National Public Radio (NPR) reviewed the end of the outpatient use of monoclonal antibodies to combat SARS 2 Coronavirus (COVID last week. These synthetically produced antibodies were infused into patients infected with COVID and were at high risk to develop severe disease requiring hospitalization or death. It cost about 200 million dollars to invent, develop and then use the drug in trials to gain FDA approval for human usage. Drug manufacturers were willing to take the risk developing these products because the US government financially guaranteed their purchase.
The antibodies were synthetic Y shaped molecules which bound to the viruses spike protein rendering it incapable of invading human cells and alerting our own immune system that the virus was present facilitating the virus’s destruction. Over time, the virus learned to mutate and evade a particular monoclonal antibody rendering it ineffective. When 30% or more of the new COVID variants in a region became able to resist the monoclonal antibody, the CDC and FDA withdrew the product. Drug manufacturers continued to develop new monoclonals due to the Federal guarantee of purchase.
Bebtelivimab was the last product that worked well against COVID and on Monday, November 21, 2022 it was withdrawn as well. The Federal government stopped guaranteeing purchase of these products so drug manufacturers have now discontinued their expensive development.
Let me explain how this impacts my patients locally. Baptist Health BOCA Raton Regional Hospital had a robust outpatient monoclonal antibody program. I phoned or text messaged Lisa, the nurse practitioner program director the patient name , demographics and reason for participation and she scheduled and her team administered the drug within the seven day window required. No one became ill from the infusions. No one had to stop their usual medications due to drug drug interactions. No one progressed to severe disease requiring hospitalization and no one died. I referred at least 100 high risk patients including myself in the last 2.5 years and now that weapon is gone. No one treated cleared the virus and then had a rebound recurrent period of sickness.
So we are now left with Paxlovid and Lagevrio oral pills. One has multiple drug interactions with so many of the common medications the high risk population takes daily for cardiac, renal , diabetic and mental health it requires cessation or a reduction in dosage. The other is just not that effective. Patients taking these drugs also at times clear the virus then several days later have a mild rebound of symptoms and are contagious for a few days more.
We head into winter with an aggressive flu bug, respiratory syncytial virus in epidemic proportions and one less successful weapon against COVID-19. As I reflect on this past Thanksgiving holiday, I am grateful for the BRRH monoclonal antibody team and everyone connected with its development. I wonder what our elected Congressional officials were thinking when they stopped funding the development of these effective and safe, but expensive, products?
Filed under: Baby Boomers, Best Doctor, Board Certified, Boca Raton, Boca Raton Regional Hospital, Broward County, Center for Disease Control and Prevention, Concierge Medicine, Concierge Physician, Coronavirus, COVID-19, Elderly, FDA, Geriatrics, Internal Medicine, Senior Citizens, South Palm Beach County | Tagged: Bebtelivimab, Lagevrio, Paxlovid | Leave a comment »