Policy & Public Affairs
ASN Testimony
Statement for the Record on Behalf of the AMERICAN SOCIETY OF NEPHROLOGY Regarding the Fiscal Year 2003 Appropriations Submitted to the United States House of Representatives Committee on Appropriations Subcommittee on Labor, Health and Human Services and Education, The Honorable Ralph Regula, Chair
May 9, 2002
The American Society of Nephrology (ASN) is pleased to submit this statement for the record to the House Appropriations Subcommittee on Labor, Health and Human Services and Education in support of the ASN's top funding and research priorities for FY 2003.
The ASN is a professional society of more than 7,500 researchers, physicians, and practitioners who are committed to the treatment, prevention, and cure of kidney disease. While there are many competing needs for health care funds, we also must not forget the lives and health needs of many Americans who face kidney disease everyday. In particular, we are asking the Committee and this 107th Congress to support ASN and kidney related research by providing a $1.74 billion, a 19.2% increase over FY 2002 levels, within the National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK). This percentage increase is necessary in order for NIDDK to achieve parity with the 5-year goal of doubling the NIH budget, of which this is the last year of the cycle.
INTRODUCTION
Many people are unaware that renal disease is a major health problem in the United States. End stage renal disease (ESRD), a condition in which patients have permanent kidney failure, affects almost 400,000 Americans, and directly causes 50,000 deaths annually. Over the past ten years, the number of patients in the United States with ESRD has almost doubled. Although the largest age group having ESRD ranges from 45-64 years old, rates increase steadily for those between the ages of 65-74 and are disproportionately high in African Americans. African-Americans make up about 32.4 percent of all patients treated for kidney failure in the U.S., but only 12.6 percent of the U.S. population. Hardest hit are African Americans between the ages of 25 and 44, who are 20 times more vulnerable to kidney failure than whites in the same age group. Native Americans, Hispanics, Pacific Islanders and Asians also have been found by researchers to suffer increasingly high rates of ESRD.
In addition to ERSD, a large number of people suffer from chronic kidney disease, with at least 13 million people having lost 50% of their kidney function without even knowing it. Another 20 million more Americans are at increased risk of developing kidney disease.
ECONOMIC COSTS
Although no dollar amount can ever be affixed to human suffering or the loss of human life, economic data can help to identify and quantify the current and projected future financial costs associated with ESRD. The 2000 report of the United States Renal Data System indicates that the total Medicare ESRD program cost is projected to more than double, surpassing $28 billion, by 2010, as the instances of kidney failure are projected to double. The annual average cost per ESRD patient is approximately $44,000.00. These escalating costs serve to magnify the need to investigate strategies for preventing progressive kidney disease in the first place.
In short, we can treat and maintain patients who have lost their kidney function but the critical need is to prevent the loss of kidney function and its complications in the first place. Meeting this crucial goal can only be accomplished through research.
CAUSES OF END STAGE RENAL DISEASE
Diabetes, a disease that affects the way the body turns food into energy, is the most common cause of ESRD in the U.S. Nearly 34 percent of all Americans being treated for kidney failure have diabetes. In 1999, diabetes accounted for approximately 38,000 new cases of kidney failure in the U.S. Moreover, only 18 percent of people with diabetes survive 5 years after beginning treatment for kidney failure. Diabetes is most common among Native Americans (65 percent) and is found to be more prevalent among older Americans (36 percent) as opposed to any other age group.
The next leading cause of ESRD is hypertension, or high blood pressure (23.6 percent). Similar to diabetes, higher rates of hypertension can be found among certain age and ethnic groups. For example, hypertension is common among African Americans (35 percent). It is also a disease of the aged and accounts for 37 percent of new ESRD cases in those 65 years old and above. Glomerulonephritis is the third leading cause of ESRD (11.6 percent). Asians and Pacific Islanders suffer from a disproportionately high rate of glomerulonephritis (19 percent). The most common diagnoses of ESRD for those under 20 years of age are connected with glomerulonephritis (over 32 percent). Inherited diseases, such as polycystic kidney disease, plus urologic diseases, and miscellaneous conditions combine to make up the remaining causes of ESRD.
A major problem with kidney disease is that it is largely a "Silent Disease". In fact, of the 13 million Americans who have lost at least half of their kidney function, the vast majority has no knowledge of this. While people with chronic kidney disease may not be show any symptoms, this does not mean that they are not going to have long-term damage to their kidney function, requiring dialysis or a transplant. These people may also be especially vulnerable to cardiovascular disease. If these 13 million people were identified early, there are new therapies, particularly special blood pressure drugs known as ACE inhibitors, which could be prescribed with potentially significant benefits. Also, vigorous treatment of hypertension and other complications that cause illnesses and loss of productivity could be administered to the patients.
Given the cost to human life and to the federal government caused by ESRD specifically, as well as other forms of kidney disease, we urge this Subcommittee to provide funding increases for kidney disease research.
CLINICAL TRIALS COOPERATIVE GROUP FOR NEPHROLOGY
Many recent advances have been made in our understanding of the causes of progression of renal failure, such as: how diabetes affects the kidney; methods for modification of the loss of kidney function in genetic disorders such as polycystic kidney disease in experimental animals; and the mechanisms responsible for acute renal failure. Yet, these advances have not been successfully translated into improved patient outcomes. The number of patients with renal failure and the numbers who die of renal failure continue to increase every year.
By contrast, death rates for both cardiovascular disease and cancer have been greatly reduced, as has the death rate due to AIDS. These successes have largely been a consequence of large multi-center clinical trials. While we understand the relationship between hypertension and diabetes and the progression of kidney disease, other areas, including potentially useful treatment modalities for other kidney diseases, specifically interstitial renal and glomerular diseases, are less well understood. Carefully controlled randomized prospective clinical trials, such as those that have been employed in recent years in the fight against cancer, are sorely needed.
The need for research into the causes and treatment of renal disease underscores the necessity of an organizational structure to facilitate the conduct of clinical trials. Management of patients with acute and chronic renal failure is challenging because the existing evidence base is weak or lacking. Gathering the necessary tools and clinical evidence will require significant work and resources. Last year, the Appropriations Committee included report language that urged NIDDK to take steps to enhance kidney clinical trials research through establishing a new mechanism - a Kidney Disease Clinical Trials Cooperative Group - that would provide a permanent infrastructure to strengthen kidney research. In March 2002, the ASN and NIDDK held a planning workshop on this issue. Now, we ask your support to continue this process by asking NIDDK to move forward to launch a kidney disease clinical research mechanism this year, and to provide the necessary funding increases for NIDDK ($1.74 billion) that will allow this work to begin without jeopardizing other important research initiatives at NIDDK.
NEPHROLOGY WORKFORCE
The recruitment and retention of the best and the brightest to pursue careers in academic investigative nephrology has been and will continue to be an ASN goal. We believe that a major obstacle to achieving the goals of a cure for and the prevention of kidney disease is the difficulty in the current environment of attracting the most talented young individuals to pursue careers in research. Therefore, we also seek to encourage NIH and NIDDK to take steps to address the serious workforce shortage in nephrology, by encouraging NIH to expand its loan repayment program to include an extra-mural component for basic research. We would also like to encourage NIDDK to enhance and develop new training initiatives to foster increased interest in nephrology.
CONCLUSION
While chronic kidney disease has a devastating reach that affects Americans of all ages and backgrounds, certain populations are especially affected. Researchers have found that minorities and the elderly suffer from disproportionately high rates of ESRD. The Census Bureau estimates that some 40 million Americans will be over age 65 in 2010. And by 2030, the number is expected to grow to 66 million as a result of the aging of the large number of "baby boomers" born between 1946 and 1964. As the nation's population ages, the number of people with kidney disease will increase as well.
Furthermore, certain types of kidney disease tend to run in families. Recent studies suggest that patients requiring artificial kidney treatment are 6-10 times more likely to have a close family relative who also has kidney disease, but is not yet on dialysis. Certain ethnic populations of Americans also have an increased risk of kidney disease, and especially progressive kidney disease requiring dialysis. Hispanics in the western United States have a four-fold increased likelihood over Caucasians and Asian Americans for end stage renal disease requiring dialysis. The risk for African Americans to require dialysis is at least six-fold greater than the white population and African Americans in urban areas being at an even greater risk. Despite recent progress and discoveries regarding major causes of kidney disease, it is among many areas of disease research that remain under-investigated.
As practicing nephrologists, ASN members know firsthand the devastating effects of renal disease. ASN respectfully requests Congress' continued support to enable the nephrology community to continue with its efforts to find better ways to treat and prevent kidney disease and we ask that you include the attached report language in the FY '03 bill.
Thank you for your continued support for medical research and kidney disease research. To obtain further information about ASN, please go to http://www.asn-online.org or contact Deborah Outlaw or Asua Ofosu, ASN Government Relations staff at 202-367-1175.
FY 2003 Draft Report Language - American Society of Nephrology
National Institute of Diabetes, Digestive, and Kidney Disease
Kidney Disease Clinical Research: The Committee previously noted the current inherent problems in conducting kidney disease research due to lack of a permanent infrastructure, such as a Clinical Trials Cooperative Group. The Committee wishes to commend NIDDK for its leadership in moving forward in this area, by holding an initial workshop to develop strategies that will strengthen kidney research and enhance researchers' ability to translate research findings to the bedside, facilitate clinical trials, and recruit patients for studies. The Committee urges NIDDK to continue with these efforts and to make the necessary funds available in this fiscal year to launch a permanent kidney disease clinical research mechanism. The Director should be prepared to report at the FY 04 budget hearings as to needed funding in order to maintain the system.
Kidney Disease Workforce: The Committee remains concerned over the alarming growth in instances of kidney disease and ESRD, where cases are expected to double over this decade, at a cost to the Medicare program alone that will exceed $28 billion by 2010. While increased kidney disease research is vital, it is also imperative that we take appropriate steps to address the anticipated workforce shortage in nephrology that will be needed to handle these cases. The Director is encouraged to consider launching new training initiatives and workshops, such as grant writing seminars, to foster increased interest in this subspecialty.
National Institute of Heart, Lung, and Blood
Heart Disease and Kidney Disease: There is a well-established and significant link between heart disease, hypertension and kidney disease. With 41 million people having decreased kidney function, and in the face of an ever aging population, the need to develop better treatment and prevention strategies to address this linkage will only increase over the coming decade. The Committee is concerned that NHLBI should collaborate more fully with NIDDK to develop appropriate research initiatives that can be undertaken cooperatively, and urges NHLBI to sponsor a workshop on hypertension as it relates to heart and kidney disease with input from the renal community to address these issues.