Skin tone can affect the effectiveness and safety of medicines

Skin pigmentation may function as a “sponge” for some drugs, potentially affecting the rate at which active drugs reach their intended targets, according to a paper published in the journal Human Genomics.

The researchers say that a significant portion of drugs and other substances can bind to the pigment melanin in the skin, which accounts for differences in the bioavailability and efficacy of these drugs and other substances in people with different skin tones.

“Our review article states that melanin, the pigment responsible for skin color, shows a surprising affinity for some drug compounds,” said Simon Groen, assistant professor of evolutionary systems biology at the Institute for Integrative Genome Biology at the University of California, Riverside, and co-author of the study. “The influence of melanin on drug safety and dosing has been largely overlooked, which calls into question the efficacy of standard dosing because skin tones vary considerably among people.”

Current regulatory guidelines for toxicity testing do not adequately consider the impact of skin pigmentation on drug interactions, the researchers said. Current practices in early drug development continue to focus mainly on testing drugs on Caucasians, especially those of Northern European descent.

In one experiment, researchers discovered nicotine’s affinity for skin pigments, which could affect smoking habits in people with different skin tones and call into question the effectiveness of nicotine patches applied to the skin for smoking cessation. Manufacturers are unwittingly preventing smokers with darker skin tones from using these patches effectively in their attempts to quit smoking.

Researchers therefore propose a new drug development process using three-dimensional models of human skin with different levels of pigmentation, which could provide pharmaceutical companies with an effective method for evaluating the drug binding properties of different skin types.

The medical community faces a monumental challenge that requires communication between scientists, researchers, clinicians and regulators. The future of medicine depends on the ability to bring these teams together.

Drug development must become, if not always personalized, then as inclusive as possible. And thanks to a new law passed in 2022 (Food and Drug Omnibus Reform Act), it will become mandatory in a few months to consider patient diversity in clinical and preclinical studies.

The researchers hope to encourage the pharmaceutical industry and the scientific community to start conducting systematic experimental evaluations in preclinical studies in relation to skin pigmentation patterns and drug kinetics.

They also encourage patients, their support groups, and clinical trial participants to ask questions related to origin-based drug efficacy and safety, such as: “Has this medication been tested to see if it is safe for people with different backgrounds, such as me?”. Clinicians and pharmaceutical company representatives should be prepared to provide an easy-to-understand document with the results of different trials, the researchers said.

“In terms of risk profile testing, drugs are most often tested on one or more human cell models, which are mostly from donors of Northern European origin,” the author tells the publication. “The drugs are then tested in rodent models. If these tests are successful, pharmaceutical companies bring the drug to clinical trials. But are drugs ready to be given to a heterogeneous group of patients if they haven’t first been tested, for example, on human cell models of different origins? Would you bungee jump off a bridge if you knew the ropes hadn’t been tested on your weight group? I don’t think so. So why is this now acceptable with respect to drugs?”

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Published: 16.10.2024

Updated: 16.10.2024

Medical author, Medical editor:

Stepan Yuk

Medical expert:

PhD. Olexandr Voznyak