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Don Mosier, MD, PhD

One of the tragedies of the federal response to the COVID-19 pandemic has been the erosion of trust in two of the most important organizations, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Advice from both agencies has been undercut by political meddling and mixed messaging from the current administration. We knew six months ago that the virus could be spread by aerosols, but the CDC said no, then yes, then no again, and just this month, yes again.

The latest fiasco is the virus-infected President saying that the Regeneron antibody cocktail he received was “curative” and urging the FDA to waive full review and grant emergency authorization for its widespread use. We know that the President received the antiviral drug Remdesivir and steroids in addition to the antibody treatment, and we do not know enough about his viral load to reach any conclusions about which of the treatments was effective. Nonetheless, the FDA is once again under pressure to fast track a treatment when clinical studies are incomplete.

Regeneron released preliminary results of its early trials in a press release (not a peer-reviewed scientific article) on September 29th. The product tested consists of two proteins that recognize different sites on the viral spike protein needed for initial infection and ideally block that infection. Volunteers who were in early stages of infection prior to generation of their own antibodies and who had high viral loads showed the most benefit from the treatment with a more rapid resolution of symptoms than placebo controls. However, because of the small number of volunteers in these subgroups, these improved outcomes were not statistically significant. This means that the results in the treated versus placebo group did not reach the 95% level of certainty that is the widely accepted standard for a significant difference. Reductions in viral loads after 7 days of treatment were significant, so the antibody treatment holds promise if future larger studies confirm these findings.

If we can’t trust the CDC and the FDA to inform and protect us, who can we trust? Dr. Fauci has been as candid and truthful as possible, but he has been absent from the COVID Task Force for many weeks. Dr. Deborah Birx is reported to be sidelined and ready to resign. We need to be patient and wait for solid, peer-review studies published in the scientific literature to make important decisions about potential treatments and vaccines. Operation Warp Speed just accelerates the probability of premature and potentially dangerous decisions for all of us. To paraphrase what Senator Kamala Harris said on October 7th, if Dr. Fauci says a vaccine is good, I will be the first in line to take it. If Donald Trump says it, no way.



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