The Age of Personalized Medicine - View of the Experts - Researchers & Investigators

On March 23, 2007, then-Health and Human Services Secretary Michael Leavitt gave the Keynote Address on Personalized Health Care at the Personalized Medicine Coalition's annual luncheon at the National Press Club in Washington, DC. Addressing PMC members, senior government officials and the many other interested constituencies, Secretary Leavitt outlined his policies and next steps for preparing the health care system to put Personalized Health Care into practice.

Throughout his service as Secretary of Health and Human Services from 2005 to 2009, Secretary Leavitt helped to lay the foundation for many government initiatives that are paving the way in making personalized medicine a reality.

Q: Secretary Leavitt, why did you identify Personalized Health Care as one of your priorities, along with such issues as Pandemic Flu preparedness and the post-Katrina Louisiana Health Care system?: A: It's clear to me, and to many others in government and throughout the health care enterprise, that we're on the threshold of a new era made possible by phenomenal leaps forward in two areas: first, new discoveries in bioscience, especially human genomics; and second, new tools in the computer age — meaning health information technology. These great leaps will enable us to give better care to all patients — by targeting the unique biology of every patient.
Q: How do you define Personalized Health Care?: A: Personalized health care is the opportunity to deliver the right treatment, to the right patient, at the right time — every time. It's the opportunity to bring health care to a new level of effectiveness and safety.
Q: What are the key elements of your Personalized Health Care Initiative so far?: A: This is a multi-faceted program, and many elements of it are already underway at the National Institutes of Health (NIH), at the Food and Drug Administration (FDA), at the Centers for Disease Control (CDC), and at the Agency for Healthcare Research and Quality (AHRQ). In fact, current efforts at HHS agencies supporting personalized health care total $277 million this year, and are proposed to grow to $352 million in FY 2008. These cover a range of activities, from advances in basic science and new approaches in regulation, to translating new knowledge and making it useful for health care professionals and patients.
Q: What new programs are you adding right now to accelerate the fulfillment of your vision for Personalized Health Care?: A: We are adding new efforts that will help to lay the foundation. These include ensuring privacy protection for genetic information; clarifying the responsibilities of HHS agencies for ensuring that genetic tests are accurate, valid, and useful; developing consistent policies for HHS agencies regarding access to and security of federally supported research; and creating a new electronic network to draw together the nation's major health data repositories to learn from day-to-day medical practice and improve safety and effectiveness of medical treatments.
Q: Can you describe what you mean by such an electronic network?: A: Well, it's been described as a "network of networks", that will draw on data repositories that are already being created across the country. Some people call it a "learning health care system." With it, researchers will be able to look in real-time for the benefits and harm of different treatments. And, researchers will be able to see from these massive amounts of data on thousands or tens of thousands of patients what the outcomes have been of very specific approaches to particular conditions.
Q: How does this "network" relate to the work done by HHS on health information technology?: A: One of the characteristics of Personalized Health Care is that it calls for collaboration among all of us — in government, in the patient community, in the private sector, and so on. Two years ago, we created the American Health Information Community, or AHIC, to bring together "know how" from across the spectrum of all these communities to develop consensus on health information technology. So, in a very real sense, the "network" I describe rests on the foundation of AHIC's work. In addition, this year AHIC created a special work-group to focus on Personalized Health Care. Based on this group's recommendations, we will begin to develop standards for genetic test information as well as family history that can go into an electronic health record.
Q: You've described the shift to personalized health care as the "health care project of our generation." What can patients and consumers expect in the near-term?: A: We're building on work already being done at each of the HHS agencies, so we actually expect to see an impact over the next two years. The investment in our "network of networks", for example, could begin to yield valuable, actionable information on the best treatment outcomes very rapidly.
Q: What should we be watching for?: A: There are numerous milestones coming up this year. This summer, the FDA will publish a draft guidance on best practices for microarray data in pharmacogenomic data submissions, and then in the fall, FDA will release its guidance on co-development of drugs and diagnostic products. Such documents are important for pharmaceutical and diagnostics innovators who are developing the next generation of targeted products. Also, the first grants from the Genes and Environment Initiative will be made this summer.
Q: What do you see as the biggest obstacles to fulfillment of Personalized Health Care?: A: There's a lot of work that needs to get done. Just to name a few areas, we still need to understand the interactions between our genes, and the environment, and our lifestyle. We need to develop and apply more widely the tool of health information technology. We need common terminologies and standards, so our health information systems can "talk" to each other. There will clearly be a need for new regulatory tools in this arena, and maybe most important — useful tools that doctors can apply easily and that patients will trust. And on the subject of trust, it's obvious that Personalized Health Care — and the use of genetic information on which it will be built — depends on public trust.
Q: What do you believe is needed to ensure such public trust?: A: We need to establish a federal law that genetic information may not be used in an unfair way to deny insurance or employment. President Bush has called for the genetic non-discrimination law to be passed by Congress since his first year in office, and we are all hopeful that will occur soon.
Q: What role do you envision patients and the public having in this transformation of the current state of health care? What are you hoping to inspire us all to do?: A: I think the real frustration, for patients and providers alike, is that so often we're not able to do the right thing for the patient. So much of medicine is trial and error. So much of diagnosis is guesswork. So, in the sense that we are all consumers of health care, I think we all need to be as knowledgeable as we can be about advances in the science, and we need to be talking to our physicians about these new approaches, and we need to support the research and the policies that will make it all happen.

For more information, visit http://hhs.gov/myhealthcare/

For information regarding the Secretary's speech at the PMC's keynote event on March 23rd, including video of the proceedings, click here.

View of the Expert posted March 2007

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