The premise behind personalized medicine seems astonishing and yet simple at the same time: Each of us receives medical treatment tailored to our unique genetic makeup. By using molecular analysis to better manage a patient's disease or predisposition to disease, physicians are able to choose the approach best suited to the patient's genetic profile. The benefits of genetic and molecular medicine are so many, says outgoing Health and Human Services Secretary Michael Leavitt, that personalized healthcare should be an "explicit goal of President-elect Barack Obama's healthcare reform plan."
In the second report from his Initiative on Personalized Health Care, Leavitt says that personalized medicine could be one of the key measures to reduce waste and overuse of prescription drugs and health resources. "We have developed powerful pharmaceuticals, yet most drugs prescribed in the United States today are effective in fewer than 60% of treated patients," he writes, noting that the "trial-and-error" approach remains the most common process for diagnosing and treating patients.
Leavitt also stresses the need for links between information technology and personalized medicine. "The base of interoperable health information technology is critical and remains far from complete. It is not merely a matter of electronic health records, but equally the capacity to exchange information securely," he writes.
Integrated IT systems are absolutely required for successful personalized medicine, says Edward Abrahams, executive director of the Personalized Medicine Coalition. "There has been considerable progress made toward eliminating our current system of trial and error and one-size-fits-all method of practicing medicine. What needs to happen now to facilitate this vision of personalized medicine is to have the infrastructure in place to support this kind of information."
A critical component of that infrastructure will be interoperable electronic health records, says Abrahams. "IT has been slow to develop in the healthcare sector. Right now systems usually are not even connected among providers and labs of one institution, much less different institutions. That has to change for personalized medicine to become routine," he says.
Getting that infrastructure in place has been the goal of Leavitt's initiative since it was launched in 2006. Specifically, the initiative has been preparing electronic health records to accommodate genetic test information. This year, standards were created for exchanging genetic test results and embedding them in EHRs. Those standards are scheduled to be finalized in 2009, clearing the way for those elements to become a standard feature of EHRs.
However, even with those new standards in place, Leavitt says this is the "work of a generation" and that it will likely take as much as 10 years before personalized medicine becomes a standard part of the diagnostic process.
Abrahams agrees, saying that not only will take more work on getting the EHR network in place, but it's going to take more cooperation and communication between government agencies. "Right now they really don't communicate very well, and they have different agendas. The federal government is not coordinated around removing the barriers to personalized medicine," he says.
It's easy to recognize the benefits of being able to diagnose and begin treating a disease before symptoms even appear. But to focus today on personalized medicine ignores more immediate IT needs. With EHR adoption rates still minute, our time and resources would be better spent making that technology available and affordable for all providers, and then focus how best to integrate the patient's genetic information within the EHR.