Aricept 23—A Misleading Drug Enabled by the FDA

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.'”

That doctors are considered easy marks for Big Pharma is depressingly old news.

Unless drug company labels make inaccurate claims, the FDA does not intervene, even if a drug’s risks, benefits and uncertainties aren’t communicated.

As explained in the Los Angeles Times, drug companies commonly respond to an expiring patent with a practice called “evergreening.” To prolong the profitability of successful drugs, they make a slight change to a drug’s formula or dosage, or combine it with another drug. These are legal measures that require FDA approval.

Aricept’s new 23-milligram tablet, The Times story explained, “created a dose that couldn’t be reproduced by any combination of Aricept’s existing 5- and 10-milligram pills, making the product new enough to win a three-year reprieve from low-cost competitors.”

Dr. Howard Brody, a medical ethicist at the University of Texas Medical Branch in Galveston, told The Times that the Aricept 23 case is “a perfect storm” of commercial marketing and regulatory failure whose victims are patients who are desperate, discouraged and vulnerable.

As Dr. Marcia Angell, former editor of the New England Journal of Medicine, told the newspaper, Big Pharma’s manipulative ads illustrate “very well how drug companies exaggerate the benefits of their drugs, minimize the side effects and through misleading marketing to both doctors and the public convince them that a new version of a drug, with a new patent, is better than the old one, whose patent has expired.”

If your loved one is prescribed Aricept for his or her Alzheimer’s disease, ask the doctor what is the dose. If it’s 23 milligrams, ask for a lower dosage. It’s just that simple.

First published on Technorati.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information