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Lecturer in Law, University of Warwick, Coventry CV4 7AL, UK
How should the courts respond to medical progress in the context of patient
need, scientific uncertainty and finite health care resources? This was the
question before the High Court in Simms v Simms and An NHS Trust 
EWHC 2734, Fam. The Court ruled that it would be lawful to use experimental
drugs to treat two patients, Jonathan Simms, a young man of 18 and one JA,
a girl of 16, both suffering from variant Creutzfeldt Jakob Disease (vCJD)
and therefore lacking capacity to consent to the treatment themselves. The
case arose because expert committees of the Department of Health and of the
local NHS Hospital Trust refused to approve the therapy sought. The families
of the two patients had tried unsuccessfully to persuade the Secretary of
State for Health to ignore this expert advice and to facilitate treatment.
Attempts to obtain treatment abroad had also failed. While the declaration
sought would not compel provision of the therapy it would pro tanto
insulate the doctors involved from suit in negligence.
The decision in Simms is significant in three general respects which will be considered in the rest of this note. 1) It recognizes that doctors have a certain leeway to use therapies that have not yet been fully tested as to safety or efficacy. 2) It specifically permits such innovative treatment even where the patient is incompetent. 3) It confirms the tendency of the courts to evaluate and in certain cases reject the views of medical experts on the appropriate use of health care resources. In the next section the facts of the case are explored with a particular focus on the disease from which the patients suffered and the precise therapy which was proposed. The application by the High Court of the Bolam test of acceptable medical practice and its reasoning as to the best interests of the patients are then examined. The following section considers the practical obstacles to implementation of the Court’s ruling. In conclusion the decision is considered as a rhetorical performance with particular reference to the commonsense assumptions upon which it is based.
Variant CJD is widely known as the human form of ‘mad cow disease’,
or BSE (Bovine Spongiform Encephalopathy) because of the generally accepted
link between the two conditions.(1)
The first case of vCJD was identified in 1996 and, with a few exceptions,
the outbreak remains confined to the United Kingdom (see National CJD Surveillance
Unit 2002). The disease is characterized by a multiplication of abnormal proteins
in the brain, leading at the clinical stage to progressively impaired neurological
functioning. Symptoms include an inability to walk or stand, loss of memory,
and failure of speech. vCJD was found on the facts of Simms to have
transformed two ‘normal energetic teenagers into helpless invalids’
within a year of the first symptoms being diagnosed (para 4). Both were confined
to wheelchairs; some, very limited communication and recognition of family
members was possible. Without treatment both were bound to die of the condition:
average life expectancy from the discovery of symptoms is a mere 14 months,
though JA had already survived for three years from this date. As a result
of their illness both patients lacked capacity to refuse or consent to the
Pentosan polysulphate (PPS), the drug at issue in the case, has long been used to treat conditions such as thrombosis. However, its use in cases of vCJD has only recently been suggested. Trials conducted in Japan seem to indicate that PPS may be capable of delaying the onset of scrapie, a disease of animals very similar to vCJD (para 13). However, research is at an early stage: tests have only been carried out on rodents and dogs, several of whom suffered seizures within 24 hours of administration of the drug. The effectiveness of PPS against vCJD has not been studied directly, nor can the results of testing on animals be automatically generalized to include humans. While the Japanese researchers expect to be able to use PPS on vCJD patients in that country in the near future, a paper containing their preliminary results was still under peer review by a leading journal at the time of the hearing.
In cases of vCJD it is not possible to administer PPS intravenously as molecules of the drug would be not be capable of passing directly through to the brain. Consequently the trial protocol drafted for the two patients specified that PPS would have to be administered intracerebrally, ie. into the brain itself. The risks of complication attending this operation were put at around 2%. More serious was the possibility of haemorrhage within the brain, leading to seizure, stroke, or death. The greater the dosage of PPS the higher the likelihood of such haemorrhage.
The claimants in Simms sought a declaration that it would be lawful
to administer PPS and to perform the necessary surgical operation to allow
intracerebral infusion. Giving the judgment of the Court, Dame Butler-Sloss
P held that in cases of this type doctors come under a two-fold duty. First,
they must comply with the well-known Bolam test by proceeding only
in accordance with the practice of a responsible body of relevant professional
opinion (see Bolam v Friern Hospital Management Committee  2
All ER 118, McNair J). Second, they must act in the best interests of the
incapacitated patient. She, thus, upheld the distinction, now well established
in English case law, between what is proper as a matter of medical practice,
and what is in the best interests of the specific patient.(2)
The latter certainly includes their medical interests, but as, we shall see,
it also extends to encompass emotional and other welfare issues.
The reiteration of this distinction is to be welcomed especially coming as it does in the context of highly innovative treatment. The deference to medical opinion embodied in traditional understandings of the Bolam test, may have some justification where well-tested treatment is proposed. By contrast, experimentation, however ad hoc, is always done with a mixture of motives. Though doctors want the best for their patient, they will also have an eye to the scientific value of their work. Recent medical history shows that incompetent subjects of experimentation are uniquely vulnerable in this regard (see McNeill 1993). A combination of eager researchers and desperate relatives may obscure the fact that the patient’s condition is best addressed with conservative, rather than aggressive therapy.
In applying the Bolam test the Court had to consider the expert testimony of four neurologists working on vCJD, including the doctor who would treat the patients should it be declared lawful to do so. All four were agreed that there could be no certainty as to whether treatment with PPS would have any significant beneficial effect in the case of either patient. In the opinion of Dr Wills and Dr Knight, directors of the UK National CJD Surveillance Unit, the potential harm accompanying treatment outweighed the remote benefits therefrom. However, Butler-Sloss P preferred the evidence of Dr Doh-ura, leader of the Japanese researchers mentioned above and a proponent of the drug. Having given evidence by satellite link from Tokyo he was found to be ‘a most impressive witness’ (para 10). He had not displayed over-confidence in his results; modesty clearly becoming the pioneer in this context.
Furthermore, notwithstanding their scientific reservations, the other witnesses agreed that it would not be ‘irresponsible or unethical’ to give the drug to these particular patients (para 33). The inconsistency here is only apparent, and can be explained with reference to the tension between the scientific basis of medicine and the doctor’s primary duty to his or her patient. From the generalized perspective of medical research and clinical governance, there were insufficient aggregate data to support the administration of PPS in these cases. As scientists, the experts were, therefore, unwilling to recommend its use. From the individualized perspective of clinical care, by contrast, there remained a chance that therapy might benefit the particular patients. As clinicians, the experts would be willing to try it out. This split, and its ratification by the Court, attests to the enduring importance of clinical judgment notwithstanding the rise of evidence-based medicine and clinical guidelines. Rejecting medical dogmatism courts have held that ‘each request for treatment [must] be considered on its individual merits’: North West Lancashire Health Authority v A, D, and G  Lloyd’s Rep Med 399, CA per Auld LJ at 404; see also R v Secretary of State for Health, ex parte Pfizer Ltd  Lloyd’s Med Rep 289, QBD.
What is applied in Simms, therefore, is a fairly weak version of the Bolam test: one which permits treatment in the absence of negative opinion, rather than on foot of positive endorsements. To search for affirmative support for every type of novel therapy would run counter to the public interest in medical progress. Butler-Sloss P noted (at para 48) that:
“if one waited for the Bolam test to be complied with to its fullest extent no innovative work such as the use of penicillin or performing heart transplant surgery would ever be attempted.”
“a patient who is not able to consent to pioneering treatment ought not to be deprived of the chance in circumstances where he would have been likely to consent if he had been competent.”
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The final issue raised (but not directly resolved) in Simms concerns
the practical implementation of the Court’s decision. In making the
declaration of lawfulness Butler-Sloss P was prepared to go against the views
of both the Department of Health’s CJD Therapy Advisory Group and the
Committee on the Safety of Medicines. In October 2002 both of these expert
bodies had advised that, given the lack of data on safety and effectiveness,
there was ‘no rational basis for prescribing PPS’ in cases of
vCJD. Further animal trials were necessary before the advice could be changed
(see DOH 2002). This general stance was reflected at an operational level
in a decision of the Clinical Governance and Quality Committee of the NHS
Hospital Trust responsible for the care of the patients. The Committee felt
unable to approve the use of PPS within its auspices.
A neurosurgeon employed by the Trust was willing to perform the operation necessary for intracerebral administration of PPS. He would not, however, be provided with the necessary facilities to do so. This ‘impasse’ had arisen because of the form taken by the claimant’s application. In the case of Jonathan Simms, an adult incompetent, a declaration of lawfulness permitting treatment was sought; in that of JA, still a minor, the court was required to exercise its inherent jurisdiction subject to the ‘welfare requirement’ of Children Act 1989 s 1. The Trust was joined as a second defendant, but it made no submission to the Court on the issues, and it was not the direct addressee of its orders. These were permissive not compulsory as regards the Trust. A separate application for judicial review of its refusal to co-operate would be necessary if the operations were to go ahead.(3) Consequently, as Butler-Sloss P noted, the decision in Simms amounted to no more than an ‘unacceptable academic exercise’ (para 70). The only prospect of realizing the intentions of the Court was to request the Department of Health to find another Trust willing to carry out the operation; a task made more difficult by the objections of the Department’s own expert committees, reiterated on the day after the Court’s ruling.
This normative lacuna appears to have been overcome in practice. The parents of Jonathan Simms were able to find an alternative venue for treatment in Northern Ireland after the High Court in Belfast held that the decision of Butler-Sloss P was also applicable in the province (see Dyer 2003). Treatment has already commenced, with early indications that his condition has stabilized (see BBC News 2003). The fate of the other patient is not known. There was no suggestion in the case that the objections of the Departmental experts stood on anything other than scientific grounds. Nonetheless it is true that at the time of the decision the number of persons affected by vCJD in the United Kingdom was increasing steadily (see National CJD Surveillance Unit 2002). Use of the PPS in NHS facilities would thus constitute a further, as yet unquantifiable burden on the Service’s strained resources. An argument from scarcity would have been admissible in the case: while the courts have sought to circumscribe outright bans on treatment, they do accept the need for priority-setting in the allocation of health care (see R v Cambridge Health Authority, ex parte B  2 All ER 129, CA; North West Lancashire HA v A, D and G  Lloyd’s Rep Med 399, CA).
(1) Case-control studies have shown
a correlation between the incidence of vCJD and the consumption of meat products
of a type likely to have carried BSE, such as sausages and meat pies (see National
CJD Surveillance Unit 2001, s 3). For a sceptical view see Venters 2001.
(2) It is true that in earlier cases purely medical evidence was taken to be determinative of the broader question of best interests: Re F (Mental Patient: Sterilisation)  2 AC 1, HL. But subsequent decisions have confirmed the need for a two-stage analysis: Re SL (Adult Patient) (Medical Treatment)  2 FCR 452, CA; Re A (Mental Patient Sterilisation)  1 FLR 549, CA.
(3) Denial of treatment found to be medically justifiable could be claimed to be a violation of the patients’ right to be free from inhuman and degrading treatment under Article 3 ECHR: D v UK (1997) 24 EHRR 423, ECtHR. It has been argued that the Strasbourg jurisprudence recognizes a core right to health care, going beyond the provision of emergency services, where there is an immediate risk to life (see Clements and Read 2003, p 52).