Let's Watch Pfizer, Eisai, And The FDA Take A Perfectly Reasonable Situation And Shoot It All To Hell.

First off, a little tip. Any article that starts with the words: 

Four months before a best-selling Alzheimer’s drug was set to lose its patent protection

Will not end well. It just won't. No matter how normally the story starts out.


 “The hypothesis was that patients with more advanced Alzheimer’s disease could benefit from a higher dose of Aricept,”


You see? That sounds reasonable enough. I have a hypothesis that a 500mg dose of Viagra would give me a mother of all boners, allowing me to make sweet love to my girlfriend for a month straight.

Who, by the way, is the most awesome girlfriend ever. Have you noticed the lack of  "Oh my god, does he need an intervention" type posts of late? There's a reason for that. But I digress.

The thing about hypotheses is that they need to be proven before being put to use in the practical world. At least ideally. I mean, I wouldn't just take a handful of blue diamonds and book an oceanside retreat for the month of June, you know?

The F.D.A. had initially said that to be approved, Aricept 23 would have to improve both cognitive and global — or overall — functioning in patients with the disease.

Yay FDA. Making people prove things. Pretty much how this science stuff is supposed to work.


 But the clinical trial found only a slight improvement on the cognitive measure and no improvement on the global measure.


There we go, guess the end of the story will be coming up soon. 


As a result, a clinical and a statistical reviewer for the F.D.A. each recommended against approving the higher dosage. 



Yawn. This story is so boring and routine it's starting to put me to sleep.


Nevertheless, the drug was eventually approved by Dr. Russell Katz, director of the F.D.A.’s neurology products division

Huh?

who acknowledged that 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.


Welcome to bizzaroland. We crossed the border so quick there some of you might be a little disoriented. Let me repeat something:

the higher dose could lead to significant morbidities and even increased mortality.


"Increased mortality" means more dead people.

but concluded that the drug most likely improved overall functioning even though the study did not show that. 


"the study did not show that" is probably self-explanatory.

So why on earth would the FDA approve a dosage not shown to work but that was more dangerous? I mean, that's the exact fucking opposite of how things are supposed to work.


Aricept generated more than $2 billion in annual sales since its first approval in 1996


Oh. Just a theory, but I'm gonna go ahead and go with it. Just like the FDA did. Except I have more evidence than they did.

In 2009, Eisai applied for a 23-milligram version of Aricept, a dosage that, the journal authors note, cannot be reached by combining the 5 and 10 milligram dosages, which are available in generic form.

 Yup...there's me some evidence right there. I think I can close this case and move on to the Viagra question now...

...after careful consideration, I've decided I'll be keeping my regular boners. No matter what the FDA might have to say on the matter.

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Let's Watch Pfizer, Eisai, And The FDA Take A Perfectly Reasonable Situation And Shoot It All To Hell.
Let's Watch Pfizer, Eisai, And The FDA Take A Perfectly Reasonable Situation And Shoot It All To Hell.
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