Clinical Trials

Yes, yes.

 

 

I thought about it and I think the answer, it didn’t matter to me from the point of view of taking part in the trial. I think it would have been interesting to me to know how I would react in that situation, because they do say that you are - how shall we say - influenced by, you know, your mental state at the time as much as anything else. So I’d be interested to know whether I was one of those people that was influenced or not. So it didn’t concern me, and I did think about it and I made a positive decision to go ahead regardless.

 

They would have told me, I think when I asked a question of the doctor at the time, they would let you into it at the end, obviously not during the course of it.

 

They would have told you. I would like to think I would have been aware [laughs], because I actually asked the question what happens, you know, if things weren’t happening, because, you know, it’s these moments when they come you want to take advantage of them [laughs]. And if it wasn’t working then I’d want to take some other form of help and basically they said you could drop out of the trial at any stage, and so that satisfied me on that particular question.

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.  

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.