Thursday, January 10, 2013

FDA'S DOUBLE STANDARD



A mad-as-hell Sid Wolfe of the watchdog group Public Citizen sued FDA about the agency's refusal to ban the highest dose of the Pfizer Alzheimer's drug Aricept--and lost. Studies don't show increased efficacy of the 23-milligram pill compared with the lower doses of 5 and 10 milligrams.  However, the higher dose does show increased toxicity, including, Wolfe said, increased mortality.


According to a comprehensive article by reporter Ed Silverman, the director of the FDA’s Division of Neurology Products, Rusty Katz, explained his reasoning for keeping the higher dose by posing a question and then answering it:  “Does the absence of a demonstration of any superiority of the 23 milligram dose to the 10 milligram dose on measures of overall functioning, coupled with the increased incidence of potentially significant adverse events, argue against the approval of this product?” The 23 milligram dose is “clearly superior to the 10 milligram dose” on a cognitive measure.* “In my view, this strongly argues for a conclusion that the 23 milligram dose is very likely to also have an effect on overall functioning, despite this not having been demonstrated directly in this study” [emphasis added].

Reporter Ed Silverman also wrote that given the few Alzheimer's treatments available, FDA believes that physicians may decide the added side effects justify the benefits. 


Following that logic, FDA, Ampligen's side effects are in most cases, minor or manageable, and given that there are no FDA-approved ME treatments, shouldn't Ampligen be approved?  Instead the FDA committee, while endorsing Ampligen's safety, voted that the drug didn't meet FDA's standards for efficacy--though it was "probably effective."  Probably effective sounds an awful lot like the "very likely" of two paragraphs up.

Why the double standard, FDA?  Could it be FDA is throwing the pharmaceutical giant a big bone because the patents on the lower doses are expiring?  Could it be that FDA believes Alzheimer's to be more important than ME?  Could it be, as Sid Wolfe suspects, that FDA doesn't want to admit it was wrong in approving the 23 milligram dose in the first place?


Sid Wolfe also testified at the FDA Ampligen hearing on December 20 that Ampligen shouldn't be approved either.  (And a patient I talked to at the meeting said she overheard him say that cognitive therapy works.) 

Here's Ed Silverman's story, if you want more info.

*In three of the four tests, there was no increase in cognitive function at the higher dose.