This Tuesday the Food and Drugs Administration (FDA) prohibited the use of monoclonal antibody treatments, a popular therapeutic medicine that has been widely used by COVID-19 patients across the country. The decision, which was taken as the FDA argues the treatments are not effective against Omicron, has been heavily criticized by Governor DeSantis (R-FL), who has said this decision was taken “without a shred of clinical data.”
The two drugs in the middle of the controversy were first given emergency approval by the FDA back in November 2020 and the state of Florida made wide use of this new treatment for COVID-19 patients, with more than 130,000 doses being administered as of October 2021. The sunshine state was scheduled to open dozens of new antibody therapy treatment sites just a few days ago, but the FDA’s decision will force Florida to close them immediately.
According to the statement published by the FDA, “data shows these treatments are highly unlikely to be active against the Omicron variant” which is why the agency revoked the authorization for the use of these treatments “in any U.S. states, territories, jurisdictions at this time.” The FDA also said that they might reinstate the authorization in the future “if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments.” The omicron strain is the most prevalent in the country as, according to CDC estimates, it accounts for 99% of the new COVID cases in the country.
The federal government also argued that there are still many other therapeutic treatments that are projected to remain effective against the Omicron variant (Paxlovid, sotrovimab, remdesivir, and molnupiravir), and that health providers can still treat some patients with them.
Gov. DeSantis blasts the Federal government over the cancellation of antibody treatments
The decision has been heavily criticized by the governor of Florida and his administration. In a statement, the Governor’s office called the decision an “abrupt and unilateral decision” that will “prevent access to lifesaving treatment for Floridians and Americans.”
As a result of the FDA’s decision, the Florida Department of Health issued a statement confirming the state has closed all antibody monoclonal treatment sites as a result. However, the department also expressed its strong disagreement with the prohibition, saying “Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence. To date, such clinical evidence has not been provided by the United States Food and Drug Administration (FDA).”
DeSantis blasted the rationale for the FDA’s decision, saying that the Biden administration is “relying, to revoke this decision on a single, non-peer-reviewed, clinical study, that was actually done by a consultant from a rival company to the other two antibody monoclonal treatments.” He said that “even if with Omicron is half as effective or even 25% as effective, that is better than nothing” and lambasted the decision as “reckless.” The Republican Governor said that while the country is facing a series of major challenges at home and abroad, the Biden administration has decided to “pull the rug out of elderly patients” who have been relying in these treatments.
Florida’s Surgeon General Joseph A. Ladapo also criticized both the decision and the way it was made, tweeting out a letter he sent to the Department of Health and Human Services calling out their inability to provide transparent and timely information after Florida requested more antibody doses. According to Ladapo, the FDA “suspended without any warning the use of multiple MABs treatments. Such decisions should be made based on clinical data- which the FDA hasn’t provided.”
The author of one of the studies that discredits regeneron has competing financial interests
According to the NIH’s open Data portal on therapeutic treatments, there is only one study measuring the effectiveness of both drugs (REGEN-COV and bamlanivimab and etesevimab administered together) on the virus, which indeed concluded that the drug “showed an almost complete loss of neutralizing activity against B.1.1.529 (omicron).” However, as Gov. DeSantis pointed out, this particular study had yet to be peer-reviewed, and the site where it was published clearly displays a warning that the paper has “not been formally peer-reviewed and should not guide health-related behavior or be reported in the press as conclusive.”
Furthermore, as the governor claimed, the preliminary study did clearly laid out a “competing interest statement” as one of the main researchers of the trial is a consultant (among other companies) for Vir Biotechnology, which developed an alternative antibody treatment that competes against REGEN-COV, this treatment (called sotrovimab) is one of those the FDA does deem to be effective against the Omicron variant.
To the FDA’s credit, there is an additional study measuring the effectiveness of REGEN-COV on a partial pseudo-virus, which shows the treatment is ineffective against the Omicron variant. That non-peer-reviewed paper is not authored by academics with competing financial interests.
Interestingly, the NIH open portal does not show a single study proving or disproving the effectiveness of paxlovi on the Omicron strain. A very curious fact, as the FDA quoted the antiviral treatment as one of those that look to be effective against Omicron. There are only two studies available on the effectiveness of Molnupiravir (one saying its effectiveness is mildly affected and the other saying it doesn’t), while there are four studies that do show Remdesivir and sotrovimab remain more or less effective against the new mutation.
According to the documents that are accessible to the public, the FDA did decide to revoke the authorization of two treatments based on a single, non-peer-reviewed study. While at the same time proposing an alternative treatment as effective without any scientific paper proving or disproving that diagnosis.
This does not mean the FDA does not have additional scientific documentation proving their assertions. However, the agency did not produce those documents in the statement released to the public, and the NIH’s COVID-19 treatment guidelines dataset does not include any additional clinical trial.