Lester - Interview 06

Age at interview: 59

Brief Outline: Lester's son Ellis died in 2001 of variant CJD. Lester later became involved as a lay chair of a trial looking at the effectiveness of a drug called quinacrine for people with variant CJD.

Background: Lester is a business consultant. He is married with 1 adult son. His older son died in 2001. Ethnic background/nationality' White British.

More about me...

In 2001 Lester’s son Ellis was diagnosed with variant Creutzfeldt-Jakob Disease (vCJD), the human form of bovine spongiform encephalitis (BSE) or ‘mad cow disease’. Ellis was in his early twenties, and died within three months of the diagnosis. At the time there were no trials running on vCJD, and Lester is still unsure whether he would have been happy with the idea of Ellis taking part in a trial. The family just wanted Ellis to be as comfortable and peaceful as possible. After Ellis’s death, Lester became the chair of the Human BSE Foundation.

 

The Department of Health and the Medical Research Council felt there was a need to conduct trials into treatments for vCJD because it had become such a high profile condition. It was decided to set up a trial of a drug called quinacrine, which would be compared with standard palliative care. Normally a scientist is asked to chair the committee overseeing the trial, but in this case the scientist asked to have a lay person as co-chair, because he felt it was such a rare condition it needed the in-put of someone who had personal experience of vCJD in the family. Lester’s name was put forward, and he spent several years helping to set up and run the trial.

 

There were a number of problems in trying to run the trial – firstly, although a systematic review of previous evidence had not been undertaken, there was pressure to get the trial started anyway. If the review of evidence had been available at the time, Lester feels they might not have thought it was worth testing quinacrine anyway. The results have not yet been published, but as far as he is aware it has not made much difference to survival. Another problem was recruitment – just as Lester felt he wanted Ellis’s last few months to be peaceful, other families also just wanted their relative to be disturbed as little as possible and found it difficult to agree to the trial. It was also difficult to find enough people because the disease is so difficult to diagnose and progresses so fast that by the time people are diagnosed they usually have only a few months left.

 

After the trial was started, a few people with vCJD started exploring the benefits of and subsequently taking a new drug called pentasan polysulphate (PPS) which has not yet been formally tested in humans. There seem to have been some promising results, but because this has not formed part of a scientifically conducted trial we cannot draw reliable conclusions.

 

Having never previously given much thought to medical research and clinical trials, he has since learnt a great deal. At the same time, there are still some things he finds difficult to understand fully. He believes that research is essential for medicine to advance, and that we should all think carefully about taking part in trials if asked. Each person has to weigh up their own circumstances, the potential risks and side effects to themselves, and the benefits to society to make their decision. His message to health professionals is to think themselves into the patient’s shoes.

 

In the trial Lester chaired it was hard to approach patients with CJD (Creutzfeldt-Jakob Disease)...

With the study that you were co-chairing, what was recruitment like? Was it quite easy to --

 

No.

 

-- get people involved? No?

 

No. Well, for a start there aren’t many people who have CJD, very low numbers. And so therefore any numbers that you get - the more numbers the better, but there just fortunately aren’t many people with that disease, so therefore there weren’t high numbers. And one of the biggest problems is there is such a short timescale between diagnosis and death, generally speaking it can be about four months, that by that time people say, “No, no, just let, let matters take their rest.” Because unless it was a silver bullet type thing, it isn’t going to work. So from - what happens with CJD typically, the first symptoms come up about fourteen months before death, but you don’t recognise them as CJD, you think they’re other things, depression or schizophrenia. And it’s only about four months generally before death that people say, “Gosh, we know what it is.” And so recruitment’s not great because, you know, what difference can taking the drug for four months make? Now it has made a difference to a couple of people taking pentosan, but that’s, that’s by the by. With, the challenge for researchers with drugs that have a – or with diseases that have a quick sort of lifespan is to get to the diagnosis early. And to be fair to the researchers they did all they could to communicate with the people who are likely to see some of the symptoms early on. They communicated with GPs and neurologists and people like that. But the trouble with a rare disease, you can write and say, “Look, if you’re seeing a young person with these sort of conditions, can you just think a little bit it might be CJD?” But because there’s so few, most GPs will never see a case in their lives. So they read it and say, “That’s interesting” and they’ve got a million other things to do. So had we been able to find people who still had a year to live, if you like, then I think recruitment would have been hugely greater, because there would have been more of a chance. 

When his son was dying, Lester wouldn't have wanted anything to be intrusive. He knows trials are...

I suppose I’d heard about trials, but I’d never really thought the issue through. Then after thirty-five years, in 2001, my eldest son, Ellis, contracted variant CJD, Creutzfeldt-Jakob disease or, as it was known at the time, the human form of mad cow disease. And we looked after Ellis - well, we, as soon as we knew what was wrong, it was inevitable he was going to die and we only had about three months between knowing that, what he had and when he eventually died. And at that time there were no trials of anything. It, it remains a disease that has an incredibly bleak outlook, it is terminal, and that’s, that’s the long and the short of it. And I suppose our strategy at that time was simply to care for him the best. Now, of course as I’ve learnt more - and this was in 2001 and we’re now in 2008 - as I’ve learnt more I wonder if, had a trial been available, I would have put Ellis down for it, or we would have done. And I don’t, I still really don’t know the answer to that. Now, when I say ‘we’, we were faced with Ellis, who couldn’t communicate, and by the time - he was a very bright young man, he was a teacher at a private school - but the way the disease goes, it quite soon cuts off your comprehension, your ability to comprehend anything and your ability to speak. So all our concerns, and when I say ‘our’ I mean myself, my wife, Wendy, and my other son, Nik, the three of us sort of basically considered what Ellis would want at every particular stage. And, as I say, there weren’t trials at that time, so we didn’t have to make that decision. But I suppose, at that moment I am I suppose unlikely to have entered him into a trial, unless I knew a heck of a lot about it. You have somebody who has only a few months to live, you’re not going to want to do anything that may be intrusive or in any way worsen their situation, cause them even a moment’s discomfort. Because I suppose at that moment and, you know, it may sound very selfish, first and foremost it wasn’t about helping other people, it was about Ellis.

 

And I guess trials are in some way about helping the individual who enters the trial, but in many respects it is also about helping the common good. Because I’m sure that without trials in the past for various things, I may not even be here now. So I owe my longevity, in part, probably to the fact that people went into clinical trials. So I sort of feel quite awkward that I had that very protective view back in those days. But, as I say, there was, there was no trial around, and our job was just to look after Ellis until he eventually died. 

Even with experience of helping run a trial, he is unsure if he would volunteer if he was...

I suppose because I’ve been involved a lot with trials from that side, I’m almost no clearer on what I’d do as an individual. I think it would be, I think it would be the nature of the trial. I often think if, for instance, I was unfortunate enough to have cancer and, you know, I think we’re all aware that a lot of the therapies for cancer are pretty horrible, the side effects are pretty grim, and I don’t think any of us can predict how we’d feel before that moment happened to us. But I think, and I’ve talked to, about this with my wife and friends, and I think if it was a case of somebody saying, “Well, you’ve got six months to live. But go on this trial and it might give you another three months, but that will be horrible” I wouldn’t do it probably. Now it’s okay for me to sit here and say that now, but would I? Would I cling to those last extra three months so hard? And knowing that, as I said, all of us should be grateful for people who go into trials because we probably wouldn’t be here if we, if they hadn’t, how magnanimous, how public-spirited would I be if it was that tough for me at that moment? Would I think about other people? I’d love to think that I would, but I can’t be sure. If it was a screening, yeah, absolutely. I’m very sort of supportive of that. And if, I suppose if it was a bit of a no-hope situation, with no known side effects, I might. One of the things, again when we look back on Ellis and think, “Well, would we have encouraged him to go into a trial?” one of the things that might have affected us was that we knew he carried a donor card. And so therefore he’d made his own decision and statement on that. Now because of the nature of his disease, his organs were, would have been not allowed for donations. But because it was a rare disease they were absolutely invaluable for medical research, after his death. So Wendy and I had absolutely no problem, you know, when people said, “Well, look, could we take some of these organs?” Absolutely no problem at all. Because we know that’s what Ellis would have wanted. But would - so therefore I suppose we’re saying, “If you carry a donor card and you can’t make a decision yourself, people around you might say, ‘Well, actually, you know, maybe it’s, that’s what he or she would have wanted’.” I think it would be quite helpful if we had a system now where we carry cards that say, “Look, if I’m knocked down by a bus or I catch something and can’t communicate, I’d, I’m very happy to go into clinical trials.” I sort of think it’s that important, really, that you know, it’s - and I would carry one, I would carry one of those.

Drug companies will of course research products in order to make money, but the UK has a good...

One of the challenges for trials, I think, is that it’s highly unlikely we’ll ever see dramatic results. It’s all about making improvements on the periphery. If the, you know, penicillin’s already been found. I don’t imagine, although I’m not a medical person, that there’s many more penicillins about, you know? So therefore if you’re going into a trial, you shouldn’t expect a eureka moment. It’s going to be improvements on the margins. And so your expectations should be placed like that accordingly, I think, really. I think some people get very nervous and concerned about trials sponsored by drug companies. Well, drug companies are set up to make money for their shareholders. I quite understand that. And so therefore the work they do will be about trying to find a therapy that is so good that they make a lot of money out of it. Nothing wrong with that, really, as long as they don’t take chances with wild cards that affects people’s health, on the hope that it might do something. Now that would be a fear of a lot of people. My view on that is that within the country you have sort of a very strong ethics governance and the risks of that happening are very, very low.

 

What I do think is important, though, for drug companies is if they do a trial and it doesn’t work, they publish that as well. Because you can learn as much about what doesn’t work than you can - I mean, that’s a trite phrase, but you can. And I think whilst it would be a heck of a disappointment for them, I think it’s just a civil duty to share that with everybody. 

It takes a long time for most trial results to be published. Sometimes when results seem...

The trial that I was involved with lasted for three years and it’s finished now. And what happens is that all the data is collected. It’s anonymised, that’s to say none of us ever know who the individuals were. It’s just on numbers and averages. And that goes through an independent committee. And then the results are published, really.

 

Now, there are quite a lot of issues with all of that. Number one, it takes a long time for data to be published in a trial. And that’s one of my disappointments, if you like, that because people quite rightly are frightened to jump to early conclusions, they say, “Oh, we’ve got to get all the data in before we publish.” Well, sometimes if you’ve got a three-year trial or a four-year trial, you might know after a year what’s really going on, but people very rarely publish it. And that then puts the people going into the trial at years two, three and maybe four at a disadvantage, because more is known about the likelihood of success than what they may be told. So I wish there were ways in which data could be more freely available. I think - and I’m not talking necessarily about my own experience - but I think one of the risks is, if you’ve got a group of people who are absolutely passionate about a trial for a therapy that might work, if in the early part it isn’t giving them what they expect, there was a very natural, understandable reluctance to publish that or to tell anybody. You just sort of keep on, “Well, maybe this is a bit of a tweak. Maybe it will get better.” I feel almost guilty saying that, because that’s making them feel that they’re less than honest. They’re not. They’re just human. And I think it’s absolutely understandable. I could sort of take it back to my time in the bank. If we were trying to sell a particular - if my team, my colleagues were trying to sell a particular mortgage and it wasn’t selling, you wouldn’t sort of very often look back and say, “Gosh, is the mortgage right?” You’d just try and keep selling it a bit harder and hope it would go through and ignore the customer complaints. You know, you’d set up a call centre. It’s human nature. You don’t do it out of nastiness. It’s just how it is.

 

FOOTNOTE' Researchers are right to be cautious about jumping to conclusions too early in a trial. Large trials can take a long time to get enough people and enough data to draw reliable conclusions. However, sometimes results are so obvious that a trial has to be stopped early, either because the one of the treatments is strikingly better than the other, so it becomes unethical to withhold it, or because risks are revealed that are too great.

Lester describes the process of designing and approving a trial, from steering group and...

But anyway, the trial was decided. It would be run in England and, or in the UK, and they set up what they call a trial steering committee. I didn’t know what that was, but it’s just like the overview group, the group that sits above, if you like, the researchers, the chemists, the scientists, and has a range of people on it who can actually give advice and say, “Well, this doesn’t feel right. This is...” - not in respect of the data. Not in terms of the scientific stuff that’s coming out, but more, “Does this feel right? Does it feel right for people?” Anyway the, I was asked if I’d sit on that committee and I said, “Absolutely.” Ellis by then was, had died, so it was just an interest of mine. And they asked a man called Iain to head up the trial steering group. And he’s, you’d call him an academic, I guess, but an interesting man, and he agreed to do this job, but only on two conditions. One, he wanted what’s called a systematic review done of all other therapies, so that we could see if quinacrine had been trialled before and what the results were. And he also insisted that he’d only do it is if a layperson co-chaired it with him, on the basis, “What does he know about the disease?” Well, the Medical Research Council suggested he might like to meet me. We met, we got on. And so for the trial steering group there were two chairs, myself and Iain.

 

And what did we do? As the trial was set up, what happens is that the researchers design a protocol, a sort of a set of rules of what they’re going to trial, and also importantly what they’re going to look at as important indicators if something’s working or not. And it’s a very, very complicated document. It starts with what is going to be done to people on the trial and it ends up with what they will look at to see if there is any benefit. So you could say I suppose in its very simplest form with something like CJD, where people always die, “Do people stop dying?” You could use that as a marker. “Do they live longer?” So all of that sort of thing was brought in. It then has to go through to an ethics committee, a group of people, a broad range of people who sit two or three steps away from all of us, and look at it and say, “Look, does this feel right?” Because I guess people who are going into a trial, participate in a trial, need to be reassured that there’s no self-interest at stake here, that the researchers, it’s not just one of their pet themes, a little idea, “Let’s give it a go.” So therefore the structure around setting up a trial, before it even gets going, before even the first person gets into it, is very pure.

 

I guess sometimes it could be too pure. There could be times where an ethics committee would look at something and say, “Wow, that’s just too risky. We don’t think that’s fair.” Whereas the people who were going to take part in it would say, “Actually, it is fair. There’s nothing else going on for us. We want it.” And again, CJD would have been a good case in point, because if you are caring for somebody you love and they are definitely going to die, you may well feel it’s better to take a bit of a chance than no chance at all. So when we went to the ethics committee, I went as an observer and sat at the back, not commenting. But had the ethics committee said, “Well, we’re not sure about this”, I would have been happy to stand up and represent the families, if you like, and the patients, and say, “Well, look, actually just think about it. Let’s take a balance on it.” So ethics committee sets up, everything gets going and the trial starts.

Lay people can help make trial information leaflets more responsive to patients. There are...

Within the trial steering committee there are people from a broad range of disciplines and say several laypeople. And one of the things the laypeople would look at, and have quite a lot of control over, is things like, “Well, from, what would be acceptable to a person with no other agenda other than to get better or to learn? And how can you present that information?” So things like patient information leaflets, patient briefings, all of that would really have a big stamp of the layperson on it, so that they could look at it and say, “Yeah, this fits the bill.” Because again, you can imagine if you’re seeing somebody like a doctor or a surgeon who you hold in high esteem - because we do hold them as a profession in high esteem - it’s not a meeting of equals. They are in a position of power. I’m not saying they abuse it, but they are. They’ve got the knowledge or some of the knowledge, they’ve got the strength, they’ve got the reputation. There are you, or either as the individual or as a representative of an individual, sort of feeling vulnerable because you’ve got an illness, lonely because you’ve got the illness and here’s somebody who wants to talk to you about it, and also ignorant of a lot of what’s going on. So that meeting is a meeting of un-equals. And the trial steering group, I think, just try and make sure that all the information that a patient or a carer has is good enough to be able to get over that, that element really.

Lester advises people to get lots of information. Now he knows more about trials he'd be more...

I think if people were, had been invited to partake in a trial and were just thinking, “Well, is it right for me?” I would say, “Just ask as many questions as you can. Ask the clinician, whoever’s sitting in front of you just to talk through what the real chances are, the real options are. Have a look at all the patient information leaflets that come with it. And maybe speak to other people who are on the trial” - although I suppose that might be difficult because of confidentiality. I suppose I can only speak for myself now. But if I had something wrong with me, I would be far more likely to enter a trial now than I would six years ago when I didn’t know about it. But I can’t expect everybody else to go on a six-year learning circle. So all I could say would be, “Find out as much about it as possible. Read everything. And then just take time and think, ‘Is it right for you?’”

 

In terms of the professionals, my advice to them would be, “As far as always possible just put yourself in the other person’s shoes.” I still, I’m a great fan of hierarchy. I look up to people. That’s my age and that’s the way I was brought up. So quite honestly if a clinician said to me, “Lester, I think this is worth trying”, I would. Now, I’d have to make sure I wasn’t doing that just to please him. But I think I’d ask questions. But I think I’m more likely than not to go in a trial. If it was a screening trial, a big data collection trial, I would say absolutely, go into it. And you’d almost have to have strong reasons, very strong, good reasons not to. Because if it’s not hurting you, but it’s helping others collect information, I don’t work on the principle that they’ll then misuse it, I don’t worry if somebody loses my CD-ROM with the data on, I really don’t mind at all. You know, that’s life. We all make mistakes, we all have errors. Just get on with it, really. So I would think in terms of screening, in terms of big sort of social service type trials, just do it, absolutely. And yeah, my advice to professionals would be, “Just put yourself in the other person’s shoes.”

 

Lester never gave a thought to clinical trials for most of his life. If it were raised in...

I suppose one of the things I think about now is that for thirty-five years I, you know, I didn’t think about trials at all, and yet I just expected my doctor to sort everything out. And that’s almost childlike, but I didn’t have time or the inclination to think about anything else, really. And I, we live in a more enlightened time now, I probably wish that I had known more about this sort of thing. And, and, you know, it’s sort of one of those things, we talk about citizenship, I think it could easily come up in sort of, in education now, really. Not to make a big deal of it, but just so that people are aware of what a, a trial is. So that people would be more ready to make some decisions if, if the opportunity came along or the chance came along.

Lester first found out about trials after his son died of CJD (Creutzfeldt-Jakob Disease) and...

After that time I chaired the, one of the charities for people with human BSE founda-, human BSE*, called the Human BSE Foundation. And it was at the time where there was a lot of media attention, and the Medical Research Council and the Department of Health knew they had to do something, because basically every time somebody mentioned CJD it would get on to the front page of the tabloids. So they held a workshop, a CJD trials workshop, where they invited carers of people who were still alive with CJD, bereaved parents or friends, and researchers, trialists. And it was a well-facilitated meeting, where they explained to us all what they meant by trials. So the whole, this was for the first time the world opened up. Randomised, double-blind, placebo-controlled - all those phrases that meant nothing to me came tumbling out. And they were just seeking our views, which I thought was excellent really. And they explained what trials were. And the question they were asking mainly was, “What sort of trial structure did we think would be acceptable to people suffering from variant CJD?” And we gave our opinions and they produced a report. And at that time there was no known therapy that would be of any help. But there were some trials going on in America. And in fact it was one of those trials that a UK father saw on the website and flew his daughter over to America so that she could participate in this trial. And it was quite a well-known case. So really this was a bit awkward for the government, because they, it was known as a British disease but here they were without any form of trial or learning structure, and people were going to America. So they realised that we really ought to crack on and have a trial. And the best bet at that moment was something called quinacrine.

 

*FOOTNOTE' Human BSE is human bovine spongiform encephalitis, an alternative name for Creutzfeldt-Jakob disease (CJD). 

It comes down to whether you can trust your doctor if they tell you they do not know which...

Yeah. A couple of my chums have had cancer. And it’s interesting listening to them talk, because there’s often the case of, they will say, “I’m with one of the best cancer specialists in the country.” And they have to believe that, and they probably are. And they, there is certainly almost a badge of honour in trying out new therapies. And again I... sort of when you’re within a trial you have got lots of people around you, and I know there’s this real thing about the support, that, you know, you’re welcomed in. And rightly so. So maybe randomisation, if you think you’re being dealt with by somebody who’s really good and they truly honestly don’t know whether x or non-x is better, and they say, “Look, we truly don’t know. Would you be prepared to be randomised?” I’d probably say, “Yes.” So actually thinking about it, and thinking it through in my own mind, it absolutely and utterly comes back to the trust of the person you speak to. So therefore thinking about that, we know that there’s great, there can be great trust in the structure of a trial because of the influence of the ethics groups. It’s about having the sort of clinicians, having the absolute trust, both individually and also as a group of people, never to lose that. Because once you’ve lost that, you’ve, you’re on a sticky wicket really.