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Transcript of Dispatches interview with Professor Martin Bobrow, former chairman of ULTRA (the Unrelated Live Transplant Regulatory Authority) 1990-98, the committee that vets UK applications for unrelated donor tansplants

Is there a crisis?

I don't think there's a crisis at all. I think there is a mismatch between the number of people who want transplants and the number of transplants that are happening. This is largely because transplants have become a better thing, they work better. It's also partly because the number of kidneys available from people who've recently died has been going down steadily for reasons that we all understand, road safety particularly. That's a good thing but it does mean that there's a need to think more widely about how to get an appropriate number of transplant donors in order to be able to cope with the demand.

How has ULTRA functioned since it was established and how successful has it been?

One of the things that's changed a lot in transplantation is the recognition, with the new chemicals and new treatments around, that one can do transplants very successfully from donors who are not very closely related to the person who is getting the organ. This facility for using unrelated donors is an opportunity for people other than close relatives to give kidneys or other organs in donation.

ULTRA was set up about 10 years ago specifically in order to allow donations of that sort to go ahead, while protecting the donors. There was a fear that some people would be forced into donating organs by being threatened or offered money, being coerced in some way or not being properly informed. The law that set ULTRA up specifically said you can do organ transplants between unrelated people but only if ULTRA says it's okay. So ULTRA essentially looks at each case where that is proposed and says whether it's alright. What ULTRA's looking at is: Does the donor understand exactly what they're doing? Does the donor understand the risks? Have they been pressured in some way? Have they been offered undue inducement? Or is it all just an open, voluntary, reasonable, altruistic act? Provided it falls in the latter category ULTRA agrees to it and the donation goes ahead.

How is ULTRA made up?

ULTRA is a group of a dozen people appointed by the Secretary of State and they rotate. As these things go it represents quite a wide variety of people. There are obviously some people who are interested in transplant surgery but not many. There are one or two other medical people usually, but not in transplant medicine, and there are a variety of people who are nurses, health service managers, religious people, members of the public and patient organisations, drawn from pretty wide range of people.

The way in which ULTRA worked when it was set up was that the whole group came together initially and asked what are the ground rules on which it is going to operate. It spent quite a lot of time doing that and it decided that it needed to have clear instructions and clear information both for the transplant and for the customers -- for the patients and for the potential donors. So it drew up information leaflets which it constantly goes back to and revises. We made a rule that you should have a separate doctor responsible for the donor from the one responsible for the recipient. You don't want a conflict of interest where someone who's desperately concerned to preserve the life of patient X then starts leaning unreasonably heavily on some totally different person in order to achieve that. So we have these two different doctors and each of them is responsible for one patient. The donor and the recipient each has a form to fill in, which is pretty straightforward -- it asks the sort of questions you might imagine, and there's a signed consent at the end.

We also have one other requirement. We bring a third party into this who doesn't have to be, although often is, a medical person. It's someone who is of stature and standing and who is not involved in the field of transplantation and who doesn't know any of the parties. That third party is our local representative on the scene and he has to speak to the donor and to the recipient separately and often speaks to them together as well. In the end that's the person who certifies to us that the donor understands what they're doing and has had it properly explained to them, that they don't have any doubts and that they aren't under obvious pressure.

We get these various pieces of paper -- the report from the third party, the forms that have been filled in and signed by the donor, the recipient and their respective doctors -- and we work on those in the first instance. We have to do it quickly, so we don't have meetings. We have a way of delegating the work to different groups of people so that there would be a different three people each time round, who would be sent the papers on each individual case. They have a team leader and they each either phone, fax or e-mail the team leader. If everyone is agreed that this is straightforward and above board they simply pass the message back that it is okay and it would go forward. If there was a problem then there would be further discussions.

Then the authority as a whole meets once or twice a year, reviews everything that's gone before, formally endorses the straightforward decisions, discusses things that are major problems, makes new policy, sets new rules for the future and learns by its experience.

Is it possible to put a figure on the number of cases which are given permission to go ahead and the number which are never allowed to go ahead?

It is extremely rare for ULTRA actually to refuse a case. I think there are two reasons for that. One is that the very fact that there is a mechanism in existence basically means that people play by the rules. Secondly, in those situations where there have been question marks raised, the first thing that a body like ULTRA does is not to just issue a rejection notice, but to go back to the people concerned and say 'Have you thought about this?' Not surprisingly a little bit of dialogue and very often the problems either go away or everyone decides to call it off and find some other way of dealing with the problem. The great bulk of applications, as you would expect them to be, are absolutely straightforward. They are voluntary donations from people who are doing this because it's what they want to do.

What about a Ron Johnson type situation, a stranger donor?

The law is very broad on this. As long as ULTRA is satisfied that the person who is donating the organ understands what they're doing and is doing it voluntarily without pressure and without undue inducement, as long as you have a reasonably clear case where they are doing this in a knowing, understanding and voluntary fashion, there's no restriction on what ULTRA can agree to.

ULTRA, at least up to the point at which I left, had not made a specific decision on that sort of donation where a person who is totally unknown to the recipient comes forward and offers an organ. The law is fairly clear: ULTRA could make such a decision if it was satisfied that all its criteria had been met.

In my personal view such donations could well be acceptable. There is no ethical reason I know of to debar them. I think there are a number of practical problems, however, that sometimes make it very hard to be as sure about that sort of situation as you are when there is a more obvious connection between the donor and recipient. The sorts of things that are difficult to understand are: What motivates the person? Do they really understand what they're doing, or are they slightly oddball and don't really understand what they're doing? Do they really understand the risks? Things of that sort can be sorted out, there's nothing impossible about it, but it does need a little bit of care looking into it.

But it's never happened?

To the best of my knowledge no specific case has been presented to ULTRA of that nature.

In the future people may feel they want to do this - how do they proceed?

I think it's possible that with more publicity and a growing awareness of the issue there will be an increase in people coming forward to offer organs for donation. However, I would have to say my feeling is that the great bulk of growth in organ transplantation will come from simpler things. It'll come from a greater awareness of people who are within the close friends and family of the person who needs the organ. They may be unrelated in the technical, legal sense of the word -- they may be neighbours, close friends or a spouse. I think those people who have an obvious motive for wanting to help the patient are likely to form the bulk of the unrelated living donors who may come forward in future to try and alleviate this.

The other place that there is lots of room for improvement is in simply having more of us walking around carrying donor cards. We don't do brilliantly at that as a nation just yet. I think those are the areas that are likely to do the most towards really producing the numbers that will reduce the deficit of donors in this country. If there are more people coming forward of the sort that you are describing, though, well and good. I'm sure ULTRA will deal with it. ULTRA's well set up to deal with more business of that sort if it arises.

There are people within the medical profession who feel Ron Johnson would have been turned away in the UK . . .

I can't comment on other people's views and of course I don't even know who it is you're speaking of. Lungs are difficult to transplant as compared to say kidneys or some other organs that you may think of. Kidneys are the ones that are done most commonly.
Most lung transplants are whole lung transplants and usually it's both lungs at once. By definition, if you take both lungs it's from someone who's recently died, because if they aren't recently dead they soon will be when you've taken both their lungs out.

Lung transplants are a much more adventurous, much less commonly practised procedure. These partial lung transplants from living donors are a bit newer and there's a bit less experience. It's a bigger operation, one is less certain about the complication risks for the donor. All of those things make people a bit cautious when someone simply comes in and says 'I'm a perfectly fit healthy person and I don't know this other person from a bar of soap but I'm quite happy to run a significant medical risk myself in order to donate'. That may be a partial answer to the reason that people don't go out recruiting very actively for that particular sort of scene.

What about kidneys and swapping between couples?

It's not terribly common, but it does crop up from time to time that someone really wants to donate a kidney to a spouse or a close friend of theirs. They sometimes find that it just doesn't work, that the two people are not compatible in the immunological sense of the word, so the transplant wouldn't work well. One of the things that then does occasionally get discussed, is whether there is another couple somewhere else in exactly the same position -- what if A gave their kidney to B and B's donor gave it to A's recipient? ULTRA's view has been that if a case of that sort came forward, provided all other criteria were met there is no reason that they shouldn't consider and give permission for such a transplant to go ahead.

I think I'll add, much as I did previously, that it's hard to imagine that this is going to be the big solution to a really large number of cases. It's going to be a relatively uncommon thing and it's always going to need looking at a little bit more carefully to be sure that everything is clearly in accordance with the rules as one would want it to be.

What are the best solutions for the future?

There is no question at all that transplant surgery has advanced enormously. It has become so successful that it transforms people's lives in the great majority of cases. Probably more than anything else, it has led to this disparity between the number of organs available and the number of people who need, and that is terrible because there are people leading half a life or dying simply for lack of an available organ for transplant.
I wish I knew how one pressed a button and got a lot of other people to carry donor cards. I think that the professional societies and the Department of Health have had really big drives on this and it's not all bad news. The number of people who are registered on the central computer donor register has increased quite a bit and the number of us who carry cards has increased and is increasing.

One of the things that people need to do is to hear more about it. Programmes that put this out in the public eye are all to the good. They bring home how important it is that people make their own decisions about whether they'll donate or not. They also need to discuss it with their own families. One of the things that's distressing for all concerned is when someone does carry a donor card but the relatives don't know about it. The relatives at a critical moment are presented with this situation of not having really thought about this and not knowing what the recently deceased donor's wishes were. I think we are changing and I think that more and more of us are understanding how important it is and how much good we can do by becoming organ donors.

Secondly, I personally think that live donors will become a much bigger part of the scene in the future. That again is partly a matter of getting the news out and getting the ideas out. In this country we have a lower proportion of live donors than some other countries, particularly smaller countries. Some of the Scandinavian countries do a lot more and I suspect that that again is a matter of getting the understanding out there. Getting society's views changing -- that's what it requires.

So the areas that are going to make a big difference in the in the immediate future are more people carrying donor cards and more people volunteering to donate organs to people that they know. People who are part of their circle of friends, or their neighbours or their family. These other suggestions will all play a part but they'll be a small part.

I suppose one can get into science fiction for the medium to long distant future and think about specially constructed organs that come from either other species or from genetically changed cells of one sort or another. But that's all a very long way ahead, both in terms of the ethics and in terms of the science.

Do you back the campaign of the BMA for a change in the law for opting out instead of opting in?

I'm not sure I want to answer that one.

Even in the context of the BMA having agreed?

I think the problem is it's really not an issue that ULTRA has discussed because ULTRA doesn't have anything to do with cadaver donors. Of course I have an opinion but I think it confuses the two roles.

One of the things we didn't do earlier on is to make explicit what ULTRA does and doesn't deal with. The biggest group of transplants in this country is for kidneys. ULTRA only deals with organ transplantation it doesn't deal with what is called tissues. A tissue is blood or bone marrow. ULTRA's remit is to deal with unrelated donors of organs. So, organs in the jargon of this trade are different from tissues. Blood is regarded as a tissue and so lots and lots of people every day give blood and it is used to help someone they don't know anything about. This has nothing to do with ULTRA at all. Bone marrow transplants don't go through ULTRA. The main distinction is, is what you're taking off the donor something that they can just replace and come to no harm or is it a part of them which is important enough medically, that you really need to have precautions in place that they aren't being pressed?

Secondly, even if we look at organs, most organ donations come from cadavers. That's got nothing to do with ULTRA because it's not living. Most living organ transplants come from related people: brothers, sisters, fathers, mothers, uncles, aunts, close relatives, first degree family. Those again, in terms of the law, can just go ahead -- there's a little testing procedure to be sure that they are all relatives, and provided they're relatives that's fine. It doesn't come anywhere near ULTRA. ULTRA's brief is only living donors of organs who are not related within the meaning of the act.

What sort of contribution can people make?

ULTRA obviously is a regulating authority and its business is to have proposals for transplants put in front of it. It makes decisions, it isn't in the business of going out there and drumming up business. That's other peoples' jobs.

My personal view is that many of these forms of transplant are in principle okay, but in practice quite difficult. One of the sorts of practical issues that comes out, for example in the situation where someone simply wants to donate an organ and isn't at all bothered about to whom that organ goes, is who's going to choose who gets that organ? Who is going to put the donor and the recipient in touch with one another? They do have to have operations pretty much at the same time in the same place so it's not like packing a blood sample off into the fridge and using it the week after next, and this means that whoever takes that on begins to act as a broker. They're beginning to act as a dating agency between potential recipient and potential donor, and that's something that people feel uncomfortable with.

It's only a step away from being the vendor, being the person who puts advertisements in, being the person who is actually trying to introduce people to one another. In a way that would look as though it was getting awfully close to the limits of what the law does and doesn't permit. So the mechanics of being satisfied that all of those things can happen without anyone else exercising undue interference does trouble some people. I again do not think these are insuperable problems, but they're not totally trivial. They do need thinking through and they need thinking through with care, because amongst the great majority of people who will be totally genuine and perfectly well motivated, there will be a minority of cases where in principle one could do something that most people wouldn't want to happen. We need to be sure that it all goes properly before we get too deeply into those things.

On the question of the business of organ donation, has ULTRA ever been confronted with a case where there's been a financial transaction involved?

The legislation that set ULTRA into existence says quite specifically that you can't sell organs. One of the things that ULTRA looks at very carefully is that the people who are offering to donate organs are doing just that -- donating them, not selling them. If there is any suspicion that a financial transaction is taking place then ULTRA would not permit that transplant to go ahead. It would be outside of the law as it exists in this country.

Do you expect any big changes to come as far as government policy is concerned?

I don't know that they are about to issue anything at all.