Research reveals widespread use of ineffective COVID-19 treatments after FDA deauthorized their use

Monoclonal antibodies are laboratory-designed treatments tailored to fight specific infections. In early 2021, the US Food and Drug Administration issued an emergency use authorization for two monoclonal antibodies (bamlanivimab/etesevimab and casirivimab/imdevimab) for the treatment of mild to moderate COVID-19 in patients non-hospitalized high-risk However, these treatments were shown not to work against the omicron variant of COVID-19, which emerged in the United States in December 2021 and was responsible for a record surge in COVID-19 in the winter of 2021-22. As a result of the reduced efficacy of monoclonal antibodies against the variant, the FDA disallowed their use in early January 2022.

In an article published in Open JAMA NetworkPhysician scientists at Beth Israel Deaconess Medical Center (BIDMC) evaluated the use of these two monoclonal antibodies for patients with COVID-19 before and after the FDA disapproval. The team noted that although the overall use of the two monoclonal antibodies gradually declined after the deauthorization, a large number of doses were administered to patients well into 2022. In total, more than 158,000 doses of monoclonal antibodies were administered, providing little or no benefit to patients and potentially contributing millions of dollars in costs. At this time, it is unknown if the FDA will take regulatory action against those who violate the guidance.

“Continued use of these treatments represents low-value care and may reflect conflicting guidance from state government or a lack of hospital awareness about undermining,” said lead author Timothy Anderson, MD, MAS, a leader in improving care. value of healthcare at the Center for Healthcare Delivery Science at BIDMC and an assistant professor of medicine at Harvard Medical School. “Although the FDA clearly stated that these treatments were no longer authorized for use, the FDA did not completely revoke their emergency use authorizations based on the possibility that they may work to treat future variants of COVID-19. This could have generated confusion and misunderstanding.”

Anderson and colleagues examined mandatory public reporting by hospitals to the US Department of Health and Human Services from October 2021 through June 2022. They found that, as of early 2022, hospitals administered more than 158,000 doses of unauthorized monoclonal antibody treatments bamlanivimab/etesevimab and casirivimab/imdevimab. The researchers also noted wide variability by state in the use of treatments after disavowal.

While the use of ineffective drugs declined steadily after the deauthorization, the proportion of COVID-19 cases for which unauthorized treatments were used did not peak until late March. Additionally, post-disavowal use varied widely by state, with Florida and New York accounting for 24% and 20% of monoclonal antibody use in 2022, respectively. Eleven states managed more than half of their remaining supply after disavowal, while 14 states used less than 10% of their remaining supply.

“We think these findings are quite surprising and indicate a need for the FDA to investigate the continued use of ineffective treatments for COVID-19,” said lead author Jennifer Stevens, MD, director of the Center for Healthcare Delivery Science in BIDMC and Associate Professor of Medicine at Harvard Medical School. “Efforts to improve transparency, fairness, and value in the COVID-19 response must include public facility-level reporting for all COVID-19 therapies. We hope our findings will generate increased attention and awareness.” more diligent regulation by health service providers Y governmental agencies prohibit the use of unauthorized treatments”.