Linda - Interview 12

Age at interview: 43

Brief Outline: Linda received an invitation for her youngest child to take part in a clinical trial to test a drug for children with a heart condition. At this time her child was aged two months. Linda agreed to take part.

Background: Linda, aged 43, is White South African, works part-time as a Staff Nurse, is separated and mother of three children; all born in the UK; ages 7, 9 and 15 years. Linda's youngest child was diagnosed with a heart condition 12 hours after she was born.

More about me...

 Linda, aged 43, is White South African, works part-time as a Staff Nurse, is separated and mother of three children who were all born in the UK; ages 7, 9 and 15 years. Linda’s youngest child was diagnosed with a heart condition 12 hours after she was born. Linda recalls this moment vividly' their precise words were, ‘There’s something not quite right with your baby’’. The next day Linda met with a cardiologist who gave a diagnosis of a aortic valve problem, a fairly common heart condition among children. However, ‘it is a ‘big one’ to fix’. When her daughter was two months old, Linda was invited to consent for her daughter to take part in a clinical trial. The purpose of the trial was to test a drug to prevent respiratory infections RSV (Respiratory Syncytial Virus) among heart children. After reading the information she received and discussing it with her husband, she agreed and gave her consent. The fact that the drug was licensed was important to Linda as knew it was tested and safe. 

 

The trial was a double blind randomised controlled trial that lasted in total 18 months. Linda says that this meant some children would receive a placebo and some children the actual drug and that no parents and no one in the medical team would know who was getting which drug. The first six months were the most traumatic and involved the blood tests, check-ups and attendance at the hospital on a monthly basis. Linda says this first six months of the trial were the most time consuming, as she had to drive to the hospital which was half an hour away, park her car, go through the procedure, and then wait an hour to make sure her daughter was okay before going home again. With her other children to think about, this did add extra demands on her time taking 4-5 hours out of the day each month. During this time Linda also had to complete a diary to record if her daughter had any coughs, colds etc, she continued to complete the diary for a further 12 months. However, this information could be sent by email, so was easy and convenient to do. She says that if her daughter had been older, she may have been more reluctant to take part, as it was fairly traumatic. She says she would have been fearful that her daughter would worry about going to the hospital. Whereas at the moment, when they go to see her cardiologist, she doesn’t worry about it at all. She also felt that her background as a Nurse helped her through the whole situation and events. 

 

Linda’s primary reasons for consenting her daughter to take part in the trial were to help other people and the chance that her daughter would receive the drug, that was ‘really, really expensive’. And would help her ‘little chest’ and prevent her from getting any infections. Even though the trial has now ended and the results available, Linda does not know whether her daughter received the actual drug or a placebo. When asked about this, Linda says that her daughter has done so well that she is certain her daughter did receive the actual drug, and it seems immaterial now. 

 

Linda adds that taking part in the trial she felt she was giving back' she says ‘because I know how much everything is costing to keep her fit and well, taking part in the trial is a big part of wanting to give back’. Linda reflects on the information she received about the trial and the initial invite. She remembers feeling a bit overwhelmed with being informed about the procedure and what would happen at a time when she really just ‘wanted to get through the week’. However, she also felt that everything was very well organised, clear, and there was no pressure to take part. She says that rather than feeling vulnerable at this time, being asked to take part in the trial gave her a sense of empowerment, that she had some control of the situation. She also feels it is important to have a good relationship with the cardiologists. Trust in the medical profession was a major factor in Linda’s experience. She says ‘had my cardiologist said no he didn’t think it was a good idea I would have said no’. 

 

In giving advice to other parents who may be invited to take part in similar trials, Linda says that firstly ensure that it doesn’t do your child any harm and secondly She recognises that for medicine to progress and to find cures to things that are now life threatening, ‘we unfortunately have to bite the bullet, subject our children and ourselves to these tests’. 

 

Advances in medical care for children have resulted from children participating in clinical trials.

 I would say firstly as long as it doesn’t do your child any harm, you knew that guarantee. And secondly I’d say that, you know, considering from the time that Alexander Fleming invented penicillin, all the drugs and all the advances we’ve got now to help our children have been based on people being prepared to put their children forward or themselves forward and that for, you know, our children’s benefits. I remember very well when my little girl was born they said to me, you know, the longer we can stave off her heart surgery the more techniques are being perfected and perfected. And they said you’ll be surprised that in ten years time we’ll be able to do things that we can’t do now. Which is true because I know in France they’re certainly replacing the valves by just going through the groin which, you know, 20 years ago people would have not been able to do or even ten years ago. And so it is, you know, I would say unless it’s going to do your child any harm to, for us to progress in medicine and find cures for things that now are you know, life threatening we unfortunately just have to bite the bullet and, you know, [laughter]. And unfortunately, you know, subject our children and ourselves to these tests so.

Linda explains that they were testing a drug used in the treatment of respiratory conditions in...

 The purpose was mainly to see if, I think they were getting a lot of hospital admissions of cardiac children who had contracted RSV [Respiratory Syncytial Virus]. And so they were trying to see if it could help, the vaccine could help children, cardiac children by well preventing them from getting, contracting RSV. Whereas they at that stage it had only been licensed for children I think with cystic fibrosis. And it had only purely been licensed for lung drugs rather than for cardiac. And I think they were trying to, very much driven by the cardiologists that if they, their patients could also get access then, especially for the, it appears that the sort of danger period is the 18 month, first 18 months. So they could have the drug for first, you know, get access and get, stay healthy for the first 18 months, their side effects would be less.

 

And certainly where I had worked at that point, I often worked in the infectious diseases unit in and knew cystic fibrosis people had come in with it and, you know, that once you get it it’s quite a severe virus and that people who immune are compromised get it. So I think for us from that point of view because, I think had he been a surgeon or something he might not have been that caring. But his main thing was if she can get, even if she only has a 50% chance of getting the vaccine it’s got to help her. So, you know, so that was my main motivation I suppose.

 

The nurse explained everything, even about the practicalities of parking, how long she would have...

 They did yes, very thoroughly I think I met with the research nurse for probably a good hour before I even saw the doctor and she explained everything very simplistically, you know. She was very clear about what was going to happen and how it would happen and even practicalities like, you know, parking and where I should park and remembering to zero my car so that they could pay me mileage for the, you know, very simple things and about the blood taking and things so.

 

What was involved for your daughter and you? [Yes.] Because you mentioned about having to travel?

 

Yes and the waiting you know and explaining about I would have to wait an hour but also being clear about why I would have to wait an hour to make sure that she didn’t have a reaction to the medication that they were giving her so.

 

I don’t remember them mentioning I think it was on the sheet they sort of sent us. There weren’t any that sort of flagged up red, you know, sort of where I went oh, you know, so but they certainly would have, I mean I would have remembered if they hadn’t because I would have sort of thought wait a minute all drugs have got side effects.

 

Linda will involve her daughter in making an informed decision about taking part in trials when...

 Yes I would, yes. I, now would probably wait until she was older to be able to make more of an informed, not consent but where she could take, we’re getting to that now where not her, not her cardiac hospital but her, the hospital, we live about an hour away from her cardiac hospital but we have a local hospital, the local trust uses her for exams for the diploma in child health or the diploma not, the membership for the Paediatric exams. And she’s now getting to the point where I won’t just say yes, I will ask her whether she wants to go and do it because that now her little body is changing and things are becoming more and more sensitive about, you know. Taking her top off for any Tom, Dick or Harry whereas when she was three or four the promise of a lollypop was enough to sort of. And now I would involve her more in the decision but trying ultimately to steer her towards saying yes.

 

I think as she gets older she will have more say.

 

Yes and certainly even now she’s an exceptionally bright little girl so she is more able to sort of say what she wants to do and so.

 

Having received excellent care for her daughter, Linda was keen to help other children with heart...

Part of it was a] to help people and see if this could help other heart children. But also to help her in the hope that she did have the actual drug, so.

 

Very much so, I think. For the same reason I’m doing this today is that there’s a big part of wanting to give back. I’m fully aware of how much my daughter’s care is costing now and she hasn’t even had surgery. But it is a big part of wanting to give back, which I might not have had if I wasn’t a nurse and knew how much things cost behind the scenes.

 

Yes, yes and especially as her heart condition, although serious enough to warrant, oh how they explained her heart condition to me is that it’s one of the better ones to live with day to day, it’s still a horrendous one to have to fix. Although in all fairness they didn’t use the word horrendous you know, it’s still, she’s still requires a very large open heart surgery to fix it when she gets, when eventually her heart deteriorates to the point where she can’t when she needs the surgery. But she, day to day she’s still, you wouldn’t, you’d seen her you wouldn’t think that she has a heart condition. Whereas other children with heart conditions who have to gasp for every breath of air, if it could help them then, you know, that would be, that was sort of our main aim was, we, we would prefer not to have a child with a heart condition but as heart conditions go we got the milder one. So as sort of in gratitude for that we’re prepared to give back for the other children, so. 

 

No I’m just grateful to all the people who went before me [laughter] who did subject their children to different, you know, trials and, you know, things like [xxx] her, you know, cardiac testing stuff, you know. Obviously people went before me and I’m reaping the benefits from what they’ve done so you know, so thank you to them and their doctors for doing it so that I, well she can get the benefit but as 80% broken heart mummy about her, repairing, repairing my heart too, while her heart repair so yes I think it’s more of remembering that this didn’t just spring from someone’s head overnight, lots and lots of testing has gone into it so.

 

Whether her daughter received the placebo or the actual drug was of less importance than seeing...

 No, it was a six month thing where she was injected for six months then it gives cover for I think three or four years they said. And certainly even though I don’t know the results I just anecdotally think that whatever she had, helped or we were just particularly lucky. Because certainly for the first four years of her life you wouldn’t have known that, she was a lot less ill than people had predicted she would be. People had, you know when she’d seen the cardiologist they had said that she would need if she got a cold it would hit her hard etc and none of that happened so. You know at one point I actually started thinking maybe they’d got it wrong and there’s nothing wrong with her [laughter] a bit of wishful thinking I mean because she was doing so well, you know, it was impossible to even contemplate that she would need open heart surgery she was doing that well so.

 

Mainly because I think I have phoned once and they hadn’t broken the code yet. I think the reason I haven’t because she’s done so well that it’s almost now immaterial to me whether she had it. Had she been less well I would have wanted to know. I think because we’ve got to eight, you know, she’s getting distinctions for ballet exams and taking part in cheerleading and, you know, had she been less well I would have more time to focus on her, her heart condition and everything that’s been involved with it. It’s there but it’s there kind of thing, it’s not, it’s part of us on a daily basis, we know that she needs surgery but we are able to, apart from her cardiac appointments, put it to one side it doesn’t interfere that much with us, which sounds strange. Because I mean I do sort of look at her and go “Oh my little girl needs open heart surgery” or she’s with her swimming costume and I think one day there’s going to be a scar running down her. So I do think about it. But we try not to, for me it was important that she live her life as her and not as a heart child. She’s a child who has a heart condition but she’s not a heart child, you know. I want her to live, sustain life but I also want her to have a life while she’s alive so I do let, I mean her cardiologist said that there are children who are never even allowed to learn to ride a bike. Because with heart children if they fall then they can get if they get an infection, if they get a deep cut they’re meant to have prophylactic antibiotics so they don’t develop endocarditis. So the parents won’t let them ride a bike in case they fall down and cut themselves. And for me I don’t want her to die but I want her, if she lived until she was 20 having had a full, loving, wonderful, exciting filled life with rides on Lego Land etc. then that would be more important for me than that she was kept locked away never able to do anything and live to a 100, you know, so, I want her to have a good quality life. And because she has had, she’s had such a full life, her test results have almost become, you know, not an irrelevance but I almost don’t need the test results because I know that whatever they gave her a) it didn’t harm her and b) almost did her some good so. It would be more of an interesting point to see whether I was right that she had had the real one because she did so well for the first few years of her life, you know. Which is the bit where they said would be the danger part so.

 

Linda's daughter was born with a serious heart condition. She was invited to enrol her daughter...

 Okay well my little girl was born at four minutes past midnight on the 23rd July 2001, and by 11.56, I remember it rather well, a nurse listened to her chest to see if she, for her well baby check to see if she could go home, and they said she couldn’t and their precise words were; “There’s something not quite right with your baby”, which is not really words a mum wants to hear, you know, after hour long of waiting and labour and things. So she was referred to a cardiologist the next day, and diagnosed with a [heart valve problem] aortic valve which is a fairly common heart condition apparently it’s the most common childhood sort of heart condition there is. It’s a big one to fix but about one in about every 100 people have one but probably don’t know that they have one, that’s what research has shown. She was sort of followed up fairly regularly at the hospital where she was born by their fantastic cardiology team. And I was then approached by one of the directors of intensive care, or the Director of Intensive Care, to see if I would take part in a trial for a drug, which name has completely escaped me, its [Res] something like that. It’s, basically it’s a drug for RSV [Respiratory Syncytial Virus] which is a respiratory virus that children get. And it had already been licensed and that for me I think is a very important part because had it not been licensed I might not have been as keen for her to take part. But because it had already been licensed I knew it was tested and safe. 

 

I think getting your head around the fact that you have a cardiac child and then getting your head around the fact that some doctor wants to take blood and poke your child was making it difficult for him to find suitable parents. 

 

I was going to say at the time, you know when you sort of took part did you feel sort of vulnerable?

 

No actually for me it was more of an empowering thing. Because I thought well I’m actually here being able to take control of something, you know. I’ve got a say finally in something that happens, up to then I had had no say in anything it had all been based on, you know, what they wanted to do, doctors wanted to do rather than what I wanted to do, so.

 

Linda considered the risks of her daughter taking part in the trial to the risks of her getting a...

 I was interested in the sort of the consenting to take part really when you know you’re not sure what you’re going to have and that actual yes we’re going to take part anyway.

 

Yes only because the drug had been tested for the lung patients before, I don’t think I would have taken part had it not been a safe drug.

 

Yes that was important, that knowing, and trusting that it was safe.

 

Yes I knew it had been licensed for normal for the lung complaint. I wouldn’t, I don’t think I could have taken part had it been just a completely new drug. For myself I could have but not my child, you know, yes. No I couldn’t have taken a completely randomly untested drug for myself for my child no.

 

Slightly different to consenting for you than it is for consenting for someone else.

 

Yes, and especially for your child. The rest of your life you would think if only I hadn’t, if only I hadn’t, you know. It’s, it would be different if her life, if she had say cancer and it was an experimental drug that, an unknown drug that could help her and without it she would have no prognosis and that would increase her chance. This drug was purely for giving her less of a chance of contracting the RSV virus, Respiratory Syncytial Virus I think something like that. And it’s something that cystic fibrosis patients suffer and if she had got it with her heart condition it could have made her very, very ill. There was no guarantee that it was going to help her but I thought if it helped, it increased the odds. But if she had a condition where giving her, taking part in a trial would be her only chance in a way then I could do it. But, you know, if it was say if she had any form of leukaemia or something and the drug that was being tested had a proven success rate but the only way she could get access to it was by taking part in the trial then I would say yes, you know, so. Anything that would increase her odds of survival would be the thing, you know, so.

 

I mean for us the risks of her taking part in a trial versus the risks of her getting RSV. RSV was by far the worst case scenario. So her getting the vaccine potentially outweighed the risks of, you know, for us that was, you know. Even though we don’t know which one she got and we had no guarantee of her getting it so.

 

Linda didn't like to take the money for expenses because her daughter had received such good care...

 To be honest it wasn’t I kept insisting that they gave it to the children’s heart unit. Because at that stage she was having cardiology appointments about twice every two weeks and having all the echo’s and by the time we’d had cardiology appointment about six qualified people had in some way or other they had some involvement in her care. Whether they would have been a dietician or the echo lady who does the echo or the ECG lady or the cardiologist or the nurse and so getting £7 for parking £7 for petrol or something in the days when petrol prices were slightly cheaper [laughter] seemed almost to me not being, not insulting towards me but insulting towards the hospital that I would even consider taking their money when they’ve given my child so much. And they’ve got at the hospital the children’s heart units got a fund and I just said please put it in there don’t give it to me. They made me sign for it to say that they had given it to me because they still had to get me to sign so that they could put the expenses through. So it was all paid for by the drug company it wasn’t paid for by the hospital. And the nurse was seconded to the drug company she wasn’t actually employed by the hospital and but it still just didn’t feel right taking money. 

 

So did you give money to them?

 

Yes I did as a, but in saying that had I been like my mum who when I was a child my mum was a teacher, a single parent for her the money would have been a necessity, you know. I think if you had to pay the money, I was fortunate in a sense that I didn’t need the money. But if there was a point where I needed the money it would definitely have helped, you know, so I can see that having your expenses paid would definitely help so. 

 

Linda would consider another trial especially if it might benefit her daughter.

 And now, that’s a, I mean because at the hospital where she’s seen for her heart, it’s sort of sister hospital does trials for nuts and that’s something I would take her for. They haven’t offered it to her yet but that’s a clinical trial where they do that where they rub a bit of nut on the lip and you have to, it’s all done in intensive care under very careful monitoring, and then systematically increase over a few days the exposure to nuts and that’s meant to, they have said that they probably wouldn’t offer it to her because she’s allergic to three kinds of nuts so that would be, you know, but then might peanuts which is the most severe allergy they might do. And that’s something I would consider but that would purely be for her benefit [laughter] yes, you know, that’s yes so that would be nobody else would benefit from that, that would just be her, you know.

Randomisation was a bit like a lottery. She does not know if her daughter got the actual drug,...

 A placebo, they probably did but I forget now what kind. They did say that some of the children would be receiving placebos some, they said it was, is it a double blind, does that mean, that rings a bell as where some children will be getting placebo, some will be getting the actual drug. They themselves didn’t know what was, it was all in I think, not, I don’t mean unmarked files but it wasn’t marked placebo. It wasn’t marked with the medication it was marked trial drug and you had to complete a diary for about 18 months afterwards to make sure that the child, to sort of say if they’d had any chest, it was all specifically respiratory problems, whether they had any colds, sniffles, coughs.

 

Well because it was a tested drug that didn’t bother me. It was more that I was sort of, a bit like the lottery were I was hoping she was getting the proper drug but knowing that even if she got the placebo it’s better than her not, you know. The odds were still there that she was getting the proper drug and if she didn’t take part in the trial she wouldn’t be given anything. So at least I was increasing her odds of getting the proper drug rather than her, you know, if she didn’t take part in the trial there would be no chance, this way at least she had a chance that was.

 

The drive to the hospital each month with her daughter, having tests and treatment with thinking...

 Well, we’d get there, and they’d take her blood I think to check for levels it wasn’t a sort of an instant thing or it wasn’t waiting for results or, I think it was to check if she got any antibodies or anything in her bloodstream. They would then inject her with whatever it was; they were injecting her either the placebo or the proper drug and then we have to wait for the hour. And then they take more blood, whether it was also to check for levels or, but certainly it was quite, it was quite time consuming. Only, I mean it was one day every, I forget when it, there was about four to six weeks, I think there was a window which we had to go for four to six weeks, it had to be done in that time because it’s not just a one injection thing it’s a series of injections that these children get. And I think that they so it was time consuming I think the fact that I was on maternity leave helped and things. Had I been at work it would have been more of a hassle trying to fit it in but the fact that I was off, it sort of just worked out quite well, you know, so but I suppose if you had been at work and you didn’t want to take part you could have the excuse of saying sorry I’m at work [laughter] whereas I had no excuse [laughter].

Giving her daughter a fifty-fifty chance of getting the treatment was worth the chance.

 And certainly where I had worked at that point, I often worked in the infectious diseases unit in and knew cystic fibrosis people had come in with it and, you know, that once you get it it’s quite a severe virus and that people who immune are compromised get it. So I think for us from that point of view because, I think had he been a surgeon or something he might not have been that caring. But his [husband] main thing was if she can get, even if she only has a 50% chance of getting the vaccine it’s got to help her. So, you know, so that was my main motivation I suppose. I mean for us the risks of her taking part in a trial versus the risks of her getting RSV. RSV was by far the worst case scenario. So her getting the vaccine potentially outweighed the risks of, you know, for us that was, you know. Even though we don’t know which one she got and we had no guarantee of her getting it so. But it is certainly extremely expensive. So it is very, very she would have had no chance of getting it if she hadn’t taken part in the trial. It was very much, it’s very carefully screened who gets it and that is really on a, you know, you have to be really unwell before you’re considered to get it so I think this was one way of her getting it or potentially getting it with would be the only way of getting it.