New Alzheimer's Drug Questioned

Same effectiveness, more side effects than earlier formulation, doctors say


Last updated: March 23, 2012
Into the fog

Writing in the prestigious British Medical Journal, two investigators say that a new version of the Alzheimer's drug Aricept was brought to market for purely commercial reasons, produces improvements that would be no more noticeable to caregivers than the earlier version did, and can cause more gastrointestinal side effects.

The new drug, Aricept 23, a 23 mg. dose of donepezil, was approved by the Food and Drug Administration in 2010 as an Alzheimer's treatment. (Earlier versions have 5 mg and 10 mg dosages.)

The BMJ authors accuse the Japanese manufacturer, Eisai, and its U.S. marketing partner, Pfizer, of "evergreening" -- the practice of creating a new version of a drug that's purported to be better and has its own three-year exclusive patent rights. The patent on the earlier Aricept was to expire in November, 2010, which would mean others could manufacture cheaper generic alternatives.

Drug makers often try to thwart competition from generics, notes the New York Times "by finding novel ways of extending their exclusive rights to sell a drug "” by altering its chemistry slightly, for example, or offering it in extended-release versions." Applying for a patent on a new dosage of an existing drug is a relatively new practice.

Despite FDA approval, the manufacturer's own clinical studies didn't show substantial improvement in patients. Clinical and statistical reviewers for the F.D.A. each voted against Aricept 23, but Russell Katz, director of the F.D.A.'s neurology products division, approved it anyway, the NYT reported.

The theory had been that a higher dose would produce more benefit. Clinical trials showed no noticeable improvement in functioning, however, and "substantially more harm," said article co-author Steven Woloshin, a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice. The main side effects in clinical trials were vomiting and diarrhea.

The critique "illustrates 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," Marcia Angell, former editor of the New England Journal of Medicine and author of The Truth About the Drug Companies, told The Los Angeles Times.

Image by Flickr user raindog, used under a Creative Commons license.

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11 Comments So Far. Add Your Wisdom.

about 2 years ago

Thank you for this information. My husband has enough problems and does not need additional ones from his medication. As his care taker, I do not need to feel guilty for refusing the more expensive Aricept. Shame on Pfizer!


about 2 years ago

It's not a new drug - just a new dose, carefully designed so that 5 and 10 mg generic tabs can't exactly replace it. Only a fool would think a 23mg tab of a poorly performing medicine is worth payinguch more than generics at 20mg or 25mg. The only possible justification I'd profit, and FDA should be ashamed of putting profit ahead of other considerations like the expense, poor results and side effects.


about 2 years ago

We should weigh the relative benefit of a new or pseudo-new product in the price allowed - FDA should allow only modest pricing for a product like this one that offers little if any benefit relative to adverse effects. No clinician I've ever spoken to in years of geriatric practice thought Aricept offered much real benefit even when it was the only such option available, and there is no reason to richly reward firms that bring marginal products to market. They claim they need rich subsidies to find cures for cancer and such but spend their profits mostly on developing other marginally needed safe profit makers. We can no longer afford such wasteful largess.


about 2 years ago

@ dutiful deb ~ Aricept and Memantine are supposed to be considered like a lock and key. Without one the other is not much useful. That is why the psychiatrist did not recommend Aricept. By itself you only end up with 1/2 of the medications. My husband takes both and they work well together.


about 2 years ago

Aricept is worthless according to the geriatric psychiatrist I recently took my mother to see. He stopped it and I have not noticed a difference. Less medication is better.


about 2 years ago

Aricept is worthless, according to the geriatric psychiatrist I started taking my mother to see. He took her off it and I have not noticed a difference. Less medication is better. She still needs to take zyprexa to prevent her paranoid delusions.


about 2 years ago

Chinese medicine is way ahead of anything else and their theory is that a lower dose is better than a higher dose. Modern medicine believes that the stronger = better. Not necessarily true. My husband is in the advanced stages of his disease but I still give him the two Alzheimer's drugs to help with keeping his disposition more balanced. The best supplement I have introduced in the morning and in the evening is Pycnogenol. You can see more about it at http://rememering4you.com and http://www.webmd.com/vitamins-supplements/ingredientmono-1019-PYCNOGENOL.aspx?activeIngredientId=1019&activeIngredientName=PYCNOGENOL ~ he is now able to talk to me on the phone after almost a year of not knowing what to do with a phone, he can stay awake longer spells during the day, and this morning I was told by his nurse that he was giving everyone the peace sign with his fingers. This supplement is amazing in supporting the heart and vascular system.


about 2 years ago

I can't imagine a 23mg dose of Aricept except for one who may weigh more than 200 pounds whose body can process that large amount in a single dose. Drs. usually prescribe a 5mg dose twice daily to start and up it to 2 10mg doses...but one 23mg dose? ANYONE in the Caring.com community whose loved one has been prescribed the 23mg dose? I'm curious.


about 2 years ago

Thanks Anon. She drinks Glucerna as recommended by her doctor to help gain weight.It is available in our grocery store. It is similar to Ensure but does not have lactose. I believe it is for diabetics needing to maintain/gain weight. She is not diabetic but does like the taste and is drinking it on her own without encouragement from us. Day by day.


Anonymous said about 2 years ago

hello jean's daughter, my mom-in-law who is 93 also in lactose intolerant. About 5 years ago she suffered some kind of stomach virus. Through all the testing, the virus has cleared up, the doctors say she can eat anything. However, she is convinced and has talked herself into saying "I don't like that" or "I can't eat that". The family is frustrated. I wish I had an answer for you. Most doctors suggest the Ensure or Boast shakes. To drink slowly, may not have the reaction. Readily available at most stores or your community Senior Centers. Sometimes coupons are on-line. You may sign up and write to www.AVVO.com. This is a site for free legal and medical advice. Within a day or so someone will response to your questions. They have been very helpful for my circumstances. Hope this helps, Good luck to you.... Hope this helps


about 2 years ago

The lower dosages of Aricept caused diarreah in my mom. She wound up losing 30 lbs before we figured out what it was ( she is also lactose intolerant). The "booster" drug her doctor tried to add ( sorry, can't remember name-oh no!) caused dizziness resulting in two nasty falls. Be careful and watch closely for side effects. ANYONE HAVE ANY SUGGESTIONS ON HOW TO GAIN WEIGHT WHILE LACTOSE INTOLERANT? Blessings.


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