On August 19, we first reported on the FDA’s decision to halt use of convalescent plasma for COVID-19. On August 21, we dug a bit deeper into the story; Mayo Clinic investigators were “puzzled” by the decision, and there is evidence that NIH Director Francis Collins and NIAID Director Fauci intervened with the FDA to at least temporarily halt the plasma EUA. Dr. Michael Joyner of the Mayo Clinic led their National Convalescent Plasma project, along with 34 other institutions from 17 states. This project has included 8,000 doctors, 3,000 hospitals, and 100,000 enrollees. And while “there have been rumblings that the Mayo Clinic nation program has monopolized clinical trial subjects,” Dr. Joyner says, “That’s a false dichotomy.” Apparently, FDA was about to issue an EUA for plasma, but Collins and Fauci intervened positing that the data on efficacy was inadequate. Results so far from the Mayo project are considered unreliable as there was no control group or RCT. Now, According to CNN, President Trump announced the FDA will maintain an EUA for convalescent plasma. The FDA, of course, has its mandate and it must objectively assess the data and science and then make the call—its not the job of the NIH, or the White House, or any other group to make the final decision on whether a drug or therapy is safe and effective.
Republican National Convention Looms
As the RNC is set to begin, President Trump can boast he overrode a “political” agenda hampering EUA for convalescent plasma for COVID-19 patients. This treatment has already been given to over 70,000 patients. Late Saturday evening, the White House announced, “a major therapeutic breakthrough on the China virus.” And officials confirmed that the treatment is convalescent plasma. This plasma is rich with antibodies that might fight the coronavirus, but evidence as to whether it works is lacking. Per MSN, former FDA commissioner Scott Gottlieb says the treatment is “probably beneficial,” but that since it is available without the EUA, the change is “incremental.” The president has been putting extraordinary pressure on the federal government to test and approve COVID-19 treatments, especially a vaccine. His advisors think, “having a vaccine by Election Day is key to his prospects for winning.”
Trump Accuses “Deep State” of Hampering Clinical Trials
Trump’s plans come a day after he, “accused the FDA of impeding enrollment in clinical trials” for political reasons. “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” according to Trump on Twitter Saturday. He went on, “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!” Long used for a variety of ills, plasma lacks “rigorous clinical trials” for COVID-19. The patients who have gotten it were enrolled in an “expanded access program” run by Mayo and sponsored by FDA. Carlos del Rio, who is executive associate dean of the Emory School of Medicine, says, “The problem is, the President, in my mind, has lost total credibility because of what he’s done with hydroxychloroquine. He’s touted so many things that don’t work.”
“Insane Fights” Over EUA
Arturo Casadevall, who is chair of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, was in favor of an emergency use authorization, “saying it could make it somewhat easier to access the treatment.” Anonymous officials said that there were two weeks of “insane fights” prior to the president’s announcement. Apparently, Trump convinced others to give a “tentative try” with the EUA. Reported earlier in the day Sunday, August 23, insiders expected an announcement from FDA sometime this week. There have been weeks of discussions over whether to issue an EUA, which is a temporary approval during an emergency and requires less evidence than a full approval. Some NIH scientists argue that, “the efficacy data wasn’t strong enough,” but this decision is left to the FDA. While Trump has praised FDA previously, on Wednesday he asserted that they were delaying an EUA for plasma until after the presidential election.
EUA Granted: Message on Sunday
According to CNN, today Sunday August 23, the FDA announced that an EUA has been issued for convalescent plasma for COVID-19 treatment. According to FDA, the “known and potential benefits of the product outweigh the known and potential risks of the product.” President Trump said, “Today I am pleased to make a truly historic announcement in our battle against the China virus that will save countless lives,” and, “Today’s action will dramatically increase access to this treatment.” A source close to the White House Coronavirus Task Force informed CNN, “the FDA had reviewed additional data to inform its impending EUA decision.” Reportedly NIH officials had intervened and put the EUA on hold. Anand Shah, FDA’s deputy commissioner for medical and scientific affairs, “said he could not comment but suggested the NIH was out of line.”
A fast and furious, full-throttle, gloves-off, bare-knuckle contest now unfolds as the twin tower of parties fight to control the government. On the one hand, the incumbent party desperately seeks to remain in control while the other furiously strategies and mobilizes to get the current group, and themselves, back in power. Both sides, unfortunately, will be inclined to exploit the pandemic and associated health conditions as a weapon against the other in a bid for supremacy. However, in the meantime, as recently suggested by Matt Taibbi writing for Rolling Stone, the race for treatments and vaccines, supported by both parties and all rational and sound people, will possibly lead to any number of twists and turns leading to “historic” windfall profits for at least just a few of the winning biotech firms. In reality, the rest may well pay a dear premium of a price for both the pandemic and how its leadership, on both sides, reacted. The vast majority of the people, no matter how one views the world, may not end up the better unfortunately. Only the history books will judge if COVID-19 triggered a unified, scientific and evidence-driven, generational and historically significant shared pursuit, in the U.S. and beyond, to overcome a health crisis of a generation.