An excerpt:
Personalized drug therapy uses biological indicators, or “biomarkers”—such as DNA sequences or the presence or absence of drug receptors—as a marker of how patients should be treated and to estimate the likelihood that the intervention will be effective. This concept is not new. It has been known for decades, for example, that persons genetically deficient in an enzyme called G6PD can experience severe and precipitous anemia if they are exposed to certain drugs.We have increasing ability to take advantage of new technology to create personalized therapies. However, our current regulatory scheme (and the various ObamaCare provisions) will push doctors into more "one size fits all" treatment protocols.
Similarly, various ethnic groups and individuals have widely varying abilities to clear medications from the bloodstream because of differences in the activity of the enzymes that metabolize, or degrade, drugs. For that reason, drug safety and efficacy are affected by variants of genes coding for the enzymes that metabolize chemical compounds; one genetic locus, for example, is responsible for the enzymes that degrade as many as 20 percent of commonly prescribed drugs; in the population, there are a large number of variants of this gene, some of which only poorly metabolize the enzymes’ substrates.
This is important because low metabolizers clear certain drugs slowly and have more medication in their blood for longer periods of time than high metabolizers. Thus, the former might be prone to overdose, and the latter to insufficient levels of the same drug...
Whether the pace of technological progress will stay ahead of the regulatory "drag" is still an open question.
