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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