July 23, 2015 at 5:00 am ET
You will often hear the terms “precision” and “personalized” medicine being used interchangeably by policy makers, the media, and sometimes even healthcare professionals. Unfortunately, they are not the same and the distinction is critical when it comes to how these two concepts will impact healthcare in the 21st century.
Precision medicine is a principle that describes how genetic information about a person’s disease is being used to diagnose or treat their illness. It is also an approach to discovery and development of new medicines which integrates genetic information that helps researchers understand which particular subgroup of patients will most likely benefit from that treatment. A facsimile of precision medicine has been in play as far back as when infectious disease physicians began using antibiograms to detect which antibiotic had the best therapeutic sensitivity towards the bacteria infecting the patient. However, the true evolution of precision medicine has been in the past decade as we have been able to sequence the human genome giving us a better understanding of the underlying diseases in areas such as oncology and immunology. We have learned that cancer is a disease of the genome, and as more is learned about tumors, the more we find out that each tumor has its own genetic makeup. In some companies, greater than half of the investigational medicines are coupled with a companion diagnostic that relies on genetic specificity.
Personalized medicine, on the other hand, has been in existence since physicians began practicing medicine and pharmacists began providing medication management. It is how we provide care for that individual patient at that particular time. The concept of personalized medicine is an inherent part of practicing medicine. For instance, if a patient is not taking his blood pressure pills three times a day as prescribed, then a physician may switch him to a once-a-day treatment to improve adherence. If a patient has severe arthritis and is incapable of injecting themselves with an anti TNF drug then the pharmacist may recommend switching him or her to an oral immunosuppressant therapy. Beyond drug therapy, a traditional way personalized medicine is best manifested is when a provider uses laboratory results to manage the best course of treatment for a patient.
Although different in practice as well as meaning, precision and personalized medicine concepts share one very important characteristic – promotion of better patient outcomes. We need a concentrated effort to champion policies that help stimulate use of these two principles together as they will lead to improvement in drug effectiveness, reduction of drug toxicity and eventually a decrease in overall healthcare costs.
To achieve the promise of better patient outcomes through both precision and personalized medicine we ought to focus on the creation of data systems which allow greater flow of information about various genomes and patient intricacies to the providers and patients in real-time. Great strides have been made recently to open up access to such information through government-funded databases. For the first time, the Centers for Medicare and Medicaid Services (CMS) will allow pharmaceutical companies as well as device manufactures and other for-profit entities much broader access to previously-restricted CMS data files. However, for us to fully take advantage of precision and personalized medicine in improving care we need a healthcare data analytics system that not only uses information from the past through claims or encounter data, but one that incorporates real-time information prospectively. We need a system that includes patient vital signs or caloric counts from apparatuses like Fitbit™, or patient experience data like quality of life or patient satisfaction regarding various medical interventions. Most importantly, we need a system that is interoperable and is embraced and used by physicians.
As we strive towards a healthcare system that will highlight heterogeneity of patients and support physicians’ decision making in providing the right drug to the right patient at the right time, it is important to uphold the ideals of both precision and personalized medicine. For our part, the biopharmaceutical industry continues to invest heavily in understanding and utilizing genetic makeup for treatment of a wide range of diseases which will improve patient outcomes and reduce overall healthcare costs. This month, the U.S. House of Representative took a major step forward in support of biopharmaceutical innovation through the passage of the 21st Century Cures bill. The legislation that passed the House supports both precision and personalized medicine by committing resources to the development of biomarker regulatory science, and promoting the concept of telemedicine as an alternative to in-office visits.
Understanding the differences between precision and personalized medicine will bring about a transformation in the practice of medicine as we move away from “one size fits all” in treating serious diseases. Supporting policies that advance these two concepts will bring lifesaving therapies to the patient waiting for the next cure for his or her deadly disease.
Robert Popovian is the Senior Director of U.S. Government Relations at Pfizer Pharmaceuticals.