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For about five years before he died, my father had Alzheimer's disease. When it was first diagnosed we asked him how he wished his condition to be described when other people asked us about his health. He chose “bewildered”; and, indeed, bewilderment characterised his slow decline over the next five years. By far the most important part of his care was the loving support he received from a carer, who helped our family to cope.
We briefly considered the possibility of drug treatment at one point. The particular drug that we looked at caused diarrhoea in some patients, and that was not going to be welcome in someone who was already incontinent of urine and faeces. But the main problem was that we couldn't interpret the outcome measures from research studies (often scales of some sort). Although sufficient to secure drug marketing licences they had little practical meaning in my father's bewildered life.
In a paper published in 2001 Julia Cream and Harry Cayton of the Alzheimer's Society drew attention to this problem—the mismatch between the outcome measures used by researchers assessing the effects of drugs or other interventions for dementia and the manifestations of dementia that were rated most important to people with the condition and those caring for them.
This mismatch was probably one of the important factors in prompting the Alzheimer's Society to launch its “quality research in dementia” programme, in which patients and carers were integrated into the charity's decision making processes. The Alzheimer's Society was the first large medical research charity in the United Kingdom to do this, and because I have a longstanding interest in promoting such patient and carer involvement, I regarded the society's initiative as a beacon to other funders of research.
I suppose that it is particularly because I used to regard the society as a trail blazer that I have been disappointed by its recent alliance with drug manufacturers in bringing the first legal challenge to judgments reached by the National Institute for Health and Clinical Excellence (NICE). On 10 August Justice Linda Dobbs ruled against the alliance of the Alzheimer's Society and drug manufacturers on five of the six charges they had brought against NICE (BMJ 2007;335:319, 18 Aug doi: 10.1136/bmj.39307.630347.DB).
NICE is an independent body established to tackle the difficult—some would say near impossible—but essential task of trying to judge how the resources of the NHS can be used effectively and equitably in a service built on the principles of shared risk and social solidarity. This process is bound to result in “winners” and “losers,” but those like the Alzheimer's Society that now regard themselves as losers must make it clearer whether they support the principles upon which NICE was established.
I find it disturbing that in response to the legal judgment, Neil Hunt, the society's chief executive, stated, “NICE failed to listen to the views of thousands of carers who told them drug treatments make a huge difference to their lives. It is deeply disturbing that a public body, required to use rigorous standards of evidence based decision making, can simply guess at vital data. This is simply unacceptable . . . To retain its authority as a public body it must command the confidence of the public. The result of this case must call into question whether NICE has lost that confidence.”
But how might the Alzheimer's Society's close alliance with drug manufacturers erode its own authority as a charity subsidised by the public— which thus also needs to retain the public's confidence? The society could take the following steps to restore my respect for and confidence in it.
First, it should declare clearly on its website the sources and amounts of support it receives for its work.
Second, having challenged NICE's judgments about the most effective use of NHS resources for the care of people with dementia, the society should make clear what alternative distribution of limited resources it regards as more appropriate—and why.
Third, it should campaign for treatments for dementia to be evaluated using outcomes that are meaningful to patients and carers, and challenge the licensing and use in the NHS of any new drugs that fail to conform to these expectations.
Fourth, it should insist that all data from clinical trials are published and that anonymised data for individual patients are made available, so that researchers can try to identify which patients are most likely to be helped by treatments and which patients are unlikely to benefit or may be harmed.
These steps would be more effective and enduring ways for the Alzheimer's Society to serve the interests of people with dementia and their carers than forming alliances with organisations with vested commercial interests to take a public body to court.
Competing interests: The author is a member of the NICE research and development advisory committee and provided written evidence challenging the Alzheimer's Society's charge that NICE's assessment and consideration of the AD2000 study (of donepezil in Alzheimer's disease) was irrational.