Scientists doubt convalescent plasma as an effective treatment for Covid-19 patients even if it received an emergency use authorization.
Scientists and health authorities emphasize the importance of more data from randomized controlled trials, which are regarded as the “gold standard” in science, in order to prove the effectiveness of convalescent plasma.
The World Health Organization (WHO) said that the trials have not been conclusive, were small, and have presented “very low-quality evidence."
“We’ve been tracking this,” said Dr. Soumya Swaminathan, the WHO’s chief scientist. “We do ongoing meta-analyses and systematic reviews to see where the evidence is shifting or pointing, and at the moment it’s still very low-quality evidence. So we recommend that convalescent plasma is still an experimental therapy. It should be evaluated in well-designed, randomized, clinical trials.”
She added that countries can use it on an emergency basis “if they feel the benefits outweigh the risks, but that’s usually done while awaiting the more definitive evidence, which is yet to come.”
The Food and Drug Administration (FDA) granted convalescent plasma emergency use authorization for Covid-19 treatment.
According to the FDA, there is reason to regard convalescent plasma as an effective treatment for Covid-19 patients and that the identified and potential benefits outweigh the potential risks of such products.
According to the Mayo Clinic, which is studying the treatment, the convalescent plasma treatment involves the use of blood from recovered Covid-19 patients who were able to develop antibodies against the virus and injects it into patients who contracted the virus to prevent severe cases.
"Politics won"
Some health experts, such as White House coronavirus advisor Dr. Anthony Fauci and Dr. Francis Collins, the director of the National Institutes of Health, warned about the insufficient data on the country’s largest blood plasma study. Their concern about weak data compelled the FDA to postpone granting emergency authorization for the blood treatment.
Dr. Scott Gottlieb, a former FDA commissioner, said the treatment could be beneficial to patients but it “doesn’t look like a home run.”
“It might be weakly beneficial,” Gottlieb told CNBC's “Squawk Box.” “It doesn’t look like a home run, but right now we’re looking for singles and doubles. There aren’t really going to be any home runs on the horizon until we can get the other therapeutic antibodies on the market and hopefully eventually vaccines and better therapeutics.”
Meanwhile, Lawrence Gostin, a professor and faculty director of the O’Neill Institute for National and Global Health Law at Georgetown University, expressed skepticism over the treatment’s effectiveness. He said he was concerned the FDA's decision to grant such authorization was rooted in political pressure.
President Donald Trump's announcement on Sunday night came before the beginning of the Republican National Convention and 10 weeks before the Nov. 3 presidential election.
Dr. Jeremy Faust of Boston’s Brigham and Women’s Hospital and Harvard Medical School blasted the FDA, tweeting that “science lost today” and “politics won.”
“Breakthroughs come from randomized controlled trials,” he said. “Not cherry picking subsets of existing datasets and finding one promising finding amongst a sea of disappointment.”
