This case concerned 2 young people, JS a boy of 18 years of age and JA girl aged 16. Both were suffering from variant Creutzfeldt-Jakob disease (vCJD). In each case their parents sought declaratory relief that each lacked the capacity to make a decision about future treatment proposed for them and that it was lawful as being in their best interests for them to receive it. The proposed treatment was new and untested on human beings. Variant CJD is one of a group of rare and fatal neurodegenerative disorders in which the infectious agent enters the body orally into the stomach and reproduces itself in peripheral parts of the body and in the spinal cord from where it reaches the brain. Over a period which may take from 4 years to 40 years, abnormal prion proteins become deposited in the brain where they multiply. This results in clinical signs of neurological damage and it is at this stage that the disease can be diagnosed.
Following the appearance of the illness, JA and JS’s enjoyment of life became severely limited. Both families were very committed to persuading the court that it was in the best interests of JS and JA for them to be given this treatment. JS’s parents gave evidence that he could still recognise and communicate with family members in various ways. He could smile in appreciation and could feel pain. Both parents stated that they would rather have JS in his present condition than not at all, and believed it was worthwhile to try the treatment. JA was mostly awake and aware of her immediate surroundings. She was able to move her finger and make her feelings clear to her family. The family stated that it would be content if the proposed treatment only prolonged her life in her present condition and slowed the course of the disease. Evidence from those who were nursing the patients gave evidence that extending their survival was worthwhile, despite their severe neurological impairment. Both sets of parents gave evidence that, if either JS or JA had retained capacity, they would have been likely to have chosen for themselves to try this proposed treatment. It was agreed by the consultants from whom the courts sought opinions, that neither JS nor JA was competent to make decisions about the proposed treatment.
The proposed treatment arose as a result of research carried out by a Japanese Neuropathologist (D) who had conducted experiments using a drug called PPS on rodents and dogs. The treatment would be administered into the brain of each patient through an intraventricular drug infusion device. The effects of PPS were quite dependent on the timing of the infusion initiation, with the earlier initiation rendering a better prognosis, although he was unable to say at what clinical stage PPS was effective.
A second consultant, T, agreed that the treatment might not work in humans or against CJD but he was prepared to try it as it might have an effect on the accumulation of the abnormal proteins in the brain, thereby limiting the deterioration of the patient’s condition. He also stated that testing on animals was of limited value and the treatment could only properly be tested on humans. The main risk identified in providing this treatment was possibility of intra-cranial haemorrhage which could range from mild to extreme. The risk of this occurrence was assessed by T to be at its highest, a maximum of 5%.
Given the strong views of both families, he could not on balance see grounds for denying JS and JA the treatment. He was prepared to give the treatment on the understanding that there was a theoretical chance of success. If the families understood the uncertainties he would give a great deal of weight to their views. He was aware of his duty not to cause undue suffering to a patient and acknowledged that the risk of haemorrhage and the toxic nature of PPS need to be balanced against the uncertainty of success. The progressive and fatal nature of the disease tipped the balance in favour of treatment and he agreed to administer the treatment.
In W’s opinion, even if the treatment were effective, it would be unlikely that there would be evidence of neurological improvement. Treatment using PPS would involve discomfort, possible distress and might only prolong survival without any clinical improvements. The likely benefits were speculative and there were clearly risks. He did not believe that the benefits outweighed the risks and did not believe the treatment was in the best interests of the patients.
The court held that the first duty of a doctor in the case of an incapacitated patient when making a decision about treatment was to ensure he was acting in accordance with a responsible and competent body of medical opinion Bolam v Friern Hospital Management Committee. The second duty was to act in the best interests of the mentally incapacitated patient. It was satisfied that the proposed treatment was consistent with the philosophy underpinning the Bolam test i.e. there was a responsible body of medical opinion which supported the innovative treatment. Furthermore, it was reasonable to consider experimental treatment with unknown benefits and risks where there was some chance of benefit to the patient. A patient ought not to be deprived of such a chance where it is likely that he would have consented had he been competent. The court held therefore that the PPS treatment complied with the Bolam test. It was also in JA and JS’s best interests to have the treatment as there were potential benefits that might otherwise not be afforded to them, notwithstanding the chance of improvement was only slight. Both patients had little to lose by going ahead with the treatment. The court made a declaration that it would be lawful and in the patients’ best interests for the treatment to be carried out in the way suggested by T.
Following its declaration, the court expressed a view that it was unsatisfactory that a hospital Trust that would be involved in providing this treatment to its patients such as this one, had not formed its own conclusions in relation to the treatment before the court made its decision. After judgment was given, in brief form, the court was informed that the Hospital Trust’s Clinical Governance and Quality Committee had since met and decided it was unable to approve the treatment. The judge emphasised that whilst a declaration as to what is lawful is sufficient clarification of the legal position, it does not constitute a mandatory order, and no court could force medical professionals to give the treatment. The Department of Health were taking urgent steps to investigate other potential facilities elsewhere for the provision of the treatment. The more recent case of Rogers, involving the quashing of a PCT’s irrational refusal of Herceptin, may need to be read in conjunction with this principle, however, since once a court has declared it to be in the best interests of a patient to be given a particular reason, it is hard to see what reason for refusal of it would be rational, unless it was cost, and cost alone.