Apr 2, 2012
Aricept – a two-billion-dollar a year drug – is supposed to improve memory for people with Alzheimer’s. In 2010, the drug was set to go off patent, meaning much less expensive generic forms could be made and sold.
To avoid losing sales, drug-maker Eisai and distributor Pfizer ran a clinical trial with 1400 people that used a higher dosage of Aricept. They told the FDA that this 23-mg dosage would do more for the brain than the old 10 mg and 15 mg doses of Aricept.
In fact, when FDA researchers looked at the data, they found the side effects of the 23-mg Aricept were far worse than for those using the lower doses. And the benefits scarcely improved functioning. They recommended NOT approving the 23-mg dose.
But they were overruled by an FDA director.
It’s obvious why drug makers proposed a 23-mg dosage: Doctors could not make up the unusual dosage by giving patients a prescription for the old 10 or 15 mg sizes already available in the cheaper version.
But why would an FDA official agree? In any case, Alzheimer’s patients can expect to puke their guts out so that Eisai and Pfizer can make billions more dollars on their “new”, “patented”, and useless drug.