Quoted from http://www.bloomberg.com/news/2011-05-18/higher-doses-of-pfizer-alzheimer-s-drug-targeted-in-ban-request.html
Higher Doses of Pfizer Alzheimer’s Drug Trigger Ban Request
By Anna Edney - May 18, 2011 11:01 AM ET
Higher doses of an Alzheimer’s drug sold by Eisai Co. and Pfizer Inc. (PFE) endanger patients and don’t enhance the treatment’s effectiveness, according to a consumer group that wants the regimen banned.
Public Citizen of Washington petitioned the Food and Drug Administration today to remove the 23 milligram dose of Aricept to treat moderate to severe Alzheimer’s from the U.S. market. The nonprofit organization has filed 34 petitions to ban drugs, 22 of which are off the market, said Sidney Wolfe, the director of health research.
U.S. regulators approved a 23 milligram dose in July, four months before a patent on Aricept’s 10 milligram dose expired. Patients taking the larger amount had more side effects than the 10 milligram level, including nausea, vomiting and gastrointestinal bleeding, according to the companies’ website.
“Eisai, Pfizer 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,” Wolfe said. Users are “getting something that’s gratuitously extra toxic,” he said.
As many as 5.1 million Americans may have Alzheimer’s, the most common form of dementia in older people, according to the U.S. National Institutes of Health. While there’s no cure, drugs such as Aricept can ease symptoms.