circumcision is linked to HIV prevention.

Equally emotive arguments have raised ethical questions about the age at which a person needs to be circumcised for the practice to be effective.

There are worries that older men may be left out in the strategy, since studies elsewhere in Africa show that circumcision, as a measure against HIV infection, is more effective if done before or soon after puberty begins.

In a 1999 research on the age of male circumcision and HIV infection risk in rural Uganda, Kelly Kiwanuka found that males circumcised before puberty - between 13 and 20 - had a much reduced risk compared with their uncircumcised counterparts.