Is the FDA to be trusted?
Solving the biggest healthcare crisis of our time so the world of orthopedics and patient care can get back to normal will require trust. Any therapies and vaccinations developed by healthcare scientists to treat COVID-19 will only work if providers and patients trust and use them.
The keeper of that trust is the Food and Drug Administration (FDA).
“Deep State” at the FDA
In the early hours of Saturday, August 22, 2020, the ultimate boss of the FDA, the president of the United States, tweeted, “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed and saving lives!” He then added “@SteveFDA,” Steve Hahn, M.D., the Commissioner of the FDA.
Earlier that week, the president suggested the delay by the FDA in an emergency measure supporting blood plasma was a political one. National Institutes of Health (NIH) Director Francis Collins expressed his opposition to granting emergency use status, saying the evidence was too weak. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, believed the plasma treatment met the low bar for emergency use.
According to the Washington Post, the president became increasingly annoyed by the disagreement among the scientists, setting up his tweet to pressure the FDA.
“I hear great things about it, that’s all I can tell you. It could be a political decision because you have a lot of people over there that don’t want to rush things because they want to do it after November 3rd,” said the president during a news conference.
Hahn “Shocked and Upset”
Hahn, a Washington political newcomer, was “shocked and upset” by the president’s comments, according to published reports and immediately called his White House contacts to find out why his boss’ boss was angry. In those calls he said the agency was on the verge of granting emergency use of the plasma treatment.
By the end of Saturday, the White House press secretary tweeted that the president was going to announce, “a major therapeutic breakthrough on the China Virus.”
