[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


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              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:]

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    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:]

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    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:]

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    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:]

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    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:]

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    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:]

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    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:]

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    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:]

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