FDA wants race, ethnicity factored in administering COVID drugs

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FDA wants race, ethnicity factored in administering COVID drugs

The Food and Drug Administration is urging healthcare providers to consider race or ethnicity as well as underlying medical conditions when classifying individuals as “high risk for progression to severe COVID-19″ and qualifying for antibody treatment. 

A fact sheet issued by the agency detailing the Emergency Use Authorization of the drug sotrovimab for treatment of mild-to-moderate COVID-19 cases includes a list of medical conditions that may qualify patients for the treatment.

Those conditions include advanced age (65 or older), obesity, pregnancy, diabetes, cardiovascular disease, chronic lung disease, and neurodevelopmental disorders.

The document, which was last updated in December, also notes that “[o]ther medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19.”

Registered Nurse Salah Hadwan, right, infuses patient Rebecca Ivey, 54, of Battle Creek with monoclonal antibody treatment
The FDA wants to consider race or ethnicity when classifying individuals as qualifying for antibody treatment.
© Kimberly P. Mitchell/Detroit Free Press/TNS via ZUMA Press Wire

As the treatment is specified as being for mild-to-moderate cases, it is not authorized for patients who are hospitalized because of COVID-19, require oxygen therapy due the virus, or require an increase in oxygen flow.

Similar advisories have been administered in states like New York and Utah. 

A recent notice from the New York State Department of Health detailing the criteria for individuals to receive oral antiviral treatment stipulated that “non-white race or Hispanic/Latino ethnicity should be considered a risk factor” due to systemic health and social inequities which have “contributed to an increased risk of severe illness and death from COVID-19.” 

A monoclonal antibody treatment called Sotrovimab is proving to be effective against the omicron variant
A monoclonal antibody treatment called Sotrovimab is proving to be effective against the Omicron variant.
GSK/Vir Biotechnology

While race is accounted for in prioritization of patients, New Yorkers must also meet age requirements, test positive for COVID-19 through a specific test, have mild-to-moderate symptoms, cannot be hospitalized due to the virus and must be able to start treatment within five days. 

In Utah, health officials are using a point system to determine which individuals should receive monoclonal antibody treatment for the coronavirus. 

When calculating the “risk score,” the state awards two points to patients who are of “Non-White race or Hispanic/Latinx ethnicity.” The same number of points is given to patients who have “Highest-Risk Comorbidities” like obesity.

The Food and Drug Administration is urging healthcare providers to factor in race or ethnicity, as well as other medical conditions, when placing individuals as “high risk for progression to severe COVID-19,”
The high-risk conditions include advanced age, obesity, pregnancy, diabetes, cardiovascular disease, chronic lung disease, and neurodevelopmental disorders.
FDA

“Risk factors for hospitalization and mortality are now well-recognized and include age, cumulative comorbidities, male gender, shortness of breath, and importantly, but for reasons not well-understood, non-white race/ethnicity,” read state guidelines on the standards of care of monoclonal antibody treatment

However, Utah has also provided “ethical justification” for its patient selection. 

“Utah Data from more than one hundred thousand patients with COVID-19 confirms that even after controlling for age and comorbidities, Utahns who identify from communities of color have a significantly higher risk of severe disease requiring hospitalization,” the guidelines read. “Public health interventions may be used to attempt to mitigate these disparities in COVID-19 by recognizing the structural inequities that underlie them. One way to do this is to include race/ethnicity in the patient selection criteria.”

Minnesota health officials have also urged healthcare providers to “consider heightened risk of progression to severe COVID-19 associated with race and ethnicity when determining eligibility” for monoclonal antibody treatment of COVID-19.

Rebecca Ivey, 54, of Battle Creek hangs her arm out the window while she receives monoclonal antibody treatment at Wayne Health Detroit Mack Health Center in Detroit, Michigan on Dec. 10, 2021.
The treatment is specified as being for mild-to-moderate cases.
© Kimberly P. Mitchell/Detroit Free Press/TNS via ZUMA Press Wire

“[D]ata show elevated risk of poor COVID-19 outcomes for Black, Indigenous and other people of color (BIPOC populations), and … this risk cannot be adequately addressed by determining eligibility based on underlying health conditions (perhaps due to underdiagnosis of health conditions that elevate risk of poor COVID-19 outcomes in these populations),” guidelines from the Minnesota Department of Health read

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