FDA says two US Eisai TV ads are misleading

The US Food and Drug Administration (FDA) has said that two TV advertisements for the Alzheimer's drug Aricept, which is produced by Eisai and Pfizer, were misleading as they showed patients making a greater recovery after taking the medication than has been proven through clinical trials.

The claims were made in a letter sent by the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC). The letter said that the TV ads were misleading because they overstated the efficacy of the drug and therefore misbranded Aricept in violation of the Federal Food, Drug, and Cosmetic Act and FDA implementing regulations.

The first of the two advertisements in question was referred to as the 'Beach'. According to the FDA letter, the commercial showed "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."

After a discussion about Aricept between the patient, his daughter and the doctor, the behaviour of the man was seen to change 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," said the FDA.

The 'Garden' advert followed a similar pattern – showing an elderly woman looking away from family members, appearing confused, aloof and disorientated.

After a similar discussion with a doctor, as seen in the 'Beach' advert, the woman was 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."

The FDA stated that "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."

In the letter, the FDA went on to say that the presentations implied 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, would be restored to normal.

The DDMAC requested that Eisai immediately ceased "the dissemination of violative promotional materials for Aricept such as those described above".

The pharmaceutical company was asked to provide a written response, stating whether or not it intended to comply with the request. In addition, Eisai must list all promotional materials for Aricept that contained the violations outlined by the division and explain its plans for discontinuing use of "such violative materials".