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A recent study published in Human Genomics sheds light on how skin pigmentation may influence the effectiveness of medications. Researchers Simon Groen, Assistant Professor of Evolutionary Systems Biology at UC Riverside, and Sophie Zaaijer, a DEI expert in preclinical research, suggest that melanin, the pigment responsible for skin color, could act as a “sponge” for certain drugs. This binding could affect the speed and efficacy with which medications reach their intended targets in the body, particularly for individuals with darker skin tones.
The researchers point out that many drugs and compounds have a strong affinity for melanin, leading to variations in how drugs are metabolized. This raises concerns about the efficacy of standard drug dosing protocols, which often do not account for differences in skin tone.
“Melanin’s interaction with drug compounds has been largely overlooked,” said Groen. “This oversight may lead to disparities in drug safety and efficacy across different populations, particularly since skin tone varies widely among individuals.”
Diverse Clinical Trials and FDA Guidelines
One of the key issues highlighted in the study is the lack of diversity in early-stage drug testing. Zaaijer noted that many clinical trials and preclinical studies are conducted primarily on populations of Northern European descent, which may not represent the broader global population. The U.S. Food and Drug Administration (FDA) has made efforts to increase diversity in clinical trials through its Diversity Action Plan, but current toxicity testing guidelines still fail to adequately consider the impact of skin pigmentation on drug interactions.
The study provides an example involving nicotine, which has been shown to bind to melanin. This could potentially affect the efficacy of nicotine patches, raising questions about whether smokers with darker skin tones may be at a disadvantage when using this method for smoking cessation.
A Call for Change in Drug Development
Groen and Zaaijer propose a new workflow that uses human 3D skin models with varying pigmentation levels to assess drug binding properties across different skin types. This approach could help pharmaceutical companies ensure that drugs are safe and effective for individuals with diverse skin tones.
“Skin pigmentation should be considered as a factor in safety and dosing estimates,” said Zaaijer. “The biomedical industry must embrace inclusivity, not just in clinical trials but also in early-stage drug development.”
In addition to skin pigmentation, the researchers highlight the importance of considering genetic variations among minority groups, which can lead to different drug responses across races and ethnicities. According to their findings, up to 20% of medications may be affected by these variations.
Towards a More Inclusive Future
The researchers are hopeful that changes in drug development are on the horizon. The FDA’s draft guidelines, mandated by the 2022 Food and Drug Omnibus Reform Act, are expected to include considerations for patient diversity in clinical trials and preclinical research. However, much work remains to be done to ensure that all populations are represented in drug testing.
“The future of medicine depends on our ability to create a more inclusive drug development process,” said Zaaijer. “This will require collaboration between academics, industry researchers, clinicians, and regulators to ensure that diverse groups of patients can trust the drugs they are prescribed.”
The researchers encourage patients and their advocacy groups to ask whether drugs have been tested for safety and efficacy across different ancestral backgrounds. Clinicians and pharmaceutical representatives should be able to provide clear, accessible information on the results of these tests.
As the biomedical industry moves towards more inclusive practices, there is hope that medications will become safer and more effective for people of all skin tones and genetic backgrounds.
