One of the hot, increasingly heard terms in healthcare is “personalized medicine.” But Michael Leavitt, secretary of the Department of Health and Human Services, worries a bit about that phrase.
“For some, it creates a mental picture of a patient having one-of-a-kind pharmacology developed specifically for them, based on their phenotype, environment and genetic make-up,” Leavitt writes in a blog posted Tuesday on the HHS web site on “defining personalized medicine.”
“That model, while appealing, raises doubts,” he says. “Intuitively, people develop questions about the scalability and sustainability of trying to treat a population of people in that fashion. The vision we are moving toward, in my mind, is best described as mass personalization. Using a thorough understanding of a person’s genetic and clinical history, a doctor will select a combination from a group of biological and chemical treatment tools.”
Following up on these comments, Leavitt has released the first department-wide report on the goal of “personalized healthcare” — essentially retrofitting the “personalized medicine” term — and said work in biomedical science, health information technology [HIT] and health delivery should be aligned to produce “the right treatment, at the right time,” for each patient.
The report, “Personalized Health Care: Opportunities, Pathways, Resources,” presents a long-range plan for achieving much more individualized treatment for patients, by using genetic information and HIT. Combining health information with IT can give clinicians better information about each patient and more support in choosing “best care” options for treatment, according to HHS.
“In the coming years, new gene-based knowledge, combined with the advent of health information technology, can make possible a new kind of medical care for Americans: Personalized Health Care,” Leavitt writes in a foreword to the report. “Healthcare professionals have always aimed at making medical care as individualized as possible. But in truth, our ability to deliver the right care for each person has been limited.”
The report was produced as part of Leavitt’s priority initiative on personalized healthcare, HHS said. It describes how the “exploding knowledge” of the human genome will increase the capacity to predict, detect, preempt and treat disease, by enabling physicians to “look beneath” visible symptoms and see signs and causes of disease at the molecular level.
For example, the report notes that in the past doctors had to practice medicine as an art form, using macroscopic tools to alleviate symptoms. Personalized healthcare will provide molecular tools and IT support to deliver care with “greater precision, confidence, and individualization,” according to the report.
“Making use of genomic profiling tests, large databases of predisposing factors, sophisticated monitoring devices that provide data in real time, and streamlined electronic patient records, physicians will better prevent disease, predict outcomes, and help patients heal faster through personalized care,” the report says.
According to the report, HIT can make patient information accessible securely, while maintaining confidentially, and can support high quality care.
“Despite growing complexity in healthcare, there is limited online support at the bedside to help healthcare professionals deliver the best standard of care for each patient,” Leavitt said in the report. “In addition, while controlled clinical trials remain the staple of progress in biomedical science, the additional wealth of information that might be reaped from millions of encounters in day-to-day medical practice remains untapped.”
Leavitt said the combination of genomic medicine, HIT, and better use of medical evidence will make possible much more effective healthcare — such as learning which medicines, at what dosages, work best for which patients.
“Personalized healthcare means knowing what works, knowing why it works, knowing who it works for and applying that knowledge for patients,” Leavitt said. “These goals may sound elementary, but a generation of effort lies ahead of us in achieving them.”
Leavitt emphasized that personalized medicine, especially the use of genomic data, will require further attention to using information correctly, including protecting the privacy of identifiable personal health information and protection against misuse of that information.
The report also outlines several challenges to achieving personalized healthcare, such as public trust and translation of knowledge into clinical practice.
“We need better and more efficient ways to provide useful information to support clinical decisions of healthcare providers and consumers,” the report says. “The lack of user-friendly information sources often hampers adoption of newer approaches, such as the incorporation of genetic testing practices in routine clinical decision-making.”
In his blog on personalized medicine, Leavitt makes an analogy to golf, pointing out that consumers have become “quite familiar” with mass customization in a variety of consumer products.
“When I bought my first set of golf clubs, I bought a set the golf professional had on the shelf. After many years, I decided to buy new ones. The technology has improved and there were several aspects of my game that would fall into the category of needing treatment,” Leavitt wrote. “This time, I was confronted with a different experience. The golf professional and I measured my height and arm extension (my phenotype) and inventoried my game (genetic and health history) until we knew what the best length and flexibility of the new golf clubs shaft should be, the angle of the hosel, the weight distribution of the club head and grips to fit my touch.”
Leavitt said the golf professional then told him, “now that we know how you align your clubs (medication) with your game (ailments), we can fit you properly. We carry ten different models of club with different combinations; the X20 Long has most of the attributes you need.”
Leavitt said he bought a set of clubs, off the shelf, that was personalized to him. The company is now engaged in mass customization, he noted. His blog also jokes about the emergence of a system of electronic golf records (though it doesn’t say whether his golf game has improved).
“All kidding aside,” it says, “we do need to begin defining personalized medicine in ways people can understand. We have the technology now to make healthcare much more personal and much more efficient.”