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If you want to know if a new drug or therapy is going to work in the people it affects the most you need to test the drug or therapy in the people most affected by the disease. That would seem blindingly obvious, wouldn’t it? Apparently not.
Case in point. A new asthma medication, one that seemingly shows real promise in reducing attacks in children, was tested on an almost entirely white patient population, even though Black and Puerto Rican children are far more likely to suffer from asthma.
The study enrolled more than 400 children, between the ages of 6 and 11, with moderate to serious uncontrolled asthma and treated them with a medication called Dupixent. The results, published in the New England Journal of Medicine, were impressive. Children given Dupixent had an average drop in severe asthma attacks of 65 percent compared to children given a placebo.
The only problem is 90 percent of the children in the study were white. Why is that a problem? Because, according to the Asthma and Allergy Foundation of America, only 9.5 percent of white children have asthma, compared to 24 percent of Puerto Rican children and 18 percent of Black children. So, the groups most likely to suffer from the disease were disproportionately excluded from a study about a treatment for the disease.
Some people might think, “So what! If the medication works for one kid it will work for another, what does race have to do with it?” Quite a lot actually.
A study in the Journal of Allergy and Clinical Immunology concluded that: “Race/ethnicity modified the association between total IgE (an antibody in the blood that is a marker for asthma) and asthma exacerbations. Elevated IgE level was associated with worse asthma outcomes in Puerto Ricans… Our findings suggest that eligibility for asthma biologic therapies differs across pediatric racial/ethnic populations.”
The article concluded by calling for “more studies in diverse populations for equitable treatment of minority patients with asthma.” Something that clearly didn’t happen in the Dupixent study.
While that’s more than disappointing, it’s not surprising. A recent study of vaccine clinical trials in JAMA Network Open found that:
- Overall, white individuals made up almost 80 percent of people enrolled.
- Black individuals were represented only 10.6 percent of the time.
- Latino participants were represented just 11.6 percent of the time.
Additionally, in pediatric trials, Black participants were represented just over 10 percent of the time and Latino participants were represented 22.5 percent of the time. The study concluded by saying that “diversity enrollment targets are needed for vaccine trials in the US.”
I would expand on that, saying they are needed for all clinical trials. That’s one of the many reasons why we at the California Institute for Regenerative Medicine (CIRM) are making Diversity, Equity and Inclusion an important part of everything we do, such as requiring all applicants to have a written DEI plan if they want funding from us. Dr. Maria Millan, our President and CEO, recently co-authored an article in Nature Cell Biology, driving home the need for greater diversity in basic science and research in general.
DEI has become an important part of the conversation this past year. But the Dupixent trial shows that if we are truly serious about making it part of what we do, we have to stop talking and start acting.
2 thoughts on “Lack of diversity leaves cloud hanging over asthma drug study”
Different races have different cultures, diets and lifestyle of living. Different types of diets and activities influence development and behavior of cells. Hence, tissues, organs and immune system response differently to the new drugs. Different races have different requirement of dosage, schedule and route of drug administration for treatment. Drug development of one clinical trial of one race can be taken as reference for other race to study the safety and efficacy of medicine . In some circumstances, there is possibility for all races show similar response and endpoint results of clinical trials on the new drug. Thus, the health and well being of patients are very depended on the effectiveness of dosage, schedule and route of drug administration for treatment.
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