Precision Medicine Is Coming

On January 20, 2015, in his State of the Union Address, President Obama launched a new Precision Medicine Initiative. This research initiative is a bold new effort to improve how we treat disease and how we cure diseases like cancer and diabetes. The Precision Medicine Initiative will pioneer a new model of patient-powered research that aims to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients. Personalized medicine is often described as providing “the right patient with the right drug at the right dose at the right time.”

Currently, medical practitioners follow a trial-and-error approach when treating patients. In other words, if a patient has a disease, his or her doctor will prescribe a treatment plan based on general information, and re-assess after a few weeks. If the treatment is not working, the doctor will change some variable in the plan, and wait a few more weeks to see if there is any improvement. This approach can lead to patient dissatisfaction, adverse drug responses and interactions, and poor adherence to treatment regimens by the patient. While this may seem bleak, there have been rapid developments in a variety of medical fields like genomics, medical imaging, and computational biology that are making it possible for scientists and doctors to personalize diagnosis and treatment of diseases. Precision medicine gives clinicians tools to better understand the complex mechanisms underlying a patient’s health, disease, or condition, and to better predict which treatments will be most effective. I believe the Precision Medicine Initiative is just what is needed to continue encouraging creative approaches to precision medicine and build the evidence base necessary to guide clinical practices.

The main objectives of this initiative are:

  • An increase in better cancer treatments: The National Cancer Institute (NCI) will accelerate the design and testing of effective, tailored treatments for cancer by expanding genetically based clinical cancer trials, exploring fundamental aspects of cancer biology, and establishing a national “cancer knowledge network,” that will generate and share new knowledge to fuel scientific discovery and guide treatment decisions.
  • Creation of a voluntary national research cohort: The National Institute of Health (NIH), in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of one million or more Americans who volunteer to participate in research. Participants will be involved in the design of the initiative and will have the opportunity to contribute diverse sources of data – including (but not limited to) medical records, profiles of patient genes, chemical makeup, and environmental and lifestyle data.
  • Commitment to protecting privacy: The White House will launch a multi-stakeholder process with Health and Human Services (HHS) and other Federal agencies to solicit input from patient groups, bioethicists, privacy and civil liberties advocates, technologists, and other experts to identify and address any legal and technical issues related to the privacy and security of patient data.
  • Regulatory modernization: The Initiative will review the current regulatory landscape and work with the Food and Drug Administration (FDA) to determine whether changes are needed to support the development of this new research and care model.
  • Public-private partnerships: The Obama Administration will forge strong partnerships with existing research cohorts, patient groups, and the private sector to develop the infrastructure that will be needed to expand cancer genomics, and to launch a voluntary million-person cohort.

Key Investments to Launch the Precision Medicine Initiative:

  1. $130 million to NIH
  2. $70 million to NCI
  3. $10 million to FDA
  4. $5 million to The Office of the National Coordinator for Health Information Technology (ONC)

In sum, the Precision Medicine Initiative is a great endeavor and its greatest benefits will likely be seen many years in the future. However, this initiative will revolutionize the practice of medicine, and give patients a better chance at good health than they have ever had.

 

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