Danny - Interview 26

Age at interview: 61

Brief Outline:

Danny joined a trial of high blood pressure medication, but stopped because of side effects. She has concerns about the way some staff communicated with her and a lack of rapport and respect for her as a volunteer interested in her own health.

Background:

Danny is a retired teacher, who now does voluntary work with her grandchildren and their schools. She is married with 2 adult children. Ethnic background/nationality' White, mixed ethnicity.

More about me...

Danny’s husband had previously been in a big trial of medication for high blood pressure and cholesterol. Through the monitoring on the trial he had discovered he had type 2 diabetes, so they both felt being in a trial could benefit their own health. The same research institute approached them about another placebo-controlled trial, and they both volunteered. When they were screened, Danny’s husband turned out not to be eligible to take part because his blood pressure was normal, which they felt showed how he had benefited from the last trial.

 

Danny was eligible, but told the staff running the trial that she had previously developed an unpleasant dry cough as a side effect of one blood pressure tablet. If the same thing happened to her in the trial she said she would have to withdraw. Danny’s understanding was that for the first two weeks everyone would be given a placebo or dummy tablet, to see how they got on without medication, and then they would either continue on the placebo or be given the trial drug. Danny thought if she got side effects she would know she was taking the active drug.

 

She met with several problems during the trial. Firstly, she was surprised to discover that some of the people working on the trial were called ‘research scientists’ and it was unclear to her what their clinical qualifications were. She thinks it should be clearly explained to patients who they will meet. She had a good rapport with one research scientist, who she felt listened to her and took an interest in what she was saying about side effects, and was always willing to share information with her. This contrasted with one doctor, who would never tell her what her blood pressure measurements were, so she always looked in the file when he was out of the room. She thinks trial staff should remember that trial participants are volunteers who are interested in their health, and should be treated with respect and openness. They should answer any relevant questions.

 

The other research scientist struck her as uninterested and quite dismissive, and poorly informed about health and safety regulations. Danny felt she was being ‘told off’ on a few occasions about things that staff themselves had not made clear were important and which she did not remember being in the information leaflet. One was when she said she was going on holiday (in July), and so would not be there at exactly the right time for her next appointment. The research assistant suggested she might have to be ‘excluded’ from the trial – a word which reminded Danny of school exclusions for bad behaviour – though eventually a solution was found. Another occasion was when she brought back some unused tablets as requested, and they were not still in their original packaging, because Danny used daily medication boxes (left over from her husband’s trial) to help plan what tablets to take over several weeks. Again, she was given the impression that she had caused problems with their procedure. In both cases, Danny felt these were things which trial staff could reasonably have anticipated.

 

When she withdrew from the trial because of side effects, she felt dismissed as useless to the staff, rather than being thanked for at least trying. She believes people who volunteer for trials need a more equal relationship with trial staff than she experienced.

 

Danny's husband learnt he had diabetes when he was being monitored during a previous trial. They...

I was written to, my husband and myself were written to by, I think, our GP who - or the labs where the stuff was being done, the trials were being done, wrote to us and said that, “We’ve got your name from the GP.” I really can’t remember, but my doctor was connected. And so my husband and myself went, were invited to go to the trials, which we did. And we, because my husband had been on previous trials, which had lasted, they were supposed to last five years and I think they nearly did, but they concluded. They had a result, so. But while my husband was on the trials they found out he had type two diabetes. And that was something that had he not been on the trials might not have become evident, and it was picked up at an early stage. And because my husband was on the trials, and because I used to go with him, because it was interesting to me just to get up, and we used to go on our bike for a bit of exercise sometimes, I felt that we were getting a real bonus from being on the trials, because I knew what they were doing with his health, how they were monitoring it. He was getting ECGs. He was getting blood tests frequently, which [sighs] - I mean one could say [laughs] you don’t need to keep looking at your blood, but it was a small issue and a small sacrifice for something that enabled the two of us to focus and deal with his problems seriously, rather than a random visit to the doctor that might have had a much lighter touch.

 

So I think that it, the whole thing helped him to focus more - well, for both of us to focus on our health - not that we didn’t before, but it’s like you’re under scrutiny. So it didn’t seem a bad thing to do. It didn’t seem to be very imposing in terms of time or effort, and obviously one gets accustomed to going there, and the staff there, a small rapport builds. So that’s quite nice in a way, that there is a personal element to it. It’s not cold. 

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

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.  

When it was discovered her summer holiday clashed with the next trial appointment, Danny was told...

Anyway, then I told him - this trial started in July, I’m sure it was July - and I told him that I was going to France, because as an ex-teacher I still live by school holidays, especially as I’ve got grandchildren and we all go on holiday together. And I said we were going away for a month. Well, that threw them into some degree of apoplexy, and they said, “We might have to exclude you from the trial.” Well, where I come from, in my language exclusion’s bad, you know [laughs]. You get excluded from school for doing bad things. Have I done something bad? Not, “Oh dear, [tut] should have really thought about the summer holidays because there’s going to be a lot of people who might not be able to get up here because they’ve got children to look after, etc etc.” So there is an element of not taking on the wider life. Now, nobody - I mean although I told them I was retired, throughout the trial there was an assumption, a tacit assumption, that I was available. Had they said to me at the outset I could have given them my availabilities, and mine are very flexible. Now, it raised the question with me, are they not random trials? Are they just trials for people [laughs] that can go up there at the drop of a hat, or are retired and sick, or unemployed?

 

Because that issue was not addressed in the screening that got me there, and so because it wasn’t addressed it became a bit of an issue because I wasn’t available.

 

But it wasn’t a big deal, so the doctor went and spoke to the senior doctor.  

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

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?

When Danny's blood pressure was monitored during the trial, one doctor would never tell her the...

So it’s a blood pressure trial, one of the things was your blood pressure got taken. And it got taken lying down three times in a machine that people who have their blood pressure taken probably know, their doctors have got one. It prints out - like Tesco’s - it prints out the blood pressure and they take three. There’s a little gap between. I don’t know why, if it’s because it’s high and they wait. I don’t know why. But you lie there and you have your blood pressure taken, and they take it three times, and they take your pulse which this machine reads as well. Then they ask you to stand up and they do the same again, and the blood pressure is different. Now when the doctor was doing it I’d say to him, “What is it?” And he’d say, “It’s all right.” Well, that’s not the answer to that question, “What is it?” “It’s all right.” And I’d ask him again, “What is it?” “It’s all right.”

 

Now, it’s my blood pressure [laughs]. I didn’t say that to him, but it’s my blood pressure. Why does he see fit to not answer my question and to tell me it’s all right? Because if I’m monitoring my own health, I need to be aware of what he considers all right is, and I know my historic blood pressure much better than him. And it’s not all right for me to not know, because I’m not up there because I’ve got nothing else to do.

 

Anyway, so that sort of irritated me a bit, and said rather a lot to me about [sighs] the difference between a bedside manner that he needs to have when I might be being looked after, and they might have decided not to tell me things that might worry me or not, and me being there in my own time giving them my body to write notes about and not tell me. I mean, I just used to sit and read the file as they went out of the room to get something or came back or something like that. I would just sit and read the file, knowing full well that I could, and they’d left it, and I could read it anyway. But, you know, I don’t want to think, “I’m having my blood pressure taken - as soon as he gets out of the room I’m going to look at it”, you know? But what’s the big deal? Anyway, that was strange, and I found it irritating, because every time I went back I thought, “Well, he’s not going to tell me, you know. Why not?”

 

There’s a different way of dealing with people when, as far as I’m concerned, I’ve been asked to come and give something. I’m coming to give it knowing what I’m going to get out of it, which is a little bit of health monitoring, a little bit of - well, there’s all kinds of things. But there’s some kind of mismatch between me, the research. I don’t know. I don’t want to say guinea pig because I didn’t feel like a guinea pig, but basically I’ve subjected myself. I am not being cared for by the doctor. I am being used, and I don’t mean that in a pejorative way at all. I’m being used, and I believe with hindsight there’s a different way of dealing with people like me. I’m not a patient. I’m entitled to know the results of everything that is written down about me without taking issue and saying, “But I’m right. I’m entitled to see my file.” I suppose I was a subject of the trial, but I became an object of the trial. That’s what, and as a subject I would have felt there was a two-way thing, and as object I was just getting done to by them. That’s what, and it was sad, really. It was sad.  

Danny put her tablets into a dosage box from a previous trial. Staff were very concerned that...

Now, so they did the requisite tests that okayed me to be on the trial and they gave me these tablets [laughs] and I couldn’t believe the size of the package. It was nearly A4, and it was that thick, and it was a sealed foil bag. And in the sealed foil bag were these giant bubbles with fairly large pills in… I just thought, “What’s this waste?” I mean I was quite shocked that I had to take them out of a box, out of a bag, out of a capsule to take the tablet and then to pack it all back in.

 

So I got put on the twenty-eight day trial, that’s right, and I took all but three. Now, if anybody is on multiple medication - and I have to take five tablets daily and one at night. Previous trials gave us boxes of seven, so after you’d been the chemist you can dish out a week’s. I usually dish out a month’s. So it’s the best way to encourage you to take your tablets, knowing that you haven’t got to sort them out. So I dished these twenty-eight out into four lots of seven, along with my other medication, and at the end of the month I went back

 

And she said to me, “Did you bring the three back that you didn’t take?” So I said, “No, because I didn’t know I was supposed to.” Now I showed her, I’d brought the packet back, because they’d asked me to. And at this point I must mention, interestingly, although my husband’s now off the trial, we were both given a packet and there was no way of differentiating his packet and mine, and I think there, I read there was serial numbers on it the same, but they were the placebos and we knew that at that time. It was to see how we managed with no drugs, right? But it did strike me a bit strange. Anyway, he got thrown off the trial so it wasn’t an issue, but it could have been, and there needs to be some demarcation.

 

Anyway, so I said, “I didn’t know I had to bring them back.” And she was looking at this sort of empty thing like I’d messed - you know, I felt, “Oh god, I’ve messed up the trial.” Because this is a ‘what if’ that hadn’t been considered. What if somebody takes their tablets out and lays them in rows and doesn’t take them? And I wasn’t doing anything abnormal, because it was going into ASCOT* boxes. It’s my previous experience of what trials expect from people.

 

The one thing that seemed really important to them was that the same tablets that weren’t taken stayed with the packet. No-one had said that [laughs]. No-one had said that at all, because they could have done it so easily. But they maybe need to say, “How do you manage your drugs? Are you going to get this thing out of a box, out of a bag, out of a - and take one, put it all back, every day?” Of course you’re not. You know, like it’s bad enough just taking it out and pressing it out. People are going to manage their drugs differently.

 

*ASCOT = Anglo-Scandinavian Cardiac Outcomes Trial.

 

FOOTNOTE' It is possible that some medicines may lose their effectiveness if they are left out of their sealed packaging for too long. If you are thinking about using a tablet dispenser you may want to check with trial staff first.