It is hard to describe the Arthritis Advisory Committee’s December 20 rejection of Hemispherx Biopharma Inc.‘s Ampligen for Chronic Fatigue Syndrome as in any way surprising.
How Not To Develop A Drug
What is the best way to encourage drug development in an unmet medical need? Chronic Fatigue Syndrome advocates argue that FDA should approve a drug—specifically Ampligen—even if it falls far short of reaching typical standards of evidence. FDA disagrees, and gained the backing of its advisory committee on that point. But the vote was close…