Marcia Diljak, a spokeswoman for Eisai, declined to comment on the BMJ article but noted that the FDA approved Aricept 23 mg for patients with moderate to severe Alzheimer's disease on June 23, 2010.
"So it's been on the market a long time," she said.
"The drug companies write the labels," and unless they make inaccurate claims, the FDA does not intervene, Woloshin said. But in the process, he added, many of the fine points of a drug's risks, benefits and uncertainties aren't conveyed to consumers.
Medical ethicist Dr. Howard Brody of the University of Texas Medical Branch in Galveston said the Aricept 23 case is "a perfect storm" of commercial drive, regulatory failure and a patient base that is desperate, discouraged and vulnerable.
Because patients with Alzheimer's disease have good days and bad, caregivers would be powerless to counter the claims of Eisai that its new product is working better than its old product, Brody said.
Marina Del Rey resident Mel Schwimmer, who cares for his 72-year-old wife, Barbara, was among those who jumped at the chance to see if she might respond to something new on the market.
He said he got her physician to write a prescription to replace her 10-milligram dose as soon as he heard about it. In a recent interview, Schwimmer said, "I wouldn't pass up the opportunity to try anything that comes out, in the hopes that it might be something that would slow the progress of this."
Barbara Schwimmer, diagnosed four years ago with Alzheimer's, appears to be tolerating the new dose without signs of stomach upset, her husband said. But he is not sure how much it has helped.
"She seems to be doing well," he said. "But there's no scale I can measure other than my own observation. Even though she's doing well, there's some slippage."
The FDA needs to do a better job for consumers like the Schwimmers, Woloshin said, either by limiting the practice of "evergreening" or, at the very least, communicating what research has shown — and not shown — about the possible harms and benefits of a drug it approves.
New Alzheimer's pill more likely to cause misery, medical experts say