My Lords, I am honoured to follow the noble Lord, Lord Field, and the noble Baroness, Lady Meacher. I too have put my name to Amendment 15.
Before I specifically address the amendment of the noble Lord, Lord Field, I would like to acknowledge the Minister’s reply to my Oral Question earlier today about the negative effect of Brexit on the legal supply of Bedrocan, and probably other cannabis medicines, to patients in the UK. He knows that this is a life-changing and life-saving medicine, so he will understand that patients and their families are very anxious. Can he assure me that they will be kept informed about progress on sorting this out? They and their clinicians were very worried by his suggestion that there needs to be compromise on both sides. There can be no question of compromise; it would be dangerous to try to substitute this medicine for a different formulation, extracted from a different strain of cannabis.
In response to the DHSC’s suggestion to pharmacists that one cannabis medicine can easily be replaced by another, I will quote from evidence that I have received from Evan Lewis, director of the Neurology Centre of Toronto. He is a clinician with extensive experience of medicinal cannabis for adults and children, and has said:
“It is imperative that children who are benefiting from a particular medical cannabis product are not changed to another product. There is significant variation from one product to the next, and many unknowns as to how all the cannabinoids interact with each other to treat seizures”.
He goes on to say that swapping backwards and forwards between products can be extremely dangerous and is often ineffective. This misunderstanding nicely illustrates some of the problems we face in our campaign to make the benefits of cannabis medicines more widely available to UK patients on the NHS.
On the wider issues in Amendment 15, the key issue is how evidence is obtained about the safety and efficacy of these medicines. I see the Government’s fixation with random-controlled clinical trials as a real barrier to progress in the field of cannabis medicine. When scientists are trying to investigate any issue, they always use procedures that are appropriate to the material being investigated and to answering the question asked. When you have a very small patient cohort, such as the cohort of children with drug-resistant epilepsy, it is impossible to have a meaningful clinical trial. Besides, when giving a placebo to half the sample could be life-threatening, it could be unethical.
As the noble Baroness, Lady Meacher, said, many drugs and medical devices are already used on an anecdotal basis. For example, as she said, 78 drugs are available and in use in the NHS that have no random control trial. The vagal nerve stimulator, which is successfully used to prevent seizures in some epileptic patients, also has no RCT in relation to it. There are many drugs used on children that have not been tested in clinical trials for use in children. Indeed, some of them were used on Alfie Dingley and the other children who now receive cannabis medicines before they fortunately discovered the benefits of the latter.
These drugs are used off-label. This is a well-used way of prescribing in the NHS. Unfortunately, clinicians are being deterred from prescribing cannabis medicines in this way by very negative government messaging, and are even threatened with sacking by their health trust. They also need more information on these matters.
It would be appropriate to set up a formal system of observation, recording and clinical evaluation of these products in use in the UK, alongside accepting the mass of evidence from other developed countries. Such observational studies are not the same as anecdote and would most certainly result in the acceptance of the safety and efficacy of these products for certain indications. Such evidence should then be included in medical education, particularly for neurologists and general practitioners, so that they can have the confidence to write free NHS prescriptions for patients who could benefit from cannabis medicines that have been used safely for years elsewhere.
I hope the Minister is able to tell us in response what appropriate system the Government are prepared to put in place as an alternative to clinical trials, so that UK patients can have the benefits that patients in the Netherlands, Canada, the United States and many other countries have had for years.