Public Citizen strikes again. The consumer group has petitioned the FDA to ban another drug, or at least high doses of one. The Alzheimer's drug Aricept, sold by Eisai and Pfizer, is not more effective in the 23-mg strength than it is at the lower dose, Public Citizen says, so the higher-strength pill should be taken off the market.
The 23-mg pill was just approved in July, Bloomberg notes, based on data from a 1,400-patient study. That was just four months before a patent on the 10-mg strength expired. That study showed the 23-mg dose was better than the 10-mg pill at handling cognitive symptoms, but in overall functioning, there was little difference. Patients on the higher dose had more side effects, including vomiting and gastrointestinal bleeding.
Public Citizen's Sidney Wolfe called the 23-mg pill "extra toxic," saying that the higher dose wasn't a treatment improvement, but a ploy to salvage sales in the face of generic competition. The companies "knew the patent was going to expire and since it was the leading Alzheimer's drug, they wanted to figure out a way to retain their leading share," he said (as quoted by Bloomberg).
- get the Bloomberg story
- see the article in the Los Angeles Times