FDA Commissioner Admits He Mislead the Public About Unproven COVID-19 Treatment

At a White House press briefing on Sunday, President Donald Trump announced that the Food and Drug Administration had granted emergency approval of convalescent plasma as a “breakthrough” treatment for COVID-19, also known as the coronavirus, the highly contagious pathogen that has killed 177,000 Americans since March.

Convalescent plasma is extracted from the blood of patients who caught the coronavirus and recovered. It “contains antibodies to severe acute respiratory syndrome coronavirus 2 or SARS-CoV-2 (the virus that causes COVID-19)” and “is being studied for administration to patients with COVID-19,” the FDA explains on its website.

Antibodies are proteins generated by the immune system to neutralize viruses or bacteria that enter the bloodstream.

Moments after Trump spoke, his remarks were expanded upon by FDA Commissioner Dr. Stephen Hahn.

”What that means is — and if the data continue to pan out — 100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma,” Hahn said.

Photo by Kevin Dietsch-Pool/Getty Images

But on Monday, Hahn admitted that he mislead the public about the efficacy and safety of convalescent plasma as a coronavirus therapy.

“Media coverage of FDA’s decision to issue emergency authorization for convalescent plasma has questioned whether this was a politically motivated decision. The decision was made by FDA career scientists based on data submitted a few weeks ago,” Hahn wrote on Twitter. “They had confidence that convalescent plasma has potential to benefit many sick patients and the safety profile is well defined.”

This is not true, according to the FDA.

“Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic,” the agency explains. “Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19. Therefore, it is important to study the safety and efficacy of COVID-19 convalescent plasma in clinical trials.”

Normally, a series of successful clinical trials are required for cures, treatments, and vaccines to be cleared by the FDA. That was not the case this time.

Hahn wrote that “we unfortunately do not have randomized trials for convalescent plasma” and that the emergency approval was based on “reliable sources” and “a century of experience.”

Hahn placed the blame on “FDA scientists,” but the decision was ultimately his, and he took responsibility for the error.

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma,” Hahn concluded. “The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”

At a separate press briefing on Monday, World Health Organization Chief Scientist Dr. Soumya Swaminathan cautioned that there is “very low evidence” Dr. Soumya Swaminathan that convalescent plasma is effective or the “breakthrough” Trump promoted.

“The results are not conclusive,” Swaminathan told reporters. “The trials have been relatively small, and the results in some cases point to some benefit but have not been conclusive.”

The WHO was not the only organization to lobby the FDA to allow the proper scientific process play out. Last week, it accused Trump of “putting his political goals ahead of the health and well-being of the American public.”

Trump“has pushed a narrative that scientists are slow-walking treatments for COVID-19 until after the November election in an effort to hurt his re-election chances,” the ASBMB said in a statement. “These accusations are baseless and dangerously politicize science.”

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