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 hai, 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.

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 enoug, 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 lik – quite bizarre, really – he said, Ah, I’m glad you’re getting these side effect, 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.

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.

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.

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.

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 whos 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. Butnonetheless 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.

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 di you know. So I got up and I pottered about and I thought, Well, I’ll tidy the place u, 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 5, 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 frankl 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.

And so apart from that, there weren’t any times when you thought, I’ve had enough of this. I want to sto?

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.

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 whod 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, whos 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,

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.

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.

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.

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.

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.

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 nee 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.

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 oclock 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

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 ofthe 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.

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.

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.

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 whod 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 wel 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 tha, 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 aliv, 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.