Did Drug Companies and the FDA Collude to Harm Patients with Alzheimer’s Disease?

If you were pharmaceutical corporation Eisai, working with Pfizer to peddle the biggest-selling Alzheimer’s drug of all time, Aricept — with $2.4 billion U.S. sales in 2010 — and a looming patent expiration guaranteed a lightning-fast switch to generic drugs, what would you do?

Faced with this scenario, the company’s decision was to test out a much higher dose of the drug — 2.3 times higher — and compare it to the approved, 10-milligram (mg) dose to see if it worked better. If it did, several years of extended market exclusivity would be the reward for the new drug, Aricept 23.

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. It was only minimally more effective in improving cognition. Furthermore, the high dose was predictably associated with a much higher incidence of vomiting, which, in Alzheimer’s patients, “can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture or death,” according to the Food and Drug Administration (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, 23-mg 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 no 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. In November, the FDA decided that it was correct in approving the drug and rejected our petition. 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, making $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 FDA’s dangerous approval of Aricept 23.

With close to $700 million in drug industry money directly funding FDA drug review each year, the question is whether the FDA, in this instance, is protecting the public health or, in effect, colluding with the drug industry in approving Aricept 23. Allowing Eisai to exploit and harm vulnerable patients with Alzheimer’s disease is unconscionable.