PHARMACOKINETIC DIFFERENCES BETWEEN EAST ASIANS AND CAUCASIANS AND THE ROLE OF GENETIC POLYMORPHISMS
An increasing number of East Asian clinics at medical tourism destinations are offering affordable cellular therapies targeted at Western tourists. As the demand for unregulated therapies rises globally, many entities now provide cellular products sourced from locally harvested human tissues, the procurement and refinement processes of which are often unknown to both the provider and the recipient. These products can include human blood, fat, umbilical cord tissue, amniotic fluid, and even biowaste from abortions. These products are often claimed to align with current online medical trends. Terms such as Wharton’s jelly cells, mesenchymal cells, muse cells, embryonic cells, neural cells, and fresh cells have gained popularity and attention. A wave of misinformation has become the guiding light for many desperate patients seeking supposed stem cell miracles.
A common perception is that big pharmaceutical companies are villains suppressing stem cell treatments to protect their profits, and that medical tourism destinations are leading the charge. Cellular therapies are not the first treatments to undergo such unfortunate transformations; snake oil and many other unproven “belief” products have been marketed similarly in the past. While these therapies may seem harmless, akin to vitamin water, there are significant risks associated with receiving unknown human cells. The viability of these cells is often overlooked. Allogeneic human tissue transplants carry risks comparable to those of human organ transplants, yet many clinics that now label themselves as “labs” are able to conduct these transplants without the necessary hospital infrastructure or legal accountability. This represents a troubling time for stem cell research, where belief often outweighs scientific validity, and potential dangers remain unaddressed.
One serious concern is the interethnic variability in pharmacokinetics, which can lead to unexpected outcomes such as treatment failures, adverse effects, and toxicity in patients of different ethnic backgrounds receiving medical treatment. It’s essential to recognize that both genetic and environmental factors contribute to these differences among ethnic groups. The International Conference on Harmonization (ICH) has published guidance to facilitate the registration of pharmaceutical drugs within ICH regions (European Union, Japan, and the United States). This guidance recommends a framework for evaluating the impact of ethnic factors on a drug’s effects, efficacy, and safety at specific dosages and regimens. Such differences are crucial for international pharmaceutical and biopharmaceutical approval, as regulatory agencies must decide whether to accept results from clinical trials conducted in other parts of the world.
The attached publication titled “Differences in Drug Pharmacokinetics Between East Asians and Caucasians and the Role of Genetic Polymorphisms” highlights the challenges in biocompatibility that hinder accurate drug action and metabolic outcomes due to genetic factors separating these two populations. This is a well-known issue within the pharmaceutical industry, which complicates any reliable clinical trial activities aimed at Western pharmaceutical registrations. Meanwhile, cellular products classified as biological drugs (as per the US FDA) are often harvested from East Asian donors and administered to Caucasian subjects in unregulated settings across countries such as Thailand, China, Malaysia, Vietnam, Indonesia, etc. The long-term risks associated with these intergenetic transactions are well-documented in pharmacokinetics but have yet to be fully explored within the unregulated “stem cell” sector, forecasting safety concerns that are not currently being addressed.
References
Differences in Drug Pharmacokinetics Between East Asians and Caucasians and the Role of Genetic Polymorphisms. 08 March 2013. Kiman Kim, Julie A. Johnson, Hartmut Derendorf