The Food and Drug Administration (FDA) has recently chastized two television commercials for Aricept, the most popular medication for Alzheimer's Disease, as "misleading," "deceptive," and "not supported by the available research data."

In a letter dated February 3, 2010 to Eisai Co., Ltd and to Pfizer, Inc., who co-market Aricept (donepezil hydrochloride), the Food and Drug Administration (FDA) stated that the two commercials imply that as a result of taking Aricept a patient's cognitive abilities and daily functioning, including attention and focus, orientation, communication, and social interaction and engagement, will be restored to normal. They pointed out that respected clinical trials of the drug have indicated only a small degree of improvement in some subjects taking Aricept, and that some subjects have shown no measurable improvement at all. They requested that the advertisements in question be pulled from television.

Commercials for Aricept Overstate It's Efficacy

According to the FDA letter, promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience. They found that the two commercials described below fit the description of "misleading:"

The "Beach" TV ad for Aricept presents an elderly man staring off into space, appearing distant, confused, and disinterested, while the rest of his family walks on the beach, and the man's daughter has a look of concern on her face. While this beach scene is taking place, the man's daughter makes the following statements:

• "Dad had been repeating things and acting disoriented for a while, like something was stealing him away from us."

• "We wanted to be there for him, to hold on to him." (While this statement is being made, a young boy clasps the man's hand.)

The ad then shows the man and his daughter discussing Aricept with his doctor. Specifically, the daughter states:

• "Dad's doctor said his symptoms were signs of Alzheimer's, a type of dementia, and that prescription Aricept could help." (While this statement is being made, the daughter poignantly clasps her father's hand.)

After the patient and his daughter discuss Aricept with the doctor, the man's behavior changes dramatically. The man is shown happily interacting with his family members, moving more quickly and with greater focus. For example, he pats his grandson on the head while pouring cereal, winks while feeding the dog under the table, energetically cheers and points at a soccer game while following the plays, and clasps his daughter's hand. While these scenes are taking place, the ad makes the following statements:

• "Studies showed Aricept slows the progression of Alzheimer's symptoms."

• "It improves cognition and slows the decline of overall function."

• "If it helps Dad be more like himself longer, that's everything to us."

• "Don't wait. Talk to your doctor about Aricept."

The "Garden" TV ad presents an elderly woman looking away from family members, appearing confused, aloof, and disoriented. While these scenes are taking place, the woman's daughter makes the following statements:

• "We'd been noticing mom acting forgetful and confused, like she was drifting away."

• "We wanted to be there for her, to hold on to her." (While this statement is being made, a young girl clasps the woman's hand.)

Similar to the "Beach" ad, this ad then shows the woman and her daughter discussing Aricept with her doctor.

After the woman and her daughter discuss Aricept with the doctor, the woman's behavior changes dramatically. The woman is shown interacting happily with her daughter and her grandchildren, trying on a hat, helping them plant seeds, and working with them in the garden. At the end of the ad, the daughter looks at her mother, smiling and hugging her, and the woman clasps her daughter's hand.

According to the FDA letter, which was posted to their website on Friday, February 19, 2010  "...the totality of the above claims and presentations misleadingly overstates the efficacy of Aricept, implying a greater benefit than has been supported by substantial evidence or substantial clinical experience. As described above, the beginning segment of each ad presents 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 results from the Aricept efficacy trials in patients with mild to moderate and severe Alzheimer's disease do not support such a drastic improvement.

"...the claims and presentations in both TV ads are not representative of the results from the clinical trials for Aricept, and misleadingly overstate the efficacy of the drug. The inclusion of the superimposed text, "Individual results may vary," does not mitigate these misleading presentations."

The full text of the Aricept letter is available on the FDA website.