Marie - Interview 25

Age at interview: 69

Brief Outline: Marie was diagnosed with chronic lymphocytic leukaemia in 1992. She was recently invited to take part in a clinical trial of a new monoclonal antibody. At first she thought she would take part but after reading all the details decided against it.

Background: Marie is a housewife, married, with two grown-up children.

More about me...

On her return from living in Africa in 1989 Marie developed pains which her GP attributed to the change in climate and possible rheumatism. A year later a pain in her groin prompted the GP to do a blood test. Marie was referred to a consultant who told her it was chronic lymphocytic leukaemia. She was shocked and assumed it meant she would die but was told that her disease had been caught early so would be monitored with regular blood tests and she should get on with her life.

 

She spent two years ‘watching and waiting’ during which time her symptoms became more troublesome and she began to feel tired. Since then she has had several courses of chemotherapy tablets called chlorambucil, which kept her symptoms under control. Three years ago her body failed to respond to the chlorambucil in the usual way so she was given FluCy (a combination of fludarabine and cyclophosphamide), also in tablet form. She was well again for fourteen months but then began to feel tired, had pains under her arms and a lump formed in her neck and she had no immunity to infections.

 

Marie’s consultant invited her to take part in a drug company-run clinical trial of a new monoclonal antibody called HuMax-CD20 (ofatumumab). This was a single-arm trial in which every participant would be given the treatment. She tentatively agreed to take part but after reading all the details decided against it. She found the written information provided quite complex and was concerned that the trial was being run by a drug company rather than the hospital. The information said the trial could be stopped at any time if the company felt it had enough information, and that it would not continue to provide the drug after the trial was ended, even if it was working. Marie felt quite angry about the way it was presented.

 

She advises people to think very carefully whether or not to take part in a trial. She feels staff running trials have a responsibility to be clear about the drawbacks of taking part as well as the advantages. She worries that people may feel under pressure to take part if they see it as a life-line.

 

Marie has since had further FluCy treatment and is now feeling well again.

Marie did not realise at first the doctor talking to her about the trial worked for a drug...

In the consultant came and met me in the haematology day clinic with a doctor and introduced this lady doctor as a doctor that is dealing with other forms of treatment. My consultant didn’t say a word. He sat there and let this doctor talk to me about this trial and then she said, “Well, what do you feel?” And then I said, “If it’s a life-line* I can’t refuse it as long as the conditions are all right.” The only other thing that my consultant said was, “I thought that’s what she’d say.” But it didn’t turn out to be for me.

 

So was that lady doctor from the drug company, do you think?

 

That lady doctor, [tut] there were two. There were two doctors on this, on the letter headed note paper I looked for my own consultant and he wasn’t there. This lady doctor I had never heard of before but the other doctor, he has always been at the local hospital for years and years and years. This lady doctor I don’t know but I was told by another lady doctor, when I told her that I was refusing the treatment and she asked me why, and I said, “I didn’t like the conditions.” And she said, “Oh.” And then I said, “I didn’t realise I was dealing with a drug company. I thought I was dealing with research from the local hospital.” And she said, “It is a drug company.” She said, “What happens is”, she thinks that the drug company pay the local hospital for the use of the hospital and allow them to do the research.

 

* FOOTNOTE' It is important to remember that you can have treatment anyway outside the trial and do not have to consent to a trial in order to be treated. Sometimes a new treatment will only be available as part of the trial, but in most cases there will be other treatments available.

 

It's vital to understand all the trial information, but that's difficult for ordinary people....

I’m not saying that people shouldn’t go on trials but I think you’ve got to fully understand what they’re telling you, and for the general public that’s very difficult because we don’t understand medical terms. I was lucky because I had medical people behind me that could help me and I’m not stupid. And because it was just funny that the points that I made about this clinical trial were brought up by medical people as well, and they all seemed to have the same impression that you go into the trial, you go on, you give the approval and you do it.

 

But I think people have really got to understand the implications of doing it and I don’t think there is enough care given that they do understand, because we’re not medical.

 

What would you say to anyone else thinking whether to take part in a trial, not necessarily this one?

 

I’d tell them not to agree. Get all the information from them that you can. If you don’t understand it find somebody that can help you. It’s got to be somebody medically because without medical experience you can never understand it. It depends on your situation. As I say, if you’ve got six months to live and there is no hope for you and the trial is a chance, I think you have to take it. But if there’s hope with other things I think I would sooner put my faith in the drugs that are already available. But that is personal, this is me. I can’t read how other people feel but I do know that when anyone ever offered a drug and they’re seriously ill, their only hope that they’ve got, or what’s in their back of their mind is, that this trial is going to get me well. And that’s in everybody’s mind, not just me, that’s not personal. And I feel that you have to consider it at your own merits but you cannot go into that trial unless you have sat down with a friend or family who’s probably, or preferably, with medical experience, and he goes through with it with a fine tooth comb. And then you have to consider it. But I still think you’ve got to be very careful. 

She didn't like the idea that the trial could be stopped whenever they had enough data. She would...

And at the end of the day, it seems very, very selfish, but I was not out to give them information for other leukaemia sufferers, I was just trying to work out whether that was actually going to do me any good. I’m thinking of me and my life. And there’s no guarantee that after going through all that, lots of visits, and lots of treatment, that it was going to me any good. And secondly, which was also brought up, when I refused it, was they said they have already been doing trials in Belgium and Germany. This would refer to the fact that the trials had been going on for some time. So when they state, “What happens when the drug is withdrawn?” In a heading in the information it states that this company can withdraw this research and trials whenever they basically have enough database and information that they require. And you will then be sent back to your consultant for alternative treatment or you may decide not to have any treatment. Well, what a silly remark to make. If you’d gone through the trials because you wanted to live how are you going to refuse any further treatment if it doesn’t work? It’s not acceptable and you don’t know what kind of mess they’ve made of your body when they transfer you back to your own consultant.

 

So you didn’t feel in this instance any sense that you should be doing it to help other people?

 

I thought to begin with that this research was, the research was being done by my hospital, because it’s a research hospital. And I probably didn’t realise the implication of trials anyway and I thought that if I went on the trial and I could help somebody else by the information, apart from helping myself, it would be good. But I don’t think there is anybody that is prepared to be fighting for their life and then give it up knowing that there’s no success in it. That is too much to ask for anybody, and I think that what they could have done was, the fact that you had decided to go through all this for their information, the least they could have done was to have stated that, “We will complete the trial with you”, not abandon you when we have the information. And that basically is telling you that you’re a guinea pig, which is also not acceptable.

She feels you have to be desperate to go on a trial. She wants to live, so she can look after her...

And I think that, you know, research is brilliant and I think they’ve got to try it on somebody but I think you’ve got to know the details first. And you’ve got to be I think you’ve got to be a bit desperate before you go on a trial. And I think I was desperate because, not because I was so sick but because I’ve got a sick daughter and I wanted to live as long as I could. And I think I thought, “Oh, this is a chance”, you know. So in that way I was desperate but there are people in certain circumstances that are so desperate and I think then, I don’t think you’ve got too much to lose.

 

So you weren’t desperate enough for this particular trial?

 

No, frankly.

 

Perhaps you were offered it too early.

 

I probably if I’d been told I’d got six months to live I might have considered it but I think the emphasis on this trial was [coughs] they really didn’t have very much proof that it was going to help CLL anyway.

 

The information leaflet was complicated and reading it made Marie angry. She was worried about...

If it was, if you were a doctor or you had medical experience, I think you would have probably read it and understood it. But it took me from one o’clock in the afternoon until six o’clock at night reading it, reading it and reading it. And in the end I decided what I wanted to query I had to mark on it, and there was quite a lot that I was querying. I wasn’t very happy that they said that one person on this particular drug, a lupus patient, had now become ill and developed leukaemia with it, and that put me off. It also said that they gave you a list of side effects it could be, but of course being a trial there were probably side effects they didn’t know about yet. It didn’t seem as though it’s been going on for long so they don’t know what was going to happen in the long term. Legal implication was that you could have your statutory rights when claiming any damage caused by the drug company, but then underneath it said quite clearly, of course, this has got to be confirmed that it was actually the drug that caused the complications in the first place, which alarm bells went. How do you fight a drug company and how do you prove it was them if you’re not well? And these are all the things I underlined but I think there were about five pages which were absolutely full of medical jargon, sort of medical information which I frankly couldn’t understand. It was a doctor talking to a doctor not a doctor talking to a patient. I class myself as reasonably intelligent but had I not been intelligent it would have been very hard to understand. And after six hours I was angry because I saw the implications. The more I read and the more I understood it the more it annoyed me.

 

But the, most of the information I think has got to be in a language which the general public can understand, not the language of a doctor. And I think that’s where they failed as well.

 

So what did you understand about the trial? Did you understand what its aims were?

 

[Laughs] I read all about it and it explained in full detail it, its claims and its aims but it then stated, as the lady doctor had already stated in the hospital, that it might not do me any good at all. If it did I wouldn’t be able to get the drug again. And also it was supposed to be the genetic make-up of the CLL [chronic lymphocytic leukaemia] that they were investigating and a lot of things that I didn’t actually, I never did understand. I rang a friend who was a consultant at Harley Street, a Nigerian doctor I was with in Nigeria, and he, I sent him a copy and he actually went through it and he said, “No way.” And he understood it.

 

He understood the medical implications of it. 

Marie's GP spent time discussing her concerns about the trial and her consultant contacted the...

I went to visit my local doctor and he said, “You’ve made up your mind?” And he read exactly the same details that I gave him and he shook his head and pointed out the same things. And he said, the only thing he advised me to do was, “Do nothing until you’ve seen your consultant. Don’t answer the letter, don’t do anything.” But he said that, he said, “All I can say to you is have you made up your mind?” And I said, “Yes. Nobody’s going to change my mind.” And he said, “Well, put it this way, if any drug company tried to put pressure on you I want to know.” And then I said, “They can put the pressure all they like but it wouldn’t work because my answer is no and my no is no.”

 

I went to my consultant and I gave him the details and I said, “I’m not going on it.” And he looked at me and he said, “Why?” I said, “Read it.” And he said, “Oh.” He said, I said, “It’s caused so much argument in the family. My son is annoyed with me for even considering it.” I said, “He doesn’t understand that I didn’t know all the details.” I said, “And it’s caused a bit of friction in the family,” I said, “And they’re all arguing with me I shouldn’t do it but I’d already made up my mind not to do it anyway.” And he said, “The most important thing is I wonder how long these trials have gone on?” I said, “I don’t care. I’m not doing it.” And he said, “No, I’m not suggesting you do but I’m curious how long have they been going on?” I said, “I don’t know and I don’t care. I’m not doing it.” He said, “Okay. I agree with you. You don’t have to contact them, I will do it myself.” And while I was there he got on the dictaphone and he gave them a message that I would not be doing it, that I would be having my FluCy. So no pressure was put on me at all. I was totally allowed to make up my own mind, and in all fairness the drug company have not, well, the drug doctors have not been on to me. They’ve not bothered me at all.  

She had heard bad things about commercial trials. She thought a trial in an NHS hospital would be...

The only information that I heard about clinical trials was bad information. And the few, about a year ago when all those boys had clinical trials* and they all went wrong and I know that they’re still fighting for compensation, trying to prove it with the drug companies, and I don’t agree anybody would ever be able to fight drug companies. They have too much money behind them. I knew that, but had I have known it was a foreign drug company and not my NHS research team, I wouldn’t have agreed. But I just thought that it was because I knew nothing about trials and it was put to me from an NHS hospital that it would be NHS. I don’t know why I thought that because I was totally ignorant about trials but I thought it would be done through my local hospital research.

 

*FOOTNOTE: Marie is referring to a Phase 1 trial at a commercial research unit based at Northwick Park Hospital in 2006 when 6 healthy volunteers became extremely ill. A copy of the Inquiry Report of this incident can be downloaded from the Department of Health website.