Sadly, what I’m about to tell you is possibly the vilest con game I’ve heard of… well, at least that’s according to my standards. Unfortunately, if you’re a caregiver for an Alzheimer’s patient, you may find yourself on the losing side of this con.
Steady cash flow
Based on a new investigation from Dartmouth researchers, in the US, here’s an urgent and very important warning for all Alzheimer’s caregivers:
Aricept is a blockbuster Alzheimer’s drug with sales worth well over $2 billion in the US alone. However, the patent on the drug was due to run out in November 2010.
So Eisai executives (the maker of Aricept) came up with a clever idea for ‘evergreening’ their drug – evergreening is drug-world slang for avoiding patent expiration… and to keep the cash flow steady.
Aricept was only available in doses of 5mg and 10mg. So they simply created a 23mg dose. Then they conducted a study at this dosage and submitted Aricept 23 to the American Food and Drug Administration (FDA) as a ‘new’ drug.
As expected, FDA officials got out their rubber stamp and said, “Of course! That’s approved!”
The agency generously extended the Aricept 23 patent for three years and Eisai followed suit by launching an aggressive marketing campaign touting the proven clinical benefits of the higher dosage.
However, when the Dartmouth team looked at the study, they found that, “overall cognition” benefits of Aricept 23 were small. And there were no improvements in one important measure known as “global functioning.”
Global function improvement prompts the type of behavioural changes that would be noticeable to a caregiver.
As for adverse effects, Aricept 23 caused significantly more nausea and vomiting compared to the 10mg dose. These side effects can be especially upsetting for dementia patients, and even increase the risk of pneumonia. Cases of diarrhoea and anorexia were also higher among Aricept 23 subjects.
One Alzheimer’s expert said that it was fair to say the results of these studies were not positive and were not what we were all expecting.
“Not positive” results obviously didn’t discourage FDA officials. After all, they wouldn’t want to miss a chance to enrich drug company executives by approving an unnecessary “new” drug that’s virtually certain to make some patients ill.
If you’re a caregiver for an Alzheimer’s patient, beware of the hype about Aricept 23. It also goes without saying that if you know anyone who is an Alzheimer’s caregiver, share this information so they don’t fall victim to this evergreen scam.
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Disclaimer: Bear in mind the material contained in this article is provided for information purposes only. We are not addressing anyone’s personal situation. Please consult with your own physician before acting on any recommendations contained herein.
“How the FDA forgot the evidence: the case of donepezil 23 mg” Lisa M. Schwartz, Steven Woloshin, British Medical Journal, Vol. 344, 3/22/12, bmj.com
“New Alzheimer’s pill more likely to cause misery, medical experts say” Melissa Healy, Los Angeles Times, 3/22/12, latimes.com