Analysis reveals administration of ineffective COVID-19 therapies after FDA deauthorization

Monoclonal antibodies are laboratory-designed therapies tailored to combat particular infections. In early 2021, the U.S. Meals & Drug Administration issued emergency use authorization for 2 monoclonal antibodies (bamlanivimab/etesevimab and casirivimab/imdevimab) for the remedy of delicate to average COVID-19 in high-risk, non-hospitalized sufferers. Nonetheless, these therapies had been proven to not work in opposition to the Omicron variant of COVID-19, which emerged in the USA in December 2021 and was accountable for a record-breaking COVID-19 surge within the winter of 2021-22. Because of the monoclonal antibodies’ diminished efficacy in opposition to the variant, the FDA deauthorized their use in early January 2022.

In a paper printed in JAMA Community Open, physician-scientists at Beth Israel Deaconess Medical Middle (BIDMC) assessed using these two monoclonal antibodies for sufferers with COVID-19 earlier than and after FDA deauthorization. The staff noticed that although total use of the 2 monoclonal antibodies declined progressively following deauthorization, a lot of doses had been administered to sufferers nicely into 2022. Altogether, over 158,000 doses of monoclonal antibodies had been administered, offering little to no profit to sufferers and probably contributing hundreds of thousands of {dollars} in prices. Whether or not the FDA will take regulatory motion in opposition to these violating steerage stays unknown at the moment.

“Continued use of those therapies represents low worth care and should replicate conflicting state authorities steerage or an absence of hospital consciousness of deauthorization,” stated lead creator Timothy Anderson, MD, MAS, Lead for Enhancing Worth in Healthcare at Middle for Healthcare Supply Science at BIDMC and assistant professor of medication at Harvard Medical College. “Although the FDA clearly acknowledged these therapies had been not approved to be used, the FDA didn’t absolutely revoke their emergency use authorizations based mostly on the chance that they could work to deal with future COVID-19 variants. This might have led to confusion and misinterpretation.”

Anderson and colleagues examined necessary public reporting by hospitals to the U.S. Division of Well being and Human Companies from October 2021 to June 2022. They noticed that in early 2022, hospitals administered greater than 158,000 doses of the deauthorized monoclonal antibody therapies bamlanivimab/etesevimab and casirivimab/imdevimab. The researchers additionally noticed broad variability by state within the therapies’ use following deauthorization.

Whereas use of the ineffective drugs steadily declined after deauthorization, the proportion of COVID-19 instances for which the unauthorized therapies had been used didn’t peak till late March. Furthermore, utilization following deauthorization diversified broadly by state, with Florida and New York accounting for twenty-four p.c and 20 p.c of monoclonal antibody use in 2022 respectively. Eleven states administered greater than half of their remaining provide after deauthorization, whereas 14 states used lower than 10 p.c of their remaining provide.

We consider these findings are fairly stunning and point out a necessity for the FDA to research the continued use of therapies discovered to not be efficient for COVID-19. Efforts to enhance transparency, fairness and worth within the COVID-19 response ought to embrace public facility-level reporting for all COVID-19 therapies. We hope that our findings will result in larger consideration and extra diligent regulation by well being care suppliers and authorities companies to ban using unauthorized therapies.”

Jennifer Stevens, MD, senior creator, director of the Middle for Healthcare Supply Science at BIDMC and affiliate professor of medication at Harvard Medical College