The role of the Court in assessing alternative medical treatment

 A discussion of  An  NHS Trust v SR 2012

This case made a lot of the national press over the last month, and I wanted to wait for the judgment before discussing it.  It involves a child who is seven years old and has cancer, and a mother who disagreed with the proposed medical treatment and removed him from hospital.  You may recall that the mother and child then went missing, and the High Court took the unusual step of identifying them in the press so that they could be located, and an interim care order was made to convey the child to hospital once the child was found. The mother was prepared to speak to the press and put forward her arguments as to why the proposed treatments were not in her child’s interests.

The Court were asked to resolve this dispute and made orders directing that the hospital could undertake the treatment they wished to. 

[That decision was made potentially more simple by the parents disagreeing about whether the medical treatment should or should not happen, so the Court were in a position to treat it as a dispute over the exercise of parental responsibility, rather than both parents being adamantly opposed to treatment]

[Caveat – although I might well know some of the people who were involved in this case, I have not discussed it with any of them, and the discussion here is purely my own thoughts arising from the judgment]

The case can be found here :-

http://www.bailii.org/ew/cases/EWHC/Fam/2012/3842.html

Mr Justice Bodey sets out the factual background very succinctly, and I do not hesitate to steal his construction

1. This is an application by an NHS Trust in respect of N a boy aged 7, who is suffering from a Medulloblastoma, a malignant brain tumour. The consultant paediatric oncologist “Dr A” and his multi-disciplinary team of child cancer experts at the hospital treating him (a recognised centre of excellence) are of the opinion that following surgery he now requires radiotherapy and chemotherapy. Generally speaking such a treatment package has about an 80% success rate, sometimes put at 86%.

2. N’s father (whom I will call “the father”) agrees with the advice that radiotherapy and chemotherapy should now be delivered to N as soon as possible; as does N’s Guardian from CAFCASS who represents N in these proceedings. However, N’s mother (whom I will call “the mother”) does not consent, believing that there are alternative methods of treatment which should be used and which would avoid or reduce the undoubtedly detrimental long-term side effects of the treatment package being proposed. Since a child is unable to give the necessary consent for medical treatment, such consent is usually given by one or both parents. In law, medical professionals can act on the consent of either parent. However, when the matter is a very serious one and the parents cannot agree, it is accepted that an application will or may need to be made to the court for a declaration that the procedure in question is lawful. That involves a decision as to the child’s best interests, being the court’s paramount consideration. Hence this present application by the NHS Trust concerned to the High Court to determine the issue of N’s treatment following on from his brain surgery.

It is important to note that this is not a case where the mother was in denial that the child had an extraordinarily serious medical condition, nor one where she was flatly refusing that he should have any form of treatment, but rather that she felt that her reasons for opposing the radiotherapy and chemotherapy were compelling and persuasive, and that she was acting properly as a parent in objecting to them.

The Court had to deal with the mother’s reservations about the treatment and her alternative proposals. There was clearly an interesting day in Court where eminent cancer specialists were cross-examined by Queen’s Counsel about alternative therapies.   {The underlining for emphasis here is my own}

13. Yesterday, Thursday 20^th December 2012, the court sat again for further consideration and determination of the issue about radiotherapy. Early on, Mr Peddie QC handed up a report dated 19^th December 2012 by a Dr D. Usually rules apply about expert evidence, such that the expert’s expertise is checked by the court in advance for its relevance and then his or her report, when prepared, is shared between all parties. Arrangements are made for the experts to meet or speak in advance, so to narrow the issues between them and thus their evidence is able to be dealt with in an orderly way. However, in proceedings of this nature and urgency, that is not always possible and in practice substantial latitude is allowed – although this may make, as here, for a somewhat disorganized hearing. Dr D’s statement makes clear that he is not a medical doctor and he does not purport to be so. His CV refers to him as ‘an internationally acclaimed expert in agricultural, environmental and health sustainability’. His work has focused on diverse issues including ‘the development of natural and sustainable approaches to health care’, and also to ‘the development of sustainable agricultural systems, the reduction of synthetic chemical load among urban and rural communities and the protection of natural ecosystems’. He sets out a number of alternative treatments and therapies which exist, but which I do not need to go through here, and he gives the names and addresses of a number of Harley Street doctors who practise complementary or alternative medicine. Mr Peddie cross-examined Dr A on these various alternative procedures referred to by Dr D, seeking to show that they are worth looking into further, as being actual or possible treatments suitable for N. Dr A dismissed the applicability of all of them here, explaining that they are either experimental, or else used with patients who are already in relapse, or who are otherwise unable to be treated with standard doses of radiotherapy and / or chemotherapy. None of the techniques put to him have, he said, been subjected to the rigorous clinical trials which would need to have been carried out before approving a course of treatment for a child. (The case of an adult is different, as he or she can weigh risks and take his or her own decision as to his or her preferred treatment).

14. Late yesterday afternoon, Miss Butler-Cole asked the mother in cross-examination about her (the mother’s) folder of material on which she (the mother) was appearing to rely in the witness-box when referring to thousands of children who have survived cancers without mainstream treatment, including radiotherapy. It was arranged that overnight M would chose and produce the two papers or reports which she was putting forward and relying on as being the most supportive of her stated case about the existence of credible alternative treatments. That has been done this morning. Mr Peddie has cross- examined Dr A about her two chosen papers. To put it shortly, neither paper supports the suggestion that there should not be radiotherapy and chemotherapy for N. One of the reports is concerned with studies carried out as long ago as 1987 to 1994, which attempted reduced radiotherapy but which in fact turned out to be rather unsuccessful; and the other paper is actually one upon which Dr A is in any event basing the proposed treatment package for N. Nothing has been produced from the mother’s folder supporting the suggestion that there are Chinese or Russian or other reports which speak to thousands of children surviving cancers without mainstream treatment, including radiotherapy.

15. The underlying issue is, as I said at the outset, whether radiotherapy and chemotherapy are in N’s best interests? The advantages have to be balanced against the disadvantages (of which there are several and to which I will come back). The “gold standard” orthodox approach contained in the CCLG guidance (the Childhood Cancer Leukaemia Group to which oncologists in this country belong) is that a package of radiotherapy and chemotherapy is necessary to produce optimum survival rates. Much research, investigation and deliberation by cancer experts over decades has determined the minimum dosages to produce maximum survival rates, with the minimum possible detrimental consequences as regards quality of life. Before radiotherapy was developed during the course of the last century, patients who had N’s cancer invariably or almost invariably died in spite of surgery.

16. Various research papers have been placed before me and have been discussed in evidence. I do not need to descend to the detail of them, although I have read and carefully considered them. One particular statistic was extracted by Mr Tolson QC and is adopted by Mr Peddie QC. It is based on studies of infants (children under three years of age) who were treated by way of chemotherapy alone, that being reasonable treatment for that particular age group, since the detrimental side-effects of radiotherapy for children with developing brains are far worse than they are for children aged around 7, whose brains are that much more developed. Extrapolation from the studies concerned, being in respect of a different age group to N, is not therefore necessarily reliable in any event. The statistics relied upon on behalf of the mother are that with chemotherapy alone, 35% of the infants in the study achieved “event-free” survival at five years (i.e. survival without relapse) which compares with 80% of those who received both radiotherapy and chemotherapy. The statistic for “overall survival” at five years (i.e. the combined total of those infants who had not relapsed plus those who had relapsed) is tabulated as being 67.5%. That appears to compare quite well with the figure of 80% for those infants originally treated with both radiotherapy and chemotherapy (being only about 12.5% lower). However that figure of 67.5% for “overall survival” (set out under the heading ‘chemotherapy only’ in Mr Tolson’s table) in fact includes all those infants who had relapsed after treatment with chemotherapy alone and who had only survived to the five year point by being ‘rescued’ by subsequent radiotherapy and by further (and often more aggressive) chemotherapy. The disadvantages of radiotherapy are much the same whether it is administered as a first-line treatment or as a second-line ‘rescuing’ treatment after a relapse. Thus whatever the statistics may appear superficially to show, there is in fact a significant tested and reported difference regarding the survival rate of infants as between whether they are treated with chemotherapy only, or whether they have both radiotherapy and chemotherapy. Such tests do not exist in respect of children of N’s age because it has not been considered ethical, since radiotherapy began to be used, to treat them without it. There is another all-embracing series of studies which reports on the outcomes without radiotherapy, measured at 8 years on, as being lower still: 27% “event-free survival” and 42% “overall survival”. I add for completeness that the figures under discussion assume treatment starting without undue delay, which is not N’s situation now; his rate is likely to be or may be somewhat lower than it would have been, whether treated with radiotherapy followed by chemotherapy, or with chemotherapy only

It is fairly clear from that that the medical evidence was strongly in favour of the appropriate course of action for the child being that recommended by the hospital.   (Of course, as we know, today’s medical orthodoxy can become tomorrow’s discredited leech therapy, but the Court have to make decisions on the facts as best they know them)

That was one limb, the efficacy of the radiotherapy and chemotherapy as against alternative therapies. The second was comparing the negative consequences of the therapies, and here the mother made more headway

18. I now turn to the disadvantages of the proposed treatment package, in particular radiotherapy. I put it that way because radiotherapy was the live issue when most of the evidence on the point was given on 7th December, 2012, since the mother was not then opposing chemotherapy. Dr A has from the outset acknowledged the existence of the detrimental side-effects on patients which the treatment package recommended by him and his colleagues has. As regards intellectual and cognitive impairment, his evidence was originally that one can expect to see about a 4 point per annum IQ loss over each of the four years after treatment, although it could be less or more. He thought there would be some intellectual detriment from radiotherapy, although said it could be minimal. Subsequent research by him has produced a later paper which suggests a very much less significant decline in IQ. He accepted that radiotherapy would decrease anyone’s chances of ‘growing up to be a lawyer or doctor’, but said that he has treated many patients with this disease using the standard treatment he recommends for N and that they even go to school with some additional help, play sports and do the normal sort of things which others do who have never had the disease. Generally, he said they cope pretty well with the side-effects. He expressed concern that the reduction in cognitive function attributable specifically to radiotherapy has been overstated. He did not consider that there would be any effect on the N’s personality.

19. As regards hormonal detriment, Dr A accepted that there could be impact to the growth hormone, although he said the progress of the child is monitored and hormone replacement therapy is routinely given. Generally speaking, therefore, any loss of growth ‘…would not be noticed in the street’. As regards the thyroid, Dr A told me that a negative impact is much less common. It can make the patient more lethargic and cause a weight increase, but again this is monitored and is dealt with by tablets. As to fertility, Dr A accepted that there are risks of sub-fertility or infertility. He said that older patients are usually counselled to the effect that ‘…there is a risk of sub-fertility which, at its worst, could mean that you cannot have a child’. Nevertheless, he advises older patients to take contraceptive measures. Further, Dr A pointed out that chemotherapy (which, as I say, the mother was accepting) has a greater role to play in threatening fertility, roughly 60 to 70%, as compared with radiotherapy’s role of perhaps 30 to 40%. As regards the risks of secondary malignancy later on in life, Dr A accepted that such a risk exists. The most common such cancer is benign and therefore normally treatable by surgery. In ‘ballpark’ terms, he placed the risk of later-life cancer (of all types, benign and malignant) at a figure of some 2% to 4%, although the individual might have suffered such cancer in any event. There are one or two other downsides to the suggested treatment which I have well in mind, but do need to go into individually.

20. I have heard Dr A give evidence at length. He has been a consultant paediatric oncologist for 10 years, with hands-on responsibility for child patients. His knowledge and experience of the subject matter is highly impressive, as would have been obvious to anyone in court. He and his team work at the cutting-edge of this discipline, anxious to keep up with the developing techniques as they are tested and reported on, both here and elsewhere. He told me how the team strives to strike the necessary balance in giving their children treatment which has the best possible rate of survival, but with the least possible detrimental side-effects. Having seen and heard Dr A, I find it hard to see that he and specialists like him would keep back or fail to explain the possible benefits of credible alternative therapies which work, or might work, for such very ill children. He told me of ongoing trials in the USA aimed at further reducing the standard dose of radiotherapy, but explained that these will not be reported upon until about 2016. For the moment, he regards the idea of using chemotherapy alone as ‘a big risk and a big gamble…reducing the prospects of survival by an experiment’. I accept Dr A’s evidence and I reject any suggestion that he has minimised the disadvantages of the recommended treatment package. I find that he has shown dedication to this case and therefore to N’s best interests, devoting much time to it, beyond the call of duty. He has been in court and available to assist throughout the hearings, except during the delivery of this Judgment. He has answered many questions both in court and outside court in writing, some inevitably rather repetitive (due to the change of legal representation) doing so clearly and with patience. I am satisfied that he has done his best to assist the court neutrally and fairly.

21. The mother, having heard Dr A’s evidence and being asked whether it affected her view on radiotherapy replied that, following upon her many hours of research, she still feels there are other ways to treat N. She told me that to her mind the orthodox view of oncologists is the product of indoctrination. I cannot accept that. I find it on the evidence before me to be the best we have at the present time to deal with what the mother’s own expert, Dr X, described to Ward L J as ‘…a highly malignant disease’, and one which will very probably cause death if not conventionally treated. It may well be that some of the complementary techniques which the mother has in mind, for example as to diet and lifestyle, or as to oxygen therapy, can beneficially be used in conjunction with the mainstream therapy proposed. Dr A said he and his team have no problem with this and can work with parents along those lines, so long as the alternative suggestions do not conflict with or disrupt the primary treatment.

22. The mother has been through a very stressful time. What the parents have suddenly had to confront over the past two or three months is every parent’s nightmare. I have every sympathy with them; and with the mother in not wishing to see N subjected to the risks and side-effects which conventional treatment carries with it. Her wishes and views as a parent are obviously an important part of the balancing exercise, both in their own right and because of their potential effect on N. But I am worried that her judgment has gone awry as to the extent of the seriousness of the threat which N currently faces. As I have said, she did originally agree to chemotherapy at the hearing on the 7^th December, 2012; and, when Mr Peddie made his submissions at the end of this hearing, he spoke of her continued agreement to it, although in her evidence I noted her disagreeing to it, alongside her continuing objection to radiotherapy. During the course of Ward LJ’s judgment at the telephone hearing three nights ago, he observed that “… the mother is becoming increasingly implacable” and I too have the perception that her approach has hardened as these stressful days in court have gone on. It concerns me that she may have become somewhat overwhelmed by the process whilst this case has been in court, which is most unfortunate from N’s point of view. I express the hope that, when she has had time to stand back and reflect upon his best interests, she will come to terms with the court’s decision (as she told me at the first hearing she would) and support him through the very difficult times ahead. N clearly needs both his parents to be pulling together alongside the treating team and nothing could be worse than for him to pick up on any sense of maternal opposition to the treatment.

The Court had to make a decision, and the decision was fairly easy to predict

It will be obvious from the above what I have decided should happen. I accept the submissions of the father, the NHS Trust and the Guardian. The balance of advantage and disadvantage tilts well in favour of radiotherapy and chemotherapy, notwithstanding the detrimental side-effects. One cannot enjoy even a diminished quality of life if one is not alive. I shall therefore make a Declaration that the treatment package proposed by the NHS Trust is lawful.

There was then an issue about whether that should be a final decision, or whether the treatment should commence but be reviewed, with mother having an opportunity to fully assemble her evidence of the case both for her alternative therapy/treatment and against chemotherapy and radiotherapy  {Again, underlining for emphasis is my own}

24. The question then arises as to whether this should be a final decision, or whether I should give the mother a further opportunity to marshal and call expert evidence on complementary or alternative treatments. The time for everyone to prepare for this case has been short and she clearly has her Article 6 right to a fair hearing. I am very conscious that she feels catapulted into this litigation, without proper time to get her case together. It is however the fact that the mother has been fully aware since early November 2012 about the opinions of the treating clinicians that N requires radiotherapy and chemotherapy. She herself mentioned today having ‘done a crash course on the issue over the last 6 weeks’ and she spoke earlier of having ‘numerous people working on it’. On both the 3^rd December and 4^th December 2012, Hogg J gave her permission to call expert evidence, although I accept that the mother’s having gone missing with N that week made it impossible in practice for her then legal team to do much about that. On the 13th December, 2012, by an e-mail order, I gave the mother further permission to call an oncologist. It is now clearer, with the emphasis at this hearing on entirely complementary therapies, that that may not have given the mother exactly what she may have wanted; but my order also gave her ‘liberty to apply urgently to seek further or other directions’. That was some eight days ago. The mother has had representation by and advice from Leading Counsel and solicitors since before the 3^rd December 2012, as Mr Tolson QC prepared a robust Position Statement on her behalf for the hearing before Hogg J of that date. She changed her legal team during the hearing on Tuesday of this week (the 18^th December 2012) and it follows that her current legal team has struggled to read into the case and to get very much together to support her position in the time available. She has referred several times to research from and treatments available in Russia and China and elsewhere, which research she has not been willing to pass across to the NHS team, although asked by them to do so, for fear (as Mr Peddie put it) that she might be seen as seeking support ‘from quacks’. Mr Peddie submitted today that the mother’s search has been hampered by the S.4 of the Cancer Act 1939, which prohibits the advertising of cancer services; but on her own case the mother has been able to carry out much research on the internet, which anyone can do without difficulty. Dr D set out in his report of 19^th December, 2012 a list of Harley Street doctors who he says offer complementary medicines; but nothing has been heard from any of them.

25. I have to keep firmly in mind what is required for there to be any realistic prospect of the court’s preferring some complementary alternative to the standard mainstream treatment for N’s condition. It is not just a question of demonstrating that there is research and experimentation going on out there; nor that there are ideas and possibilities being floated, nor even that there are reported success stories of cures occurring without the use of radiotherapy and / or chemotherapy. What is required is the identification of a clinician experienced in treating children aged about 7 having this kind of brain cancer; a clinician with the access to the necessary equipment and infrastructure to put the suggested treatment into effect and able and willing to take over the medical care of and responsibility for N. As Ward LJ said at paragraph 38 of AVS v NHS Foundation Trust [2011] COPR Con. VOL. 219: “… if there is no one available to undertake the necessary operation, the question of whether or not it would be in the patient’s best interests for that to happen is wholly academic…”. The treatment proposed by any such clinician would have to be (or should preferably be) properly studied, tested, reported on and peer-reviewed. To have any realistic prospect of becoming selected by the court (and I repeat that this is not a decision to be made by an adult for himself, but for a child) the proposed plan would have to have a prognosis as to probable survival rate not much less than (and preferably equal to) the sort of survival rate achievable through the use of the orthodox treatment universally applied at present by oncologists in this country.

26. Giving the mother a review hearing date after Christmas, or just a “liberty to apply ” provision in my order, would also have an incidental downside to it. This is because everyone working at the hospital with N should ideally be able to go forward with as much certainty and confidence as possible that the necessary decisions have been taken. They need to be able to get on with making the necessary booking arrangements for the equipment, making the restraining mask and planning their commitments. They need to be able to prepare N with play-therapy which is able to be confidently delivered, and not in some half-hearted way because they are aware that the radiotherapy might never happen. It is not in N’s interests that everything should be ‘semi-on-hold’ awaiting notification after Christmas or in the New Year as to whether or not there is still to be further litigation. Whilst recognising therefore that the mother’s right to a fair trial is absolute, I am satisfied in all the circumstances (i) that she has had a sufficient opportunity overall to put forward a case for complementary treatment for N and (ii) that it is not unfair for this decision to be taken today, without there being any pre-ordained opportunity for her to apply at a further hearing after Christmas. Obviously, in any case involving the best interests of a child, a dramatic change of circumstances would enable a party to turn to the court, but that is not something for which I consider I should specifically plan.

I found these passages to actually be the most interesting in the judgment. The suggestion here is that it is appropriate for the Court to rule in favour of mainstream treatment unless a parent can show that the prognosis and survival rate in terms of the alternative treatment is “not much less than and preferably equal to the orthodox treatment universally applied by oncologists in this country”

The reasoning behind that is that the Court is looking not at the decision of an adult to make an informed decision about treatment for themselves, but on behalf of a child. Where the adult is aware that the treatment for themselves may not be as efficacious as the treatment they are rejecting, they are taking that decision for themselves and are entitled to more leeway in making a decision that other people might not make for themselves.

This does seem to me, to set the bar quite high, and perhaps does not fully take into account that there is more than simply the efficacy of treatment, there is also the negative impact of the treatment on quality of life, pain, discomfort etc, that a parent might legitimately want to shield the child from.

To put it this way

If  Treatment A has a score out of 100 (1 being bad, 100 being good) of

Prognosis  85     Patient comfort   20

And Treatment B has the scores

Prognosis  60  Patient comfort 65

And Treatment C has the scores

Prognosis 5  Patient Comfort 100

Well then a great many parents might well decide that the only factor that matters to them is prognosis, the survival chances of their child and Treatment A is obviously the right one. But others might well say that with both treatments, there is some chance that the child won’t survive and they don’t want the child to be in pain or distress during the treatment, so they would prefer Treatment B. 

It would seem fairly easy to reject Treatment C as simply not being good enough at treating the condition, and so there’s a point at which lower prognosis for higher patient comfort stops being a valid trade-off. I’d suggest that opting for Treatment C would be an unreasonable decision, if A and B were instead available for the child   [though it would be a viable decision for an adult to make for themselves].   Treatment C might for example, be sugar pills, which would have themselves no adverse impact on the child, but do very little for the actual condition itself.   [cough, homeopathy, cough, cough]

It might be that the average parent would go for Treatment A, but would a parent going for Treatment B be manifestly wrong, to the extent that a Court should intervene?

These numbers are of course plucked out of the air, I have no idea what evidentially the mother might have been able to produce that would show the prognosis on her proposed model of treatment, or the comparisons of pain, side effects, discomfort.

But I am a little troubled that this case, with those fictitious numbers above, would mean that a parent could not plump for Treatment B, because the prognosis is not  “not much less than and preferably equal to the orthodox treatment universally applied by doctors in this country”  

For the avoidance of doubt, I think the Court made the right decision in this case, and that there simply wasn’t the compelling evidence presented to them to diverge from the very clear and strong medical opinion that this child needed urgent and orthodox medical treatment;   and that the State has to have power to intervene where a parent ignores that medical advice and is seeking to provide treatment which is untested, or crackpot.  But is there some room in the middle where a parent can choose between two valid treatments, one of which is less efficacious than the orthodox one?

I always get worried, as a bleeding heart liberal, when parental autonomy is eroded. In this case with this evidence, choosing between what mum wanted and what dad wanted, was very straightforward, but that construction that a parent seeking to provide unorthodox or alternative therapy for a child has to show that the prognosis is as high as the orthodox treatment seems to me to set a very high bar, and to not fully take account of the other factors than prognosis that might properly influence a parent.