Dr. Scott Gottlieb told CNBC on Monday that the blood plasma treatment for coronavirus patients who have just received emergency clearance from the Trump administration may be somewhat effective.
"I think this could be beneficial. It could be weakly beneficial," Gottlieb said on Squawk Box. "It doesn't look like a home run, but right now we're looking for singles and doubles. There won't be any homers on the horizon until we can bring the other therapeutic antibodies to market and hopefully eventually vaccines and better therapeutics."
The Food and Drug Administration on Sunday announced emergency approval to use convalescent plasma to treat coronavirus patients. The Trump administration announced the day before the start of the Republican National Convention. President Donald Trump touted it as a "breakthrough" just days after pointing out without evidence that FDA opponents may have upheld the emergency clearance until after the November 3rd election.
Blood plasma treatment has reduced Covid-19 mortality by 35%, Trump claimed on Sunday. However, the results of the Mayo Clinic study, which the FDA cited in their approval of the treatment, show that about 35% of patients under 80 who did not wear a respirator and received plasma with high levels of antibodies within three days of diagnosis. They are more likely to survive an additional 30 days compared to patients who received low-antibody plasma. However, the study acknowledged that its results are limited, especially because there was no placebo comparison.
Convalescent plasma is a centuries-old treatment that was also used on patients during the 1918 pandemic flu. The Mayo Clinic, which is conducting studies on the treatment, says blood will be drawn from recovered Covid-19 patients who have developed antibodies to the disease. The convalescent plasma is then given to people with the coronavirus in hopes of preventing serious illness.
"We have a lot of experience with the use of convalescent plasma in causing viral infections. We have seen situations where it is beneficial. We have seen some situations where it doesn't," said Gottlieb, who headed the FDA the Trump administration from May 2017 to April 2019.
In late March, in the early stages of the U.S. coronavirus outbreak, the FDA began allowing doctors to use convalescent plasma to treat Covid-19 patients on a case-by-case basis. In its press release on Sunday, the FDA stressed that clinical trials to determine its effectiveness are "ongoing".
Gottlieb said he believes that convalescent plasma "certainly" met the standard for an emergency permit "in the context of a public health emergency."
"So the standard is not the typical standard for safety and efficacy that applies to a new drug approval," he added. "I think based on the available dataset, it can be concluded that this can be beneficial for patients with Covid."
There are approximately 5.7 million confirmed cases of Covid-19 in the United States, according to Johns Hopkins University. At least 176,809 people have died. After a renewed increase in infections this summer, the number of new cases of Covid-19 decreased every day.
Disclosure: Scott Gottlieb is a CNBC employee and a member of the boards of directors of Pfizer, the genetic testing startup Tempus and the biotech company Illumina.