Why the FDA matters

In recent days, concerns over blood-clotting possibly caused by the Oxford-AstraZenica COVID-19 vaccine have led to the suspension of that vaccine in Europe. 

This is not an issue in the United States, as the Food and Drug Administration has not approved the use of that vaccine.  The three approved vaccines, by Pfizer, Moderna, and Johnson & Johnson, have yielded an adequate supply so the need for a fourth vaccine is remote here.

As the Pfizer vaccine was entering into final FDA review, then-President Trump, in a demonstration of his usual contempt for the “deep state” tweeted a chest-thumping threat to the head of the FDA: approve the vaccine by the end of that day or be fired.  Since the board was already meeting that night to give approval, Trump’s tweet was pretty meaningless – it was just a way to throw red-meat to his diminishing cadre of followers.  But it still set a bad precedent.  Whatever the urgency of the situation, this kind of threat is the last thing a leader should do – especially as the FDA has already been criticized for allowing the hasty approval of unsafe drugs.  Trump’s tweet was part of a pattern of his attempted dismantling of the Federal government’s regulatory powers. 

The FDA began in 1906 with Theodore Roosevelt’s signing of the Pure Food and Drug Act – a time when pharmacological drugs were unregulated and your corner pharmacist (called a “druggist” back then) could whip up whatever concoction he thought was efficacious.  One can easily imagine what was actually in these drugs, especially as the initial formula Coca-Cola contained trace amounts of Cocaine!  Those who were predisposed to distrust the government repeatedly called for rolling back the FDA’s power to approve or reject drugs for medical use, including homophobe Pat Buchanan who pushed the FDA to allow the use of unsafe drugs for treatment of AIDS.  It’s part of a pattern that included Trump’s touting of Hydroxychloroquine as an effective treatment for COVID.  It was a quack treatment with adverse side-effects.  At the risk of their jobs, experts including Anthony Fauci stated that Hydroxychloroquine was not a suitable treatment for COVID.  The lesson is simple: be guided by the science (itself a Latin word for “knowledge”) and defer to the experts, not the soccer mom who gained her ”science” from youtube conspiracy videos.