We all know that it doesn’t take much to convince Big Pharma
to stoop as low as they can go to turn a dangerous drug into a
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
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
If you’re a caregiver for an Alzheimer’s patient, beware of Then why not get more expert health recommendations just like this delivered direct to your inbox? "It is truly refreshing to read a newsletter on the topic of alternative medicine which is scientifically based and reviewed by professionals..." - Robert Sinott
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
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“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,