How would you have felt about a placebo trial, if it had been offered to you, where you might have got a drug or you might have got nothing?

I would do it. My mother-law did one for tamoxifen, when she was diagnosed with breast cancer. And I took her along to the various – to her clinics and sessions and talked to people there, which was quite a long time ago, sort of fifteen years ago. And I thought well, if it – I mean, you can’t project – but I’d like to think that that was what I would do if I was in that situation. Mm.

[Sighs] it would be hard, I suppose, but then how – you’ve got to go through the procedure because you’ve got to satisfy the authorities that the drug is capable of doing what it says. And you’d never get new drugs, would you, if people – you’d never get them ratified and if people don’t volunteer. So, yeah.

I mean, some people tell me that their main reason for taking part in a trial is more to get access to a particular type of treatment, or to, that they feel they’ll get better care if they’re in a trial. It doesn’t sound as though that was at all part of your thinking, really?

No, no it wasn’t. And it wouldn’t be. I mean, there are, as I mentioned there’s a drug earlier that I would have love to have a go at, but I know that if I went into a trial it would be random as to whether I did. it’s interesting, the placebo thing, though, isn’t it? How many people do make progress because they believe that they’re taking something that’s doing them good. I mean, yeah. You know, I, it wouldn’t – no, I’d have to do it if I had the chance, because we wouldn’t have those new developments. We wouldn’t have them ratified. We wouldn’t have the treatments if people didn’t.

And after about a year I was contacted by the, by my GP to ask if I’d like to go on a, a medical trial looking into blood pressure and how to, various ways of treating it, which I, it seemed a good idea to me to do it. So I took part in the trial and that lasted for about, about six years. And I was glad I did, because the treatment was monitored, I was thoroughly checked twice a year, six-monthly intervals, and the whole thing was much more relaxed than going to the GP. It was friendly sort of doctors and nurses. It was all, obviously everything was tailored towards blood pressure. So they were able to, any little things that cropped up they were able to look into straight away, change the medication if necessary, and it was much more – well, I found it much more beneficial than going to my GP, and I was quite happy doing it. There were no real problems. After the initial trials, I was tested on certain, several different tablets and eventually they got, they found the right combination and blood pressure started to go down, in fact. So after about, I think it was about two years, I actually came off the blood pressure tablet and I was just on a diuretic. Blood pressure stayed fairly stable for the next few years and I was on, as I say, just a diuretic tablet until I came off the trials in I think it was 2006. I’ve since gone back to my GP for treatment and I’ve been, he’s put me back onto another type of a blood pressure pill. Personally I don’t think I need to, but that’s, that’s the situation at the moment. But I’ve just started a new trial, so I’m, I’m now under the supervision of another clinical trial and taking experimental tablets. I don’t know what that one is. it’s like a placebo at the moment. I’m not really sure what combination of pills I’m on. But I’ve had a check-up and so far it seems to be working, and the blood pressure’s at a reasonable level. So once again I’m quite happy to be taking part in a trial and being supervised.

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 horribl 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.

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 tria – 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?&rsquo

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 tryin, 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

No, but I’m telling you if they’d said to me that they’d been trying it on pigs the day before and it had cured them, I don’t really think I [laughs] would have accepted it. It was something that’s been around for years. I have heard of people, known people who are still around today because of chemotherapy and radium, so it was an acceptable treatment. It wasn’t a placebo treatment. I don’t know whether I’d have gone for something like that – other than I was in the latter stages of the disease, and really I had no choices to make, then I might turn round and say, Well, all right I mean I’ve already, my children know that there isn’t any way, other than I’m like I am at the time before I became ill, that I want resuscitation, anything like that. I wish not to mess around like that. So in the latter stage – I might for thinking, Well, even if it’s only a one per cent chance Life is a funny thing, isn’t it? I mean it’s, it’s precious, you know, so.

So in that case you might go for some experimental treatment–

Yeah.

— versus placebo.

Yeah, yeah. But that would not necessarily be for me. My thinking would be, Well, they’re telling me I’m going to die in a couple of weeks or something. I could, it would perhaps help my granddaughter.

Were you worried about being given the placebo and not getting the real drug?

Not at all, at that, at that time. Later on, one or two years ago, perhaps you know, there was an ex-, a research in London, I think it was in London, and some people, they were affected for some experimental tablet. It was a famous case.* So since then of course I, I was more comprehensive, more aware that I have to be, to be careful if I participate in other, another research. But until that moment I trust completely. I think it was a gen-, a mistake, understandable, whatever the result’s awful. But I suppose it’s part of the research in general, mistakes, everybody can make mistakes.

So in a way that’s made you more worried about the thought that you might get a dangerous drug rather than getting a placebo? Because sometimes people —

Yes.

— worry the other way, that they’re not going to get something that might help them.

Yes. I suppose so. And, what can I say? I thought at the beginning when this problem happened with the mistaken, mistaken tablets, medicine they were giving to some people, well, they, I do remember that those people were in hospital for the trial, I think for two or three weeks, some time. But I’ve never been in hospital for a trial, just some couple of hours or whatever. Or only hospitals that’s in particular areas, not to stay for more than four hours, to say. And, and the, the only once, the time that I participated in this research with tablet, I suppose I was completely, I trust. I trust, I trust completely the research. But, as I say, with this other case later on I am, I could be more aware to make sure. But at the same time I’m sure the, the people who make, organise the trial or the research, they have to be more careful because it was a, this situation affected everyone, the people that could participate in the research and the organiser as well. Loss of trust, something like that. So, but in general I do support research, investigation, whatever.

And the idea of being randomised doesn’t worry you?

No, no, no, not at all, no.

*FOOTNOTE’ Sergio is referring to a Phase 1 trial at a commercial research unit based at Northwick Park Hospital in 2006 when 6 healthy volunteers became extremely ill. ‘First-time-humans’ studies are carried out precisely because we need to find out about possible risks and side effects before giving the treatment more widely. Most of the people we talked to took part in trials of treatments which had already been tested in humans before. A copy of the Inquiry Report of this incident can be downloaded from the Department of Health website.

There are a few, a few other things that I’d quite like to ask about. I mean one is from your experience of that, how you would feel now about going into another trial, whether you’d volunteer again?

Not for an invasive one I wouldn’t. Definitely not injections. Anything else I don’t mind [laughs]. Tablets, yes. I did actually start another one with -because I’ve got very high cholesterol – it was a trial for lipids, because I’ve got familial mixed hyperlipidaemia, and they can’t get my lipids and my cholesterol balancing. But unfortunately, I was on it for a couple of weeks and then I was called back to say that the drug company didn’t want me after all because of the, I wasn’t actually on statins, I was taking some – what was it? cipra?* Anyway the tablets I am taking aren’t statins, and they wanted somebody on statins.

How did you feel about that? Were you disappointed about that?

Yes, I was, because he said, the doctor had said Oh, people who use this definitely lose some weight, and it’s under guaranteed that your cholesterol will go down even furthe – even further, it’s still quite high, but further [laughs]. And yes, I was very disappointed about that one, because I thought, Miracle drug, it’s going to help [laughs].

I mean that is something that presumably they could have found out before you’d got that far down the —

Yes, because he was really excited looking at the check list saying Yes, yes, yes, you qualify for all of thi, and then go back in embarrassment, was not needed after all [laughs].

* Ciprofibrate (brand name Modalim)

Have you thought how you’d feel another time? If another trial came up that was relevant to you, would you be interested, or would it depend on the kind of trial?

I think I’d probably want to know quite a bit more about it, but I think in a different circumstance I might be interested, but I think I’ve got a lot more knowledge now about making a decisions about, about trials. I’m still occasionally a bit cynical about them, I’m afraid. It’s made me think a little bit more about things, looking at it from a wider perspective really.

Tell me more. Why are you cynical?

Well, I just [sighs] I don’t want to [laughs] I think there’s a big push to get answers to things, which and what’s, as I said before, what’s right for one person isn’t necessarily right for somebody else. And I think it’s unfortunate that people have to make these decisions at a very vulnerable time, when, you know, it’s difficult enough going through treatment without having to make a life-changing decision. I understand that for some people where, you know, the outlook isn’t very good, they want to grab hold of any trials that are going, because they want that opportunity to take part and, but I think if the opportunity came up again I probably would be interested to know. I’d probably do a bit more research about it. I’d ask people about it. But I think I’d still be quite determined to make my own decision, rather than being – I would take on board everybody’s views but I think I would want to make my own decision and not be swayed by anybody.

We just have to advance by comparing in a very rigorous way how we go forward with treating patients, otherwise we’re going to be stuck in not knowing. So yes, I thought trials were a wonderful idea, but it did occur to me that if I’d been on the trial working party, I would have some things to say about the information sheet. I would have had things to say about the end points. I would have had things to say about the possible outcomes, and about the feasibility of this trial. Because a huge amount of money was spent on it. It was a very costly trial, because of all the contention, I suppose. So there are economic aspects that need taking account of. Yes, I’m totally for clinical trials but they must be good quality clinical trials.

And, as I found with the people that I have spoken with and worked with, and indeed the clinicians more locally, I think it can only come about by a partnership between patients and health professionals, because we each have something different to give to, to devising any project, concept, trial that needs to be done. And the prior-, prioritisation of topics as well. You know, what is important to patients? What do they, what would really make a difference to their care? What do they want to know? Because they’re at the sharp end. They know what they want to know. They know what research would benefit.

And I think those patients that have become involved in this are able to stand back. They don’t do it – they do it based on their own experience because they know what it feels like – but they do it in a sort of detached manner. They have to become professional in their own way, in order to realise that this is an activity that’s undertaken on behalf of future patients. You do it on the basis of what you’ve learned today, what you’re learning today, but you’ve got to go forward and I think to do it in partnership is really the only way to do it. So yes, I’m totally for it. But the trial has to be well designed, well balanced, and presented in such way as to make sense to those who are going to participate. Otherwise it’s pretty futile if they don’t understand what’s happening.

What do you think are the characteristics of a good, well-designed trial?

Hmm. It’s easier to describe a bad one, isn’t it? And this is why I got involved, because I was invited to participate in one that was not balanced. The first thing that springs to mind is of course that it should be, let’s call it a legitimate comparison. It has to be utterly legitimate. In other words it has to be a comparison with, that is based on first of all the best standard treatment, a thorough overview of what is known on that topic – you can’t just have a bright idea and plunge in and ask for money. You have got to do your homework and find out what is known about this particular topic, before you even go, go there. I think I suppose the next requirement is to sort out, prioritise the question itself. In other words, how are you going to frame the question? It has to, I think, accommodate what are the important things about the thing you’re researching.

So framing the question that means something to both the clinician – in other words the sort of scientific, clinical treatment aspects – together with the aspects that the patient wants to find out. It’s, I think, no good having a trial that’s got an outcome that is meaningless. How are you going to get people to participate if they can’t identify with the purpose of the whole comparison? So it has to be a fair comparison.

If somebody offered you the chance to take part in a trial now–

Yes.

–and you were confident it was well designed would you say yes now?

It would depend entirely upon the trial, but if I thought if it was, I think, yes, I would. And if it suited me as an individual, at that point in my let’s call it disease progression, and my – yes, if it was suitable. If it was tailored for me – which is after all what all trials ought to be, isn’t it? They ought to be tailored for the group of people that are trying to be helped. So I think the only answer to that can be yes, but I never say a qualified – an unqualified yes, because there always are circumstances and values that you bring into you decision-making that are not apparent until you’re actually at the point of making a decision.

You can’t make a decision for anybody else, and you can’t make a decision of your own in the future, in the same way that you can’t retrospectively decide what you would have done if. So, as far as it goes, yes, I’m for trials, but I think it would be foolish to say that yes, I definitely would because it would have to depend upon what it was, when it was, and whatever it was.

I mean you’d need to be very clear about what each one entailed and what sort of effects it would have. I mean, I’m thinking again of the chemotherapy one, you know, if you’re in a trial for looking at different types of drugs and you’d want to know what sort of effects each was having, so that you – you would need to know that whichever option you were offered you could feel comfortable with. So you’d need to know about all of those. I mean it’s quite a lot of learning and input, I think, from a research team to give you that sort of information, but it is important I think. Yeah, it would be important to me.

What about placebo-controlled trials? What would you feel about being offered that?

[Sighs] I don’t think, I don’t think it would bother me particularly. I’d be quite happy to be involved in something like that because, because I understand the reason why placebo trials are offered, that, you know – and actually even, I mean placebos are there in order to make sure that any – this is my understanding – that it’s blinded then. If you’ve, if you don’t, if you have a placebo you’re taking something, so there is an equity in terms between two groups, between – in terms of you’re actually taking something. You don’t know whether it’s the actual drug or it’s not the drug, and therefore you’re not going to be influenced by -your two groups are perhaps more equal, so that you don’t know as a patient whether you’re getting the right, the trial drug or not but you’re getting something.

Would it depend on what kind of aspect of the condition it was for? I mean I was thinking say with menopausal symptoms that that might be quite a reasonable area–

Yeah, yeah.

–to accept a placebo. If it were chemotherapy maybe you might feel less happy about it. I don’t know.

Well, again I think it’s probably back to the idea that, that I wouldn’t want to be offered something that I didn’t think was at least standard practice [laughs]. So if it’s not standard practice to give you nothing, then I don’t think you should have nothing. So it’s about, you know, the genuine uncertainty, again, between two different types of treatment. So in chemotherapy or yeah – I mean if there was in menopause it may be a genuine uncertainty that we don’t know actually whether nothing is as good as something. But actually in most, in chemotherapy it’s about two somethings, isn’t it, rather than something and nothing [laughs]. So I don’t think I’d want nothing if I was told that actually standard practice is to have something, we just don’t know which something.

What would you think about placebo trials? Would you be willing to even think about it?

Well, my cousin’s husband has got MS and it’s very, very progressed now. But I know he’s been on, he was on a clinical trial and he was on a placebo, and I think he was really miffed about that [laughs].

That’s quite interesting, so that experience in your own family might make you think–

Yeah.

–differently about it?

Yes, it would. It would. I don’t think I’d like it at all, actually.

That’s interesting. Even though you’re, I mean most of the, what you were taking part in research for was to benefit other people really rather than benefiting yourself, apart from the two weeks, obviously.

Yes.

But there’s something different about a placebo trial for you.

Yes, definitely, definitely. Especially if cancer is involved. I think that, I think that’s an issue as well. If it was to test in-growing toenail creams or something like that then, you know, or something – I mean it’s very painful but, you know, something that wasn’t life threatening. But as soon as somebody says, Cance it changes everything. You just, it’s like having an intruder in your house, you just want it gone and out and finished with, and I just want to get on and not have it. I mean, I’m not in a state of complete panic or anything like that. I have complete confidence that this will sort it out and it’ll be gone. But then again there’s so many different types of cancer, and I know some people are on this watch and wait’, so maybe, maybe that would be different.