Dr. Scott Gottlieb told CNBC on Monday that the treatment of blood plasma for patients with coronavirus just getting permission for emergency services by the Trump administration may have been somewhat effective.
“I think this could be beneficial. It could be weakly beneficial,” Gottlieb said on “Squawk Box.” “It does not look like a home team, but at the moment we are looking for singles and doubles. There will actually be no home runs on the horizon until we can get the other therapeutic antibodies on the market and hopefully eventually vaccines and better therapy. . ”
The Food and Drug Administration on Sunday announced the authorization for emergency use of convalescent plasma for the treatment of coronavirus patients. The announcement by the Trump administration came a day before the start of the Republican National Convention. President Donald Trump described it as a “breakthrough,” but a few days later suggested, without providing evidence, that opponents in the FDA may have held emergency permits until after the November 3 election.
Blood plasma treatment has reduced Covid-19 mortality by 35%, Trump claimed on Sunday. However, results of the study by the Mayo Clinic that the FDA cited in its authorization for treatment indicate that patients under the age of 80 who were not on a respirator and received plasma with a high level of antibodies within three days of diagnosed about 35% were more likely to survive another 30 days compared to patients who received plasma with a low level of antibodies. However, the study acknowledged that their findings were limited, mainly because it did not have a placebo comparison.
Convalescent plasma is a century-old treatment that was also used on patients during the 1918 flu pandemic. It involves taking the blood of recovered Covid-19 patients who have developed antibodies against the disease, according to the Mayo Clinic, which is conducting research on the treatment. The convalescent plasma is then given to people with the coronavirus, in the hope of preventing serious illness.
“We have a lot of experience with using convalescent plasma in the setting of viral infections. We have seen situations where it provides an advantage. We have seen some situations where it does not,” said Gottlieb, ‘ t led the FDA in the Trump administration from May 2017 to April 2019.
In late March, in the early stages of the US coronavirus outbreak, FDA doctors began allowing convalescent plasma to be used to treat Covid-19 patients on the case. In its release Sunday, the FDA stressed that clinical trials to determine its effectiveness “remain ongoing.”
Gottlieb said he believed plasma recovery “certainly” met the standard for emergency use approval “in setting up an emergency public health facility.”
“That standard is not the typical standard of safe and effective, as it is for a new approval for medicines,” he added. “I think based on the data set that is available, it is reasonable to conclude that this could provide an advantage for patients suffering from Covid.”
There are approximately 5.7 million confirmed cases of Covid-19 in the US, according to data compiled by Johns Hopkins University. At least 176,809 people have died. Following a new onset of infections this summer, daily new cases of Covid-19 began to decline.
Announcement: Scott Gottlieb is a CNBC participant and is a member of the boards of Pfizer, start-up of genetic testing Tempus and biotech company Illumina.
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