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FDA Rejects Petition to Ban Aricept 23: Did Drug Companies, FDA Collude in Approving Dangerous Alzheimer’s Drug?

Statement of Dr. Sidney Wolfe, Director, Public Citizen’s Health Research Group

Allowing drug manufacture Eisai to exploit and harm vulnerable patients with Alzheimer’s disease is unconscionable. With close to $700 million in drug industry money a year directly funding the Food and Drug Administration’s (FDA) drug review process, the question is whether the FDA, in this instance, was protecting the public health or, in effect, colluding with the drug industry when it denied a petition to ban Aricept 23, deciding to leave the dangerous drug on the market.

Eisai and Pfizer, peddlers of the biggest-selling Alzheimer’s drug of all time — with more than $2.4 billion U.S. sales in 2010 — were facing a threat to that revenue stream when the patent was set to expire on the lower-dose version of the drug. A study presented to the FDA in 2009 failed to show that Aricept 23 was more effective than the lower-dose drug in improving overall patient function and while showing it to be only minimally more effective in improving cognition.

Furthermore, the high dose was predictably associated with a much higher incidence of vomiting, which, in patients with Alzheimer’s disease, “can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture or death,” according to the FDA.

For this reason, the primary medical reviewer and the statistician at the FDA recommended that the agency deny the company’s application to market the higher-dose version of the drug.

That recommendation was rejected by the director of the FDA’s Division of Neurology Products, Dr. Russell G. Katz, and the drug was approved despite the FDA’s primary function of protecting citizens from harm caused by needlessly dangerous drugs — in this case, a drug barely more effective but significantly more dangerous than the lower doses of Aricept.

In May 2011, Public Citizen petitioned the FDA to ban Aricept 23. Public Citizen subsequently sued the FDA in September 2012, after the agency failed to respond to our petition. Today, the FDA decided that it had not made a mistake in approving the drug and rejected our petition to ban it. 

Although Eisai/Pfizer did lose 96 percent of their market on the patent-expired lower doses by this year, they have managed to sell 672,000 prescriptions of Aricept 23, taking in $172 million in U.S. sales between the original marketing in the summer of 2010 and September of this year. It is inevitable that thousands of Alzheimer’s patients were needlessly harmed, some fatally, by the FDA’s dangerous and legally questionable approval of Aricept 23. More will be injured and killed because of the FDA’s reckless adherence to their original mistaken approval.