Eisai got an FDA untitled letter for two Aricept TV ads that the agency said overstate the efficacy of the drug.
The ads, “Beach” and “Garden,” feature women recounting seeing the signs of advancing dementia in parents with Alzheimer's. “Dad had been repeating things and acting disoriented for a while, like something was stealing him away from us,” says a woman in “Beach.” “We wanted to be there for him, to hold on to him.” After treatment with Aricept, the man is shown engaging vigorously with family members. “If it helps Dad be more like himself longer, that's everything to us,” says his daughter.
Each ad implied “a greater benefit than has been supported by substantial evidence or substantial clinical experience,” said the agency's Division of Drug Advertising, Marketing and Communications. Both ads, said the February 3 letter, start out “presenting patients with Alzheimer's disease looking blank, confused, distant, and walking off apart from their family members. However, after talking to their doctors about treatment with Aricept, the patients are seen interacting and communicating with their family members, happily and actively involved in activities with them. These presentations imply that, as a result of Aricept treatment, patients' cognitive and daily functioning, specifically aspects of attention and focus, orientation, communication and social interaction and engagement, will be restored to normal.”
The agency requested that Eisai pull the ads and submit a written response. Eisai said in a statement: "We will give careful consideration to the FDA's comments and will respond in the requested timeframe. However, at this time, we will fully cooperate with the FDA and will discontinue broadcast of the Aricept television commercials currently being aired."