WASHINGTON – After expressing frustration over the slow pace of approval for coronavirus treatments, President Donald Trump on Sunday announced the emergency authorization of convalescent plasma for COVID-19 patients.
The announcement came after days of White House officials suggesting there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutic for the disease that has slashed Trump’s chances of re-election.
On the eve of the Republican National Convention, Trump issued the emergency order – it would make it easier for some patients to get the treatment – in a news conference Sunday night, according to White House officials.
The blood plasma, taken from patients who have recovered from the coronavirus and are rich in antibodies, can provide benefits for those battling the disease. But the evidence so far has not been conclusive about whether it works, when it should be administered and what dose is needed.
In a letter describing the emergency authorization, FDA Chief Scientist Denise Hinton notes: “COVID-19 convalescent plasma should not be considered as a new standard of care for the treatment of patients with COVID-19. Additional data will be followed by other analyzes and ongoing, well-controlled clinical trials in the coming months. “
The White House had grown angry with the pace of plasma approval, but the allegations of a slowdown, presented without evidence, were just the latest attack by Trump’s team on the “deep state” bureaucracy. Staff Ms White House general association did not address any specifications, but said that “we have seen a number of people who are not as eager as they should be in terms of it coming to an end.”
“This president is about cutting desktop,” Meadows said in an interview with ABC this week. “He had to make sure they felt the heat. If they don’t see the light, they have to feel the heat, because the American people are suffering.”
The push on Sunday came a day after Trump tweeted harsh criticism at the process of treating the virus, which has killed more than 175,000 Americans and undermined his chances of re-election. The White House has put enormous resources into an accelerated process to develop a fax machine, and Trump officials have banked that it was an “October surprise” that could help the president make ground in the polls.
“The deep state, or whatever, at the FDA makes it very difficult for drug companies to get people to test the vaccines and therapeutics,” Trump tweeted. “Of course, they hope to delay the response until after November 3. Must focus on speed, and save lives!”
Earlier this month, researchers from Mayo Clinic reported a strong hint that COVID-19 survivors’ blood plasma helps other infected patients recover. But it was not considered evidence.
More than 70,000 patients in the U.S. have received convalescent plasma, a century-old approach to protect against flu and knives before vaccinations. It is a go-to tactic when new diseases appear, and history suggests that it works against some, but not all, infections.
There is still no solid evidence that it covers against the coronavirus and, if so, how it can best be used.
The Mayo Clinic reported preliminary data from 35,000 coronavirus patients treated with plasma, saying there were fewer deaths among people who received plasma within three days of diagnosis, as well as among those given plasma who contain the highest levels of anti-antibodies.
But it was not a formal study. The patients were treated in various ways in hospitals around the country as part of an FDA program designed to gain access to the experimental therapy. That so-called “extended access” program follows what happens to the recipients, but it can not prove the plasma – and not other care they received – was the real reason for improvement.
Administration officials discussed in a conversation with reporters Sunday an advantage for patients who were in a hospital and not on a respirator within three days of admission, and received ‘high titer’ convalescent plasma with higher concentrations of antibodies. They were then compared with similar patients who received lower titer plasma. The findings suggest that deaths were 35% lower in the high titer group.
There was not much data on how effective it is or whether it should be managed fairly early in a disease to make a significant difference, said Dr William Schaffner, an expert at Vanderbilt University.
With the aim of awaiting a possible follow-up to the announcement of plasma after the announcement, government officials have been working to obtain plasma and work with business partners and non-profit organizations to generate interest among previously infected patients to donate.
FDA chief Stephen Hahn said Trump did not speak to him about the timing of the announcement, which comes just before a pivotal week ahead of the presidential election. Hahn said “this has been in the works for several weeks” and came after a validation of data for which the agency was waiting.
Rigorous studies around the country have been designed to provide this evidence, by comparing similar patients randomly assigned to receive plasma as a dumb infusion in addition to regular care. But those studies are difficult to complete as the virus grows and grows in different cities. Some patients have also requested plasma instead of agreeing to a study that could give them a place.
Former FDA commissioner Dr. Scott Gottlieb dismissed the suggestion of a delay.
“I reject the idea that they would run everything slowly or accelerate everything based on any political consideration or any other consideration other than what is best for public health and a real sense of mission for patients,” Gottlieb of CBS told “Face the Nation. “
Hundreds of drugs are currently being developed as possible treatments against the coronavirus infection, taking a range of approaches.
Trump has made “all kinds of therapeutic suggestions in news conferences,” which have not been proven supported by science – and are even dangerous, Schaffner said. This includes explanations about the potential value of treating COVID-19 patients with ultraviolet light and bleach. Trump also recently reported enthusiastically about oleandrin, a plant extract derived from a poisonous shrub that scientists immediately warned against.
But the president is perhaps best known for his early and poor embrace of the malaria drugs hydroxychloroquine and chloroquine.
The FDA last March issued emergency authorization for distribution of the COVID treatment drugs. But in June, the agency introduced the authorization in light of growing evidence that they are not working and could cause serious side effects.
Not only that, the FDA warned doctors against prescribing the drug in combination with remdesivir, a drug that has been shown to help patients with COVID-19. The FDA said the anti-malaria drugs could reduce the effectiveness of remdesivir, which the FDA removed in May for emergency use.
Earlier this month, Hahn stressed that routine evaluation procedures will remain in place to evaluate COVID vaccine candidates.
“I think this administration has put more pressure on the Food and Drug Administration than I can remember” that has ever happened in the past, Schaffner said.
“Everyone is just a little nervous,” he said.
