This case will be of interest to commissioners, providers and care co-ordinators involved with patients receiving novel and experimental treatments.

Case

University College London Hospitals v KG [2018] EWCOP 29

Relevant Topics

 

 

 

 

  • Experimental Treatment
  • Creutzfeldt-Jakob Disease
  • PRN100
  • Mental Capacity Act 2005
  • Best Interests Decision

Practical Impact

  • When contemplating a novel, experimental treatment, it is sensible to meet with the Official Solicitor even before a particular patient is identified. To permit the thought processes about the relevant matters to develop in relation to any proposed experimental treatments on patients lacking capacity without the pressure of a case imminently coming before the courts;
  • Should draw up detailed Care Plans setting out how the treatment will be administered and monitored – and in particular, how the organisation administering it will internally audit and monitor;
  • The effects of any experimental treatment should be monitored to the highest standards and in the instance that the treatment does become invasive, another best interests decision will be required, and the treatment may need to be adjusted or stopped;
  • Even following recent case law about the necessity of application to CoP for serious medical treatment,  it would be premature to say that these experimental treatment cases do not require an application to Court anymore - any clinician proposing to use PRN100 or any other experimental treatment on a patient lacking capacity should make an application to the Court of Protection for authorisation until clinical results of the treatment are known;
  • Applications are likely to be approved where there is agreement from patient and family, where there is no alternative treatment and the prognosis is fatal;
  • Updates to the press on progress are appropriate – but only if anonymised and approved by the family at the time. Press Association to be updated within 72 hours if KG dies.

Summary

Mr Justice Cohen

KG, a middle-aged man, suffers from sporadic Creutzfeldt-Jakob Disease (“CJD”). It was diagnosed 3 weeks prior to the Court hearing – but the average life-span is 6 weeks from diagnosis (albeit, it was anticipated KG’s life-span would be slightly longer as he is younger than most patients – no more than 12 months). There is a proposal to treat it with PRN100 (an antibody) – but that treatment has never been tested on or administered to any person, anywhere. It is completely novel.

Code of Practice to the MCA (paras 6.18, 6.19 and 8.23) specifically refers to the potential need for Court approval for ethical dilemmas concerning untested or innovative treatments – e.g. new treatments for CJD where it is not known if the treatment will be effective).

Due to the progressive neurodegenerative effects of this disease, KG is unable to retain the details of the risks and benefits of the treatment and therefore does not have the capacity to make an informed decision about treatment, although he is able to express his view.

This case was brought before Mr Justice Cohen in the Court of Protection (“CoP”) to consider whether or not it is in KG’s best interests to be treated with PRN100. The factors against treatment are as follows:

a) No evidence as to whether PRN100 is safe or effective in humans – animal trials rendered some adverse effects;

b) There may be negative side effects or adverse reactions which may be serious or life-threatening – it is not known whether any side effects will be reversible;

c) It is possible that KG’s death will be accelerated or that he will be maintained in a poor state for a longer period than otherwise would have been the case;

d) It is impossible to quantify the chances of a significant or material benefit to KG – may be small or even non-existent.

The factors in favour of the treatment are:

a) KG wishes to have the treatment;

b) KG’s wife and family wishes for him to have the treatment;

c) KG’s quality of life, while diminishing, is still one that is clearly worth preserving;

d) There is some evidence from animal studies that PRN100 could have a positive effect on the progression of sporadic CJD in humans – it could:

a. delay the profession of the disease

b. stabilise the disease; or

c. improve KG’s condition;

e) There is “a sufficient possibility of unquantifiable benefit to justify the risks involved when, without treatment, KG will certainly deteriorate further and die within a short period” (Simms v NHS Trust)

f) There is a clear and thorough plan for protective monitoring and oversight.

The Judge considered the invasiveness of the treatment, the standards of monitoring that will be adopted throughout the course of the treatment, current UK legislation and the wishes of KG and his family.

Judge recognised that, the proposed treatment is not especially invasive, however, if it were not effective, may change to direct administration to the brain (requiring an operation to cite the equipment to so administer). There is potential that this could change if KG was to have an adverse reaction or negative side effect. In this scenario, treatment may need to be adjusted or stopped. The monitoring includes lumbar punctures, which are quite uncomfortable.

The court is satisfied that the highest standard of monitoring will be maintained given that the clinical team has developed a detailed treatment plan and is fully aware of its duties to promote and safeguard the health, wellbeing and rights of KG. An Oversight Committee has been set up (to monitor the administration of PRN100 to a small cohort of patients at the Trust) and has already convened 8 meetings to fulfil those duties in relation to the administration of PRN100. The court is also comforted by the fact that the hospital is a recognised world leader in the process which is to be undertaken.

Taking account of the current legislation (Article 83 of the relevant EU Regulations) and guidance published by the Medicines and Healthcare Products Regulatory Agency (“MHPRA”), Mr Justice Cohen is satisfied that this case falls under the “Specials” scheme. The Trust has also provided evidence of its own correspondence with MHPRA that has reiterated its support for the use of PRN100 under the “Specials” scheme and formally confirmed that the plans are appropriate stating that “the proposed individual prescription of PRN100 to a patient under the personal responsibility of a clinician would not constitute a clinical trial.”

Lastly, Mr Justice Cohen turns to the wishes of KG and his family. KG has been seen regularly by doctors and the Official Solicitor, and by his family on a daily basis. It is clear that KG wants the treatment. He has a very clear wish to live longer with his wife.

KG still had a quality of life – he could walk, talk, recognise people and have an interest in what is going on around him and an ability to discuss the issues concerning him.

In considering the case of Simms v An NHS Trust, Mr Justice Cohen considers that it is plainly within KG’s best interests to receive the treatment as the prospect of a prolonged life is a benefit worth having. Although KG does not have the capacity to consent, he ought to not be deprived of the chance in circumstances where he would have been likely to consent had he been competent.

Following the case of An NHS Trust & Ors v Y & Anr [2018] UKSC 46, the Trust suggested that it would not make an application to CoP for future PRN100 cases where the family and patient were in agreement – Judge considered this was too premature and applications should still be made in these cases because the outcome of the treatment remains unknown.

The Press Association argued that there should be regularly, anonymised updates as to progress. The family argued that they wouldn’t want “bad” results or progress made publically available whilst KG was still alive as it would make a difficult situation more unbearable. Judge weighed in the balance and concluded that information could be updated from time to time as requested and as approved by the family – acknowledging the force of the submissions by the Press Association and asking that if information can be given, that would be helpful. Press to be notified within 72 hours of KG’s death.

Background

There are about 100 new sporadic CJD patients diagnosed annually in the UK and as yet there are no effective therapies to modify the progressive disease course of sporadic CJD. Life expectancy from symptom onset is typically only four to six months.

CJD is a neurodegenerative condition that is associated with a build-up in the brain and some other organs of an abnormal or rogue form of a naturally occurring prion protein (change in shape of the normal prion protein).  These rogue proteins recruit and convert more of the normal protein into abnormal protein leading to a progressive accumulation of the rogue protein, which causes problems with the normal function of the brain such as memory, thinking, speech, balance and movement. During the end stages of the disease, patients will enter a comatose state followed by death.

The National Prion Clinic has developed a humanised monoclonal antibody known as PRN100 with the aim of seeking regulatory approval for phase one clinical trial in patients with clinical CJD. Unfortunately, it has not been possible to raise the funding for a formal clinical trial; PRN100 has therefore not been tested on a human.

The Trust, anticipating that there would be a need for such a case for PRN100 in the imminent future, proactively met with the Official Solicitor before a specific individual was identified. This is very rare.

KG was diagnosed in September 2018, with a lifespan of a several months rather than a few weeks due to his young age and slower level of deterioration than usually seen. However, it is very unlikely that he will survive longer than 12 months.

Key Findings

  • The treatment itself is not especially invasive, but it is not known whether any treatment directly into the brain will be required, so it is essential to closely review the effect of the treatment so that it can be adjusted or stopped if required;
  • The court must be satisfied that the highest standards of monitoring will be maintained to authorise novel/experimental treatment decisions;
  • The proposed individual prescription of PRN100 to a patient under the personal responsibility of a clinician would not constitute a clinical trial. It is the provision of a treatment or procedure under the Specials Exemption to a patient in need as set out in Article 83 of the relevant EU Regulation;
  • Where there is no alternative treatment available and the disease is progressive and fatal, it seems to be reasonable to consider experimental treatment with unknown benefits and risks, but without significant risks of increased suffering and some chance of benefit to the patient (Simms v An NHS Trust)
  • The prospect of a slightly longer life is a benefit and it would be in the best interests of the patient to have the treatment subject to an assessment of the risks (Simms v An NHS Trust)