My New Book Is Now Here In All Its Glory And In All Forms Paper And Electronic. Get Your Copy Or Be Forever Doomed To Pay Too Much For Your Vicodin.

Because those of us in the know all know that the new Vicodin is a rip off. Nothing but a cynical ploy to take advantage of the brand name of the most prescribed drug in America in order to score some unearned dollars.

If you don't know that, then you seriously need to get on Amazon right now. Click on this link as fast as you can. 

Or click here if you get your words from a Nook. 

If you do know that, and wanna know more about this kind of crap in a bottle, than you really should click on that link too. 'Cause you'll find a new book chock full of examples of the bullshit that sometimes passes for innovation in the world of Big Pharma.

Doryx anyone? Treximet? Makena? And more zit creams than you can shake a stick at.

Actually now that I think about it, I'm realizing this may just be the most important book ever written. Seriously. Everyone from kids with zits to seniors with Alzheimer's will benefit from the words I have written. I never realized until now just what a humanitarian I am.

I should get an award. Anyway, here's another excerpt so you can see what I'm talking about.

 Aricept 23

The Med

Aricept, the brand name of donepezil, is a member of a class of meds known as cholinesterase inhibitors. It works by increasing the amount of acetylcholine in the brain, and has become a cornerstone of Alzheimer's therapy. While not a cure, it can delay the progression of symptoms and is one of the limited options available to sufferers of the disease. As such it became a blockbuster seller for its makers, the Japanese company Eisai and their American partners Pfizer, generating over $2 billion in annual revenue. It was set to lose its patent protection in November of 2010 however, which would lead the way for generic competition.

The Scam

I almost didn’t list the meds in this book alphabetically, because I wanted to save this one for last, as it crosses a line I thought would never be crossed. Aricept was available for years in 5 and 10 milligram strengths. Shortly before its patent protection was set to expire however, Eisai and Pfizer applied for approval of a 23 milligram version.

“What an odd number” you may be saying to yourself. Notice how that odd number cannot be reached by using the soon to be cheap 5 and 10 mg strengths.

Still, it is intuitive that a higher dose of medication would improve clinical outcomes. Science doesn’t run on intuition though, in science things have to be proven, so a study was started. The FDA set a benchmark that said the new strength had to improve both cognitive (mental) and global (overall) function in Alzheimer's patients in order to be approved.  

Aricept 23 flunked. The study showed only slight improvement in cognitive function and no improvement at all in global function. The FDA however, against the advice of both a clinical and statistical reviewer, approved Aricept 23 anyway. The New York Times reported that Dr. Russell Katz, director of the F.D.A.’s neurology products division, “acknowledged side effects from the higher dose ‘could lead to significant morbidities and even increased mortality,’ but concluded that the drug most likely improved overall functioning even though the study did not show that.”

Two points about what just happened here:

1) “but concluded that the drug most likely improved overall functioning even though the study did not show that.” So much for science not running on intuition, as the intuition of the right person was what got this drug approved. The medical professions have become used to numbers being massaged, facts being twisted, and any and everything possible being done to put a med in the best light possible in the scientific literature, but this is the first time I’m aware of when they’ve given up on even pretending like the scientific facts matter. “The study did not show that,” and it still didn’t matter.

2) Which might be forgivable if it were done in the name of trying anything possible to help the victims of a terrible disease. But Katz also “acknowledged side effects could lead to significant morbidities and even increased mortality.” Just to be clear, morbidity is a fancy word for sickness. Mortality is one for death.

So the FDA approved a drug that did not meet its criteria for effectiveness, and that its head of neurology products said may leave more people dead. That’s the story of Aricept 23 in one sentence.

Oh, and Aricept 23 costs about 90 dollars a month more than the safer and effective 10mg generic version.

What To Do

Let me be clear: Aricept 5 and 10mg are perfectly appropriate choices for Alzheimer's patients. It’s only when the dose went up to 23mg that it crossed the line into bullshit. There may be isolated cases where a dose that high is beneficial, but they tried to prove its effectiveness at that dose and got marginal results. What Aricept 23 does do is more than triple the incidence of nausea and vomiting, increase by 60 percent the chance of diarrhea, and depletes your loved one’s assets by over a thousand dollars a year. Unless there is a good reason not to, stick with the lower doses.

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Wow. That was awesome. And there's plenty more where that came from my friends.

You are just a click away.