Key Points:
- Treatment of COVID-19 with two monoclonal antibodies gained traction in early 2021.
- After the antibodies were deemed inefficient with the rise of the Omicron variant, the FDA deauthorized their use.
- Physicians, however, continued to use the antibodies, which proved wasteful and potentially cost states millions of dollars.
In an effort to combat COVID-19, the U.S. Food & Drug Administration (FDA) authorized the use of two monoclonal antibodies in early 2021. Monoclonal antibodies are synthetic proteins created to trigger an immune response to a specific infection. It was thought that the two antibodies authorized by the FDA—bamlanivimab/etesevimab and casirivimab/imdevimab—would make viral replication more difficult, thereby reducing COVID-19 cases.
But in late 2021, the highly transmissible Omicron variant become the predominant form of COVID-19 around the world. In the wake of escalating infection rates, doctors noted that treating Omicron variant cases with bamlanivimab/etesevimab and casirivimab/imdevimab was not effective. The FDA, therefore, deauthorized their use in January 2022.
Scientists at Beth Israel Deaconess Medical Center (BIDMC) launched a study to investigate how often doctors prescribed the antibodies after the FDA deauthorized their use. The study, published in JAMA Network Open, found that over 158,000 doses were given to patients after January 2022.
“Continued use of these treatments represents low value care and may reflect conflicting state government guidance or a lack of hospital awareness of deauthorization,” said Timothy Anderson, lead author of the study. He explained that the FDA did not explicitly ban the use of bamlanivimab/etesevimab and casirivimab/imdevimab, which may have contributed to ongoing treatments with them.
The BIDMC scientists observed that monoclonal antibody treatment rates in early 2022 differed from state to state. Treatments in Florida, for instance, were responsible for 24 percent of all cases. New York followed closely behind, with 20 percent of cases reported in that state. Eleven states administered more than half of their remaining supply after deauthorization, while 14 states used less than 10 percent of their remaining supply.
“We believe these findings are quite surprising and indicate a need for the FDA to investigate the continued use of treatments found to not be effective for COVID-19,” said Jennifer Stevens, co-lead author.
Stevens said she hopes for more effective government oversight to control the use of medications that have not been authorized by the FDA.