Experts want to know why the agency approved a questionable Alzheimer’s drug but has withheld full approval from Covid vaccines.
Gregg Gonsalves feels guilty. Now a professor at Yale’s School of Public Health, Dr. Gonsalves remembers standing with other AIDS activists outside the Food and Drug Administration headquarters in the 1980s, accusing the agency of murder for not approving medications that might save lives but hadn’t been proven effective in clinical trials yet. “People were dying. We didn’t know what to do,” Gonsalves told me.
The activists demanded an expedited approval process for medications that showed potential with improving immune system markers like CD4 cell levels, while studies on whether the drugs actually prolonged lives were still being conducted. Rapid approval, even before a drug was shown to help, could mean the difference between life and death, they argued.
In 1992, the FDA established precisely this kind of rapid approval process. Now the FDA has used it to approve a controversial drug for Alzheimer’s disease, even as the agency hasn’t fully approved Covid vaccines with far greater evidence of efficacy.
Melody Schreiber – New Republic – 2021-07-14.