Who Is In Your Clinical Trial?

Yesterday, I was interviewed about the medical mistrust among the African-American community concerning the COVID-19 vaccine.  Mr. Hoggard had interviewed me earlier in the summer about a study on North Carolina’s sterilization program.

Like many, the COVID-19 vaccine has been on my mind, but probably for different reasons.

Last semester, I taught quantitative methods to doctoral students at the L. Douglas Wilder School of Government and Public Affairs. One of my students, Anna, wrote about how people who misuse drugs and alcohol are seldomly selected to participate in clinical trials. She noted that this group is a significant portion of the population and often have other comorbidities, diseases, and syndromes.

Anna and I are both concerned about the inclusion of marginalized populations in clinical trials for similar reasons.  Namely, how do you know if the drug will be effective for marginalized people?

A population that I am concerned about are those with sickle cell disease (SCD).  According to the Center for Disease Control (CDC), sickle cell disease is widespread among those with ancestry from sub-Saharan Africa; Spanish-speaking regions of South America, the Caribbean, and Central America; Saudi Arabia; India; and Turkey, Greece, and Italy.

The CDC estimates that:

  • SCD affects approximately 100,000 Americans.
  • SCD occurs among about 1 out of every 365 Black or African-American births.
  • SCD occurs among about 1 out of every 16,300 Hispanic-American births.
  • About 1 in 13 Black or African-American babies is born with sickle cell trait (SCT).

Although sex-disaggregated data are not available for sickle cell disease, according to the Office on Women’s Health, older women with sickle cell have more chronic pain than younger women. Older women may also have more organ and tissue damage.

Some common complications for older women are:

  • Pulmonary hypertension, or high blood pressure in the lungs
  • Chronic kidney disease
  • High levels of iron in the blood because of many blood transfusions in the past. High levels of iron can cause liver disease, heart problems, organ failure, and cancer.
  • Leg ulcers or open sores
  • Blood clots in the legs or lungs

Additionally, people with sickle cell disease who contract the coronavirus have higher rates of hospitalization and death.   Therefore, older women with sickle cell have a high risk of death from COVID-19.

Mr. Hoggard asked if I thought Black women would take the vaccine.  I told him I thought education and class would influence Black women’s decision to take the vaccine.

Although he asked about Black women, women who are front-line workers are more likely to be low-wage workers with families dependent on their income; therefore, I expect these women to take the vaccine.  I also expect women in households with vulnerable workers to contracting COVID-19 to take the vaccine.

Until the vaccine proves to be effective and safe for populations with a history of medical neglect, I expect highly educated women from these communities who have a low risk of contracting COVID-19 not to take the vaccine.

Mr. Hoggard asked if I thought we would ever get beyond the history of medical mistrust.  I do.  But first, the medical profession must treat all patients, especially those from poor and vulnerable populations, as if their life matters.

Be well this holiday season.