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As a doctor, I yearn for us to have effective therapies for #COVID19. However, @realdonaldtrump& #39;s rushed "Emergency Use Authorization" for convalescent plasma (an unproven treatment) may actually *harm* our ability to fight the virus. That& #39;s right - harm it. Here& #39;s why: (1/12)
When someone recovers from #COVID19, their blood will have antibodies that may help others currently infected. By transferring these antibodies via plasma, immunity could (in theory) be passed to the patient to speed recovery & save lives. But we must *study* this theory. (2/12)
Before the president& #39;s "Emergency Use Authorization," patients could get this plasma in studies & through an FDA program that made the treatment available to patients if a study was not available. Over 70,000 patients received it & data was collected from each of them. (3/12)
But the president& #39;s order short-circuits this step & makes collecting data on those who receive convalescent plasma *more difficult*. It also makes enrolling patients in the “gold standard” Randomized Controlled Trials (RCTs) much more difficult. Here& #39;s why... (4/12)
This happened with hydroxychloroquine: patients stopped enrolling when it got the EUA. We& #39;re now left with a potentially beneficial treatment that we can& #39;t effectively study to see who benefits. When should it be given? How much? For how long? Much of this may be lost now. (5/12)
Why was this EUA issued one day before the #RNCConvention began? The President tweeted his displeasure with the FDA the day prior, suggesting politics held up the EUA. He claimed some “Deep State” -- which he ostensibly oversees -- was conspiring against him. (6/12)
In the old days (aka, pre-2017), the FDA (and CDC, HHS, etc, etc) was seen as an apolitical science-based entity within the US government intended to utilize the best available evidence to recommend the best ways to cure & manage diseases. Now? Not so much. (7/12)
During the #pandemic, @realdonaldtrump & his administration have repeatedly rejected recommendations of the experts inside their own government. He pressured the CDC to alter its return-to-school recommendations. He pressured the FDA to issue an EUA for hydroxychloroquine. (8/12)
He has repeatedly rejected the need to wear masks, has only worn one in public a handful of times, and refused to issue a national mask mandate that would likely save 40,000+ lives before the end of summer. (9/12)
He& #39;s also resisted calls to massively increase testing & utilize the Defense Production Act to ensure availability of the rapid-turn-around tests that he & his White House use daily, for all Americans to safely open schools & resume business as usual. (10/12)
In a pandemic that& #39;s claimed nearly 180,000 American lives, cratered a fragile economy & lead to widespread unemployment, one would think that a President would do anything possible to improve the US response & path to recovery. Yet, this EUA could actually set us back. (11/12)
