Will FDA Forget Body Size Diversity in Clinical Trial Guidance?
FDA is working hard to push drug companies to get more diversity into the clinical trials that are the foundation for bringing new, safe, and effective drugs into the market. In June, the agency issued guidance for diversity action plans to improve the representation of marginalized populations. But unfortunately, it has nothing to say about body size diversity in this clinical trial guidance.
This is unfortunate because we know that obesity can have a big effect on how drugs work and safety problems they might have. The physiology of the body of a person with with obesity is different. It makes a difference for the safety and effectiveness of many drugs.
Gender, Racial, and Ethnic Diversity
For good reasons, racial and ethnic diversity is a key focus of the draft guidance. Too often, racial and ethnic minority groups, as well as women, have been underrepresented in clinical trials. Diverse populations may experience the same disease in very different ways. The historical bias for less inclusive trials has contributed to mistrust, critical gaps in medical knowledge, and disparities in the quality of medical care. More diversity in clinical trials is essential.
Representation of Real World Body Size Diversity
But merely requiring quotas for gender, racial, and ethnic diversity will not be adequate if clinical trials continue to screen out diversity in body size. Women, Hispanic, and Black people live with a much higher prevalence of obesity than White males. Fulfilling racial, ethnic, and gender quotas will not be very helpful if the people recruited do not represent the diverse body sizes of these populations. Recruiting only lean Black women into a clinical trial in no way ensures that the medial needs of a typical Black woman will be represented.
Obesity can have a profound effect on the safe and effective use of a drug. We know, for example, that the exclusion of persons with obesity from clinical trials of brexpiprazole in schizophrenia and depression means that dosing recommendations in the drug label will typically be subtherapeutic for someone with significant obesity.
In another instance, we know that posaconazole (an antifungal that interacts with a lot of other drugs) can take nearly twice as long to eliminate from a person’s body if they have significant obesity. But information on this extended half-life is nowhere to be found in the posaconazole drug labeling. Nowhere.
This is why the American College of Clinical Pharmacology has called for action to ensure better inclusion of people with obesity in clinical trials.
Implicit Bias for Neglect
Tolerating the historical exclusion of persons with obesity from clinical trials amounts to a perpetuation of weight bias that marginalizes people with obesity in medical care. We urge FDA not to make the mistake of forgetting the importance of body size diversity in clinical trial guidance.
You, too, can urge the FDA to pay attention to this issue by submitting your thoughts, however brief, to the FDA by this Thursday, September 26.
Click here for the FDA draft guidance, here to submit a comment. For further background, click here, here, here, here, and here.
Large Wooly Sheep, painting by Rosa Bonheur / WikiArt
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September 23, 2024
