The US Food and Drug Administration issued an emergency use authorization for the use of convalescent plasma to treat coronavirus patients on Sunday, despite top experts urging caution over its use.
Announcing the move, US President Donald Trump called it a “truly historic breakthrough” in the fight against the virus, which he had been “looking to do for a long time.”
“This is a powerful therapy. Today’s action will dramatically expand access to this treatment,” Trump said. “The FDA really stepped up, especially in the last few days,” the president said.
Convalescent plasma has been used on at least 70,000 patients suffering from the novel virus. The therapeutic treatment takes the plasma from people who’ve previously had Covid-19 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, including the United States’ top infectious disease expert Dr. Anthony Fauci, have cautioned that more research is needed on the treatment before it is rolled out across the country.
Dr. Francis Collins, the director of the National Institutes of Health [NIH] and Dr. Clifford Lane also expressed skepticism over the emergency authorization before the announcement.
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.
“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Dr. Lane said in an interview on Tuesday.
The FDA was prepared to issue the emergency authorization for the therapeutic last week. But these efforts were stalled after multiple doctors and experts advised against it, arguing there was not enough research to back up its potential positive effects.
Trump appeared to express his dissatisfaction with the hold-up just a day before the announcement.
“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,” he wrote on Twitter.
Tagged in the tweet was Stephen Hahn, the commissioner of the FDA who was in attendance at the press conference on Sunday. Secretary of Health and Human Services Alex Azar was also in attendance.
Trump reaffirmed his tweet during the press conference, stating it was in his “strong opinion” that some members of the FDA wanted to halt the therapeutic from getting the authorization.
Sunday’s announcement is not the first time the FDA issued an emergency authorization for a therapeutic to treat the coronavirus. The agency previously gave that authorization to malaria drugs hydroxychloroquine and chloroquine at the beginning of the pandemic. This emergency authorization was rescinded months later after studies found the drugs ineffective against the virus and sometimes more harmful to patients.
This latest emergency authorization on convalescent plasma will now ease any clerical problems hospitals might have when prescribing the treatment for patients.
Source: Agenceis
