Scientists called out FDA’s authorization of plasma treatment

Lack of study for convalescent plasma as treatment prompts scientists to question the Food and Drug Association’s grant to use it for hospitalized COVID-19 patients.

Convalescent plasma treatment is now approved as a coronavirus therapy following the Food and Drug Association’s authorization announced last Sunday, August 23. Concerns over the agency’s approval, however, grew in the scientific and medical community.

The next day, several medical professionals expressed skepticism over the efficacy and validity of plasma treatment, emphasizing that President Donald Trump’s “breakthrough” cure hasn’t undergone adequate clinical testing yet.

Data was “grossly misrepresented”

Convalescent plasma is known as potential treatment scientists are still looking into. But with the FDA’s unforeseen authorization of the therapy, experts are bewildered as to what evidence the agency had based its decision.

A scientist even called out FDA’s “misrepresentation” of the data surrounding convalescent plasma treatment. Dr. Wallid Gellad from the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh argued that the statistics presented by the FDA are unknown and cannot be found in any of the publicly released data—be it the study or the agency’s official authorization letter.

“For the first time, I feel like official people in communications and people at the F.D.A. grossly misrepresented data about a therapy,” said Dr. Gellad said, per The New York Times.

The study cited by the FDA was led by Mayo Clinic—sponsored by the National Institutes of Health—which was published earlier this month. As seen in the paper, the study suggests that plasma treatment may lower the mortality rate of hospitalized coronavirus patients.

The study also demonstrates that COVID-19 patients who are not on ventilators and are below 80 years old are 35% likely to survive another 30 days given that the person received convalescent plasma with a “high level of antibodies” three days after diagnosis.

On the flip side, patients who received plasma treatment with the same context but with a “low level of antibodies” have a lower chance of surviving.

Scientists called out FDA's authorization of plasma treatment

Lack of clinical testing

For the most part, lack of study and randomized clinical trials also worries scientists.

WHO’s chief scientist Dr. Soumya Swaminathan, for instance, said that there is no solid proof yet that plasma treatment is effective in treating COVID-19 patients with severe infection. And that it must be assessed thoroughly using “well-designed, randomized, clinical trials.”

“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,” said Dr. Swaminathan, per CNBC.

However, it can be used for “emergency purposes,” particularly if the benefits outweigh the threat it presents.

Former FDA commissioner Dr. Scott Gottlieb also expressed a similar sentiment. “[It] could be beneficial. It might be weakly beneficial,” he said during his interview with CNBC’s Squawk Box.

In addition, he also argued that plasma treatment “does not look like a home run.”

As of this writing, there are no officially approved coronavirus cure nor vaccines.

Images courtesy of Iryna Kalamurza/Shutterstock, Edward Jenner/Pexels

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