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ARTICLE · 14 SEPTEMBER 2020

FDA Surrenders On Science

To us – and we suspect to most of the exceptional public servants employed by the FDA – Sunday, August 23, 2020 will be a day they would rather forget.

United StatesCoronavirus (COVID-19)

To us - and we suspect to most of the exceptional public servants employed by the FDA - Sunday, August 23, 2020 will be a day they would rather forget.  On that day the Agency, appears to have yielded to overt political pressure and issued an "emergency use authorization" ("EUA") for what is known as "convalescent plasma" for the treatment of COVID-19, notwithstanding a relative dearth of scientific support for the effectiveness of this treatment for this indication.  Beyond the plasma treatment itself, which at least doesn't seem dangerous, we worry that this will not be the Agency's only step down the path to Lysenkoism.  In the not-too-distant future, when the FDA is called upon to evaluate the safety and effectiveness of an actual COVID-19 vaccine, will the Agency follow the Russian example?  That could cause a true disaster, should a rushed, unproven vaccine prove ineffective, while at the same time having crowded out more efficacious competitors, and poisoning

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