Donald Trump Announces Emergency Authorisation Of New Coronavirus Treatment
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Donald Trump has announced the Food and Drug Administration has approved an emergency authorisation of a new coronavirus treatment.
Convalescent plasma will now be used on patients with Covid-19 in hospitals after research showed it could reasonably help with their symptoms.
Top American doctors have cautioned the use of plasma, saying it too early to tell whether it makes a difference in a patient's recovery.
But the FDA said the 'known and potential benefits outweigh the known and potential risks'.
At a press conference, the US President said: "Today's action will dramatically expand access to this treatment. We're removing unnecessary barriers and delays."
The treatment involves taking plasma from people who have already contracted and survived coronavirus and giving it to those still battling the virus. The belief is that the plasma will contain antibodies that were created in the donor's body, which can help fight Covid-19 in the recipient.
The same type of treatment has been used in the past to help treat the likes of measles and the flu.
Trump accused the FDA of holding the treatment back and even accused 'the deep state' of being involved in its delay to help swing the election to the Democrats.
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. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA
- Donald J. Trump (@realDonaldTrump) August 22, 2020
In a White House press briefing last week, the President said: "It could be a political decision because you have a lot of people over there who don't want to rush things because they want to do it after November 3, and you've heard that one before."
In a separate tweet over the weekend, Trump added: "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. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!"
But the reason, in part, why the treatment has taken longer is because of the concerns surrounding its efficacy.
Thousands of Americans have received convalescent plasma as part of a clinical trial, but top officials said more research is needed to confirm whether it's an effective treatment.
According to the New York Times, federal health officials including Dr. Francis Collins, Dr Clifford Lane and Dr. Anthony Fauci intervened in the FDA authorisation, saying the data was too weak.
"The three of us are pretty aligned on the importance of robust data through randomised control trials, and that a pandemic does not change that," Dr. Lane said.
Former Food and Drug Administration chief Dr. Scott Gottlieb added in an interview to CBS that there isn't enough information to accurately claim that the treatment will work.
"The trial that that's going to be based on 70,000 patients wasn't a very rigorously done trial. It was an open-label study where everyone got treated. So it's hard to draw conclusions," Gottlieb said.
"I believe plasma is probably beneficial. It's probably weakly beneficial in the setting of this treatment. But I think some people wanted to see more rigorous data to ground that decision. And I think that's part of what is going on here with respect to that tweet and questions about the FDA decision making."
But it seems like there is enough data now to proceed and the treatment will be used.