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INSIDE THE ETHICS COMMITTEE

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Programme no. 4 – Disclosing Illness to a Child

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RADIO 4

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TX DATE:ÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýWEDNESDAY 27TH AUGUST 2008Ìý 2000-2045ÌýÌý

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PRESENTER:ÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌý VIVIENNE PARRY

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CONTRIBUTORS:ÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌý DEBORAH BOWMAN

ÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýPRISCILLA ALDERSON

ÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýGARETH TUDOR-WILLIAMS

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PRODUCER:ÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýBETH EASTWOODÌý

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NOT CHECKED AS BROADCAST

PARRY

Welcome to the last in the current series of Inside the Ethics Committee.Ìý When is the right time to tell a child that they've got a serious medical condition? And what happens when a mother's refusal to tell stops her child getting medicines that might be life changing.

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Sarah has hepatitis B, which she caught from her mother when she was born.ÌýÌý The clinical staff involved in her care first met Sarah when she was 16 months old.Ìý Let's hear first from her nurse and then the doctor. Remember, these are real life testimonies and this is a real case.

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NURSE

Sarah was found to have hepatitis B because her mother had it and her mother had acute infection just before Sarah was born.Ìý If children have the infection they're usually very well and she was a normal healthy child.

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PARRY

So like many other children with hepatitis B, she had no outward symptoms.Ìý But the virus that causes hepatitis B may silently damages the liver eventually causing it to fail.Ìý There is also a long term risk of liver cancer, in fact worldwide, about three quarters of all cases of this cancer are caused by the hep B virus.ÌýÌý Sarah's mum had to take her to hospital on a regular basis for checks.

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DOCTOR

She'd come every year for blood tests, physical examination - check of her growth and development - check to see if she developed any early signs of cancer from blood tests and every five years we do a scan of her liver to see if she developed any odd little lumps and bumps.

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PARRY

What was she told?

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NURSE

For the first few years until she was about six, seven years old we didn't think that she would understand her infection, so the question didn't arise about discussing the actual infection with Sarah.Ìý But as she was getting older we mentioned this to her mother that it's time to inform Sarah and we would help her in how to disclose to Sarah.

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DOCTOR

Our normal policy is that we are honest with our patients and we tell them in an age appropriate and sensitive way what their diseases are and what the prognosis is.Ìý We do have effective ways of telling children about liver disease and how it affects them - information leaflets, playthings - and we use a combination of these techniques in telling them.Ìý I tell them they've got a virus called hepatitis B sitting in the liver, it's difficult to get rid of, at the moment it's not causing them any problems but it might when they're grown up and so we want to treat it.Ìý Usually children are not too bothered.

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PARRY

But Sarah's mother felt very differently.ÌýÌý

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NURSE

Mother was very adamant that she did not want her child to know and her reason for this was that hepatitis B has a big stigma and if anybody in school or in her community found out she would ostracised.Ìý According to mother she wasn't responsible enough to use her discretion in school.Ìý We did mention that we can explain this to Sarah that it's her secret but mother wasn't happy with it.Ìý So we just explained that she's got a liver problem, we were not allowed to use the word hepatitis B in front of Sarah.

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DOCTOR

The issue for the family is the social stigma and so in the early days, although we were uncomfortable with mother not mentioning that she had hepatitis B, we understood that partly Sarah was quite young, partly that there was at that time a particularly difficult social stigma with hepatitis B.

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NURSE

We had a child, a young teenager, a Caucasian family, living in a rural area and this child needed treatment at home and the nurse had to go and provide this and mother had asked the district nurse to park her car in another street and then walk down to her house because she didn't want any neighbours asking questions about why this nurse was coming every week to see their child.Ìý And these families, as soon as they hear the word hepatitis, they think of Aids and because of lack of awareness I've seen children refused admission to school, one mother had to leave her home completely with her family and in the end the trauma in the family was so much that she was separated from her husband and I spoke to her about five years after the event and she said she had lost contact with all her family members because of this.

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PARRY

Stigma isn't the only problem.Ìý For the mother, there can be an overwhelming sense of guilt.

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NURSE

She did feel very guilty about having passed hepatitis B to her child.Ìý There are many mothers who are like that, they do not - many of them - don't even want to know that their child has got the infection because of this guilt.

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PARRY

At this stage Sarah was 10 years old.Ìý Some 10 year olds are very inquisitive, was Sarah?

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DOCTOR

Sarah was not at all inquisitive about her condition.Ìý She came very calmly with her mother and didn't at any time show any curiosity about precisely what it was.Ìý I'm not sure that's particularly unusual actually because she'd always been told she had a problem with her liver and often children don't ask.

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PARRY

So does it matter that Sarah doesn't know? After all, if she's happy and the mother is more comfortable not telling, is there an ethical issue?Ìý Does Sarah have a right to know?Ìý With me to discuss this case today are:

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Deborah Bowman - Deborah is a senior lecturer in medical ethics and law at St George's, University of London.Ìý

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Gareth Tudor-Williams, who's a paediatrician from Imperial College Healthcare NHS Trust, he has a special interest in hepatitis B and is a member of the St. Mary'sÌý Hospital Research Ethics Committee.

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And finally Priscilla Alderson who is Professor of Childhood Studies at the Institute of Education.Ìý She is also a member of her institute's research ethics committee and her research is focused on children's participation in research.

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And you too will have an opportunity to give us your thoughts by telephone or on the programme's website and I'll be giving you those details later on.

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So Deborah Bowman, what are the ethical issues so far?

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BOWMAN

I think this case well demonstrates how children come as part of a family, they come as part of a unit in which particular values may or may not prevail, we may or may not understand them and it is often, quite naturally, the parents or parent who we assume knows the child best and that, in this case, is one of the big issues.Ìý The other challenge is what happens when healthcare professionals begin to question whether or not their relationship is with the child, the mother or of course, most properly, both of them.

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PARRY

Gareth, hepatitis B is a very infectious disease; does that have an impact on the ethics of this case?

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TUDOR-WILLIAMS

Well at this stage we're talking about a child whose coming up for 10 years of age and hepatitis B is an infectious disease but it's only acquired via either blood to blood transmission or sexual contact or of course mother to child transmission.Ìý And in a young child in the first decade of life the sexual contact and the mother to child transmission issues are clearly not relevant.Ìý And so it's only a question of the blood to blood contact which is mainly around intravenous drug use and the use of needles, there's a much, much lower risk from playing in the playground and contact sports and so on.Ìý And I can't see that from this child's point of view any of that is relevant because in the school setting the school's have a policy that takes care of any blood spills that might put another child at risk and it's really not a great consequence to the child under the age of 10.

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PARRY

Is it unusual that the mother finds so much stigma associated with hepatitis B because certainly in many countries of the world hepatitis B is endemic and doesn't have a stigma?

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TUDOR-WILLIAMS

Yes I think that's a really good point, I think in this situation we've already heard the mother's sense of guilt about what has happened, which goes back to presumably her own acquisition of the virus through perhaps intravenous drug use.Ìý For the vast majority of the people in my clinic in London who come from all corners of the world, including particularly South East Asia and Africa, hepatitis B isn't really stigmatising because it's so very common - 350 million people are living with this virus worldwide and the vast majority have acquired it either through mother to child transmission or early in childhood.

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PARRY

I should say that we don't know how the mother got her hepatitis B in this particular incident and it is actually a Caucasian family.Ìý Priscilla, should children be told and is there a right age to tell them?

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ALDERSON

It varies very much with the disease.Ìý If they begin to feel and experience the symptoms in the early months and years and have treatment then the earlier they are begun - begin to be told the better.Ìý Even in 12 months plus because children are not just blank slates, if we don't explain to them it doesn't mean they aren't thinking or questioning, children are meaning makers, they're making up their own rationale and if it seems to them that the treatment - like blood tests, it sounds simple to us but it's very serious to many children, very harrowing for some - if that's happening to them and they don't know a reason why usually they explain it that they know their parents love them and want the best for them and therefore their parents must be punishing them and the children feel guilty.

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PARRY

So telling the truth is really very important?

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ALDERSON

It is, except you've chosen a very unusual and complicated case and I wouldn't like to dictate what people should have to do, they seem to all be trying to do their very best and we must respect the parents' knowledge of their family, their child.Ìý And also this condition is complicated in that Sarah doesn't feel the symptoms, that would in a way help a lot to excuse the treatment and the difficulties.

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PARRY

What about when the parent has a completely different idea, I mean the clinicians may feel that it's in the child's best interest to tell them for all the reasons that you outline so eloquently but what if the parent is absolutely set against it?

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ALDERSON

We've learned from research we've done in children that it's best to share this knowledge with them but not brutally tell them or lecture them, just tentatively listen to them, follow their cues, give little bits of information as it seems to be needed, working very much with families.Ìý And if the family are very much against it to remember that the child is the patient and has rights.Ìý And if there's a big worry in the family such as stigma maybe they could learn from other families in the clinic about how they're dealing with it.

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PARRY

Where are we legally with that Deborah?

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BOWMAN

Well legally are usually the person who's the law identified or the people whom the law's identified as knowing what is in the child's best interest.Ìý Best interest being drawn much more widely than best medical interest.Ìý So legally the normal position, default position, is that parents will or people with parental responsibility give consent and one parent can do that, it doesn't need to be both parents.Ìý However, there are lots of cases and lots of legal examples with situations where clinical teams have begun to question whether or not parents’ choices for their children are in their best interest and indeed there have been some very high profile cases that have gone to court and they are treated on a case by case basis.

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PARRY

Gareth, you're involved day to day in looking after children with these sort of diseases, what's your take on this?

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TUDOR-WILLIAMS

I was interested listening to Priscilla because I think that you make a really good point that children quite clearly do require honesty and they deserve to hear the truth but that doesn't necessarily require us to tell a child of six or seven or eight that they've got hepatitis B or HIV, which is a disease I deal with probably more day to day, and you can understand the kind of dimensions that that raises with the families.Ìý But it's crucial that the child does have some understanding why they've come into hospital, why they're having the blood tests.Ìý Similarly the children with HIV don't necessarily feel unwell, especially when they're on treatment, they feel fine - they go into school and everything's going fine - except for the medicines they're having to take. And as long as they have some understanding of why they're taking the medicines, you know hepatitis B it's because of hepatitis or problem with the liver, which has already been explained to Sarah, in this instance, is that not good enough?

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ALDERSON

Oh yes, it's not a matter of do you tell everything, it's how do you tell, how do you share knowledge in ways that everyone is as comfortable as possible.

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TUDOR-WILLIAMS

So provided you build it up in a sensible fashion that the child themselves can understand at different developmental ages, then actually as long as you're not telling any lies, as long as you're building it around a certain amount of truth, then you can eventually come, when the time is right, to naming the virus.

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PARRY

What about this idea that she's not curious about her condition?Ìý I must admit I listened to that and I thought well perhaps she doesn't exhibit curiosity with her mother or with the doctors but she might be asking other children she meets in the clinic, for instance.

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ALDERSON

Research with children with cancer suggests that they tend to protect their parents by not letting their parents know how much they know and to conceal some of their anxiety and suffering.Ìý I think I've seen that in some of the children I've researched too.

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TUDOR-WILLIAMS

Yeah I think you're absolutely right and I think also children pick up the clues from their parents and if they sense their parents are very uncomfortable about this then they will display this kind of inert lack of interest because they just know this is too difficult to go there, especially in front of their mothers.

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ALDERSON

But we then have to wonder what the cost is of this anxiety, this silence, and if they have heard odd remarks - whether they're making misunderstandings and unnecessarily negative interpretations themselves without help.

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PARRY

How influential, Deborah, is a clinician's discomfort, in this case about lack of disclosure, to the outcome?

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BOWMAN

I don't know how influential it is on the outcome, I think it's extremely influential on the questions that have been asked.Ìý I think ultimately clinicians are the people who are being asked to develop an effective therapeutic relationship with Sarah and actually that is going to be dependent upon trust, it's going to be dependent upon truthfulness.Ìý And I think once a clinician begins to feel that prickle of moral discomfort there are questions that have to be asked and it may or may not influence the outcome but it should certainly influential the questions.

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PARRY

You're listening to Inside the Ethics Committee on ±«Óãtv Radio 4, and today we're discussing the case of Sarah, a young girl who has hepatitis B.

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At this point in the story Sarah is 10 years old.Ìý She does not know that she has the disease - simply that she has a problem with her liver - and her mother is absolutely adamant that she shouldn't be told.

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But then something happened which cast her decision not to tell in a new light.Ìý Sarah was offered the opportunity to take part in a clinical trial of a new drug.Ìý It was hoped it would bring down the level of hepatitis B virus in her body, so reducing the chance that she would develop liver problems later.

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DOCTOR

Sarah had been in a number of clinical trials from the age of three, evaluating different new antiviral medication, unfortunately none of them cleared the virus or had a significant effect on her, and that was why we particularly wanted her to try what seemed a newer and most effective drug.Ìý It had been effective in adults, very safe without significant side effects and we felt Sarah could benefit from being treated with this medication.

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PARRY

Unfortunately, because many of these medicines have only been trialed in adults, no-one knows how well they are likely to work in children, or even whether they are safe.Ìý It means the drugs are not licensed for use in those aged from birth up to 18.Ìý Although people instinctively shrink from the idea of drug trials in children they need medicines and paediatric clinical trials are the only way to find out what works best for them.

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DOCTOR

There are no effective treatments for children with hepatitis B so my policy is that I do not treat children with hepatitis B unless they're symptomatic or in the context of a randomised clinical trial, I think this is a very important point that we should only treat these children in a way which they're very carefully monitored, the safety and effectiveness of the drug is very carefully monitored and lessons are learned, not just for that child but for other children.Ìý And the particular type of drug which is an oral medication has no side effects of significance.Ìý There's always side effects like headaches, rashes, nausea which are common to any drug but there are no significant side effects.

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PARRY

The problems arose when it came to asking Sarah to take part in the trial.

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DOCTOR

Legally children under the age of 16 cannot give consent to treatment.Ìý We always ask for the parents written and informed consent and if possible we ask for the child also to give assent.Ìý In Sarah's case assent was not necessary when she was at the ages of three, five and six but when she got to the age of 10 we felt that she should have more informed knowledge of her condition and why she was entering into the drug trial.

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NURSE

Any child who can understand information and is of appropriate age and who we think is capable of understanding and can read the information was asked to provide assent.

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DOCTOR

How we normally do this is that we use information which is age appropriate and they sit with a specialist nurse and go over the reasons for the study - you've got a poorly liver, you have a virus in your liver, you take this medicine every day, you have some extra blood tests and so on and then we say what do you think about that - it might make you better and if it doesn't make you better we will learn something that will help other children.Ìý And children are extraordinarily altruistic and unselfish and they very rarely say no to that.

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NURSE

Because this information leaflet had hepatitis B infection mentioned many times this mother was not happy with her child reading that leaflet, so we couldn't obtain informed assent from the child.Ìý So we mentioned it in the medical notes and we didn't show these leaflets to Sarah.

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DOCTOR

We obviously asked Sarah's permission to take part in the study - the extra blood tests that were required - her mother was very keen for her to be included in the study and indeed Sarah did not say no to that but she didn't realise the condition for which she was being treated was called hepatitis B and that was why mother didn't want her to sign the form that had hepatitis B on it.

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PARRY

So Sarah is enrolled on the trial, unaware that the drug is specifically for people who have hepatitis B. ÌýEighteen months go past.ÌýÌý Now 12 Sarah is nearing puberty and the clinical staff are becoming increasingly concerned that she be told about her hepatitis.Ìý And there was even more pressing reason for her to be told - changes in European law on clinical trials.

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DOCTOR

Sarah had been receiving the new drug for a year and a half when the regulations, both in the US and Europe, changed, requiring assent as well as parental consent.Ìý This meant that the pharmaceutical company, very appropriately, asked us to review all our consent documentation and it then came to light that we had an issue with the assent for Sarah.

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NURSE

When the drug company informed us that we need to obtain assent from this child and we asked Sarah's mother about this she was obviously very distressed.

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DOCTOR

Having consulted with the pharmaceutical company we had one of two options.Ìý We either had to agree that Sarah would discontinue the study because it was a protocol violation, which clearly it was.Ìý Or we could seek additional help.Ìý Sarah had been in the trial for a year and a half, we felt that maximum benefit of the drug would not be seen until two years and therefore to take her out of the study at this stage would not be in her best interest, would not allow the drug to be as effective as it might be at the end of two years.Ìý So it was important to continue her in the study.Ìý So we sought additional help in two ways.Ìý We sought additional help in the research ethics committee which was designed just to look at the research ethics but because we felt it was a broader issue we also consulted the clinical ethics committee for advice.

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NURSE

The research ethics committee asked mother for a letter explaining why she didn't want her child to know this information.Ìý So mother then wrote a letter.

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LETTER

I am Sarah's mother.Ìý I do not wish Sarah to know what is wrong with her.Ìý I have told her she has got something wrong with her liver.Ìý I know my daughter best. ÌýShe is too young to find out yet.Ìý I am very grateful for everything that has been done for Sarah and I do wish to continue with the study.Ìý I pray that one day it will be okay but without your help that day will never come.Ìý I also live in a community where if it was to come out about Sarah's condition she wouldn't be able to handle what cruel people would say to her.Ìý I will tell her when I feel the time is right.Ìý Please allow us to carry on with the treatment - you're the only hope I've got.Ìý Thank you.

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PARRY

So we're now between a rock and a hard place.Ìý Her mother says Sarah can't be told but unless she is told, she will be taken off the drug that is benefiting her.

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Deborah, what happens now and why has assent become such an issue?

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BOWMAN

I think there are two things that come out of the testimony we've heard.Ìý Probably they both relate to the fact that there's a distinction between clinical treatment and research drawn in the bioethics and legal literature.Ìý On the one hand, in a clinical context, somebody under 16 with sufficient understanding can make choices about treatment.Ìý But in the more regulated research environment different rules apply and one of those actually related to this notion of assent.Ìý It's not a legally informed notion, except insofar as it's something that the European Directive has adopted as a good thing but it's an ethical principle, it's about involving children from the earliest age and also there is another side to it which is dissent - allowing children to express what they don't want to happen to them.Ìý And both of those are important in ethical practice with children.

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PARRY

This drug is not licensed for use in children so if you gave it to a child it would be what's called "off label", why couldn't you just do that?

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TUDOR-WILLIAMS

Well of course in the past that's exactly what has been happening all too often and in fact I fully support the European legislation that tries to address this paralysing problem in children that we have a whole number of drugs that are useful in adults for which we don't really know the right doses in children and which could be potentially harmful at the wrong doses.Ìý We genuinely don't know whether exposing this girl to a drug that may not clear the virus completely and may leave her open to either side effects or to the selection of resistant virus down the track could be doing more harm than good.Ìý So I wouldn't feel comfortable about doing that.

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BOWMAN

I think what was very interesting as well Vivienne was you said a rock and a hard place which implies moral polarity and actually I think what we've now seen is that the interests of the drug company, the interests of science and getting this knowledge, the interests of Sarah, the interests of her mother and the healthcare professionals who are both researchers in this context and also treating clinicians and they may collide and they may be given greater weight in different contexts but I'm not so sure that it's as polar as a rock and a hard place.

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PARRY

Priscilla, this girl is 12, she's coming up to puberty, she's got a virus that is sexually transmitted, why does it take a trial to force the issue of disclosure?

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ALDERSON

Because we want to protect children and keep them as children so often.

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PARRY

Should we really force the issue with the parent in that case?

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ALDERSON

Deborah said that assent doesn't have legal background, I wonder if it's an idea from America when people say children cannot consent, well they can't consent in the United States but in this country they can, they can give legally valid consent to treatment.

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PARRY

Oh is this the thing called "Gillick Competence"?

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ALDERSON

Well it's more than that, Lord Donaldson even said that if a child consents and the parents refuse the child's consent can override the parents refusal to treatment.Ìý However, it's very different for research which is much more cautious about getting parents' agreement and support.Ìý But so often research involves treatment, as in this fascinating case, and then we have to decide which of the two principles really - to protect children or to respect their decision - apply.Ìý And it would seem that it would be most important for English people - I say this because of English law - everyone in Great Britain, with the Gillick case, can respect children's decisions in a way in many European countries they can't.Ìý

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PARRY

Deborah, just remind us about Gillick.

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BOWMAN

Yes Gillick was a case in the mid-'80s, it went all the way to through legal system, eventually ending up in the House of Lords.Ìý And the essence of Gillick is that if a minor, an adolescent or a child, had sufficient understanding of any issue - although it was a contraception case it actually applies to all treatment decisions - then clinicians should be seeking consent and the minor can give valid consent.Ìý Although it is variably interpreted, for example parents still continue to sign consent forms when the child may indeed be Gillick competent.Ìý And it's a functional test, rather than a test of age, there's no magic number so 10, 12, 7, 15 - it doesn't matter - it's about sufficient understanding which may vary depending on the type of decision the child involved, the context in which that child is experiencing illness etc.

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ALDERSON

So in our research nearly 20 years ago we found parents and surgeons respecting the consent of children aged from eight years but we started our research from then and that was a long time ago.Ìý This is the principle - the actual reality - of listening to children, not operating if they refuse, waiting for them to agree and be committed but you can't generalise about it.

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PARRY

Why does seven keep coming up as the kind of age that people think of as being somehow an age when children were ready to start thinking about things more seriously?

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BOWMAN

I think it's because everybody likes certainty, it makes it much clearer and it's developed as a sort of moral myth - seven has all sorts of values, Jesuits said it was the age of moral responsibility, it's a transition often from infant to junior school - there are all sorts of reasons potentially but ultimately it doesn't reflect the position which is about function and what a child understands.Ìý And what clinicians do can of course have huge bearing on either enhancing or inhibiting a child's understanding.

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PARRY

Sarah is taking just a tablet every day and there are very few side effects, would it be different it were something much more invasive?

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BOWMAN

Well I think what's very interesting is that the testimony said there were no significant side effects and then said headaches, rashes etc.

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PARRY

Yes I noticed that.

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BOWMAN

Also mentioned blood tests, which for children are ...

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PARRY

Miserable.

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BOWMAN

... difficult and I suppose what I'm interested in, and perhaps it happens inevitably, is that people focus on risks, benefits, outcomes whereas actually there might be moral value in simply telling the truth or simply giving the information irrespective of whether the outcomes are poor or whether or not the risk is perceived to be significant, it might just be that we say it doesn't matter whether there are side effects or not, what matters is that we develop trusting relationships with children and that is why we give information, not because we perceive there to be a risk benefit equation that we can somehow conjure up.

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PARRY

Gareth, let me turn to that question of giving information to children.Ìý How do you give information on something like this - a clinical trial?

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TUDOR-WILLIAMS

I totally agree with Deborah and Priscilla that it comes down to openness, honesty and directing the information to a level that the child of each age can comprehend.Ìý And certainly we talk to children if they're entering clinical trials from any age at which they're capable of understanding.Ìý We have 13 year olds who are developmentally delayed and wouldn't begin to understand.Ìý We have six year olds who would really wish to know what's going on.Ìý And we try and adapt our information accordingly.Ìý We're just being asked to present a patient information leaflet to a group of children who are between the age of 7 and 12 that totally discloses their HIV status, now that's a very big issue for us, we don't think it's appropriate that children should be excluded from the trial by the parents because they're not allowed to read the patient information leaflet and we come into conflict with the company who is driving the clinical trial and have to fight on behalf of the children that they don't get blocked from being involved in the trial on the grounds of inappropriate patient information leaflets.Ìý I'm all for them having information that they can comprehend but I wouldn't wish to jeopardise their well being by telling them the diagnosis, for instance, of HIV at an age that's inappropriate and that it isn't in step with our clinical practice.

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BOWMAN

And I think one of the things that Gareth's saying there, and I'm picking up, but I think is terribly important is that ethical practice is about negotiation and consent isn't about leaflets, it isn't about one party dispensing law or information to another who is generally more vulnerable than the person doing the dispensing.Ìý It's about gauging the child in front of you, it's about responding, it's about being imaginative.Ìý And I think that's - that's the virtuous practitioner, if you like, in this context.Ìý And it's much more of interest to me than risks, benefits etc., I think it's a much more helpful moral guide.

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PARRY

How do you tell, Priscilla, what to tell and exactly when to tell.

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ALDERSON

Well one famous psychologist says you can tell a two year old everything important as long as you explain it properly.Ìý And we've got plenty of adults in this country who don't read much and haven't got much English, so we have to be very good at communicating to people of all ages.Ìý A basic thing that children have to understand, if they're going to enter a double blind randomised trial, is that they may not be getting the new treatment, they may be getting the standard which isn't working very well, they may be getting a placebo.Ìý Another thing that worries me about assent, somebody ought to work out exactly what it means and what it's doing because if you understand enough to give consent why don't we call it consent and if you don't why are we calling it assent?

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PARRY

That's a very good point Deborah.

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BOWMAN

Absolutely.Ìý It's because the law is socially and legally constructed and it's because we're a risk adverse society and because it's complicated.Ìý And there are very few papers, Priscilla has done a great deal of empirical work with children, there isn't that much out there.Ìý We assume we know about children - we don't.Ìý Nor do we know what really constitutes assent and why it may or may not be different from consent.

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PARRY

I mean it's a pretty tricky concept for adults - this idea that you go in for trial and you might get nothing - I mean so it's very difficult for children.

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ALDERSON

It is.Ìý Once you break it down though to things like randomisation - lots of people watch the lottery balls on television - they really can understand randomisation.Ìý What they can't understand is how come my doctor carelessly assigned me to the wrong arm, why doesn't my doctor know.Ìý And that depends on healthcare staff and researchers being very honest about the limitations of their own skill and knowledge.

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PARRY

Gareth, how can you carelessly do such a thing?

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TUDOR-WILLIAMS

I do it every day of the week.

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ALDERSON

Because you're an honest doctor.

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TUDOR-WILLIAMS

No I take your point.Ìý I think that it is entirely about us as clinician scientists recognising that there is truly equipoise in the question...

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PARRY

What exactly is equipoise?

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TUDOR-WILLIAMS

Equipoise means that there's an honest balance that there is no clear prior knowledge or evidence that one treatment or one approach is better than another.Ìý Because if we'd seriously thought that one arm was categorically better than another then we couldn't possibly randomise children into those studies.Ìý We have to have uncertainty ourselves.

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ALDERSON

There's a lot of emphasis on trial research leaders having equipoise - believing there's an equal chance in every arm of the trial.Ìý But our research found it's essential that all research team, and they often don't, have equipoise.Ìý But we need to convince parents to understand equipoise and children and they can but it's very difficult if the trial leader believes in it but most of the researchers who actually collect the blood and deal with it don't.

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PARRY

Deborah.

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Ìý

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BOWMAN

What I'm struggling with here is that the ethical standards appear to be different for clinical treatment, which has to be of immediate benefit and it seems like in this case it was the only way in which this child could access clinical treatment and research ethics which require a different way, that Priscilla's already explained, of looking at the person in front of you, so it may well be that you can create a situation of equipoise - and that's a very good and sound ethical rationale for it - but actually equipoise is quite difficult here because Sarah was given the opportunity to access something potentially in a way she couldn't otherwise access it.Ìý So the uncertainty is around benefit - was she going to benefit - but the alternative was nothing.Ìý And I'm not sure whether that's come out as clearly as maybe it ought to or whether Sarah understood that or her mother.

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TUDOR-WILLIAMS

If I can butt in, I think one of the problems with this case is that we are assuming that this treatment is beneficial - Sarah's mother is totally wedded to the idea that without this treatment her child's going to do very badly.Ìý But the truth is it might be doing Sarah more harm than good.Ìý You know, she's on a drug that may potentially not clear the infection, she may end up with virus that is therefore resistant not just to this drug but to future drugs in that class, and her treatment options down the line may be limited as a result and that's another really important reason and there's a complexity of this specific case that we need to think about.

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PARRY

I just want to return to one final thought which is about Sarah's mother and we heard in that letter she wants to tell Sarah in her own time and I wonder how long you can allow a parent to do that, when does there come a point where you have to say actually this is no longer in a child's interest to be denied this knowledge?

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ALDERSON

Again, going back to research, for example about adoption, over decades it's been found that on the whole the earlier they are told the more children adjust and see it as part of their identity and find it less horrifying and painful.

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BOWMAN

I think I referred earlier to the prickle of moral discomfort that clinicians may be feeling and I think once you are feeling that there needs to be a discussion that explores options but nonetheless names the discomfort that the clinical team feels about this child being uninformed.

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PARRY

Okay.Ìý So now we've come to that part where we want your advice.Ìý So what would you say to the people who would have come seeking your advice in this particular case?Ìý Deborah.

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BOWMAN

I feel that a decision does have to be made.Ìý I guess I would go back to the idea that is it really the rock and the hard place that it appears?Ìý So part of the process would be exploring what the child had been told, what the concerns are, how much the mother knows about other families where diagnosis has been disclosed, supporting the mother in doing that, offering options but negotiating a plan and ultimately I do feel that Sarah should be told her diagnosis but in a supportive way that maintains the trust.Ìý Remember this mother has trust in her team, Sarah needs access to good clinical care, it is very important that in the pursuit of truth that isn't forgotten.

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PARRY

Gareth.

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TUDOR-WILLIAMS

Sarah clearly needs to know her diagnosis and reasonably soon because of her becoming sexually active and putting other sexual partners at risk.Ìý She has a right to know before any of that becomes an issue for her.Ìý But in terms of continuing in the clinical trial I would personally fight for an amendment to the patient information leaflet so that that isn't the overriding issue, so that you can continue working in a sensitive way with this mother and with the family to ensure that in the long run the child is enabled to stay in the clinical trial, because I do think that that's in both this child's best interest and in the broader realm for children with this condition, that's what I would do.

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PARRY

Would you keep her in the trial Deborah?

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BOWMAN

No, I don't think I would, unless she were told and supported and the mother was supported in telling her.Ìý I think ultimately if the mother refused to tell her, notwithstanding all the exploration of options, I do feel that ultimately it would be unethical for Sarah to continue in the trial not knowing what was happening, why it was happening and what the potential outcome might be for her.

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PARRY

Priscilla, keep her in the trial or not?

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ALDERSON

I like Gareth am saying fighting for a change so that the label might not have to be in the information to make sure that children are as informed as fully as they can.Ìý Deborah has persuaded me that there should be a much firmer line there, that Sarah does have the right to know.

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PARRY

Okay.Ìý Well thank you to all our panel:Ìý Priscilla Alderson, Deborah Bowman and Gareth Tudor-Williams.

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And now let's find out what happened in the real life case.

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DOCTOR

The research ethics committee advised that under the social circumstances outlined by the mother the fact that the child understood she had a poorly condition that it was appropriate to continue with the trial and that the cause of the poorly liver did not need to be disclosed to the child.Ìý And the pharmaceutical company agreed with that and Sarah continued in the study.

Ìý

The clinical ethics committee were very much in support of the mother's position.Ìý They felt on balance the mother was acting in the best interests for her child.Ìý She had attended every outpatients, she had been meticulous in giving the medication, so there's no evidence that she was in any way failing her child and that the social circumstances in which she described very clearly in her statement were such that for the best interest of the whole family it was better that the child did not understand she had hepatitis B in case she might inadvertently reveal this at school or to friends or to relatives.

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PARRY

All this happened when Sarah was 12.Ìý She's now 14 and still in the trial.Ìý So what's happened since?

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DOCTOR

The drug has been effective, has cleared the activity of the virus down to a very low level which is the most that we can expect in terms of modern treatment.Ìý So she's no longer infectious to other people and her risk of developing significant liver disease is much reduced.

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NURSE

The following year we suggested to mum that it is time to inform Sarah and we would help her.Ìý Mother wanted to tell her in her own way at home.Ìý At the following appointment we then had a proper discussion with Sarah about implications of having this infection and all the precautions that she needs to take.Ìý Because she's a happy and a lively child and doesn't ask many questions we don't know really what's going on in her mind.Ìý She's also a typical teenagers who when we explain information to her or discuss it with her she gets restless after a while and doesn't want to know very much.Ìý And mother says that's how she is at home.Ìý It's been more difficult for mother, although she's glad that Sarah knows about this now, she still needs support which is ongoing.

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PARRY

You've been listening to Inside the Ethics Committee and if you'd like to comment or find out more information about the topics covered in this programme, go to bbc.co.uk/radio 4 and follow the links to Inside the Ethics Committee, where you can leave your comments. Or you can call the Radio 4 Action Line on 0800 044 044.

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And that's the last in the present series of Inside the Ethics Committee which is returning again next year.Ìý Goodbye.

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ENDS