A therapist outlines a plan to improve the balance of drug development

In a new scene published in the February 5 issue of Science, pharmacist Namandje Bumpus, Ph.D. – who recently became the first African American woman to head the Johns Hopkins University School of Medicine department, and is the only African American woman to lead a medicine department in the country – describes the molecular origins for differences in how well certain drugs work among specific populations. It also sets out a four-part plan to improve the balance of drug development.

Mankind is more like us than we are different. However, the slightest changes in our genetic material can cause big differences in how well drugs work in our bodies. This is not a new idea. “

Namandje Bumpus, Ph.D. Pharmacologist, Johns Hopkins University School of Medicine

Genetic changes may be more likely to occur in some ethnic groups compared to others, and, as a proponent of diversity in science, Bumpus claims that these differences make it even greater. important to increase diversity in clinical trials of new drugs and treatments. However, many clinical trials persist in the absence of mixed participation, which can lead to adverse outcomes for people with color and reduced access to new treatments.

Some medicines available today, such as warfarin, which is used for blood thinning, have been found to be less effective in people of African descent; and, according to previous studies, one in five FDA-approved new drugs showed differences in efficacy across ethnic groups.

Now, as new treatments and vaccines push us toward an emergency turning point in a pandemic that has had an adverse effect on humans, the need for better standards for diversity in larger clinical trials than ever, said Bumpus, EK Marshall and Thomas H. Maren Professor and Director of the Department of Pharmacology and Molecular Sciences at Johns Hopkins University School of Medicine.

But simply increasing the number of underrepresented minorities in clinical trials is not enough to solve the systemic problems, she said.

Bumpus ’framework for improved drug development includes a four-part plan including laboratory study of cell and animal models to study genetic variability; better recruitment practices to diversify scientific staff; diversity requirements for funding bodies; and diversity reporting requirements on clinical trial demographics in articles published in scientific journals.

By implementing diversity requirements that seek diversity among clinical trial participants and in study design, funding bodies would ensure accountability – and scientific journals would increase visibility to their audience , said Bumpus. At the level of research institutes, biotechnology and pharmaceutical companies, Bumpus advocates for hiring practices to build a more diverse workforce. With a diverse workforce comes diversity in thinking, she said, with a higher likelihood that researchers will be better able to incorporate genetic variation into their study.

She notes that animal models can be genetically engineered to reflect the changes that occur across ethnic groups, perhaps to “strengthen the prediction of drug outcomes and provide a mechanical basis. over to understand inequalities. “

Genetic differences associated with drug response are often associated with a family of enzymes that are essential for drug metabolism, known as P450 cytochromes. This family of enzymes in humans processes approximately 75% of clinically available drugs.

However, subtle genetic differences can alter the enzyme in humans and some gene mutations are more common in certain ethnic groups. The altered enzyme may affect how medicines are processed and used by the body, so that what works for one person may be ineffective or toxic to another.

Since most clinical trials of these drugs involved people of European descent and very few people of African descent, differences in drug efficacy are often not immediately recognizable.

Bumpus says the framework could lead the drug development sector to take steps towards a future where “treatments are more likely to work for all” and “the Existing health differences exacerbated. “