Building on my 2006 report laying out the Personalized Health paradigm and my 2010 HP white papers on the emergence of translational research, I walked into the HMS Personalized Medicine Conference with few expectations of more than incremental progress towards transformational change and changes that could impact patient care over the near term. I was surprised to find that, consistent with my own views on the likely ways that new knowledge will be transformed into improved patient outcomes, there is
As I tweeted during the conference, I believe that the FDA is likely to be significantly marginalized as a major player in the transformation to a more personalized care scenario. While still rigorous in their role as gatekeeper to ensure that drugs are safe and effective, the ability to apply growing genomics, EMR, and CDSS data and knowledge to routine medical treatment is likely to be executed outside of FDA purview. If the FDA decides to lay down the heavy hand and demand that all testing be FDA approved, then all bets are off and medical innovation will be delayed by at least 10 years or more. With payers, clinical laboratories, and others (e.g. PBMs) all buying genomics testing capabilities, it becomes increasingly possible to deliver the latest genomics insights to the point of care and amortized over large patient populations, recognizing that what are probabilities for the individual become real outcomes for portions of patient populations. Net improvements in patient outcomes become real and avoidances of treatment with little or no likelihood of success reduce both wasted efforts and unnecessary adverse drug exposure.
Foundational changes in information infrastructure and management across the health ecosystem is changing, a topic that will be highlighted in an upcoming major report on the translational research ecosystem. We're hopefully way past data silos and on our way to information transparency and actionable analytics. Sorry for the excess use of jargon, but it all makes sense and should provide the basis for change, both from process and business perspectives.
We're at the cusp of badly needed change, with the potential for long term sustainability. While many stakeholders are perfectly happy with the way things are today and are maintaining or expanding their profit margins over the near term, the writing is on the wall and change is coming. I'm just glad to see that my vision is shared and the signposts of change are increasingly available for all to see.
As always, alternate opinions and comments are welcomed.