President Trump announced on Sunday that the U.S. Food and Drug Administration has approved for the emergency use of a unproven treatment known as competent plasma therapy for COVID-19 patients, and states that it may reduce the chance of dying in some by 35 percent. But scientists were quick to doubt the claim, with one calling it “scandalous.”
Convalescent plasma therapy involves extraction of blood from people infected with the coronavirus, and remove components, including red and white blood cells and platelets to leave a straw behindcolored fluid containing antibodies. It is to be hoped that this liquid will be injected COVID-19 patients were able to help her recover.
Said Trump during a press conference regarding the FDAs emergency use authorization (EUA) that a study on the treatment launched by the Mayo Clinic and the federal government “had proven that mortality decreased by 35 percent.”
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Health Secretary Alex Azar told the briefing: “We saw about a 35 percent better survival rate in the patients who benefited most from the treatment, that was, patients under 80 who were not on artificial respiration.
“I just want to emphasize this point, because I do not want you to shine on this issue. We dream in drug development of something like a 35 percent reduction in mortality. This is a major advancement in the treatment of patients. This is a great advance. “
De EUA did not indicate where the 35 percent figure originated.
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De USCovidPlasma.org website for the program states: “COVID-19 convalescent plasma has not yet been shown to provide clinical benefit in patients affected by this disease. It is not known if this treatment will help those with will or not COVID-19 or if it will have harmful effects, but this is one of the only treatments we have at the moment. “
In May, the FDA considered convalescent plasma a “investigative product “so that it could be used in clinical trials and administered to seriously ill patients.
In June, the Mayo Clinic published a safety report with 20,000 people suggesting that the treatment was safe. This was followed by a study released as in front ofprint on the server medRxiv earlier this month some indicated that giving convalescent plasma to patients with severe COVID-19 within three days after they were diagnosed could reduce their risk of death.
Submit data as in front of-print means it has not been through the rigorous peer review process required to publish in scientific journals. Releasing data this way allows scientists to request a discussion on a topic, and it is useful in a fast-paced situation such as a pandemic.
The study did not have a placebo group and was not a randomized clinical trial, the gold standard for treating treatments is safe and effective, leading experts to express skepticism about the data and the reason behind issuing a EUA.
Last week, top federal health officials called the FDA set syn EUA for the treatment on hold, claim that the data was too weak, The New York Times first reported.
Eric Topol, founder and director of the Scripps Research Translations Institute, tweeted to the EUA was issued to claim that on the basis of a in front of-print, observational (non-randomized controlled trial) study that the therapy improved the mortality rates by 35 percent was “outrageous.”
“There is no evidence to support a single survival effort,” he wrote.
Scandalous to listen to @realDonaldTrump @secAzar @SteveFDA claim that a 35% improved survival was observed in an observational preprint study compared w / late-treated patients. There is no evidence to support a single survival level. 2 days ago the FDA website stated that there was no evidence of an EUA
– Eric Topol (@EricTopol) August 23, 2020
On Sunday, Drs. Thomas M. File President of the Infectious Diseases Society of America in a statement that although the data show “some positive signals” that it may be helpful in treating COVID-19 patients, particularly those in the early stages of the disease, “we lack the randomized controlled trial data we need to understand the usefulness in COVID-19 treatment. “
“For this reason, IDSA supports the ongoing collection of data in randomized clinical trials to better understand the benefits of restorative plasma therapy before authorizing wider use in patients with COVID-19, “he said.
Ashish Jha, director of the Harvard Global Health Institute, tweeted that “sadlyy“the FDA” name [a] big hit for credibility in the way they announced EUA for plasma. “
“To be clear, the FDA has the authority and data can even meet the criteria. But way of role out: hyperbole, mischaracterization of evidence by @SteveFDA [FDA Commissioner Stephen Hahn] very disappointing. “
He said: “Bottom line for EUA is this: if you end up in the hospital, your doctor will not know if plasma is useful or not. That’s what we do science. En EUA puts us back. Makes it harder to equal science. “
Echo her worries, the Journal of the American Medical Association tweeted an explorer article about the treatment, next to the message: “People who have had #COVID develop anti-# SARS-CoV-2 antibodies in plasma, the yellow liquid part of blood. This convalescent plasma may be transmitted to COVID19 patients, but its effectiveness has not yet been demonstrated in RCTs [randomized control trials].“
People who have had #COVID develop anti-# SARS-CoV-2 antibodies in plasma, the yellow liquid part of blood. This convalescent plasma may be transmitted to COVID19 patients, but the effectiveness of the treatment has not yet been demonstrated in RCTshttps: //t.co/CAhcSzKTYI
– JAMA (@JAMA_current) August 23, 2020
A spokesman for NHS Blood and Transplant, which manages blood donation services in the UK and transplant services in the United Kingdom, said in a statement that the “observatory studies coming from America” but “they are not concluding.
“Randomized control tests are the gold standard for determining the effectiveness of a new treatment.”
Newsweek has contacted the White House, FDA, HHS, and Mayo Clinic for comment.
SAUL LOEB / AFP via Getty Images
