March 30, 2000
The Honorable John E. Porter
Subcommittee on Labor, Health and Human Services,
Education and Related Agencies
Committee on Appropriations
2358 Rayburn House Office Building
United States House of Representatives
Washington, D.C. 20515
Dear Mr. Chairman:
On behalf of the more than 9000 members of the American Urological Association (AUA) and the patients they serve, I am pleased to have the opportunity to submit our recommendations for fiscal year 2001 funding for urology research at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Cancer Institute (NCI). We are also recommending that the Centers for Disease Control and Prevention (CDC) receive additional funds to expand their efforts on prostate cancer.
On behalf of the AUA, I want to thank the Congress, and especially this Subcommittee for its strong support of NIH and CDC. Last year we took another step toward doubling the budget for biomedical research. This was welcome news for the medical and scientific communities, and most importantly, for our citizens who will one day benefit from the results of this research. NIH is among our best investments, and the nation needs to strengthen its biomedical research infrastructure if we are to continue to improve the health of our citizens. This Subcommittee has been steadfast in its support of biomedical research, and AUA greatly appreciates those efforts.
Urological diseases can affect anyone, from early infancy through the later years of life. As our population ages, the incidence and consequences of urologic disease will become more profound and a greater burden to individuals and society. Genitourinary diseases and conditions result in estimated health care expenditures in the United States of nearly $50 billion each year. One third of all new cancers in 2000 will involve a urologic organ. Fifty percent of all new cancers in men are urologic in origin.
The effect of these diseases on minority populations and women is significantly greater than the overall effect on the entire population. For example, the incidence of prostate cancer among African American males is twice that of white men. Women suffer from urinary incontinence at twice the rate of men.
Although measurable advances in the prevention and cure of these diseases have been made, much remains to be done, and the funds available for urologic research remain small when compared to those available for other diseases of similar impact. We believe that urological diseases and conditions constitute a major public health problem in this nation; one that is not being adequately met by existing research and public health mechanisms. We hope that the commitment of Congress to foster growth in the overall budget at NIH will translate into comparable gains in support for urologic research. Our recommendations cannot be acted upon unless NIH is willing and able to allocate a greater percentage of its growing budget to this disease category.
National Cancer Institute
The American Cancer Society (ACS) estimates that 180,400 new cases of prostate cancer will be diagnosed in 2000. This means that prostate cancer continues to be the most commonly diagnosed cancer (excluding skin cancer) among men. ACS further projects that 31,900 men will die from this disease this year. It is imperative that we continue to improve our ability to detect and treat prostate cancer. AUA is pleased with the initiatives in prostate cancer that are underway at NCI. If adequately funded, they will help unlock even more of the secrets of this cancer. In recent years there has been measurable progress in earlier diagnosis and improved outcome. Prostate cancer rates have declined, largely, we believe, because of earlier detection and improved treatments. This is only possible because of the support Congress has provided to the National Cancer Institute and the willingness of NCI to respond effectively to the encouragement provided by the federal legislature. Prostate cancer comprises 29 percent of all new male cancer cases diagnosed each year, but still receives less than five percent of the dollars expended on cancer at NIH. While we have made progress, much remains to be done. Our ability to detect prostate cancer at an earlier, more curable stage is vastly improved, but still could be better. Early detection of prostate cancer allows men to have a greater choice of treatment options. However, we need a better understanding of which treatments are the most effective. All of us who treat prostate cancer would like to see better treatments become available to our patients. Only research, backed by a strong commitment of federal funding, can lead us there. In order to meet the needs in prostate cancer research, we join with the National Prostate Cancer Coalition in asking for a 15 percent funding increase for the NIH which would also support at least $324.4 million for prostate cancer research, and full funding ($4.1 billion) of the NCI Bypass Budget for FY 2001.
However, we should not forget that the other urologic cancers, including testicular, bladder and kidney cancer, also affect thousands of Americans and their families each year. As the budget for NCI increases, new funds must be allocated to work in these areas. Currently, they are not adequately funded. AUA recommends that NCI develop a comprehensive plan showing how these other urologic cancers can be addressed. Such a plan, worked out with the urologic scientific community, can help Congress determine the appropriate level of funding for these cancers and assure that federal funds are spent most effectively to combat these diseases.
National Institute of Diabetes, Digestive and Kidney Diseases
A key part of the effort to combat prostate cancer is to increase our understanding of the basic science of the prostate and of the factors that regulate prostate growth. A better understanding of these factors is one of the goals of the urology program at NIDDK. These new funds would strengthen work to evaluate factors that affect the regulation of prostate growth. In addition to helping in the fight against prostate cancer, this research can lead to new breakthroughs in our understanding of prostatitis and benign prostatic hypertrophy (BPH). Prostatitis is a painful condition affecting younger men and it has been estimated that the cost of this disease exceeds one half billion dollars annually.
BPH affects more than 12 million men over age 50, and twenty percent of them require treatment. Surgical treatment for the symptoms of the disease is the most common operation in the male over 65 years old in the United States. Although new treatments have become available, there is still a poor understanding of the factors that affect prostate growth, and new funds are very much needed to stimulate additional work. We also need to focus more attention on the bladder and urethral changes in response to the enlarged prostate. Bladder dysfunction and urinary obstruction are important problems associated with BPH, yet the relationships, causes and mechanisms are poorly understood.
There is a pressing need to increase research into the urologic disorders that affect women: urinary incontinence, urinary tract infections, interstitial cystitis (IC) and other problems of the bladder. These diseases affect millions of women of all ages and result in major U.S. health care expenditures. There is very little funded research that focuses on either the prevention or effective treatment of these diseases. NIDDK has not been responsive to Congressional efforts to advance clinical and basic research in women's urology. There is a compelling need for additional research into urinary incontinence, IC, urinary tract infections, and other basic bladder problems. This Subcommittee has previously called for renewed efforts in this area, but, other than a conference, no action has taken place. The generous increases that Congress has made available should help NIDDK pay closer attention to these issues.
We believe that insufficient attention has been paid to health problems that affect women to a much greater degree than men. Urological problems of women fall into that category of neglect. Urinary incontinence is a major cause of nursing home admissions for women. The management of incontinence remains an escalating cost for nursing homes. Research targeted to this problem could substantially reduce these health care costs and prolong the ability of many elderly women to remain in their homes.
Three other areas of research need attention, male infertility and impotence, congenital anomalies of the genitourinary tract and kidney stone diseases. In the area of male infertility for example, funding is extraordinarily limited although in couples who are infertile 50% of the infertility is due to male factors. Impotence affects as many as 30 million men, yet virtually no research is directed to the problem, and this may relate to the increasing cost associated with treatment of this problem. Urinary stone disease is a common and very painful occurrence for many Americans. Although effective treatments are available, almost no work is being done to advance this field.
Urology problems that are present at birth result in significant physical and psychological stress for both the parents and the child. Most of these problems are due to congenital errors in the development of the urinary tract. The NIH devotes minimal research dollars to investigating either the genetic origin or effective treatment strategies for these abnormalities. The reality of genetic intervention could provide an entirely new method of understanding the inheritance, the cause and the effective treatment of these defects. We recommend that the NIDDK collaborate with other interested institutes in developing a strategic research plan to address congenital urological disorders in the pediatric age group. We need to initiate new, innovative research projects in these areas, especially such prevalent conditions as ureteral reflux, fetal hydronephrosis, and the effective treatment of the bladder dysfunction of spina bifida.
There is a great need to increase training programs for physicians who wish to pursue careers in the epidemiology of urologic disease and in the development and conduct of urological clinical trials. NIDDK should be directed to initiate such a program in order to meet critical manpower needs. NIDDK is the home of the George M. O'Brien Kidney and Urology Research Centers that have made a significant contribution to progress in these disease areas. We urge continued funding for their activities. In addition, AUA recommends the creation of two new urologic centers, both of which should have a clinical component and a research training component.
NIDDK should increase research into the effective treatment of bladder dysfunction associated with spinal cord injury and neurological diseases. Bladder dysfunction associated with these disorders is frequently the cause of protracted illness, kidney failure and even death from overwhelming infection. We need to make sure that the most effective methods of treatment and new and innovative approaches to treatment are investigated and utilized.
We believe that many of the problems with urology research are due to the lack of focus for urology at NIH and within NIDDK. Until recently, grant applications in urology were being sent to as many as nine Institutes with possible review by any of over 20 study sections, none of which had any expertise in urology. These compare to cardiology grant applications that typically go to only three study sections, each of which has a concentration of cardiovascular expertise.
NIH has finally responded to repeated Congressional requests, and has created a urology "special emphasis panel" (SEP) to bypass the regular process. NIH has more recently created a Renal and Urological Sciences Integrated Review Group (IRG), clusters of scientifically related study sections. We believe this IRG will improve urologic peer review at NIH as reviewers will have the critical mass of expertise needed to fairly evaluate applications in the urologic sciences. AUA is encouraged by the early progress of the SEP and thanks the Center for Scientific Review's (CSR) new leadership for their willingness to respond to our concerns regarding peer review. We will continue to monitor the progress the SEP, IRG, and other CSR initiatives and report our findings to this Subcommittee.
However, despite these changes, we continue to recommend a concentration of urology research into fewer Institutes, as well as a reduction in the number of study sections reviewing urology applications. These remaining study sections should be expanded to include additional urologic scientists to insure that the necessary expertise is there to have adequate peer review of the applications.
At the present time, there is still little coordination of urology research at NIH. AUA believes that better research outcomes in urology could be achieved if a stronger organizational structure can be established. We recommend that this committee direct NIDDK to establish a National Center for Urological Research reporting to the Director of the Institute. This Center should have its own advisory committee and sufficient funding to bring all the modern tools of biomedical research to bear on the many challenges in urology research. Similar structures have proven their worth over time. The urological health of the nation deserves no less. Such an office would be responsible for monitoring all ongoing research related to men's urological health, would stimulate and co-fund initiatives in the NIH Institutes, would prepare for the Director of NIH and the Secretary of HHS an annual report on men's urological health funding at NIH, would develop an NIH wide strategic research and education plan to address the many problems related to men's urological health, could develop and fund a national education program related to specific male urological diseases, and could fund from its own resources pilot and feasibility studies to stimulate new research in targeted areas.
Centers for Disease Control and Prevention
Since prostate cancer does strike African American men at a much higher rate, it is imperative that we conduct prevention and outreach programs within this community to assure early intervention and treatment using the best tools available. CDC is a logical place for such an effort given its experience with similar programs in breast and cervical cancer. We are pleased that the efforts of Congress to stimulate such a program have succeeded, and a small activity has been developed. These activities show great promise, and we ask that an additional $10 million be allocated to this effort in order to expand CDC's ability to target high-risk populations for this disease. Education, awareness and early detection are key to reducing the extremely high prostate cancer rates among African American men. CDC does not conduct prostate cancer screening programs, since there are many programs throughout the country that provide screening for free or at reduced rates. However, men must be motivated to take advantage of these opportunities, and this is an area in which CDC can play a critical role. AUA urges careful consideration of these recommendations and appreciates the opportunity to submit them to the Subcommittee for the record. We urge the Subcommittee to maintain its efforts on behalf of NIH and to focus greater attention on urologic diseases and conditions in this next fiscal year. Please contact Richard Williams, MD, AUA Urology Research Funding Committee Chair, at 319-356-0760 if you have any questions.
Lloyd Harrison, MD,
American Urological Association