THE makers of anti-dementia drug Aricept will appeal against a High Court verdict yesterday upholding a ban on patients receiving treatment for the mild stages of Alzheimer's.
Eisai Limited said it would continue the fight to broaden access to the drug, despite a crushing defeat in the High Court.
In a strongly worded statement, Dr Paul Hooper, the managing director of Eisai UK, said the guidance issued by the independent drug watchdog Nice was "morally reprehensible," and vowed to fight on.
The drug company, backed by fellow drug manufacturing companies Pfizer and Shire and the Alzheimer's Society, had hoped to force the National Institute for Health and Clinical Excellence (Nice) to change its controversial guidance.
Nice said that only patients in the moderate stage of Alzheimer's should be given new types of drug, including Aricept, Exelon and Reminyl, which cost as little as £2.50 per day.
The Alzheimer's Society argues that the drugs have a proven record in slowing the development of dementia.
But in a ruling that dashed the hopes of protestors outside the court, Mrs Justice Dobbs backed Nice in five out of the six areas of contention brought by the drugs companies.
Crucially, she accepted that the watchdog had done enough to justify its decision to restrict the drugs to those patients who have reached the mid-stage of Alzheimer's.
While there was a crumb of comfort, in that the judge upheld a charge that Nice discriminated against people with learning difficulties or those who spoke English as a second language when people were assessed for the drugs, it did not change the main direction of the ruling.
In the past year, thousands of campaigners have marched and signed petitions across the UK calling for patients with early-stage dementia to be given either Aricept, Exelon or Reminyl on the NHS.
In the North, hundreds of people joined marches in Newcastle, York and Harrogate, and more than 3.000 people responded to The Northern Echo's Don't Stop Dementia Drugs campaign by sending protest emails to the Department of Health.
Dr Hooper said: "The guidance Nice has issued is morally reprehensible. They are denying patients access to early treatment, and that is wrong.
"For Nice to deny treatment to patients with mild Alzheimer's disease is disgraceful."
Nice chief executive Andrew Dillon said: "Our guidance stands, and the drugs continue to be recommended only for people with moderate Alzheimer's disease, but the court has asked us to clarify our guidance when it is used for certain groups.
"We will reissue our guidance to the NHS and make this crystal clear."
Dr David Anderson, chairman of the faculty of old age psychiatry at the Royal College of Psychiatrists, said; "It seems we will blindly continue to lag behind every country in north-western Europe in making these treatments available to patients. I really fear the Government will live to regret this decision."
Dementia patient Ken Clasper, 60, from Chester-le-Street, who has been able to lead a near-normal life after he was put on Exelon several years ago, said: "I am really disgusted by this decision.
"I cannot understand it. It will cost the Government more in the long run by doing it this way."
Carole Woodcock, 52, from Darlington, whose husband, Ian, 61, has been cared for in a nursing home for the past few years after he developed dementia, said: "I think this really stinks. They have not listened enough to the carers. Giving it in the early stages is when it makes a difference."
Age Concern director Gordon Lishman said the decision was extremely disappointing.
Harriet Millward, of the Alzheimer's Research Trust, said she was devastated that the restrictions would remain in place.
Neil Hunt, the chief executive of the Alzheimer's Society, said: "Nice failed to listen to the views of thousands of carers who told them drug treatments make a huge difference to their lives... the campaign goes on."
THE judge backed the National Institute for Health and Clinical Excellence (Nice) on five points:
* That Nice appropriately took into account the benefits the drugs bring to carers.
* That Nice appropriately reflected the costs of long-term care in its calculations.
* That Nice's assessment and consideration of an earlier study was not irrational.
* That Nice was not irrational in concluding there was no cumulative benefit to patients after six months of treatment.
* That Nice did not breach principles of procedural fairness in relation to an economic model it used.
The judge ruled against Nice on one of the grounds:
* That Nice breached its duties by not offering advice regarding people with learning disabilities and people for whom English was not their first language in its technology appraisal guidance.
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