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August 2016, Vol 4, No 8 - The First Word
Donald J. Dietz, RPh, MS

I recently became aware of precision medicine, a new opportunity for healthcare in the United States. President Obama introduced the Precision Medicine Initiative during his 2015 State of the Union Address.1 Precision medicine is an evidence-based approach that uses innovative tools, biologics, and data science to customize disease prevention, detection, and treatment to improve the effectiveness and quality of patient care.

Precision medicine focuses on individualized medical treatment based on specific patient characteristics (eg, genes, environment, and lifestyle). The closest application of precision medicine that we have today is likely in the treatment of many types of cancers (eg, HER2-positive breast cancer).2 Precision medicine involves separating a population into subgroups to more accurately treat or prevent a disease, and includes a different treatment method, because until now medical treatments have primarily been based on the “average patient.”1 Furthermore, many diseases today have no proven means of prevention.

The Precision Medicine Initiative Cohort Program

The mission statement of precision medicine is “to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care.”1 Recently, this topic received mainstream coverage in an article published by The New York Times titled, “Uncle Sam Wants You—Or at Least Your Genetic and Lifestyle Information.”3

What are the forces leading us to precision medicine at this time? Several factors come into play, including electronic health records, mobile health technologies, reduced genetic testing costs, more sophisticated data science, and increased consumer interest in participating in biomedical research.4

Our government believes the time is right for precision medicine; it has funded $215 million to this effort, with a large percentage allocated to build a national, large-scale cohort participant group. The goal is to recruit ≥1 million volunteers in the United States to be part of this research project. Volunteers would provide a medical history, body fluid samples (eg, blood, saliva, or urine), and a host of demographic information.5

The government also wants to learn about volunteers’ lifestyle habits and hopes to collect information about their diet, exercise, sleep, tobacco use, environmental, and the like. This will help with the cohort’s goal of measuring risk based upon genetic and environmental factors. As you can imagine, the use of mobile health technologies, including wearable devices, will be important to gather lifestyle information.

Anticipated Outcomes and Enrollment

An outcome of this project will be new disease classifications and relationships. As a pharmacist or a healthcare practitioner working in a retail pharmacy, it is beneficial to be aware of this program. Enrollment will begin in 2016, and the National Institutes of Health will announce when volunteer sign up begins.6 Walgreens Boots Alliance Inc. has announced that it will help recruit patients to the cohort program via its daily interactions with customers in stores, retail clinics, online, and through the company’s mobile application.6 Anyone living in the United States can participate, and efforts are underway to recruit participants who reflect the true racial, ethnic, geographic, and socioeconomic diversity of our population.4,5 Children will also be recruited.4 In addition to samples collected, participants will undergo a baseline physical, have data taken from their health records, and complete a questionnaire.6

Participants will have access to their study results, as well as summarized results from the entire cohort, along with tools to help interpret the results.6 It is estimated that it will take 3 to 4 years to enroll the minimum 1 million volunteers. The hope is to continue enrollment beyond 1 million participants.6

This is the beginning of a long-term project. If enrollment takes 3 to 4 years, we can expect it to take just as many years to see results from the study. Although this feels a bit like science fiction, we have the capabilities and science to uncover opportunities to prevent and treat diseases with the goal of overall healthcare improvement. Another reason it may take a while to see results is that it is also important that this database have the proper security and safeguards in place. Hopefully, you can discuss this topic at your next social gathering, or with a patient who brings up the topic. Are you ready to sign up?




References

  1. The White House. The Precision Medicine Initiative. www.whitehouse.gov/precision-medicine. Accessed July 25, 2016.
  2. Reynolds K, Sarangi S, Bardia A, Dizon DS. Precision medicine and personalized breast cancer: combination pertuzumab therapy. Pharmgenomics Pers Med. 2014;7:95-105.
  3. Pear R. Uncle Sam wants you—or at least your genetic and lifestyle information. Published July 23, 2016. www.nytimes.com/2016/07/24/us/politics/precision-medicine-initiative-volunteers.html. Accessed July 24, 2016.
  4. National Institutes of Health. Precision Medicine Initiative Cohort Program. www.nih.gov/precision-medicine-initiative-cohort-program. Accessed July 26, 2016.
  5. National Institutes of Health. NIH awards $55 million to build million-person precision medicine study. Published July 6, 2016. www.nih.gov/news-events/news-releases/nih-awards-55-million-build-million-person-precision-medicine-study. Accessed July 26, 2016.
  6. National Institutes of Health. Precision Medicine Initiative Cohort Program—Frequently Asked Questions. Published July 6, 2016. www.nih.gov/precision-medicine-initiative-cohort-program/precision-medicine-initiative-cohort-program-frequently-asked-questions.
  7. Bossetta B. WBA joins USA Precision Medicine Initiative. Chain Drug Review. Published July 25, 2016. www.chaindrugreview.com/wba-joins-usa-precision-medicine-initiative. Accessed August 9, 2016.
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Last modified: August 18, 2016
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