Personal paper: New drug treatment for Alzheimer's disease: lessons for healthcare policy

Abstract

The launch of donepezil (Aricept), a specific treatment for patients with mild or moderate Alzheimer's disease, attracted intense interest. Clinicians and others were quoted in the media as being optimistic about the drug's effectiveness, but concerned that NHS funding would be withheld or uneven. However, reaching consensus on the clinical rather than statistical importance of this drug requires open debate, given the relatively small effect sizes and uncertainty over side effects in typical patients. Debate has been hampered because publication of the full results of the main clinical trials has been delayed. This episode highlights several issues of general policy importance that must be resolved if access to the information needed for clinical and other decision making is to be improved. Alzheimer's disease is a common and devastating condition, and the launch of a specific treatment naturally attracted intense interest. The new drug, donepezil (Aricept), an anticholinesterase agent, was licensed in the United States in December 1996, with reports that it had produced “highly significant improvements in cognitive and clinical global assessments” in randomised trials lasting 30 weeks and had increased the proportion of “treatment successes” by 245%.1 The drug's launch three months later in the United Kingdom was greeted with optimism. The lay press quoted eminent clinicians as saying that donepezil “marks a sea change” in management of dementia,2 that it should be seen as “a way to alleviate the burden of a terrible disease,” and that it would “give hope to many people and their carers.”3 Several clinicians voiced fears about funding, including a comment that “we must make sure health authorities do not try to hold back.”2 One respected journalist even suggested that inability to fund treatments like donepezil could result in a mass move of all but the poor into private medical …

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