The Food and Drug Administration will add 50 additional reviewers for cell and gene therapy and anticipates 200 new drug applications by 2020. The ramp up underscores the rapid pace of genetic research and resulting potential for new cures—but those come at a cost. Some would prefer to see prevention take a front seat. Carlos Bustamante, professor of genetics at Stanford University, hopes the next phase of genetic research will identify people at risk of disease so they can start preventive treatments “that could avert heart attacks and strokes.” (PRI
; FDA statement
Only a third of consumers responding to a recent survey said they’re familiar with personalized medicine, up 4 percentage points from 2018. Those over age 65 were the most likely age cohort to recognize the term. Older respondents (those age 55 and up) were also more likely to say their medication dosages aren’t optimized for them personal. Nearly half of those familiar with personalized medicine said they would take a diagnostic test for personalized medicine if referred by a provider. (MobiHealthNews
; DOSIS study
Evidence & Innovation
With health IT’s current focus on information exchange standards, Doug Fridsma, CEO of the American Medical Informatics Association, says it’s critical we don’t lose sight of the purpose of interoperability—to enable new ways to analyze and use the data. Being able to share data first is key to make that happen. Sharing now and standardizing the details may be a better approach than focusing on the minutest details on the front end, he says. “If we try to standardize or structure it all before we have an opportunity to share it, it’ll never get shared.” (HealthcareITNews)
For hemophilia, a chronic disease that affects people of all ages, treatment should take a personalized approach, and a new range of therapeutic options makes that possible. Proactive, personalized therapy beginning in childhood has been shown to preserve joints and allow children with the disease to function regularly in school and at play. Carefully monitored dosing of medication to reduce bleeding enabled more than half of the patients in one study to reduce dosing from three times weekly to less than twice a week. (MedPage Today)
The National Institutes of Health initiative designed to gather genetic data from a diverse cohort of 1 million Americans unveiled a preview of its first data dashboard last week. The data browser includes electronic health record data from more than 30,000 participants and self-reported data from more than 100,000. To date, 80% of the data gathered is from historically underrepresented communities, and more than half of database participants are from racial and ethnic minority groups. Scientists were encouraged to start exploring the biometric and other data and to start thinking about research opportunities to come when a researcher portal opens at the end of the year. (HealthITAnalytics
; All of Us Browser Tool
Expensive gene therapies with the potential to cure disease carry a high short-term price tag, but promise to add years to life. Payers are struggling to structure payment that aligns with the long-term benefits of a million-dollar cure. “I think the fear is that the funding for this type of innovation might dry up if we don’t figure out how we’re going to pay for this,” said an industry insider. (AJMC)
What’s the difference between comprehensive medication management (CMM) and medication therapy management (MTM)? What are the implications for pharmacists’ education and training? How are physicians, pharmacists and teams working in collaborative practice to provide CMM-level services?
Learn from two of the researchers who identified the $528 billion opportunity to reduce the overall cost of health care: Jan Hirsch, Ph.D. and Dr. Terry McInnis.