Last night, President Trump announced that the FDA has granted emergency authorization to use plasma from patients who have recovered from COVID-19 to treat others who have contracted the disease. Plasma-based treatments have been in the works for some time, and the Mayo Clinic has carried out an extended test of the type of therapy the FDA approved yesterday.
To my knowledge, there are no safety concerns relating to plasma treatments, but critics were quick to claim that there is insufficient evidence of efficacy to support the expedited approval. As usual, the reaction to Trump’s announcement was political, not medical:
“The FDA must approve drugs or vaccines based on their safety and effectiveness – NOT political pressure from the White House,” House Speaker Nancy Pelosi tweeted on Saturday. “The President’s dangerous attempt to inject himself into the scientific decisions of [U.S. FDA] jeopardizes the health & well-being of all Americans.”
Some are anticipating that a vaccine might be approved before November 3, a critical date in the minds of those who hope that the Wuhan flu will help to elect Joe Biden:
Trump’s pressure on regulators has drawn criticism from scientists and lawmakers who have warned that the president is pressuring regulators to deliver a vaccine before the Nov. 3 election, even if data from clinical trials do not support widespread use.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, has vowed to resign if the Trump administration approves a vaccine before it is proved to be safe and effective.
I don’t know whether Trump’s belief that regulators are deliberately dragging their feet for political reasons is correct or not, but it wouldn’t surprise me. Trump Derangement Syndrome is present in the medical bureaucracy, as everywhere else in Washington. I doubt that a vaccine will have been tested long enough to be approved for general use by the beginning of November, but we can be sure that if such a vaccine is approved by then, it will be greeted with the same howls of politically-motivated dismay that we saw following yesterday’s announcement.