Former FDA Commissioner Dr. Scott Gottlieb says blood plasma treatment for coronavirus may be beneficial but not a "home run."
In an interview with CNBC, Dr. Gottlieb said that the blood plasma treatment that received emergency approval by the Trump administration may be somewhat effective.
“I think that this could be beneficial. It might be weakly beneficial,” said Gottlieb. “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.”
The Food and Drug Administration (FDA) announced the emergency use authorization granted to convalescent plasma as treatment for Covid-19 patients on Sunday.
President Donald Trump touted it as a “a breakthrough,” just a few days after suggesting, without providing evidence, that opponents in the FDA may have been holding up emergency approval until after the Nov. 3 election.
“We have a lot of experience using convalescent plasma in the setting of viral infections. We’ve seen situations where it does provide a benefit. We’ve seen some situations where it doesn’t,” said Gottlieb, who headed the FDA in the Trump administration from May 2017 to April 2019.
The FDA started allowing doctors to use convalescent plasma to treat coronavirus patients on a case-by-case basis in late March. On Sunday, the FDA noted that clinical trials to evaluate its effectiveness “remain ongoing.”
Gottlieb stressed that convalescent plasma “certainly” met the standard for an emergency use approval “in the setting of a public health emergency.”
“So the standard isn’t the typical standard of safe and effective as it is for a new drug approval,” he noted. “I think on the basis of the data set that’s available, it’s reasonable to conclude that this may provide a benefit to patients who are suffering from Covid.”
Potential benefits vs. risks
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.
Several health authorities are worried about the use of convalescent plasma because the data from its clinical trials is not enough to ensure the effectiveness of its widespread application. The
“Today’s action will dramatically expand access to this treatment,” Trump said at a White House press briefing on Sunday evening, a day before the Republican National Convention. “We’re removing unnecessary barriers and delays.”
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.
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.
Clinical trials have not determined whether convalescent plasma can aid patients in fighting the coronavirus. However, an emergency authorization does not require the same amount of proof for FDA approval. To date, there is no FDA-approved drug or vaccine against the coronavirus yet.
