Watchdog Accused of 'Diabolical Behaviour'

Jun 26, 07:25 AM

Current Headlines: THE Government's medicines watchdog was yesterday accused of "outrageous and diabolical" behaviour over its refusal to continue recommending NHS funds for anti-dementia drugs for victims in the early stages of Alzheimer's disease.The accusations came from protestors at the High Court, in London, as a legal action began to force the National Institute for Health and Clinical Excellence (Nice) to reconsider its decision.A judge was told changes to national guidance made by Nice last year meant that annually 96,600 patients with mild Alzheimer's disease previously eligible for certain drugs would be refused treatment with them.The Northern Echo has been at the forefront of moves to have the drugs, which cost [pounds]2.50 for a day's supply, prescribed to everyone who needs them.In the first challenge of its kind to a decision by Nice, Eisai, the Japanese company that makes one of the drugs, Aricept, and Pfizer, which distributes it, are asking the court to force a rethink.David Pannick QC, for Eisai, told Mrs Justice Dobbs that Alzheimer's was an appalling disease that was wrecking lives.He said there were drugs that could buy time and quality of life for sufferers with mild symptoms. They included acetyl cholinesterase inhibitors - Aricept, also known as donepezil, Exelon (rivastigmine) and Reminyl (galantamine).Nice, backed by an appeal panel, decided they should no longer be available on the NHS for people in the early stages of Alzheimer's after it found the [pounds]2.50-a-day cost was too expensive, given their "small clinical effect".Mr Pannick argued that the Nice approach was procedurally flawed and irrational.He said Eisai had been unlawfully denied access to a computer model that would have allowed it to test the watchdog's assessments.Mr Pannick also said changes in the guidance included the exclusive use of a cognition test called the mini mental state examination for distinguishing between the various stages of Alzheimer's.He said the examinations produced arbitrary and inconsistent scores, making the decision to rely on them irrational.Nice argues that when its appraisal committee examined the cost effectiveness of the inhibitors, it found the drugs had only a small clinical effect.It says Eisai had also not come close to establishing that Nice had acted unlawfully or irrationally, nor that there had been procedural unfairness.The legal action is backed by the Alzheimer's Society, which represents 630,000 people with the disease and their carers throughout England and Wales.There are about 100,000 new cases a year.The society has accused Nice of ignoring the proven benefits of the drugs for those with mild symptoms, and grossly underestimating the savings they bring by enabling sufferers to remain in their homes longer. The hearing continues.

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