This Alzheimer’s drug is ineffective and potentially very dangerous

Few things are more disgraceful than a treacherous drug. To qualify as treacherous, a drug has to fall within these three categories…

1) Mostly ineffective

2) Potentially very dangerous

3) Targets a virtually helpless population

To bring those three elements together in a single drug is shameful. Then add an FDA rubberstamp approval, and you’ve got a monster.

That perfectly describes Aricept 23. It’s an unnecessary Alzheimer’s drug that can put patients at great risk.

And according to the FDA, that’s just fine.

Absolutely treacherous

I first told you about Aricept 23 earlier this year.

It’s a familiar story. A drug is about to lose patent. A scheme is hatched to extend patent protection. The FDA says, “Yes.” It’s a win-win for everyone.

Everyone except patients.

In this case, Aricept (made by Eisai) was about to lose its patent. It was available in two doses — 5 mg and 10mg. So Eisai executives had a brainstorm. They created a 23 mg Aricept.

Yes! A super potent Aricept! More than TWICE as good as a paltry 10 mg!

Sure. In their dreams. Now for the dirty details…

Eisai tested Aricept 23 against the 10 mg dose of the drug. Super? Not quite. It barely performed any better than the lower dose. But the higher dose was considerably more dangerous.

Patients who took Aricept 23 were far more likely to be agitated, confused and fatigued. They were also more than three times more likely to experience vomiting. In Alzheimer’s patients, that can prompt a cascade of agonizing events. They include, in the FDA’s own description, “…pneumonia, massive gastrointestinal bleeding, esophageal rupture or death.”

Add to that, the drug lingers in a patient’s system. If vomiting occurs and the patient stops using the drug, vomiting risk remains high for as much as two weeks!

The agency’s primary medical reviewer said the drug should not be approved. So… The FDA approved it.

Agency officials probably hoped that approval would make the scrutiny go away. The drug would get three years of patent protection. Over and out. Simple.

Not quite.

In May 2011, Public Citizen petitioned the FDA to remove Aricept 23 from market. The FDA ignored the petition. Well over a year later (after more than $90 million in sales), Public Citizen filed a lawsuit to force a decision from the FDA.

Finally, just days ago, the FDA responded with a simple, “No.”

Honestly, I don’t think anyone expected the FDA to do the right thing. So we’ve got to appreciate Public Citizen’s efforts. They’ve kept the horrendous dangers of Aricept 23 on the national radar.

Alzheimer’s caregivers must beware of this drug. It’s intended for patients with moderate to severe AD. But these are the very patients who are most vulnerable to side effects.

Just say what the FDA said. “No.”

Sources:
“FDA rejects petition to remove high Aricept dose” Associated Press, 11/6/12, ap.org

“Public Citizen v. Food and Drug Administration (Aricept 23 mg)” Public Citizen, 9/5/12, citizen.org

“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