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You are here: BAILII >> Databases >> England and Wales Court of Protection Decisions >> D, Re (Medical Treatment) [2017] EWCOP 15 (05 September 2017) URL: http://www.bailii.org/ew/cases/EWCOP/2017/15.html Cite as: [2017] EWCOP 15 |
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Neutral Citation Number: [2017] EWCOP 15
Case No: 12405885
IN THE COURT OF PROTECTION
IN THE MATTER OF THE MENTAL CAPACITY ACT 2005
IN THE MATTER OF D (MEDICAL TREATMENT)
Royal Courts of Justice
Strand, London, WC2A 2LL
Date: 5 th September 2017
Before :
THE HONOURABLE MR JUSTICE BAKER
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Between :
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B |
Applicant |
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- and - |
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D (by his litigation friend, the Official Solicitor) (1) THE MINISTRY OF DEFENCE (2) |
Respondents |
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The Applicant in person
Bridget Dolan QC (instructed by the Official Solicitor ) for the First Respondent
Nicola Greaney (instructed by Government Legal Department ) for the Second Respondent
Hearing dates: 28 th April and 5 th July 2017
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Judgment Approved
This judgment was delivered in private. The judge has given leave for this version of the judgment to be published on condition that (irrespective of what is contained in the judgment) in any published version of the judgment the anonymity of the incapacitated person and members of their family must be strictly preserved. All persons, including representatives of the media, must ensure that this condition is strictly complied with. Failure to do so will be a contempt of court.
MR JUSTICE BAKER :
1. These proceedings in the Court of Protection concern a twenty-seven-year-old man, hereafter referred to as "D", who lacks capacity as a result of a traumatic brain injury. The application before this court is made by D's mother, hereafter referred to as "Mrs B", for a declaration and order that it is in D's best interests to receive stem cell treatment for his brain injury at a clinic in Belgrade in Serbia. The application is opposed by the Official Solicitor, who has been appointed to act as D's litigation friend in the proceedings, and by the Ministry of Defence (" MOD") who, for reasons set out below, are responsible for D's care and treatment.
Background
4. D was then transferred to a rehabilitation hospital and in 2014 moved to a military rehabilitation centre, X House, where he remained for over two years, apart from a short unsuccessful move to another brain injury centre. He underwent an extensive multi-disciplinary rehabilitation programme incorporating physical mobility therapy, cognitive/neuropsychological input and speech and language rehabilitation, and as a result made substantial improvement. He continued to suffer, however, from very significant disabilities, including extensive physical disabilities, and global cognitive impairments including reduced attention, concentration, information-processing capacity, memory, executive functioning, and receptive and expressive language. He presents with severe dysarthria, with reduced intelligibility when tired and when speech is out of context. It is said that he is highly impulsive when emotionally aroused and his behaviour became increasingly difficult to manage at various times during his admission to X House.
6. Mrs B has extensively researched treatment options for D and identified stem cell therapy as a possible way forward. She initially approached a clinic in Germany but it transpired that establishment was unable to provide appropriate stem cell therapy tailored to D's particular traumatic brain injury. After further research, Mrs B identified a clinic in Moscow, the Swiss Medica XXI Century SA ("Swiss Medica") as a safe and appropriate clinic. The medical staff at X House, however, opposed this proposal on the basis that the use of stem cell therapy for patients such as D was not yet established in this country and that there was insufficient evidence to suggest that the benefits outweighed the risks.
7. On 21 April 2016, Mrs B filed an application in the Court of Protection for declarations and orders pursuant to ss 15 and 16 of the Mental Capacity Act 2005 to determine D's capacity and, in the event that he lacked capacity, to make best interests declarations, in particular regarding his medical treatment, and further for an order appointing Mrs B as his health and welfare deputy. The application included an assessment by his treating neuropsychologist to the effect that, as a result of the impairment to his brain, D lacked the capacity to make decisions concerning his medical treatment. In particular, he lacked the capacity to understand, use and weigh the relevant information. The neuropsychologist expressed the opinion that, due to his cognitive difficulties, D was not able to understand more complex information. He was able to say that the stem cells will make him "normal" but was not able to follow the description or the rationale of how they work. Furthermore, as a result of his difficulties, he was unable to use or weigh up the options as part of the decision-making process. His rigid thinking patterns made it impossible for him to think flexibly about the pros and cons of the treatment. The neuropsychologist added that D was assessed as being vulnerable to being suggestible to others. He said that his mother thinks the treatment will make him "normal" and therefore he will do it.
8. On 26 August 2016, the MOD filed an acknowledgment of service, stating:
"The Respondent does not support the application for [D] to travel to Moscow and receive stem cell treatment. The treatment is at a pre-clinical stage in the UK and there is insufficient evidence to demonstrate its efficacy and safety. However, the respondent is willing to take a neutral position and let the court determine the issue."
The MOD added that it opposed the appointment of Mrs B as deputy on the grounds that such an appointment was unnecessary. In addition, the MOD filed an application for an order for D's transfer to a civilian unit, hereafter referred to as Y Hospital, to continue his rehabilitation. The grounds for this proposal were said to be that the facilities at X House were insufficient to enable D to progress to the next phase of his rehabilitation, whereas Y Hospital was a more secure facility which operated a sequential care programme under which patients initially resided in a locked area and then moved on to a less restrictive unit.
10. The matter came before me first on 1 September 2016. I made an interim declaration that there was reason to believe that D may lack capacity to conduct proceedings and make decisions about his medical treatment, care and residence. I substituted the Official Solicitor as litigation friend for D in place of Mrs B and instead joined Mrs B as a party to proceedings in her own right and substituted her as the applicant. I joined the MOD as a respondent to the proceedings, and directed that all hearings of the serious medical treatment matter should be held in public in accordance with Practice Direction 9E. At a further hearing on 23 September 2016, I gave further directions in the proceedings for the disclosure of relevant documents, expert and other evidence, and listed the matter for a final hearing in December 2016.
The hearing
The evidence
My telephone conversation with D
Mrs B's evidence
Dr Bulboh's evidence
23. In response to Prof Martino's comments, Dr Bulboh replied:
"Of course, Prof Martino is right when he claims stem cells are not researched enough, established and approved. We are aware of and understand that stem cells therapy is very new and not yet thoroughly studied to the point of established guidelines, FDA and other health authorities' approval. However, latest medical information delivers medical evidence that shows that the stem cell represent a promising, effective and safe way of management of patients with neurodegenerative diseases (such as strokes, MS, Parkinson's, brain injuries etc)."
In response to concerns raised by Prof Martino arising out of published articles, Dr Bulboh stressed that his clinic did not use neural stem cells or modified stem cells. In respect of other published articles cited by Prof Martino, Dr Bulboh stated that there was insufficient information about the exact method of treatment described in the articles. Dr. Bulboh himself cited two published articles as evidence that stem cell therapy may be an effective treatment for brain injury. The first paper ("Umbilical cord mesenchymal stem cell transplantation significantly improves neurological function in patients with sequelae of traumatic brain injury", Wang and others, Brain Research (2013) 76-84) was based on a randomised, single-blind controlled clinical study involving forty patients with sequelae of traumatic brain injury. The authors concluded that, based on this study, umbilical cord mesenchymal stem cell transplantation can significantly improve numerous neurological functions and that it may therefore be a potential treatment for patients after traumatic brain injury. They added, however, that further research, including a multicentre and large sample size prospective randomised clinical trial, would be required to define definitively the role of this treatment in such cases. Dr Bulboh also referred to a further paper, ("Cell-based therapy for traumatic brain injury", Gennai and others, (2015) British Journal of Anaesthesia 115 (2): 203-12). In the abstract of this latter article, the authors report that, over the last fifteen years, pre-clinical studies in regenerative medicine utilising cell-based therapy have generated enthusiasm as a possible treatment option for traumatic brain injury. In these studies, stem cells and progenitor cells were shown to migrate into the injured brain and proliferate, exerting protective effects through possible cell replacement, gene and protein transfer, and release of anti-inflammatory and growth factors. The authors warn, however, that "although the benefits of cell-based therapy have been clearly demonstrated in pre-clinical studies, some questions remain regarding the biological mechanisms of repair and safety, dose, route and timing of cell delivery, which ultimately will determine its optimal clinical use." The authors also point out that "most pre-clinical trials have delivered the cells early after traumatic brain injury to suppress the initial inflammatory response and activation of the cells of innate and adaptive immunity. There is minimal pre-clinical evidence of benefit when stem and progenitor cells are delivered more than one week after traumatic brain injury."
"stem cells can produce all sorts of substances which change surrounding areas/tissues in the body. They work in such a way that they can awaken the damaged tissues so they start regenerating. They help to regenerate new vessels. They have an ability to be neuro-plastic so that the stem cells work with brain cells in the brain styles change their state. So brain injury does not mean that all the cells in the brain are dead. The brain is a very complex system and there are areas of the brain which are in a sleeping state but they are not dead. This ability of stem cells to change dormant cells to functioning cells they help to regenerate and this gives significant results."
Dr R's statements
28. Although Dr. R, D's current treating psychiatrist, was not required for oral evidence, reliance is placed on his reports filed in these proceedings. In his first report, dated 13 th April 2017, he diagnosed D as suffering from an organic personality disorder and confirmed that, as a result of this impairment of his brain, he lacked the capacity to make decisions as to his medical treatment. He described the progress D had made since arriving at Y Hospital as variable, although he had made good progress in his physical rehabilitation and had shown good motivation and level of engagement with the physiotherapist. Dr. R summarised the ongoing care programme, including psychology sessions to help him develop insight into his brain injury and its consequences, to focus his attention on one task at a time, and to help and support him to develop practical skills. In addition, he will continue to receive support from occupational therapists and psychotherapists, together with nursing support. In his latest report dated 30 th June 2017 filed between the two hearing dates, Dr. R reported that he had seen D and his mother on 28 th June, i.e. after D spoke to me. D told him: "I will be disappointed if the court were to refuse treatment, it's not my fault". Dr. R said that D is aware that the stem cell treatment is an experimental treatment, but seems to have no appreciation of the possible outcomes or the likelihood of the treatment being successful. Dr. R reported that, in their conversations, D had informed him that he has nothing to lose and he will feel happy about having tried the treatment.
Prof Martino's evidence
30. Gianvito Martino is professor of experimental biology at Vita Salute San Raffaele University in Milan. He is widely recognised as an expert in the field of neuroimmunology and amongst his many areas of interest is the use of stem cell therapy as a treatment for multiple sclerosis and other disorders of the central nervous system. In these proceedings, he prepared a preliminary report in December 2016 to which Dr Bulboh responded in a report dated 24 January 2017. Prof Martino then prepared a final report dated 26 March 2017.
"(a) there is no pre-clinical and clinical scientific evidence that the putative combination of several stem and progenitor cells used by Swiss Medica could be of any benefit to cure the permanent neurological cognitive and physical sequelae which D is suffering (b) there is no sufficient and enough detailed evidence about the characteristics of the cells to infuse and therefore short- and long-term side effects (e.g. tumour formation) cannot be ruled out;
(c) there is no evidence that Swiss Medica is strictly following the necessary rules during the procurement, manipulation and expansion of the cells and therefore life-threatening - acute (i.e. infection) and chronic (i.e. tumours) - potential risk of the medicinal product cannot be ruled out."
32. In the body of his first report, Prof Martino warned against offers of "miraculous cures based on stem cells for virtually any disease". He pointed out that "this situation increases the distress of patients who, while having an urgent need to know the real hope for success of truly effective therapies, perceived lack of appropriate information channels, which would help them make conscious and informed decisions." He reported that stem cell treatments are routinely used in certain types of treatment, in particular, bone marrow transplantation treating malignant and non-malignant forms of blood disorder and, more recently, the use of skin stem cells for treating patients with serious burns and vision problems caused by damage to the cornea. He added, however, that "in the above-mentioned areas of research, the data are real and reliable, but the evidence of real healing power of stem cells in other contexts is not clear owing to the experimental available results that are neither solid nor unambiguously interpreted. Thus, further testing and confirmation are required." He stressed the need for a cautious approach because there are many questions to be answered before permitting large-scale use of these new therapies. He recognised that stem cells can nowadays be considered a potentially useful and effective therapeutic tool, but added that "the flourishing world of so-called specialised centres for therapies based on stem cells, which do not undergo strict quality control and often make their own profit the only reason for existing, certainly does not facilitate the demanding task of proving, without any doubt, that stem cells might represent a realistic therapeutic option." He advocated new legislative tools to protect the patients who are made vulnerable by need of care and hope. "Citizens need and have the right to be protected and instructed to make an informed choice....In essence, to turn anecdotal experiences or promising preclinical results into safe and effective therapies, further research should be conducted."
33. Prof Martino was very critical of the information provided by Swiss Medica. He observed that most of the information was clearly misleading and not supported by solid scientific arguments. He contended that some assertions were simply not true, because of cases reported in the literature in which infectious diseases, tumours and immune reaction had been described even after the use of autologous stem cells. He argued that there is a lack of experimental, preclinical and clinical evidence that the "activated stem cells" from Swiss Medica could be of any benefit to cure the pathology from which D is suffering. Furthermore, he contended that it is not possible to understand clearly whether the clinic, while preparing the stem cells to infuse would follow the rules necessary to avoid life-threatening potential risks. Once transplanted, stem cells have an in vivo behaviour very dependent on a number of variables whose relative importance has not yet been fully clarified. "For these reasons, the therapies based on stem cells, of any origin, should be still considered experimental and, then, subject to all those strict controls that the medical testing requires."
36. Picking up on Dr Bulboh's response, I asked Prof Martino how he knew that the patients who developed tumours after stem cell therapy did not have them before. He replied that the tumour that originates from these patients originates from the stem cells transplanted. "This is easy to ascertain as the genes of the cells that are transplanted are different from the genes belong to the patient receiving the transplant." He stated that his observation about patients suffering an immune reaction even after the use of autologous stem cells was based on research, whereas Dr Bulboh's contrary view was merely a personal opinion. A further criticism which Prof Martino expressed about the Swiss Medica clinic was the absence of any published research to support their case as to the efficacy of the treatment. Answering questions from Ms Dolan, he reiterated his view that, according to the data that has been supplied regarding the three types of transplant proposed, there was no benefit to D. On the other hand, he identified two main risks were D to receive the therapy - the first that he may develop some illness related to the fact that the cells were not sterile, the second being the risk of developing tumours from the cells. In addition, there are risks associated with the methodology - e.g. the use of lumbar puncture - but Prof Martino regarded these as minimal.
The law
"(1) In determining for the purposes of this Act what is in a person's best interests, the person making the determination must not make it merely on the basis of -
(a) the person's age or appearance, or
(b) a condition of his, or an aspect of his behaviour, which might lead others to make unjustified assumptions about what might be in his best interests.
(2) The person making the determination must consider all the relevant circumstances and, in particular, take the following steps.
(3) He must consider -
(a) whether it is likely that the person will at some time have capacity in relation to the matter in question, and
(b) if it appears likely that he will, when that is likely to be.
(4) He must, so far as reasonably practicable, permit and encourage the person to participate, or to improve his ability to participate, as fully as possible in any act done for him and any decision affecting him.
....
(6) He must consider, so far as is reasonably ascertainable -
(a) the person's past and present wishes and feelings (and, in particular, any relevant written statement made by him when he had capacity),
(b) the beliefs and values that would be likely to influence his decision if he had capacity, and
(c) the other factors that he would be likely to consider if he were able to do so.
(7) He must take into account, if it is practicable and appropriate to consult them, the views of -
(a) anyone named by the person as someone to be consulted on the matter in question or on matters of that kind,
(b) anyone engaged in caring for the person or interested in his welfare,
(c) any donee of a lasting power of attorney granted by the person, and
(d) any deputy appointed for the person by the court,
as to what would be in the person's best interests and, in particular, as to the matters mentioned in sub-section (6).
...."
38. The leading case as to the application of the best interests criteria is now the decision of the Supreme Court in Aintree University Hospitals NHS Foundation Trust v James and others [2013] UKSC 67. At paragraph 39 of her judgment in that case, Baroness Hale of Richmond observed:
"The most that can be said, therefore, is that in considering the best interests of this particular patient at this particular time, decision-makers must look at his welfare in the widest sense, not just medical but social and psychological; they must consider the nature of the medical treatment in question, what it involves and its prospects of success; they must consider what the outcome of that treatment for the patient is likely to be; they must try and put themselves in the place of the individual patient and ask what his attitude to the treatment is or would be likely to be; and they must consult others who are looking after him or interested in his welfare, in particular for their view of what his attitude would be."
At paragraph 45, she added:
39. I also bear in mind the observation of Peter Jackson J in Wye Valley NHS Trust v Mr B [2015] EWCOP 60 at paragraphs 10 to 12:
"10. Where a patient lacks capacity it is accordingly of great importance to give proper weight to his wishes and feelings and to his beliefs and values. On behalf of the Trust in this case, Mr Sachdeva QC submitted that the views expressed by a person lacking capacity were in principle entitled to less weight than those of a person with capacity. This is in my view true only to the limited extent that the views of a capacitous person are by definition decisive in relation to any treatment that is being offered to him so that the question of best interests does not arise. However, once incapacity is established so that a best interests decision must be made, there is no theoretical limit to the weight or lack of weight that should be given to the person's wishes and feelings, beliefs and values. In some cases, the conclusion will be that little weight or no weight can be given in others, very significant weight will be due.
11. This is not an academic issue, but a necessary protection for the rights of people with disabilities. As the Act and the European Convention make clear, a conclusion that a person lacks decision-making capacity is not an "off-switch" for his rights and freedoms. To state the obvious, the wishes and feelings, beliefs and values of people with a mental disability are as important to them as they are to anyone else, and may even be more important. It would therefore be wrong in principle to apply any automatic discount to their point of view.
12 .... It is, I think, important to ensure that people with a disability are not - by the very fact of their disability - deprived of the range of reasonable outcomes that are available to others. For people with disabilities, the removal of such freedom of action as they have to control their own lives may be experienced as an even greater affront than it would be by others who are more fortunate."
40. In determining where the best interests lie, it is helpful to draw up a balance sheet of the various factors, as suggested by Thorpe LJ in Re A (Male Sterilisation) [2000] 1 FLR 549. In doing so, however, the court must bear in mind the warning given by McFarlane LJ in Re F (A Child) (International Relocation Cases) [2015] EWCA Civ 882 (at paragraph 52) which, although, as the title of the case shows, given in a different context, applies to the judicial use of balance sheets generally;
"Whilst I entirely agree that some form of balance sheet may be of assistance to judges, its use should be no more than an aide memoire of the key factors and how they match up against each other. If a balance sheet is used it should be a route to judgment and not a substitution for the judgment itself. A key step in any welfare evaluation is the attribution of weight, or lack of it, to each of the relevant considerations; one danger that may arise from setting out all the relevant factors in tabular format, is that the attribution of weight may be lost, with all elements of the table having equal value as in a map without contours."
41. In earlier cases, including PH v A Local Authority, Z Ltd and R [2011] EWHC 1704 (Fam) and CC v KK [2012] EWHC 2136 (COP), I have drawn attention to a potential risk, identified by Ryder J (as he then was) in Oldham MBC v GW and PW [2007] EWHC136 (Fam) [2007] 2 FLR 597, a case brought under Part IV of the Children Act 1989, that the professionals and the court may be unduly influenced by what Ryder J called the "child protection imperative", meaning "the need to protect a vulnerable child" that, for perfectly understandable reasons, may influence the thinking of professionals involved in caring for the child. Equally, in cases of vulnerable adults, there is a risk that all professionals involved with treating and helping that person - including, of course, a judge in the Court of Protection - may feel drawn towards an outcome that is more protective of the adult. This point was articulated most strikingly in the celebrated passage in the judgment of Munby J (as he then was) in Re MM (An Adult) [2007] EWHC 2003 (Fam)
"A great judge once said, 'all life is an experiment', adding that 'every year if not every day we have to wager our salvation upon some prophecy based upon imperfect knowledge' (see Holmes J in Abrams v United States (1919) 250 US 616 at 630). The fact is that all life involves risk, and the young, the elderly and the vulnerable, are exposed to additional risks and to risks they are less well equipped than others to cope with. But just as wise parents resist the temptation to keep their children metaphorically wrapped up in cotton wool, so too we must avoid the temptation always to put the physical health and safety of the elderly and the vulnerable before everything else. Often it will be appropriate to do so, but not always. Physical health and safety can sometimes be brought at too high a price in happiness and emotional welfare. The emphasis must be on sensible risk appraisal, not striving to avoid all risk, whatever the price, but instead seeking a proper balance and being willing to tolerate manageable or acceptable risks as the price appropriately to be paid in order to achieve some other good - in particular to achieve the vital good of the elderly or vulnerable person's happiness. What good is it making someone safer if it merely makes them miserable?"
Submissions
(1) MOD
44. On behalf of the MOD, Miss Greaney invited the court to prefer the opinion of Prof Martino to that provided by Dr Bulboh. Miss Greaney emphasised that even Dr Bulboh accepted Prof Martino's characterisation of stem cell therapy for brain injury as an experimental treatment. The MOD invited the court to accept Prof Martino's evidence that the data available as to the efficacy of the treatment in humans with acquired brain injury is very limited and that there is a need for much more research including proper clinical trials, a point made in both of the articles cited by Dr Bulboh. To date, there is no published research about the efficacy of the treatment provided at the Swiss Medica clinic and no corroboration of Dr Bulboh's assertion that there is at least some discernible improvement in 80% of patients. Furthermore, the MOD emphasised the evidence of life-threatening risks, including the development of carcinogenic tumours even after the use of autologous stem cells, as demonstrated in the case studies cited by Prof Martino. Miss Greaney described Dr Bulboh's contrary assertion as incredible and irresponsible. She submitted that the court should attach no or very little weight to Dr Bulboh's view that the stem cell treatment would be in D's best interests or his assertions as to the likely benefits of treatment for D and the absence of risks. She pointed out that Dr Bulboh expressed the view that it would be in D's best interests to have the treatment without examining him, without reviewing his medical records and without obtaining detailed information about his condition from his treating clinicians.
(2) The Official Solicitor
47. On behalf of the Official Solicitor, Ms Dolan QC recognised that primary consideration must be given to D's wishes and feelings, particularly when, as in this case, D, although lacking capacity to make this decision, is nevertheless cognitively relatively high functioning and can, and does, clearly express his own views. She accepts that D is adamant that he would like to have the stem-cell procedure and has not wavered at any point in the proceedings. He also has his own funds to pay for it. She submits, however, that it may also be relevant to consider how realistic his opinion is and why he might hold the views he does, because they appear to be predicated upon his belief that the proposed procedure is likely to be effective. He has repeatedly said that having the stem cell procedure will "make him normal". The Official Solicitor contends that, on any analysis, the likelihood of the stem-cell procedure bringing about the significant functional change that D hopes for is small. Even Dr Bulboh does not claim he can make D "normal". Ms Dolan further submits that D's wish to have stem-cell treatment may also have been influenced by his mother's strong views. While it is accepted that Mrs B is acting out of love and concern for D, and that her tireless pursuit of rehabilitation or other measures that can help her son is to be commended, the Official Solicitor submits that her own faith in the proposed procedure may have influenced D's views.
48. Ms Dolan also recognises that, given D's strongly-expressed wishes, the impact of a refusal of the application must be a relevant factor within the best interests balance sheet analysis. She points out, however, that Dr. R describes D's likely reaction as "disappointment" and submits that the anticipated psychological impact upon D of refusal of the application, although clearly relevant, is not sufficiently serious to weigh particularly heavily in favour of permitting the treatment in any balancing exercise.
(3) Mrs B
52. In her closing submissions, Mrs B submits that D persists in his wish to have the treatment, a wish which has been expressed on several occasions to her, various professionals, and the court. He has a strong belief that the treatment will improve his condition and has carried out his own research on the internet. Mrs B noted that the Official Solicitor stressed that D had stated that the treatment will make him "normal" and would "work" for him. Mrs B acknowledged that such expressions may not sound scientifically or legally appropriate, but submitted that factors such as personality, continuous military service which influenced the communication style, and physical disability must be taken into account before concluding that D cannot explain his expectations about the treatment. In reply to the Official Solicitor's submission that D's wishes are influenced by her, Mrs B pointed out that there had been nothing to stop the Official Solicitor from bringing other relevant information to D's attention. She says that the reason she brought the idea of the treatment to her son's attention was because she wanted to improve his quality of life. Before doing so, she thought about his ability to understand information, his values and beliefs that could influence his decision if he had capacity, and other factors, such as military training and personality.
Discussion and conclusion
Having the stem cell treatment
Advantages |
Disadvantages |
It accords with D's consistent and strongly-held wishes and feelings |
The efficacy of this treatment has not been established through any clinical trials. According to Prof Martino, Swiss Medica does not adhere to the international regulations that should be followed in these matters |
It accords with the views of his mother |
D will be exposed to known risks (allergic reaction, developing a tumour, risks associated with the procedure e.g. lumbar puncture and use of a catheter) and also to unknown risks which cannot be excluded because of the absence of clinical trials or research. |
Any adverse psychological reaction to being prevented from having the treatment is avoided. Regardless of treatment outcome there may be psychological benefit to D arising from (1) his having his wishes respected and (2) knowing that what he sees as a potential treatment avenue has at least been tried. |
Travelling to Serbia to undergo the treatment risks disrupting his rehabilitation programme and the ongoing physical and psychological work. |
There is a potential for improvement, although the evidence for this is only the anecdotal evidence of Dr. Bulboh unsupported by any research or by the opinion of Prof Martino. |
He has made substantial progress through rehabilitation and is anticipated, at some point, to move on to a community step-down placement. If he develops a serious illness as a result of the treatment, his future prospects would be considerably worse. |
|
D may have an adverse psychological reaction when he does not see any benefit from the treatment |
|
The treatment is expensive. He will be spending the money he received from his compensation award on an ineffective treatment when he could otherwise spend the money on care/therapies /treatment or on other things he would like to do to enhance his life |
Not having the treatment
Advantages |
Disadvantages |
He does not undergo a treatment which has no scientifically proven benefit |
The decision does not accord with D's wishes |
D is not exposed to known and unknown risks |
There is a risk that D will have an adverse psychological reaction when told that he will not undergo the treatment |
The progress he has made through rehabilitation is not put at risk |
The decision does not accord with the wishes of his mother |
He does not spend a substantial amount of his compensation monies on a treatment which may be ineffective. |
He loses the opportunity of a possible improvement which the treatment might achieve. |
"once incapacity is established so that a best interests decision must be made, there is no theoretical limit to the weight or lack of weight that should be given to the person's wishes and feelings, beliefs and values. In some cases, the conclusion will be that little weight or no weight can be given in others, very significant weight will be due."
Wishes and feelings of an incapacitated adult are an important factor in any best interests analysis. As Ms Dolan recognised, the fact that D, although lacking capacity, is in cognitive terms relatively high-functioning does not by itself mean that his wishes and feelings carry greater weight. But it may make it easier to discern and understand what those wishes and feelings are - easier, adopting the words used by Baroness Hale in the Aintree case, to "see things from the patient's point of view". In this case, I am very clear that D has a very strong wish to undergo stem cell treatment.
58. The key factors on the other side of the argument - the disadvantages of allowing treatment and the advantages of refusing it - are that it is unsupported by any or at least any significant body of research, that it has not been subjected to clinical trials, and that the evidence that it is, or might be, an effective treatment for traumatic brain injury is almost entirely anecdotal. The two research articles cited by Dr Bulboh provide, at best, only tentative support for the proposition that it is an effective treatment. For that reason, Prof Martino is right to counsel caution. I have thought carefully about his warnings as to the unregulated provision of treatment in this field and his concerns about the lack of detail about elements of the treatment. I accept his evidence that the use of stem cells in cases of traumatic brain injury is not yet established by research or clinical trials. I also accept Prof Martino's evidence that there are known risks with stem cell treatment, including the type of stem cell treatment proposed in this case. Particular concern arises from the risk that the patient may develop tumours, but there is also concern about the risk of allergic reactions, other side effects, plus the hazards of the treatment process itself, in particular lumbar puncture and the insertion of catheters. I also accept, as with any new treatment, there may also be unknown risks, particularly in the early stages.
59. On the other hand, having heard his evidence, and acknowledging that it was essentially anecdotal and not supported by any research of documentary evidence, I accept Dr. Bulboh's assertion that 80% of the patients with brain injury who he has treated with stem cell therapy have shown at least some improvement. I have some concern about Dr Bulboh's rather dismissive attitude to the possible risks, but note that, overall, he accepted in evidence that the use of stem cells for traumatic brain injury was in its early stages. He accepted that his treatment was experimental.
"Physical health and safety can sometimes be bought at too high a price in happiness and emotional welfare. The emphasis must be on sensible risk appraisal, not striving to avoid all risk, whatever the price, but instead seeking a proper balance and being willing to tolerate manageable or acceptable risks as the price appropriately to be paid in order to achieve some other good - in particular to achieve the vital good of the elderly or vulnerable person's happiness. What good is it making someone safer if it merely makes them miserable?"
In this case, I think it almost certain that D will be much more than miserable if he is denied the opportunity to have stem cell treatment. I do not accept that his reaction will be confined to mere "disappointment". It is highly likely that he will demonstrate an adverse reaction in his behaviour which may significantly impede and delay his rehabilitation. In saying that, I do not deny the possibility that D may also be distressed, and suffer an adverse reaction, if the treatment does not go well, or if he suffers side-effects or contracts an illness as a result of the treatment. But, as Peter Jackson J observed in the Wye Valley case, as cited above, "for people with disabilities, the removal of such freedom of action as they have to control their own lives may be experienced as an even greater affront than it would be by others who are more fortunate." Thus, as identified in the balance sheet above, regardless of treatment outcome there may be psychological benefit to D arising from his having his wishes respected and knowing that what he sees as a potential treatment avenue has at least been tried. As Baroness Hale emphasised in the Aintree case, decision-makers must look at the patient's welfare in the widest sense, not just medical but social and psychological. If D is denied the opportunity to have stem cell treatment on the grounds that this is the safer option, there is in my judgment a strong argument that his safety may be bought at too high a price in terms of his happiness and emotional welfare.