There was something in the literature and I, and I do believe they made me aware of, of the, any, any potential risk factor. But the risks are extremely low with this.

Did they say what they were? Can you remember?

Well, there’s, they, they tried as, as far as they can to rule out the risk of allergy, because these things are, are, are, have been chosen because they, they shouldn’t result in, in allergy. So I clearly remember them talking through that. It is I believe that the risk is that by interfering with the, the skin barrier they don’t know whether it could actually make things worse rather than better. I suppose if the baby’s barrier, skin barrier doesn’t, isn’t allowed to progress naturally. But I believe that that risk is low and it was certainly a risk I was prepared to take.

And do you think because it was kind of very kind of low risk perhaps that’s one of the reasons perhaps you took part?

Yeah, because they’d already tested the drugs, it was just really to see which one they were going to use. And both of the names were names that we had recognised as leading drug companies. Even though we didn’t know which one we were with. We felt that it was safe enough for her to actually, because she, it was 50’50 whether she was going to have the one that was going to be trialled out, or used for every, all children, or, whether she was going to have the other one. So yeah, we felt it was safe enough for her to have.

So you weren’t aware which one she’d had?

You weren’t, you weren’t supposed to be aware, but if I remember correctly the two brands, one was a chemical which was like KB and one was a B. So we’d sort of get, worked out which company we’d were having. But not that they’d actually told us, it wasn’t difficult to work out. But not that either one of them meant you know much to us really.

Would it have made a difference if you didn’t know the drug company?

Possibly. I might have asked a few more questions as to whether they, if they weren’t going to tell which of the current drug companies were, then I think we would have probably wanted to know more information whether they, if they’d wanted to keep it anonymous, what are the, what do these drug companies do? What do they specialise in? What’s their track record really?
Yes definitely. But because they were one’s that we’d heard of and knew, and we could research on the computer then we were happy for her to go ahead.

Did they talk about any side effects at all?
No the side effects, yeah it said the side effects the side effects being the same as they are for the other jabs, you know just sort of the grizzly baby for a couple of days. [Right.] But I guess if you’re trying a new thing then you don’t know necessarily what the side effects are going to be do you, so, I’m not sure, I think the link between the MMR and autism is fairly anecdotal but you you’ve got to, I always think when I say that and I lecture on that and I talk to people about that at work and stuff and then I think imagine being a mum though and your baby’s healthy and then you take it for a jab and it comes back a different baby. And it may be coincidental and it may be a whole other range of factors but imagine how that would feel just living with that even if it isn’t and people telling you it isn’t would probably just make it even harder [laughs] so, yeah. it’s sort of, it’s quite controversial isn’t it [laughs].

Yes, yes. They went through, so that’s why when she had the side effects really badly we weren’t too, we were concerned, but we knew that, to expect them so, and I think it, perhaps it was a bit more of a shock because after the first vaccine she hadn’t had any side effects. There was no redness and it was, almost a bit of a, Oh okay But not a let down, but okay, so she’s actually fine with all of this, you know. There’s all this, Oh you must contact this, and this may happen, and this may you know they’d gone over everything to the nth degree, and there was nothing. So when the, it happened the second time we were like, Oh right okay, well we must you know, you know, we had to record her temperature and how big her, the redness was on her arm and everything, so. But yeah, no she’s absolutely fine with it.

I was very nervous actually, just because it wasn’t for me. And children aren’t very good at expressing themselves anyway, not; they’re not very good at expressing feelings. So if you, if you could say to Toby, Can you describe your migraine it would just be like, Oh, well, it.. Because apparently you could have left-sided or right-sided, well, Toby’s is all over, all at the front. So, but when the doctor was asking him certain questions he was very vague in his answers, where an adult can be more specific. So I was quite nervous because I didn’t want Toby to feel as if he was under too much pressure in that he couldn’t relay back to me any side effects. And I, I was quite nervous about that. But it, it’s okay, because I don’t; I don’t think I gave him enough credit really. Because he seems to know. And if he feels a bit off he’ll tell me. Or if he looks a bit peaky I’ll say, you know, Looking a bit grey today. Are you okay Because you can usually tell when a migraine is coming on. But, no, I think once I’d been told that the medication was fine I felt a lot more at ease. Because, like you say, when you don’t know what medications do anyway.

In our experience, no. We’ve had support right from the start. We were told what we were going in to right from the start. I think it was really important about Toby getting his own literature as well as myself. That was a really big thing for him. No, because the, the experience we’ve had up to now, we’ve had a lot of support. We do know, and we keep being told, If you want to withdraw, you can withdraw But no, we’re happy. Toby’s happy.

I think they need to know as well that if anything happens or they get ill at all throughout the study that we as study personnel really need to know about that. If it’s a drug study we need to stress the point that if they are ill or they’ve experienced say a side effect or a feeling that they’ve never had before that it’s really important that that is disseminated to us so that we can report it and make the right decision about, you know, how it’s affected them and make sure that they get the right treatment and that sort of thing. So that doesn’t just encompass an admission to hospital it might just be you know, a disturbance to their sleep pattern for example, that doesn’t cause anything to happen within a hospital environment. But nevertheless it’s a change to them, which is why it’s all part of communication. it’s important that they know how to contact us or they know how to contact their research, their nurse specialist for example or their, or the principal investigator because that information can be disseminated down to me and I can contact the family if necessary. That all, that all boils down to prompt reporting of adverse events, serious adverse events that sort of thing.

Within a couple of weeks of him being on the drugs we noticed a change in Dan, and it wasn’t for the better. He, migraines, he wasn’t having any migraines, but his moods had changed. And we were a little bit, we couldn’t, Dan had changed schools at the same time, so we weren’t sure whether to put it down to the fact that he’d changed schools or whether he was getting older or whether it was the drugs. So I literally just sent a text to his nurse, saying, Unsure”. Dan seems a little bit moody. And within twenty minutes we got a phone call. A couple of hours later Dan’s doctor rang to say, We’ll drop his tablets down a little bit.

He can stay on the trial but we’ll drop him down a little bit to see how he, he goes on that, if his moods change. Any time you want to stop, we’ll stop. We’ll, and we’ll still obviously take care of Dan. Don’t worry about that. He, he seemed to settle out a bit when his, when the dosage was dropped a little bit. And then he, I think he had maybe two migraines in the whole of the trial. Which was really good, brilliant. And then he stopped on the 24th of December. We went to see the nurse and the Doctor on I think it was 22nd or 23rd and everything was stopped then, obviously for the eight-week gap in the trial. The only bad thing was within seven days Dan had a really bad migraine. So the week, exactly a week after he’d come off the tablets, and he was just out of it for the full day. And we just felt like, Does this mean we’re going to have to put him on tablets for the rest of his life? Do we know what? It was a little bit like, I don’t know, we felt uneasy. So next day I texted his nurse, explaining that obviously Dan had a migraine. I wasn’t sure if she was on Christmas break. And within ten minutes I had a phone call back off his other nurse. And then the day after that the Doctor rang us as well to see how he was getting on, how he was feeling, Anything else, just ring back again and they’d sort him out. They were absolutely brilliant.

Just basically start the medication. Before he started the medication he had a four-week period where he kept a diary, logging the migraines and any auras. Since the medication started we haven’t had a diary to keep, but I’ve been keeping one for myself anyway, just so I know what dates he’s had migraine. Basically just to take his medication, which he’s very good at doing. He’s never missed any. And just monitor. If at any time I feel that his symptoms or he’s getting bad side effects, I can stop the trial immediately. And that was made very clear to me from the outset. You don’t have to take part. Not just myself. If Toby didn’t feel comfortable with it, he could stop taking medication. He’s had a few nosebleeds on the trial. And he’s had three migraines. But I think we’ve been doing it since October, October the 31st, so it’s actually, he’s done quite well considering he was having them two, three times a week. And I’m not saying that’s anything to do, it might not be. But that’s why he’s happy himself to stay on the trial. And I’m happy for, to support that.

If it had, if he’d have got worse or there’d been more, would you?

I’d have stopped then probably, yes. And I think Toby feels the same. If, if it had had anything that would have made him feel more that he couldn’t carry on with day-to-day living activities like playing out or going to the scouts, different things, he would have stopped. Because he’s quite strong willed and he knows his own mind. But, no, he’s been, he’s been fine. And he’s, he’s happy to see it till the end of the trial. So I’ll support him in that.

Moving on to the Phase 1 trial which was, and this was the one that had all the information on it about, you know, some, some of the possible risks of it. And that’s what I did, you know, I have to say I do not sneak into his bedroom when he’s away or whatever, or see what’s lying around. [laughter]Oh just clearing up your room, oh I found thi, [laughter] so. And that, I remember having the conversation with him saying are you sure have you read it properly and, you know. And that and that one, that could be, because actually that had quite an involvement for me in the end as well which wasn’t clear at the start but, you know, he spoke about having these bronchoscopies and things. Well of course what he didn’t realise, and it was, which is good in a way for him because with all the hospital treatment he’s had over the years we’ve always just sort of made it as a normal part of life. You just get it over and done with, you do it, it doesn’t really interfere with your life or rather your life goes on around it. So he missed, even though he had hospital, hospitalisations and things, he didn’t miss that much school because to him it was normal to be ill. That was normal for him so we would just carry on and carry on and do things unless he was really, really unwell and really couldn’t get out of bed, life went on, doing it. So he had to go for these bronchoscopies and other things and he’s Oh I’ve got to have a general anaestheti, you know, But it’s only a day, so I’ve arranged for it this da. And I would say Well okay I’ll just check the calendar because I’ll just see if I’m aroun you know. Well it’s alright because, you know, I’ll just go up there and I’ll catch the train home and come bac and [laughter] and Actually Robert if you’ve had a general anaesthetic you won’t be allowed to just come home, I will have to be here to make sure I can look after yo. And just things like that. Yes so we’ve got to work out how to get you back from the hospital, and o. And yes so I had to be sure enough and they said Yes, yes you’ve got to be looked after for 24 hour you know afterwards and things. Yes I know I do work [laughter]. And so its, I mean it’s quite refreshing in a way to have that attitude towards it. But, so I had to, yes I had to be on hand, you know, for that and of course when his voice went and I’d say Perhaps you should tell them at the hospita. But well no he came out of hospital two days later, went off to Belgium, and we didn’t hear from him for a week. And then on the day he arrived back, I knew he was due home that night, we had a text, no we had a phone call from a friend of his and said Oh Robert will be arriving on such a train he can’t talk to you because he hasn’t had any voice all wee. And I’m thinking what on earth is going on, and then you find out, you know, that oh maybe 10 days after he hadn’t had a voice, not sure that this is right I think you need to ring the hospital. So it from that point of view I’ve had to be on the sidelines but still have an active role just the same.

And in fact at the hospital they did start, I know certainly by 16 he, we signed some forms that he could then consent to things or had to and it wasn’t just sort of me. So we did start that process very early on. And he was he wasn’t fazed by having to move from the paediatric department to the adult department. And although I always sort of said, you know, of course I will come with you if you want me to; you’ve got just this [laughter]. And but in the main he sort of dealt with things on his own except for, there was a few occasions when I maybe stepped in and said you really need to go to the hospital, you really need to ring them up, [laughter] you need to do this.

Yes but in that he has assumed, he assumed responsibility, you know, quite early on. And then I realised that I had to back away from making the decisions, you know, for him, he would then have to make the decision for, you know, for himself. But what I would try and do is always strike up a conversation to say Oh I see that, you know, you’ve been asked to do thi or Something’s arrived in the post, oh what was tha, you know, Can I see it or, would you like to talk about i. And then, I’ve made sure that I’ve read up on things he’s been asked to do and gone back to him and said You have read this properly haven’t yo and Had you taken that into consideratio. And I always remember he turned round, and he said to me Yes I’ve read it all I know what the risks are, I’ve read it and I’m willing to accept the.

As a parent you know, I’ve had, I’ve had to say Okay fine good, then I support you in what you’re doin, because he was very clear about I’ve made my decision, still want to do i, you know. One of the possible side effects in one of the papers was possible risk of cancer being induced by it or something. It was something like that and he was no I’ve read it, considered it and I’m willing to accept i. And we chose, we have no choice but to say well, you know, he’s an adult and it’s up to him.

But how do you feel?

You feel I think it’s, it’s one of the lessons I learnt and this was the hardest lesson to learn being a parent of a CF (Cystic Fibrosis) child. And it probably applies generally, you know, anyway, is that having being so involved in his life, and helping him, you know direct his life to get the best out of things. The hardest thing to learn is actually it’s their life. it’s not my life, you know, it’s their life to live you know, as they want to. And they are responsible at the end of the day for the decisions, you know, regarding their life. And if I’m not happy with it I can, I can’t change that for him. All I can do is make sure from my point of view that I’ve helped him to make a considered decision if that’s how it’s to be so. Sometimes you feel, when you see it in black and white there’s this, this and this risk and then and actually I’ll talk a bit more about this study and the problems he did have after it.

Yes, yes it is and then he said I didn’t contact you from Belgium because I knew you’d just worry. So he, and then, but then you think well actually afterwards, you know, a month later when he was in, he later he went back to Uni and he’d ring me and I’d say Your voice is still not better is it Oh no it’s fin No I can tell it’s not bette [laughter]. I would have thought, he should have been thinking is this going to be long term damage, is that something, you know, extra, you know, that’s happened. So yes that.

Was that on the information sheet as well?

No. No not really I don’t recall that in there, I mean other than that I know that if you have a general anaesthetic, any general anaesthetic let alone one that’s had the camera down for your lungs anyway you’ve, aside from that you will have had a tube down your throat in any case because everyone does. And it’s normal after an anaesthetic to have a sore throat or something. But no that wasn’t expected and I don’t think that the hospital were that helpful about it afterwards. Sometimes you got the feeling, you know with that one that their ultimate goal was to get the mechanics of the trial done. [Yes.] And sometimes if there were any side effects they weren’t quite so interested to do those. [Really?] Yes, that’s my sort of view of it. His sounds slightly different but [laughter].

But did you question any of it with the hospital?

No because you see you don’t have the right to. Once they’re an adult, it’s his choice.

But when you can research things on the internet anyway and you see well one of the triggers for this vasculitis he had is if you’ve had some kind of respiratory disturbance and you’re thinking well he’s had various things shoved down his lungs, he’s had a dose of gene therapy trial. it’s possible even a lay person can say well surely you can link those together and make five, but, you know. So but, you know, I did actually take it up directly, you know, with him then. And I said you know, actually he’s not doing so well generally all round because he’s got quite a burden to deal with now. And whether it’s linked of not to, to the gene therapy trial he’s left, been left with some issues that he’s got to deal with and I just want to make sure you’re actually aware of tha. And so I did feed it back to them, you know, that way. But that was, that was a very difficult time.