 |
 |
|
 |
||
Print 
Download Reader 
|
|
|
|
||
Print Download Reader
 |
||||||
Remarks as delivered to the President's Council of Advisors on Science and TechnologyGood afternoon. Thank you for that warm introduction. I'd like to thank Dr. John Marburger, Floyd Kvamme, and Dr. Kathy Behrens for their leadership on the President's Council on Science and Technology and their commitment to making personalized health care a mainstay of quality-based health care delivery systems. Secretary Leavitt and I appreciate your interest in the subject of personalized medicine, since we believe we are poised on the edge of that new frontier. There's much we can do together to bring the promise of that frontier to each person in America. I'd like to tell you about the Secretary's vision for the future, describe some of the steps HHS is taking, and then go through some of the ways in which we can work together to bring the promise of personalized medicine to the present. For my purposes, I'm going to define personalized health care as the directions we need to take in science, medicine, and technology-in particular genomics-to advance the understanding and quality of health care at an individual level. We are facing the signal point of transition in health care in the United States. Medicine will eventually be transformed from an instinctive art of alleviating symptoms to a science of personalized health care. The next several years will be viewed by future generations as the time when treatments became preventive, predictive, and personalized-where individualized, patient-centered care is made possible through richness of information. This transformation will touch every aspect of care-from sensors that allow doctors to detect the first sign of cancer to information networks that allow scientists to scan hundreds of thousands of records for the scent of a cure to a debilitating disease. We will have a health care delivery system in which doctors, pharmacists, and other health care providers customize treatment and management plans for individual patients based on vast amounts of information that is readily accessible at clinics and hospital bedsides-information like medical history, genetic variability, and even patient preferences. We will see a health care system in which doctors and their colleagues are able to predict treatment outcomes with increasing certainty, and in which they have more time to talk with their patients about their choices of treatment, and the implications that will follow. And supporting all of this will be a science of medicine that is even more patient-centric and even better information-based than it is now. None of this will happen overnight. And at times, it seems as though the more knowledge we gain-such as in genomics-the more we realize we still have to discover. But we now have the opportunity to shape the vision of personalized health care-to determine the regulatory framework, for example-and to bring it to fruition far more quickly-and with much broader benefits-than it may otherwise develop. The role of government is to create a platform that allows all the elements a personalized health care industry needs to flourish. I hope that all of you will help us at HHS continue to develop a clearer picture of the final goal, the pathways there, and the obstacles that must be surmounted to get there. Three of Secretary Leavitt's top broad priorities-out of a total of ten top priorities that he's posted on HHS.gov-are directed at creating that patient-centric, information-based foundation necessary for personalized medicine. First, value-driven health care. Let me explain what value-driven health care means by way of a story. I have a three-year old son, who has an amazing propensity to need stitches. He cut his eyebrow open, and we brought him to the emergency room. Because it was a wound on the face, the attending physician asked us if we wanted to have a plastic surgeon called in for the procedure. I then asked what would have been a perfectly normal question in any other segment of our economy. �How much more will that cost?� They looked at me as if I were from Mars, telling me that they, of course, had no way of telling me that. I never was quite clear if they truly didn't know and had no desire to find out, or if they knew, but had no interest in telling me. Then I asked another question that I naively thought was perfectly natural under the circumstances: �Would plastic surgery stitches be better than what the attending physician would do?� You see, while I am a health care regulator and am from a medical family, I am not quite up to speed on the latest in medical suture procedures. You can imagine the �response� that I got. Well, lacking all relevant information, we went the conservative route and had the plastic surgeon brought in, who, by the way, did a wonderful and professional job. But as we were leaving, a nurse mentioned in a rather off-hand way that the stitches were exactly what the attending physician would have done. And I can now answer the cost question; the cost difference was substantial. We've all had an experience or many experiences just like this. It is absurd to me that one of the largest segments of our economy is organized and operates in such a way that consumers have no real ability to learn about price or quality. Value-driven health care simply is about the highest quality at the lowest cost. It's about fixing the incentives in the system so that consumers direct their own care personal to them and everyone benefits from good choices and carries part of the burden of bad choices. That's why President Bush recently signed an historic Executive Order to empower Americans to find better value and better care by increasing the transparency of our health care system. The Executive Order directs federal agencies that administer or sponsor federal health insurance programs to:
Interoperable health information technology is itself the second of Secretary Leavitt's top priorities to help lay the foundation for personalized medicine. One of the greatest inefficiencies in our health care system is the lack of interoperable health records. I recently went to my internist-who I think is one of the best, and I have used for many years-and I had to fill out my patient history form for what must be the seventh time. I did my best to remember my life's story, but as we all know, memory sometimes fails. In the course of talking through an issue with my doctor during the exam, I happened to mention something about one of my grandparents' health history. She responded, �Don't you think that was pretty relevant information to know?� Yes, it was. But while I most likely had put it down each of the 6 previous times I had filled out that form, I had forgotten this one time. Imagine a day when you only fill out that form once, and it is updated each time to go to a provider. The death of the registration form. Think of the errors to be avoided, and the efficiencies to be gained in all of our lives. Yet even though we are decades into the computer and information age, health care providers cannot buy programs that they know can communicate and be interoperable with all the other programs out there. This problem of interoperability is why Secretary Leavitt is currently leading a process to encourage the development and adoption of the interoperable standards that are needed for health information technology to fulfill its promise. Secretary Leavitt chartered and is now chairman of a Federal Advisory body called the American Health Information Community, or simply AHIC. AHIC is composed of government officials along with leaders in the free market, and over the past year has been making recommendations to Secretary Leavitt on how to achieve interoperable health information flow while maintaining security and respecting patient privacy. The promise of health information technology will not be realized if we end up with a balkanized system where personal health information is not portable or accessible. We need standards for what information is to be included, what the fields are, etc. And we need a system for the certification of software products that are interoperable under these standards, so that when you go to a store and talk with a vendor, you'll know that what you buy is interoperable. AHIC is driving the process to develop these consensus standards and processes and to certify products. Secretary Leavitt is also currently developing personalized health care as a third one of his top priorities. His personalized health care effort has two main goals: First, to develop the information we need for personalized health care and, second, to use the information correctly. To develop the information, we need to do several things. We need to stimulate innovative approaches to aggregate data from sources such as Part D Medicare data, clinical trials data, and population-based studies. We also need to develop standards that facilitate the exchange of the information. AHIC, which I mentioned earlier, is engaged in setting the standards for personalized health records-and thereby medical data information networks. AHIC also has a working group that is addressing the incorporation of genetic test data and family history into electronic health records. HHS also has several other working groups examining how the future opportunities and challenges of genomic information-both developing and exchanging it-are affected by federal statutes and regulations. We want to address gaps and concerns about patient protection issues, and, ideally, to develop methods to protect patients whose information we anticipate using in support of personalized health care. In addition, to that end, Secretary Leavitt and I hope that Congress will revisit-and pass-the Genetic Non-Discrimination Act, which would prohibit the use of genetic information for use in making employment and insurance coverage decisions. We've also been engaging in community-wide discussions with stakeholders and identifying needs and opportunities as we come across them. A request for information which was recently published will help us obtain a clearer view of how those in the government and free market-state governments, schools, industries and hospital networks among them-are preparing for a personalized health care system. We're going to continue to seek catalytic community engagement as we go forward too. In upcoming weeks, we hope to publish an HHS report that describes what we are doing about personalized health care and the directions we are taking in much greater detail. HHS also has a number of efforts in different agencies relevant to personalized health care, such as NIH's Roadmap project, the NIH Genes and Environment Initiative, and FDA's Critical Path Initiative, which well illustrates the continuing challenges of moving toward personalized health care. Let me talk a little more about the Critical Path Initiative. In 2004, FDA released a report on the Critical Path to New Medical Products. The report advised that the primary reason that fewer and fewer drugs are being approved is that the current development process is not sufficiently advanced to predictively evaluate new treatments and move them from laboratory bench to bedside. Essentially, the applied sciences needed for medical product development have not kept pace with the tremendous advances in basic sciences such as genomics, proteomics, and nanotechnology. Often, developers have to use the tools and concepts of the twentieth century to assess twenty-first century products. The goal of the Critical Path Initiative is to take a drug from scientific breakthrough to actual, effective, approved treatment as quickly and safely as possible by increasing our ability to predict at each step of the product's life cycle whether or not the product will offer patients what they need. It will take advantage of the latest scientific developments across all steps of drug development to determine how and why diseases affect each of us and how we can create new pathways for quickly, efficiently, and effectively developing and approving safer treatments tailored to individuals. For example, take biomarkers, the measurable characteristics that can help predict the performance of a product during development, reducing uncertainties about safety or efficacy. Unfortunately, the investment emphasis in biomarker discovery has not been matched by a parallel investment in biomarker validation-demonstrating which potential biomarkers actually predict a clinical outcome, so that product sponsors and regulators can use such biomarkers in product development, physicians can use them to make treatment decisions, and regulators can use them to make approval decisions. With more informative biomarkers, sponsors could make smarter choices on which drugs to cease work on and which to move forward for further testing. Clinical trials could be shorter and less costly. Drugs could be targeted more safely and effectively in a new era of personalized health care. The biomarker example highlights how, under the Critical Path Initiative, we are now working to move from trial and error to a direct, mechanistic understanding of how medical products affect human physiology. As we move ahead with our work on personalized health care, I want to assure you that we will be looking for your expertise and insights. The success of our HHS agenda can be enhanced by this committee's vision. I'd like to suggest some areas where we are going to be looking for your help. How we can use the strength of our industrial development base in diagnostics and pharmaceuticals more productively to take on this aspect of genetic differences in disease management? What is needed from a regulatory framework that would help support more efficient and affordable clinical development? What about the intellectual property management of the data and processes involved in genetics? Should we adopt approaches similar to models used in the computer or commercial recording industry for cross-licensing of intellectual property to move it from the lab bench to the consumer? How can we most effectively establish and maintain consumer trust that their health records and genetic information will be used for their benefit, and not against them? Are there any new approaches or technology solutions that could enable the use of the information and empower consumers to control access to specific parts of their personal health information? How should we provide incentives and reimbursement for information-based health care delivery? Are there ways to make personalized health care a component of a cost-effective health care industry? How can we leverage the federal government's market share to accelerate the integration of information and technology into clinical decision making processes? In going forward, I also believe we need to be careful that we don't over promise. It will take many years to achieve a fully personalized health care system in America. But the promise is great, and the future of this new frontier is so very bright. I'm looking forward to working with you to build this future. Now, I'd love to take any questions you may have. ### Note: All speeches from the Office of the Deputy Secretary are available at http://www.hhs.gov/agencies/depsecspeeches.html. Last revised: July 5, 2007 |
|
