BOSTON — Medical professionals are questioning the use of convalescent plasma for the treatment of COVID-19, after President Trump announced in a press conference Sunday that the U.S. Food and Drug Administration issued an emergency use authorization.
“The FDA has made the independent determination that the treatment is safe and very effective,” President Trump said in his address.
However, without randomized trials, healthcare experts are expressing concern.
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“I’d like it to be effective, but the truth is we don’t know,” C. Michael Gibson told Boston 25 News on Sunday night.
Dr. Gibson is a Harvard Professor and doctor at Beth Israel Deaconess Medical Center.
“There are no randomized trials that are big enough to tell us whether it’s safe and effective. There is one study of 100 patients that was randomized. That’s not big enough to give us an answer,” he said.
Dr. Gibson explained that he was skeptical and that, until randomized trials were available, the public should have a healthy skepticism.
“The first thing that came to my mind is how tragic it is that we gave 60-some thousand patients this therapy without randomizing them to the therapy or placebo,” he said. “It could have just worked because the people who got the plasma were healthier. Maybe the people who didn’t get the plasma were critically ill and about to die. So unless you randomly assign people to plasma or no plasma, you don’t know the answer.”
According to the Mayo Clinic, side effects of convalescent plasma can include allergic reactions, lung damage and transmission of infections.
Dr. Gibson added that people should keep in mind that the FDA has not approved convalescent plasma as a COVID-19 treatment and that this is just an authorization to administer it.
“This is an emergency use authorization. It’s not an approval of the plasma, it’s just an authorization to give it. If instead you were in a trial, you would have the protections that come as part of participating in that trial. So beware of the limitations of what’s called an EUA,” he said.
Dr. Gibson said he was also concerned that people may be less likely to participate in other trials that could lead to an effective, approved treatment.
“My only concern moving forward is if people think this works, they will be less likely to participate in a trial that would really give us the answer,” he said.
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