Tuesday, September 18, 2012
Personalized medicine is back in the news, including a new “pharmacogenetic test” for genetic markers to assess the effectiveness of antipsychotic drug treatments, SureGene and PGXL Laboratories launch the SureGene Test for Antipsychotic and Antidepressant Response, and the September 15 article in The New York Times – A First: Organs Tailor-Made With Body’s Own Cells, about the developing field of growing replacement organs.
Not so slowly but surely, we’re moving from mass production to mass customization in our health and human service system – the emerging era of personalized medicine. I think consumers are ready, but I’m not so sure about payers, care management organizations, or service provider organizations.
The concept behind personalized medicine is simple – the customization of health care decisions and practices tailored to the individual by use of genetic or other personal information. How to pay for and deliver those “personalized” services is another matter. Where are we with personalized medicine? In the very first steps – including these recent developments:
$1,000 And A Gene Map all members
The combination of “big data” to develop clinical guidelines using practice-based evidence and personalized medicine could be a very powerful combination. Most current practice guidelines – and most clinical research using randomized control trial approaches – are based on the mass production concept (i.e. what works for the “majority”). They are useful but crude tools.
The effects of this were highlighted in the recent article in Health Affairs, Harnessing The Promise Of Comparative Effectiveness Research with the importance of patient-centric comparative effectiveness research that embraces the differences within consumer populations. They gave schizophrenia as an example:
Schizophrenia provides a useful illustration. Many treatments exist, each with its own unique side effect profiles, some of which are severe and permanent. In 1999, the National Institutes of Health funded the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) – a study comparing first-generation anti-psychotics with newer second-generation medications. CATIE found that newer anti-psychotics were no more effective than older medications, leaving some to call for reduced use of second-generation antipsychotics….[however] there was a subset of patients for whom the second-generation anti-psychotic may have been more effective, leading some to argue for individualization of treatments in schizophrenia. It has been estimated that requiring all patients with schizophrenia to be treated with first-generation anti-psychotics (rather than allowing patients who by trial-and-error were on second generation anti-psychotics prior to CATIE) would increase health care spending through increased hospitalizations and other health care utilization.
The key to making personalized medicine a reality is to better develop the return-on-investment (ROI) estimates for various forms of personalized medicine – The ROI for Targeted Therapies: A Strategic Perspective and Beyond Evidence-Based Research: Big Data & Practice-Based Evidence ). That analysis will give payers and care management organizations confidence in moving beyond clinical decisionmaking tools designed for the masses to clinical decisionmaking tools that allow mass customization of care delivery. And, this can get us out of the trap of always requiring consumers to “fail first” on less than optimal interventions in order to get access to newer technologies (for more on that, see my presentation Do We Always Have to “Fail First”? from this year’s National Council, Mental Health and Addictions Conference).
For more on this topic, join us on October 17 in Baltimore at The Technology & Informatics Institute for Genetics, Neurotech & Personalized Medicine: Using Emerging Science To Improve Treatment Of Cognitive Disorders with our expert panel – Genomind General Manager, Nancy Grden; Neuronetics Vice President of Marketing, Sue McMonigle; and OPEN MINDS Executive Vice President John F. Talbot, Ph.D.
Monica E. Oss
Chief Executive Officer, OPEN MINDS
For another free resource, see: With Comparative Effectiveness on the Way, How Do We Speed Up the Science-to-Service Lag? all members
This is free for the next sixty days to all registered OPEN MINDS Circle members.