On August 23 the FDA granted Emergency Use Authorization (EUA) for convalescent plasma as a therapy for Covid-19. President Trump, HHS Secretary Azar and FDA Commissioner Hahn spoke in glowing terms about this “promising therapy” with the President describing it as a “breakthrough.” Commissioner Hahn spoke positively of convalescent plasma’s ability to reduce the death rate from Covid-19 by 35%. He explained this meant that convalescent plasma would save the lives of 35 out of every 100 patients treated.

Unfortunately the next day Commissioner Hahn was forced to correct his obvious mistake. Convalescent plasma has never been shown in proper scientific studies to provide anywhere near this level of benefit. In fact no randomized controlled studies exist to confirm the value of convalescent plasma for the majority of Covid-19 patients.

The saga suggests more sinister political involvement. Several days before the EUA, Drs. Fauci, Collins and Lane of the NIH forcefully argued the available data did not support issuing an EUA. But the day after President Trump complained of the “deep state…obviously hoping to delay the answer” until after the election, Dr. Hahn sided with the administration and against the scientific experts in infectious disease.

While the American public ought to be able to access proven therapies, political pressure must be avoided. Consider the examples of hydroxychloroquine and chloroquine. In spite of scientific objection, both of these drugs received the FDA’s EUA under pressure from the administration. Within a short period the EUA was withdrawn due to significant harm to some patients as well as its lack of benefit.

With a potential vaccine in the testing phase, will the administration again press forward prior to confirmation of its safety and efficacy? Definitely this is an area of grave concern. The public is clamoring for a vaccine but leary of possible harm and lack of effect. Recent FDA actions provide a basis for our collective dismay.