Saturday, January 27, 2018

Precision Medicine and the Reinvention of Human Disease (not just the genome)

If you believe the lay press, Precision Medicine involves sequencing a patient's genome and determining the proper treatment based on the individual's unique genetic attributes. The NIH (National Institutes of Health) seems to be encouraging this interpretation of the field. From the US National Institutes of Health comes the following description: "Precision Medicine is an emerging approach for disease prevention and treatment that takes into account people's individual variations in genes, environment, and lifestyle. The Precision Medicine Initiative will generate the scientific evidence needed to move the concept of Precision Medicine into clinical practice". An Advisory Committee to the NIH Director would include, under the mantle of Precision Medicine, "providing individual side-effect profiles of drugs, and preventative health care check-ups that include specific recommendations developed from interpreting an individual's genetic risk profile".

Between the millions of inter-individual variations in our genomes, the highly personalized lifestyle choices, and the differences in our environments, there seems to be plenty of uniqueness to spread around. It is easy to forget that our uniqueness as individuals often has much less to do with our diseases than does our sameness as members of the same species. Our sameness goes a long way toward explaining why humans seem to suffer from the same list of textbook diseases, regardless of their individualized genes and geography. Someone had to put the brakes on this epidemic of uniqueness.

Much to their credit, the National Research Council of the US National Academies tacked on the following caveat to the definition of Precision Medicine: "It does not literally mean the creation of drugs or medical devices that are unique to a patient, but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease, in the biology and/or prognosis of those diseases they may develop, or in their response to a specific treatment". The Research Council wisely distinguished Personalized Medicine from Precision Medicine, by adding, "Although the term 'Personalized Medicine' is also used to convey this meaning, that term is sometimes misinterpreted as implying that unique treatments can be designed for each individual. For this reason, the Committee thinks that the term 'Precision Medicine' is preferable to 'Personalized Medicine'"

The National Research Council pointed out what should have been obvious from the start. We cannot provide individualized treatments, because treatments must be tested for safety and efficacy on groups of people. The best we can ever do is to assign patients to a group that has been fitted to a preapproved treatment. So where does this leave us?

More to follow in tomorrow's blog.

- Jules Berman

key words: precision medicine, genomics, individualized treatments, definition, jules j berman, Jules Berman Ph.D., M.D.

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