Japan to scrap rule requiring testing of new drugs on Japanese
Japan to scrap rule requiring testing of new drugs on Japanese
Dropping slow process in early clinical trials would make medicines available sooner
Dropping slow process in early clinical trials would make medicines available sooner
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I know enough to believe this isn't a great idea.
Genetic variation in target populations can result in different outcomes for a variety of treatments and is worth testing specifically.
Is it, though?
How likely is it that there's a relevant outcome vs. how likely will the massively delayed introduction of a drug (or no introduction at all) harm someone?
It's not like Japanese are aliens.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2976712/
It's significant. Biggest effect is on efficacy of drug metabolism. There are many such studies.
One size does not fit all here owing to differences in expression of metabolising enzymes and drug transport mechanisms.
No, the Japanese are not aliens but they may require far less of a given drug than a westerner, or far more. This affects the likelihood to experience side effects for any given compound, and their severity.
It's fairly ironic to make this change for Japan whilst elsewhere in the world with more racially mixed populations there has been a push in the opposite direction: a recognition that you cannot assume the results of a trial carried out on white male subjects will apply to those of African descent for example.
It's not just drug treatments either. There are many aspects of medical care which have suffered from a lack of specificity and systemic bias.
Wouldn't Japan have decades of data to analyze, though? Comparison of the global vs Japanese trials, any detected differences once released, etc. It's not like they're making this decision blind.
It's significant, sure. But it might be better to let the companies bring the drugs in, and any skeptics can wait for any news if they choose.
If I recall, this lengthened the impact of covid because they delayed the vaccines.
Are Japanese people unique compared to other Asian peoples?