DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
Fiscal Year 2009 Budget Request
Witness appearing before the
House Subcommittee on Labor-HHS-Education Appropriations
Griffin P. Rodgers, M.D., M.A.C.P., Director
National Institute of Diabetes and Digestive and Kidney Diseases
March 5, 2008
Richard J. Turman, Deputy Assistant Secretary, Budget
Mr. Chairman and Members of the Committee:
I am pleased to present the President’s budget request for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The Fiscal Year (FY) 2009 budget of $1,858,487,000 includes an increase of $1,803,000 over the FY 2008 appropriated level of $1,856,684,000, as well as $150,000,000 in specific funding for research on type 1 diabetes. Our Institute supports research into a wide range of common, chronic, and costly health problems that affect many millions of Americans. These include diabetes and other endocrine and metabolic diseases; digestive and liver diseases; kidney and urologic diseases; blood diseases; and obesity.
Obesity contributes to many health problems, including type 2 diabetes, kidney disease, and cardiovascular disease. Obesity has become epidemic in our country. According to the CDC, approximately one-third of adult Americans are obese, and the proportion of children and adolescents who are overweight has increased dramatically in the past thirty years. If we continue on this path, the results will be devastating to both the health of our nation and to our healthcare system. Many of our research efforts are therefore directed toward reversing these disturbing trends. Thus, the NIDDK supports a multidimensional obesity research effort that includes studies of the molecular pathways that regulate appetite, satiety, and energy expenditure; research into the role of inflammation in obesity-associated health problems; exploration of the genetic factors that predispose people to obesity; the development and testing of environmental modifications that may help prevent obesity; and research into bariatric surgery as a treatment for severe obesity in both adults and adolescents. Another exciting component of our obesity research effort is the new Metabolic Clinical Research Unit at the NIH Clinical Research Center, which allows scientists to collect environmental, dietary, and metabolic data in normal, overweight, or obese patients.
Obesity is a major risk factor for type 2 diabetes. Diabetes arises when the body fails to produce enough insulin to regulate blood sugar levels or when tissues stop responding to it. It leaves patients vulnerable to ravaging complications: kidney disease, blindness, and amputation among them. Nearly 21 million American have diabetes—the vast majority has type 2, previously referred to “adult-onset”—and another 54 million have “pre-diabetes.” Minority ethnic groups bear an especially heavy burden. Type 2 diabetes is becoming more common in children and adolescents, placing them at risk of debilitating complications in the prime of their lives. Research to preempt type 2 diabetes is thus a major focus of our efforts. For example, our HEALTHY study is investigating whether changes in food services and physical education classes, along with activities to encourage healthy behavior, will reduce the risk of type 2 diabetes in at-risk school children.
Studies have shown that weight loss can lead to improvements in diabetes symptoms, but long-term weight loss has proven to be difficult for most people to maintain. Our ongoing Look AHEAD clinical trial has reported that overweight and obese individuals with diabetes who received an intensive lifestyle intervention lost more weight, had lower blood sugar levels, decreased use of medication, and improved blood pressure and cholesterol compared to patients who received standard therapy. Look AHEAD may identify ways to predict underlying heart disease long before symptoms appear, and to preempt its development.
In type 1 diabetes, the body’s immune system destroys the insulin-producing beta cells in the pancreas, necessitating life-long insulin provision. The “SEARCH for Diabetes in Youth” study recently reported that there are approximately 15,000 new cases of type 1 diabetes diagnosed annually. Basic studies of beta cell development and function hold out hope of restoring endogenous insulin production. Research continues on devices that would allow continuous monitoring of blood glucose coupled with insulin infusion, “closing the loop,” and making diabetes management easier and better.
CHRONIC KIDNEY DISEASE
Diabetes is the leading cause of kidney disease. About 13 percent of the U.S. population—26 million people—has some degree of kidney impairment, and more than 485,000 have irreversible kidney failure, a condition known as end-stage renal disease, or ESRD (JAMA 298: 2038-47, 2007; U.S. Renal Data System). Kidney disease raises the risk of heart attack, stroke, and early death.
The NIDDK is actively pursuing a range of studies directed at chronic kidney disease and ESRD. One study is investigating relationship between chronic kidney disease in adults—with an emphasis on diabetes and health disparities—and cardiovascular disease. Another study focuses on the special challenges posed by chronic kidney disease in the pediatric population. The NIDDK has joined with the National Heart, Lung, and Blood Institute in a study to determine whether lowering blood pressure below current targets can reduce the risk of cardiovascular disease and chronic kidney disease in people at high risk. Ultimately, thought, our best hope for reducing the burden of kidney disease lies in prevention.
THE GENETICS OF COMPLEX DISEASES
Many of the diseases within the NIDDK research mission are complex diseases that arise from the contributions of multiple genetic factors and their interactions with the environment. For example, communication between the microbial flora in the human gut, or “microbiome,” and the body plays an important role in energy metabolism. Differences in microbial populations can result in more calories being available from food and can influence whether these calories are burned or stored, and thus may contribute to overweight and obesity. The NIH Human Microbiome Project, a Roadmap initiative that is co-led by the NIDDK, aims to generate resources and tools to enable fuller characterization of the microbiome. It has the potential to transform the ways we understand human health and prevent, diagnose, and treat a wide range of conditions, including obesity and overweight.
Basic research into the genetic factors that influence susceptibility to type 2 diabetes has recently identified four novel chromosomal regions that seem to confer increased risk. “The Environmental Determinants of Diabetes in the Young” study is searching for as-yet unidentified environmental triggers that may spark the autoimmune destruction of insulin-producing cells that causes type 1 diabetes. Work by the NIDDK’s Inflammatory Bowel Disease Genetics Consortium has contributed to the identification of up to 10 susceptibility genes for Crohn’s disease. All of this work may allow future treatment to be more personalized, reflecting a patient’s genetic profile.
The Genetic Association Information Network (GAIN) is a new public-private partnership of the Foundation for the NIH. GAIN will evaluate the subtle differences between the genomes of people with and without six common diseases that affect the public health. Data from the NIDDK’s Genetics of Kidneys in Diabetes study, which is investigating the genetics of diabetic kidney disease, will be analyzed through the network. Knowledge emerging from this effort could accelerate the development of new methods for prevention, diagnosis, and treatment of this disease. The NIDDK is also participating in the new NIH “Genes, Environment, and Health Initiative,” which will use innovative genomic tools to determine the effects of genetic variants that increase or decrease disease risk in response to environmental exposures.
REACHING THE PUBLIC
The ultimate goal of medical research is to improve public health. As such, we support a number of education, outreach, and awareness programs designed to bring science-based knowledge gained from NIDDK research to health care providers and the public for the direct benefit of patients and their families. These include the Weight-control Information Network, the National Diabetes Education Program, the National Kidney Disease Education Program, and the Celiac Disease Awareness Campaign.
MEDICINE IN 2030
Through the vigorous and innovative research enabled and undertaken by the nation’s scientific enterprise, we can hope to see improvements in the prevention, detection, and treatment of the diseases I’ve spoken of today. The rising tide of obesity may be stemmed through behavioral changes and pharmacologic therapy, shaped by insights into the molecular pathways involved in weight gain and loss, and using approaches that have proven effective. We may preempt type 2 diabetes in at-risk individuals through lifestyle interventions and by identifying susceptibility genes to enable earlier intervention. More effective interventions to reverse diabetes may emerge from ongoing clinical trials, staving off this disease’s debilitating complications. Earlier and more aggressive management of diabetes and high blood pressure may delay or prevent kidney disease, or give patients additional, improved years of life without the need for dialysis.
Medicine today is largely focused on treating symptoms after a diagnosis is made. In the future, it may be possible to predict which individuals are at risk of developing a disease, and intervene early to prevent onset. Genetic analyses may allow physicians to personalize treatment to an individual’s specific disease subtype or profile. This new model will also give patients the opportunity to participate more actively in their care, with greater knowledge of their personal risk factors.
These improvements in quality-of-life will also yield economic benefit to the nation. For example, the CDC has estimated that the yearly costs associated with obesity are between $27 and $47 billion. Success in preventing diabetes will reduce significantly the $174 billion annual cost of this disease (American Diabetes Association estimate). Preventing progression of kidney disease to the point of total kidney failure saves Medicare an estimated $250,000 per patient (U.S. Renal Data System).
The studies, trials, and initiatives I have highlighted represent just a few of the important elements in NIDDK’s research agenda. I have not mentioned our robust core of investigator-initiated grants, which represent the foundation of NIDDK’s research portfolio. Since becoming Director last year, I have made the maintenance of our investigator-initiated research effort one of my five guiding principles for the NIDDK, because the innovativeness and problem-solving ability of individual investigators are crucial for research progress. In addition, as I have noted, I strongly believe that we must continue to support clinical studies to identify better ways to prevent and treat disease. Another element that is absolutely essential to our success is to preserve a stable pool of new investigators, because the new ideas and fresh perspectives of these investigators invigorate the research enterprise. Fostering research training and mentoring is also key, because maintaining a robust pipeline of outstanding investigators is critically important to progress in research. Finally, we must ensure knowledge dissemination of science-based knowledge gained from research through education programs. Moving forward, we will continue to pursue the most promising research opportunities while continuing to support our community of researchers.
In closing, thank you, Mr. Chairman and members of the Committee, for the opportunity to share with you a few highlights of NIDDK’s research program. I would be pleased to answer any questions you may have.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases
Griffin P. Rodgers, M.D., M.A.C.P.
Dr. Rodgers is the Director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health, a position he has held since April 1, 2007, after holding the post of Acting Director for one year. As Director, Dr. Rodgers oversees a national research program in diabetes, endocrinology, and metabolic diseases; digestive diseases and nutrition; and kidney, urologic, and hematologic diseases, the goal of which is to improve the health and quality of life for all Americans. Prior to leading the Institute, Dr. Rodgers served as its Deputy Director from 2001, a position that he still holds. An active researcher, Dr. Rodgers also is Chief of the Molecular and Clinical Hematology Branch of the NIDDK’s Intramural Research Program.
A native of New Orleans, Dr. Rodgers received his undergraduate, graduate, and medical degrees from Brown University in Providence, Rhode Island. He was an intern, resident and chief resident in internal medicine at Barnes Hospital and the Washington University School of Medicine in St. Louis, Missouri. His fellowship training in hematology was in a joint program of the National Institutes of Health, The George Washington University, and the Washington Veterans Administration Medical Center. Dr. Rodgers has also recently received a Master of Business Administration degree with a concentration in the Business of Medicine from The Johns Hopkins University in Baltimore, Maryland.
Dr. Rodgers is widely recognized for his contributions to the development of the first effective—and now Food and Drug Administration-approved—therapy for sickle cell anemia. He has served as the principal investigator in clinical trials to elevate pharmacologically fetal hemoglobin to counteract the deleterious molecular and cellular effects present in the red cells of these patients. Dr. Rodgers’ basic research has focused on understanding the molecular basis of how these drugs induce gamma-globin gene expression. His laboratory also focuses on the identification and characterization of early markers of hematopoietic stem cell lineage-specific differentiation, and on the application of hematopoietic stem cell based approaches to thalassemia and sickle cell disease, including transplantation and gene therapy strategies.
Dr. Rodgers has been honored for his research with numerous awards including the Public Health Service Physician-Researcher of the Year and Hildrus A. Poindexter Awards, the Richard and Hinda Rosenthal Foundation Award, the Arthur S. Flemming Award, and Mastership in the American College of Physicians, among others.
Dr. Rodgers has served as Distinguished Lecturer and has delivered several named lectures nationally and internationally. He has published over 150 original research articles, numerous reviews, book chapters, books and monographs. He is a member of the editorial board of several scientific journals.
Dr. Rodgers served as Governor to the American College of Physicians for the Department of Health and Human Services, and is a member of the American Society of Hematology, the American Society for Clinical Investigation, and the Association of American Physicians. He is the Chair of the Hematology Subspecialty Board, and is a member of the American Board of Internal Medicine Board of Directors.
Department of Health and Human Services
Office of Budget
Richard J. Turman
Mr. Turman is the Deputy Assistant Secretary for Budget, HHS. He joined federal service as a Presidential Management Intern in 1987 at the Office of Management and Budget, where he worked as a Budget Examiner and later as a Branch Chief. He has worked as a Legislative Assistant in the Senate, as the Director of Federal Relations for an association of research universities, and as the Associate Director for Budget of the National Institutes of Health. He received a Bachelor’s Degree from the University of California, Santa Cruz, and a Masters in Public Policy from the University of California, Berkeley