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The FDA’s Good Plasma Decision


Here we go again. President Trump hypes a Covid-19 therapy that has shown potential based on early studies. The Food and Drug Administration approves the treatment for emergency use and gets lambasted for letting politics influence the science.

This is what occurred with the anti-malaria drug hydroxychloroquine and now is happening with convalescent plasma, which the FDA on Sunday granted “emergency use authorization” (EUA). Mr. Trump was wrong to tweet over the weekend that “the deep state” at the FDA was thwarting development of therapies and vaccines to sabotage his re-election.

There’s no evidence for his claim or that the FDA is making decisions based on anything but the science. There is, however, ample evidence that convalescent plasma may be effective and that the potential benefits outweigh the risks. This is the FDA standard for EUAs, and the agency was right to increase patient access to the potentially life-saving therapy.

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Convalescent plasma has been used since the late 19th century to treat infectious diseases including small pox, the Spanish flu and Ebola as well as more recent respiratory viruses like H1N1, SARS and MERS. The idea is to help sick patients mount a stronger immune response by infusing them with plasma containing antibodies from recovered patients.

But individuals produce varying levels and types of antibodies in response to viruses, so convalescent plasma from some recovered patients will be more effective. This makes it especially hard to do randomized trials with control groups. The two randomized placebo trials on convalescent plasma were inconclusive.



Sahred From Source link World News

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