Abstract
Excerpted From: Regina Ponder, A Protected Class, An Unprotected Condition, and a Biomarker--A Method/Formula for Increased Diversity in Clinical Trials for the African American Subject with Benign Ethnic Neutropenia (Ben), 49 American Journal of Law & Medicine 41 (2023) (140 Footnotes) (Full Document)
In April 2022, the Food and Drug Administration (FDA) released a guidance document entitled “FDA takes Important Steps to Increase Diversity in Trials,” which was met with widespread support. Public comments were received from more than sixty sources before the end of the comment period on June 12, 2022. Based on the public response to the guidance, interest in increasing diversity in clinical trials appeared to be gaining national momentum. Expanding on previous industry guidance relating to increased clinical trial diversity while honing more exacting treatments and “better ways to fight diseases that have often disproportionately impacted people of color is a topic [being] discussed by multidisciplinary health care experts across the nation.”
Given the unprecedented competing healthcare challenges on the 2022 midyear agenda, such as reproductive health legislation and the ongoing threats and complications of rapidly spreading communicable diseases, exposure to public announcements on increasing diversity within clinical trials could have been easily overshadowed. However, the crux of this writing is to draw attention to the subject, largely because it impacts AfricanAmericans, a demographic in the United States that is disproportionately distressed with health care disparities. Any glimpses of knowledge or medical discovery that could help to redress harm or reinforce a weakened familial-cultural infrastructure should be emphasized for sanative restoration of the impacted communities.
This Article focuses on the AfricanAmerican cohort and its nexus to Benign Ethnic Neutropenia, or “BEN.” BEN is clinically identified as an absolute blood neutrophil count (ANC) of< 1.5 G/L. More specifically, “BEN [is] defined as individuals of African ancestry with neutrophil counts<1500 cells/uL on at least two (2) laboratory tests, separated by at least 1 month, in the absence of infection (including negative testing for human immunodeficiency virus, hepatitis B or C, human T lymphotropic virus), nutritional deficiency, autoimmune disorders, or invasive cancer.” BEN seems to be gaining traction in the genomic and hematologic research spheres. Efforts to mitigate healthcare disparities require well-planned clinical studies with various racial and ethnic populations, involving pathophysiology and treatment responses. Where differences are observed among population groups, clinical trials focused on these subpopulations are required. In the author's opinion, BEN is one such difference that necessitates specific clinical focus.
This Article endeavors to convey a harmonized approach to the examination of (1) the AfricanAmerican BEN cohort within the context of basic scientific understanding, (2) the interplay of applicable governing regulatory protections, and (3) increased clinical trial participation. The Article's ultimate objective is to emphasize the need for increased diversity in clinical trials.
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In general, an adult who has fewer than 1,000 neutrophils in a microliter of blood have neutropenia. Fewer than 500 neutrophils in a microliter of blood, is called severe neutropenia. With this, even the bacteria normally living in a person's mouth, skin, and gut can cause serious infections.
However, from the standpoint of science, specifically neutrophil physiology, the absolute number of circulating neutrophils as measured in routine blood tests reflects a small number of the available pool of biologically active cells. Approximately half of the biologic pool of neutrophils outside the marrow are circulating; the other half marginate to vascular endothelium. Because of this, minor reductions in the neutrophil count should be of no clinical significance or cause for infection.
For the most part, normal ranges can vary by laboratory. The laboratory performing the test may include a reference range listed on the patient report.
Regina's career in the research industry began at the University of Arizona Health Sciences Center, Arizona Cancer Center in the mid-eighties. She has held numerous leadership positions through the years at various institutions in both academia and the biotech industry such as Dial Corporation, Arizona Heart Institute, Orthologic, Regenesis Biomedical, and the City of Hope. For the past several years, she has also served as an educator, currently instructing math and science students at the Arizona State University Preparatory Academy. Ms. Ponder has earned an Executive Juris Doctor and a Master in Health Law (L.L.M.) and is a strong advocate of culturally competent trials, diversity, and inclusion. She serves her community through participation with the National Coalition of 100 Black Women, Phoenix Metropolitan Chapter as a Vice President, and a former Chair of Public Policy. Email:
