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NICE ignored thousands of patients who said Alzheimer's drugs had transformed their lives
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27 June 2007
Despite asking patients for their opinion and being swamped with thousands of moving testimonies of how the drugs had dramatically transformed lives, they failed to be swayed.
Instead, the High Court heard, the £2.50-a-day tablets which alleviate the devastating symptoms were declared not cost-effective and banned last year in England and Wales, while remaining freely available in Scotland.
It means 100,000 new Alzheimer's patients a year are denied funding for the drugs which can slow the cruel decline into dementia.
Alzheimer's sufferers are battling the NHS's "rationing" body, the National Institute for Health and Clinical Excellence (NICE), in an unprecedented High Court challenge made possible by donations from Daily Mail readers.
The court heard that the Alzheimer's Society supplied 4,000 examples to NICE detailing the benefits of the treatment to both sufferers and carers. In addition, NICE carried out its own consultation and received 7,000 responses.
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Michael Fordham QC, for the Alzheimer's Society, told the court: "The responses set out quite clearly and in emphatic terms what this truly meant for the thousands of real people who are affected.
"If you, as carer, get your life back, and the victim is your husband or wife, you both benefit. Why are you asking for a public response if you are not going to take account of their answers when you quantify benefits?
"Why don't you rely on this material when your own guide, to your own processes, emphasises
just how valuable this evidence is? There was no document to show that it relied on any of this evidence."
He said the approach of NICE "simply defies human experience" and had "wiped out the clinical effect of a whole group of thousands of people who were relying on it".
There is no cure for Alzheimer's but there are three drugs on the market - Aricept, Exelon and Reminyl - to treat the mild and moderate stages of the disease, and up to half those who try them see an improvement in their condition.
NICE, which is tasked with deciding on which treatments the NHS should concentrate its limited resources, decided the benefit of these drugs did not justify their cost.
As a result of its decision last year, the only patients to receive funding for the drugs are those who were diagnosed before the decision, and those considered "moderate" sufferers of the disease.
Though not available on the NHS, the drugs can be bought over the counter at high street pharmacies, with a prescription from a GP or consultant.
In its defence in court, NICE said the drugs, known as inhibitors, were a "long, long way off" being cost-effective for those with mild forms of the disease.
Nigel Giffin QC said: "There is no doubt the inhibitors were clinically effective, otherwise they would not have been licensed for use. But clinically the effect was a limited one."
When the drugs were first licensed, in 2001, they had been subjected to only 13 randomised clinical trials, but this later rose to 26 and meant a good deal more was known about them.
The hearing is expected to last four days with judgment being delivered in a few weeks.
A NICE spokesman said: "The independent Appraisal Committee and Appeal Panel considered all of the comments they received, but NICE has to act on the evidence. These drugs are simply not effective for all patients, and our job is to ensure NHS resources are well spent.
"If we spend NHS funds on drugs which are not effective, we take money away from other parts of the NHS. This would be likely to cause real injustice to people suffering from other serious conditions."
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