Court Challenge for NICE Over Alzheimer’s Drugs

By The Observer25th June 2007News England

The decision to deny hundreds of thousands of people with Alzheimer’s disease drugs that can improve their condition will be condemned in the high court today as callous, irrational and deeply flawed.

For the first time lawyers will challenge a decision by the National Institute for Health and Clinical Excellence (Nice) to ration a life-enhancing drug, and accuse the organisation of causing unnecessary suffering to patients. If the decision goes against Nice, the government body that rules on new medical treatments in England and Wales, there could be a flood of legal actions from patients refused other drugs.

Patients newly diagnosed with Alzheimer’s were stopped last year from receiving three drugs, Aricept, Reminyl and Exelon, which stave off the development of dementia. Nice agreed that the drugs were proven to be clinically effective but said that they were not cost-effective for the tens of thousands of people a year who start to display a mild form of the disease.

Eisai, the Japanese drug company which makes Aricept, and Pfizer, the firm which distributes it in Britain, have secured a judicial review of the decision. Alzheimer’s sufferers and their carers will be eagerly awaiting the outcome, and some will stage protests against Nice outside the High Court in London.

Experts in mental health will tell the court that they were baffled by the decision to limit the supply of such effective drugs to patients. Health economists from the London School of Economics and Imperial College, London will argue that the cost of providing the drugs, about £2.50 a day, meant they should have been approved.

A source involved in the action said: ‘Nice’s decision was medically foolhardy, the humanity of it is deeply questionable and their economic arguments are highly dubious. Rationing these drugs won’t save any money because the patients will become sick and then either the NHS or local social services will have to pick up the tab, or families will have to give up work to look after relatives.’

Doctors claim the decision was heartless. Dr Andy Barker, a consultant in old age psychiatry who was a Department of Health adviser when Nice adopted the policy, said: ‘Nice’s stance is a gross injustice for people with Alzheimer’s disease and their carers. Without robust evidence, Nice has withdrawn these medications from people in the stage of their illness when they would benefit most. It’s a perverse stance that is contrary to common sense.’

Doctors had to tell patients displaying early signs of Alzheimer’s that they would only get the drugs once their dementia had worsened after two or three years – a possible breach of a physician’s duty of care – said Barker.

He said that Nice had only defended the policy, in the wake of huge criticism, because of its determination to protect its reputation for intellectual rigour and not admit it had made a major mistake.

Lawyers for the drug companies and the Alzheimer’s Society, which has joined the action, will claim that Nice seriously underestimated the benefits to carers of Alzheimer’s sufferers receiving the drugs and reached conclusions that were ‘irrational’ based on the evidence available.

Some better-off sufferers are now spending up to £100 each month buying the drugs through private clinics, says the Alzheimer’s Society. Around 100,000 Britons are diagnosed with dementia every year, of whom 62 per cent develop Alzheimer’s. Around 400,000 people have the condition.

Nice refused to discuss the case in detail. But Andrew Dillon, the organisation’s chief executive, said: ‘Our consultation, decision-making and appeals processes are transparent and fair. The recommendations on the use of drugs for treating Alzheimer’s disease were developed over a three-year period in which careful analysis and detailed discussions with patient groups, doctors and the drug manufacturers demonstrated our commitment to involving those whom our decisions affect.

‘The reality is that, for Alzheimer’s disease, drugs are only part of the care that needs to be offered. Non-drug interventions have an important part to play and the evidence indicates that drugs are simply not effective for some patients. That is why, in November 2006, along with the Social Care Institute for Excellence, we issued joint guidance on the treatment and care of people with all forms of dementia and the support that should be provided for carers.’