Published 11:02 IST, August 26th 2020
US FDA 'will revoke authorization' of plasma to treat COVID 'if needed', says chief
Hahn’s apology comes after a backlash from medical fraternity regarding President Trump's briefing wherein he called treatment as "life-saving".
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On August 25, US Food and Drug Administration Commissioner Stephen Hahn apologized for exaggerating the benefits of convalescent plasma therapy in the treatment of the critically ill, hospitalized COVID-19 patients. Hahn’s apology comes after a backlash from health experts and medical fraternity regarding President Donald Trump briefing wherein he called the convalescent plasma as “breakthrough” and “life-saving”. Trump’s announcement of its emergency authorization on eve of the RNC has led many to suspect that the move was “politically motivated”. Experts have raised objections on Hahn, overestimating a treatment with no scientific evidence.
The authorization of emergency use of convalescent plasma is not a final approval. FDA will continue to monitor its use and will revoke authorization if needed. We feel broader use of plasma will truly benefit many patients but will require further study.
— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
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.
— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma,” Hahn said, taking to his official handle on Twitter. “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,” Hahn added. According to reports, there haven’t been any substantiated shreds of evidence about the treatment massively curing the coronavirus patients on support and larger risk.
Hahn’s claims also vastly overstated preliminary findings of Mayo Clinic observation that says, Convalescent plasma is found associated with “reduced COVID-19 mortality” under its national Expanded Access Program (EAP). It also goes to clarify that EAP “is not and was not intended to be a clinical trial to determine the efficacy of convalescent plasma”, adding, “no data existed as to what dose might be appropriate.”
'35 percent' better survival
Trump in the presser on August 24, in presence of Hahn, said that the new therapeutic treatment can “save lives” and is “very effective”. Further, Hahn said that there’s a noticeable 35 percent better survival rate in hospitalized patients under 80 in just over a month. Not just that, citing the FDA and other partners’ early set up of Expanded Access Protocol to the treatment, Alex said that patients who were administered plasma early in their disease course within 3 days of being diagnosed containing high-level antibodies benefited the most. FDA, meanwhile, wrote about the investigational convalescent plasma in a press release, saying, “this product may be effective in treating COVID-19.”
LIVE: President @realDonaldTrump holds a news conference https://t.co/BvYoN0T57c
— The White House (@WhiteHouse) August 23, 2020
(Image Credit: AP)
11:02 IST, August 26th 2020