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Drug Firms Sue British Regulator Over Alzheimer's Drugs

Two drug firms and a charity for people with Alzheimer's disease began a legal challenge Monday against the downgrading of three anti-dementia drugs by British regulators.

In 2001 the National Institute for Health and Clinical Excellence (NICE), which issues guidance on how medicines should be used in Britain, recommended three drugs from US drugs giant Pfizer and Japan's Eisai.

But last year it changed its advice for patients with moderate Alzheimer's after consultation, saying instead that the drugs should only be considered as options.

The drugs -- Aricept, the brand name for donepezil; Exelon, also known as rivastigmine, and Reminyl, or galantamine -- had not proven especially effective for people with mild Alzheimer's, NICE said.

Pfizer and Eisai were due to argue in a four-day hearing at London's High Court that the effectiveness appraisal process for the drugs was unfair and that NICE's decision was both procedurally flawed and irrational.

Lawyer David Pannick, representing Eisai, told judge Linda Dobbs that the change in NICE's guidance meant that 96,600 people per year with mild Alzheimer's would not now receive the drugs.

The Alzheimer's Society, which represents people with dementia, claimed ahead of the hearing that NICE had acknowledged the drugs worked but, at a cost of 2.50 pounds per person per day (3.71 euros, 4.99 dollars), decided they were not cost effective.

"These treatments have benefitted so many families already -- where is the justice in NICE's decision to snatch them away?" Neil Hunt, chief executive of the charity, said.

Andrew Dillon, chief executive of NICE, countered that its recommendations were not unfair and were developed after three years of analysis and discussion with doctors, patients and drug makers.

"For Alzheimer's disease, drugs are only part of the care that needs to be offered," he said.

"Non-drug interventions have an important part to play and the evidence indicates that drugs are simply not effective for some patients."

Symptoms of Alzheimer's, the commonest form of dementia which affects about 450,000 people in Britain, include mood swings, confusion and withdrawal.


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