Personalized Medicine 2009 (1): The Healthcare System Perspective
The illustrious panel of scientists, physicians, regulators and businesspeople at the 5th Annual Burrill Personalized Medicine Meeting last week once again reaffirmed the inevitable trajectory toward personalized medicine and, interestingly, that some of the forces propelling it are also the roadblocks that must be overcome. This paradox came across most clearly for me in the discussions about physician adoption, reimbursement and regulatory perspectives, the latter by FDA Commissioner Margaret Hamburg, MD.
Over and over again, panelists spoke of the flaws of the current reward system for healthcare professionals and the environment within which they operate. The system rewards doctors for the number of patients they see and the procedures they perform, leaving them little time to learn about personalized medicine or even to think about it. Education is key, starting with the incorporation of genomics in medical school curricula. Communicating to physicians in the language they understand (clinical validation) is also critical. And, Geoffrey S. Ginsburg, MD, PhD, from Duke University and Joseph D. McInerney of the National Coalition of Health Professional Education in Genetics pointed out that we should be thinking beyond physicians and include other healthcare professionals (e.g., nurses, genetic counselors) as we consider the role of the provider in the adoption of personalized medicine. Capturing comprehensive family history, which often contains a wealth of data for risk assessment and treatment decisions, has become a luxury in the time-constrained patient care environment and one that is lacking in systematic, standardized data capture capabilities.
On reimbursement, everyone agrees that the current system and CPT code system discourage innovation. And the fact that in vitro diagnostics (IVD) accounts for only 0.01 percent of healthcare expenditures suggests that there is a long way to go and that the path to personalized medicine will be paved by good strategy supported by abundant resources as illustrated by Genomic Health’s trail-blazing reimbursement strategy. Eric L. Book, MD, of Tethys Bioscience commented that “we are distracted by how much healthcare is costing right now” to the extent that sometimes pressure to improve the bottom line detracts from thinking about “doing the right thing for society.” A sobering thought.
The earnest and disarming Dr. Hamburg vowed to engage with industry and academia to advance the scientific rigor of regulatory decisions—a broad advancement of regulatory science. She spoke of a more holistic, multidisciplinary approach (i.e., more integration of diagnostics and therapeutics in review functions and processes), and more flexibility, more transparency and more clarity. Most of the audience concluded, however, that the regulatory path would get tougher, not smoother, going forward. Last but not least, although Hamburg did not provide a release date for the new IVD/MIA regulations, she did disclose in private conversations that they could be expected before the end of the year.