May 25, the U.S. FDA approved Paxlovid to treat adults with mild or moderate COVID-19. Previously, Paxlovid was approved for emergency use authorization (EUA) only.

But, according to Dr. Meryl Nass’ Substack blog, the licensing was done under questionable circumstances, with Pfizer cherry-picking just two clinical trials, both of which are questionable in and of themselves, to submit as evidence in the drug’s favor.

Pfizer also for undisclosed reasons chose not to post any data from 19 registered, and 12 completed, studies. Although it’s common to wait if a year sometimes to do post additional studies, the lack of their posting still raises concerns.

“In summary, FDA approved [Paxlovid] based on two studies: one highly relevant to current practice, and one that may be less informative,” Nass says. “The good news is that the rate of hospitalization and death without treatment is now hovering around 1%. But that also means the number needed to treat to avoid one hospitalization or death is about 100.”

It’s also noteworthy that the “U.S. government purchased  23.7 million courses for about $12.6 billion. For context, the money spent on this one drug is about twice the 2022 budget of the National Institute of Allergy and Infectious Diseases,” she adds.

SOURCE:

Dr. Meryl Nass Substack July 1, 2023