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Campaigners today lost their landmark High Court battle to get early-stage Alzheimer's sufferers access to costly new anti-dementia drugs on the NHS.
In the first ever judicial review case brought against the National Institute for Clinical Excellence (Nice), Mrs Justice Linda Dobbs ruled that the Government's drugs watchdog was correct to state that the drugs are only cost-effective when prescribed in later stages of the disease.
The case was brought by Eisai, the Japanese pharmaceutical firm, and Pfizer, which distributes the drugs in Britain, and backed by the Alzheimer's Society charity, which said that treating people at an earlier stage could slow their mental degeneration.
They had accused Nice of acting "irrationally and unlawfully" in recommending that the drugs should not be funded on the NHS for people with early-stage symptoms. They also argued that Nice's decision was "procedurally flawed".
Although the case was defeated on five out of six counts, the campaigners were successful on one count - that tests to assess Alzheimer's were "discriminatory" against people who speak English as a second language or those with learning disabilities.
However, the key claim of the campaigners - that patients should be given NHS Alzheimer's treatment at an earlier stage in the illness - was defeated.
Last year, Nice recommended that three drugs, donepezil, rivastigmine and galantamine, not be prescribed for patients with early stage Alzheimer’s, claiming that the treatment was not effective for people with mild Alzheimer’s and was not cost effective. It recommended the drugs for patients with moderate-stage Alzheimer’s.
Speaking in court today, David Pannick QC, appearing for Eisai, told the judge that the consequence of removing funding for those with mild Alzheimer’s disease "is that the opportunity is lost for delaying the onward march of this appalling disease and maintaining a relatively good quality of life for patients for as long as possible".
He said changes made to national guidance by Nice last year meant that annually 96,600 patients with mild Alzheimer’s would be refused treatment whereas, under previous guidance, they would not have been.
Campaigners and interest groups reacted with disappointment to the ruling today.
Dr David Anderson, chairman of the faculty of old age psychiatry at the Royal College of Psychiatrists, said: “The decision by the High Court is bitterly disappointing.
“I am astonished that the Nice process has been found to be rational and without perversity in this case.
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I have to say I agree with Mike Bibby - it may be old-fashioned, and undoubtedly divisive, but the old adage "charity begins at home" is one I wholeheartedly agree with. Once we have our own house in order THEN we can start helping others. Helping them at the expense of our own country's needs is wicked and most definitely discriminatory against the British!
Alison, London, UK
"'discriminatory' against people who speak English as a second language ". I thought the real problem was that the NICE ruling was "discriminatory against the English".
Scots are unaffected, we continue to make payments for no return to Europe after Tony gave away Maggie's refund to prove he was a "good European", and we can afford another £8 billion a year for Africa to prove that Gordon is even more generous and important than Tony.
The ony people we cannot afford to look after are the English who provided the money in the first place!
MIke Bibby, St Albans, England -not Eu
This ruling is just what I've come to expect from our society which increasingly discriminates against the elderly (and not so elderly when it comes to dementia).
It's impossible to measure the effects of the drugs in a purely clinical way - for instance my mother has to attend a 'memory clinic' which is run in a morning. If she has a 9.15am appointment she is much 'worse' than if she has a 11.45am appointment. Like so many non dementia sufferers she takes some time to 'get going' in the morning.
No specialist or GP has even visited her at home to see how she copes or doesn't cope with day to day living.
I know that since she started on the Reminyl she's been 'better' than she was. But no specialist or doctor has actually bothered to ask me about my mum's behaviour.
And the cost of medicating the carers hasn't been taken into account. My father, the primary carer, is exhibiting classic signs of depression now - how much will that cost the NHS? And I'm not far behind.
Joolz, Knutsford, UK
The Guidance is due for review in two years time. Perhaps, to make the drugs more cost-effective, the drugs companies should think about lowering their prices? It would in some way pay back some of the cost of this claim shouldered by the tax-payer, who, on top of their own costs, have to pay 40% of the drug companies legal costs, according to today's ruling.
No wonder the NHS can't afford to fund every drug.
Sarah, London,
I am a psychiatrist who has treated over a thousand patients with these drugs. They work well in all stages of the disease. The problem is how we measure the effects with scales designed before the drugs became available and not designed to measure their effects. We as an academic disciplne are only just trying to deal with these questions. NICE is a conservative body as are its allies, who understand little of the real laboratory for doctors that is, the clinical scenario. How can they (NICE) have got it so wrong with our clinical evidence painting a very different picture? They understand even less of the complex academic debates going on at the highest levels of our subspeciality. A specialist doctor struggles, with this a judge cetainly cannot with the same professional proficiency.
Dr Simon Wright MRCPsych, Sheffield, South Yorkshire
Hydration is a lot cheaper and more readiliy available than any drug and is known to prevent Alzheimers.
Kay Scott, Dartmouth, UK
I wonder how many of the people of NICE would feel if anyone of them began early stages of the Alzeimer's disease and were denied compensation for taking the new drugs. The Alzheimer's disease has been in my family and I certainly would try and pay for new drugs I could take in early stages of dimentia.
marty spiegle, Cleveland, Ohio