[House Hearing, 111 Congress] [From the U.S. Government Publishing Office] PROSTATE CANCER: NEW QUESTIONS ABOUT SCREENING AND TREATMENT ======================================================================= HEARING before the COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED ELEVENTH CONGRESS SECOND SESSION __________ MARCH 4, 2010 __________ Serial No. 111-67 __________ Printed for the use of the Committee on Oversight and Government Reform Available via the World Wide Web: http://www.gpoaccess.gov/congress/ index.html http://www.house.gov/reform U.S. GOVERNMENT PRINTING OFFICE 57-975 PDF WASHINGTON : 2010 ----------------------------------------------------------------------- For sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC, Washington, DC 20402-0001 COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM EDOLPHUS TOWNS, New York, Chairman PAUL E. KANJORSKI, Pennsylvania DARRELL E. ISSA, California CAROLYN B. MALONEY, New York DAN BURTON, Indiana ELIJAH E. CUMMINGS, Maryland JOHN L. MICA, Florida DENNIS J. KUCINICH, Ohio MARK E. SOUDER, Indiana JOHN F. TIERNEY, Massachusetts JOHN J. DUNCAN, Jr., Tennessee WM. LACY CLAY, Missouri MICHAEL R. TURNER, Ohio DIANE E. WATSON, California LYNN A. WESTMORELAND, Georgia STEPHEN F. LYNCH, Massachusetts PATRICK T. McHENRY, North Carolina JIM COOPER, Tennessee BRIAN P. BILBRAY, California GERALD E. CONNOLLY, Virginia JIM JORDAN, Ohio MIKE QUIGLEY, Illinois JEFF FLAKE, Arizona MARCY KAPTUR, Ohio JEFF FORTENBERRY, Nebraska ELEANOR HOLMES NORTON, District of JASON CHAFFETZ, Utah Columbia AARON SCHOCK, Illinois PATRICK J. KENNEDY, Rhode Island BLAINE LUETKEMEYER, Missouri DANNY K. DAVIS, Illinois ANH ``JOSEPH'' CAO, Louisiana CHRIS VAN HOLLEN, Maryland HENRY CUELLAR, Texas PAUL W. HODES, New Hampshire CHRISTOPHER S. MURPHY, Connecticut PETER WELCH, Vermont BILL FOSTER, Illinois JACKIE SPEIER, California STEVE DRIEHAUS, Ohio JUDY CHU, California Ron Stroman, Staff Director Michael McCarthy, Deputy Staff Director Carla Hultberg, Chief Clerk Larry Brady, Minority Staff Director C O N T E N T S ---------- Page Hearing held on March 4, 2010.................................... 1 Statement of: Dahut, William L., M.D., clinical director, National Cancer Institute, National Institutes of Health; Otis W. Brawley, M.D., chief medical officer, American Cancer Society; Carolyn J.M. Best, Ph.D., program manager, Prostate Cancer Research Program, U.S. Army Medical Research and Material Command, Congressionally Directed Medical Research Program; Dr. Steven G. Kaminsky, Ph.D., vice president for research and director of research administration, Uniformed Services University of the Health Sciences Center for Prostate Disease Research; Faina Shtern, M.D., president and chief executive officer, Admetech Foundation; and James L. Mohler, M.D., chairman, Department of Urological Oncology, Roswell Park Cancer Institute.............................. 53 Best, Carolyn J.M., Ph.D................................. 78 Brawley, Otis W., M.D.................................... 68 Dahut, William L., M.D................................... 53 Kaminsky, Dr. Steven G., Ph.D............................ 87 Mohler, James L., M.D.................................... 109 Shtern, Faina, M.D....................................... 93 DeWeese, Theodore L., M.D., chairman, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University Hospital; Thomas A. Farrington, president, Prostate Health Education Network, Inc., prostate cancer survivor; Louis Gossett, Jr., Award Winning Actor and Prostate Cancer Victim; and Betty Gallo, Women Against Prostate Cancer, widow of Representative Dean A. Gallo...................... 15 DeWeese, Theodore L., M.D................................ 15 Farrington, Thomas A..................................... 22 Gallo, Betty............................................. 37 Gossett, Louis, Jr....................................... 36 Letters, statements, etc., submitted for the record by: Best, Carolyn J.M., Ph.D., program manager, Prostate Cancer Research Program, U.S. Army Medical Research and Material Command, Congressionally Directed Medical Research Program, prepared statement of...................................... 80 Brawley, Otis W., M.D., chief medical officer, American Cancer Society, prepared statement of...................... 70 Connolly, Hon. Gerald E., a Representative in Congress from the State of Virginia, prepared statement of............... 52 Cummings, Hon. Elijah E., a Representative in Congress from the State of Maryland, prepared statement of............... 8 Dahut, William L., M.D., clinical director, National Cancer Institute, National Institutes of Health, prepared statement of............................................... 56 DeWeese, Theodore L., M.D., chairman, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University Hospital, prepared statement of............................ 18 Farrington, Thomas A., president, Prostate Health Education Network, Inc., prostate cancer survivor, prepared statement of......................................................... 24 Gallo, Betty, Women Against Prostate Cancer, widow of Representative Dean A. Gallo, prepared statement of........ 40 Issa, Hon. Darrell E., a Representative in Congress from the State of California, prepared statement of................. 6 Kaminsky, Dr. Steven G., Ph.D., vice president for research and director of research administration, Uniformed Services University of the Health Sciences Center for Prostate Disease Research, prepared statement of.................... 88 Mohler, James L., M.D., chairman, Department of Urological Oncology, Roswell Park Cancer Institute, prepared statement of......................................................... 112 Shtern, Faina, M.D., president and chief executive officer, Admetech Foundation, prepared statement of................. 96 Towns, Chairman Edolphus, a Representative in Congress from the State of New York, prepared statement of............... 3 PROSTATE CANCER: NEW QUESTIONS ABOUT SCREENING AND TREATMENT ---------- THURSDAY, MARCH 4, 2010 House of Representatives, Committee on Oversight and Government Reform, Washington, DC. The committee met, pursuant to notice, at 12:10 p.m., in room 2157, Rayburn House Office Building, Hon. Edolphus Towns (chairman of the committee) presiding. Present: Representatives Towns, Maloney, Cummings, Watson, Connolly, Issa, and Cao. Staff present: Linda Good, deputy chief clerk; Velginy Hernandez, press assistant; Carla Hultberg, chief clerk; Mike McCarthy, deputy staff director; Ophelia Rivas, assistant clerk; Julie Rones and David Rotman, counsels; Jenny Rosenberg, director of communications; Christopher Sanders, professional staff member; Leneal Scott, IT specialist; Shrita Sterlin, deputy director of communications; Ron Stroman, staff director; Gerri Willis, special assistant; Adam Fromm, minority chief clerk and Member liaison; and Ashley Callen and Jonathan Skladany, minority counsels. Chairman Towns. The committee will come to order. Good morning and thank you all for being here. Prostate cancer is the second most common type of cancer found in American men, the first being skin cancer. It is also among the leading cause of cancer death in men, second only to lung cancer. One man in six will get prostate cancer in his lifetime, and 1 man in 35 will die from it. The good news is that the death rate for prostate cancer is declining. The bad news is that we still don't know what causes it. We still don't know why African-American men are more likely to get it, and we still don't know why it seems to be most prevalent in North America and Europe. But most importantly for today, there is still controversy over whether men should be screened for prostate cancer and there are still questions about how it should be treated. We are hoping to shed some light on these questions today. Before we begin, I would like to acknowledge the important role my colleague, Rep. Elijah Cummings from Maryland, has had in requesting this hearing and helping to ensure that these issues get the attention they deserve, and I would like to give him a special thanks for that as well. I also want to welcome to our hearing today Mr. Lou Gossett, a Brooklyn, NY native. Mr. Gossett is very well known for his work in the film industry, and has been widely recognized as one of the great actors of our time. What is not well known is that he has been diagnosed with prostate cancer. Mr. Gossett has agreed to testify today to help bring attention to the issue. I want to thank you for that as well. We also have Mrs. Betty Gallo, widow of our former colleague, Congressman Dean Gallo, who I served with, who died from prostate cancer. And we have with us also, Mr. Thomas Farrington, a 10-year prostate cancer survivor who has done a lot of work in this area as well. There is a high degree of public awareness of the need for regular screening for certain kinds of cancers, notably breast cancer, prostate cancer, and colon cancer. However, this widespread belief is now being debated. A few months ago, the New York Times reported that some scientists had concluded that the benefits of detecting many cancers, especially breast and prostate cancer, have been overstated, and that regular screening might do as much harm as good. This has caused widespread confusion, which we hope to help clear up today. To help us do that, we have assembled some of the leading medical experts in the country to discuss the latest thinking on screening and treatment for prostate cancer. I look forward to your testimony today because this is a very, very important issue. Again, I thank my colleague, Elijah Cummings, for making certain that we move forward with this discussion. [The prepared statement of Chairman Edolphus Towns follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Towns. Now I yield to the gentleman from California for his opening statement, Congressman Issa. Mr. Issa. Thank you, Mr. Chairman. Thank you for holding this important hearing today. I would like to echo your comments about our colleague, Mr. Cummings. Last year he approached me to ask for us to work together on a bipartisan basis on this legislation. I accepted and I again thank him for his leadership. As the chairman said, prostate cancer affects 2 million American men living here every day, including one of our witnesses. More importantly, when there is confusion as to what to do about it, even after decades of improvement in survivability, as there is with prostate cancer and also breast cancer, it is very clear Congress has a role to hold these types of hearings and fact-finding to reach, if at all possible, either a consensus on an outcome or a consensus on direction. I hope today is a beginning of that process so that we can provide guidance to the administration and to the health care industry about what the message should be. We are not health care professionals here at the top of the dais; we do not intend to become that. What we do intend is to try to help make the message clear and understandable to 306 million Americans, slightly less than half of whom are men, but all of whom are concerned with the effects that will happen to themselves or loved ones and the possibility of preventing it or early detection leading to a cure. With that, Mr. Chairman, I look forward to our witnesses and yield back. [The prepared statement of Hon. Darrell E. Issa follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Towns. Thank you very much. Now I yield to the gentleman from Maryland, Mr. Cummings. Mr. Cummings. Thank you very much, Mr. Chairman. I want to thank you and the ranking member for scheduling the hearing. I realize we have witnesses that have been waiting for a while, so, Mr. Chairman, I will submit my written statement. But, again, thank you so very much for addressing this very crucial issue. Chairman Towns. Without objection, so ordered. [The prepared statement of Hon. Elijah E. Cummings follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Towns. Will the witnesses stand? We always swear our witnesses in, so if you would stand and raise your right hands. [Witnesses sworn.] Chairman Towns. You may be seated. Let the record reflect that the witnesses all answered in the affirmative. Dr. DeWeese, we will start with you first. STATEMENTS OF THEODORE L. DEWEESE, M.D., CHAIRMAN, SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER, JOHNS HOPKINS UNIVERSITY HOSPITAL; THOMAS A. FARRINGTON, PRESIDENT, PROSTATE HEALTH EDUCATION NETWORK, INC., PROSTATE CANCER SURVIVOR; LOUIS GOSSETT, JR., AWARD WINNING ACTOR AND PROSTATE CANCER VICTIM; AND BETTY GALLO, WOMEN AGAINST PROSTATE CANCER, WIDOW OF REPRESENTATIVE DEAN A. GALLO STATEMENT OF THEODORE L. DEWEESE, M.D. Dr. DeWeese. Chairman Towns, Ranking Member Issa, and honorable members of the committee, good afternoon and thank you for the opportunity to testify at today's hearing. Let me also say thank you, Mr. Chairman, for accommodating my schedule. I do need to get back to Baltimore to see, actually, my prostate cancer patients this afternoon, so I do appreciate this opportunity. I do care deeply about my patients with prostate cancer, and I am committed to doing what I can to improve their health and life. By way of background, I am a professor and chairman of the Department of Radiation Oncology at the Johns Hopkins University, and I am also professor of urology and oncology. For more than 15 years I have dedicated my life to the treatment of men with prostate cancer and have treated over 2,000 men diagnosed with this disease. I also have directed a laboratory at Johns Hopkins over the same period of time and am intimately involved in research to develop new tests to diagnose prostate cancer and therapies to effectively treat the disease. I have published more than 150 scientific articles, abstracts in these areas, and I believe these experiences provide me a unique perspective on the problem of prostate cancer and the need for improvements in imaging AND genetic analyses to enhance prostate cancer care. So, my goal today is to provide a brief background on the gaps in screening and treatment approaches, and explain why more robust research funding is needed in order to help our present and future patients. Major advances supported by Federal funding have been made in the past 25 years to improve the care of patients with prostate cancer. The development of the PSA blood test has been one of the most important advances and serves as the primary means of screening men for the disease. The problem is that the PSA is not cancer-specific, it is only prostate-specific, such that changes in the PSA can occur for both cancerous and non- cancerous reasons, such as an infection. Moreover, the PSA typically does not indicate exactly how aggressive the cancer will be in any individual patient. This particular problem has produced great confusion for physicians and for patients alike. And while advances in our understanding of how to properly use the PSA test have been made, significant changes in the PSA level typically results in a biopsy of the prostate to determine if cancer is present. This is problem one. Some men do not need to be biopsied because they really do not have cancer, only an abnormal PSA. However, we cannot tell which patients have cancer from those who do not. And for those patients with cancer, we cannot tell which have the aggressive type that can be deadly. While the PSA test allows us to find some cancers earlier than we might without using the test, we find many cancers that would never have been a problem for the patient and do not need treatment of any sort. Put another way, prostate cancer comes in two general types. One is analogous to a domesticated kitten and the other to a dangerous lion. But right now we cannot easily tell them apart. Now, this is not to say our present screening and biopsy methods are useless. No. In fact, many men have had their cancer detected early enough to receive care that was lifesaving. But this has been at a cost of finding many more men with cancer that never needed treatment. This approach is problematic because it exposes many men to unnecessary risk of treatment-related side effects. That is to say, we must find a way to ignore the kittens and focus our treatment on those deadly lions. At present, a biopsy of the prostate is the only definitive way to determine if the patient has prostate cancer, and needles are placed through the rectum into the prostate to obtain that tissue. This is the second problem. Biopsies of the prostate are done in a blinded fashion. Unlike virtually any other organ we biopsy for cancer, we do not have effective imaging to guide the biopsy needles to suspicious areas of the prostate. We cannot see the cancer. Thus, it is very possible that needles placed into the prostate might miss the cancer cells. Even if the needles hit cancer cells in one area, the needles might miss a more aggressive cancer elsewhere in the prostate, which then goes undiagnosed and thus the appropriate management for the aggressive cancer cannot be used. These facts demonstrate that our present approach can result in the over-diagnosis and over-treatment for many patients, the under-diagnosis in some men, resulting in less optimal therapy because an aggressive prostate cancer was not biopsied, while some patients are left undiagnosed because the biopsy completely missed the cancer. Finally, our ability to accurately determine which prostate cancers in which patients are likely to be lethal is limited. Taken together, a strong case can be made that significantly improved prostate cancer imaging and genetic markers are needed. Such imaging would allow us to avoid blindly biopsying the prostate. Instead, these images would be used to help guide the placement of biopsy needles to the suspicious sites. In addition, advanced imaging and analyses of blood and urine may allow us to actually determine if a patient has the type of prostate cancer that will never cause harm, avoiding treatment for such men, while allowing us to direct more aggressive treatment to those that will benefit by it. So despite these concerns, I am quite optimistic about the opportunities for our present prostate cancer imaging and genomic analysis that they will afford. The positive steps forward that I believe policy planners could consider include an increase in NIH research funding to support prostate cancer imaging, genetic and biomarker research, and clinical trial development by at least 100 percent in these areas of the next 2 fiscal years; support the creation of an NIH request for proposal that would specifically encourage study of imaging, biomarkers, and genetic analysis from patients that are in large patient networks so that the uniform analyses of these techniques could occur; and, last, to urge the NIH to make these initiatives a priority and request a public report on progress by 2011 involves outside experts. So, in closing, I will say I have had the great privilege of caring for thousands of men with prostate cancer, including several distinguished Members of Congress. It has been a blessing for me, frankly, to see that most of these men are alive and doing well. However, not all of my patients have been so fortunate, and I wonder how much better their lives might have been if I would have had better imaging and diagnostic tools to take care of them. Thus, on their behalf, I am compelled to ask you to support legislation that increases research funding for prostate cancer screening, imaging, genetic analysis, and therapy; and I thank you all for your attention and for your consideration. Mr. Chairman, thank you. [The prepared statement of Dr. DeWeese follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Towns. Thank you very much, Dr. DeWeese. Mr. Farrington, good to see you. STATEMENT OF THOMAS A. FARRINGTON Mr. Farrington. Chairman Towns and members of the House Committee on Oversight and Government Reform, I am honored to appear before you today to address our Nation's prostate cancer crisis as a 10-year prostate cancer survivor and having witnessed the death of my father and both grandfathers from this killer disease. Since my treatment for prostate cancer in 2000, I have worked nonstop to help educate others about this disease, including founding the Prostate Health Education Network in 2003, with a focus on African-American men who have the highest risk for being diagnosed with and dying from prostate cancer. There is an urgent need for clarity in the fight against prostate cancer today. The high visibility debate sparked by the PLCO screening study released last year has caused public confusion, elevating the risk of men most vulnerable to the disease. This confusion comes at a time when we have witnessed a steady decline in the prostate cancer death rates over the past decade, which most attribute to earlier detection of the disease through PSA screening. These are some of PHEN's positions, concerns, and recommendations for the committee: The PLCO study included approximately 10 percent of men at high risk for prostate cancer, which would be analogous to a study on lung cancer which includes only 10 percent of smokers. Because of this and other factors in the conduct of the study, we do not believe that the results should be the definitive basis for national policies on prostate cancer, but important data to be included with what is already known. We strongly support early detection, and just as strongly disagree with any policies that would advocate men gamble with their prostates and their lives by not monitoring and knowing their prostate health through the use of the available tools. Today, those tools include screening via the PSA test and digital rectal examination. The Federal budget for prostate cancer is inadequate to meet the education and awareness outreach needs, and the research needed for new detection and testing procedures that are mandatory to move us beyond today's confusion. We recommend that the budget be equivalent to that for breast cancer, a disease with comparable incident and death rates for women. Lack of access to treatment and lack of equal treatment where there is access are critical factors in the higher African-American death rate that need to be addressed. Expanded educational efforts for the public, and for doctors, should be undertaken to address the problem of over- treatment of prostate cancer. Prostate cancer is a medical, political, and economic issue. We are concerned that the short-term political and economic factors not be allowed to overwhelm and minimize the pressing medical needs. Prostate cancer can be beaten, and it is also a disease that can end in tragedy which can oftentimes be prevented. My personal and family experiences illustrate this. In 2000, I was treated for prostate cancer after detection through regular PSA testing. Every 6 months since my treatment I would get a PSA test, and in 2009 I had a disease recurrence. However, because of the early detection of this recurrence and my knowledge about treatment options, I am free of prostate cancer in 2010. I have been blessed with no side effects from any of my treatment because of early detection and knowledge. Ironically, because of today's confusion about screening, some survivors no longer believe they should be screened after treatment, a major step backward increasing the risk to those men who should be most on guard. While battling my recurrence last year, I lost two additional members of my family to prostate cancer. One, my age, did not get annual PSA testing. The other, my uncle, because of his age, was told by his doctor that he would die of something else before prostate cancer. They both suffered horribly and needlessly. I also had another uncle diagnosed and treated successfully for the disease during this time. Unfortunately, my family situation is not unique, but represents the real and chaotic multi-generational prostate cancer devastation within high-risk families across our country today. Black America is suffering a prostate cancer epidemic where men die at a rate two and a half times higher than for all other men. At what stage the disease is detected, and with what knowledge, determine whether we live or die, and, if we live, whether we have a good or poor quality of life. However, some of the policies now being advocated would accept this epidemic within Black America as collateral damage. Chairman Towns and members of the committee, I sincerely thank you for addressing the prostate cancer crisis. We recommend that the policies and solution for this significant health issue have a primary focus on those most in need and implemented with a sense of urgency, an approach taken where most other diseases of this magnitude. This is an approach that we believe would better serve all men. With a publicly clear, well-focused war on prostate cancer and a high level of leadership and priority within the Federal Government, our Nation can save countless lives, dramatically reduce suffering, and overall impact of the disease. Thank you. [The prepared statement of Mr. Farrington follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Towns. Thank you very, very much. Mr. Gossett. STATEMENT OF LOUIS GOSSETT, JR. Mr. Gossett. Yes, sir. Thank you for accepting me to be here. I am not a politician, so I am not going to speak at any first--I haven't prepared any speeches. I haven't done that in years, and I have spoken in front of a lot of executives in committee meetings in the Black Caucus and at universities across America. I think that, at this age, if I don't know it, I never will. I trust my heart and my experience, and I have been representing, hopefully. I thank you for accepting me here. I went public with the fact that I have prostate cancer. I had a little cancer in my kidney and lost the kidney. The operation took 20 minutes and they said that the other kidney would increase its size, and it did; and a week later I was in the gym and everything was fine. But now, since I have gotten it again, I started to cancel some things in order to take care of the cancer instead of a lot of appointments, and the gossip began to hit; and gossip is the worst thing there is, it is worse than AIDS, sometimes. So in order to dispel all of the talks, I went public. I am a gentleman of service these days, and to serve all of the people who have prostate cancer who like to keep it a secret, I came out of the closet and said so, and hopefully it helped a great deal. I got a great deal of emails and texts from gentlemen across the country thanking me for being courageous to come out of the public service and encourage them to take care of their doctors. A very ironic thing happened in some of them, because some of them around Louisiana, around California, around New York and different places went to find a doctor that they could afford, and could not find one. So there is a percentage of African-American men who do get it, and they also cannot afford to see a doctor. My heart goes out to those particular men. I remember last time we had some kind of problem like this, when I was a child, you remember the polio epidemic. And what we did for the polio epidemic is we went to them with a kind of a--we took care of everybody in America, and there were no debates in Congress about whether it was pro or con. We took care of everybody in America. Now, this year, this time, above all years, I believe that the playing field must be leveled. I think we are going in that direction anyway. So we must kind of take care of everyone in the equal American way. I am concerned that these facts that have been told to us in the other meetings are true, that we lose an African-American man or two every day to prostate cancer. I think it should be modernized. I think the mammograms have shown us that we can do the same thing with prostate if we give a little accent to that research so that my mind is fairly creative. I have a book coming out next month and I plan--since I can't travel so much on planes--to take a train and a bus and promote Eracism, which is my foundation, to try and level the playing field for our next generation. If we do not plant negatives in the next generation, they will grow up free of certain prejudices that we might not know we have. So I think this generation is at the insight of making sure we don't add to the problem, but add to the solution; of how we can be one Nation under God, indivisible, with liberty and justice for all. There are some things that are very important to our children. Prostate cancer is one of those subjects. I can't imagine this great country being fought in our congresses pro and con, and eloquently, about the fact that there is somebody in this country who cannot afford to take care of their health. Of all countries in this world, I believe that we should be the one exemplary, that everyone in this country should be able to go to the doctor. I have a child who I took--when Jesse Jackson was running for President some 27, 25 years ago, and I found him homeless in St. Louis, and at that time we thought that every child in America should have free medicine, free education, free shelter, free food, free clothing, and free love; and I believe America is the foundation of that. Once you have that, then your thoughts go to loftier things. I think every American should have that. If there are African-Americans--and I get these in emails--who can't afford to go to a doctor and they know they might have some prostate cancer, then they feel like step children. We have to get rid of our stepchildren and educate them to be three-dimensional responsible Americans, and have to give them the signals that they are as equal and as loved as everyone else. The children of our stepchildren are gang-bangers, because they are planting a seed. They look at their fathers and see that they are not getting anything, and they say, well, I am going to go this way. So I am in those trenches trying to get these kids to be responsible, and my idea is to take this bus that our President is talking about, putting an incentive into the bus and the train systems, Amtrak, promote my book, my foundation, and subjects like this to tell them that they also are three-dimensional Americans and to roll their sleeves up and be prepared to be responsible; all the neighborhoods. And out of that will come a sensitive thought of going into clinics to advance the study of prostate cancer and other things so that we can realize in our minds that we are equal and we have access to being cured. I find myself special, but those who are not special will not get this treatment, unless we are more sensitive to their problem. That is basically it. Today, the subject is prostate cancer; tomorrow, the subject will be something else. But we are losing people that should be responsible, and that makes this country better. Chairman Towns. Thank you very much, Mr. Gossett. Mrs. Gallo. STATEMENT OF BETTY GALLO Mrs. Gallo. I want to thank you, Chairman Towns and the committee, for holding this very important hearing. I appreciate the opportunity to speak to you today on a topic that has had a significant impact on my own life and on the lives of thousands of other men, women, and families. One of the areas that I felt that we were lacking was the women and, according to a lot of the men, they feel that the women are much more verbalizing to talk about issues, so we have decided to create the Women Against Prostate Cancer, which I am co-founder of, and what our mission is is to unite the voices and provide support for the millions of women affected by prostate cancer; and today I am speaking on behalf of all women, widows, and caregivers, whose lives have ever been changed by prostate cancer. As you mentioned, my husband, Congressman Dean Gallo, was diagnosed with prostate cancer in 1992. Unfortunately, he had a lot of pain in his back and when he went to the orthopedist they did a bone scan and he basically lit up like a Christmas tree; it was already into his bones. Normal PSA is normally 4 or less; his PSA was 882. Due to the fact that Dean was in Congress and was a little more familiar with what was going on as far as clinical trials, he did go to NIH and was enrolled in a clinical trial, and his PSA dropped from 882 in February 1992 to 3\1/2\ the following March. He, at that point, had done other treatment options and, fortunately, when he was first diagnosed, he was actually only supposed to live 3 to 6 months, and he survived 2\1/2\ years; and in that time he still remained in Congress working with his constituents, because he felt that is where his heart was. There are some other stories. I have found that younger people, this woman, Jenny Taylor, and her husband were both physicians. Steve was 45. He had a PSA done. As a result, the PSA testing found that cancer had spread through 70 percent of his prostate. They couldn't remove the prostate because the cancer had spread, so Steve, through other means, is now in remission and the two of them are enjoying their time together. But, again, it is in remission for the time being, and how long that is one doesn't know. There are a lot of stories I have heard out there about people going through this and now I am finding that there are younger men, it is not older men. It is not an older man's disease. Women truly have a big concern and it is being a caregiver to men that is so important, and there are so many issues that come along with prostate cancer that sometimes it can create a lot of havoc in marriages because people just don't understand how to deal with the side effects. More support and education is one of the things that I think is needed for partners and caregivers and the entire family. We really haven't done a good job in that area. A lot of people have no clue what to expect after a prostatectomy or how to deal with issues, and this is one thing, in the 15 years I have been doing this, that I have found that we really need to be doing more in. One of the areas I found that even in clinical trials we don't really have any outreach component for money to be able to use that to go out and talk to people about prostate cancer, to let the community understand what clinical trials are and how it can help them. Many people are afraid of being guinea pigs, and that is not what we want them to see. We want them to understand that we have something there that could really help. Early detection and appropriate treatment of prostate cancer remains a critical priority, especially among men at high risk because of family history, ethnicity, or other factors that define such risks. Physicians of male patients should be encouraged to discuss the patient's personal risk for prostate cancer and the individual need for prostate cancer testing. Men at higher levels of risk for prostate cancer, including the African-American men and men with a family history, should be encouraged to undergo appropriate tests at a relatively early age. Additional funding is needed to increase outreach and promotion of the clinical trials, which I discussed before. The PSA is not a perfect test, but it is all we have right now. I have been, as a women, going for mammography, and through all of this I have found out that in this--where I have gone, 75 percent of the--not lumpectomies, but the--oh, I am sorry--they had done the biopsies were 75 percent benign. So you have the same issue in breast cancer as we do in the prostate, but at least with prostate cancer we, at this point, do have--this is the best we have. One of the issues that concerns me is like in New Jersey we have the Centers for Disease Control. We have prostate and breast and cervical cancer. They pay for detection and they pay for treatment. In prostate cancer they only pay for early detection. So, in other words, if they have prostate cancer, there is no way to treat them at this point. So it is almost a crazy kind of a way to do things, and this is something that really needs to be corrected in that respect. Screening should be provided in any health reform legislation. In New Jersey we do pay for it, for a DRE and a PSA, because we find that it is very important for men to have it done and done with their insurance company. There is a lot of confusion today about prostate screening, and I think with the release of yesterday's prostate cancer screening guidelines from the American Cancer Society, there are now three sets of complex and differing screening guidelines, including those from the National Comprehensive Cancer Network and the American Urological Association. One clear set of guidelines is needed to make sure men know what steps to take and when in order to safeguard their health. For the past 15 years, I have been involved in advocacy for prostate cancer. It has helped me through the grieving process and knowing how to be able to help other men and their families. As men and women in Congress, you are aware of what prostate cancer does to families and have experienced the loss of several colleagues to this disease. Increased education and awareness are the most critical issues. Chairman Towns and members of the committee, I would like to thank you for addressing this crisis. More needs to be done to help the thousands of men and women and their families across the country who are suffering because of prostate cancer, and we need to allow them to have a better quality of life. Thank you. [The prepared statement of Mrs. Gallo follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Towns. Thank you. Let me thank all of you for your testimony. At this time I will yield to the ranking member for questions that he might have. Mr. Issa. Thank you, Mr. Chairman. The next panel we are going to have will be physicians and specialists, researchers, but I think we were very fortunate that Dr. DeWeese was able to speak first, and in looking through his testimony and some of the things that he provided us in written material, an interesting fact came out, and one that I think, as survivors and, in fact, a victim of somebody who--I appreciate that he survived 2 years, but in many ways the loss is just as great, no matter how much time you had to say goodbye. One of his facts that concerns me is he says that for every man who benefits from prostate cancer treatment, 30 to 50 effectively have no benefit. It begs the question that I would ask all of you, both as survivors and the widow of one. We put in about $300 million from NIH, another $80 million from DOD, and some smatherings of others into various forms of research, and you did say we should do more, but is this not a disease that effectively, until we aim better, a great deal of our treatment is, by definition, a complete loss; if you have 30 to 1 in treatment, that there is a real risk that people are going through pain and suffering? Even when they say I am a survivor, the question is are you a survivor of somebody who had cancer, but cancer that wouldn't have killed them versus Mrs. Gallo's husband Dean, who the cancer clearly would; it was aggressive, it spread. Differentiating those, coming up with a much more targeted approach both in lifestyle decisions--because it is one of the challenges we have. We apparently don't know what makes us more likely than European or African or other people of our same DNA mix but in other countries, but, more importantly, the fact that we can't measure or predict. So no group could be more demonstrative of the people who would most likely disagree about cutting treatment, but I would like you to look at these dollars, the Federal dollars. Where would you have us put more dollars if we only had a very limited amount? Would we put in $300, $400, $500 million more into trying to get these better tests first? Mr. Gossett. May I? Mr. Issa. Of course. It is a leading question knowing that everyone would like to answer. Mr. Gossett. Well, I think the way I have been educated-- and I am one of the lucky ones, and those of us who have survived are one of the lucky ones in finding the cancer in the prostate to those who have doctors who have access to the best is still like winning the lottery. Whereas, on the other side, the women, they have mammograms, they have sophisticated things that have made their science much more successful. I see more heroines in that. We need to catch up to them. And in order to do that I think we need to concentrate our dollars or your dollars, to those particular specialists who know how to sophisticate and find an equal to the mammogram to the prostate sufferer, because the ones who fail because of our inadequacy of really pinpointing what it is is hit and miss, and I think we have the ability and the knowledge to really be better than that and save some lives. Mr. Issa. Mrs. Gallo, would you concur with that? Mrs. Gallo. Well, honestly, in the beginning, when this all happened with Dean, the first thing I wanted to do was scratch everyone's eyes out that didn't have the PSA because I lost a wonderful man and it has really been difficult to really understand why. And, again, when we talk about breast cancer, they have all sorts of testing; you start with a mammography, then you go to another mammography if there is a problem, then there is an ultrasound, there is an ultrasound biopsy. The hard part with prostate is you can't see the prostate, so everything is kind of a guessing game. I think even if they say it takes 10 years for prostate cancer to really get to the point of where you are going to see it, sometimes even doing a baseline at, say, an earlier age might be the way to go. You know, at least you can keep track of it that way. I agree we need to put more money into getting a better testing for prostate cancer and nothing is going to be 100 percent, and it is the same thing, I think, in a lot of cancers. But at the moment I feel it is something we have and it at least has saved some people's lives. I think no matter what cancer, there are going to be people who are going to die from cancer because maybe they didn't need treatment and others are going to live, and I just think that, unfortunately, I think because we have always thought of prostate cancer as an older man's disease, we didn't really look at now how it is really affecting the younger population. So I agree we need to put more money in to be able to find a better way to detect it, but also I personally feel that what we have is better than nothing at this point. Mr. Issa. Mr. Farrington. Mr. Farrington. Yes. Mr. Issa, I think there is an abundant amount of data that exists that shows that what we do now does save lives. I think if you look at the decline in deaths since the PSA was widely used, we have seen over 30 percent decline in death rates. I mean, that is real. That is not theory, that is real. Mr. Issa. Sure, but Dr. DeWeese and I think the second panel, they spend a lot of time basically saying it is like the Hubble telescope. You know, it does give you a picture of the stars, unfortunately, it is insufficiently clear to be meaningful to have only those people who have a treatable disease, or at least close to only those people, versus having 30 times as many people go through extensive treatment as receive benefit. I am not disagreeing. I think universally the early detection and improving early detection we think is important. But then that secondary--and I think Mrs. Gallo said it very well--are the tools today for prostate as good as they are for breast cancer once you think you might have something. The answer is no. I think if we were doing radical mastectomies, as we did in the 1950's, on everyone who had a lump, practically, we would be horrified at the results. But that is what we used to do in breast cancer. We have come a long way. I guess the question as a survivor is if I only have--if the Japanese will only loan us and the Chinese will only loan us another $1 billion this year for something related to prostate cancer, where would you put those dollars first if you were seeing the testimony we are seeing, such as Dr. DeWeese's. And I ask you because you are the hardest people to make the decision that you would put it into research or you would put it into better detection or better differentiation versus treatment. Mr. Gossett, you said it fairly well. There are so many people who don't have access, but it takes tens of billions of dollars to incrementally improve the access to the under- served, and it is one of our challenges here, and one of the things that I have worked on with the chairman here, is prioritizing at least some dollars to the area that could, in the long run, cause 30 out of 31 people not to suffer needlessly and those 1 to get the treatment early. Mr. Farrington. Sure. You asked for two areas. Let me respond, sir. One, in terms of research, I think we do have to better focus much about research. I think we know that there are some genetic factors related to prostate cancer risk, and I think there needs to be more research in the area of genetics and biomarkers, detection of procedures. I would put money there. The other area is in education and awareness. A lot of men really do not understand their risk level for prostate cancer, and when they are diagnosed with prostate cancer they do not understand their options and they don't know whether they should be treated or not treated. I agree that every man should not be treated for prostate cancer that is diagnosed with the disease, but today people are not educated on those factors, so they will, many times, move quickly to treatment when they should not be treated. So I would look at education awareness and research into genetics and biomarkers. And we talked about imaging today. So I think those are critical areas. Mr. Issa. Thank you. I appreciate it. Thank you, Mr. Chairman. I yield back. Mr. Cummings [presiding]. Thank you very much. First of all, I want to thank you all for your testimony. I think we are constantly addressing the issue, as we are doing it in the health care debate that we are now having in the Congress, exactly how do we take the resources that we have and spend them most effectively and efficiently. And then there comes a time when you are trying to figure that out and you say what is a life worth? In other words, do you make a decision not to go forward in a direction which might yield a, as sure as it can be, diagnosis or do you say we don't have enough money and let people suffer and die? And that is a question that I think the Congress wrestles with right now, and I fall on the side of life. But I was just wondering, when you hear all of this, Mr. Farrington, I guess your family history caused you to take extra precautions, is that right? I mean, in other words, it seems like when you see a history like that--my father, by the way, had prostate cancer, and I have many friends. I was in the bank about a year ago and I was amazed, just standing there, one person comes up, he is talking about he just got out of the hospital, and then two or three more show up. Come to find out there were seven of us standing around, and out of the seven of us four had gone through prostate cancer. Of course, we were all around the same age level. But I was just wondering what advice are you giving men? What are you saying to them? Mr. Farrington. Well, No. 1, my family history should have put me on alert, but, very frankly, my doctor never had a conversation with me about prostate cancer, which is one of the real problems with some of the guidelines that are dependent upon that discussion between doctor and patient. A lot of doctors do not have that discussion and they do not have it with Black men at an early enough age to make a difference. I did not have that discussion with my doctor, which required me, when I was diagnosed, to leave Boston to get a specialized treatment. What I am advising men to do is to know their prostate health. And the only way that you can know your prostate health today is through PSA testing and your digital rectal exam. Once you know your prostate health, if you find that you have cancer, then to understand your options. And those options may be to treat; they may not be to treat. We have talked men with PHEN out of being treated for prostate cancer and told them that they are better off through active surveillance. So I think those are the things that need to be done, but it does require some action on the part of the patient. You cannot stand back and gamble with your prostate. You cannot stand back and not be knowledgeable, because that is the highest risk of death. That happened in my family last year. So those are the things that we are trying to foster, a higher level of understanding and education. That saves lives. I would also just like to add one other point to Mr. Issa's question about where we would direct research. I failed to point out that one of the key areas is in research to be able to distinguish between cancer that will kill and cancer that will not kill. I think that is a major question that we have today relative to research. Mr. Cummings. Thank you, sir. Mrs. Gallo, in my discussions with a number of groups that address the issue of cancer in general, they say--and you alluded to this in your testimony--that when it comes to breast cancer, I think a lot of the attention that has been given to breast cancer is because there has been a very aggressive effort on the part of women, and research has shown that women are more likely to go to a doctor than men. So with all of the campaigns for breast cancer, I think it has helped to elevate it to a level that NIH and others have to pay attention to it. How do you see us raising this issue to the level of breast cancer, when one out of every six families in the United States is affected by this? I was just wondering. Mrs. Gallo. To be honest with you, Congressman, I know a lot of it is the fact that we haven't taken the ability to really get out there. As they say, ``the squeaky wheel gets what it is looking for.'' And in my 15 years of working with men, it is very difficult for them. Some of them don't believe they can make a difference, and I have explained to them I have been out there fighting this battle for 15 years. Sometimes it is difficult being a woman, but we really need to bring it to the forefront, and I think part of the problem with prostate cancer is we don't work directly with the researchers like we should, where the breast cancer coalitions do. We are lacking in a lot of areas and I hate to say that sometimes it is egos, it is, you know, whatever, but the bottom line is, as a woman, you bring the passion to the disease and you explain it to them, and that is why a lot of men that are prostate survivors have said to me and other women that they feel we are the ones that are going to make it happen, and that is why we started the Women Against Prostate Cancer, because we felt we, as women, women that have lost their husbands or their survivors or whatever, are planning to come down to the Hill, talk to the Congress and tell them the importance of losing our husbands or the possibility of it happening. There are just so many issues with prostate cancer that goes beyond just what we are talking about here that affects the family that, again, as Mr. Farrington had said, the education is so important; we just don't have it. We don't have the education like we need to, and this is one thing I felt that I really wanted to hone in on, you know, letting people know about what prostate cancer is, where they can go if they have prostate cancer. Like he said, you don't have to have it taken out, because the first thing men want to do is get rid of it, and that is not always the best thing to do for those people. So I feel that really the education is really important and we need to help the Congress to really be behind us and, of course, here are men sitting here that could have prostate cancer at one point, and it is you that myself, as a woman, are advocating for, such as these gentlemen here or any other men in my life. So I am here because I care. I am here because my husband died of prostate cancer. I don't have prostate cancer, but it has been very upsetting to me to know that you could lose a man over this disease, and when it goes to the bones like it did to Dean, it is the most horribly excruciating pain that I cannot explain to you. He was working in Congress when he had the pain, and he had a brace on from a hip replacement, and he would walk over to the Capitol in excruciating pain. There was nothing we could do to make it better for him. So that is a concern I have, that we want to make sure they don't get to that point. But I just want to give you another note here. Prostate screening, just so you know, is not included in the provided health care reform and legislation, and the problem it would do, it would wipe out the prostate cancer screening available to over 30 million men in 37 States. So that is one thing I think, when we go into the health care bill, I think needs to be looked at, that we don't overlook the prostate screenings and the importance of doing that. Like Mr. Farrington said, if you really look at the numbers, since prostate cancer has been used as a tool, you have seen the death rate go down and the incident rate go up, because even though more people are getting diagnosed, there is not as many people dying from it. So that is a good thing. So, again, I think we really need the Congress behind us to really be there and say we need to put more money into outreach, we need to put more money into finding a better tool to diagnose prostate cancer and just be able to do the best we can, because I don't want to see our men lost to this disease. Mr. Cummings. Thank you very much. Mr. Cao. Mr. Cao. Thank you very much. My first question is to Mr. Gossett. First of all, when I was a teenager, I was a very big fan of yours. One of the movies that I watch and still remember was Iron Eagle, whether or not you remember it. Mr. Gossett. I remember Iron Eagle. Mr. Cao. That was one of my favorite movies during my teens. But I represent the city of New Orleans, which is comprised of 60 percent African-Americans, and obviously prostate cancer disproportionately affects African-American males. My question to you, knowing what you know now, what advice would you give to my constituents as to, one, how to prevent prostate cancer and, two, what would they do, if they were to have it, to fight prostate cancer, since you are a survivor? Mr. Gossett. Well, some comics are saying that prostate cancer to the African-American man because of the way they have to be examined is a sure-fire way of them keeping it and dying with it. The examination---- Mr. Cao. I am sorry, can you turn on the---- Mr. Gossett. It is on. The examination of prostate cancer, especially in places like Louisiana, Detroit, places of the macho African-American man turns him off because you know what you have to do in order to examine the prostate. It really literally makes him put it aside, put it in the back of his head and forget about it. As a result, more deaths happen because he does not want to go through the experience. You understand the experience I am talking about? Mr. Cao. Right. Mr. Gossett. With the rubber glove. That is exactly the reason why most African-American men do not go to that. They need to get to that examination; they need to put it aside and go for it. I had a little bit of that, but it is over because I really know how important that is. Now, once you know you have it, then they talk about--and this is what I get from emails and faxes--a diaper, incontinence. So that is a world that the African-American macho man does not want. So, in his mind he takes it, he puts it in a drawer, and the next thing you know, it is incurable. We need to educate them. We have to do deeper research to show them that it is a little bit more pleasant, it is more like a mammogram to get them off that high horse. There is a fear, as you know, especially in Louisiana, of not being able to make love to your woman again. And I am speaking of these in real terms. That is why the African-American man, I think, has more incidences of prostate cancer than someone else, because he doesn't want to hear about it. He doesn't want to hear about not being able to make love, wearing diapers, and having incontinence. Those are real things, especially if he is poor. That is the last place he can express himself. So he takes it and puts it in his back pocket until it is a problem. Mr. Cao. Mr. Farrington, do you believe that we have done enough to inform the African-American community, the African- American male, of the dangers of prostate cancer and the preventive measures in connection with prostate cancer? Mr. Farrington. Absolutely not. I don't think we have done enough to inform the high-risk community---- Mr. Cao. And what would you recommend that we should do? Mr. Farrington [continuing]. That is African-American men, men with a family history and some Vietnam veterans, inform them about the risk and that the prevention to death is knowledge. I am not sure there is a prevention to the disease itself, but certainly the prevention of death is knowledge and early detection. As I outlined in my testimony, I am a strong advocate of education. That is the reason I founded the Prostate Health Education Network, and what we are doing is that we are outreaching across the country through a number of means to the public. We are outreaching through television, through online, and we created a survivor network of African-American men that can work on the ground in their community to talk with other men. As Mr. Gossett pointed out, there is a fear about the disease. But if a prostate cancer survivor can touch another man and talk with him about the experience and say I am here and I have survived and I am whole, and you can do the same, but you have to begin the process of knowing your prostate. Those are some of the things that we are doing. I just was speaking with Mr. Gossett. We are starting this year a nationwide Father's Day rally in churches across the country. We did that in Massachusetts last year and at Mr. Gossett's church in Los Angeles. It just so happened the first book that I wrote, it was unveiled in his church in Los Angeles. So we are going to work together on some of these things for a higher level of public education. Mr. Cao. And my last question is to Mrs. Gallo. What would be your recommendations to women? How can they encourage their husbands to I guess to be more open to the procedure of prostate cancer detection? How can you encourage husbands to take those preventive measures in order to not suffer this disease? Mrs. Gallo. Well, nagging is always the first good thing they can do, until they are blue in the face and had enough of listening to you. Sometimes, it is making the doctor appointment for them. And the other part of it is saying, ``look, honey, I want you around for a while, and this is a disease that is out there that we ought to make sure you don't end up with.'' And I think that women nowadays, even the younger women, are really learning more about prostate cancer and the need to get their husbands there. And I know that there are a lot of women that have basically dragged their husbands to the doctors. I mean, some may be a little bit more nice about it, but that is why, again, we talk about education. My feeling is educating the women to go back and get their husbands, because most of the time the women are the ones that drag the husbands to the doctors or are a little persistent about it. I think also, I say, look, the women go through exams every year. Look at what we go through. Yours is nothing compared to what we have to do. And, again, it is the importance of saving your life. I will give you a for instance. At one point Dean said to me, ``well, if it doesn't work, shoot me, OK?'' Well, when it came to prostate cancer and his possibility of dying, that whole thing went out the window, because the concern was he wanted to live. So I think people have to understand, and I don't think that we have educated men and women enough to understand the importance of getting early detection and being able to treat it at an earlier stage. You know, 10, 12 years ago, or 15 years ago, before Dean died, there wasn't much out there, and I have seen such a difference even in this 15 year time that there are different ways to be able to help through a lot of the times with the side effects and what not. But people have to understand, and if they don't tell them, then they are more upset when they find out, after the fact, that nobody talked to them about it. So I think we almost have to be kind of real now; we can't just beat around the bush. And I am talking about what Mr. Gossett was talking about, the side effects. We don't want to talk about them, but it has to be talked about because when people go through it and find out these side effects exist, then it creates another problem. So I think it is more or less just getting women to really--if they really care about their husbands, they are going to get them there one way or the other. Mr. Cao. Thank you very much. Thank you, and I yield back. Mr. Cummings. Thank you very much. We are going to--first of all, thank you all very much for your testimony. We are going to adjourn now for about a half an hour; we have three votes. This panel is dismissed, and then we will come back and hear the second panel. But your testimony has been very, very helpful. Thank you very, very much. We will be back in about a half an hour. Mr. Connolly. Mr. Chairman, just a unanimous consent. I would ask unanimous consent that my full statement be entered into the record. Mr. Cummings. Without objection. Mr. Connolly. Thank you. [The prepared statement of Hon. Gerald E. Connolly follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Cummings. Thank you very much. [Recess.] Chairman Towns [presiding]. The meeting will come to order. If you would stand. We swear all of our witnesses in. If you would stand and raise your right hands. [Witnesses sworn.] Chairman Towns. Let the record reflect that all the witnesses answered in the affirmative. Why don't we just go right down the line, starting with you, Dr. Dahut, and just come right down the line? Thank you all for being here. STATEMENTS OF WILLIAM L. DAHUT, M.D., CLINICAL DIRECTOR, NATIONAL CANCER INSTITUTE, NATIONAL INSTITUTES OF HEALTH; OTIS W. BRAWLEY, M.D., CHIEF MEDICAL OFFICER, AMERICAN CANCER SOCIETY; CAROLYN J.M. BEST, PH.D., PROGRAM MANAGER, PROSTATE CANCER RESEARCH PROGRAM, U.S. ARMY MEDICAL RESEARCH AND MATERIAL COMMAND, CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAM; DR. STEVEN G. KAMINSKY, PH.D., VICE PRESIDENT FOR RESEARCH AND DIRECTOR OF RESEARCH ADMINISTRATION, UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES CENTER FOR PROSTATE DISEASE RESEARCH; FAINA SHTERN, M.D., PRESIDENT AND CHIEF EXECUTIVE OFFICER, ADMETECH FOUNDATION; AND JAMES L. MOHLER, M.D., CHAIRMAN, DEPARTMENT OF UROLOGICAL ONCOLOGY, ROSWELL PARK CANCER INSTITUTE STATEMENT OF WILLIAM L. DAHUT, M.D. Dr. Dahut. Thank you, Mr. Chairman, for giving me the opportunity today to speak. I also wish to thank you for accommodating my schedule, allowing me to leave early today. My name is Dr. Bill Dahut, and I am the Clinical Director of the National Cancer Institute. Our particular research focuses on the development of novel therapeutic strategies for the treatment of prostate cancer. Prostate cancer is the second highest cause of cancer deaths for men in the United States. The good news is the overall death rates from prostate cancer are on the decline. Most think this improvement is due to a combination of improved treatments and possibly earlier detection. However, it is important to remember that there is not just one prostate cancer. Some patients respond to treatment and live out normal life spans, while other lives are cut short by aggressive disease. The clinical course of the disease reflects the interplay between the biology of the tumor, the genetics of the patient, factors in the environment, and available treatments. There is a huge challenge in the field right now. We are struggling to differentiate lethal or deadly prostate cancer from non-lethal prostate cancer, a form of the disease unlikely to ever cause symptoms or lead to death. Another unfortunate reality is that the burden of prostate cancer is disproportionately borne by African-American men, who have a 60 percent higher incidence of prostate cancer as compared to white men and are twice as likely to die from the disease. Many men will die with prostate cancer, but not from prostate cancer, or never have any cancer-related symptoms. Since all treatments have side effects, with some being quite significant, the potential for over-treatment is a real problem in this disease. Nevertheless, nearly 20,000 men die yearly from this disease, while many others have cancer-related pain. Thus, the single biggest challenge to researchers is to identify a means to distinguish lethal from non-lethal prostate cancer. Without this information, we are likely to under-treat or over-treat our patients. Even within these broad categories, prostate tumors may have very different characteristics, which may ultimately guide treatment decisions. Not all prostate tumors are like other prostate tumors, and they do not respond to therapy in the same ways. In fact, the biology of a given prostate tumor may turn out to be much more like a breast tumor than like another prostate tumor. NCI is moving aggressively toward the goal of distinguishing lethal from non-lethal prostate cancers by researching biomarkers, genetics and molecular characterization, nanotechnology, and imaging techniques that may help to differentiate the aggressive prostate cancers from the less threatening ones. While the use of Prostate Specific Antigen [PSA], has led to the earlier detection of prostate cancer, some patients with elevated PSA values are found not to have prostate cancer when biopsied. Furthermore, there is no safe PSA value, and even patients with very low PSA values have a surprisingly high risk of prostate cancer. We are actively searching for other biomarkers, substances that may be found in tumor tissue or released from a tumor into the blood or other body fluids such as urine that would distinguish between cancerous and benign conditions, and between slow growing cancers and fast growing potentially lethal cancers. The identification of such biomarkers is a high priority in order to provide safe and effective large population screening. The NCI Clinical Cancer Team is studying new therapeutic approaches to prostate cancer through various clinical trials. For example, an NCI-developed prostate cancer vaccine has shown significant benefit in a Phase II study at the NIH and should be moving into larger clinical trials soon. NCI has also participated in the research and development of a drug known as Bevacizumab, which is a drug developed to target blood vessel growth. The results of a very large clinical trial using this agent in men with advanced prostate cancer will likely be available in 2 to 3 months. We are continuing to press forward in our efforts to develop the knowledge that will allow us to treat prostate cancer based on specific molecular characteristics of the tumors that tell us about the way the genes and proteins interact. In order for this to be successful, we need to understand the relevant targeting of the tumor and develop potent drugs effective against this target. Although this targeted approach has been successful for infectious diseases for nearly a century; unfortunately, therapy for metastatic prostate cancer has all remained trial and error--that is, the drugs are not targeted or personalized for an individual specific type of prostate cancer. We are aggressively pursuing research to enable us to personalize cancer therapies. We are optimistic that through the specific genetic abnormalities in an individual patient's prostate tumor, that we will be able not only to identify the aggressive forms of the disease, but also to develop specific treatments appropriate for the patient's cancer, ultimately reducing death and suffering from prostate cancer. Thank you for the opportunity to testify. [The prepared statement of Dr. Dahut follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Towns. Thank you very much, Dr. Dahut. Dr. Brawley. STATEMENT OF OTIS W. BRAWLEY, M.D. Dr. Brawley. Thank you, Mr. Chairman. Good afternoon. Mr. Chairman and distinguished members, I am Otis Brawley, a practicing oncologist. I am the chief medical officer of the American Cancer Society, and I am also a professor of hematology, oncology medicine and epidemiology at Emory University. On behalf of the American Cancer Society and the millions of cancer patients and survivors, thank you for holding this hearing and for your continued leadership in the fight against cancer. As you know, the Society, yesterday, released updated guidelines on prostate cancer screening. We customarily undertake such reviews when new evidence or other information emerges. In the case of prostate cancer screening, results from two randomized trials of screening were reported in early 2009. The finding of these studies, combined with other advances in knowledge related to prostate cancer screening prompted this review. The review recommended no major changes in our position with respect to prostate cancer screening. The Society continues to recommend asymptomatic men who have at least a 10- year life expectancy should discuss with their doctor the uncertainties, the possible benefits, and the known risks of screening for prostate cancer before deciding whether to be tested. There are uncertainties, there are known proven risks, and there are, at this time, possible benefits. We also provide additional guidance about testing for African-American men and those at high risk. The bottom line is men need to have the substantive discussion with their doctors in order to make meaningful decisions about which preventive services and early detection tests are the best choice for them. Other organizations in the United States, Canada, Europe, and Australia that issue prostate cancer screening guidelines, have also issued statements calling for this informed shared decisionmaking, realizing that prostate cancer screening has not yet proven to save lives. I want to make sure my testimony is very clear about the Society's position on prostate cancer screening, as it has sometimes been misunderstood or mischaracterized. The Society is not against testing for early prostate cancer detection if a man has been given the true facts about what we know and what we don't know about the uncertainties of prostate cancer screening; what we do know about the proven harms and the possible benefits of screening. The Society, along with many other health and medical organizations, as well, are against screening when the doctor-patient conversation to describe the benefits and harms does not take place in a meaningful way. We are only against prostate cancer screening when there is no informed decisionmaking. As an oncologist, I have counseled and treated hundreds of prostate cancer patients in my career. I have observed firsthand the traumatic impact this disease has on men and their families. I firmly understand the emotion involved when someone says their life has been saved by a PSA test. But in every instance we need to better explain the limitations of the test and make sure we don't overstate the benefits. There is legitimate argument based on the scientific evidence as to whether prostate cancer screening saves lives. Clear evidence has emerged from several trials indicating that prostate cancer screening leads to unnecessary treatment. For example, many men who do not have prostate cancer will screen positive and require an unnecessary biopsy for diagnosis. In addition, even if this biopsy finds cancer, many prostate cancers grow so slowly that they may not actually pose a threat to the patient's life or his continued quality of life. This is an important point because treatment of prostate cancer is associated with symptoms and side effects that can interfere significantly with quality of life, such as impotence and incontinence. The key problem is that we don't have, and we have yet to discover, definitive tests that tell us the cancers that kill and require treatment versus the cancers that don't kill and need to be watched. One can reasonably ask how did we get into this quandary of not knowing whether prostate cancer screening saves lives? Truth is the promotion of the PSA test has delayed our medical progress, because we have come to rely on what is really an imperfect test instead of doing the clinical trials to evaluate PSA and actually defining the scientific questions and actually going out to answer those scientific questions. The plain fact is the PSA test is not good enough. We need to invest in developing something that is better. We also need to invest in a way to determine the deadly tumors versus the tumors which are not threatening life. In closing, increased funding for NIH and the National Cancer Institute would do much to enhance current discovery efforts and also enable us to design better tests and better treatments for prostate cancer. Thank you, sir. [The prepared statement of Dr. Brawley follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Towns. Thank you very much, Dr. Brawley. Dr. Best. STATEMENT OF CAROLYN J.M. BEST, PH.D. Ms. Best. Chairman Towns and distinguished members of the committee, thank you for this opportunity to convey the important efforts being supported by Congress through the Department of Defense Prostate Cancer Research Program [PCRP]. My name is Dr. Carolyn Best, and I am currently program manager for the PCRP, which has received over $1 billion in funding since the beginning of the program in fiscal year 1997. Here with me today is Captain Melissa Kaime, my supervisor and the Director of the Congressionally Directed Medical Research Programs, under which the PCRP is 1 of the largest of 19 programs. The PCRP is the second largest nationwide funder of prostate cancer research after the NIH. The program's vision is nothing less than to conquer prostate cancer, which translates into our mission to fund research that will eliminate all death and suffering from this disease. We fund highly innovative science to stimulate major advancements in research and clinical care. All PCRP funds are openly competed; we contract with hundreds of leading prostate cancer scientists, clinicians, and survivors to select research proposals that are both of the highest scientific merit and that best fit the objectives of the program. With the $1 billion in funding this program has received during its existence, it has provided nearly 2,200 grants to support prostate cancer research in almost every State and the District of Columbia. Our grantees are studying better approaches for prostate cancer prevention, screening, imaging, diagnosis, treatments, and treatment decisionmaking; identifying aggressive disease and discovering the underlying environmental and genetic factors that contribute to prostate cancer. Our grantees are also striving to answer the most critical questions in prostate cancer research and clinical care, which several of the witnesses have brought up today. Does prostate cancer screening lead to more harm than good? And, if true, how can this be corrected? Which men with prostate cancer need to be treated and which do not? How can we develop more effective treatments for preventing or curing the advanced forms of the disease that are responsible for prostate cancer death? So to briefly highlight just two of our grants, since fiscal year 2005, the PCRP, together with the Prostate Cancer Foundation, has supported the Prostate Cancer Clinical Trials Consortium, which has brought together 13 major cancer centers across the Nation to conduct faster, more precise, and more cost-effective clinical testing of new treatments. In under 4 years, the Consortium has conducted more than 60 early phase studies investigating over 30 different drugs, and has moved five potential therapies into the final phases of testing before the new drugs can be approved. Another key research effort is the Prostate Cancer Project [PCaP]. PCaP is a major collaboration, among institutions in Louisiana, North Carolina, and New York, that seeks to identify the factors that contribute to the highly disproportionate impact of prostate cancer on African-American men, as others have noted, who are more than twice as likely to suffer and die from prostate cancer than Caucasian men. Over 2,000 men have participated in this landmark study, which may finally help us understand and address the factors that cause health disparity. The effectiveness of the PCRP relies on a strong partnership between the U.S. Government and prostate cancer survivors, scientists, and clinicians. These groups work closely together to determine the program priorities, adapting them every year to ensure that we are continually addressing the most important needs. For example, for fiscal year 2010, the program is focused on two major challenges: first, to develop effective treatments for advanced prostate cancer so that fewer men will be lost from their families and society due to this disease; and, second, to distinguish lethal from non- lethal disease so that a great deal fewer men diagnosed with prostate cancer will undergo treatment that is actually unnecessary, yet causes them intense personal suffering and has an immense financial impact on our health care system. To conclude, the PCRP provides direct and undiluted support for prostate cancer research, funding innovative, gap-filling projects and researchers that might not otherwise be supported in the battle against this disease. So I thank you once again for your interest in hearing about this program and Captain Kaime and I look forward to any questions. [The prepared statement of Ms. Best follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Towns. Thank you very much, Dr. Best. Dr. Kaminsky. STATEMENT OF DR. STEVEN G. KAMINSKY, PH.D. Mr. Kaminsky. Chairman Towns, thank you very much for the opportunity to address you. The Uniform Services University is your university, and I am here to talk about one of the programs that Congress actually set up at the University, the Center for Prostate Disease Research. It was the insight of Congress that actually put this program on the map within the military, and I think that the thing that is most important about what it put on the map is the fact that within the military health care system we have equal access to health care, and with this particular Center, which is set up in three different aspects--a clinical research center, a basic science research center, and a data base and tissue repository--the Center has actually made enormous inroads into understanding the disease in an equal access medical care system. The Center was the first to actually demonstrate that African-American males in this system actually needed to be screened earlier and more often with the testing that is available today. The challenge for the Center is everything that Dr. Brawley talked about, and that is how do we really come up with better screening tools, and that is really what the Center is all about from the standpoint of trying to really look at the aggressive forms of the disease and how to actually get there quicker, faster, and better. Today we are working on new genetic tools to try to do that and actually have some products that are hopefully going to make transitions. But one of the key pieces of this Center is actually its data base, which is following over 28,000 patients in a longitudinal study with over 102,000 tissue and blood samples, so that we can actually look at and analyze the disease across time. So to keep us flowing, I am going to hold my comments there and hopefully questions at the end about this particular Center and about essentially Congress's wisdom in setting up a center like this at the University within the military treatment facility really allows us to do things that maybe some others can't because of the kind of health care system that the military has. Again, thanks for the opportunity to talk. [The prepared statement of Mr. Kaminsky follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Towns. Thank you very much, Dr. Kaminsky. Dr. Shtern. STATEMENT OF FAINA SHTERN, M.D. Dr. Shtern. Chairman Towns, thank you for the opportunity to testify today and for your continued support of the AdMeTech Foundation's work. There are many members of this committee who are supporting our work. As you know, there is no family, no community in this country that is not impacted by prostate cancer. When my father's prostate cancer was missed at the leading national hospital, a very powerful point was brought home. In spite of the magnitude of prostate cancer epidemic, men do not have accurate diagnostics for early detection, which is critical to cure cancer and to save lives. Indeed, as reflected in the new guidelines by the American Cancer Society, there is no confidence in the current diagnostic tools for screening and early detection. An American man dies every 19 minutes, even though prostate cancer can be cured when diagnosed early. Mr. Dana Jennings, an editor for the New York Times, echoed sentiments of millions of people when he said prostate cancer and its treatment breed anger and confusion among the men who have it and those who love them. Mr. Jennings, age 49, was diagnosed with advanced and aggressive prostate cancer only recently. He underwent surgery, followed by radiation and hormonal treatment, with the latter being essentially, in plain speak, medical castration. According to a recent VA study, men aged 50 and younger have had a sevenfold increase in the incidence of prostate cancer since 1986, when PSA was invented. These stories--my father's story, Mr. Jennings' story--reflect our prostate cancer crisis. Many other speakers pointed out the first aspect of the prostate cancer crisis, the sheer magnitude of the epidemic. Two million American men live with prostate cancer and many more millions face a threat of prostate cancer each year. African-American men, as was pointed out repeatedly, are disproportionately affected. Unfortunately, for all these millions of men, there is another aspect of prostate cancer crisis: current diagnostic tools are unreliable and, as has been pointed out, cause a staggering extent of unnecessary biopsy, unnecessary treatment, and failed patient care, which in turn reduce quality of life in millions of men, and at billions of dollars in health care cost. I have shared with the committee in my written testimony my estimate that there is over $5 billion each year wasted in health care costs. AdMeTech Foundation's mission is to end our prostate cancer crisis by developing accurate imaging tools for early detection and minimally invasive treatment. I would like to issue a disclaimer. Imaging will not play a significant role in mass screening and prevention, but imaging will be critical for early detection and minimally invasive treatment, and here is why. Slide No. 1, please. [Slide shown.] Dr. Shtern. On the left of the slide you can see film-based digital mammography in 1991, when I was head of diagnostic imaging at the National Cancer Institute. At that time, with small field of view digital mammography, we were lucky to see a larger breast cancer. On the right you can see digital mammography full field done today. There is a striking difference in the quality. It renders entire breast cancer tissue transparent and we can see a tiny breast cancer. Precise imaging has made it possible to guide needle biopsies to detect breast cancer very early and to save lives and, just as importantly, to replace radical and deforming surgery with image-guided minimally invasive lumpectomies. While prostate cancer is even more common than breast cancer, national screening lags far behind and men do not have accurate imaging akin to life-saving mammograms. With congressional support and Federal investment, we can create similar opportunities for men. Slide No. 2, please. [Slide shown.] Dr. Shtern. On the left you see data from Memorial Sloan Kettering in New York. It shows advanced prostate cancer missed this early imaginable current diagnostic, including blind biopsy. There are reports from all over the world that show that MRI-guided biopsy can detect at least 59 to 60 percent of prostate cancer that was missed by blind biopsies at least twice. There are growing reports, I am happy to report, that imaging technologies, molecular imaging, MRI, can determine what is aggressive and what needs to be treated, and what is not aggressive, non-lethal that cannot be treated. This report creates great hope for the future of prostate cancer care, and yet they are extremely preliminary. Further extensive research is needed. On the right hand side you see a three-dimensional MRI that shows small and early prostate cancer rendered in red. When we have this kind of three-dimensional data, we can administer image-guided minimally invasive treatment to eradicate cancer, while sparing normal tissue to avoid complications. This procedure can be performed in outpatient screening with minimal costs, complications, and discomfort to patients. And that is how we will end prostate cancer crisis, with advanced imaging. What we need to succeed is a Manhattan Project for prostate cancer diagnostics, if you will, in order to save lives, improve quality of life in millions of men, and save billions of dollars. I just was told that Representative Cummings, a member of this committee, just introduced ``the PRIME Act,'' H.R. 4756, that calls for a national investment of $500 million over 5 years in medical imaging. It is only 10 percent of the annual waste in health care costs. This act also calls for an increased $100 million for improved in vitro diagnostics over 5 years. It is only 2 percent of annual waste. The success of the PRIME Act at the end of the 5-years we will have accurate imaging technologies for improved early detection and treatment and reliable in vitro testing for improved mass screening and prevention. I hope that this committee will empower and support NIH and DOD in making research in prostate cancer diagnostics, including imaging, a much higher priority than it has been. Passage of the PRIME Act, introduced by Congressman Cummings and Senator Boxer earlier in 2009, will be an important step in that direction. Thank you for your leadership. [The prepared statement of Dr. Shtern follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Towns. Thank you so much for your testimony. Dr. Mohler. STATEMENT OF JAMES L. MOHLER, M.D. Dr. Mohler. My name is Jim Mohler, and I am the Chair of the Department of Urology at Roswell Park Cancer Institute in Buffalo, NY. Roswell Park discovered the PSA that has been taking a beating here today. Also, I chair the National Comprehensive Cancer Network [NCCN] Prostate Cancer Treatment Panel. The NCCN consists of 21 of the 40 NCI-designated comprehensive cancer centers. Finally, I am the principal investigator for PCaP, the North Carolina-Louisiana Prostate Cancer Project that Dr. Best mentioned earlier, which is the largest population-based study of prostate cancer ever undertaken, and half of our patients in that study are African- Americans. I would like to discuss just four points that warrant our attention, and then make three recommendations. The first point is that prior to the development of PSA only 4 percent of men diagnosed with prostate cancer could be cured. Most men were diagnosed with prostate cancer, like Congressman Gallo, when it had spread to their bones and caused pain. The standard treatment was androgen deprivation therapy and mean survival was 3 years. Now, less than 10 percent of men are diagnosed with incurable prostate cancer and 5 years survival after treatment is essentially 100 percent. However, the age-adjusted incidence of prostate cancer has increased 30 percent since 1994 to produce this 36 percent reduction in deaths. Now, if we had achieved a 36 percent reduction in mortality in any other solid cancer in America, there would be cause for jubilation. So why is there so much controversy about PSA? Well, that controversy stems from my second point, and that is a term that hasn't been discussed here yet, autopsy prostate cancer, also called non-lethal prostate cancer earlier. The problem is that the incidence of prostate cancer, if one autopsied the prostate, is approximately the age of the man. In other words, 20 percent of 20-year-olds already have prostate cancer in their prostate, and 80 percent of 80-year-olds already have prostate cancer. So prostate biopsies will find about half of these autopsy cancers. Because PSA, as has been mentioned here today, can be elevated for many reasons, many men may undergo prostate biopsy and have an ``autopsy type'' prostate cancer found. This cancer poses no threat to their life expectancy. The New England Journal of Medicine published back-to-back papers in their March 26, 2009, issue that has reignited this controversy about early detection of prostate cancer, which has been increased by the ACS guideline change issued yesterday. The American study shows no apparent benefit from PSA early detection, although many men were ineligible for the study because they probably had already had their potentially fatal prostate cancers diagnosed and treated, and the majority of the men in the arm of the study that was not subjected to screening annually received PSAs anyway from their personal physicians. Finally, the followup of this study is so short that any benefit from PSA early detection would not yet be apparent. The European study shows a benefit to early detection using PSA, which is actually surprising to me because its followup also is short, and the PSA screening frequency was only once every 4 years. The press has focused upon the fact that 1,400 men needed to be screened and 49 men needed to be treated in order to prevent one death from prostate cancer in the European study. Over-treatment of prostate cancer would not be an issue if the treatment had no side effects and was free. And this brings me to point three, over-treatment of prostate cancer. The NCCN guidelines have already responded by changing their guidelines last month to focus on more careful detection of aggressive prostate cancer in younger men, while urging a more conservative approach to early detection of prostate cancer in older men. The NCCN 2010 Guidelines also recommend active surveillance of men who have been found to have low risk prostate cancer when life expectancy is less than 10 years. In addition, the NCCN has created a new prostate cancer risk category, very low risk prostate cancer. Active surveillance is the only recommended treatment in this group of men when life expectancy is less than 20 years. So let me emphasize that here is a cancer treatment guideline panel recommending active surveillance instead of treatment. These changes allow appropriate aggressive treatment of men who are at high risk of death from prostate cancer while avoiding over- treatment of men at low risk of prostate cancer death. My last point is how PSA and treatment can actually perform better than it does today. African-American men and men with a family history of prostate cancer, especially in their brother or father, represent a group of men that we all agree are at higher risk of death from prostate cancer. PSA and treatment will perform better if efforts at early detection of prostate cancer are focused on these higher risk groups. So, this leads me to my three recommendations. The first hasn't been made by anyone yet. We need a blood or urine test that can be combined with PSA to indicate who doesn't need a biopsy. This is critically important because then men with autopsy type prostate cancer can be spared biopsy and the anxiety attached to the diagnosis of an autopsy prostate cancer. I agree with the other panelists that, once diagnosed with prostate cancer and tissue is available, we need better imaging or a tissue-based biomarker of life-threatening prostate cancer. Currently, PSA, extent of disease, and Gleason grade of cancer, correlate with prostate cancer aggressiveness in groups of men, but not in individual patients. More funds must be spent to develop biomarkers of aggressive prostate cancer, and I believe that these markers may come through more careful study of the prostate cancers found in African-Americans. Until we succeed in these two areas, the NCCN guidelines should be used to guide the diagnosis and treatment of prostate cancer to assure that we continue to reduce the mortality from prostate cancer, while not subjecting men to the consequences of over-treatment. I thank the committee for their wisdom in addressing these very complex issues posed by prostate cancer. [The prepared statement of Dr. Mohler follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Chairman Towns. Thank you very much. Let me thank all of you for your testimony. The way I generally start out, is to ask the witnesses are there any statements that you have heard that you would like to sort of clarify and give your input to them, be it from the first panel or from this panel. And the reason I do that is because I was at the airport 1 day and a person said to me, ``I did not agree with anything that person said, and you didn't allow me to respond.'' I don't want to be guilty of not allowing you to respond. So that is the first question. Yes, Dr. Brawley. Dr. Brawley. Yes, if I may, sir. In the first panel I heard that the mortality has gone down, so it must be because of screening. I think it is important to realize that if you go to various countries in Europe which, as a policy, have said not to adopt screening because it hasn't been proven to save lives, mortality has been going down in those countries as well. So it is hard for me to attribute all of the decline in mortality in the United States to screening when there are several other countries--Britain, France, so forth--that have a decline in mortality without having screening. Second, Dr. Mohler talked about--my good friend, Dr. Mohler, by the way; we have worked together on a number of things--talked about 5-year survival. When I am teaching epidemiology and teaching screening, we don't use 5-year survival as a good use of outcome. It is not an evaluation of outcome, especially in prostate cancer, where many of the people you pick up with screening would have never died; they had those autopsy style prostate cancers. They actually artificially push your 5-year survival rate up. And this is best seen, by the way, in the old studies of lung cancer, lung cancer screening with chest x-ray. By the way, we have been here before. Lung cancer screening was advocated in the United States from 1960 to about 1975. The Otis Brawleys of the 1960's said ``let's do a study.'' Many people said ``no, it finds disease earlier, it increases 5-year survival rates.'' When those studies were done--my favorite is the Mayo Clinic study--the death rate on the screened arm of the Mayo Clinic randomized chest x-ray study was 3.2 per 1,000 per year on the screened arm and 2.8 per 1,000 per year on the unscreened arm. Keep in mind survival was increased on the screened arm, but risk of death was increased as well. So when we teach in epidemiology and we are doing screening, we don't look at 5-year survival rates, we look at decrease in mortality rates. That is what we want to find. Chairman Towns. Thank you very much. Anyone else? Yes, Dr. Mohler. Dr. Mohler. I cannot let misstatements by Otis go unaddressed. Chairman Towns. Are you guys really friends? Dr. Mohler. Yes. I always like to say that two people can be looking at a horse, and if one is standing at the head and the other is standing at the tail, they describe something that looks very different. Many aspects of this debate are about where are you standing. Now, the decrease in mortality in Great Britain, which has been argued for to counteract the 36 percent decline in age-adjusted prostate cancer mortality in America, has been thoroughly investigated. Great Britain changed the way that their national registry recorded deaths at autopsy, and when this was accounted for the decline in prostate cancer mortality in Great Britain basically went away. I think our country is unique in having had objective evidence of a decline in prostate cancer mortality. This occurs at the same time that the worldwide incidence of prostate cancer is increasing 1.1 percent per year. The reasons for this are unknown. The best evidence suggests that this may be from westernization of the diets. But we do not know much more than we do know about prostate cancer. So Otis very appropriately is challenging the 5-year 100 percent survival being inadequate to say that treatment is effective. We know that as we follow those men longer, many of them are going to recur, but this is the data that is reported by the American Cancer Society and why I conform to the 5-year number. Chairman Towns. Yes, Dr. Shtern. Dr. Shtern. Thank you. There was a statement made at the previous panel that only 25 percent of women undergoing biopsy have breast cancer. What I would like to refocus, if you look at the number of breast cancer and prostate cancer is close. Let's say it is around 2,000 per year. The average yield, percentage of men who have cancer and undergoing biopsy, according to the largest trial NCI supported that we have, is 12 percent. So if we look from that and we know from actual numbers that 1 million women undergo biopsy every year; however, 2 million or close to 2 million men undergo biopsy every year, it means that if we had an imaging tool that will eliminate, that will be compatible to mammography and will eliminate 1 million biopsies right there and then, there is a possibility to save over $2 billion. Thank you. Chairman Towns. Thank you very much. Let me now go to you, Dr. Brawley. Now, I understand, of course, that you are perhaps an expert on cancer screening, and I respect that and really appreciate that you are here and your work over the years, but before I get to that focus, I want to ask your opinion on any correlation between education and mother's diet and why African-Americans are significantly more disproportionately impacted by the lethal form of prostate cancer. I lost a brother to it. Dr. Brawley. Yes, sir. Thank you. We have been working long and hard for probably now 30 years to try to finally start addressing the question why do Blacks have a higher rate around 1980. And, by the way, it is Blacks in the western hemisphere for sure; Blacks in Brazil and Jamaica have a higher rate, as do Blacks in Canada. I don't know about Blacks in Africa because there is no good registry there, and the National Cancer Institute of the United States actually tried to establish a registry to try to figure it out and just couldn't. What data that we do have indicates that a large number of the Black prostate cancer problem can be due to diet, it can be due to differences in diet over time, differences in body mass index. There are some studies that have been done primarily in animals that indicate that animals that are fed a high fat diet when they are pregnant, their children will have a differing sensitivity in terms of estrogen and androgen receptors when the children are born. So there are some people who have speculated that it is the socioeconomic status of the fetus and of the mother, and the diet of the mother when in utero that actually affects risk of both prostate and breast cancer 40, 50, 60 years after birth. For example, many people talk about the breast cancer problem in Black women with triple negatives. If you go to Scotland, one of the best studies on breast cancer in Black women has been done in Scotland, where they have no Black women. They figured out that women in Scotland who have a lifelong history of poverty--and you can't look at socioeconomic status at the time of diagnosis; you have to look at socioeconomic status over the entire lifetime, beginning in utero. Women who were born and have a lifetime of poverty have breast cancers that are more likely to be triple negative, more likely to present at an earlier age, just as Black women in the United States. So socioeconomic status, diet, a number of other environmental factors actually can change the genetics of a breast cancer. Estrogen receptor negative breast cancer, that is a genetic difference, but white women in Scotland who are poor tend to have more of it than white woman in Scotland who are not poor. Chairman Towns. Dr. Mohler. Dr. Mohler. So the North Carolina-Louisiana prostate cancer study is seeking to look at many of these dietary and lifestyle differences that may be contributing. I think it is very important to recognize that there is fundamental differences between the African-American prostate and the Caucasian American prostate, and Dr. Brawley is exactly correct that we don't know where these come from. But one of the fundamental questions that PCaP will address is whether the African-American prostate seems to have a revved up androgen access. The circulating androgens are the same between the two races, but the African-American prostate, for unknown reasons, has more of the protein that testosterone binds to to turn on growth than does the Caucasian American prostate. That level of protein is 21 percent higher in the benign prostate, and then once African-American men develop prostate cancer, their cancers have 81 percent more of this protein. It is completely unclear why that is and whether this is a consequence of diet and lifestyle, has something to do with genetic environmental interaction, but much of PCaP is devoted to figuring out whether this is actually true in a large number of men from a population-based series. I still think that most of the racial differences in prostate cancer mortality stem from socioeconomic disadvantage and not race, per se. In fact, when we look at our treatment results in North Carolina and Louisiana, once you correct for socioeconomic status, race is no longer a factor in treatment received or outcome of that treatment. Chairman Towns. So you are also saying education plays a part? Dr. Mohler. I think that is the greatest contributor to the racial disparity right now, yes. Dr. Brawley. Sir, we have--Dr. Mohler and I completely agree on that. And, by the way, some of the best early studies to look at Black-White differences on this very issue actually came from the Intramural Department of Defense Prostate Cancer Program that Dr. Kaminsky represents. Chairman Towns. Thank you very much. I now yield to the ranking member. Mr. Issa. Thank you, Mr. Chairman. I think it is not good to find out that to be poor in America can kill you, but it sounds like, once again, that would be the short way of expressing what you have found. We are having a lively debate on health care and I think it is pretty safe to say, on either side of the dais here, that we are concerned that there are two Americas relative to health care. But, Dr. Brawley, I am particularly interested in a couple of the things that you have attacked, because you could tell by the earlier panel--I tend to want to figure out how to fix the Hubble telescope in the sense that we have put a lot of money into this project and it doesn't appear--if 30 out of 31 people that get treated would be just as well off not being treated-- that we have yet focused on the right answer, which means we don't have the real visibility we need. Earlier, actually, it was in Dr. Dahut's--but he has left-- statement, but I think you are probably very capable of answering this. When we talk about prostate cancer, are we really talking about flu--I am using the term broadly--flu of the prostate versus H1N1 of the prostate and some other group of various things? We are using a broad-brushed statement when in fact it is cancer in the prostate, not prostate cancer. Dr. Brawley. What we are talking about is actually prostate cancer that become malignant and start growing. Mr. Issa. But they are malignant due to different forms of cancer in the sense that they react differently, they are differently treated. And if you could isolate, if you will, various strains and treat them appropriately, you could have better results? Dr. Brawley. Yes, that I would agree with, but the cancer itself originates from cells in the prostate. And there are a variety of different, more aggressive, less aggressive--one of our problems actually is that Vera Cao, in 1848, described what prostate cancer was, and he described it using autopsy specimens. And now, even though we have moved into a molecular age 168 years later, we are still using his light microscope definition of cancer, and that is why we really desperately need molecular tests are actually where I think it will come from, where we can say, Mr. Smith, you have prostate cancer, but it needs to be watched; Mr. Jones, you have prostate cancer and we need to treat it aggressively, because if we don't treat it aggressively it is going to bother you. Mr. Issa. Now, the American Cancer Society has put out figures on both breast cancer and prostate cancer, and they are relatively interesting in the sense of their similarity. Breast cancer, 192,370 cases of invasive breast cancer; 192,280 new cases of prostate cancer. I noticed a word missing there. The death today, after all the good work that we earlier talked about, from breast cancer, 40,170; from prostate cancer, 27,000. To understand the statistics and balance it here for us lay people, if I understand correctly, the 192,000 prostate cases, if you took out the ones that were likely not to kill you--that is hindsight, but if you took those out, you are probably not talking about 192,000, you are not even talking about 19,000; you are talking about probably 10,000 cases, new cases. Then you say, well, wait a second, how do I end up with 27,000 deaths from 10,000 cases. So I want to understand what that figure really is. Dr. Brawley. When Dr. DeWeese talks about 30 to 50 people treated for every one life saved, that is among people who are screened detected. OK? The European study---- Mr. Issa. Screened and found to have cancer. Dr. Brawley. That is right. The European study--remember, screening is going to find disease that we would not have found if there had not been any screening. Indeed, a man in the United States who chooses to be screened doubles his risk of being diagnosed with prostate cancer from about 1 in 10 to 1 in 5, from 10 percent to 20 percent. Mr. Issa. You mean if you don't look, you don't find; but if you look, you find. Dr. Brawley. That is right. That is exactly right. Now, by the way, on the other hand, if we take the European study, which showed that 20 percent relative risk in decrease in death with a soft P value, so we are not 100 percent sure of that finding, that is 3 percent lifetime risk of death going down to 2.4 percent lifetime risk of death. So the answer to your question is the 30 to 50 to 1 is in a screened detected population. Mr. Issa. Right. But I wanted to see how it boiled down to when you get to the 192,000 versus the 192,000 for these two types of cancers, and more people die of breast cancer, a cancer that we can look at with mammography, we have a better feel for being able to see it, feel it, and eliminate it, but you have a higher number, to me that begs the question of when we use the number 192,000 in prostate cancer, are we basically saying here is a cancer we are not very good at actually curing, but we are also not very good at putting a number up there that are really the number that kill you? Does this include a number that people would live 20 more years? Dr. Brawley. Oh, yes. Mr. Issa. So the 192 versus 192, 192,000 that says invasive breast cancer, these are going to kill women; and the 192 of prostate not so much. Dr. Brawley. That is right. Many are not going to kill. But if you will bear with me, the big difference between---- Mr. Issa. I don't want to interrupt you excessively, but I just would like to know, after the fact, if you could, if you could re-estimate that 192,000 to give me your best guess of invasive prostate cancer so that we can look at the cases versus death, because they make them look like breast cancer is less successful in treatment and more likely to kill women, when in fact it looks like there are less cases, but we don't do so good with prostate cancer. Dr. Brawley. That is actually the reason why I like to look at mortality rates, rather than absolute numbers. What I was going to say is we have nine randomized trials in breast cancer that consistently show that mammography screening decreases the mortality rate. Nine. Two of those nine happen to focus on women in their forties, by the way. We have four randomized trials in prostate cancer that have ever been attempted. One actually was with digital rectal exam and not PSA. Three of those four trials actually show a slight increased risk of mortality in the screened arm versus the unscreened arm; one of them, the European study, shows that 20 percent decrease in mortality. So the reason why there is uncertainty why there is uncertainty is we have three studies that say that this screening stuff could be like lung cancer screening back in the 1960's, and we have one study that says no, it does save lives. Mr. Issa. Let me just concentrate on two last quick questions. One is the Europeans, regardless of whether they lower mortality because of what they do or not, they spend less, is that correct? They basically decided, whether it was because of the cost or because they didn't see a benefit, they have decided to prescribe less action both in testing and in treatment. Dr. Brawley. Yes, sir, and that relates directly to the health care debate that is going on right now. There is an American tendency that if you have a technology that you think works, go out and do it. I can name 12 things over the last century--you mentioned the Halstead mastectomy earlier. Remember, we did that for 75 years because Dr. Halstead said it was a good thing, and we criticized all the people who wanted to do an evaluation of it for more than 75 years. Finally, we get around to doing an evaluation of it and we find out that a lumpectomy and radiation is equal to the Halstead mastectomy. We did the wrong thing for 75 years. This came out--PSA came out in the late 1980's and we started pushing it, started encouraging people to get it rather than doing an adequate evaluation. The Europeans actually decided to do an adequate evaluation. The contamination rate on the European study is so low--that is, the number of guys in control who did not get the PSA, because you can't get a PSA over there unless you are in a study to see if it works. Mr. Issa. OK, I realize--begging the indulgence, very quickly, Mr. Chairman. Dr. Shtern, because you are someone who is talking about an alternative, anyone who is talking about where we should invest in research for alternatives, including Dr. Mohler, if you are talking about a Next Generation PSA that wouldn't be such a shotgun approach to actually diagnosing specific cases of invasive cancer. Dr. Shtern. Dr. Shtern. Thank you very much. I would like to refute just a couple of numbers. I think the numbers you cited need to be put in a slightly different perspective with some slightly different statistics that frame prostate cancer as a patient care crisis, in spite of the numbers you just cited, which was absolutely accurate. If we look at the number of men who fail on prostate cancer treatment every year, it is 70,000 men. What that means in practical terms, about 50 percent of men undergoing prostate cancer treatment fail and prostate cancer progresses and becomes life-threatening. This is 70,000 men. If you look at another number, in August 2006, there was a study in over 76,000 men published by the University of Michigan, and it demonstrated at the necessary treatment, and it demonstrated that up to 54 percent of men with early localized prostate cancer have unnecessary treatment. That is why it is with billions of dollars in health care cost in procedures alone. We never could get access to hospitalization costs and related data. The bottom line is that you have essentially one and a half men undergoing treatment failing on treatment on one side; on the other hand, you have roughly one in two men who have failed treatment, and where we failed, we do not have accurate diagnostic information either by a marker for mass screening or imaging to create patient tailor appropriate treatment. That is why investment, as Dr. DeWeese pointed out, in diagnostic information is that critical. Mr. Issa. Thank you, Mr. Chairman. I think the day after we eulogized Jack Murtha, it tells all of us that we don't want to have procedures unless they are going to yield the right result, because procedures can lead to other loss of life and loss of qualify of life. So I thank the chairman and yield back. Chairman Towns. I thank the gentleman. I now yield to the gentlewoman from California, Congresswoman Diane Watson. Ms. Watson. Thank you, all panelists, for being here and for your testimony. I would like to address Dr. Brawley. You have argued that prostate screening began to be implemented before adequate studies were conducted, and that such studies are still needed. In the meantime, who should be screened? When should they be screened? Should Black men be first, and then--at one age and then white men at another? And how should screening be utilized in the treatment? And you might have given us some answers before I came in. Dr. Brawley. No, no, no. Good important questions. I think right now the most important thing is to tell men the truth, because a lot of what I am hearing on advertisements and other places, sometimes from hospitals that make money off of treating prostate cancer, sometimes from prostate cancer survivor groups who want to do the right thing, prostate cancer survivor groups that are frequently supported by industry that makes these tests, I will say, frequently, but not always. I think people need to know the right information, which is we don't know if this test saves lives. There are some very smart people who think that it does. I actually think it saves lives. I think it saves lives, but I know we have to treat a large number of people in order to save each life. Some men may want to take the option of getting screened, and we should support those men. Some men, knowing this, may want to not get screened, and we should support and not criticize those men for that decision. And I really do believe we need to get into informed decisionmaking. The American Cancer Society has favored informed decisionmaking since 1997 is just people would read what we said and then say the ACS says men should get screened. The ACS says men should be informed and make a decision is what we wanted people to say, so that is why we changed our guideline. Our guideline as of yesterday is, within the physician-patient relationship--none of this free screening is done to generate income by hospitals. Within the physician-patient relationship, the physician and the patient should have a conversation, talk about the uncertainties, the known risks, and the possible benefits, and make a decision as to what is right for the patient. That is what we need to be doing. Ms. Watson. You know, years ago, when I was in the Senate in California chairing the Health and Human Services Committee, I also was very involved in a statewide organization looking at Black women with breast cancer. A few months ago the question-- not the question, but the directive was out that women are to wait later, until they are 40, before they do the screenings. I am talking about breast cancer in this instance. The women that were part of our study and was directed at UCLA under Dr. Love, by the time a year or two passed, all of them were dead. So I was struck that there is something in the DNA among African-Americans that causes cancer at an earlier age, and I am recognizing that because I carry the bill for the first screenings on prostate cancer among Black males. I think you might have answered this. You said it has to be an individual thing, but I do see African-Americans more prone toward prostate and breast cancer than other groups. What will we have to do and how much time will it take us to come up with some decisions on just when? Dr. Brawley. Unfortunately, we lost a lot of time because we started advocating the screening in the early 1990's. Indeed, how we lose time is saying everybody should get screened dissuaded men from going in the studies to figure out if screening worked. And things like the American study that just reported was 5 years late because of slow accrual. Why would you go into this study when all these advertisements are saying everybody should get screened; screening saves lives? OK? That is how we slowed down. Now, once we have people to understand that this is a huge problem, it is probably going to be 10 or 15 years before we can get a good answer, and it is through supportive things like Dr. Mohler's study, it is through support of many of the wonderful things that have gone on in the Department of Defense studies and the NCI, and it takes doctors who are practicing medicine to realize this was a problem. This over-diagnosis thing was ``pooh-poohed'' by a number of physicians in practice in the early 1990's when those of us in academia were saying that it is a problem. Now we have numerous studies. The Prostate Prevention Trial is my favorite. It is the only study that ever biopsied men who had normal PSAs. It showed that PSA screening for men in their sixties over 7 years can diagnose 13 percent with prostate cancer. It also showed that PSA misses just as many prostate cancers as it found, and of that 26 percent of men in their sixties who were diagnosed with prostate cancer, we know only 3 percent are going to die, 3 out of the 26. OK? So that is an indication of this over- treatment thing. There was actually a vote in the integration committee for the Department of Defense--these are survivors and doctors-- earlier in this decade that said that more money for the Defense Department ought to go toward seeing how to get men screened and take that money away from studies of the biologic behavior of prostate cancer. So we are letting our emotions--I am very emotional about this because I want men to get the right thing, and I know that I am hearing that men are not getting the right information. Chairman Towns. The gentlewoman's time has expired. I now yield 5 minutes to the gentleman from Maryland, Mr. Cummings. Mr. Cummings. Thank you very much, Mr. Chairman. Dr. Brawley, let me ask you this, and any of our other panelists. You know, the problem is that I think it was Lou Gossett said it a little bit earlier when he was talking about--he was talking about African-American men, but he could have applied this to men, period--are squeamish about the prostate and the exams. So I am trying to figure out--so they already are not likely to go in for the exam. Don't want to talk about it. So how do you make the jump--with all this new information that just came out yesterday, it gives men an excuse not to do it. I am telling you. And men look for excuses not to do this. They already don't want to do it, but they really don't want to do it. They say, see, told you it is not going to do any good anyway. I can hear them now. So, I mean, how do we deal with that? Then the question also for them becomes, well, even if I go in, it sounds like there is confusion. You follow me? Dr. Brawley. There is confusion, sir. Mr. Cummings. So what is the best argument to a man who is looking at you right now to go and try to address this issue? Dr. Brawley. Well, I can tell you the argument to address the issue. I can't tell you the argument why a man should be screened, because I actually think that our guideline yesterday--and the experts came together and said if a man doesn't want to be screened, we should support that man in that decision. Mr. Cummings. OK. Dr. Brawley. OK. But I do think that we should be talking about prostate cancer. A big problem in the Black community is a number of men who don't have prostate cancer, but have benign prosthetic hyperplasia, difficulty urinating, and are suffering from that and won't go get it treated or get it assessed. I do think we need to talk about these things openly. And I will also tell you, growing up and becoming a screening expert, growing up from the inner city of Detroit, where all my relatives were afraid that people weren't telling them the truth, I grew up to find out that my relatives were pretty wise, because on this issue there are a lot of things out there that are not truthful, that is misleading. We do not know if prostate cancer screening saves lives. Some of us think it does, but I hear routinely that prostate cancer screening saves lives. I hear routinely that any man who doesn't get screened is a fool. Yet--I had nothing to do, by the way, with the ACS guideline; I am a staff person. These were volunteers; these were doctors, epidemiologists, outcomes people, and some patients who met over a period of a year looking at all the literature that we have, and they came up with--and, indeed, they came up with the same thing that they came up with in 2001--there are huge uncertainties here. People need to know there are huge uncertainties and then make a decision about what is right for them. Mr. Cummings. OK. Dr. Shtern, and then I will go to you, Dr. Mohler. Dr. Shtern, the imaging, does it appear that the imaging-- Dr. DeWeese, a little bit earlier, testified that there is the radical type of prostate cancer and then he said there is more like a, I don't know, dormant? I don't know whether that is the right word. But is it the belief that this imaging will be able to detect which one it is? Nice and loud, please. Dr. Shtern. Not only did we always believe that with appropriate research funding it would be possible to develop imaging tools that will be able to differentiate dormant from aggressive prostate cancer, but there is current emerging scientific information that points us in that direction. Specifically, at the University of California in San Francisco, data were produced that magnetic resonance spectroscopy may help to differentiate aggressive from non-aggressive prostate cancer. Only in a few days, on March 10th, there would be a study published by my co-leader of AdMeTech finding international prostate MRI working from Dr. Berenson in Holland, and he will be presenting data, pilot studies in 51 men where novel MRI technology, diffusion-weighted imaging was able to discriminate aggressive from non-aggressive prostate cancer. Now, these are pilot studies. Further extensive research is needed in order to have definitive answers. That is why investment in imaging research is critical. Thank you. Mr. Cummings. I see my time is up, Mr. Chairman. I think Dr. Mohler wanted to say something, but I know we are running out of time. Chairman Towns. Yes, Dr. Mohler, if you could be brief. Dr. Mohler. I just wanted to reiterate that I think you have heard a message here that we need, in addition to a way to detect prostate cancer, we need a way to separate autopsy from the lethal prostate cancer. Mr. Cummings. Right. Dr. Mohler. That is a common theme. The problem right now is that men have to decide what to do now; they cannot wait for Dr. Brawley's 15-year studies from now. What happens in the 15 years since the American and European screening studies were designed is medicine advances, and then the results 15 to 20 years into the future become obsolete. So men are being faced with this difficult problem of what to do now, and the NCCN guidelines emphasize aggressively finding prostate cancer in young men, because the young man who you can detect prostate cancer, he is going to live so long that he is going to die from it. You need to relax as men get older, because they will suffer the increasing incidence of the autopsy type cancer that you don't want to go aggressively find. So PSA and treatment are being justifiably criticized right now because there has been overzealous use of both PSA for early detection and treatment. We need more science to separate this autopsy cancer from the lethal cancer, and then we wouldn't have to be having so many of these discussions. Mr. Cummings. Thank you, Mr. Chairman. Chairman Towns. Thank you very much. Let me indicate that we will leave the record open for 5 additional days for additional comments and information. Let me just thank all of you for your testimony today. I tell you, it points out that we still have a long way to go, but we appreciate your work and what you are doing, and we look forward to working with you as we move forward. I think this is a very important hearing when you look at the statistics and what is really going on. So let me thank you again. At this time, the hearing is adjourned. [Whereupon, at 3:09 p.m., the committee was adjourned.] [Additional information submitted for the hearing record follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]