FDA ignores damaging evidence for Alzheimer’s drug

April 17, 2012
Volume 09    |   Issue 16

If you or a loved one suffers from Alzheimer’s disease, the FDA just sent you a message: “We don’t care about your health!” If that sounds harsh, wait until you see the evidence.

Most Alzheimer’s patients take the drug donepezil. You may know donepezil better as Aricept. This is a “quality of life” drug. That’s because there’s no evidence that it slows the progression of the disease. It just gives temporary relief from the symptoms.

But Aricept has some problems. First, it can cause very serious side effects. These include nausea, vomiting, and in rare cases, death. And, second, its patent was about to run out. That’s where the FDA shows it doesn’t care about you — only the drug companies and their profits.

According to The Dartmouth Institute for Health Policy and Clinical Practice, “Donepezil was a blockbuster drug for Alzheimer’s disease, with over $2 billion in annual sales in the United States alone.”

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That means the patent for Aricept was extremely valuable. So protecting it was a very high priority for the manufacturer. So, just before the patent ended, the FDA gave its approval to a new 23 mg dose. This change extended the patent for three more years.

So what’s wrong with the FDA’s actions? To start with, the drug was only available in 5 mg and 10 mg doses. And at those doses, it had some very serious side effects. Now the FDA has more than doubled the dose (for some people, the dose has more than quadrupled). Imagine the side effects at that dose!

Actually, you don’t have to imagine.

The FDA’s own medical and statistical reviewers recommended the agency NOT approve the new dose. Why? In studies set up to evaluate the new dose, the drug did improve cognitive symptoms, but it didn’t improve overall functioning.

Interesting, the researchers said the cognitive symptoms improved — but not enough to improve functioning? That means the improvement was negligible at best. What’s worse, though, is that the increased side effects were not negligible. In fact, the higher dose caused even more side effects, and worsened nausea and vomiting. We can only assume it will lead to more deaths since the studies didn’t last long enough to find out.

As if that weren’t enough, the new ads for the drug claim the new dose helped patients “experience important clinical benefit on both measures [cognition and overall functioning].” While the FDA climbs down the throat of walnut growers because they make true statements (see the alert I wrote about this), it does nothing to drug companies that will outright lie in their ads.

Friend, this is scandalous! It’s clear the FDA cares more about drug company profits than it does your health. It’s time to put a stop to the madness. If you or a loved one has Alzheimer’s, don’t consent to taking the higher dose of Aricept. It’s not going to help — and it could do significant harm. Next week, I’ll have some of the best natural ways to treat Alzheimer’s that really work. Don’t miss it.

Your voice of reason in Women's Health,

Sources:

http://press.psprings.co.uk/bmj/march/UKCAT.doc.

http://www.bmj.com/cgi/doi/10.1136/bmj.c478.

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