On Sunday, Donald Trump announced that the U.S. Food and Drug Administration has allowed for the emergency use of an unproven treatment known as convalescent plasma therapy for COVID-19 patients.
Trump stated that the therapy reduces the chances of dying by 35 percent. Several scientists were quick to speak out stating that Trump’s claims were “outrageous.”
This is how convalescent plasma therapy is supposed to work: First, they draw blood from people that have been infected with the virus. Second. They then remove red and white blood cells and platelets to leave only a straw-colored liquid that contains antibodies. The antibodies are then injected into COVID-19 patients and it could help them recover.
During the press conference, Trump stated that a study on the treatment was launched by the Mayo Clinic and that the federal government had “proven to reduce mortality by 35 percent.”
“We saw about a 35 percent better survival in the patients who benefited most from the treatment, which were patients under 80 who were not on artificial respiration,” Health Secretary Alex Azar said during the briefing.
“I just want to emphasize this point, because I don’t want you to gloss over this number. We dream in drug development of something like a 35 percent mortality reduction. This is a major advance in the treatment of patients. This is a major advance,” Azar added.
The USCovidPlasma.org website for the program reads: “COVID-19 convalescent plasma has not yet been demonstrated to provide clinical benefit in patients affected by this disease. It’s not known if this treatment will or will not help those with COVID-19 or if it will have any harmful effects, but this is one of the only treatments that we have at present.”
The FDA ruled convalescent plasma as an “investigational product” back in May. It can be used in clinical trials or administered to patients who are gravely ill.
The Mayo Clinic released a safety report back in June that involved 20,000 people that suggested the treatment was safe.
A top federal health official called for the FDA to put EUA for treatment on hold last week. They argued that the data was just too weak.
Eric Topol, founder and director of the Scripps Research Translational Institute, tweeted that the therapy improved mortality rates by 35 percent was “outrageous.”
“There’s no evidence to support any survival benefit,” he wrote.
On Sunday, Dr. Thomas M. File president of the Infectious Diseases Society of America released a statement sharing that while data showed some positive signals “we lack the randomized controlled trial data we need to better understand its utility in COVID-19 treatment.”
“For this reason, IDSA supports the continued collection of data in randomized clinical trials to better understand the benefits of convalescent plasma treatment before authorizing its wider use in patients with COVID-19,” File added.
Duncan Young, a professor of intensive care medicine at the University of Oxford, U.K., stated that “The biggest problem with an EUA for convalescent plasma therapy is that we will not know if it works, as the EUA essentially causes clinicians to give the treatment rather than entering patients in clinical trials. There may also be a rationing problem as it may be in short supply.”
Ashish Jha, director of the Harvard Global Health Institute, tweeted that “sadlyy” the FDA “took [a] big hit to credibility in the manner in which they announced EUA for plasma.”
“To be clear, FDA has the authority & data might even meet the criteria. But the manner of role out: hyperbole, mischaracterization of evidence by @SteveFDA very disappointing.”
He then added: “Bottom line for EUA is this: if you end up hospitalized, your doctor won’t know if the plasma is helpful or not. That’s why we do science. And EUA sets us back. Makes it harder to do science right.”
The journal of the American Medical Association then tweeted, “People who’ve had #COVID19 develop anti-#SARSCoV2 antibodies in plasma, the yellow liquid portion of blood. This convalescent plasma can be transfused into COVID19 patients, but the effectiveness of the treatment hasn’t yet been shown in RCTs [randomized control trial.”
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