The Arizona Attorney General’s Office recently submitted a petition to the U.S. Department of Health and Human Services requesting the agency immediately adopt a rule prohibiting the allocation of COVID-19 medical therapies based on race or ethnicity.
Such a rule would ensure the Food and Drug Administration does not violate the Equal Protection Clause of the 14th Amendment or the Arizona Civil Rights Act when providing guidance for allocating lifesaving treatments such as a monoclonal antibodies.
Support for the rule among lawmakers and medical professional comes after the FDA updated its mAb guidance in December, noting that “race or ethnicity” should be considered as an independent risk factor for the allocation of scarce COVID-19 monoclonal antibody treatments (mAb).
Such treatments are administered via an intravenous infusion to those who test positive for COVID-19 and who are considered at high risk for developing serious symptoms even though they are not hospitalized at the time.
The FDA’s updated guidance was issued when news broke that only one of the three mAbs approved for treating COVID-19 patients -Sotrovimab- appears to retain its efficacy against the Omicron variant. As a result, demand for Sotrovimab, which is sold in the U.S. as Xevudy, has skyrocketed in the last several weeks.
In its guidance, the FDA stated that Sotrovimab can be prioritized toward patients whose race or ethnicity may place them “at high risk for progression to severe COVID-19.” The problem, according to many health care workers, is that the FDA’s inclusion of non-medical racial or ethnic factors in the assessment process leads to discrimination in who gets the potentially life-saving treatment.
Here is how it happens, according to the administrator of one Arizona hospital:
Three male neighbors -one identified on medical records as White, one as Black, and one as Hispanic- who are of the same age, physical characteristics, medical history, and symptom status are assessed for a monoclonal antibody infusion. The White patient would likely end up at the bottom of the list due to factoring in assumed potential health risks to the other two men.
It is not only mAbs for which non-medical considerations could come into play for who receives a treatment before someone else. There is also a low supply in many states of oral antiviral medications which target specific parts of the COVID-19 virus to help reduce its multiplication and spread.
The guidance put forth by federal public health officials also provides for consideration of race and ethnicity in how the medication is allocated to community health organizations.
But the race / ethnicity issue has not only come under criticism on an ethical basis.
Some legal experts warn that prescribing doctors, hospitals, and infusion centers could be held liable for discrimination in basing treatment decisions on non-medical considerations. Those concerns are also addressed by the attorney general’s office to federal public health officials, who are called on to ensure all Arizonans are treated equally in the distribution of COVID-19 treatments.
Anyone who believes they or a family member has been the victim of such discrimination at any medical facility or pharmacy is able to file an online civil rights complaint with the Arizona Attorney General’s Office via https://www.azag.gov/complaints/civil-rights
MORE ABOUT MONOCLONAL ANTIBODY TREATMENTS HERE