Americans today are guinea pigs in a "one-size-fits-all" approach to medicine. Clinical trials designed to gauge if a treatment works for most people most of the time, ignore the influence of genes on health and wellness. Since one size does not fit all, patients are left to travel down a winding path of physician-led trial and error.
Different people don't respond the same way to the same medical treatments. We have known this for quite some time, but we don't have a cohesive system for organizing and using the information we have. Granted, there is still a lot we don't know, especially when it comes to genetics. But we are learning fast. The fact is, personalized medicine will represent a marked improvement over the current system, a new kind of medicine where physicians, researchers and patients get the information they need in a form that they can understand and use, a place where the results of genetic and other kinds of tests are used to tailor drugs and treatments to individual patients.
So how can the biomedical community use individual patient information as quickly and effectively as possible?
The answer: Personalized medicine will need to be seen as part of a larger goal of turning medical practice broadly into a total learning environment. Not only will physicians apply the most recent findings about available treatments, they will also be able to record the real-world outcomes so that researchers can then update the findings. Medical scientists should also have access to this information so that they can gear their research and product development in more patient-specific directions. The hope is that everyone involved will make better decisions as the information gets better and better. Thus, the system keeps learning.
A few weeks ago, at the Bio-IT World Conference and Exposition in Boston, Microsoft sounded the trumpet of innovation by announcing the coming release of a software platform for aggregating and interpreting data from research, clinical trials, clinical health care and consumer health information. But this is just one of many private and public efforts to bring about the age of personalized medicine.
Due to the various stakeholders, bringing about the era of personalized medicine will not be an easy task. Many lingering legal, political, and administrative questions remain about patient privacy and about the ownership, organization, and security of personal medical information. And those are just the tip of the iceberg. Last fall, the Department of Health and Human Services published a 300-page report on the multitude of governmental projects that all play instruments in the orchestra of personalized medicine.
But instead of getting bogged down in details, this is a ripe time for defining the principles that should guide our vision of personalized medicine; what tools we already have available to bring that vision about; and how responsibilities should be divided up or combined by public and private stakeholders.
There needs to be coordination, but we do not know enough yet about personalized medicine in practice to set in stone any policies for thorough, system-wide coordination. We must avoid calling for government to micromanage every stakeholder's part of the personalized medicine symphony. A conductor does not write the music or play the instruments for the musicians. Instead, government must be the maestro who listens closely and guides the timing, intensity, and harmonization of the stakeholders.
The best course of action for now is for government to promote broad goals such as streamlining access to data, including genetic subpopulations in research, protecting patient privacy, and ensuring the accuracy of diagnostic tests.
Implementation and evaluation must proceed aggressively and in tandem. Only then can the United States rapidly build a knowledge repository for the future of personalized medicine while it also learns how to develop the right policies for shaping that future.
The ultimate goal is to make medicine more of a pure science and less of a combination of science and art.
By Michael Rugnetta and Jonathan D. Moreno
Special to CBSNews.com