'No such thing as zero-risk blood'
In the past two weeks, two controversial issues hit the South African National Blood Service (SANBS) hard. The press revealed that blood donated by President Thabo Mbeki was destroyed, and the service’s system of risk management through racial profiling caused even more havoc.
Risk management through racial profiling means that donated blood is divided in four categories after testing, according to race.
Blood from black people is considered the most risky, and is only donated when no other blood is available.
This profiling is done because the donated blood can be HIV-infected without it being detected in a test, during what is known as the window period, when the body has not yet started producing antibodies for the virus.
Prof Anthon Heyns (64) has been CEO of the SANBS since it was founded in April this year. He started his career working at the department of haematology at the University of the Free State. He answers 10 questions from the Mail & Guardian Online.
1. The past two weeks must have been quite stressful. How are you coping?
The past two weeks have been very difficult for us. But blood transfusion is always a sensitive and difficult topic, so we are used to it.
I am tired but absolutely not disheartened. That is my nature. I always face the morning and the challenge, and I always try to find a solution for everything.
2. What is the problem exactly?
As a doctor and the head of this organisation, I only have one role to play and that is to make sure that the patient can benefit from a sufficient and safe blood supply.
I am not a racist and this is not a racist organisation. Our statistics show that there is a strong correlation between demography and the prevalence of HIV/Aids.
When the seriousness of the HIV/Aids pandemic became clear around 1992, we started working on a model through which we could guarantee a safe and secure blood supply—a model that would minimise the risk of transfusing blood that was in the window period. It might have been naive to look at race.
The Department of Health was very much involved in developing this system. In 1998 and in 2000, it signed reports and documents. The government actually agreed with the racial profiling as a method to minimise the risk of transferring HIV through blood transfusions.
I must say I was a bit surprised that it took until late 2004 before it became an issue.
Why did it only now become an issue if the government already knew about it?
Maybe there was no adequate communication with the Department of Health, or at least there has not been sufficient communication with the Minister of Health, Manto Tshabalala-Msimang, and her director general.
We were in the full understanding that the department knew what system we were using since we had developed this system together and since the Department of Health is a member of the board of the SANBS. I thought we understood each other very well, which clearly was not the case.
So why now this fuss?
Lightning strikes when you at least expect it. There was a new employer in Bloemfontein who was the whistle-blower. She was not willing to sign her contract because she did not agree with the racial profiling as a method of risk management.
The human resource department said, ‘If you cannot comply with our policies then you will have to quit.’ She was the one who started talking to the press.
And the press accused us of racism and we now have to deal with that accusation, while we are not racist; we only act in the best interest of the patient.
Then it also became a political issue, because of course the minister does not want to be associated with an organisation that is accused of racism. She has an electorate and a party to deal with and she wants to stay far away from such accusations.
There are two strains to this problem. There is the medical strain that wants to protect the patient and there is the political strain that wants to stay far away from the system we use and we consider safe because it has connotations with racism.
3. Do you think the minister did not know about the system the SANBS was using?
After this came out, she started quite rightfully to gather facts. So, then I had to fax her all the documents from 1998 and then she was confronted with the issue. I do not want to say she did not knew. She had to find out all the details.
I understand the political issues and I do not even want to argue about the political issue. She has her job and I have mine. She is elected by people and I am appointed by people. I think she [the minister] needs to take that stand. And it is also good for us that someone challenges us and says maybe there is an alternative view to this. Maybe we have been naive in this regard.
It is a pity that we suddenly have to deal with the difference between the political and the medical viewpoints.
Now we have to solve this issue and come to some sort of a solution because I do not believe that blood transfusion in this country can carry on as it does without the support of the Department of Health and the minister.
The minister and the department are responsible for blood transfusions, and they delegate this responsibility to us by issuing us with a licence. This delegation means that we have to act in accordance with the wishes of the department.
We can’t say, bye-bye minister, we are not listening to you, and we carry on the way we like it. We will have to come to an understanding.
4. What is the way forward?
The minister is obviously not going to accept race [as a profiling method] and we are not going to accept another model that will put our patients at risk.
An expert committee will have to find another model where race is not a profile indicator but that still guarantees the safety of our blood.
We are actually meeting the minister on Friday to discuss this. The committee has been told to come up with an alternative model by the end of January 2005.
What will this model look like?
The model must include something to profile the risk of blood containing HIV. So if you take race out, then other things come to mind, like socio-economic factors, the educational level of the donor or what church the donor attends. You can even exclude people in certain residential areas from donating blood.
But would that not boil down to the same thing?
Yes, it is saying the same thing in a different way. But I want to go to this meeting with an open mind, and say, look at all these options, maybe there is a different model—an alternative that can minimise the risk of transferring infected blood without mentioning the political sensitive issue of race.
5. How many people are infected with HIV through blood transfusion and how many would get infected if you skip racial profiling?
We have two ways of determining how many people would get infected; one is a theoretical model and the other is actually reported cases.
Through the model, it is estimated that with the current system we have about four cases per year. When it comes to actual reported cases, it is two per year.
But with these actual cases there are a few problems. Most of the patients who get blood are already HIV-positive. Many of the people who receive a blood transfusion die because of the disease they are suffering from, and many people disappear and cannot be followed up.
If we were to remove this programme of racial profiling as it is and we do not find a suitable alternative, the estimated cases of infections will rise to 30 a year. And if the system cannot be maintained, it is out of control and we can expect this number to rise to a hundred cases a year.
6. How do other countries deal with this problem?
The minister looks at the neighbours. She says, look at what is happening in Zimbabwe, is the blood service there categorising blood according to race?
The answer is no, but I do not think that Zimbabwe is comparable to South Africa. Their donated blood is not as safe as ours. And in other countries outside the developing world there is not such a big problem with HIV/Aids, so the threat of donating infected blood is not that [serious].
The problem is that this is not about the right of the donor, it is about the right of the patient.
We do not allow men who have sex with other men to donate blood, not even if they practise safe sex. You can call that discrimination, but it is an internationally accepted criterion to prevent diseases from being transmitted through blood transfusion.
7. How affordable is the risk of transmitting HIV?
There is the question of informed consent, which is a very important issue in regard to this discussion. The doctor will inform the patient of the risks.
There is no such thing as zero-risk blood. We think, yes, the patient could be infected, but they could also have died if they did not get that transfusion.
Unfortunately people do not think that way. They think the SANBS acts greatly negligibly and irresponsibly. The reaction of people who get infected is understandably a very violent reaction.
Do people sue the SANBS, asking for claims when this happens?
Well, yes, we do get sued. And that is exactly what makes the situation so difficult in this country. According to the South African law we have no so-called product liability. In other words, we cannot be liable for the product if this product gives you HIV.
But if a patient wants to show that we were responsible for giving the person HIV, he or she will have to prove that the SANBS had been negligent, that we did not test the blood or we did not exclude the donor because he has tattoos or has had a blood transfusion.
We work in a very strict quality system, so it is almost impossible to prove that we are negligible, so we are never going to be liable.
The legal system needs to determine what is negligence, and all of the lawyers we have been speaking to have come up with the same argument. It would be seen as negligent and irresponsible if we were to transfuse blood to a patient from a donor population that is at high risk of transmitting the disease in the window period.
In other words, if we drop racial profiling and don’t find a suitable alternative, we become liable for transmitting HIV through transfusions.
8. Is the day ever going to come when South Africa will say we will not accept blood from black people?
No, I don’t think so, not at all. If we would be a racist organisation we would say, you are a group with bad blood and we do not want your blood. We will get our blood from the good people and if we do not have enough blood, we will import it from somewhere.
That would be unacceptable and immoral. I believe that the patient has rights, and I believe that the patient has a right to quality blood and I believe that this may in fact be a constitutional right.
I believe that what we have done is utilising race as a tool to guarantee the patient the constitutional right to safe blood.
9. Is there in hindsight anything you would have done differently?
One thing that I learned from this is communication, communication, communication.
We should have communicated better with the Department of Health, we should have communicated better with our donors and we should have communicated better with our blood users and with our staff.
We thought we were communicating, but obviously our message did not get across.
10. How could the blood of the president have been destroyed?
The president came and he donated blood and I don’t think this was seen by the staff as a real donation.
It was viewed as publicity or promotion. He did not go through the process of filling out forms and it would have been terrible to put his blood into the system without it going through the normal safety proceedings, so we kept him out of the system.
Now, this should of course never have been exposed to the media. That was a big mistake. I think the media were wrong and we were even more wrong. I feel terrible about it and it was hugely unfortunate. But it is not like his medical records were leaked to the press; it was just the fact that we did not use the blood that came out.
The minister of health does not agree with this, though. She says when I donated blood and when the president donated blood it was a real donation. They did see it as a real donation.