Monday, May 18, 2015

Personalized Medicine: Better, Together

 Guest Blogger: Subha Madhavan, Ph.D., Director, Innovation Center for Biomedical Informatics, Georgetown University Medical Center. Follow her on twitter: @subhamadhavan
“Nirvana or Gattaca?” was the title of the panel on the future of Personalized Medicine at the 1776 challenge festival health day last week. 1776 is a global incubator and seed fund that helps startups revolutionize education, energy, health, transportation and cities. The health day was co-sponsored by MedStar Innovation Institute (MI2) and I had the great opportunity to discuss new developments and challenges in Personalized Medicine, on a panel moderated by Politico’s Arthur Allen, with Kavita Patel of the Brookings Institution, Jasvir Zonobi of Kuveda and Grant Elliott of Ostendio.

Personalized Medicine (or the newer term Precision Medicine) promises to revolutionize healthcare. The rush of innovation enabled by big data has made possible precision medicine, or the tailoring of medical treatment to the individual characteristics of each patient. Near daily discoveries of biomarkers, molecular profiling techniques, and the other tools of precision medicine have stimulated innovative research and inform regulatory decision-making about genetic diagnostic tests or specific treatments for patients with cancer, cardiovascular diseases, neurological disorders and other conditions.
There are more than 15,000 tests for over 2,800 genes. These tests can identify inherited susceptibility to conditions ranging from hearing loss to sudden cardiac arrest. Some genomic tests have the ability to predict disease before symptoms occur. A patient who learns that he/she has inherited cardiomyopathy, for example, can benefit from lifestyle changes and disease-monitoring options to avoid the risk of sudden death. Patients with melanoma, leukemia, or metastatic lung, breast, or brain cancers are now routinely offered a “molecular profiling” in some clinical centers including at MedStar Health; this allows their physicians to select tailored treatments that can greatly improve the chances of survival. Targeted therapies paired with genomic tests are giving fresh hope to late-stage cancer patients and their families. Research is showing that genetic testing to titrate dosing of blood thinner drug Warfarin resulted in 31% fewer hospitalizations overall thus reducing total cost of care.

However, before precision medicine is universally applied in healthcare practice, lingering practical and policy issues need to be examined and resolved. This was the primary topic of discussion for the 1776 panel. We discussed technology challenges associated with converting Patient’s $1000 genome to just few bytes of data in the Electronic Health Record to support the decision support process for the clinician; should genomic data be considered the 19th HIPAA identifier; the complexity of laws and regulations that govern personalized medicine products and services; and finally coverage and payment policies that govern which genomic tests are paid for and evidence required to prove their clinical and economic value. Smart teams of innovators, regulators, payors, policy makers, clinicians and researchers are activated and are working hard to make personalized medicine a routine aspect of health and healthcare.

For our part within the MedStar Health system, we have initiated comprehensive molecular testing for refractory, metastatic cancers. Efforts are underway to collect and curate patient outcomes in standardized databases to demonstrate value of molecular diagnostic testing. Recently, a new collaboration between Georgetown Lombardi Cancer Center, MedStar Washington Hospital Center’s Cardiology department and the Georgetown Innovation Center for Biomedical Informatics (ICBI), funded by MHRI pilot clinical research grant program, is building a predictive model to assess cardio-toxic risk in women with breast cancer who are treated with Trastuzumab, a personalized, targeted therapy. AACR and PanCAN recently awarded a collaborative grant to develop a molecular algorithm for treatment of Pancreatic adenocarcinoma. Many more such efforts are needed to make personalized medicine mainstream in our healthcare systems. As Medicine v2.0 moves in the direction of predictive, preventive, personalized and participatory, patient involvement and shared decision-making will be key.

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