A vital warning for all caretakers of Alzheimer’s patients

Low blow

There are few things much lower than giving false hope and collecting billions of dollars in return.

Can you imagine what it must be like to be the victim in such a remarkably vile con game? Unfortunately, if you’re a caregiver for an Alzheimer’s patient, you may find yourself on the losing side of this con.

And THAT’S about as low as you can go.

Keeping the coffers evergreen

A new investigation from Dartmouth researchers reveals an important warning for all Alzheimer’s caregivers.

Here’s what they knew going in…

Aricept is a blockbuster Alzheimer’s drug. Sales run higher than $2 billion per year. But the patent on the drug was due to run out in November 2010.

Executives at Eisai (the maker of Aricept) had a shrewd idea for evergreening their drug. (“Evergreening” is drug-world slang for avoiding patent expiration.)

Aricept was only available in doses of 5 mg and 10 mg. So they simply created a 23 mg dose. Then they conducted a study at this dosage and submitted Aricept 23 to the FDA as a new drug.

In a rational world, this is where the story ends. The FDA says, “Of course not! That’s absurd!” But FDA World is located several time zones away from Rational World.

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 that launched an aggressive marketing campaign touting the proven clinical benefits of the higher dosage.

But 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 behavioral changes that would be noticeable to a caregiver.

As for adverse effects, Aricept 23 caused significantly more nausea and vomiting compared to the 10 mg dose. These side effects can be especially upsetting for dementia patients, and even increase the risk of pneumonia. Cases of diarrhea and anorexia were also higher among Aricept 23 subjects.

One Alzheimer’s expert told the Los Angeles Times, “It’s 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 faze 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 caretaker for an Alzheimer’s patient, beware the hype about Aricept 23. And if you know anyone who is an Alzheimer’s caretaker, share this information so they don’t fall victim to this evergreen scam.

Sources: 
“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