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