On Sunday, the US Food and Drug Administration released an emergency use approval, despite top experts recommending restraint over its use, for the use of restorative plasma to treat COVID-19 patients.
President Donald Trump said, ‘This is a powerful treatment. Today’s action will significantly increase entrance to this treatment. The FDA really paced up, especially in the last few days.’
A Truly Historic Breakthrough Against the China Virus That Will Save Thousands of Lives
Proclaiming the move, Donald Trump called it a ‘truly remarkable breakthrough’ in the fight against the virus, which he had been considering doing for a long time.
Convalescent plasma has been used on at least 70,000 patients undergoing the unique virus. The medicinal treatment takes the plasma from people who have formerly had coronavirus and puts it into current patients.
If the treatment goes as expected, the antibody-rich plasma should boost up the current patient’s immune system and form antibodies to fight against the virus.
But some doctors, as well as the nation’s top infectious disease expert Dr Anthony Fauci, have advised that more investigation is needed on the cure before it is spun out across the country.
Uncertainty over the crisis approval before the announcement was conveyed by Dr Francis Collins, the director of the National Institutes of Health (NIH) and Dr Clifford Lane.
Their reasoning was that a recent Mayo Clinic study, the largest one looking into convalescent plasma against the novel virus, did not provide enough data to prove the potential benefits, the doctors said.
On Tuesday, in an interview, Dr Lane said, ‘The three of us are fairly supported on the value of vigorous data through randomized control trials, and that an epidemic does not change that’.
The FDA was willing to give out the emergency permission for the therapeutic last week. But, after multiple doctors and experts warned against it, these endeavors were stalled, arguing there was not enough study to back up its possible positive consequences.
Just a day before the publication, Mr. Trump seemed to convey his frustration with the hold-up.
He wrote on Twitter, ‘The deep state, or whoever, over at the FDA is creating it very hard for drug corporations to get people to test the vaccines and therapeutics.’
Labeled in the tweet was the commissioner of the FDA who joined the press conference on Sunday, Stephen Hahn, Secretary of Health and Human Services Alex Azar was also in audience.
Members of FDA Wants to Halt the Cure from Getting the Permission
During the press conference, Mr. Trump repeated his tweet, declaring it was in his robust judgment that some members of the FDA wanted to cease the therapeutic from obtaining the approval.
Sunday’s announcement is not the first time the FDA released an emergency authorization for a therapeutic to cure the virus. The organization earlier gave that approval to malaria drugs hydroxychloroquine and chloroquine.
Months later after investigations found the drugs ineffectual against the virus and sometimes more dangerous to patients, this emergency permission was withdrawn.