Aricept 23—A Misleading Drug Enabled by the FDA

Author: Patrick Malone
Published: March 31, 2012 at 7:37 am
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In some ways, Alzheimer’s is like arthritis. Its symptoms can wax and wane, making it difficult to determine if a particular treatment is successful. Who’s to say if a symptom subsided because a drug worked, or because it was going to diminish anyway?

And, like arthritis, Alzheimer’s cannot be cured, only moderated. That can lead sufferers and the people who care for them to become desperate for any new treatment—what have they got to lose?

So dementia leaves its victims particularly vulnerable to new, if not improved, ways to treat it, and one such recent attempt raised the ire of two professors at Dartmouth’s Institute for Health Policy and Clinical Practice. As reported by Merrill Goozner, Drs. Lisa Schwartz and Steven Woloshin claim that the FDA has “breached [its] own regulatory standard” in approving a new dosage of a best-selling Alzheimer’s drug.

Aricept, whose generic name is donepezil, is earning its manufacturers $2 billion a year for improving memory lapses in the short term. With its patent about to expire (Aricept was introduced in 1996), and generic manufactures poised to compete with their own versions, manufacturers Eisai and Pfizer were motivated to keep the cash flowing. They appealed to the FDA to approve a higher dosage, claiming that a trial of 1,400 patients demonstrated improvements in the ability to think. The feds gave the drug makers three more years to market the stronger drug exclusively.

But as Schwartz and Woloshin wrote in the British Medical Journal (BMJ), patients had only slightly better cognition on the higher dose, and it had absolutely no effect on day-to-day functioning, the measure by which caregivers determine disease status. Unfortunately, the stronger Aricept conferred significantly negative side effects, including nausea and vomiting. For patients with dementia, that can lead to pneumonia. The FDA had told the trial sponsors that the drug wouldn’t be approved unless it had a positive impact that patient caregivers could notice.

So at best, the contrary approval makes the FDA look dysfunctional; at worst, it looks incompetent and corrupt.

Aricept’s manufacturers went merrily along their marketing way, their advertisements implying to consumers that the drug helped the Alzheimer brain function better, but not mentioning the severity of side effects. And the ads aimed at doctors, Schwartz and Woloshin charged, were worse: “[They contain] a stunningly erroneous statement in a large bold font: ‘Patients on Aricept 23 mg/day experienced important clinical benefit on both measures [cognition and overall functioning],’ which is simply not true. In fact, this statement is directly contradicted by a statement in a smaller plain font that says that the results for global function ‘did not show statistical significance.’”

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Article Author: Patrick Malone

Patrick Malone is a leading patient safety advocate and attorney who represents seriously injured people in medical malpractice lawsuits, product liability cases and other types of lawsuits. He appeared on the Today Show to discuss his book for …

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