Aricept

Aricept, a FDA-approved drug to alleviate the symptoms of mild to moderate Alzheimer's, is being promoted as having an effect on late-stages of the disease as well, according to a Wall Street Journal (January 7, 2002) article by Ann Davis. Aricept and similar drugs block the action of cholinesterase, an enzyme that breaks down acetyicholine. The drug's marketers, Pfizer Inc. and Eisai Co. (Tokyo, Japan) have sponsored post-marketing studies to encourage long-term use of the drug. Some insurers and European governments that pay for medicines have objected to the long-term cost of Aricept, which sells for $4 or more per day. The post-marketing studies are published in professional journals and promoted at conventions.

The promotion of these studies, which are often small and poorly designed, does not always reflect the actual outcome. In one study, for example, 208 nursing-home patients (only one-fourth of whom had severe Alzheimer's) were given Aricept; and their behavior problems (delusions, anxiety, irritability, depression, and nighttime wandering) were monitored. The outcome showed no significant difference between patients receiving Aricept and those who did not. Yet, doctors involved in the study, which was published in the Journal of the American Geriatrics Society, have maintained that Aricept has a beneficial effect. Another study sponsored by Aricept's marketers, published in Neurology (August 2001), found that the drug improved cognition, behavior, and daily activity in 290 Alzheimer's patients. The study was promoted as looking at Aricept's effect on people with moderate to severe Alzheimer's, but only 80 of the 290 had severe dementia. The drug's effect on those 80 was inconclusive, according to one of the re searchers involved in the study. "Zaven Khachaturian, former head of Alzheimer's research for the National Institutes of Health, says that given the modest effects of the Alzheimer's drugs and the difficulty of measuring symptoms, any study with fewer than several hundred to 1,000 people would be problematic," reporter Ann Davis explains. Exelon, made by Novartis, and Reminyl, made by Johnson & Johnson's Janssen Pharmaceutica, have also been the subjects of small, company-sponsored, post-marketing studies.

According to FDA regulations, companies cannot promote their drugs for off-label use (for purposes other than those for which they received FDA approval) by providing doctors or researchers with scripts to use at conferences or professional gatherings. The companies are, however, allowed to sponsor conferences where post-marketing and preliminary studies for off-label uses are discussed. In an effort to encourage the use of Aricept, Pfizer-Eisai's public relations firm, Hill & Knowlton, has recruited doctors to talk to news media about Alzheimer's and Aricept and coached them on how to be effective 'spokesdoctors' for the drug.

Davis, Ann. Tactic of Drug Makers Is Raising Questions About Use of Research. The Wall Street Journal 2002 January 7; p A1.

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