Tom - Interview 14

Age at interview: 63

Brief Outline: Tom took part in a phase 2 trial of a new chemotherapy drug for lung cancer in 1993. Without the trial, the only other option at the time would have been palliative radiotherapy.

Background: Tom is a retired engineer. He's married with 2 adult sons. Ethnic background/nationality' White Scottish.

More about me...

In 1993, Tom travelled to Saudi Arabia to work as an engineer. At a medical check it was discovered he had lung cancer. He returned home as soon as he could to Scotland, where he was told that surgery was not possible because he had some smaller cancerous nodes in his chest, as well as the main tumour. There was no known effective chemotherapy, and radiotherapy could not cure it. The only available option was palliative radiotherapy, to keep him comfortable, but he was not expected to live more than 9 months. Tom and his wife Helen felt very shocked and alone. There were several communication mix-ups over fixing appointments and sharing results between different members of staff which did not help the situation.

 

Eventually, about three months after diagnosis, Tom saw an oncologist who told him there was a phase 2 trial of a new chemotherapy drug (gemcitabine), for which he was eligible. This meant the trial was not a randomised trial comparing one treatment against another. Everyone in the trial got the new treatment for 6 months, to see whether it had any effect and what the side effects were. Tom felt he had no choice but to take the opportunity in the hope it would help him, and said yes immediately.

 

The small group of patients involved in the trial built up a strong supportive bond amongst themselves. Sadly, nearly all of them have since died, but in Tom’s case the chemotherapy seemed to get rid of the cancer in the smaller nodes, and the main tumour shrunk to a size which made it possible for him to have radical radiotherapy. He has had to retire because of the damage to his lungs, but 15 years on he is still alive and well, and able to tell the tale. He feels being offered the trial saved his life and gave him hope in an otherwise hopeless situation.

 

Tom has since become involved in a number of patient groups, and is the patient representative on the executive committee for the cancer clinical trials unit for Scotland. He is a strong supporter of the need for more medical research, including tests involving animals. He thinks it is easy for people to oppose it if they or their family have not faced a life-threatening illness. He feels the health service needs to do more to make sure people know what trials are available and have a chance to take part. He would advise anyone thinking about a trial to think about it positively, and bear in mind that you will be carefully monitored and you can withdraw at any stage if it is not working or the side effects are too great.

 

He knew he could stop if the side effects became too bad. He felt the staff explained it well,...

We were all getting the drug, and there were, the explanations from what I can recall were very good. It was explained again about I can withdraw at any time, if they find I’m having bad effects with the drugs that they’re giving me or, then they would pull me out, because I think obviously they were looking at the quality of life, as well as trying to find out if this drug was effective, you know. I have no complaints about that side of it at all and the nurse, the research nurses who were involved also were very good at explaining, and they would take their time, either if myself, or Helen, or any of the other patients who were there had questions. Some patients didn’t have questions. As usual some people want to know everything and some people don’t want to know anything, some people want to know a wee bit, you know. But because my, I felt whatever was going to happen to me, whatever decisions I was going to take it was going to affect my whole family, so I wanted to know everything, which perhaps maybe made it a bit easier for the medical staff because they knew, “Well, Tom wants to know, so we can talk to him, we can tell him”, you know. But I have no - on recollection the medical staff at that time were very good with their explanations.

Tom believes a public website listing available trials and eligibility criteria would be a good...

But I’m involved with CACTUS, which is the cancer clinical trials unit for Scotland. I’m the patient representative on the executive committee for that, and I was talking to one of the guys there, and I was talking to someone else, maybe it was the lung clinical studies group, about a website for clinical trials. And they said, “Oh, well, it’s very difficult” and all that, because we spoke about it before as part of the West of Scotland cancer network, the lung cancer part, and we said then the professionals weren’t too keen about putting available trials on a website or anything like that. He says, “No, we don’t want people phoning up and demanding to be put into trials.” I said, “Well”, I said, “It’s not quite that.” I said, “It’s a case of putting up what is available, but also having on it that these trials are not available, are not suitable for every patient, and every patient’s not suitable for these trials. It’s up to being acceptable and the many different aspects.” But it would be interesting for people to be able to say to their consultant, “Well, what about this trial, what about that trial? Explain it to me, is it feasible for me?” I says, “Whereas just now people just don’t know, and it’s up to the physician, the oncologist, whoever it is, to tell the person about a trial.

 

Now, that medical professional might not be too interested in that particular clinical trial, therefore he won’t, or he or she won’t offer it. There’s also the fact that, with all due respect, there are medical professionals who don’t like losing their patients to somebody else, so if they’re not doing that trial but somebody else is, they don’t want to lose their patient to that other professional. So I said, “There are various aspects of it. I think people need to be aware that there is a possibility of trials without it always having to come from their clinician, like I say, who might not be into clinical trials.” “Well, that’s too much work for me, I’m doing enough.” Because there is a bit of work involved in them, because they’ve got their own NHS, probably all their own private work as well, some of them - no disrespect meant. So there is a workload aspect probably too, but I think people should be allowed to question, “Well, can I go into this clinical trial? No? Why not?” and if they’re not suitable then that’s fine, you know. But yeah, there should be something where people can challenge the chance or the opportunity of clinical trials. 

Tom encourages other patients to think about taking part in a trial if it is offered. You can...

What would you say to other people who may be watching this and who’ve been invited to take part in a trial and are thinking about it? What would your message be?

 

Give it serious consideration, get as much information from your consultant, oncologist, whoever’s talking to you about it, talk to your family about it also. And again, as I said earlier, I think a lot will depend on the individual’s prognosis and how you view the best possible treatment that you can get. The treatment won’t be any worse, because if, as I said earlier, if you feel as a person that’s it not doing you any good or if it’s making, your quality of life is being reduced by it, speak to the doctor, speak to your consultant. If they see also that it’s having serious effects and negative effects, they’ll pull you out of it. So you always have the option of stepping back from it. But do give it serious consideration, because you will be treated well. There is the aspect also that a lot of people say, “Well, if you’re in a clinical trial you get better treatment.” I don’t know if it’s a case of getting better treatment. I think probably there are more tests done on you to make sure that the drug is not having a negative effect, so in that way perhaps people think they’re getting better treated. But I was involved in doing, as a part of the working group with the NHS Quality Improvement Scotland, doing the standards, reviewing the standards for lung cancer, and also for the core cancer standards, and that was one of the things that I got them to put in it was that just because you take part in a clinical trial doesn’t mean that, if you don’t take part in a clinical trial doesn’t mean you’re not getting the best of medical attention. So you are. But no, I would seriously give it serious consideration for taking part in a clinical trial, yes.

Tom was invited to join a non-randomised Phase 2 trial of chemotherapy for inoperable lung cancer...

So this young lady asked me if I would like to take part in a clinical drug trial, and she explained the situation. She says, “It might not help you. There’s no guarantee.” She says, “It might help other people further down the line.” And again she said, “You’re a perfect patient for a drug trial, for a clinical trial.” She says, “You’re young, you’re fit and you’re healthy” [laughs]. You know, even I had to laugh – I was young, fit and healthy, the only problem I’ve got is I’m dying from lung cancer, you know.

 

So anyway, that was okay, so she says, “Right, I’ll phone the trials unit and see what I can do.” So she phoned up, got an appointment there for the following week. Went along and, you know, a medical, a check-up to see that I was okay to take part in a trial, so I was accepted into the trial, which I believe was a phase 2 trial. It wasn’t randomised and as I said, I think I just quite followed, not quite followed the mice, but their tails were just disappearing round the corner.

 

It was six months of chemo. I was quite fortunate I wasn’t too bad with the side effects. It ended up there was a kind of group of us of four or five. There was about eight people I think getting the drug, but there was about four or five of us always seemed to be at the same point where we were, of getting the course of the drug but we’re at different stages of actual lung cancer. So during the course of that, you know, one was dying, a couple of weeks later another one would die, so it was a case of thinking, “Well, you know, who’s next? When’s it going to be your turn?” so to speak.

Joining a trial when you have a serious illness is very different to 'healthy volunteer' trials....

I still speak to people who talk to me and they say, “What did you say? Clinical trial, what is that?” There is a lack of knowledge, a lack of education, perhaps, coming out about clinical trials. One of the things that did surprise me about the episode – what was it - a couple of years ago, at was it Northwhich?

 

Northwick Park*.

 

Northwick Park, there was bad publicity about clinical trials at that time, but I think what people have got to remember, and possibly what didn’t come out enough, was the fact that that was not a clinical trial that we are actually talking about today. That was a clinical trial where it was healthy people being paid to take part in a trial, in an experiment, say. That is a totally different thing from if you have an illness and you’ve got the best treatment, but you’ve got the option of taking part in what might be something new. It’s a whole different ball game, it’s a different kind of trial, I believe. I think one of the things that did come out of it I was told that all of a sudden there was many more volunteers to take part in clinical trials. That was a clinician said that, it’s not that long ago in fact that we were talking about it, and he said yeah, the enquiries they got about people taking part in clinical trials rose because of Northwick Park, so which surprised me. But that, like I said, that was a totally different kind of trial and I think there was bad publicity about that, but that’s not the kind of trial, I think, that we are seriously discussing here. But yeah, I don’t know how you, it’s a difficult one to get people - because it’s something that probably people don’t really want to know about anyway, until they’re in the situation. One of the things that clinicians have said to me, and I have briefly mentioned earlier, was the fact of patients asking them questions, and the sort of inclination was that, “Well, patients should know what to ask”, and I said, “Well, with all due respect”, I said, “Patients don’t sit, people don’t sit at home and say, ‘Well, maybe in the future I’ll get heart disease or a cancer, I’d better read up on it now and find out what I’ve got to ask’.” I said, “Come on, join the real world. People don’t do that. It’s when they’re diagnosed, that’s when they go, or if someone close to them gets diagnosed with a serious illness, that’s when they go and try and find out about different things, but they’ve got to be able to get the information.” And I said, “You can help give them that information.”

 

*FOOTNOTE' Tom 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.

A copy of the Inquiry Report of this incident can be downloaded from the Department of Health website.

 

It was a relief when the trial ended and he no longer had to cope with side effects and lots of...

Because apart from that, because it was a trial as well, you were getting needles put in and blood taken and all that on regular intervals, you know, sort of three times a day, before food kind of thing, [laughs] or whatever. You know, because they wanted, obviously because it was a trial, they were checking your blood continuously, you know. And then there was one of the guys, he really had a needle phobia, he was really bad with getting the needles, yeah. But no, I mean, like I said I think earlier, I was quite fortunate with the chemotherapy. Well, yeah, there were side effects I got after two or three sessions, a couple of sessions, the night after getting the chemo I would take the shivers. I wasn’t cold, but I’d just take the shivers. And then this is where the carer and your partner – and Helen would just bring down a duvet and just wrap it round me and, you know, and that was it. I don’t know whether it was one of the side effects, I don’t remember, I don’t recall it being as a side effect. There was a bit of numbness, itching and that sort of thing which was expected, but no, it was a…

 

But basically quite a relief when it ended, then?

 

Yeah, yeah, in that way it was. You know, here you are at six months and that’s your average, you’ve hit your average now. You’re three to nine months, you’re six months - you’ve made it. Now what happens next, kind of thing. And then you get to the stage where you hear about all the targets, you know, after a year, after two years, after five years, and of course you’re going through things, saying, “Well, will I make it to the year? Or will I make it to two years? Will I make it to five years, as time’s going on?” It’s not a depression. It’s… I don’t think I was ever depressed, not to my knowledge, but there is the concern, you know, that, “How’s things going to develop? You know, what’s going to happen?” and you’re living with it all the time. I mean, it’s very difficult. It’s easy, you know - I’m not being derogative - but it’s easy for a clinician to say, “Well, you’re cured, because you’ve not got a tumour”, but you’re not, you might have - you might not have the tumour any more but you’ve still got the after effects which you’ve got to live with, the breathlessness, the disability, unable to work, and the concern because you’ve had a cancer you’re susceptible to other cancers, you know, the rogue cell or whatever it might be is there.  

When someone is seriously ill it's not the best time to explain clinical trials. We need more...

When a person is in the system it’s not always at diagnosis that’s the best time to talk to them about different things, because at diagnosis, you’re, “Oh God, I’ve got this, I’ve got that, I’ve got the other.” Well, you’ve got to give people a chance for that to register, and it’s all very well saying, “Well, we’ll give patients all the information there and then.” That is not necessarily the best time to do it. But I think in general, I think there could be more awareness made regarding clinical trials, whether it be through newspaper articles, or wherever where people get the opportunity of really understanding what they are and what they’re about, rather than, I suppose, the general consensus of opinion is still the guinea pig effect. And it’s not necessarily the guinea pig syndrome kind of thing, and I think that’s perhaps what needs to be more expressed and more explained to people.