A-Z

Clinical Trials

Side effects and queries about clinical trials

Clinical trials are carefully designed to minimise the risks and maximise the benefits to everyone taking part, whatever treatment they receive. Some trials will involve very little risk. Researchers should explain to you what they already know about possible side effects to help you decide whether to take part. Clearly this will depend very much on the type of treatment being tested, so you will need to ask questions about the specific trial. Of course it can be worrying hearing about all the possible side effects, but it is important to bear in mind that not everyone reacts the same way.

 

She experienced many of the side effects she was told might happen. It was a worrying list, but...

She experienced many of the side effects she was told might happen. It was a worrying list, but...

Age at interview: 51
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
So what kind of side effects were they?
 
I got - it varied throughout the cycle - but throughout the whole cycle I would experience extreme diarrhoea, nausea and sickness, so you’d feel sick but sometimes you’d actually be sick. I had a sore mouth, ulcers in my mouth, cold sores on my lips. I had gums bleeding, so every time I cleaned my teeth my gums would bleed. I had the hand and foot syndrome, which is a well-known side effect of it, which meant that your, your hands go very red and sore and dry and blister, ulcerate - which is not so bad on your hands. You can put rubber gloves on or you can put hand cream on them. But on your feet, sometimes it was really difficult to walk. But, and, and also increasingly incredibly amounts of tiredness, really feeling lethargic. So that, you know, you’d have a good night’s sleep and you, you just couldn’t get out of bed. Or you just couldn’t do anything, you were so tired, to the like of which I’ve never ever experienced. And obviously with that as well I suppose psychologically I felt quite depressed, because none of the family could understand how bad I was feeling. I could only explain that to them.
 
And did you have to stop work?
 
Yes.
 
Yeah. OK. You didn’t get hair loss?
 
No, no hair loss at all. They did actually say to me that was the one plus. And the funny thing was I didn’t, that didn’t really bother me. I’m not a vain person. I wouldn’t have minded if I’d lost my hair. They did say that, “You’re very unlucky if you do lose your hair, and if you do it’ll only be very minor amounts. You know, you’ll notice, when you’re combing it a little bit will come out more than normal. But you shouldn’t, shouldn’t lose any hair”, which I didn’t.
 
And looking back at the information that you were given when you were making your decision and all the way through really I suppose, I mean, how do you feel about that now in hindsight?
 
What, you mean whether I was critical of it, or whether I thought it was enough?
 
Either. Whatever you, you felt.
 
I thought they were, they gave me more than enough information in the start. In fact actually it was quite worrying when the big list of possible side effects - and he did explain, “That is everybody’s side effects ever, that’s ever taken that drug.” The ones that you’re more likely to get were the sickness, the diarrhoea, and sore hands and the bleeding gums. And that’s exactly what happened. So I felt I was well equipped to deal with the decision, because all the things that he mentioned did actually happen. It was exactly the way he described it would be. 
 

Anthea knew she could withdraw if she had bad side effects, but in fact they were generally mild....

Anthea knew she could withdraw if she had bad side effects, but in fact they were generally mild....

Age at interview: 58
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
And I, I also knew about the randomisation, that if I fell in one category I would just have the four weeks of intravenous interferon, but if I fell in the other category that it would be four weeks and then another forty eight weeks. But depending on how the side effects, I could pull out at any time. That’s always been stressed.
 
If you - it is a trial. If you want to say, “That’s it. I’ve had enough”, then that’s fine. And that didn’t happen to me until about four weeks before the end of the trial, I came for an appointment and I said, “I’m feeling really, really tired.” And I wasn’t quite certain how many more weeks I’d got to go, and they said, “Well, you can stop it now if you want to. You’ve only got four weeks to go.” I said, “I’ve this done this far. I’ve don’t this long. I’m quite prepared to do another four weeks.” And the doctor said to me, he said, “Well, you’ve had flu-like symptoms for a year, so it’s not surprising that you’re feeling, beginning to feel low.” So…
 
And I think you said other people had dropped out of that trial.
 
A lot of people had dropped out. They, they just couldn’t take the side effects. And I know of some other people, I actually know of two other people that started on interferon and they, they just couldn’t take it. Even they couldn’t take the four weeks of intravenous. I was ill after the two weeks, and they had to stop for a week and reduce the dosage then. But the consultant said to me, “We like” - quite bizarre, really - he said, “Ah, I’m glad you’re getting these side effects”, he said, “because we know we’ve given you enough.” He said, “Now we can halve them.” And once I’d halved them I was, I was okay and then they started and I got through the four weeks so.
 
I was hoping that I was going to be one of the ones that went for the year. It might sound bizarre, but I thought, “If I’ve got a chance, then that might be the chance that I’ve got. If it, if I go for the year and it’s successful, I’ve done it.” And if I’d only had the four weeks and the, it had reappeared again, then I might have thought, “Well, if I’d have gone for the whole, if I’d have been one of the ones for the year, perhaps it wouldn’t have happened.” But I did the whole year, and I said when the next lump appeared, I said, “Well, interferon didn’t really work.” And they said to me, “But it’s given you two years. It given you the year you were on it and the year after. You’ve had two years.” So in lots of ways I was lucky.
 
FOOTNOTE' Anthea has been in three trials. Here she is talking about the first, a 12-month randomised trial of interferon. 
In all trials the treatment may cause side effects or problems that doctors cannot predict. The risks may be greater when less is known about the treatment being tested, as in the Phase 1 trial for prostate cancer that Julian was involved in.
 

Testing treatments that target people with cancer who have the BRCA genetic mutation may be of...

Testing treatments that target people with cancer who have the BRCA genetic mutation may be of...

Age at interview: 61
Sex: Male
SHOW TEXT VERSION
PRINT TRANSCRIPT
I do have some mild side effects. I get intermittently every day a little bit of nausea and stomach discomfort but it’s not terrible. And most of the other patients also have had only mild side effects. A few people have had more troubling things.
 
In the long term, nobody knows what the effect of the drug might be, so I’m quite interested in staying alive for long enough to see what the long term side effects are. And I’ve got strong reasons to be interested in that question, because I’ve got three daughters and they’re at risk, and so it would be nice to know whether they should consider taking the drug, you know, if something goes wrong, or even taking the drug prophylactically to prevent disease from ever developing. That’s something that would not be contemplated now.
 
Because we don’t have the evidence about long term side effects, and as I say, it’s potentially quite a worrying drug.
 
But it’d be, you know, if I live a good long time then that would be a bit of evidence that maybe it’s a good idea to start the drug treatment very early and maybe even before any disease is apparent.
 
Have they been tested for the mutation?
 
No, they haven’t. They know the situation, but we thought, my wife and I thought that they should be left to make their own decision about whether to get tested.
 
So they’ve not had tests so far.  
One of the main reasons for carrying out trials is so researchers can find out about side effects and measure how serious they are. If you take part you will be monitored carefully. You will have regular tests and may be asked questions about how you feel. (See also ‘Appointments, monitoring and questionnaires’). Many people mentioned the Phase 1 trial at a commercial research unit based at Northwick Park Hospital in 2006 when 6 healthy volunteers became extremely ill. A copy of the Inquiry Report of this incident can be downloaded from the National Archives (Expert Group on Phase One Clinical Trials: Final report).
 
Even though this was a different kind of trial to those experienced by the people we talked to, it had caused them to reflect on the balance of possible risks and benefits. However, most people felt they had been cared for very safely.
 

Every trial has some risk, but medical research is carefully regulated to protect patient safety,...

Every trial has some risk, but medical research is carefully regulated to protect patient safety,...

Age at interview: 41
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
And that’s the other, that’s the other issue as well, is that the issues that happened at Northwick Park* are rare. And every trial has a risk, we know that, of course we do. But, you know, the chance of that happening is quite low, not because the drugs aren’t necessarily seen as safe at that stage, but because the safety precautions are much more rigorous. We’ve now got, you know, the Research Governance Framework, which is, I think, become much more rigorous in time. And also the, the way research and consent is carried out is much, much better. The clinical standards have improved, as have the standards in things like clinical practice in research, which have been revised and, I think, and are continually being scrutinised. I know some researchers see it also as a, as a bar to research, all this unnecessary paperwork and regulations and stuff. But at the end of the day, it’s patient safety that’s important. And it’s important that the public are aware that, you know, that there’s, you know, a shed load of policies out there to help them keep, to help the safety be maintained. And that traditionally research, you know, was seen as higher risk many years ago, as they had less effective monitoring. I think today with the increase of information technology, with the increase of, you know, testing facilities - we’ve got very advanced now screening facilities, it’s much, much better. So I think that makes it safer. And also the public are aware that, that research isn’t just about, you know, rare cancers or something, but that it is about very day-to-day stuff. Like, you know, it might be looking at a, at a cholesterol-lowering drug, or it might be looking at ways of managing stress using a computer programme.
 
FOOTNOTE' Fenella is referring to an incident in 2006 when healthy volunteers in a phase 1 trial at a commercial research unit based at Northwick Park Hospital became extremely ill. A copy of the Inquiry Report of this incident can be downloaded from the Department of Health website.
 
 

There was a small risk from the injections of anaphylactic shock, but there were safety...

Text only
Read below

There was a small risk from the injections of anaphylactic shock, but there were safety...

Age at interview: 38
Sex: Female
HIDE TEXT
PRINT TRANSCRIPT
The main thing with the trial was that we were getting injected with grass pollen or a placebo. So we were randomised to either get the injection with the grass pollen, or get just an injection of nothing, really. And we didn’t know, and the nurse who was running the trial, he didn’t know either. And he had some assistants as well. And so no one knew whether we were on the grass pollen or on the placebo. We had to stay in the hospital for an hour after the administration of the injection, because they explained to us from the outset that one of the possible side effects, of an injection of something you’re allergic to, is that you go into anaphylactic shock [laugh]. And so they had a doctor always on site and stores of adrenalin. It was a precautionary measure but a quite interesting thought. But it was nice to know that they’d put that level of thought and care into it. And obviously it was part of them getting permission to do the study. So we would go in, we’d get gradually increasing levels of the grass pollen injected throughout the spring. So at the beginning you noticed very little local reaction from the injection, but as you got closer to your maximum strength of the dosage, towards May, I noticed certainly a local reaction, a swelling on my arm. And we were asked to monitor any reaction and tell them, like measure the size of the reaction, the lump that appeared, how itchy it was. So we’d feed that back to them. And throughout this whole period, and then throughout the entire summer, we kept a daily diary of our symptoms. But we didn’t have to go into the hospital during the summer months. So that made it a little easier and less of a time commitment. And we would pop into the hospital I think probably twice over the summer to drop diaries off and pick up new diaries, and so the nurse could discuss with us any issues we were having with the diaries.
Iain Chalmers, one of the authors of the book 'Testing Treatments' (a web resource is available at www.testingtreatments.org), points out that side effects of treatment are a feature of medical care generally, and well-designed trials can in fact reduce unnecessary side effects for future patients.
 

Treatment for prostate cancer can have unpleasant side effects. Because the best way of treating...

Treatment for prostate cancer can have unpleasant side effects. Because the best way of treating...

Age at interview: 62
Sex: Male
SHOW TEXT VERSION
PRINT TRANSCRIPT
Would you like to go back to prostate cancer, what is the evidence at the moment about treatments?
 
Well one of the reasons that there is uncertainty is that prostate cancer is quite common, far more common than people realise, but it doesn’t kill people. In other words, you can die with prostate cancer but not of prostate cancer. So it’s quite important, given that fact, that one is very clear about the quality of the evidence upon which you intervene early with some of the quite radical things which people are intervening with. For example radical prostatectomy, quite a major operation, to remove a prostate with some cancer in it, has side effects. It can cause incontinence, men can become impotent as a consequence of it and then of course it has the risks associated with any large operation, those associated with the anaesthesia or bleeding and so on.
 
And then there is treatment given with radiotherapy as an alternative to that. There again there are problems which can be associated with the radiotherapy, so some people say, even when they know there is cancer there, well actually let’s just watch the situation and if it does seem to be deteriorating fast only then intervene with one of these more radical treatments. And that uncertainty is currently reflected in the fact that men are participating in this country in a very big controlled trial comparing those three different options, the radical surgery, the radical radiotherapy and active monitoring of the situation. And as a result of that study and other similar studies, although I think the British one is probably the biggest and the best, people like me are going to be in a far better position to take an informed decision if we find ourselves in the circumstances where we do have an early prostate cancer diagnosed. And indeed, if I went to my doctor with symptoms and it did lead to a diagnosis, I think I would want to be invited to participate in that controlled trial. It’s a way of hedging my bets because we don’t know which is best, but also helping to produce the information that will make decision making in future by people in my position more informed than it would otherwise have been. 
 

Joanna argues for more public debate about the trade-offs between side effects and gains in...

Joanna argues for more public debate about the trade-offs between side effects and gains in...

Age at interview: 63
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
Again I think these are the sorts of things that need to come up in the public debate. But a QALY, you know, a quality of life, year life, or whatever it is, and what the measure is for the benefit that you might get from a particular drug seems to me extremely wide-ranging in its, one’s understanding of what it might be about. Because when I’ve looked at some results of trials, and thought about what the papers have said, even if you get a sort of eight-week improvement in the length of life that counts as a terrifically good outcome. And yet that might be at huge physical trauma for the patient. And I’m not sure whether that’s understood when people are saying, you know, the drug is beneficial.
 
I’m not even sure whether you have to go through that stage in order to get something that will give you eight weeks of good life. You know, whether you have to go through eight weeks of something, before you can get to a point where you’ve worked out what will give somebody eight weeks of beneficial life, or whether you can even say to someone, “Well, it might give you an extra three or four weeks” and they might say, “Well, that’s what I want, because my daughter’s going to have a baby” you know. I don’t know. I don’t think these things are clearly enough described for the public to understand what the issues are. And so, you know, when you look at the situation for Alzheimer’s and whether or not a relatively expensive drug, from the sound of it, could make a big difference to the rate of decline in Alzheimer’s, and you think about how long people have to live with Alzheimer’s, because they’re not necessarily going to die of ill health, one feels that that benefit may be much, much more important than the few extra weeks you can give to someone who’s extremely ill with something that’s definitely going to kill them fairly soon. And I think those sorts of discussions are what’s really needed in order to help us prioritise how our Health Service money should go.
 
And that doesn’t mean that I feel that the trials that have been done in leukaemia and obviously helped [husband] - they gave him ten extra years of life, after all, which otherwise he would definitely not have had. So those trials which may have been pretty dramatic and appalling in the early days have led to something that is clearly worth pursuing at a later, you know, in their later development. But I don’t think enough of the, if you like, the longitudinal life history of medical events is, is understood. And I think that you need that if you’re going to understand whether or not to push or encourage or entice more people into trials and of what sort.
 
Yeah, and the side effects issue as well.
 
Yeah, yeah.
 
Because it sounded like this had some quite unpleasant --.
 
Yes, it was an unpleasant treatment, because it was two huge subcutaneous injections every day for seven days, which in themselves were painful and produced painful results, and were sore for another week or so. But also a lot of people felt very, very tired and, and dragged down for the next week. So for two weeks you were having, you know, two bad weeks, two good weeks. Well, I think for a lot of people that’s worthwhile. In fact, I think, you know, compared to the leukaemia treatment, a doddle, you know, nothing like as bad. But that’s, you know, still something that you have to explore, for each individual, and across an average. I mean my husband was jolly lucky not to have all the awful side effects from the leukaemia treatment of serious soreness and sickness. He had a bit, but some people were appallingly badly affected by that. But nonetheless if that then gives them, you know, either the rest of their lives or another five or six years relatively healthy, that’s one sort of outcome. But I don’t know that that was the case when they first started trying these very tough drugs on people. I suspect it wasn’t. But as a result of all of that work, childhood leukaemia is completely different. You know, the prognosis for that is dramatically changed, and even for adults it’s a lot better.
It is important to report any side effects promptly, as this tells the researchers something important about treatments being tested. They may be able to help manage the side effects, or advise you whether you should stop taking part. Withdrawing from a trial because of side effects is entirely reasonable and no-one should feel they have to stay in for the sake of the trial or that they have failed if they stop. (See also ‘Thinking about withdrawing from a trial’).
 

After the dose of the drug was increased, Harry had bad side effects. He almost gave up, but the...

After the dose of the drug was increased, Harry had bad side effects. He almost gave up, but the...

Age at interview: 83
Sex: Male
SHOW TEXT VERSION
PRINT TRANSCRIPT
My first experience was slightly, a slight disaster. Well, what happened was that they took my blood pressure and it was over 200, so I was in the right place. They then gave me a medication, 50mg of atenotol [atenolol] I think it was. And that was all right. And then after two or three weeks, after I’d been up there two or three times, they put me onto 100. And I woke up one morning, I thought I was having a stroke, like bands of steel round your chest, I couldn’t breathe. I thought, “Well, this is how people feel when they’re going to die” you know. So I got up and I pottered about and I thought, “Well, I’ll tidy the place up”, you know. I like to if somebody comes in. And I couldn’t think what to do. And I sat by the street door in a chair, because I thought, “Well, if I fall off the chair, somebody will see that I’m not very well.” Anyway after about half an hour it went, disappeared. So I thought, “Well, that’s, that is, that’s useful.” So I phoned ASCOT and told them about it and she said would I come up right away? So I went up there. And he, I didn’t see the same doctor that had gave me the pills, but he had a look and he said, “Well, I see you had been on 50. You went onto 100 and then you had the trouble?” And I said, “Yes.” He said, “Well, I’ll put you back on 50”, which seemed reasonable at the time. Except that once you’ve been primed with 100 and you went back to anything below it, you got 50 per cent of the reaction that you did with 100. So I, I got the same thing back again. But I thought, so I don’t know if they were a lot of apprentices up there, but they should have known about that. They should, it wasn’t a new drug, it was an old drug - unless he was trying to do something for his statistics. And I was so annoyed about it, I never went back. I thought they should have known about that. That is something I thought they should have known about. I couldn’t expect them to know that it would affect me adversely, because I’d never taken it. But once I had taken it and the pattern begin to emerge I thought he would have said. I saw it, and I don’t know nothing about medicine. Anyway I never went back.
 
Then I got a phone call. I think it was from [doctor] enquiring why I hadn’t turned up. So I explained to him what I’ve just explained. And I just had no choice other to explain it completely. No watchwords. Just tell it exactly how it happened. I said, “And quite frankly” I said, “I was a little bit alarmed about it.” I said, “Because if you look at it, I’ve come to see you quite well and finished up in a sort of personal disaster.” Anyway he explained it to me. Over an hour he was on the phone. And I was determined not to go back. But he was so, he was like he was treating me like I was somebody rare. So I thought, “Well, I must honour his concern for my welfare.” So I went back again. And he put me on another medication, that I took right the way through all the years I was in there. And it worked. So I was glad I went back. So the important thing with this is that if you go on one of these long projects, these clinical trials, don’t be discouraged if something goes wrong. Because it’s the overall picture that counts.
 
FOOTNOTE' It is important to report any side effects promptly, as this tells the researchers something important. They may be able to help manage the side effects, or advise you whether you should stop taking part. Withdrawing from a trial because of side effects is entirely reasonable and no-one should feel they have to stay in for the sake of the trial or that they have failed if they stop.
 

Trials are designed to find out things that don’t work. Doctors are there to help, and if you...

Trials are designed to find out things that don’t work. Doctors are there to help, and if you...

Age at interview: 83
Sex: Male
SHOW TEXT VERSION
PRINT TRANSCRIPT
And so apart from that, there weren’t any times when you thought, “I’ve had enough of this. I want to stop”?
 
No, no. Because by then I was beginning to understand that this is a project, and it’s designed to find out things that don’t work. When the things don’t work, stay there and get them straightened out. Don’t do a runner. You know what I mean? That’s, and of course that’s a, I’m, I was beginning to learn that, so that when I got a bit, all I did was I went back and told them, you see.
 
[Laughs] Are there other things that you’d want to say to anybody else thinking about whether to take part in a trial?
 
Well, it’s diff-, see, it’s very difficult to say. A lot depends on what kind of trial it is. A lot depends on, there are some trials which you - the pain’s so excruciating, so that any trial, any effort, they will take it. “Stop and think, that’s all you’ve got to do.” Stop and think, stop and think. Apart from very, very rarely, the people in the medical profession are there because they want to help you and if, you’ve just got to give them the opportunity to do that, you see. But as I say you’ve got to, you’ve got to use your – it depends, as I say, sometimes I look back on it and I think, “How could I have been so silly, not wanting to go up there no more because the tablet didn’t, the tablet didn’t work?” I should have known better than that [laughs]. You know what I mean? Because I think basically people are frightened of going to the doctor, they’re a little bit nervous. They leave it and leave it and leave it.
Harry was able to stay in the trial with a change of medication, and others also said they were determined to keep going.
 

Angela had some distressing side effects. She told staff but kept going because she had made a...

Angela had some distressing side effects. She told staff but kept going because she had made a...

Age at interview: 59
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
And having been diagnosed, the first clinic that I went to, the first visit to the neurosurgeon was, he asked me if I’d like to do a drug entry trial which was being run from Birmingham. They’re trying to find out about - there are four commonly prescribed drugs on entry when you’ve, it’s been discovered you’ve got Parkinson’s diagnosed.
 
He rattled off the names of the four, which didn’t really mean a lot to me, except Sinemet which I’d known somebody who’d had a really bad experience with. And so I said, “Okay, what’s involved?” And he told me. He said, ‘Well, you know, we, I would prescribe something normally, you won’t know, but in this case if you’re in the trial, I’ll phone Birmingham and they will randomly allocate you a drug which you then have to agree to take for--” I think it was it was either a week or a month, I think it was only a week. “--as a minimum. You must keep taking it.” And my husband was also involved. We fill in - there’s a follow up, so that we fill in questionnaires every six months, me from my perspective and [husband] from his as carer.
 
We did, and they phoned Birmingham and I got put on Sinemet. Oh, and it was absolutely awful. I really thought I was dying. It gave me very low blood pressure, so that when I stood up I fainted or fell back down. I had lots of falls on the stairs, disorientated, slurred speech, probably like somebody totally inebriated, as you’d say, legless. And I frightened a lot of people because my, my mother, who’s dead now, but I went to her place and sat down on the sofa and of course I went to get up and I just passed out. So it wasn’t just me, it was very frightening for everybody else. However, we stuck it for the minimum, phoned and told them straight away, you know, that it was a problem. And I took it for the minimum, which I think was a week, and then went back and got changed to ropinirole, which I’m still taking now.
 
But I’d had, I think it was explained very clearly what was wanted, and obviously one hopes to get whatever it is that’s going to be the most effective. But if you’re going into a trial you can’t, you’ve got to accept the fact that you have what you’re given, you know. I mean, otherwise there wouldn’t be any point in having trials, and I am very keen on trials.
 
And when you were getting those side effects, which sounded really quite unpleasant, did you think about pulling out at that point?
 
Yes, but I knew that there wouldn’t be any point doing it if I did, so I carried on, yeah. Yes, if [laughs] it’d had been a free - [laughs] if I wasn’t in the trial - well, I wouldn’t have been on it anyway - but if it wasn’t for the trial, then I would have come off it sooner, but when you’ve made a commitment, you’ve got to honour it. I mean, you know, it’s not very comfortable, but there wouldn’t be any point in doing it, would there?
 
Had they told you could pull out if you wanted to?
 
Oh yes, yeah.
 
Yeah.
 
Yeah.
 
So it was a kind of sense of duty to them and to research and--?
 
Yes. Mm.
 
Mm, mm.
 
Yeah, it wasn’t pleasant but there was an end coming to it, wasn’t there? So, you know, it’s [laughs] you’ve got to be prepared to do these things, haven’t you, otherwise we’re not going to make any progress,
However, some people stopped, or took a break. Joanna’s husband was advised he could not continue in a trial of chemotherapy for leukaemia. She explained, “The treatment made him far too ill for them to be able to give him another treatment… Each time, when he was without immune resistance, his lung function got worse and worse and he got infected lungs. And by the time he had the last treatment…they said he couldn’t have another one. They wouldn’t risk it.”
 
Pam had serious side effects when taking part in an open-label expanded access study, and was advised to stop taking the drug for two weeks to give her a chance to recover from them.
 

Pam has breast cancer which spread to her bones and liver. Taking a trial drug seemed‘a lifeline’...

Pam has breast cancer which spread to her bones and liver. Taking a trial drug seemed‘a lifeline’...

Age at interview: 70
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
Then I stayed on herceptin after the taxol regime had finished, and I was scanned, and the scans seemed to be showing things were stable, and this lasted for a year. And then suddenly, yet returning from the Edinburgh Festival once again, I was told that the tumour in liver had doubled in size. That was very dramatic, although on paper it doesn’t look that dramatic because it had gone down to 1.3 cm and it only went up to 2.7 cm, which of course was much less than the original, but it was still awful. And the oncologist said to me, “You wouldn’t have felt anything, you wouldn’t have known any difference, but we recommend that you go onto this trial drug.”
 
That at that point seemed to be the only option at the time*, and she left it entirely to me, and other people like my husband, to discuss whether or not I should go on the trial drug. Well, what would you do if you were handed a lifeline? It would have been very foolish, I think, to have refused that, and I felt very privileged to be able to go through it.
 
The first session - it’s tablets, which means that you don’t get a three-hour infusion, so in a way that’s better, but they have to work out the amount of tablets you should have depending on your weight and all sorts of things, and at the very beginning it’s experimental. Well, the first three weeks were pretty dire. At the end of the third week two of my toenails had come off and that was extremely painful. If it’s not losing your hair, losing your toenails is not a particularly viable option, but that was really very nasty. I had lots of horrid diarrhoea, which was copeable with because I had tablets for that, but it was not much fun, and in fact I was taken off the tablets and everything for two weeks while my body had a chance to recover, because it can be cumulative, and then the side effects can be worse in the end, and so it’s not worth it.
 
Anyway, we settled down to a happy regime, and the tablets have been varied, depending on my weight and how I’ve been reacting. Fortunately, the first scan after the first two sets of treatments showed that the cancer in the liver had reduced back to where it had started, in fact it went down to somewhat smaller - 1.2 cm - so that was very encouraging, so I forgot about the rotten old toenails. And then the next scan, which took place after two more treatments, showed that my condition was stable even though it had gone up by 1 mm they still reckoned that was stable, and happily it’s been stable ever since.
 
*FOOTNOTE' At the time Pam agreed to take part, the drug was only available as part of this study.
While most people felt the researchers responded carefully and quickly to any worries about side effects, a few people felt they had not met with such a good response. Elizabeth decided not to take part in a trial of chemotherapy for ovarian cancer. (See ‘Deciding not to take part in a trial’).
 

When she told the consultant her decision, he seemed angry, which made her feel vulnerable and...

When she told the consultant her decision, he seemed angry, which made her feel vulnerable and...

Age at interview: 53
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
So I went back in three weeks time. I was very, very nervous because we’d all come to a decision that it really, I didn’t feel it was appropriate for me to go on the trial. And they were – well, the consultant was quite cross with me that I’d decided not to go on the trial. The registrar I was seeing was very supportive, understood completely why I’d chosen not to go on the trial but [pause] the consultant was cross and said it was only because I was didn’t want to lose my hair, couldn’t understand why I didn’t want to take part, and I felt very, very vulnerable and very upset.
 
And it made me think that there was another side to trials, that maybe, you know, consultants wanted to get something out of it for themselves. And if it hadn’t been for the very supportive registrar I would have been very upset. It was nerve-wracking enough going up to the hospital anyway to discuss this sort of thing, but then to be met with this, this anger that I wasn’t taking part in the trial. And I understand that people do need to take part in trials, that it is important that they get results, but I didn’t think that my particular situation was particularly going to be beneficial in this trial because I didn’t feel I was a normal person - well, an average person with ovarian cancer. Most people with ovarian cancer unfortunately are diagnosed at quite a late stage, which I wasn’t, and if they were going to do a trial about this, I didn’t fit into an average ovarian cancer patient. Neither was I an average ovarian cancer patient age. But it was very hard to deal with somebody being cross with you that you’re not taking part in a trial. And I understood that I could have opted out at any stage, but it left a bit of a difficult mark on me, really.
 
Did it ever cross your mind to say yes, wait and see what you were randomised to, and then if you were randomised to the arm you weren’t happy with, to drop out?
 
Yes, it did, it did [laughs]. But I still felt that actually that, that would make people angry as well, and that even, however many times you read the bit that says that your care won’t be compromised, you still have something at the back of your mind that if you opt out of something or if you change your treatment or whatever, there is going to be, somewhere along the line, an element of somebody may be thinking, “Oh well, she opted out of the trial”, that your care might be compromised in some way.
 

It’s important to tell people about trials, but she wonders if clinicians always appreciate the...

It’s important to tell people about trials, but she wonders if clinicians always appreciate the...

Age at interview: 53
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
I think it’s very difficult, because you have got to have trials, you have got to have something to prove that something works before it becomes licensed, and I think that that’s important. But I don’t think there’s always quite the understanding of the implications of taking part in a trial, and going through what people go through, and experiencing what may seem to a clinician’s point of view a minimal side effect, may not be minimal at all, you know. It may be something that makes a huge difference between somebody going back to work and somebody not going back to work, and all the financial implications that that involves.
 
What do you think could be done better to improve clinicians’ awareness of that, the patient perspective?
 
…I don’t know, apart from them going through the experience themselves [laughs]. Somebody was saying to me, I was discussing with somebody about something the other day, and I almost felt irritated because I could see that he had no idea what it was like to be in that situation at all, and he was saying, “Of course you’d do this, and of course you’d do that”, and I thought, “You don’t know, because if you’d been in that situation, if you’d just been through major surgery, you’ve just had six months chemotherapy, you wouldn’t necessarily come to that conclusion.” …it’s difficult because people want to be told about these things, and they want that opportunity to help. I think it’s very difficult to change it because you’ve got to press it a bit, really, for people to take on board and if people don’t take part in these trials, then you’re never going to get any results. 
 

She was told she wouldn’t be paid, but any drugs she needed to manage side effects would be...

She was told she wouldn’t be paid, but any drugs she needed to manage side effects would be...

Age at interview: 51
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
They said that I wouldn’t get paid for going in the trial, there was no financial gain, and now I come to mention it they were going to let me know of the outcome of it, I will get told about the outcome of the trial, but it won’t be for over five years. There was no financial gain, I’d get access to the final results in five years’ time, and any medicines that I needed relative to the treatment they would provide me with. However, when I got certain side effects, I had to go to my GP about the mouth ulcers and whatever, I was prescribed things by the doctor, rang the hospital and said, “How do I go about getting these without having to pay for them?” They said, “Ooh, no, you have to pay for them.” And I thought, “Well.” So they must have meant the traditional sickness and diarrhoea, but I was also told you would get these, you could get mouth ulcers, which I got. And I had to go through my GP and get [door bell chimes] prescribed drugs and pay for those. So that was a bit of a, that was a naughty one. Because that, when you’re earning no money at all, and it’s over six pounds something a go, was a lot of money.
Some people said they felt they were not being listened to, or that staff were not very interested in what they were reporting.
 

Rose wonders if she saw a doctor less often because she was in a trial. The nurse dealt with side...

Rose wonders if she saw a doctor less often because she was in a trial. The nurse dealt with side...

Age at interview: 68
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
I had the radium, thirty six doses of radium. I was told the side effects to expect and got them, but not as bad as - I suppose I was fortunate I didn’t get them as bad as obviously some people get them. Because of course you, your oesophagus is, it’s quite difficult to eat. But then I think it’s also the person. I have a high pain tolerance. I knew I had to eat to stay healthy, so I therefore I would persevere, whereas I think a lot of people would probably not because it hurt. I felt the after care, I wondered whether because I was on the INCH trial - I don’t know what happens with other patients who are not on a trial - but I felt the, I always saw the research nurse who asked, it was always the same questions, I saw her every month. And I wondered whether I would have seen a doctor more often. Because sometimes if I had a problem that would probably be minor, minor problem, she would say, “I’ll just pop off and see if the doctor needs to see you.” And then would come back and, “Oh, that’s the radium causing that,” she’d say, the doctor’s nurse. But, you know, and I felt sometimes had, had I gone on a trial - and in some ways sometimes regretted it a little - that because I was seeing a professional nurse that would I have been seeing a doctor every month? Do you do you understand what I mean?
 
So you mean if you hadn’t been on the trial?
 
Uh-huh.
 
You think you might have seen a doctor more often?
 
Uh-huh. I, you know, it kind of, I was relaying to her how I felt, she was going out of the room and going to another room and mentioned to the doctor, “Rose, you know, says she’s still having a bit of a problem with eating.” “Oh well, that’s the radium.”
 
And also I think that my profession went against me. Somebody said to me once, “It’s so nice talking to you, because I feel as if, well, you know it all so I don’t have to explain all the time.” You see? And so therefore when you did need an explanation, it is not within my nature to not really say anything. So I would ask for an explanation, but in my own head I was thinking, “She’s, she’s going to think I’m stupid,” - but I really felt, “Did I not get all of the attention?” And yet I have no doubt that’s in my own head.
 

Danny stopped taking the trial tablets when she developed side effects, as she thought might...

Text only
Read below

Danny stopped taking the trial tablets when she developed side effects, as she thought might...

Age at interview: 61
Sex: Female
HIDE TEXT
PRINT TRANSCRIPT
Anyway, we were given stuff to read. Now I’d had an adverse reaction to a blood pressure tablet, and I can’t remember which one it was, but one of the doctors decided to put me on two, at my GP’s surgery, and I started to get a dry cough. And I realised that it had to be that. And I read - I was away in France - I read the leaflets and it said, “Dry cough”, so I stopped taking them. Now when I - my husband and myself both embarked on the trial, but he was discarded because his blood pressure wasn’t bad enough, which was really good news for him, and testament, really, to the way he looked after himself because of the previous trials. And I told them that if I got this cough - they explained to me that I would have no medication for two weeks, and I would be on a placebo, and then after two weeks I would come back and they would put me on a placebo or the medication they were trialling. That’s the best I can describe it.
 
And I told them that if I got this cough I would stop, because it was hopeless and it just got worse and worse and worse. It was terrible. So they understood that, and they said that that was fine. So basically if I hadn’t got the cough then I’d have known that I was on the placebo.
 
So after a few days I started coughing, and it built up and it built up. And I decided it was the tablets and that I couldn’t take them any more, that I was not on the placebo, I was on the other one. And so immediately - I was told I was keeping other people awake. I was coughing all night. I know I was up numerous times a night because of it. So after about a fortnight I decided that was that, that it was the tablets and I wasn’t taking them, and I had made them aware of that.
 
Anyway, again, she didn’t use the word ‘excluded’ like I’d been naughty but it was basically, “Well I’d have to go, wouldn’t I? I was no good to them”, which I suppose is what the exclusion thing is about, “You’re no good to us,” [laughs]. Rather than, “Thanks for trying. You’ve had a different experience, and maybe there might be five per cent of you that have this experience.” Because I can’t be the only one that ended up with that cough having to come off it.  
 

Danny noticed there seemed to be a pattern that the side effect of coughing happened when she...

Text only
Read below

Danny noticed there seemed to be a pattern that the side effect of coughing happened when she...

Age at interview: 61
Sex: Female
HIDE TEXT
PRINT TRANSCRIPT
I had noticed that the coughing at night would also start about three hours or four hours after I’d eaten. And likewise it was like that at night. It would start about two in the morning, go on, get worse and worse. But on thinking about it at the time, I also realised that I’d start coughing around noon, and get something to eat, and the coughing stopped. I wasn’t aware of it until I started to think about it. And then it would start again about four in the afternoon, and I’d have some fruit, perhaps a coffee or a cold beer or something, and it would stop. And then that period would usually run up to a shorter period where I’d a meal. So, and that meal seemed to give me cover until about midnight. That that’s how I viewed it, and I thought it was very interesting, because I thought it was something to do with digestion, or associations with hunger. And I thought it was quite significant, actually, highly significant.
 
Anyway, [laughs] so when I went back to the research place, there was the woman who was not the more pleasant of the two, and I said that I’d stopped taking the tablets and that I’d notified them that I would, should this cough occur, and it had occurred.
 
So I tried to tell her about this business with mealtimes, and she really wasn’t interested, so obviously that wasn’t in her remit, which I just think why not? You know, like, don’t they talk to each other?
Leslie’s experience was particularly bad, and he remains very angry that his gastro-intestinal symptoms were not taken seriously for so long, even though the trial information sheet said there was a 1 in 10,000 risk of ulcers and bleeding in the gut.
 

During the trial, Leslie became more and more ill, but the trial staff didn't seem to connect his...

Text only
Read below

During the trial, Leslie became more and more ill, but the trial staff didn't seem to connect his...

Age at interview: 75
Sex: Male
HIDE TEXT
PRINT TRANSCRIPT
I was on a clinical drug trial sponsored by one of the world’s major drug companies and I was being supervised by a supposedly competent GP. As the weeks passed by, January, February, March... I became increasingly unwell. I was being allowed to die and nothing was being done to stop my illness. I felt that I was on an accelerating path to death, unable to convince the supervisor how ill I was, whilst my wife could only look on whilst, inch by inch, I grew more ill and despondent. I should have taken myself to hospital, I now realise this, but I still put my faith in my doctor. 
 
In spite of having very severe bloody diarrhoea for several weeks and in spite of the supervisor noting ‘GI [gastrointestinal] bleed?’, no action was taken. Such diarrhoea may presage bowel cancer and should result in an urgent hospital referral. This basic medical procedure was ignored. By May I had become anally incontinent with foul-smelling faeces. I was virtually housebound and unable to eat anything more than an occasional egg. My wife was distraught' she was watching me die, slowly but inexorably. We were convinced that the tablets were the cause of my illness. Our view was ignored. What did we know? Who were we to tell the doctor what we thought? 
 
The trial information sheet notes that ulcers and bleeding in the gut was a rare (1 in 10,000) side effect of rofecoxib. It seemed that neither the GP nor the trial doctor saw me as that 1 in 10,000. For a couple of days mid-May I stopped taking the tablets but I was advised to restart. The trial doctor did, however, take a stool sample. Two days later he prescribed codeine phosphate — a standard drug for diarrhoea, I understand. The stool sample showed ‘normal’ and ‘no action’ was taken. So, to put it bluntly, he seemed to be seeking for some reason to explain my bloody diarrhoea but was happy to accept the results of the stool test. He took no further action. He had seen me, spoken to me, had a perfunctory poke in my stomach area. He had the result of the test and that was as far as he would go. I was still anally incontinent; I was still losing weight; I was still desperately ill — but ‘no action’.
 
At the beginning of June we entered the grand finale — I needed help, urgently. I could not contact my GP on Friday, the 4th of June, and I had to wait an agonising 2½ days before I was able to speak to her. I had no other contacts, no one else to turn to. I did not even have any indication that I was on a drug trial. I learned, too late, that these are a legal requirement. So, on the 7th of June I did contact the doctor. What follows may seem to be unbelievable' it is true. I told her that I felt much worse; that the diarrhoea still persisted up to a dozen times a day; that I was unable to eat — please, please, help me. She said that she would prescribe Fybogel granules — this is an over-the-counter remedy which I had tried many weeks before. She then, incredibly, suggested that I drink a bottle of Guinness. ‘Guinness is good for you’, so went the old advertisement. Not for me it wasn’t. But we were desperate, clutching at any straw. My wife rushed out to buy a bottle; I drank it. We later thought about this. What on earth was a responsible GP doing when she prescribed strong stout to someone suffering a very severe stomach condition? And what on earth was I doing to actually drink it? But we were doing what the doctor ordered, like good trusting patients. Blood test results that showed ten readings well out of acceptable limits were ignored and I was asked to return to the surgery in a fortnight to have a further test.  I would, I am convinced, have been dead before then.  

Anyone taking part in a drug trial should also be told about other drugs or other substances, such as food or herbal remedies, which may interact with the trial drug and cause harmful side effects.
 

Pam was told grapefruit, evening primrose oil and antibiotics can interact with the trial drug ...

Pam was told grapefruit, evening primrose oil and antibiotics can interact with the trial drug ...

Age at interview: 70
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
Those side effects have been quite severe. Have there ever been any times when you’ve felt like stopping taking the drugs?
 
At the very beginning. When my toenails fell off, my local GP thought that I had an infection in my foot and she gave me some antibiotics. When I was put on this trial I was given a list by the oncology nurse of exactly what I could have and what I couldn’t have. For example, I’m not allowed grapefruit* - don’t ask me why - or grapefruit juice, or evening primrose oil, and various antibiotics, and we had to go carefully through and make sure I didn’t have this. But this particular antibiotic plus I don’t know what else that I was taking at the time gave me the most awful stomach cramps, and yes, then I just really just did want to curl up in a little hole and just disappear off this earth, and that was really awful. That was the worst time. I call my little booklet Ruth, because in the Bible, in the story of Ruth, she says to her mother-in-law, “Whither thou goest, I will go.” And that’s what happens to my booklet. Everywhere I move, I don’t go anywhere without my little booklet, because suppose I were to have some sort of accident when I’m out? Then the hospital, or wherever I go and see the first aid department, must know exactly what they’re allowed to give me and what they’re not, so it’s really important that I carry that with me. So that’s yet another thing to think about.
 
What made you stick with it in the end?
 
The alternative, as my husband keeps saying, is not really to be countenanced, and truthfully while I still think that there’s some “need” for me [gestures inverted commas] - I mean, I’ve got three gorgeous grandchildren and one on the way - and I’m conceited enough to think that there might be some people that might be sorry if I wasn’t around, I’m going to plod on. Also I, I tend to fight and I won’t take no for an answer, and that’s about it really.
 
*FOOTNOTE' Grapefruit can increase the amount of the drug lapatinib which is absorbed by the body. 
 

Harry had two unexpected drug interactions when he started taking other drugs alongside the trial...

Harry had two unexpected drug interactions when he started taking other drugs alongside the trial...

Age at interview: 83
Sex: Male
SHOW TEXT VERSION
PRINT TRANSCRIPT
Were there ever any times when you thought about dropping out of the trial?
 
Only at the beginning, only at the beginning. See, I had no idea, I’ve been very lucky really. I’ve had some operations. I got into a bit of trouble during the war, but I come out of that all right. So I really had no expectations at all - or my expectations were very naive, that I’d go up there, they’d give me the pills and I’d live for another fifty years, see. But it’s a little bit more complicated than that. And it’s only when you learn about it that, when it - now for example I got acid. And I went back to my doctor and told her, “I’m taking ever such a lot of acid tablets and nothing seems to be working.” So she put me on some medication. Right? And… I felt suicidal. You know, I actually felt suicidal. And I’m not the suicidal - because I like myself too much, you see. So I thought, “Well, I’d better go back and talk about this one.” So I went back and told her. So she sent me to hospital and I had an endoscopy, where they had a look down. And so, what - have I told you about this before, about, about the acid tablet, what they did?
 
No.
 
So she said, “It’s surprising.” I’ll, I’ll remember the name of the, of the tablet. “It’s surprising” she said. “These tablets they’ve not been noted for doing that.” “Well” I said, “I could, the best way I could guess it is to say that what’s happening is the acid varies and the medication doesn’t.” So if I’ve got a lot of acid and there’s a lot of tablets, it’ll get rid of it and I won’t get any problems. But if on the other hand I haven’t got very much acid, the strength of the tablets is constant and it’ll work on the acid, and when it’s gone it’ll work on all the other stomach, stomach fluids, the digestive fluids. And that is what could cause, be causing the problem. Anyway she put me on a lower tablet and it went away. I never had it any more.
 
So, then I started getting, I think I told you, started getting hallucinations, get a bit - and I was taking two tablets together. Right? So what I did, I separated. Now tonight I’ll take the statin drug at 5 o’clock and the other one I’ll take at 9.
 
And I took one a day for, I suppose I took one a day for years. Anyway, later on I was given another drug that had nothing to do with what I had. And I was taking them both in the morning. And there was something going on with the drug that – if you’re with a drug and you notice a pattern of behaviour and you try and make a note of it, you can note any change when it occurs. If you’re lucky. Right? Anyway, I thought, “This bendroflumethiazide, it’s a bit feeble. I wonder what’s going on?” And I never thought about it too much. Anyway, by that time I eventually ran out of the, of the drugs which they were providing, and I had to go on the same drug which I got from the chemist. Because when you get a drug from the chemist, there’s a leaflet in there telling you about the drug.
 
So I had a good look at the leaflet and it was speaking about, it spoke of another drug that if you have to take this drug, it’s best to leave it for two hours before you take this other, otherwise it appears to affect the efficiency of bendro-. And that’s what I did. I wasn’t taking that drug, but I used that as a criterion, “Leave a space of two hours.” And everything went back to normal again, you see. So
 
So that’s just a question of the information that you were given?

That was just, there was no information there from ASCOT*. Although it, I have to be fair. They may have said, “Are you taking any other drug?” And if I’d have said, “Yes”, then they might have told me, they might have. But I can’t remember if they did. But nevertheless it, it was the writing in the, [cough] what you get with it, alerted me to the fact that it was affecting the, the efficiency of the other tablet.

* ASCOT = Anglo-Scandinavian Cardiac Outcomes Trial
 
Sometimes trials which do not involve drugs can also involve side effects. Joanna took part in an ovarian cancer screening trial and found the internal scans were often uncomfortable, but it seemed to depend on the skill of the scanner. This seemed very important to her, so she was surprised this was information that the researchers did not collect. She was also made very anxious when she received an unexpected call to say she needed further tests. Again, she felt this was not well handled. The trial did include a questionnaire to measure people’s anxiety and emotional state, but Joanna felt the design of the questionnaire was flawed.
 

Joanna thought the questionnaire about feelings was badly designed. She tried to point out that...

Joanna thought the questionnaire about feelings was badly designed. She tried to point out that...

Age at interview: 63
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
And there were a number of features about the trial which I feel were less than brilliantly handled, which is in a way why I thought it was worth discussing it with you. It’s not that I thought the trial was badly set up. And it’s not that it was a silly thing to be doing, because I don’t actually have any knowledge at all about how sensible it is to do. But it’s not massively invasive, and it seems like anything that would be a sensible screening tool is a good thing to look for.
 
But I thought the questionnaire was both badly written and badly managed, inasmuch as it was cumbersome to fill in, long and tedious, and it had no way of distinguishing whether or not the mood impact that you were describing at the time had anything at all to do with the screening. And I wrote to the hospital who were managing it centrally, which is not the hospital I was going to, but another London hospital, and I tried to ask the team whether they would consider this particular issue as being a bit of a flaw. And I never even got an answer to that, which I thought was, well, which demonstrated to me that the whole study was being very, very badly managed.
 
I mean it was just about at the time when my husband had had a relapse and all my feelings were related to that. They were absolutely not related to anything to do with I was coming along for screening and might it be worrying me that, that the results might be positive, and I didn’t want to know. It had nothing to do with that. And at that point I thought, “Well, why am I wasting my time with these stupid people?”
 
But again, given a whole year before you’re called back, and you only go for, you know, an hour, in the end it’s a jolly low-level involvement. And I think, you know, time goes by and you sort of get more rational and you think, “Well, I’ll give it another go. If it’s bad this time, perhaps I’ll drop out then”, you know? It’s very low-level exposure to anything.
 
So the questions were things about your general mood and --
 
Yes.
 
-- anxiety?
 
Yes, yes, yes. And they were totally unconnected to the rest of your everyday life. They, I think the assumption was that somehow because you were filling it in at the moment when you were about to be screened or had just been screened - I think perhaps they sent it just before you went. I’m sorry to be so hazy about these things but, you know, once a year over six years and all finished a year ago, it’s probably a bit difficult to recall. But I think that they made a totally unwarranted assumption that it was, because it was delivered in association with the trial that somehow your responses would be associated with the trial. And there was absolutely no way at all that you could indicate that there was some other life event. I mean I wrote it all in, all over the thing [laughs], and I sent it off with a letter saying, “I think you ought to get in touch with me.” But I don’t, I’ve no knowledge about whether they would be able to take it in. I would doubt that they could take it into account, you see, because the way you set up questionnaire responses doesn’t allow for that.
 
I suppose the only thing would be that they would hope through randomisation that they would, the chance of having people who had something else going on in their life would be equal in all three groups.
 
No problem with that. But that doesn’t make it any better if you’re being asked a whole lot of questions that you think are irrelevant, I mean from the point of view of the recipient. From the point of view of the researcher, it may not be a problem. But then they still might have had the courtesy to write back and say, “Actually we randomise, and it doesn’t matter”, you know? Any of those things could have happened.
 

Joanna found the internal scans quite uncomfortable, and the way she was called back for further...

Joanna found the internal scans quite uncomfortable, and the way she was called back for further...

Age at interview: 63
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
And there was another thing that actually only came up at the very, very end, that I realised should have been being, information should have been being requested about it, which was the skill of the scanner. Because the very last person I had doing a scan was fantastic. She was really, really good. She had some very good techniques for making it possible to actually see the ovaries, even if like me you have a fair bit of gas and etc etc, one way and another.
 
Because a lot of other scanners had failed to find them easily, and then you have to do a lot of pressure to get rid of the obstructions so that they can see it and so on. It’s quite uncomfortable. She had some nifty techniques which didn’t involve any of that and which were really brilliant. She was slightly older than some of them, a bit more experienced, but I think she was just a better scanner. It would have been very, very sensible for them to ask about what was easy and difficult to experience during the scanning process, because they could have learnt something about how to train people better, which I thought was important.
 
The other thing that, that occurred to me on two occasions, which I don’t know how often it’s occurred to anyone else, but was disruptive and again rather badly managed, was on two occasions they found something that they wanted to investigate further. They said, you know, “You’ve got to come back for another scan. We’ve seen something.” Now in both cases it was a cyst rather than anything else. But on one occasion, I had a phone number I was supposed to ring to deal with the appointment to come back and I rang up. And I was on a bus actually, it was a bus to Oxford, and the young nurse at the other end said, “Oh, yes, you’re being called back. You’ve got to have an operation.”
 
And I was absolutely horrified, because that had never entered anybody’s description of what might be going to be a problem. And she clearly was again very badly trained. But there was no way for me to tell anyone that these sorts of things were going wrong. And by then I’d already tried sending off my letter and had the experience of not being listened to. And I felt all of that was actually pretty low grade for a trial that’s dealing with 200,000 women. So if even a small percentage of them are having my experience, it’s a hell of a lot of women who are being treated a bit cavalierly one way and another, which I don’t actually think is acceptable. So I would have liked to have been in a position to help people to get it better, because I wasn’t trying to say they shouldn’t do it. I was just trying to say, you know, “I have a fair bit of experience with questionnaires. I’m a perfectly rational person. I can understand what things might be helpful to improve a situation.” Nobody wants to know - which I didn’t think was in the spirit of research.
 
 
 
Merilyn was in a trial of different types of heart bypass surgery. She has since had a lot of pain, and has had psychological problems related to the size of her scar. She has a very good relationship with the research nurse, but she has found it difficult to get advice about the pain and whether it is related to the way the operation was done.
 

Since the bypass surgery she has had pain for several years. She wonders whether it was because...

Since the bypass surgery she has had pain for several years. She wonders whether it was because...

Age at interview: 57
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
Where there any different side effects, as far as you’re aware, from having it done one way rather than the other, I mean apart from the scarring, obviously?
 
I’m not sure. I had quite a few problems, even now four years on. My, the skin around my, my scar is very, very sensitive, extremely sensitive, in fact I have to take painkillers for it, and this is four years on. Whether or not that’s because that’s the way I had the operation, I don’t know. I had a lot of problems earlier on with it. The, it was so sensitive, very, very sensitive. I couldn’t wear clothes like I’ve got on now anything that touched my skin, it was just, it was horrible. It wasn’t a pain, it was just sensitive, I didn’t want anything to touch my skin. It’s not too bad now. I think I’ve learnt to live with it now, because I was advised to wear clothes so that it sort of desensitised your skin, so that the nerves got used to something being on the skin. But I don’t know. I don’t know really.  
 

She has found it hard to deal with how the scar looks. She’d have liked to talk to other women...

She has found it hard to deal with how the scar looks. She’d have liked to talk to other women...

Age at interview: 57
Sex: Female
SHOW TEXT VERSION
PRINT TRANSCRIPT
I just, I felt that when I had my operation it was very difficult to talk to somebody. I had a lot of support from the family, but there was nobody actually who I could talk to who’d actually gone through what I’d gone through. I used to go on the web, everything. I tried everywhere to find a woman I could talk to, to find out how I was feeling, if they felt exactly the same. You know, did she - I couldn’t put a bikini on, not that [laughs] I’m a page three model. I’m not like that. But if I went into my bra and pants I had this awful twelve inch scar, which I have now, looking at me and it, and if you’re looking in the mirror you’re constantly, it’s a constant reminder what you had done. My husband said no, it doesn’t bother him, he doesn’t take a blind bit of notice, but he must do. It’s there, it - I see it, so [laughs] other people must see it. And obviously with a bloke, if a bloke gets a scar down his chest - big macho, this is good. It’s not the same for a woman. I found that hard to deal with. Not that I go about in flimsy stuff or anything like that. Even what I’ve got on now, I’m aware that this, I mean this is the good bit of my scar. Although people say to me, “God, that’s healed really, really well” I can still see it, it’s still a scar, and they don’t make me feel any better because I can still see it. They say to me, “Oh that’s, you can hardly see that”, but you can see it. It’s not a cleavage - because they muck about and say “God, you’ve got a really good cleavage.” It’s not a cleavage, it’s a scar [laughs]. So, and I’ve never met another woman that I can actually sit and have a conversation and say, “How did you feel when you had it done?” I suffered with a lot of psychological problems that really nobody could help me with. The hospital dismissed it with, “Well, you’re alive”, but that didn’t make me feel any better. I know that I’m alive, I had a problem and they sorted it out, but they left me with a - not the same as what I was.
 
Did you ask them if they could find anybody for you to talk to?
 
It was extremely difficult, they couldn’t find anybody either. It, every, this, this bypass business is very male-dominated. In the hospital the whole ward was men, in the cardiac rehab it was all men.
(See also ‘Appointments, monitoring and questionnaires’).

Last reviewed September 2018
Last updated September 2018

donate
Previous Page
Next Page