After expressing frustration over the slow pace of approval for coronavirus treatments, and controversy caused by the Food and Drug Administration publicly linking the “deep state” conspiracy theory, Donald Trump announced on Sunday the emergency authorization of convalescent plasma to, a method that has been used to treat flu and knives, for Covid-19 patients.
Covid-19 has killed more than 175,000, cratered the economy and raised the president’s hopes of re-election. The White House has put enormous resources into an accelerated process to develop a vaccine, known as Operation Warp Speed, which hopes to produce an “October surprise” for the November 3 presidential election.
The announcement was made at a press conference, and with FDA commissioner Stephen Hahn standing by him, Trump added to days of White House officials suggesting politically motivated delays in approving a vaccine and therapy.
“This is what I have been looking for a long time to do,” Trump told reporters at the White House on Sunday. “I am pleased to make a truly historic announcement in our fight against the China virus that will save countless lives.”
Critics say the name for the virus, based on where it originated, is racist. Furthermore, although more than 64,000 Covid-19 patients in the US have already received a convalescent plasma, a go-to tactic for new diseases, there is no solid evidence that it fights the phytus.
On Saturday, Trump tweeted: “The deep state, or whatever, at the FDA makes it very difficult for drug companies to get people to test the vaccines and therapeutics. Of course, they hope to delay the response until after November 3rd. Must focus on speed, and saving lives! ”
The “deep state” conspiracy theory implies that there is a permanent government of bureaucrats to withhold the president’s agenda. Former Trump campaign manager and White House adviser Steve Bannon, an enthusiastic proponent of the theory, has also said it is “for convenience” and “none of this is true”.
Chamber member Nancy Pelosi called Trump’s tweet “scary” and “out of the blue.”
The news website Axios, meanwhile, said that trade adviser Peter Navarro was a driving force behind claims about the “deep state” and Covid treatments. Axios told two sources at a meeting last Monday, saying Navarro aggressively confronted FDA officials, saying, “You are all deep state and you need to get on Trump Time.”
White House staffer took the plunge to talk shows on Sunday, telling ABC’s This Week: “We’ve been looking at a number of people who are not as eager as they should be in terms of coming to an end. This “President, it’s about cutting desks. He had to make sure they felt the heat. If they do not see the light, they have to feel the heat, because the American people are suffering.”
Former FDA commissioner Scott Gottlieb defended his former employer.
“I reject the idea that she would trust everything or accelerate everything based on any political consideration or anything other than the best for public health and a real sense of mission for patients,” he told CBS’s Face the Nation.
At the White House, in response to a frank reporter, far right One America News, Trump doubled him down.
“We broke the logjam last week,” he said, “to be honest I think there are people in the FDA [who] things can be kept and will not matter so much. ‘
Shortly after he was challenged over his recommendations on plasma treatment compared to caution from officials including FDA Commissioner Hahn, Trump ended the briefing.
There is not much data on how effective plasma is or whether it should be managed fairly early in a disease, Dr. William Schaffner, an expert at Vanderbilt University, told the Associated Press.
Hundreds of drugs are being developed, he added, and Trump “has made all sorts of therapeutic suggestions” that are unsupported by science and even dangerous.
Those statements by the president include claims about the potential value of treating patients with ultraviolet light and bleach. Trump was reportedly recently enthusiastic about oleandrin, a plant extract derived from a poisonous shrub that scientists have warned against.
The president is perhaps best known for his fierce embrace of the anti-malaria drugs hydroxychloroquine and chloroquine. In March, the FDA granted emergency authorization for drug distribution. In June, the agency withdrew it, in light of growing evidence that they are not working and could cause serious side effects. The FDA also warned doctors against prescribing the drug in combination with remdesivir, a drug that has been shown to help patients with Covid-19.
Axios quoted an official of the administration as saying Navarro, “a fervent proponent of hydroxychloroquine … remained angry with the FDA because he said the drug did not work against Covid-19.”
Trump told reporters that the plasma order “was only possible … because of Operation Warp Speed. Everyone is working together. We are years ahead of approval. If we went through the speed levels of past administrations, we would be two years old,” three years behind where we are today and that includes and faxes that you will hear about very soon. “
The president also expressed support for the idea that the American people have a “right to try” treatments that are still under investigation.
Hahn has stressed that routine evaluation procedures will remain in place to evaluate candidates for faxes. Furthermore, an official FDA official promised to dismiss if the administration approved a vaccine before it was shown to be safe and effective.
Peter Marks, director of the Center for Biologics Evaluation and Research, made his promise during a conversation with pharmaceutical executives, officials and others, Reuters reported.
“I think this administration has put more pressure on the Food and Drug Administration than I can remember,” Schaffner told the AP. “Everyone is just a little nervous.”