Statement of CSPI President Dr. Peter G. Lurie
The announcement today that the Food and Drug Administration has granted an Emergency Use Authorization for convalescent plasma illustrates how dramatically we have failed in our efforts to establish whether this product actually works.
Almost 100,000 patients later, we still lack clear evidence of effectiveness, because a randomized, placebo-controlled trial has not been completed. Instead poor quality, non-randomized data have been generated through an Expanded Access Protocol, a process never designed for this kind of situation or number of patients.
The Emergency Use Authorization may be a step in the right direction if it generates better data. But if it draws still more people away from clinical trials, it will be a step in the wrong direction. But it is emphatically not a drug approval and that approval should await the completion of appropriate randomized trials clearly demonstrating safety and effectiveness.
More than anything, the hyping of this modest administrative move illustrates how this administration abuses both science and the regulatory process for its own political ends.
Contact Info: Jeff Cronin, email@example.com, 202-777-8370