Lack of access to medicines produces a cascade of anguish and suffering, from no relief for a child’s terrible earache to mothers bleeding to death during childbirth to deaths from diseases that may be simply and cheaply prevented or healed. One inequity that can be quantified is a lack of access to medicines, which can be assessed using a starkly visible yardstick: the number of unnecessary deaths.
Pharmacologists explain the biological causes of variances in how well different medications perform in different populations. She also lays out a four-part plan to increase drug development equity.
Pharmacologist Namandje Bumpus, Ph.D., who recently became the first African American woman to head a Johns Hopkins University School of Medicine department and is the only African American woman leading a pharmacology department in the country, outlines the molecular origins of differences in how well certain drugs work among different populations in a new perspective piece published in the issue of Science. She also lays out a four-part plan to increase drug development equity.
“We are more alike than we are different,” explains Bumpus. “However, even minor variances in our genetic makeup can have a significant impact on how well medications work in our bodies. This is not a novel concept.”
Genetic variants may be more common in some ethnic groups than others, and as a supporter of diversity in science, Bumpus believes that these differences make it even more important to increase diversity in clinical trials of new drugs and therapies. Despite this, many clinical trials continue to be conducted with a lack of diverse participation, potentially contributing to poor outcomes for people of color and a lack of access to developing medicines.
We are more alike than we are different. However, even minor variances in our genetic makeup can have a significant impact on how well medications work in our bodies. This is not a novel concept.Namandje Bumpus
Some current medications, such as warfarin, which is used to thin the blood, have been found to be less successful in people of African descent; and, according to earlier studies, one out of every five new treatments approved by the FDA revealed disparities in effectiveness among ethnic groups.
As new treatments and vaccines bring us closer to a critical turning point in a pandemic that has disproportionately affected people of color, the need for better diversity standards in clinical trials is greater than ever, according to Bumpus, the E.K. Marshall and Thomas H. Maren Professor and Director of the Department of Pharmacology and Molecular Sciences at Johns Hopkins University School of Medicine.
However, she says, just increasing the number of underrepresented minorities in clinical trials will not alleviate the systemic issues.
Bumpus’ framework for better drug development consists of four parts: laboratory research using cellular and animal models to study genetic variability; better hiring practices to diversify the scientific workforce; diversity reporting requirements for funding agencies; and diversity reporting requirements on clinical trial demographics in articles published in scientific journals.
Efforts to expand access to medications are motivated by a strong ethical obligation. People should not be denied access to life-saving or health-promoting interventions for arbitrary grounds, including economic or social ones. Millions of children dying each year from diseases that could have been avoided or treated with existing medical solutions would be inconceivable in a fair and just world.
According to Bumpus, imposing diversity guidelines that demand diversity among clinical trial participants and in research design would assure responsibility – and scientific journals would boost transparency for their audiences. Bumpus advocates for more diverse employment practices at research institutes, biotechnology businesses, and pharmaceutical corporations. She believes that a varied workforce fosters diversity of thought and increases the possibility that researchers will be more sensitive to incorporating genetic variation into their findings.
She mentions that animal models can be genetically altered to reflect ethnic differences, thereby improving “predictability of treatment outcomes and providing a molecular underpinning for comprehending discrepancies.”
Genetic differences associated with drug response are frequently linked to the cytochromes P450 enzyme family, which is essential for drug metabolism. In humans, this enzyme family is responsible for the breakdown of over 75% of clinically accessible medications.
Even so, tiny genetic changes can affect the enzyme in people, and certain gene variants are more common in certain ethnic groups. Because the changed enzyme may impact how drugs are absorbed and used by the body, what works for one person may be ineffective or dangerous for another.
Because the majority of clinical studies for these medications comprised persons of European ancestry and few people of African ancestry, discrepancies in treatment effectiveness are frequently unknown. According to Bumpus, the framework may drive the drug research industry to take steps toward a future in which “treatments are most likely to work for all people” and “current health inequities are not exacerbated further.”