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Polly - Interview 09

Age at interview: 61
Brief Outline: Polly was invited to be in a trial comparing tamoxifen against a placebo for breast cancer in the 1990s. She decided not to take part, because she felt there was already good evidence to support the use of tamoxifen.
Background: Polly is a journalist. She is widowed, with 4 grown-up children. Ethnic background/nationality' White British.

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Polly discovered she had early-stage breast cancer in the 1990s after her sister was diagnosed with breast cancer and other family members were called in to be screened. She had a lumpectomy, and was then asked to take part in a trial comparing the drug tamoxifen with a placebo or ‘sugar pill’. In principle, Polly feels it is important for people to take part in research, and is in favour of well-designed clinical trials as the best way to advance medical knowledge. However, she already knew quite a bit about tamoxifen, partly because of family history and partly through her work as a journalist. She had heard of a trial which had already been conducted in the United States. She understood this had shown that taking tamoxifen gave you a 30% better chance of survival. She also knew that tamoxifen was already being prescribed outside the trial to other women at the same hospital.
 
Polly therefore had doubts about the value of this particular trial. She discussed it with medical friends and with the doctor running the trial, who said that although there was some evidence, they needed more studies to be sure, and more evidence from the UK. Polly was not convinced that the extra knowledge that might be gained was worth the risk to her of being randomised to the group not receiving tamoxifen. She therefore decided not to take part, and was prescribed tamoxifen anyway. She took it for five years, and had some initial side effects of menopausal symptoms. She tried hormone replacement therapy (HRT) to help with this, but found it made her gain weight, so she stopped taking the HRT.
 
She still feels it is important for people to take part in clinical trials unless they have good reason not to, but advises people to seek out as much evidence-based information as possible and ask as many questions as they need to. She feels health professionals running trials should ask themselves whether they’d be happy for one of their family members to be randomised before they ask this of their patients.
 
 

When people are sick they may not want choice. They may want their doctor to be honest about...

When people are sick they may not want choice. They may want their doctor to be honest about...

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I think choice in medicine is a very difficult thing, and I think patients are often themselves uneasy about it. And you do go to your doctor because your doctor’s the expert and say, “What do you think, doctor? What should I have?” And you can ask for lots of explanations. But in the end if you trust your doctor the odds are very strongly from all the evidence that most people will do whatever their doctor suggests, probably sensibly. If you don’t trust your doctor, then go to another one and then you’ll do what the other doctor suggests [laughs]. A lot of people will come to doctors with great piles of documents they’ve printed off the Internet, some of it from rubbish sites, a lot of dangerous stuff out there on the Internet. And, you know, the doctor then will spend a long time going through them and saying why they think they’re right or not right. But in the end it is down to trust. So choice is quite difficult. And I think, you know, the same is true about choice of which hospital to go to or which consultant to be sent to. In the end you probably trust your doctor to say, “Well, Mr so-and-so at X hospital has, you know, always seems to have done very well to my patients.” And I think lots of patients, and particularly the sicker they are, don’t really want choice. They want trust. And choice and trust are in different boxes. And very often if you’re left on your own to make really life-and-death decisions it can be very upsetting. You want to be reassured by someone who seems to know.
 
I guess there’s another conundrum, really, isn’t there? Because in trying to present a trial as a case of genuine uncertainty, there’s a risk that the doctor may undermine your trust by sharing that uncertainty with you.
 
I think that’s true. I think if a doctor says, “Well, I really don’t know. You’ll have to choose”, it can be very unnerving, because you really do want him to know. Or at least you want him to, you say, “Well, all right. I understand you don’t know.” Perhaps you want him to be honest about uncertainty. I think you don’t want him to pretend that he, to pretend he’s God. You want him to say, “Well, actually not enough is known about this condition” or, “Here are the options.” But in the end you want to say to the doctor, “But of what you know, what do you think the odds are? Which way would you really go?” And in the end you want the doctor to plump one way or the other, as best they can. I mean that’s, that’s their job. 
 
 

Polly decided not to take part in a placebo-controlled trial of tamoxifen because she felt there...

Polly decided not to take part in a placebo-controlled trial of tamoxifen because she felt there...

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I had a lumpectomy, had the bit taken out, and then I was asked if I would like to go onto a clinical trial. I’m strongly in favour of clinical trials. I think they’re the only way you can ever find out what works and what doesn’t, and I think it’s very important. So in theory I was strongly predisposed to do that, would want to help in any way I could. But when it was explained to me what the trial involved, I had deep doubts about it. The trial, basically I was being asked to be randomly put into a group of people who would not have tamoxifen, which was an anti-breast cancer drug, or into a group that would have tamoxifen, and it would just be random. So if I agreed to go on the trial I might well fetch up in the group that didn’t have it. I’d have a placebo, I’d have a little white sugar pill, and I would never know whether I’d actually had the tamoxifen or not. I knew a bit about tamoxifen and a bit about breast cancer, partly because it had been in my family. And anyway it’s the sort of subject that I was writing about and interested in. So I did a bit of investigation, rang round a few people, talked to a few people. Tamoxifen had already been widely used. There had already been a very large trial in the United States, which had shown that it seemed to have a very strong positive effect. It seemed from this large trial as if it might improve your chances of not recurring, not getting another episode of breast cancer, by about 30 per cent, which is, you know, a very strong positive effect. So I then became very worried at the idea of going into a trial where I might not be given it, and I might never know whether I’d had it or not. So I talked to the doctors about it and they said, “Well, the trouble is, you know, we do need more research. We do need more evidence to be absolutely sure. That was American research. We need British research. We need to find out more details.” But when it came to it, I felt that we already did know pretty much. And every doctor and other people and other sources I looked at, everybody was really positive about tamoxifen.
 
That particular hospital already had quite a lot of people on it. And I thought to deny myself tamoxifen for the sake of a, you know, just a rather academic study, I thought that the disbenefit to me would be much greater, really, than the extra little bit of knowledge that would be acquired on top of the knowledge they already had. I felt badly about it because, you know, obviously we need more and more knowledge as time goes on about exactly what drugs work and how well they work. But I just felt on this occasion that we already knew a lot.  
 

Polly never felt she got a straight answer about why the trial was needed and whether the doctor...

Polly never felt she got a straight answer about why the trial was needed and whether the doctor...

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I was first approached by the surgeon who’d operated on my breast and who put it all in a, in a very plain-speaking simple way, so that it was easy to understand what the proposition was. You know, “Here’s the sugar pill and here’s the tamoxifen, and we need to know more about whether tamoxifen really works or not.” I asked him quite a lot of probing questions about, “But don’t you already feel that you know quite a lot about the benefits?” And actually I thought he was slightly shifty on this. He said, “Well, yes, we do, but we don’t altogether know. We haven’t got British results, we’ve got American results, and we do need to know more.” I felt he wasn’t entirely honest about, about it.
 
So that I said, “Well, look, if I were just coming to you as a patient and you were not doing a trial and I said, ‘Should I take tamoxifen or not?’ I suspect you would say, ‘Yes.’ On the basis of what we know so far you would prescribe it to me.” At that point he sort of denied it and said, “Well, I don’t know that I would. I don’t know that we know enough.” But I felt he probably would. If he wasn’t conducting a trial, I felt he would probably have offered me the tamoxifen. In which case I thought it wasn’t totally straight. And therefore I went to talk to another doctor in another hospital and, who said, “I would prescribe it to my patients.” So I thought, “Well, really, I’d better go for the prescription.”
 
Who was it who eventually prescribed it? Did you go back to the first surgeon?
 
I went back to the first surgeon, back to the hospital. Well, by then it was no longer, as I was not on the trial, not to the surgeon, but to the person in the diagnostic unit who I’d been under in the first place, and who I continued to see every six months for check-ups and later every year for check-ups. And she prescribed it to me as I was no longer, you know, on, on the surgeon’s books as being part of the, the trial. But it was the same hospital and the same doctor that I’d originally seen for having diagnostic investigations in the first place.
 
And did you get any sense from that doctor that, that there was any question about whether or not tamoxifen was a good idea?
 
I asked her. She was discreet, because obviously she was talking about her colleague. But she said that on the whole she thought the odds were that tamoxifen was a pretty good drug and she prescribed it to me very contentedly. It wasn’t as if I had to prise it out of her. I felt that she was probably prescribing it to a lot of her patients. And so I think I made the right decision. And I think she probably did too.
 
I did push her a bit about, “Well, in that case isn’t this a rather unethical trial that lots of women may end up being denied a drug that could give them a 30 per cent improved chance?” Doctors are very discreet about dishing the dirt on their own colleagues [laughs] and I never quite got her to admit that.
 

Polly believes we need more evidence about the effect of alternative therapies. The NHS is under...

Polly believes we need more evidence about the effect of alternative therapies. The NHS is under...

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I think that it’s a very good idea that there have been recently proper trials and, and reviews of all the trials that have been done for alternative treatments, because huge claims are made for them. And in fact it turns out that all of them have a good effect, but no better effect than placebo, no better effect than a sugar pill, or being given an ordinary massage or some, some other treatment. And I think it’s very important people should know that. There’s a big mystique around alternative medicine. There’s a lot of pressure on the NHS to provide all sorts of treatments that people say make them feel better, and may make them feel better.
 
But I do think we need to know the actual science. So I think, you know, if there’s a lot of pressure for one particular form of treatment on the NHS, it’s very important that we should have proper scientific controlled trials. A lot of these alternative treatments of course you can’t quite do that with. It’s quite difficult to stick pins in people [laughs] without them knowing they’re having a pin stuck in them. If you’re going to do a clinical trial on acupuncture, they will know whether they’ve had it or not had it. Nevertheless we do need to know what works. And I don’t think it’s any good to just go through in a kind of fog, where you say, “Well, patients say they like this. So therefore the NHS ought to provide it.” That way you waste an awful lot of money and time.
 

Polly advises people to ask a lot of questions and get a second opinion if possible.

Polly advises people to ask a lot of questions and get a second opinion if possible.

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I think anyone being asked to take part in a trial should ask some quite penetrating questions. I mean, I think first of all they should approach it in a positive state of mind that on the whole we patients would like to help science wherever at all possible. Doctors are trying to provide better proof, better evidence, better treatments, and I think it’s the least the patient can do is to help as much as they possibly can. But in the end you have to look at the particular trial very, very carefully. And I think really you need, it’s a good idea to get a second opinion from somewhere else, if it’s on something that’s very important. I mean, if it’s something minor, obviously not. But if it’s something, you know, possibly life-threatening that you suffer from, then I think you really need to know all there is to know about the treatments that you’re being offered, or possibly denied, if you’re going to be randomly put into a group that’s going to get a, what might be a very good treatment or into a treatment that perhaps might do you some damage. You need to know what those risks are and decide whether you’ll take them or not. Of course some trials, you’re not going to be offered the treatment unless you’re on the trial. I think that’s a very, very difficult call and I think that puts a lot of pressure on, on patients who perhaps very much want the treatment, can’t get it any other way, but might be randomly assigned to a group that don’t get it.
 
And I think that’s a deep ethical dilemma. Of course if it is a very, very new treatment and the scientists genuinely don’t know if it’s going to work or not, I don’t see how else they can proceed except on that basis. So I wouldn’t rule it out and say, “That’s unethical, that’s unfair”, because I can’t quite see any other way of, of resolving it. You can’t give everybody every drug that might have some effect indefinitely. It could be dangerous as well as expensive. 
 

She would probably have taken part if tamoxifen had been available only through a clinical trial....

She would probably have taken part if tamoxifen had been available only through a clinical trial....

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Oh, if tamoxifen had only been available as a clinical trial I would certainly have gone for it in the hope that I might have had it. Of course I probably would have been more nervous, because we also at that early stage wouldn’t have known whether or not it might have other alarming side effects. But I think if the doctor had said, “Well, you know, we have high hopes of this drug” I think I would have gone into it, though I think it does make you uneasy not to know, and never to know, whether you had a drug or not. But certainly if that had been your only chance, I’d have taken it.
 
I feel that the placebo effect is so well understood now. We all know. We are all easily fooled [laughs]. And, and doctors make us feel better, and being given pills and treatments make us feel better. And whether it’s some homeopathic bit of nonsense or whether it’s a, a genuine drug there is that plus effect. And I accept that about myself. So I would, I wouldn’t be worried about the idea of taking a placebo. I suppose you always feel uneasy about whether you’re missing out on a drug that might do you good. Or alternatively of course [laughs] you might be feeling worried about taking a drug that nobody knows quite yet what its side effects might be. I would want to look into it very carefully. I don’t see anything wrong with the principle of it, but as long as people, patients really, really know what they’re getting into, understand why, and think that the trial is worth it, that the knowledge they’re going to get is worth either giving or denying you the chance of a particular drug. And I think in the end that’s something you have to weigh up carefully. I think I would suggest all patients always try and get a second opinion, go back to their GP, talk to somebody else, these days, you know, look up on the Internet for all of the valid information from responsible sources that they can find. And there is a lot of information around now.
 
 

Professionals need to be very honest with patients, and be sure they really feel the trial is...

Professionals need to be very honest with patients, and be sure they really feel the trial is...

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I think the professionals have got to be very honest with the patient. And in some ways I think perhaps the doctor who was offering to put me onto a clinical trial in the end when the chips were down was just slightly more interested in getting people onto his clinical trial than stopping to think very hard. You know, if this was, this is his patient, is he really making sure that his patient gets the absolute best treatment there is available? I mean, often that won’t be the case with trials. But where it is I think the doctors have to be quite sure that if this was their wife, their daughter, their best friend, are they sure they would say, “Go on the clinical trial.” Or would they say, “Actually I think there’s something else better we could do for you than the risk of being randomly assigned to no treatment or perhaps not the best treatment that we know.”
 
I think it’s very difficult, because I think probably all doctors doing clinical trials have high hopes of the treatment that they’re testing out is going to prove to be some kind of breakthrough, is going to be useful and valuable for their patients.
 
So part of them must be saying, “I think my patients will do well out of this.” When you ask, when I asked my doctor, it was, “Well, I may think that, but I don’t know it. I can say I’ve got a hunch, but should I really be prescribing on a hunch?” And I said in the end, “Well, yes, actually. Because I come to you, my doctor, for your best hunch. There are going to be, may be lots of things that doctors don’t altogether know. But from your long experience, I would like the benefit of what you on the balance of what you kind of feel, even if you can’t prove it, is going to do me best, most good.” And I think that is a tricky dilemma for doctors with these clinical trials. 
 

Polly wonders if we could run trials where people could choose a treatment rather than being...

Polly wonders if we could run trials where people could choose a treatment rather than being...

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And I had a feeling about this trial and possibly about other ones that I’ve read about that there isn’t a very strong reason why people shouldn’t have cho-, been allowed to choose which treatment they had and then be followed through the trial according to which they’d chosen. I can understand that in some treatments you would get people with certain levels of illness or disease who would choose one treatment rather than the other, which would then distort the results. But if you could have people all, say, at exactly the same level or condition of breast cancer as far as it was measurable who were then free to choose which they had and followed them through, it might have slightly distorted, made it a slightly less perfect trial, but I suspect it wouldn’t have had a very big impact, whereas it would probably have attracted many more people to go onto the trial if they felt in control of what they decided to do.
 
Have you debated that view with doctor friends or scientists that you know? And have they persuaded you otherwise?
 
I have talked to doctors about this, about whether or not people could actually choose which treatment they were going to opt for when they went into a clinical trial. And of course it depends very much what the trial is. I mean, there are some things that are really quite straightforward, where everybody on the trial has more or less the same condition in more or less the same stage, and it isn’t going to make a huge difference whether they have actually chosen to go onto one treatment rather than the other. Other, in other conditions you can see that if somebody, if you had a very wide range, where some people were at a very acute stage, perhaps near to death, and would take anything, and other ones at a very early stage, it would distort the results of the trial because the people the most desperate would be more likely to be the ones that would take the treatment. But they might of course be the ones who had the least good results at the end.
 
So I think it would vary depending on what the trial was. But it seems to me that it should be an option considered when doing a random - when doing a, a clinical trial, whether it might be possible to let the patient choose. But I can see it would vary very much depending on what the case was.
 
FOOTNOTE: There are trials called ‘patient preference trials’, in which patients with treatment preferences are allowed their desired treatment, and those without strong views are randomised as usual. However, in analysing such trials it is not clear how to allow for the fact that patients who choose a treatment may not be comparable with other groups. An article from the British Medical Journal explains more about what a patient preference trial is and its limitations.
  
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