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Monday, March 29, 2010

US FDA Says Eisai, Pfizer Alzheimer Ads Misleading

FDA says TV ads overstate Alzheimer drug's results. Two television commercials for Eisai Co Ltd (4523.T) and Pfizer Inc's (PFE.N) Alzheimer's drug Aricept are misleading because they suggest the therapy offers a drastic improvement not supported by available data, U.S. regulators said in a letter released on Friday.

The Food and Drug Administration, in a letter dated Feb. 3, said the ads depicted patients whose behavior changes dramatically after taking the medication even though results from clinical trials do not support such an improvement.

"The inclusion of the superimposed text, 'Individual results may vary,' does not mitigate these misleading presentations," the FDA added.

The letter is the latest in a series of warnings to drugmakers and other companies about problematic advertisements, warnings that have increased under the Obama administration. Most are resolved between the agency and drugmakers without further incident, but the administration has been moving to make them public more quickly.

Both ads show a parent and their adult child discussing Aricept with a doctor then shifting to scenes with the patient interacting with their families, moving quickly and tackling tasks such as gardening or feeding pets, according to the FDA.

Such a characterization "misleadingly overstates the efficacy of Aricept, implying a greater benefit than has been supported by substantial evidence," the FDA said.

In its letter, the FDA asked Eisai to respond to the agency in writing by Feb. 18.

Eisai, in a statement, said it would weigh the FDA's comments and in the meantime would discontinue the commercials. Pfizer, which co-markets the drug, could not immediately be reached for comment.

Source: http://www.globalaging.org/health/us/2010/usfda.htm

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