After Donald Trump expressed his frustration with the slow pace of approval of coronavirus treatments and sparked controversy by publicly linking the Food and Drug Administration to the “Deep State” conspiracy theory, he announced on Sunday the emergency approval for convalescent plasma, a Method previously used to treat flu and measles in Covid-19 patients.
Trump made the announcement at a press conference and with FDA Commissioner Stephen Hahn by his side. He added days of White House officials suggesting politically motivated delays in getting a vaccine and therapeutics approved.
“This is what I’ve been looking for for a long time,” Trump told reporters at the White House on Sunday. “I am excited to make a truly historic announcement in our fight against the China virus that will save countless lives.”
Critics say the name of the virus is racist based on its origin. Although more than 64,000 Covid-19 patients in the US have already received convalescent plasma, a tactic for new diseases, there is no solid evidence that it fights the virus.
On Saturday, Trump tweeted, “The deep state or whoever at the FDA is making it very difficult for drug companies to get people to test the vaccines and therapeutics. Apparently they hope to postpone the answer until after November 3rd. Must focus on speed and save lives! “
The “deep state” conspiracy theory holds that a permanent government of bureaucrats exists to thwart the president’s agenda. Former Trump campaign manager and White House adviser Steve Bannon, an avid theory propagator, also said it was “for nut cases” and “none of it is true”.
House spokeswoman Nancy Pelosi called Trump’s tweet “scary” and “beyond the pale”.
The Axios news site, meanwhile, reported that trade advisor Peter Navarro was a driving force behind allegations about the treatment of “Deep State” and Covid. Quoting two sources in a meeting last Monday, Axios said Navarro had aggressively confronted FDA officials, saying, “They are all in deep condition and must comply with Trump Time.”
White House chief of staff, Mark Meadows, took up the fight on Sunday talk shows, telling ABC’s This Week, “We looked at a number of people who are not as hardworking as they should be to figure it out to go. This president is about cutting red tape. He had to make sure they could feel the heat. If you don’t see the light, you must feel the heat because the American people are suffering. “
Former FDA commissioner Scott Gottlieb defended his old employer.
“I strongly oppose the idea of doing anything slowly or speeding up anything based on political or other considerations other than what is best for public health and a real sense of mission for patients,” he told CBS’s Face the nation.
In the White House, Trump doubled in response to a reporter for the far-right One America News.
“We broke the blockade last week,” he said, “to be honest, I think there are people in the FDA [who] I can see things get held up and I wouldn’t mind that much. “
He ended the briefing shortly after Trump was challenged by officials like FDA Commissioner Hahn over his plasma treatment claims versus caution.
There is little data on how effective plasma is or whether it needs to be given relatively early in disease, said Dr. William Schaffner, an infectious disease expert at Vanderbilt University, told the Associated Press.
Hundreds of drugs are being developed, he added, and Trump “has made all kinds of therapeutic proposals” that are unscientific and even dangerous.
These statements by the President contain claims about the potential value of treating patients with ultraviolet light and bleach. According to reports, Trump recently became excited about oleandrin, a plant extract from a poisonous shrub that scientists had warned about.
The president is perhaps best known for his passionate embrace of the anti-malarial drugs hydroxychloroquine and chloroquine. In March, the FDA granted emergency approval for the drug to be distributed. In June, the agency revoked this amid growing evidence that they weren’t working and could cause serious side effects. The FDA also warned doctors against prescribing the drugs in combination with remdesivir, a drug that has been shown to help patients with Covid-19.
Axios quoted a senior government official as saying, Navarro: “A passionate proponent of hydroxychloroquine … was angry with the FDA for saying the drug did not work against Covid-19.”
Trump told reporters the order on plasma was “only possible … because of Operation Warp Speed. That is, everyone works together. We’re years ahead of approval. If we went to the pace of previous administrations, we would be two years, three years behind where we are today, and that includes vaccines, which you will hear about very soon. “
The president also expressed support for the idea that the American people have the right to try treatments that are still being researched.
Hahn stressed that routine evaluation procedures for evaluating vaccine candidates will remain in place. In addition, if the government approved a vaccine before it was found to be safe and effective, a senior FDA official overseeing studies promised to step down.
Peter Marks, director of the Center for Biologics Evaluation and Research, made his promise during a call with pharmaceutical executives, government officials and others, Reuters reported.
“I think this government put more pressure on the Food and Drug Administration than I can remember,” Schaffner told the AP. “Everyone is just a little nervous.”