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House Appropriations Committee Regarding NIH Funding

April 2, 2001

The Honorable Ralph Regula
Chairman, 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 2002 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 this Subcommittee for the 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.

AUA joins its colleagues in One Voice Against Cancer (OVAC) in recommending a FY 2002 appropriations of $23.7 billion for the National Institutes of Health. This $3.4 billion increase will keep NIH on track with the goal of doubling its budget over five years.

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. Genito-urinary 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 2001 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 real gains in support for urologic research.

National Cancer Institute

The American Cancer Society (ACS) estimated that 180,400 new cases of prostate cancer would be diagnosed in 2001. This means that prostate cancer continued to be the second most commonly diagnosed cancer among men. ACS further projected that 31,900 men would die from this disease this year which is a slight decrease that appears to be a sustained trend and represents what we believe is a result of early detection. 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 death 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.

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 $307.5 million, the amount of the bypass budget, in prostate cancer research at NIH for the next fiscal year. This amount will allow NCI to implement fully the five-year prostate cancer investment strategy it submitted to Congress last year.

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 has previously recommended 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 and the National Institutes of Health determine the appropriate level of funding for these cancers and assure that federal funds are spent most effectively to combat these diseases. We are pleased that NCI has responded to our request and established progress review groups for both kidney and bladder cancers. We look forward to their recommendations.

National Institute of Diabetes and Digestive and Kidney Diseases

Last year's appropriations conference report contained the following commentary on NIDDK, the home of the urology basic science program. "The conferees are concerned that the urology research effort is not addressing the large public health impact of urological diseases and conditions. NIDDK is strongly urged to enhance its research initiatives in urology."

Congress has provided substantial increases in the budgets of all Institutes, and now is the time for NIDDK to show Congress that it heard the message in last year's conference report. This means that existing programs must grow along with the overall agency budget. It also means that additional efforts are required because some key areas in urology research have been neglected in the past. It is critical that NIDDK provide this Subcommittee with specific plans for addressing these issues. There is no shortage of unmet need or opportunity in urology research.

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. 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 and to capitalize on developments in other fields of science. 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 increasing use of patient self-administered phytotherapy (saw palmetto) to treat BPH. However, there is little information available to clinicians or patients about the relative safety and effectiveness of this therapy. NIDDK should move forward on clinical trials aimed at aiding the public and urologists better understand whether or not there is a role for phytotherapy.

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.

We believe that insufficient attention has been paid to health problems that affect women, and 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. 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, particularly in areas such as etiology and prevention.

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 and increased 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.

Congress has provided NIDDK significant amounts of money to study diabetes and its complications. Urological complications such as impotence and urinary retention are frequent, yet the Institute is devoting no funds to examining this aspect of diabetes. AUA believes that this is a major oversight and recommends that NIDDK provide the Subcommittee with its plan to address this problem.

Centers for Disease Control and Prevention

Prostate cancer is the second leading cause of cancer death among men in this country. Other than skin cancer, it is the most commonly diagnosed type of cancer, and has considerably higher incidence and mortality rates among African American men. Despite this impact, the importance of providing screening, outreach, education and treatment for men, especially those at higher risk, is neglected. CDC's prostate cancer awareness campaign is an important part of the overall effort. 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. This program shows great promise, and we ask that $15 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. Men must be motivated to take advantage of these opportunities, and this is an area in which CDC can play a critical role. As this targeted effort succeeds, it can be expanded in the future to include the broader male population at risk.

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.


Irwin Frank, MD, F.A.C.S.
American Urological Association


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