FDA authorizes the use of plasma of recovered patients to treat COVID-19

(Washington) – President Donald Trump announced Sunday for the emergency authorization processing COVID-19 patients with plasma recovering – a movement that it is a “step forward,” one of her health officials “promising” as and other health experts said it needs more study before it famous. The announcement came after officials of the White House there delays for political reasons have complained by the Food and Drug Administration, had a vaccine and treatment for the disease in approving the odds Trump declined re-election to the head. On the eve of the Republican National Convention, Trump began to center the announcement of the FDA approval of a press conference on Sunday night. The approval makes it easier for some patients to receive treatment, but it is not the same as full FDA approval. The blood plasma from patients who have recovered from the crown and rich in antibodies that can fight the benefits to those of the disease. But the evidence so far is inconclusive about whether it works, if they can, and what dose is required. It describes in a letter to the authorization of emergency chief scientist for the FDA, Denise Hinton, said: “COVID-19 convalescent plasma should not be considered a new standard of care for the treatment of patients with COVID-19 into consideration. More of data is absent from other analyzes and ongoing clinical trials well controlled in the coming months. ” But Trump had helpers clear that he was eager to present good news for the virus in the battle, and the timing allows him to head in agreement with momentum. He and aides announced the development as “great” and used to make the briefing room of the White House for the announcement. Trump also showed a certain discipline on rare news conference in the evening, in a sign of his argument to return to the top of the FDA, Stephen Hahn, and take only three questions from reporters. The White House had become agitated with plasma pace of approval. Allegations of an FDA downturn have presented no evidence was just the latest attack by the Trump team means what he called “deep state” bureaucracy. White House Chief Mark Meadows does not deal in detail, but said that “we are in a number of people who have always searched for the reason that it should not as diligent against her.” “This president is about cutting red tape,” Meadows said in an interview Sunday on “This Week” on ABC. “He had to make sure that they feel the heat. If you do not see the light, they have to feel the heat, because the American people who are suffering.” While Sunday’s press conference 18 minutes, said Trump, he thought it was one at FDA “block” had granted emergency approval of, he said that there are people at the FDA “stop things … and that is to see political reasons.” Dr. Joshua Sharfstein, the statement said, and touch silence while Trump said it was “a shame.” “The commissioner of the FDA in essence, the President allowed the decision mischaracterize and integrity of the FDA for the people to attack. I was horrified,” Sharfstein, vice dean of the John Hopkins University School of Public Health, who officially over the Obama administration has been a top FDA said. “This is a promising therapy that are not yet fully established,” said The push on Sunday one day came after Trump sharp criticism of Twitter procedure for the treatment of the virus, more Americans killed 175,000 and his likely reelection at risk, the White House has enormous resources on an expedited basis sunk to develop a vaccine, and aides Trump on the shore had to be an “October surprise” that the president could help make up ground in the polls. “I was down, or anyone, the FDA makes it very difficult for pharmaceutical companies to get people to test vaccines and treatments,” Trump tweeted. He continued: “Of course I hope to delay the response until after the November 3rd. It must focus on speed and save lives!” Earlier this month recorded a strong indication of the Mayo Clinic researchers have discovered that blood plasma helps COVID 19 survivors recover other infected patients. But it was not considered evidence. More than 70,000 patients in the US were administered convalescent plasma, a secular approach to ward off flu and measles vaccines before. It is a go-to tactic when new diseases coming, and history suggests that works against some but not all infections. The Mayo Clinic reported preliminary data from 35,000 patients corona plasma treated, and said there were fewer deaths in plasma persons were within three days after diagnosis, and also the plasma date with the highest levels of antibodies to the virus -combat. But it was not a formal study. Patients are differently developed in hospitals across the country as part of an FDA program, treated for early access to experimental therapy. What the “expanded access” program title, what happens to the recipient but can not prove the plasma – and the others do not care they received – was the real reason for improvement. Government officials, in a call with reporters Sunday discussed a benefit to patients in a hospital within three days after admission and were not given on a respirator and were above high-strength concentrations’ convalescent serum antibodies. They were then compared with similar patients who were given lower plasma title. The results suggest deaths in the high titer group were 35% lower. There were few data on how effective, or whether it is a disease administered make a significant difference soon enough, said Dr. William Schaffner, an infectious-disease expert at Vanderbilt University. reject the target can have a race on convalescent plasma after the announcement, government officials have worked to obtain the plasma and generate team with business and non-profit organizations interested in patients previously infected to donate. Hahn, who he said that the development as “promising”, Trump does not speak to him about the time of the announcement. He said “this has been in the works for several weeks.” But some health experts were skeptical. Benjamin Corb, by the American Society for Biochemistry and Molecular Biology, called it “surprising timing”. “President Trump execute his policy goals set before the health and welfare of the American public,” said Corb. rigorous studies are under way, similar to the country, compared with patients randomized assigned to receive plasma or a dummy infusion, in addition to regular care. But these studies were difficult because due to the end in different cities, the virus takes over and. In addition, some patients required Plasma match rather than a study that could have given a placebo instead. Former FDA Commissioner Dr. Scott Gottlieb has rejected the proposal of slowing down. “I is firmly reject the idea would be something or accelerate all based on a political vision or any other value than it is for public health at best, and a real sense of mission for the patient slowly walking “Gottlieb told CBS” Face the Nation. “Trump, in press conferences,” has made all kinds of therapeutic proposals “that are not supported by science has shown – and even dangerous, said Schaffner. These include statements about the potential value of COVID-treat 19 patients with ultraviolet light and disinfectants. Trump reportedly was recently thrilled oleandrin, a plant extract from a poisonous shrub suggests that scientists have warned immediately. But the president is perhaps best known for his early and ardent embrace of drugs against malaria hydroxychloroquine and chloroquine. Earlier this month, Hahn pointed out that the routine assessment procedures in place remain COVID to evaluate vaccine candidates. “I think this government has put more pressure on the Food and Drug Administration, as I can remember” ever before, said Schaffner. “Everyone is a bit ‘nervous,” he said. ___ Stobbe reported from New York.
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