Personalized medicine has finally arrived and is poised to deliver significant health improvement and healthcare cost savings. With respect to drug therapy, genetic differences between us can now be easily measured in terms of our ability to break down or metabolize drugs, our ability to ‘ferry boat’ drugs across the gut or brain, or the differences in our targets of the drugs themselves inside our bodies. It is those differences that can make a large difference in beneficial effects, safety or both.
Most pharmaceutical companies today have ramped up their drug development programs to include studies of genetics and drug response, while the FDA has provided a regulatory pathway for the approval of drugs with their companion tests.
The two most prominent near term challenges are (1) incenting comparative effectiveness studies to demonstrate that personalized medicines make a quantifiable improvement in outcomes (i.e. clinical utility) among patients treated in ‘real world’ settings and (2) setting up a platform to both house and take action on this deep and nuanced information since it’s nearly impossible to imagine that clinicians can keep up with the pace of discovery.
CONDITIONS THAT ARE BEING PERSONALIZED
Oncology is one of the leading categories where personalized medicines have been developed and marketed, and recently sales for cancer drugs that are personalized or targeted surpassed the sales for last centuries’ chemotherapies and hormone therapies. For a form of chronic leukemia, we have decreased the five year mortality from 50% to 5% for those with a particular genetic aberration. For breast cancer that follows a particular genetic path, there has been a nearly 50% improvement in outcome rates as a result of targeted therapies. Similar improvements have been seen or will soon be available for genetic sub-groups of colo-rectal and lung cancer, and even malignant melanoma.