By David Jolley
It was my favourite story as a small boy and I remain glad of it. The two tricksters persuaded the vain king (or Emperor) that they could provide him with the very finest suit of clothes – for a price. The suit is so fine that it can be seen only by the wisest people – to fools it is invisible. They laboured away to sew this invisible garment and a parade was organised so that the king could show it off. Everyone said how fine the king looked and what a magical suit of clothes he was wearing. They could not own up to being fools. But one small boy, not knowing the rules, but peeping through the legs of his elders, looked and saw and said: ’The king is in his all-together! The king is in his all-together – he is as naked as the day that he was born’.
I am faced daily with a wish to find a cure or way of living with the weakness and pain, which is my right knee. There is limited help from the advice of doctors and physiotherapists, but we read and hear adverts for therapies of collagen, ginger, snail extracts and more – all supported by stories from people who believe they are being helped.
Just now we await the ruling of the FDA on the proposal that Aducanumab, a substance manufactured by Biogen and Eisai and which acts as an antibody to amyloid, be given a licence to treat people in the earliest stages of Alzheimer’s disease. As I understand it, this treatment has been shown to reduce accumulation of amyloid but has no clinical effect on symptoms of Alzheimer’s. It has previously been considered by the FDA and rejected – to the dismay of the researchers and companies involved. The share prices of the companies fell.
Yet here we are again, a resubmission and a hope that this substance can be of help to millions of people and make the companies millions of pounds. If it were to be introduced it would be a complicated and expensive business: very detailed investigation is required to confirm that a patient has early onset Alzheimer’s – minimal symptoms so little certainty as to how matter might progress, or not. This would need to be backed by a test to find high levels of amyloid. If all is positive, the therapy involves monthly intravenous infusions ongoing.
If the therapy is effective, the evidence seems to be that the benefits will not be spectacular and will only become evident over a period of years. A perfect model for a con.
The main arguments for accepting this new therapy seem to be that many people are desperate for a new treatment for Alzheimer’s disease – this would be the first since 2003. But if it is of doubtful efficacy and very costly, these arguments seem to me to be of no consequence.
The biggest hazard is that people continue to believe in the magic bullet. Money and effort are poured into a fantasy based on a model of medicine, which has delivered well in many other conditions, but frankly has not done so in dementia. Much, much more can be achieved by the application of knowledge, which we have of the benefits of non-pharmacological approaches: prevention, which leads to a healthier body and brain, avoidance of toxins and reduction of pollution, equal and generous opportunities for work and income, regular sleep, and a balanced social and intellectual round. All these we know and they deliver results. For therapy once dementia is established and progressing, we know the principles of good care and the benefits of art-based activities and social integration.
Looking back, I am not convinced that the introduction of cholinesterase inhibitors and memantine have provide a net advantage to the world of people with dementia and their families. Have we been diverted to routines that worship the pill and lose sight of the flesh and blood of caring?
I fear the FDA may let loose more demons.