Budget Request for FY2012, May 11, 2011

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

Fiscal Year 2012 Budget Request

Witness appearing before the

Senate 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

May 11, 2011


Mr. Chairman and Members of the Committee:

I am pleased to present the President’s Fiscal Year 2012 Budget request for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The FY 2012 budget includes $1,837,957,000, which is $47,272,000 more than the comparable FY 2011 level. Complementing these funds is an additional $150,000,000 also available in FY 2012 from the Special Statutory Funding Program for Type 1 Diabetes Research. The NIDDK supports research on a wide range of common, chronic, costly, and consequential diseases and health problems that affect millions of Americans. These include diabetes and other endocrine and metabolic diseases; digestive and liver diseases; kidney and urologic diseases; blood diseases; obesity; and nutrition disorders.

UNCOVERING THE GENETIC AND ENVIRONMENTAL CAUSES

OF DISEASE TO INFORM THERAPY AND PREVENTION

Unprecedented discoveries in genetics continue to lead the way toward the development of personalized treatments and prevention of devastating diseases and disorders. Scientists revealed that certain variants in the APOL1gene may be responsible for the differential risk of developing kidney disease for African Americans. These variants also provide a degree of protection against African sleeping sickness, a degenerative and potentially fatal condition caused by a parasite that is endemic to Africa. This could explain why these variants are more commonly found in individuals of African descent, despite the increased risk of kidney disease they confer.

Many of the diseases within the NIDDK research mission result from the interaction between multiple genetic and environmental factors. Research on the human microbiome—the microorganisms associated with the body—has demonstrated that the composition of bacterial communities is determined mostly by their location on or in the body and varied between people. In a separate study, scientists reported that bacteria in the mouse gut contributed to changes in appetite and metabolism. Therefore, excess calorie composition and obesity may be affected by these bacterial populations. Researchers in The Environmental Determinants of Diabetes in Youth are using newly developed technologies to study the microbiome of children at high risk for developing type 1 diabetes and explore whether viral or bacterial-based treatments could be used to prevent or treat the disease. NIDDK will continue to capitalize on recent genetics and environment discoveries to transform prediction, prevention, diagnosis, and treatment of diseases within the Institute’s mission.

IMPROVING PATIENT CARE THROUGH RESEARCH

Obesity is a major health epidemic in the U. S., and it increases the risk for type 2 diabetes; kidney, heart, and liver disease; and other health issues. Therefore, efforts to curb this rising trend are vitally important. The NIDDK’s HEALTHY study revealed that while a middle school-based intervention did not reduce obesity school-wide, it lowered the obesity rate in students with the highest risk for type 2 diabetes. This important result will inform future school-based efforts to reduce overweight and obesity in children. Research also shows that weight loss can improve the health of people with diabetes. NIDDK’s Look AHEAD study showed that weight loss in overweight and obese people with type 2 diabetes can lead, with lower medication requirements, to long-term favorable effects on diabetes control and cardiovascular risk factors.

NIDDK continues to support efforts to test potential treatments for NIDDK-related diseases and disorders. Investigators demonstrated in a preliminary trial that salsalate, an anti-inflammatory drug used for years to manage arthritis pain, can help people with type 2 diabetes control blood glucose levels. If the expanded trial is successful, it could lead to a safe and inexpensive way to treat the disease. Non-alcoholic steatohepatitis (NASH) is a form of fatty liver disease associated with overweight and can lead to liver cirrhosis and liver failure requiring a transplant. Currently, there are no specific, FDA-approved treatments for NASH. NIDDK scientists compared vitamin E, the insulin-sensitizing drug pioglitazone, and placebo for treatment of adult NASH, and reported promising improvements in response to 2-year therapy, especially for vitamin E.

It is important to compare available, effective treatments and combine this knowledge with a patient’s history to identify the best option for treating an individual. A recent NIDDK study demonstrated that, on average, a lower blood pressure goal was no better than the standard goal at slowing progression of kidney disease among African Americans who had chronic kidney disease resulting from high blood pressure. However, the lower blood pressure goal did benefit patients who had protein in their urine, a sign of kidney damage. In light of the APOL1 results I described earlier, this and other findings suggest that genetic traits more common in African Americans may subtly alter the pathogenesis of kidney disease in this population, and new classes of drugs that target these pathways might be more effective in preventing the onset and progression of chronic kidney disease in these patients.

Millions of American women suffer from stress urinary incontinence, an underdiagnosed public health problem that is associated with diminished quality of life. An NIDDK trial demonstrated that two different surgical approaches were equally effective – although they had different side effects -- in treatment for stress urinary incontinence, a major milestone in treatment for this condition. This information will enable women and their doctors to weigh more accurately the benefits and risks of available treatment options. In concert with identifying the best treatment options, NIDDK research aims to ensure that patients are able to take advantage of these results to improve their health and care.

DISSEMINATING RESEARCH RESULTS TO IMPROVE PUBLIC HEALTH

It is critical that the results of research reach the American public quickly and clearly to translate to real improvements in health. NIDDK supports a number of public health campaigns such as the National Kidney Disease Education Program, the Weight-control Information Network, a Celiac Disease Awareness Campaign, and the National Diabetes Education Program (NDEP).

Diabetes continues to be a growing worldwide public health concern; rising rates of obesity and an aging populance are driving the increasing prevalence of type 2 diabetes. There is hope, however: research has shown that it is possible to delay—or even prevent—the disease. The NIDDK’s landmark Diabetes Prevention Program (DPP) was a tremendous success, demonstrating that loss of 5-7 percent of an individual’s body weight—or treatment with the drug metformin-- can delay type 2 diabetes. By eating less fat and fewer calories and doing moderate exercise, such as brisk walking, DPP participants were able to lose body weight and maintain the loss. These lifestyle changes worked particularly well for participants age 60 and older, and were equally effective for all participating ethnic groups and for both men and women.

To transfer the lessons of the DPP to the community level, NIDDK supports translational research, which included a trial of less costly delivery of the DPP intervention in YMCAs in group settings. The results have led CDC and private organizations to fund the intervention at more Ys and United Health Group to cover the cost for plan participants to use the intervention at Ys. Additionally, the NDEP is disseminating the good news from the DPP follow-up study that development of type 2 diabetes continued to be reduced 10 years after the intensive lifestyle change or treatment with metformin. NDEP has partnered with NIH’s Office of Research on Women’s Health to also raise awareness of the increased risk of type 2 diabetes for women who have a history of gestational diabetes.

GENERATING RESEARCH OPPORTUNITIES

The future of public health depends critically on the development of the next generation of scientists and the pursuit of scientific opportunities. NIDDK continues to vigorously support new investigators, and training and mentorship in biomedical research. NIDDK held its 2nd annual New Investigators’ meeting to enhance their ongoing research and spur future success. NIDDK also held its 8th annual workshop for the Network of Minority Research Investigators to encourage and facilitate participation of members of underrepresented racial and ethnic minority groups in the conduct of biomedical research in NIDDK-relevant fields. These new investigators will be poised to take advantage of a wealth of opportunities to improve the health of Americans; such opportunities have been identified by a number of recent strategic planning efforts undertaken by the NIDDK.

The development and application of new technologies will also improve patient care. Through support for small business innovation research grants and other efforts, NIDDK will foster cutting-edge research in this area. New technologies could facilitate analysis of organs, tissues and biological molecules, and, with mobile communication, help convey critical information quickly to patients and health care providers. This research would enhance our ability to monitor disease progression or how a therapy is working and would improve diagnosis of disease or risk, to enable earlier intervention.

In closing, Mr. Chairman, NIDDK will continue to emphasize my guiding principles: support a robust portfolio of investigator-initiated research; vigorously support clinical trials to identify better ways to prevent and treat disease; preserve a stable pool of new investigators; disseminate science-based knowledge from research through education programs; and foster research training and mentoring.

Thank you Mr. Chairman and members of the Committee for the opportunity to share with you a few highlights of NIDDK’s research and outreach efforts to improve the health of Americans. I will 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

Biographical Sketch

Griffin P. Rodgers, M.D., M.A.C.P.

Dr. Griffin P. Rodgers was named Director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)—one of the National Institutes of Health (NIH)—on April 1, 2007. He had served as NIDDK’s Acting Director since March 2006 and was the Institute’s Deputy Director from 2001-2009. Dr. Rodgers also has been chief of the Molecular and Clinical Hematology Branch since 1998; the branch is now administratively managed by NIH’s National Heart, Lung, and Blood Institute.

Dr. Rodgers received his undergraduate, graduate, and medical degrees from Brown University in Providence, R.I. He performed his residency and chief residency in internal medicine at Barnes Hospital and the Washington University School of Medicine in St. Louis. His fellowship training in hematology/oncology was in a joint program of the NIH with George Washington University and the Washington Veterans Administration Medical Center. In addition to his medical and research training, he earned a master's degree in business administration, with a focus on the business of medicine, from Johns Hopkins University in 2005.

As a research investigator, Dr. Rodgers is widely recognized for his contributions to the development of the first effective—and now FDA approved—therapy for sickle cell anemia. He was a principal investigator in clinical trials to develop therapy for patients with sickle cell disease and also performed basic research that focused on understanding the molecular basis of how certain drugs induce gamma-globin gene expression. Recently, he and his collaborators have reported on a modified blood stem-cell transplant regimen that is highly effective in reversing sickle cell disease in adults and is associated with relatively low toxicity. He has been honored for his research with numerous awards, including the 1998 Richard and Hinda Rosenthal Foundation Award, the 2000 Arthur S. Flemming Award, the Legacy of Leadership Award in 2002, and a Mastership from the American College of Physicians in 2005.

Dr. Rodgers has been an invited professor at medical schools and hospitals in France, Italy, China, Japan, and Korea. He has been honored with many named lectureships at American medical centers and has published over 150 original research articles, reviews, and book chapters and has edited four books and monographs.

Dr. Rodgers served as Governor to the American College of Physicians for the Department of Health and Human Services from 1994 to 1997. He is a member of the American Society of Hematology, the American Society of Clinical Investigation, the Association of American Physicians, and the Institute of Medicine of the National Academy of Sciences, among others. He served as chair of the Hematology Subspecialty Board and is a member of the American Board of Internal Medicine Board of Directors. He is board certified in Internal Medicine, in Emergency Medicine, and in Hematology.

Page last updated: May 13, 2011

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