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David - Interview 34

David - Interview 34

Age at Interview: 56
Sex: Male
Background: David is a full-time student. He is single.

Brief outline:David volunteered for a placebo-controlled trial of a new treatment derived from mouse DNA to improve asthma symptoms. He later discovered he was in the group taking a lower dose of the treatment, but he would not have minded being in the placebo group.

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David joined a trial of treatments for asthma because he wanted to learn more about the condition, as well as to help medical research. The expenses package offered was another reason.
Print So I’ve always been asthmatic, and it’s, I would describe it as managed. The last full blown attack I had was about fifteen years ago where I had to go to A&E and be put on a nebuliser. I recently had a chest infection which dragged on for about two months, and the symptoms of asthma were overlapping with that, so it as difficult to tell what was asthma and what was the chest infection. And I was tempted to go to A&E about a week ago because it seemed particularly bad, and I was worried about cardiac symptoms, because I was coughing a lot. I, the clinical trial I was involved in came through my GP and the practice that I was a patient of at that time had a very good asthma clinic. So through that, I was asked if I would be interested in participating in a trial at the [specialist] Hospital which would be educative for me, and would be helping to find an up-to-date cure for asthma. So I looked into it, and I went to meet the doctor in charge of the trial, and it was very much sold as an altruistic thing, that we would be helping people with the same condition. And I decided to do it because I was interested in what the trial was about. I have to say that there was a fairly generous sort of expenses package [laughs]. That was one of the factors, I have to say.

After he’d started the trial, there were scare stories about the type of treatment being tested. He felt it was too late to stop, but might have thought differently another time.
Print Commencing the trial I was aware that the nature of the trial was genetic. I can’t recall, actually, if we were told if there might be side effects, but I remember the doctor being very reassuring that it was safe, and I wouldn’t have done it if I’d have thought it was unsafe. Funnily enough, shortly after commencing the trial there was a lot of information in the newspapers to do with these kind of trials, and it was said that mouse DNA was being used to engineer, or re-engineer the DNA of some people that had certain conditions. So I was quite alarmed by this because I immediately thought, well, there must be a risk to your blood. And I was worried about leukaemia, actually – and I voiced my concern to the doctor and he reassured me that it was safe. Obviously, I wouldn’t know, and I probably wouldn’t know now if there were any side effects. I don’t know. But I continued with the trial because I thought, “Well, I’m in it. I’m in it now so I might as well see it through.” So I did. But as I say, I was slightly concerned about the negative reports in the press about DNA-type clinical trials. I haven’t done one since, and certainly the unfortunate episode at - was it Northwick Park* - has probably put a lot of people off clinical trials. I would be very surprised if anything like that happened again, but I’ve not been tempted to do a clinical trial since, I must say. And when all the stuff broke in the papers about concerns about using mouse DNA, you stuck with it. Did you think for a bit about giving up? Well, I’d already had at least one injection, possibly two, so I thought [laughs], “Well, if there’s going to be any damage it’s already done”, so I thought I might as well stick it, you know, see it through, yeah. But I was concerned, I must say. If I’d seen some of the newspaper reports prior to commencing the trial, yeah, I would have definitely had second thoughts. But as the reports only started to appear once I was a third or half-way through the trial, that’s why I thought, “Well, I might as well see it out.” But I would definitely have had second thoughts. And do you think they should have said more, then, in the information? Ah, possibly, yes, possibly. I mean if they genuinely believed that there couldn’t be negative side effects in any event, then okay, fair enough. But that’s not what the newspaper reports were saying. The newspaper reports were definitely putting around scare stories about it messing around with nature, you know. Can you remember what they said about possible side effects or risks? They must have said something about it. Well, I mean, I think they were of the nature of if it’s affecting your DNA then it could put everything into imbalance or, or - I don’t know. I’m not a scientist. *FOOTNOTE: David 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-in-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: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_063117

He’d have been interested to see what happened if he had been in the placebo group. Before the trial he might have felt disappointed to get a placebo but his views have changed.
Print And did you notice any improvement in your asthma during the course of it? Asthma’s a funny thing because it’s partly self-perpetuating. Because you panic when you’re breathless, it’s sort of cumulative... There may have been a placebo effect on me because I may have wanted to believe that it was having a beneficial effect on me. As I recall, I thought that my symptoms had improved. That may have been because I was working near the coast and I’ve often found that being near the coast the symptoms aren’t as bad. When I was living in New York many years ago, I didn’t have any symptoms at all, and I thought that’s obviously because the sea air is just coming straight off. And what about the peak flow readings? Did they show any sort of objective change? I think they did. I mean, I wouldn’t have been the one to know that, because I was simply posting the paperwork off to the doctor at the [specialist hospital]. I think he pointed out to me at the end of the trial that there had been a change, so yeah. And then he told me that I’d been on the lower dose, so that maybe makes sense, yeah. How do you think you’d have felt if you’d been on the placebo when he told you at the end? I would have found that very interesting indeed, because with regard to the self-perpetuating element of it, you know, it is partly self-perpetuating, that if the symptoms start you think, “Oh I’m asthmatic.” And then you can sort of, it’s a self-fulfilling prophecy. You can make yourself even more asthmatic than you would otherwise have been. I mean asthma is a bit of a mystery, I think. I think it still is, actually. I don’t think they entirely understand it. No, I would have been genuinely interested, because I am genuinely interested in the condition and I would’ve been very interested to find out if there was a psychosomatic element to my condition. Yeah, I would have been very interested, very interested indeed, yeah. And before the trial took part when you were being randomised, what were your thoughts at that point about whether or not you might end up on the placebo? Did it worry you if you were in the placebo arm at that point? When I started I think I would have been disappointed if I was on the placebo, because I would have thought to myself, “Well, that’s been a bit of a waste of time, and I have just done it for the money.”* And I wouldn’t have found out anything about my condition, although I don’t feel like that now. As I’ve just said, I think I would have been very interested to learn that I was on the placebo, especially if there’d been a change in my peak flow throughout that time, because that would have confirmed the psychosomatic element of it, and that would have been very interesting. * FOOTNOTE: David was in a trial where every participant was paid a generous fixed sum for expenses. (See also ‘Time commitment, money and other practical issues’).

The offer of a generous expenses package was attractive to David, though looking back he feels it was fair compensation for his time and effort.
Print The clinical trial I was involved in came through my GP and the practice that I was a patient of at that time had a very good asthma clinic. So through that, I was asked if I would be interested in participating in a trial at the [specialist] Hospital which would be educative for me, and would be helping to find an up-to-date cure for asthma. So I looked into it, and I went to meet the doctor in charge of the trial, and it was very much sold as an altruistic thing, that we would be helping people with the same condition. And I decided to do it because I was interested in what the trial was about. I have to say that there was a fairly generous sort of expenses package [laughs]. That was one of the factors, I have to say. I mean, it was about a thousand pounds, actually. But I mean it was quite a lot of work, actually, to actually remember to take your peak flows three times a day, and to fill in the paperwork was, you know, quite a lot of work really, so I think the remuneration was probably quite appropriate. If you add up all the travelling and the time taken to actually do the peak flow and fill in the paperwork it probably wasn’t that much, actually.

David advises people to think carefully about taking part in trials only for money. It’s different when it’s a new treatment for a condition you have.
Print I think clearly the ones that people do just for money, they target students, don’t they, and travellers, people who are travelling from Australia. I’ve noticed in a couple of the Australian periodicals that there’s tons and tons of ads in the back of those for clinical trials. And that is clearly for money. People do that for money. But if, in the case of the trial that I was involved in there was an altruistic element, and I suppose that if they’re sold on the basis that you’re doing some good to the human race, then that’s an incentive, because I think we’re all a bit altruistic, somewhere. If people were tempted to do it just for the money, I’d say, “Do you really need the money? Or is there another source for the money?” Because I don’t have a good feeling about those kind of trials. And, as Northwick Park* has proved, they can be dangerous. But if you have an interest in a particular condition that you have, and I mean if it’s new treatments for life-threatening diseases, for example, and especially if you have been diagnosed with one of those diseases, I think yeah, it’s worth a go, you know. There’s a long way to go in terms of finding cures for a lot of diseases so if we can contribute, then that’s a good contribution. Are you glad you took part, thinking back? Yes, I am, yeah. *FOOTNOTE:David 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-in-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: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_063117

David had to attend several appointments for tests and a series of injections. In between he had to take his own peak flow (breathing) readings and record them on a chart.
Print The trial was over several months, and involved I think about four or five visits to the [specialist] Hospital, to have, you know, the full check, blood pressure, all the rest of it, blood tests, the machine that tests air flow. I can’t remember what it is. Peak flow? Yeah, but it’s a really posh one. I mean, you know, it’s about six foot high as I recall. And all the information was processed through the doctor’s computer. And shortly after I commenced the trial, I got a job in Chichester where I was in a play, and I had to take my own peak flow three times a day, and fill in a chart. And I was given a posh sort of machine with which to do this, which was electronic. I did forget a few times because, because I was preoccupied with rehearsals and performances, so I did forget a few times, I have to admit. But I pretty much kept to the strictures of the programme. And there were, I think there were about twenty-five people involved in this particular trial. And one section took a placebo, and there were two different doses. We didn’t know obviously which of those we were on until the end of the trial, when we were told, which was interesting. And the actual intervention was I think an injection? That’s right, yeah, yes. What was that like? It was in the bum and it was quite painful [laughs]. Yes, it was quite painful. And how often was it? I think in all we had about four. Over the course of several months? Yes, I think it was about four. It may have been one or two more than that but yeah, it was quite painful.

David had expected to feel like a guinea pig, but actually felt it had been interesting and worthwhile. He was pleased to have a personal debrief with the specialist at the end of the trial.
Print At the end of the trial, how did you feel when it all stopped? …I expected to feel like a guinea pig, but the doctor was particularly sensitive, and obviously had a genuine interest in asthma and chest conditions. And he sort of did a full debrief, really, and for example, I found through the test that apparently I had fluctuating levels of white blood plasma, which was slightly alarming, but I was glad that he’d pointed it out. He said that it may have been to do with the serum, or it may have been to do with a local infection that I’d had during the trial. But he didn’t have a complete answer to it, but he did take the trouble to discuss it with me and thank me for taking part. And I felt that - he made me feel in fact - that I’d contributed. So at the end I didn’t feel like a guinea pig, although I had expected to, yeah. It may sound an odd question, but did you miss it once it finished? Sort of, yeah, yes. Yes, I did, kind of, yeah, yes. I appreciated the relationship with this particular doctor. I found him very interesting and over the course of the months I sort of developed a proper relationship with him, and it’s always interesting to have access to a doctor’s knowledge when it’s not, you know, in a surgery. It’s sort of privileged information, really, which, yeah, I found very interesting, yeah. Yeah, I had no misgivings after it ended. I did feel as if I’d contributed positively to something, and that it had been worthwhile, you know, yeah.

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