And then the last trial was very recently, which is, I have irritable bowel syndrome, not – it comes and goes, I mean, I can be perfectly normal for months, and then I can get attacks. And so there was a local researcher in the university I was working who was doing a trial of pro-biotic yoghurt versus plain yoghurt, not pro-biotic yoghurt, to see whether it controlled the symptoms of irritable bowel, and I was eligible and I signed up for it and it required you to drink, to eat two cartons of yoghurt a day for six months, I think it was, or – I can’t even remember. It was a long time, I remember feeling quite yoghurted-out by the end of it. And you’d just pick up your yoghurts in boxes with a number, you know, LR0911 on the top or whatever it was, and had to fill in a diary about how you felt. And I was interested in doing this trial because I’m interested, I’m actually interested – I’ve just switched jobs – I’m interested in the public running trials on themselves, you know. So people who like myself were interested in generating knowledge, we’d get together and we’d do it. And I just wanted to see how easy it was, and actually it’s, it’s quite difficult. You forget to fill in the diary and you think, Oh, what was it last Wednesday? or you scribble it on a piece of paper because you don’t have your book with you because you’ve gone away and, you know, you really don’t feel like a yoghurt but you have to eat it, and I was very compliant, I’m sure I was much more compliant than most people, just because there’s part of me that’s a bit of a researcher and so it makes you realise just how much noise or rubbish must be put into trials really because you’re thinking, you know, What was it? And then I’d think, Oh, well, I remember and then I’d find my bit of paper and it wasn’t true. Then I’d have to go back and change it, you know. So, but if I hadn’t found the piece of paper that misinformation would then have been put in. You had to, how many stools did you pass and what, how firm were they. There was a little chart where you had to categorise your, [laughs] your stool and this sort of thing. And actually during the whole period I was asymptomatic, and I was actually quite interested in how the research nurse dealt with me, because she, I think she was frustrated because there were no symptoms.

And also I was neither better nor worse and so the other half of her was wanting me to say I was better, when I didn’t necessarily feel I was better, I just felt I was unchanged. And I felt people were wanting a certain result, I really did get that impression, so I thought it’s, you know, it’s really important that staff are blinded as well. They can’t, you can’t help but want a result, that what nobody wanted to hear was, Well, I’m just the same. You know, I haven’t noticed any change at all, you know, so which is, was my situation. Later they told me that I had been on, on the pro-biotic yoghurt, which was a good thing because I was asymptomatic and I remained asymptomatic. So, who knows? Well, I say it was a good thing, but who knows whether that was, I haven’t seen the results of the trial yet, so.

Very difficult isn’t it? Particularly with those self-report kind of conditions–

Yeah,

–where there’s no sort of objective kind of, you know, like a tumour size shrinking is in a way easy to measure, isn’t it, but something like that?

I really think these things have to be blinded from staff as well, because you can’t help, I mean, if you’re running a trial, I want to run a trial, you can’t help wanting the result, because you, you wouldn’t be doing the trial unless you believed your intervention was effective, really, I think. Although they say you’re supposed to be in equipoise*. I don’t think you would ever begin a trial unless you actually believed there was good grounds to think that this will work.

* FOOTNOTE: ‘Equipoise’ means a situation where clinicians are uncertain which treatment is best literally it means they are balanced equally between them.

I knew what blood pressure pill it was. That was a particular brand of pill. The only one I didn’t know, of course, was the, the cholesterol thing. And that was, because that was like a separate, it was like the two studies in one. You know, it was on the one hand you had the blood pressure test, on the other they wanted to see what result cholesterol lowering had. So that was, that was the one you didn’t know if you were on or not.

How did they do that? Did they have a, sort of a blank bottle or something, with no label on, or how–?

Yeah, yeah, you’re just taking the pill and you’re just marked up with the, the, you know, the actual name of the trial, ASCOT trial. And it didn’t say anything. You didn’t know if you were taking sugar or a cholesterol-lowering thing. You’re just taking a tablet for, you know, several years. And it was marked up, it was coded, each one was like coded with your, I suppose your own code number and the trial number. So eventually they could, they knew at the end of the trial what, who had been taking what, but not, not during the actual trial.

So did the doctors send you off to another room to get that from someone else? Or did they just take the coded bottle out of the cupboard?

They took it out of a cupboard. While you, when you went every six months to have your tests done, while you were there they gave you the next six months’ worth of pills. There was the cholesterol, you know, the dummy pill, or whatever it was in one box, and there was the, the actual cholesterol – the blood pressure tablet.

But they didn’t know which?

They, no – well, they said they didn’t anyway [laugh]. I trust, I take it they didn’t.

It was hinted about halfway through, it was hinted at that I was on the cholesterol anyway. Because the, although the doctor didn’t actually, he couldn’t really tell me, he said, I don’t know what the.. you know, he didn’t know himself which one I was on. But he said, Whatever it is, I would keep taking it. It seems to be doing you goo you know. I mean, my cholesterol came down from about over 6 to about 3½. Which is pretty reasonable, you know. So having been told that, it was obvious that, you know, I was on the cholesterol pill.

I had been on gold injections for many years for my arthritis and, you know, if I got iller they put the dose up and then as I got better they would lower the dose and, and I was just thinking, Well, you know, this is crazy. Of course I’m going to get better. If I’m ill I’m going to get better, because it’s a disease that cycles. And I had asked them – this was long before I was a doctor – if they would just give me water sometimes instead of gold and not tell me about it, at which they laughed and said Oh no, we can’t do that.

Later on I was told I was being withdrawn from the gold, because I had beginnings of kidney damage and, you know, they would try something else, azathioprine, which is quite a toxic drug. So this time I asked if it could be introduced experimentally without me, you know, being told what the drug was, because they said the gold had probably not been doing me much good even though I’d had it for years and years and years. So it’s known as an ‘n of 1′ trial – a one person trial where you have the drug, then you have something that looks like the drug that isn’t the drug, and you don’t know when it’s starting and ending, to see whether actually it is related to your symptoms, because in a disease like rheumatoid arthritis you can be very ill and then you can be better just because the natural variability of the disease.

And my rheumatologist, she was very keen to do it with me and we looked up how these trials were done. We found a pharmacist who is experienced in n of 1 trials, we got the drugs from the [laughs] pharmaceutical industry, and we were going to do the trial. But then, interestingly enough – which was simply giving me the drug – we were then told we couldn’t do it because it would have to go to an ethics committee because it was an experiment, which I found ridiculous. You know, you can give me the drug, you don’t know whether it’s doing me any good, it’s toxic, but to give me it in a way that I could actually find out whether it’s doing me good suddenly we weren’t allowed to do it. And the other thing that was very interesting about that trial was the placebo was different from the drug, so you could tell which was which. And we contacted the pharmaceutical company concerned and they said yes, it was always like that, and it was like that in the trial, which made me very suspicious now about blinding in trials. You just think, God. I could distinguish those. So then we had to look up things like, we were going to crush them or put them in capsules, but because it’s toxic, that breached health & safety regulations. Then we were thinking about covering [laughs] them in chocolate. But by the time we’d done this I was getting very ill. My consultant just started me on the drugs, she said, We just can’t wait to set this up, and it didn’t work. I actually got to quite a toxic dose. She said This is clearly not working We were upping the dose and then we just stopped it, so we never got through the process of doing the trial, because it was blocked by the powers that be saying it needed to go to an ethics committee, and that was just taking way too long for me as an individual patient.

Were you trying to go through the ethical process?

Yeah, we, at that stage we were going to go through the ethical process, we’d drawn up a protocol, we had everything written and we were still exploring methods of making the drug truly blinded so I wouldn’t know what I was on and that – so we, we hadn’t actually submitted it to an ethics committee because we were still, hadn’t we’d just got to the chocolate-coatedtablet idea when, by which time [laughs] we she’d decided it was toxic and was not going to do any good anyway.

So then I stopped that.