Enabling Personalized Medicine Through Health Technology Innovations

As numerous studies show – and the Personalized Medicine Coalition’s education and advocacy efforts further underscore – personalized medicine is poised to play a big role in improving patient care and health care delivery in the U.S.  It offers earlier prevention, better-targeted treatments, health system cost savings and enhanced understanding of the differences in effectiveness of different treatment options for different patients.  

Despite its promise, personalized medicine faces challenges; the science is emerging and complex, regulatory pathways are not optimal, and health care financing and delivery create barriers to its adoption.  The successful implementation of health information technology can help address these challenges by creating a new infrastructure for developing data on personalized medicine interventions, and by giving them up to date information on available treatment options.  
 
Even while the government has made significant strides toward improving the technological infrastructure in the U.S. health care system, we must keep in mind widespread use of health information technology does not guarantee the advancement of personalized medicine.  As the government continues to expand and adapt the criteria for “meaningful use” of electronic health records (EHRs) in the coming years, we must continue to work to ensure that new systems are capable of handling, sharing and analyzing the genetic and outcomes data needed to promote the continued development of personalized medicine.
 
On January 28, I will be presenting findings from a paper I’ve developed that outlines key findings and recommendations about the public policy actions needed to ensure that health information technology facilitates the adoption of personalized medicine in the U.S. health care system. A fantastic panel of experts, including Mark Boguski (Center for Biomedical Informatics, Harvard Medical School), Donald W. Rucker (Siemens Medical Solutions USA), Emad Rizk (McKesson Health Solutions) and Paul Billings (Life Technologies Corp.), will further discuss the policy and operational changes that would facilitate connectivity, integration, reimbursement reform and secondary analysis of information.  Plus, David Brailer, chairman of Health Evolution Partners and the first “health information czar” during the Bush administration, will deliver a keynote address.   

We encourage you to join us on January 28.  If you’d like to attend, please register here.  We look forward to seeing you there!

PCORI Methodology Committee Named; No Private Sector PM Experts Included

The  Government Accountability Office (GAO) today announced the members of the Methodology Committee for the Patient Centered Outcomes Research Institute (PCORI). We don’t  dispute the credentials of the 17 appointed members,  and we appreciate NIH Director Francis Collins’ participation on the committee. Yet it is nonetheless disappointing to see that none of these appointed members from the private sector bring expertise in personalized medicine, particularly since including experts in genomics was one of the specific fields identified in statute.  This will make it all the more important for leaders in the personalized medicine field to continue to advocate for alignment of PM and CER in development of research methods and study designs.   For the past year, the Personalized Medicine Coalition (PMC) has been a strong advocate in support of CER that is aligned with personalized medicine.   In October, PMC submitted a letter to GAO nominating ten experts in personalized medicine from across academia and industry.   While many on the methodology committee  bring strong expertise in their research fields, the lack of in-depth expertise in genomics and personalized medicine will make it more challenging to advance research methods that are aligned with personalized medicine and recognize “advances in medical technology” as specified by statute. 

Perhaps  the PCORI Board could create an  ad hoc advisory panel focused on personalized medicine and innovation that would help to ensure that sufficient focus is brought to these important issues as PCORI  moves forward with developing research methods and priorities .   Having such a committee could help PCORI fulfill other mandates such as public engagement, stakeholder representation, and keeping the science up-to-date.

Conference Will Highlight Developing Science of Personalized Cardiovascular Medicine

More than one third of U.S. adults have at least one type of cardiovascular disease.  It is the number one cause of death in the U.S. Every 25 seconds, an American suffers a coronary event, and every minute, someone in the U.S. dies from one. 

The burden of cardiovascular disease can also be measured in economic terms: in the United States the disease cost more than $500 billion in 2010 in medical care and lost productivity.  Addressing the underuse of medicines that can prevent disease complications has the potential to save money.  For example, one study found that if all patients who have hypertension were treated according to current guidelines over 400,000 hospitalizations a year could be prevented.  By shifting to models of care that are predictive and preventive, personalized medicine can help address this problem and improve health care value.  Likewise, addressing the problem of overuse of medicines presents an opportunity to improve value by ensuring patients do not receive ineffective or inappropriate medicines.  Warfarin treatment selection and dosing guided by genetic information is an example of this emerging capability.

The potential of personalized medicine is to identify which individuals are at risk as well as those not at risk for developing cardiovascular disease and target appropriate testing and treatments accordingly.  When it comes to treatment, health care providers need to know which tests are necessary to develop a treatment plan, which medications (singly or in combination) will prevent the development and progression of disease on an individual basis, what procedures can improve cardiovascular health and how to advise patients on managing their own health through diet and exercise.   

The challenge of personalized medicine for cardiovascular disease is to identify the information that will redirect medical care based on individual needs.   And that challenge is only made more difficult when physicians are not trained to use genomic and protein-based data to guide their decision-making.

On January 6, at a conference organized by the Personalized Medicine Coalition entitled “New Frontiers in Personalized Medicine: Cardiovascular Research and Clinical Care,” we will examine the new technologies that are facilitating the matching of treatment to patient to improve outcomes.   We hope you will join the conversation in person in Washington, DC.  For more information on the conference, or to register, visit www.personalizedmedicinecoalition.org/events/cardiovascular2011.