Biotechnology will improve our ability to customize patient-specific strategies based on individual genes and proteins so as to better predict, prevent, diagnose, and treat subtypes of disease rather than using the "one-size-fits-all" approach. Although population subgroups across the world vary widely in terms of phenotype and disease incidence as a result of environmental conditions, only 5 to 10% of total human genetic variance occurs between populations and ethnic groups.1 We are much more genetically similar than different. And increasingly, human beings all over the world face many of the same health issues: heart disease, cancer, obesity, and diabetes. It is prudent that we use the emerging tools of individualized medicine (IM) to track and search for answers to these common health problems. Individualized medicine is in a pivotal position in the evolution of national and global health care in the 21st century.
IM and value
As the science of IM develops, trial and error in medical practice will be replaced by more precise diagnosis and evidence-based treatments based on genetic and proteomic characteristics. In a Boston Globe editorial, Francis S. Collins, who led the Human Genome Project, envisioned a time when patients will have their genomes sequenced for $1,000 or less, possibly through microchip or other innovative DNA sequencing technology: "That information can then be used to guide prescribing patterns and develop a lifelong plan of health maintenance customized to our unique genetic profiles."2
IM has tremendous potential to increase the value of health care by allowing medical professionals to get it right the first time. As a whole, health care in the United States currently lacks value—meaning high-quality health care (good outcomes, safe care, and great service) at the lowest cost over time.3 With the promise of IM, health-care professionals will be able to better predict disease risk, prevent disease development, and manage disease treatment more efficiently—thereby keeping people healthier and active longer, improving outcomes, shortening hospital stays, and decreasing long-term health-care expenditures. Thus, IM has an instrumental role in realizing the full clinical value of advances in medicine due to the new biology driving translation of discovery to evidence-based practice.
Furthermore, clinical pharmacology—the most cost-effective tool in the clinical armamentarium today—will benefit from IM advances. Genomic testing will allow health-care professionals to perform both prognostic and predictive subtyping of patient populations. Patients may benefit from therapeutics targeted to their specific disease processes and will no longer suffer life-threatening adverse events due to genetic differences in drug metabolism. The shift from palliation to cure with the revolution in regenerative medicine and therapeutics offered by IM has the potential to transform the efficiency of managing disease.
US Health and Human Services (HHS) Secretary Mike Leavitt, who identified IM as one of his priorities, believes in the power of IM to reinvent health care: "Our opportunity in personalized health care is to deliver the right treatment to the right patient at the right time, every time."4
A construct for implementation
IM draws from across all life sciences and provides a common operating platform among distinct medical specialties. A proposed model to bring IM to patients of an integrated delivery system is shown in Figure 1. With proper infrastructure and protection for patient confidentiality, it could serve as a starting point for a framework that could be replicated nationally and globally. Key components include:
- Clinical (patient-specific data) and biological patient data (laboratory testing, imaging, genomics, and proteomics testing);
- Data integration, which collects, stores, and collates patient data, and provides it in a retrievable format;
- Informatics computation, which uses analytical methods, mathematical modeling, statistics, and computational simulation techniques to analyze individualized data at the molecular level; correlates the information among patient groups and subtypes; and generates knowledge to guide individual patient-care decisions;
- Decision support, which aids in clinical decision making at the point of patient care. This process can provide professionals and patients with the latest knowledge and serve as an educational resource related to a specific condition.
The integration of IM and the science of health-care delivery (systems engineering) within the setting of a learning organization for health care in the nation, or world, is a powerful image for the health-care system of the 21st century.
Requirements to maximize the potential of IM
Information technology. People have reached the point of information overload. Medical practitioners simply cannot retain, process, and consistently apply everything there is to know. It takes many years to complete the process from translational research to a recognized standard of care in the United States, and even then a patient may receive the best advice less than 50% of the time.5 We need to find a better way to shorten the time it takes to disseminate and implement higher-value medical knowledge. A technological solution is necessary. We must work toward having access to all medical knowledge—anywhere in the world—at the simple click of a computer key.
If the information technology (IT) industry does not voluntarily create standards and formats for interconnectivity, it is left to government to set standards and foster projects to make national IT interoperability a reality. In August of 2006, an advisory group to HHS Secretary Leavitt recommended three sets of interoperability specifications. A presidential executive order requires federal health-care delivery systems that provide direct patient care to develop an adoption plan to integrate these standards into their IT systems by December of 2007. HHS is also working to create the Nationwide Health Information Network—a network of networks—to provide a secure, interoperable health-information infrastructure, connecting providers, consumers, and other groups involved in health care. President Bush's 2008 budget includes only $15 million in funding for this initiative.7
Teamwork. To realize the potential of IM, integrated and coordinated care for individuals is mandatory. Medical professionals must become team players rather than independent practitioners. Currently, medical students are exposed to a highly competitive process that fosters individual knowledge, responsibility, and autonomy. IM requires health-care professionals to share information and work together—across disciplines, across national borders—to integrate care for the patient. We must modify medical school curricula and residency programs to ensure that students learn how to work in teams and provide coordinated care. The full impact of the implementation of IM necessitates the integration of communities of practice, achieving "individualized medicine without borders."
Systems engineering. Medical education programs should teach engineering skills to students early on in their academic careers. Industrial and systems engineering skills are needed to improve the value of health care. Teaching providers how to improve outcomes, safety, and service and reduce costs in a systematic way leads to better-value health care. A recent report by the National Academy of Engineering and the Institute of Medicine suggests that a partnership between health-care professionals and engineers could significantly improve how patient-focused health care is delivered.8
Intermountain Healthcare's (IHC) Diabetes Care Management System (DCMS) is a contemporary example of how systems engineering can influence not only individual patient outcomes but also outcomes of a large subgroup of patients. Through the teamwork of multiple stakeholders, IHC designed the population-based DCMS with the goal of improving patient-specific, diabetes-related outcome measures. The DCMS includes patient and provider education programs, performance feedback to physicians, patient- and physician-specific reminder systems, and the tracking of physician behavior change and patient compliance with diabetes therapy. Through this comprehensive systems approach, IHC achieved both clinically and statistically significant improvement on key performance measures for each diabetic individual as well as the diabetic population under its care.9
From one to many: a global opportunity
IM is an emerging solution to the crises in health and health-care delivery nationally and globally. Examples include vaccination and drug treatments of global populations for targeted eradication, prevention, and control of diseases. Pharmacotherapy will particularly benefit from IM advances, leading to enhanced value for individuals by prognostic and predictive subsetting/subtyping of patient populations, targeting disease processes, and avoiding life-threatening adverse events.
Lower-cost genomic technology, IT proliferation guided by common standards, professional and public education, teamwork, systems engineering, and innovation will help us make the leap from IM to improvements in global health. The Grameen Bank in Bangladesh provides an example of this concept at work in the real world.
Muhammad Yunus, who created the Grameen Bank, won the Nobel Peace Prize in 2006 because of the impact that collateral-free microloans have had on poor women living around the world. In his Nobel lecture he explained, "In 1974, I found it difficult to teach elegant theories of economics in the university classroom, in the backdrop of a terrible famine in Bangladesh. Suddenly, I felt the emptiness of those theories in the face of crushing hunger and poverty. I wanted to do something immediate to help people around me, even if it was just one human being, to get through another day with a little more ease."
When he couldn't persuade the local bank to lend money to the poor, Dr. Yunus gave a total of US$27 out of his own pocket to a total of 42 needy people. The poor paid back their loans, on time, nearly every time. Still, Dr. Yunus couldn't get conventional banks to buy into his idea. So, in 1983, he created the Grameen Bank to serve the poor. Today the bank gives small, collateral-free loans to nearly 7 million poor people in Bangladesh, 97% of whom are women. According to the bank's internal survey, 58% of borrowers have crossed the poverty line. Best of all, Grameen-type programs have been replicated in many countries.10 This example shows us that it is possible to effect great change one person at a time.
The overarching goal of the discipline of IM—defined by a systems-integration approach—is to enhance the medical management of each patient by ensuring the availability of innovative, effective, efficient, timely, and safe diagnostic and therapeutic modalities. By synthesizing patient-specific information and linking it with clinical guidelines, relevant publications, and new research, IT can bring educational tools to physicians, nurses, aides, and patients to support IM at the point of patient care—anywhere in the world. The collective improvement of the health of individuals leads to improved health of a population. All for one, and one for all.
This article is part of the Global Theme on Poverty and Human Development, organized by the Council of Science Editors. All articles from the Nature Publishing Group are available free at www.nature.com/povhumdev. The content from all participating journals can be found at http://www.councilscienceeditors.org/globalthemeissue.cfm
References
- Cavalli-Sforza, L.L. & Feldman M.W. The application of molecular genetic approaches to the study of human evolution. Nat. Genet. 33, 266–275 (2003). | Article | PubMed | ISI | ChemPort |
- Collins, F.S. Personalized medicine, a new approach to staying well. Boston Globe (17 July 2005).
- Smoldt, R. & Cortese, D. Pay-for-performance or pay for value? Mayo Clin. Proc. 82, 210–213 (2007). | PubMed | ISI |
- Leavitt, M. Remarks as Delivered to Personalized Health Care: Delivering Value to Patients
http://www.hhs.gov/news/speech/2007/032307.html
. - McGlynn, E.A. et al. The quality of health care delivered to adults in the United States. N. Engl. J. Med. 348, 2635–2645 (2003). | Article | PubMed | ISI |
- US Department of Health and Human Services. Health Information Technology Initiative Major Accomplishments: 2004–2006 http://www.hhs.gov/healthit/news/Accomplishments2006.html#2006.
- US Department of Health and Human Services. HHS Secretary Leavitt Announces Steps toward a Future of "Personalized Health Care" http://www.hhs.gov/news/press/2007pres/20070323a.html.
- Reid, P.P., Compton, W.D., Grossman, J.H. & Fanjiang, G. (eds.). Building a Better Delivery System: A New Engineering/Health Care Partnership (National Academies Press, Washington, DC, 2005).
- Larsen, D.L., Cannon, W. & Towner, S. Longitudinal assessment of a diabetes care management system in an integrated health network. J. Managed Care Pharm. 9, 552–558 (2003).
- Yunus, M. Nobel lecture http://nobelprize.org/nobel_prizes/peace/laureates/2006/yunus-lecture-en.html (10 December 2006).
Acknowledgments
The author thanks Shelly Plutowski for her editorial contributions to this manuscript.
