[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]




 
   WOMEN AND CANCER: WHERE ARE WE IN PREVENTION, EARLY DETECTION AND 
                   TREATMENT OF GYNECOLOGIC CANCERS?

=======================================================================

                                HEARING

                               before the

                   SUBCOMMITTEE ON CRIMINAL JUSTICE,
                    DRUG POLICY, AND HUMAN RESOURCES

                                 of the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             FIRST SESSION

                               __________

                           SEPTEMBER 7, 2005

                               __________

                           Serial No. 109-128

                               __________

       Printed for the use of the Committee on Government Reform


  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
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                     COMMITTEE ON GOVERNMENT REFORM

                     TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut       HENRY A. WAXMAN, California
DAN BURTON, Indiana                  TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida                PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota             CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana              ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio           DENNIS J. KUCINICH, Ohio
TODD RUSSELL PLATTS, Pennsylvania    DANNY K. DAVIS, Illinois
CHRIS CANNON, Utah                   WM. LACY CLAY, Missouri
JOHN J. DUNCAN, Jr., Tennessee       DIANE E. WATSON, California
CANDICE S. MILLER, Michigan          STEPHEN F. LYNCH, Massachusetts
MICHAEL R. TURNER, Ohio              CHRIS VAN HOLLEN, Maryland
DARRELL E. ISSA, California          LINDA T. SANCHEZ, California
GINNY BROWN-WAITE, Florida           C.A. DUTCH RUPPERSBERGER, Maryland
JON C. PORTER, Nevada                BRIAN HIGGINS, New York
KENNY MARCHANT, Texas                ELEANOR HOLMES NORTON, District of 
LYNN A. WESTMORELAND, Georgia            Columbia
PATRICK T. McHENRY, North Carolina               ------
CHARLES W. DENT, Pennsylvania        BERNARD SANDERS, Vermont 
VIRGINIA FOXX, North Carolina            (Independent)
------ ------

                    Melissa Wojciak, Staff Director
       David Marin, Deputy Staff Director/Communications Director
               Rob Borden, Parliamentarian/Senior Counsel
                       Teresa Austin, Chief Clerk
          Phil Barnett, Minority Chief of Staff/Chief Counsel

   Subcommittee on Criminal Justice, Drug Policy, and Human Resources

                   MARK E. SOUDER, Indiana, Chairman
PATRICK T. McHenry, North Carolina   ELIJAH E. CUMMINGS, Maryland
DAN BURTON, Indiana                  BERNARD SANDERS, Vermont
JOHN L. MICA, Florida                DANNY K. DAVIS, Illinois
GIL GUTKNECHT, Minnesota             DIANE E. WATSON, California
STEVEN C. LaTOURETTE, Ohio           LINDA T. SANCHEZ, California
CHRIS CANNON, Utah                   C.A. DUTCH RUPPERSBERGER, Maryland
CANDICE S. MILLER, Michigan          MAJOR R. OWENS, New York
GINNY BROWN-WAITE, Florida           ELEANOR HOLMES NORTON, District of 
VIRGINIA FOXX, North Carolina            Columbia

                               Ex Officio

TOM DAVIS, Virginia                  HENRY A. WAXMAN, California
            J. Marc Wheat, Staff Director and Chief Counsel
                        Michelle Powers, Counsel
                           Malia Holst, Clerk
          Richard Butcher, Minority Professional Staff Member


                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on September 7, 2005................................     1
Statement of:
    Karlan, Dr. Beth, president, Society of Gynecologic 
      Oncologists; Dr. Mark Jay Rosenfeld, scientist/researcher; 
      Sheryl Silver, sister of Johanna Silver; and Kolleen 
      Stacey, ovarian cancer survivor............................    71
        Karlan, Dr. Beth.........................................    71
        Rosenfeld, Dr. Mark Jay..................................    78
        Silver, Sheryl...........................................    86
        Stacey, Kolleen..........................................    94
    Trimble, Dr. Edward L., M.D., M.P.H., head of the surgery 
      section, Division of Cancer Treatment and Diagnosis, 
      National Cancer Institute; Dr. Ed Thompson, M.D., M.P.H., 
      Chief of Public Health Practice, Centers for Disease 
      Control and Prevention; and Dr. Richard Pazdur, M.D., 
      Director, Division of Oncology Drug Products, Center for 
      Drug Evaluation and Research, U.S. Food and Drug 
      Administration.............................................    15
        Pazdur, Dr. Richard......................................    33
        Thompson, Dr. Ed.........................................    24
        Trimble, Dr. Edward L....................................    15
Letters, statements, etc., submitted for the record by:
    Karlan, Dr. Beth, president, Society of Gynecologic 
      Oncologists, prepared statement of.........................    74
    Pazdur, Dr. Richard, M.D., Director, Division of Oncology 
      Drug Products, Center for Drug Evaluation and Research, 
      U.S. Food and Drug Administration, prepared statement of...    36
    Rosenfeld, Dr. Mark Jay, scientist/researcher, prepared 
      statement of...............................................    80
    Silver, Sheryl, sister of Johanna Silver, prepared statement 
      of.........................................................    89
    Souder, Hon. Mark E., a Representative in Congress from the 
      State of Indiana, prepared statement of....................     4
    Stacey, Kolleen, ovarian cancer survivor, prepared statement 
      of.........................................................    96
    Thompson, Dr. Ed, M.D., M.P.H., Chief of Public Health 
      Practice, Centers for Disease Control and Prevention, 
      prepared statement of......................................    26
    Trimble, Dr. Edward L., M.D., M.P.H., head of the surgery 
      section, Division of Cancer Treatment and Diagnosis, 
      National Cancer Institute, prepared statement of...........    18


   WOMEN AND CANCER: WHERE ARE WE IN PREVENTION, EARLY DETECTION AND 
                   TREATMENT OF GYNECOLOGIC CANCERS?

                              ----------                              


                      WEDNESDAY, SEPTEMBER 7, 2005

                  House of Representatives,
Subcommittee on Criminal Justice, Drug Policy, and 
                                   Human Resources,
                            Committee on Government Reform,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10:45 a.m., in 
room 2154, Rayburn House Office Building, Hon. Mark E. Souder 
(chairman of the subcommittee) presiding.
    Present: Representatives Souder, Burton, Cannon, Issa, 
Foxx, Waxman, Cummings, Watson, Sanchez, Ruppersberger, and 
Norton.
    Staff present: Marc Wheat, staff director and chief 
counsel; Michelle Powers, counsel; Malia Holst, clerk; Kristin 
Amerling, minority general counsel; Tony Haywood and Naomi 
Seller, minority counsels; Richard Butcher, minority 
professional staff member; Earley Green, minority chief clerk; 
Cecelia Morton, minority office manager; and Christopher Davis, 
minority investigator.
    Mr. Souder. The subcommittee will come to order.
    Good morning and thank you all for being here.
    Today's hearing will examine the Federal efforts targeting 
gynecologic cancers, specifically where we are in the areas of 
education, research, prevention, and treatment. The hearing 
will also provide an opportunity for medical and research 
specialists, patients, and family members to discuss the 
relevant issues involved in gynecologic cancers and where more 
work is needed.
    This month marks Gynecologic Cancer Awareness Month, as 
well as National Ovarian Cancer Awareness Month. According to 
the American Cancer Society, over 79,000 women are diagnosed 
every year with cancers affecting the reproductive organs. If 
diagnosed in the early stages, the survivability rate is as 
high as 95 percent. Nonetheless, this year alone, more than 
27,000 women will die from gynecologic cancer.
    Any woman is at risk for developing a gynecologic cancer.
    The most deadly gynecologic malignancy is ovarian cancer. 
Patients with ovarian cancer often report that they had 
symptoms for months before diagnosis, but early signs of this 
cancer are frequently mistaken for more common digestive 
disorders. As a result, most ovarian cancer cases are diagnosed 
at an advanced stage, where the chances of survival drop to 
only 20 percent. This year, out of the more than 22,000 new 
diagnoses of ovarian cancer, more than 16,000 women will die 
from the disease.
    The most common gynecologic cancer is uterine cancer, which 
will afflict more than 40,000 women this year and kill over 
7,000 women. While there have been advances in therapy for 
uterine cancer, including the innovative new surgical 
treatments, women are largely unaware of the risk factors 
contributing to this disease, which include obesity, 
hypertension, diabetes, and inappropriate estrogen use. 
However, if a women is diagnosed early, surgical therapy is 
usually adequate for a cure.
    Where there is effective screening, there has been a 
significant reduction in deaths from certain gynecological 
cancers; over the last 50 years, routine use of the pap test to 
screen for cervical cancer has reduced deaths from that disease 
by 74 percent. However, there are no widely accepted and 
effective screening tests for other gynecologic cancers. This 
leaves women vulnerable to late diagnosis, and lower chances of 
recovery.
    Even with effective screening, the American Cancer Society 
estimates that cervical cancer will kill more than 3,700 women 
this year. The primary cause of virtually all cervical cancers 
is human papillomavirus [HPV], which is transmitted through 
sexual contact. More women will die from this disease than from 
AIDS, among non-injection drug users. Although Federal agencies 
are working on vaccines developed to prevent HPV infection, 
current proposed vaccines do not address all strains of HPV.
    Moreover, the FDA has yet to comply with Public Law 106-
554, signed by President Clinton in 2000, requiring that 
condoms be accurately labeled to reflect the fact that condoms 
do not protect women from HPV infections. The Gynecologic 
Cancer Foundation's 2005 State of the State Report on 
Gynecologic Cancers notes that both women and men do not fully 
understand the association between HPV infection and its severe 
health consequences.
    It is inexcusable that Federal agencies have yet to comply 
with a law passed more than 5 years ago and, in the meantime, 
thousands of women continue to die from this preventable 
disease. The cost to comply with the law requiring accurate 
condom labeling is quite low. The benefit is measured in terms 
of women's lives. There is simply no justification for the FDA 
and the White House Office of Management and Budget dragging 
their feet on this critical public health matter.
    I am surprised that the FDA's testimony today makes no 
reference to their progress in complying with this law since 
the FDA last appeared before this subcommittee on this very 
issue on March 11, 2004. Perhaps the FDA witness is not 
prepared to address this matter this morning, but I would ask 
that FDA provide a full explanation on this matter in 5 days, 
and we will be happy to forward FDA's response to all 
subcommittee members. I hope the other agencies represented 
here today will address these issues in oral testimony.
    There is an evident need to raise awareness among patient 
and medical communities about all aspects of gynecologic 
cancers, including prevention, symptoms, screening, and 
treatment. A recent poll commissioned by the Gynecologic Cancer 
Foundation found that the majority of women believe that they 
are at risk for developing gynecologic cancers, and fear them 
even more than lung cancer, which is the leading cause of 
cancer deaths among women. More than a third of women say they 
have little knowledge about gynecologic cancers, and in fact, a 
staggering 47 percent of them could not name any symptoms of 
gynecologic cancers.
    Parallel to the important education needs is the necessity 
for innovative research and therapy development.
    I hope the outcome of this hearing is a better picture of 
what efforts the Federal agencies are making to raise awareness 
among practitioners and among patient and medical communities 
of gynecologic cancers, and where there are unmet needs. In 
particular, I hope the agencies address their critical role in 
protecting the public from HPV infection and preventing more 
cervical cancer deaths. I also hope we can learn the status of 
current funding paths for innovative and cutting edge research 
for gynecologic cancers, and whether we are meeting the 
challenges to deliver new therapies.
    Finally, I hope the first-hand experience and perceived 
needs of those who deal with gynecologic cancers as patients, 
family members, doctors, and researchers provide us with a 
better understanding of how to address gynecologic cancers.
    I am now going to turn this hearing over to Congressman 
Cannon to chair the hearing. His daughter passed away from 
cancer late last year at the age of 25, and he is particularly 
interested in innovative research issues. I will be in and out 
of the hearing this morning, and I appreciate his leadership in 
this field and his willingness to chair the hearing.
    [The prepared statement of Hon. Mark E. Souder follows:]

    [GRAPHIC] [TIFF OMITTED] T6657.001
    
    [GRAPHIC] [TIFF OMITTED] T6657.002
    
    [GRAPHIC] [TIFF OMITTED] T6657.003
    
    Mr. Cannon [presiding]. Thank you, Mr. Chairman.
    First of all, I would like to thank Chairman Souder for 
holding this hearing today. This is an issue affecting millions 
of Americans currently: 1 in 2 men and over 1 in 3 women will 
be diagnosed with cancer. In 2000, more than 1.2 million new 
cancer diagnoses were expected and 550,000 died from the 
disease. Nearly 10 million people in the United States alone 
were living with cancer in 2001, up from 3 million in 1971, and 
the American Cancer Society estimates that in 2005 nearly 1.4 
million new cases of cancer will be diagnosed.
    While we say that we are winning the war on cancer, the 
statistics don't seem to represent that. Although I am pleased 
to hear that we are making progress in the length of survival 
of those with cancers, we need to eliminate the incidents of 
cancer and completely cure this illness. Tremendous strides in 
research and treatments are being made; however, there are 
numerous challenges in getting those treatments to patients 
effectively and efficiently. There are some serious gaps in 
research and failures to optimize research to produce new 
treatments. Drug approval takes years, withholding potentially 
life-saving drugs and treatments from patients.
    We need to look at all of these areas and optimize research 
among agencies, fill the gaps in research, and incentivize 
entrepreneurial research and produce life-saving treatments.
    Today we will specifically hear from our witnesses 
regarding gynecological cancers, including the role of human 
papillomavirus and cervical cancer. Most Americans are not 
aware that HPV is one of the most common sexually transmitted 
diseases and that at any one time approximately 10 percent of 
women have a cancer-causing HPV infection. These HPV types 
cause nearly all cervical cancers, and this year about 11,000 
women will be diagnosed with cervical cancer.
    Additionally, as many of you may know, the Gynecological 
Cancer Foundation reported that men and women do not completely 
recognize the association between HPV and its severe health 
consequences. We need to better educate the public on the 
health risks of HPV and gynecological cancers. Although PAP 
test is the standard procedure to check for cervical cell 
changes, it is my understanding that it does not test for 
uterine or other gynecological cancers. I am anxious to learn 
how we are doing in developing tests for these other cancers.
    Many of us have been personally affected by cancer, 
unfortunately. We now have reached a time that I believe we can 
all say we know someone who has been diagnosed with this 
devastating disease.
    I thank all of our witnesses for appearing today, and I 
look forward to hearing your testimony about where we are on 
cancer research and what we need to do to win the war on 
cancer.
    I would now like to recognize Mr. Cummings for an opening 
statement.
    Mr. Cummings. Thank you very much, Mr. Chairman. And I am 
very pleased that we are holding this hearing.
    Breast, lung, and colon cancers are the most frequently 
diagnosed cancers among women in the United States. The 
gynecologic cancers, including cervical, ovarian, and uterine 
cancers, also account for a significant number and percentage 
of cancer diagnoses and deaths among U.S. women.
    The American Cancer Society reports that approximately 
79,000 U.S. women are diagnosed with cancers affecting the 
reproductive organs each year. Although the survivability rate 
is as high as 95 percent when these cancers are detected in the 
early stages, each year 27,000 U.S. women die from gynecologic 
cancers.
    Fifty years ago, cervical cancer was the leading cause of 
cancer death among women in the United States and around the 
world. Thanks to advances in cancer screening and treatment, 
most notably widespread use of the Pap test, the threat of 
mortality from cervical cancer has been dramatically reduced in 
the United States. Nevertheless, thousands of women are newly 
diagnosed each year, and the American Cancer Society estimates 
that more than 3,000 women will die from it in 2005.
    Unfortunately, despite improved screening rates, enabled by 
congressionally authorized CDC screening programs, unequal 
access to screening remains a problem that contributes to 
significant disparities in cervical cancer death rates, along 
the lines of race, educational level, income, and age. Although 
racial and ethnic disparities have decreased sharply, there is 
more progress that must be made.
    Women who belong to racial and ethnic minority groups still 
are disproportionately represented among the new cases of 
cervical cancer. Asian, African-American and Hispanic women 
have significantly higher mortality rates from cervical cancer 
than White women. Women with less than a high school education 
are less likely to have testing than more highly educated 
women. And despite the peek incidents of cervical cancer among 
women 40 to 55 years of age, women in this age group are less 
likely to have been screened than younger women. African-
American women are 60 percent more likely to have cervical 
cancer and 33 percent more likely to die from it, as compared 
to White women.
    The great tragedy in the American Cancer Society's 
estimates of the thousands of lives that will be lost to 
cervical cancer is that these deaths are avoidable. The 
Department of Health and Human Services notes in its Healthy 
People 2005 Initiative that the likelihood of cervical cancer 
survival is nearly 100 percent if early detection is followed 
by appropriate treatment and followup. But costs remains a 
barrier to access Pap tests and DNA tests for HPV.
    Used together, these tests can accurately determine whether 
a woman is or is not at risk for cervical cancer or precursor 
conditions. Genital HPV infection is a necessary precursor for 
cervical cancer and the main cause of the disease. In recent 
years we have seen vigorous efforts from certain quarters to 
force the FDA to relabel condoms to indicate that condoms are 
ineffective in preventing transmission of HPV. These efforts, 
if they succeed, are likely to undermine progress in preventing 
not only HPV infection and the development of cervical cancer, 
but also the spread of other sexually transmitted diseases, 
including HIV.
    The American Cancer Society specifically recognizes HIV and 
chlamydia as risk factors for development of cervical cancer, 
and condoms are widely recognized as a primary intervention for 
prevention of HIV and chlamydia. The best available scientific 
evidence, moreover, supports the conclusion that condoms 
significantly reduce the risk of genital HPV infection and, 
therefore, development of cervical cancer.
    In July of this year, a study entitled, ``The Effect of 
Consistent Condom Use on the Risk of Genital HPV Infection 
Among Newly Sexually Active Young Women,'' was presented to the 
International Society of Sexually Transmitted Disease Research. 
The study found that condoms significantly reduce the risk of 
HPV acquisition among female university students who use them 
100 percent of the time, as well as among those who use them 
between 55 percent and 99 percent of the time during the course 
of an 8-month study.
    The bottom line, then, is that cervical cancer can be 
prevented, detected, treated, and cured, and health screening 
and condom use are essential components of a sound, realistic 
public health strategy for combating cervical cancer and the 
spread of sexually transmitted diseases. Unfortunately, 
ovarian, uterine, and other gynecologic cancers are less 
susceptible to prevention and early detection, and mortality 
rates, as a result, are much higher.
    But great progress has been made in developing treatments 
that are highly effective when these cancers are detected at an 
early stage. We must therefore support efforts to promote 
awareness of risk factors for ovarian, uterine, and other 
gynecologic cancers, as well as research that can lead to 
development of new and better diagnostic and therapeutic tools.
    That is precisely the aims of Johanna's Law, legislation 
pending the House and Senate named for the sister of Sheryl 
Silver, who will tell her sister's story during panel two of 
today's hearing. I am proud to be an original co-sponsor of 
this important bill in the House, and I sincerely hope that 
this hearing serves to improve the prospects for enacting this 
legislation.
    Finally, Mr. Chairman, it is worth reiterating that we have 
made enormous strides in reducing cervical cancer deaths over 
the past few decades. Ensuring that cervical cancer death rates 
continue to go down for women in all parts of American society 
and working to duplicate that success with other gynecologic 
cancers are important objectives that we should fully support. 
Expanding access to screening and treatment for women at risk 
should remain the foundation of a public health strategy that 
puts health and wellness before ideology and science, and 
before politics.
    I want to thank you for holding the hearing. I sincerely 
hope that it will lead to further advances toward eliminating 
gynecologic cancers as a cause of illness and death for women 
in these United States.
    With that, I yield back.
    Mr. Cannon. Thank you, Mr. Cummings.
    Let me just add that you point out that we want to solve 
this for American society, and that is our goal. But if we 
solve it in America, we solve it for large parts of the world, 
including the many, many women who die of cervical cancer in 
Africa because their partners and spouses have not only brought 
back AIDS and other diseases, but HPV, and that ends up being a 
principal cause of death in Africa. If we can solve some of 
these problems here in America, it is cheap and easy to solve 
them in other parts of the world, and that is why I think this 
is such an important hearing.
    Are there other members who wish to make an opening 
statement?
    Mr. Issa. Yes, Mr. Chairman.
    Mr. Cannon. Let me come over here.
    Mr. Issa. Thank you, Mr. Chairman. And I would ask that my 
complete statement be placed in the record.
    Mr. Chairman, I want to thank you on behalf of the 
thousands of women fighting this fierce battle against 
gynecological cancer. As you know, this bill has been 
previously introduced in early Congresses, it has been 
something that we wanted to get on the front burner for 4 years 
plus, and I think your leadership is really making a difference 
in getting this bill moved and moved quickly. As you know, 
there are 220 plus Members of Congress who have co-sponsored 
this. As a general rule, that means that you have enough votes 
to pass it on the House floor, and I am hoping that today is an 
important step toward that.
    I won't repeat the good words that have been said by 
previous speakers, but I would like to simply add a couple of 
items. First of all, this is a cancer in which awareness can 
save lives. Cervical, ovarian, and uterine cancer really is, to 
a great extent, about what we don't know and, to be candid, as 
we will hear in the second panel, to a great extent what 
doctors don't know.
    The story of Johanna is the story of misdiagnosis. It is 
the story not of an underserved population, a poor person or a 
minority; it is somebody who had professional care, and that 
care failed to save her life. And it has failed to save her 
life not out of malice, but out of a lack of the kind of 
information that we hope the funding we provide on a Federal 
level can do.
    I do think that it is important. I was not an original 
cosponsor of this in previous Congresses, but came on board as 
the principal author, along with Sander Levin and others, 
because of an awareness that came into my office. If I may 
share this personally, last year I discovered first-hand the 
importance of early diagnosis when my legislative director, 
Paige Anderson, who is with us here today because of early 
diagnosis. She is one of the lucky ones. She stands here today 
a cancer survivor.
    However, it was not until early diagnosis that she even 
learned of HPV, cervical cancer, and the importance of early 
Pap smears and pelvic exams. Unfortunately, her story is the 
story that is going to repeat itself until this legislation not 
only passes, but that we fully fund it and start bringing about 
the kind of awareness of this cancer that, candidly, we have 
had success stories in other areas.
    This is a bipartisan bill, and I would particularly like to 
thank, once again, Sander Levin, who was the author of it in a 
previous Congress; Kay Granger; Rosa DeLauro; and Congressman 
Dan Burton, who will speak in a few moments. They really made a 
difference in previous Congresses in moving this, and now, 
together, we are very happy to be able to move this.
    Last, but not least, I want to recognize Dr. Beth Karlan. 
Dr. Karlan is the president of the Society of Gynecological 
Oncologists. She practices medicine at Cedars Sinai Medical 
Center in my home State of California. But beyond being a 
doctor, a researcher, a professor, and mother, Dr. Karlan has 
been an inspiration and motivator in the fight for 
gynecological cancers, and she is also the person whose efforts 
saved my staff person, Paige Anderson's, life. So I am looking 
forward to seeing the energy that she brings to the Congress, 
just as the energy that she has brought to her practice.
    And with that I yield back.
    Mr. Cannon. Thank you, Mr. Issa.
    Are there other Members who would like to make an opening 
statement? Ms. Watson. The gentlelady is recognized for 5 
minutes.
    Ms. Watson. Thank you, Mr. Chairman, for having this most 
critical hearing. I too had cancer visited on my family: my 
sister, 18 months older than I, had cervical cancer and did not 
survive.
    It reminds me of a discussion we had in our legislature 
maybe 20 years ago, when we were startled to learn in the 
1980's that most of the cancer testing for breast cancer was 
done on men. So about seven of the women in both Houses--I was 
in the Senate--and my colleagues in the Assembly ganged 
together and we said we will not vote for the budget in a block 
unless you put $28 million in for research on breast cancer on 
women.
    And we got it in. We had to gang up; we had to terrorize. 
UCLA's Dr. Love worked with us and reported on the status of 
the research over the years. The women--and particularly 
minority women--who had breast cancer, by the time we finished 
up, were all dead. So we really forged ahead.
    I was heading Health and Human Services for 17 years, and 
we forged ahead on the studies. But we required in the State of 
California that every woman over 40 have a mammogram yearly. We 
had to drop that down to 20 because we found that breast cancer 
was spreading faster among African-American women--we didn't 
know why--at an earlier age. And by the time we would get to 
them and we would try to follow them and profile, they were 
gone as well.
    So in 2005 we cannot stress that we really have not made 
that much progress. So I do hope, listening to the panels, that 
you will encourage us--and particularly women--and let us know 
the intensity of the effort. Are we putting enough resources 
in? And what are America's priorities when it comes to fighting 
cancer? We have new kinds of cancers appearing every day. And, 
particularly in my State of California, skin cancer is becoming 
very prevalent. So we must keep pace; we must keep focused; we 
must keep allotting the necessary resources.
    And I want to tie it in to the tragedy that we are all 
going through in the Gulf Coast. We need to place a priority on 
health; health of all Americans. And I just have to say this: 
When we talk about homeland security, it is not the land I am 
worried about; it is the people on the land. If they are 
weakened by disease, contagious diseases and cancer, we have no 
defense; we have no security. So I hope that our subcommittee 
will keep the focus going on the health delivery system, and 
specifically on the prevention and detection of cancer.
    Thank you, Mr. Chairman.
    Mr. Cannon. Thank you.
    Other members who wish to make an opening statement? Mr. 
Burton. The gentleman is recognized for 5 minutes.
    Mr. Burton. I have a very, very brief statement. First of 
all, I want to thank Darrell Issa and Sander Levin for 
sponsoring this; I think it is very important and you should be 
congratulated for that. I want to thank Chairman Souder. He 
just added his name as a cosponsor of the bill, so we are up to 
221 or whatever it is, so we should be able to get this passed. 
I want to also thank Kolleen Stacey and Sheryl Silver for being 
here. They have been doing yeoman's service for this cause for 
a long time, and I personally really appreciate it.
    My wife was misdiagnosed and died about 3 years ago because 
of misdiagnosis on her cancer, and I just hope that part of the 
solution that we finally realize is making sure that the 
doctors across this country are educated in how to deal with 
analyzing the various kinds of cancer that women have. One of 
the big problems we have right now is, unfortunately, some of 
the doctors misdiagnose, and because of that the cancers spread 
too rapidly before we find out about it, and that is what 
happened with my wife.
    So I thank you very much for sponsoring this bill, Darrell, 
and thanks for having this hearing. And I look forward to 
hearing the testimony.
    Mr. Cannon. The gentleman yields back. I want to thank the 
gentleman. This is actually sort of a hard topic to talk about, 
isn't it, Mr. Burton?
    Other Members who wish to make an opening statement? Mr. 
Ruppersberger.
    Mr. Ruppersberger. Thank you, Mr. Chairman.
    Mr. Cannon. The gentleman is recognized for 5 minutes.
    Mr. Ruppersberger. This is an extremely important issue, 
and I hope this hearing today will really call attention to us 
and to what we need to do to bring this issue to the forefront. 
As we all know, gynecologic cancers, if detected early, can 
help the issue, and it is very important to do this.
    But we do need to understand that early detection is 
sometimes not possible, where the symptoms demonstrated by 
afflicted women are identified as something else. And we must 
continue to be at the forefront of science and technology when 
it comes to diagnosing and treating these types of cancers. If 
adequate resources, expertise, and manpower exists, there is no 
excuse for delay.
    I am looking forward to the testimony today from our 
witnesses in an effort to again raise the awareness about this 
type of cancer among patients and doctors, and how we, as 
Members of Congress, can help.
    Thank you, Mr. Chairman.
    Mr. Cannon. The gentleman yields back.
    Mr. Waxman. The gentleman is recognized for 5 minutes.
    Mr. Waxman. Thank you very much, Mr. Chairman.
    I welcome our witnesses today, and I am pleased we are 
holding this hearing.
    Over the last 30 years, the rate of lung cancer among women 
in the United States has more than doubled. The rate of breast 
cancer has increased by 20 percent. But the rate of cervical 
and uterine cancers has dropped in half. And the racial 
disparities in diagnosis of these cancers have also 
substantially narrowed.
    Credit for progress against cervical cancer goes largely to 
a single preventive health intervention: the Pap smear. By 
diagnosing precancerous lesions, this test permits eradication 
of the problem before cancer develops. By any accounting, the 
Pap smear ranks as one of the most major advances in women's 
health of the 20th century. Yet, there is much more to be done 
to combat gynecological cancers. Cervical cancer kills 4,000 
women each year; ovarian cancer kills nearly 15,000.
    The key to progress is to continue implementing sound 
public health practices and supporting crucial research. To 
start, we must make sure that all women have access to routine 
cervical screening. An estimated 60 percent of cervical cancer 
cases occur among women who did not get routine Pap smears. We 
also must make sure that women who screen positive for 
gynecological cancers have access to needed medical treatment. 
This is not something to be taken for granted. The President's 
proposed cuts to the Medicaid program threaten the basic access 
to care for women around the country, and, if passed, they 
could expect it to lead to more suffering and death from 
cancer.
    We must take advantage of new technology. And we will hear 
today about vaccines that seem to be very, very promising and 
very successful in their tests. We need to pursue progress at 
the same time we resist calls to politicize policy decisions on 
women's health. And there are two ongoing ideological campaigns 
that could seriously undermine the progress that the public 
health system has made. The first is the call to require 
warning labels on condoms stating that they don't protect 
against HPV. This policy makes no sense.
    The National Institutes of Health and CDC have both 
concluded that condoms reduce the risk of cervical cancer. That 
is the benefit, the health benefit outcome that we are all 
concerned about. In addition, the most recent scientific 
evidence indicates condoms do reduce the risk of HPV 
acquisition among women. In a carefully designed study of HPV 
and condoms by researchers at University of Washington, 
consistent condom use reduced the risk of HPV among young women 
by 70 percent.
    A second attempt to politicize science involves early 
efforts to reject HPV vaccine. A spokeswoman from one right-
wing group has expressed concern that giving the HPV vaccine to 
young women could be potentially harmful because they may see 
it as a license to engage in premarital sex.
    It is a good thing that this sort of reasoning did not 
prevail when the Pap smear was invented. We would not have seen 
the major decrease in cervical cancer rates over the last three 
decades. The HPV vaccine offers the potential of saving 
thousands of lives. We should follow the advice of experts, not 
ideologs, in determining who should receive this intervention. 
After all, it is science that has guided our success in 
cervical cancer, and science will lead the way to continuing 
success.
    I have looked at the list of witnesses. I think that we 
have a good two panels before us. I particularly want to single 
out Dr. Beth Karlan, who is my constituent, and welcome her to 
our hearing today, and also all of the witnesses that are here 
to make their presentations.
    Thank you, Mr. Chairman.
    Mr. Cannon. The gentleman yields back. Thank you.
    I would now like to recognize the Honorable Sandy Levin of 
the 12th Congressional District of Michigan, who will introduce 
Sheryl Silver, the sister of Johanna Silver.
    Mr. Levin.
    Mr. Levin. Thank you. My thanks to everyone on the panel 
for your eloquent statements.
    My opportunity today is to introduce Sheryl Silver, who is 
on the second panel, and I will do just briefly so you can move 
on to the distinguished people here on the first panel.
    Several years ago Sheryl Silver was in touch with us and in 
touch with me. It was the aftermath of the death of her sister, 
and she decided to take that tragedy in the life of her family 
and see if she could impact the lives of others. And for these 
years that has been, I think, her main preoccupation, as well 
as her mother, who is here today, and other members of the 
family.
    What she brought to our attention is what has been repeated 
here, that wasn't well enough known: that as to gynecologic 
cancers, early detection almost invariably works and late 
detection is almost invariably fatal. So we introduced the 
legislation and there was a lot of interest shown across the 
isle and across the Rotunda. So I am here today to introduce 
Sheryl, who has been so dedicated to this cause, Johanna's Law, 
named after her sister.
    Last session, Darrell Issa and I talked. He was very much 
moved by the experience within his own office, and we set upon 
a course to try to maximize the chances of passage of this 
legislation.
    So let me just finish by suggesting the challenge here. One 
is for us in this Congress to prove that one person in our 
country can indeed make a difference, and it is up to us to do 
that. And, second, I think it is our charge to take personal 
experiences so eloquently and personally expressed here, and 
take personal experiences and place them into public action. 
And if we fail to do that, we have failed in our 
responsibilities as elected officials.
    I am glad you are holding this hearing. I think we all 
appreciate the expression of personal backgrounds of personal 
experiences. We appreciate the interest of the scientists who 
are here. And I hope very much, to all of you, that the result 
of this hearing today will be action on the floor of the Senate 
and the House. We have enlisted Senators in this effort, and I 
think now, after you hear this, the responsibility will be 
ours.
    Thank you for letting me proceed out of turn, and I wish 
you the best of luck.
    Mr. Cannon. Thank you, Mr. Levin. Let me just make a 
personal note. I appreciate your initiative on this action, 
your support. I truly believe that individuals make the 
difference, so I appreciate your introduction, your initiative, 
and thank you for being here with us.
    Mr. Levin. Thank you very much. Thank you to all of you.
    Mr. Cannon. I would just also add thanks to Mr. Issa. I am 
a co-sponsor of this bill, and I think it is great legislation. 
Thank you.
    A couple of procedural matters. I ask unanimous consent 
that all members have 5 legislative days to submit written 
statements and questions for the hearing record, and that any 
answers to written questions provided by the witnesses be also 
included in the record. Without objection, so ordered.
    I also ask unanimous consent that all exhibits, documents, 
and other materials referred to by Members may be included in 
the record, and that all Members be permitted to revise and 
extend their remarks. Without objection, so ordered.
    Our first panel is composed of Dr. Edward Trimble, Head of 
the Surgery Section, Division of Cancer Treatment and Diagnosis 
at the National Cancer Institute; Dr. Ed Thompson, Chief of 
Public Health Practice at the Centers for Disease Control and 
Prevention; and Dr. Richard Pazdur, Director of the Division of 
Oncology Drug Products, Center for Drug Evaluation and 
Research, U.S. Food and Drug Administration.
    It is our custom as an oversight committee to swear all of 
our witnesses in. Would you mind rising while I administer the 
oath?
    [Witnesses sworn.]
    Mr. Cannon. You may be seated. The record should reflect 
that each member of the first panel agreed in the affirmative 
to that oath.
    Dr. Trimble, thank you for joining us, and you are 
recognized for 5 minutes. Before you begin, let me just point 
out that, since we are probably going to have quite a bit of 
questioning, the 5-minute limit is not fixed, we don't get 
lightening from heaven, but if it goes beyond, I may tap just 
to remind you to draw your comments to a conclusion. And then 
we may go a second round of questioning.
    But for the panel members, I intend to enforce the 5-minute 
rule fairly strictly, so that people who are waiting have a 
chance to ask questions. But, again, we may go to a second 
round or more of questioning if those here would deserve.
    Dr. Trimble, you are recognized for 5 minutes.

STATEMENTS OF DR. EDWARD L. TRIMBLE, M.D., M.P.H., HEAD OF THE 
 SURGERY SECTION, DIVISION OF CANCER TREATMENT AND DIAGNOSIS, 
NATIONAL CANCER INSTITUTE; DR. ED THOMPSON, M.D., M.P.H., CHIEF 
  OF PUBLIC HEALTH PRACTICE, CENTERS FOR DISEASE CONTROL AND 
PREVENTION; AND DR. RICHARD PAZDUR, M.D., DIRECTOR, DIVISION OF 
    ONCOLOGY DRUG PRODUCTS, CENTER FOR DRUG EVALUATION AND 
          RESEARCH, U.S. FOOD AND DRUG ADMINISTRATION

               STATEMENT OF DR. EDWARD L. TRIMBLE

    Dr. Trimble. I am honored to testify on the topic of 
gynecologic cancer for the National Cancer Institute. Over the 
past century, we have made major progress toward the defeat of 
cervical cancer in the United States. Today I would like to 
talk to you about some of the exciting work NCI is doing to 
eliminate the scourge of gynecologic cancer in the United 
States and around the world.
    NCI scientists developed a new vaccine approach to prevent 
the transmission of HPV. We have licensed this technology to 
two large pharmaceutical companies who have recently reported 
that the vaccines were almost 100 percent effective in 
preventing spread of the virus. We have also been working to 
make screening for cervical cancer less expensive, more 
reliable, and more available. Even with the arrival of HPV 
vaccines, we will need to continue screening for many years to 
come.
    In one of our most exciting projects, NCI is working with 
the CDC, the University of Alabama at Birmingham, and the 
Mississippi State Health Department to improve screening for 
cervical cancer among poor rural women in the Mississippi Delta 
who have had some of the highest rates of cervical cancer in 
the United States for the last 50 years.
    Again in collaboration with the CDC, as well as with the 
U.S. Department of Agriculture and the American Cancer Society, 
NCI is implementing TEAM-UP, a national pilot program to 
increase cervical cancer screening among never or rarely 
screened women in eight underserved Appalachian States.
    We are also making major strides toward the elimination of 
death and suffering from ovarian cancer. We are currently 
evaluating screening for ovarian cancer among 70,000 women 
through our PLCO trial. Our laboratories are developing new 
screening tests for ovarian cancer. One of the most promising 
is the identification of proteomics, protein expression in the 
blood, as a screen for ovarian cancer.
    The NCI discovered and developed paclotaxol, or Taxol, 
which is now one of the standard drugs used to treat ovarian 
cancer. We have just completed the largest treatment trial, 
5,000 women, ever conducted in ovarian cancer with the help of 
investigators across the United States, Canada, and five other 
international partner countries.
    We have established four specialized programs of research 
excellence to foster translational research in ovarian cancer.
    We are also working to strengthen our research portfolio in 
endometrial cancer, which is the most common female pelvic 
malignancy. The identification of new targets and treatments 
will lead us to new strategies to prevent women from developing 
endometrial cancer and to avoid the need for hysterectomy.
    We have also developed an extensive educational program 
focused on gynecologic cancers. Our Cancer Information Service 
Partnership collaborates with local, State, and other Federal 
agencies to conduct outreach on cervical cancer, particularly 
in medically underserved populations. For example, NCI has 
joined with county and local officials to raise awareness, 
provide education, and build a community-based sustainable 
cancer control infrastructure for urban American Indian women 
in Los Angeles. We also collaborate with the CDC in addressing 
the needs of underserved populations using our 1-800-4-CANCER 
number to refer thousands of eligible women to low-cost and no-
cost CDC services.
    We have an extensive educational program focused on 
gynecologic cancer, including Web sites and educational 
material for both patients and medical professionals, available 
in English and Spanish.
    Ending pain and suffering from gynecologic cancer is among 
the highest priorities of the NCI. We are working to implement 
the recommendations of the Gynecologic Cancer Progress Review 
Group. We have also undertaken, in partnership with the CDC, 
the American Cancer Society, the International Agency for 
Research on Cancer, the World Health Organization, the Society 
of Gynecologic Oncologists, and the Gynecologic Cancer 
Foundation, a global initiative on women's cancer so that we 
can lift the burden of gynecologic cancer from women around the 
world.
    That concludes my oral testimony. You have additional 
material in my written testimony. I would be happy to answer 
any questions.
    [The prepared statement of Dr. Trimble follows:]

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    Mr. Cannon. Thank you, Mr. Trimble. And I note that the 
light was still yellow when you finished. I appreciate that 
testimony.
    The other members of the panel don't have to be so careful. 
We actually are interested in what you say.
    Dr. Thompson, you are recognized for 5 minutes, or as much 
time as you would like to use.

                  STATEMENT OF DR. ED THOMPSON

    Dr. Thompson. Thank you, Mr. Chairman. I am Dr. Ed 
Thompson, a specialist in preventive medicine and Chief of the 
Public Health Practice at the Centers for Disease Control and 
Prevention. It is an honor to be in front of this committee 
again. We appreciate the commitment of this committee to this 
important issue.
    I would also like to thank Mr. Levin for referring to the 
members of this panel as distinguished. But we are 
distinguished by the degrees that we hold and by the positions 
that we occupy. The next panel will bring before you people who 
are distinguished by their personal courage, by their 
commitment to this important cause; and they are far more 
distinguished than we.
    Gynecological cancers, cancers of the female reproductive 
organs--including, most importantly, those of the uterus, its 
endometrium, and cervix, the ovaries, and also, to a lesser 
extent, vaginal and vulvar cancer--are some of the most 
important cancers that affect women in this country. According 
to the most recent CDC and National Cancer Institute data--and 
as you have observed, Mr. Chairman--more than 71,000 women in 
the United States were diagnosed with a cancer affecting the 
reproductive organs in 2002, and approximately 27,000 women in 
the United States died from some form of gynecological cancer 
in that year.
    Endometrial cancer may be the most common gynecological 
cancer; ovarian cancer the most deadly. Cervical cancer is the 
one cancer for which we currently have an effective and 
approved screening tool; and we will speak more about that in a 
moment as well.
    At CDC, we are actively engaged in providing most current 
cancer prevention and control strategies at the community 
level, primarily through State and local health departments. 
These efforts reach hundreds of thousands of women every year 
in the United States. Our efforts are directed largely toward 
surveillance screening, where recommended, public education and 
awareness, health care provider education, epidemiology, and 
behavioral research. I would like to tell you about a few of 
our cancer initiatives, in particular those directed against 
cervical cancer. But by no means are we limiting our activities 
to those against cervical cancer.
    The CDC's National Breast and Cervical Cancer Early 
Detection Program, which was established by Congress in 1991, 
has received growing support that helps low-income, uninsured, 
and underinsured women gain access to lifesaving screening 
programs. The national program currently provides screening 
support in all 50 States, the District of Columbia, four U.S. 
territories, and to 13 Indian tribes.
    Since 1991, this program has provided more than 2.9 
Papanicolaou tests and detected more than 1500 invasive 
cancers. Testament to the benefit of prevention and early 
detection is the fact that more than 74,500 cancer precursor 
lesions had been detected or treated since the program's 
inception. The program represents a national infrastructure of 
more than 22,000 health care providers designed to reach those 
most in need.
    Now, each year, between 10,000 and 12,000 women will be 
diagnosed with cervical cancer, and approximately 3,700 women 
will die from cervical cancer in the United States in 2005. The 
sad thing is that, in a very real way, every one of these 3,700 
deaths is preventable and every one represents a failure of our 
American public health system.
    We have achieved some success with cervical cancer 
mortality, reducing it by more than 70 percent over the last 
five decades, so that cervical cancer, once the No. 1 cause of 
cancer deaths among U.S. women, is now 14th. This is in large 
part due to widespread application of the Pap test to detect 
cervical abnormalities.
    But as has been noted, approximately half of the cervical 
cancers that are diagnosed today in this country occur in women 
who have never received a Pap test. Another 10 percent occur in 
women who have not been screened within the past 5 years. So we 
are still not using this remarkable tool as effectively as it 
needs to be.
    CDC also manages the National Comprehensive Cancer Control 
Program, which provides supports to develop comprehensive 
cancer control plans in all 50 States across the Nation. These 
plans serve as blueprints for developing and implementing 
cancer control activities. As an example, the California and 
the Florida Departments of Health, through this program, have 
identified and implemented strategies in their Statewide cancer 
control plans to identify the burden of ovarian and/or cervical 
cancer in local communities, strategies which include promoting 
referrals of ovarian cancer patients to clinical trials, 
promoting education and awareness within communities, and 
supporting ovarian cancer research.
    In Alabama, the ovarian initiative focuses on enhancing the 
public's understanding of hereditary factors that increase the 
risk of developing ovarian cancer. And West Virginia's Raising 
Ovarian Cancer Awareness Initiative enlists ovarian cancer 
experts to speak with women in high-incidence counties about 
the symptoms of ovarian cancer and the importance of 
gynecological exams. Since implementing the program, the State 
has been able to demonstrate a 40 percent increase in 
participants' knowledge of the symptoms and risk factors for 
ovarian cancer.
    In addition, CDC's national program of cancer registries 
collects information about incidents, diagnosis, treatment, and 
mortality. This data helps us to understand both the 
epidemiology of cancer occurrence and, in some cases, our 
effectiveness in bringing women to treatment.
    In conclusion, gynecological cancers constitute a serious 
health problem in this country that CDC, along with our fellow 
Federal agencies, takes extremely seriously. Our role at CDC is 
focused on risk reduction, early detection, identifying and 
improving barriers to appropriate clinical practice, and to 
enhancing survivorship for women. There is much work to be done 
in all of these areas. I look forward to the opportunity to 
answer any questions that you may have.
    [The prepared statement of Dr. Thompson follows:]

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    Mr. Cannon. Thank you, Dr. Thompson. We appreciate that.
    Dr. Pazdur. Is that an appropriate pronunciation?
    Dr. Pazdur. Pazdur.
    Mr. Cannon. Pazdur.

                STATEMENT OF DR. RICHARD PAZDUR

    Dr. Pazdur. Mr. Chairman, members of the subcommittee, I am 
Dr. Richard Pazdur, M.D., FDA's Director of the Office of 
Oncology Drug Products within the Office of New Drugs at the 
Center for Drug Evaluation and Research [CDER]. I am pleased to 
be here today to discuss prevention, early detection, and 
treatment of gynecological cancers.
    The FDA's mission is to promote and protect the public 
health by helping to assure the safety and efficacy of human 
drugs and medical devices. Let me begin by informing you of 
recent structural changes within the FDA that are intended to 
provide a stronger and more consistent approach to the review 
process for drugs used to diagnose, treat, and prevent cancer.
    In July 2005, the FDA created a new Office of Oncology Drug 
Products. This office has three divisions that will review 
applications for safety and effectiveness: the Division of Drug 
Oncology Products, Biological Oncology Products, and Medical 
Imaging and Hematology Products. Also, the Office will develop 
and lead a comprehensive oncology program to facilitate 
coordination of oncology activities across all FDA centers and 
ensure ongoing outreach and collaboration between the FDA, the 
National Cancer Institute, and other cancer-related 
organizations.
    The Office expects to improve the consistency of review and 
policy toward oncology drugs and bring together a critical mass 
of oncologists who will help guide the development of these new 
therapies. Although many details of this new structure are 
still evolving, I am pleased to be working with many talented 
and dedicated scientists who comprise this new office.
    The access process for cancer drugs usually starts with a 
sponsor seeking to develop a new cancer drug. A sponsor is 
usually a pharmaceutical company or a research scientist at the 
university or at the National Cancer Institute at the National 
Institutes of Health. Before clinical testing begins, 
researchers analyze the drug's main physical and chemical 
properties in the laboratory and studies its pharmacological 
and toxic effects in laboratory animals. If the laboratory and 
animal studies show promise, the sponsor submits an 
investigational new drug application to the FDA prior to 
initiating testing in patients.
    New therapies for the treatment of gynecological cancer are 
being investigated. Hundreds of clinical trials in ovarian, 
cervical, endometrial, and other gynecological cancers are 
publicly listed. The FDA has several programs to expedite drug 
development and expand access to unapproved therapies. All of 
these programs have been instrumental in shortening the time to 
marketing approval for cancer drugs and biologics.
    Under the Accelerated Approval Rule, the FDA can approve 
treatments for serious or life-threatening conditions that 
demonstrate the potential to address unmet medical needs on the 
basis of a ``surrogate endpoint'' that is reasonably likely to 
predict clinical benefit. A surrogate endpoint is a measure of 
drug effect--for example, tumor shrinkage--that does not by 
itself show direct clinical benefit such as decreased pain or 
longer survival, but is thought to lead to such benefit.
    Priority new drug applications and effectiveness 
supplements are those that could have important therapeutic 
impacts. The FDA's goal is to review a priority product within 
6 months, rather than the standard review time of 10 months.
    The fast track refers to a process for frequent and timely 
interaction between sponsors and the FDA during drug 
development. The fast track programs are designed to facilitate 
the development and to expedite the review of new drugs and 
biologics to treat serious or life-threatening conditions that 
demonstrate the potential to address unmet medical needs.
    We are currently in the early stages of planning a workshop 
for oncology experts, radiation oncology, statisticians, 
industry representatives, and patient advocates to discuss 
endpoints related to ovarian cancer, and hope to hold this 
meeting sometime in early 2006. A steering committee including 
representation from the FDA, the NCI, the American Society of 
Clinical Oncology, and the American Association for Cancer 
Research is planning these workshops.
    The FDA's Office of Special Health Issues works with 
patients with life-threatening diseases. Patients usually call 
to obtain information about unapproved treatments currently 
being researched. We direct callers to public information about 
clinical trials for which they might be eligible and provide 
additional sources of information to patients and their family 
members.
    The formation of the NCI-FDA Interagency Oncology Task 
Force, in 2003, was an important strategic step toward 
achieving FDA's goal of increasing availability and the use of 
safe and effective treatments for cancer, and the NCI's goal of 
eliminating pain and suffering and death from cancer by 2015. 
The purpose of this Task Force is to leverage the expertise and 
capabilities of both agencies to help streamline and accelerate 
the overall development of the diagnostic, preventative, and 
therapeutic interventions of cancer.
    Finally, we want to mention the FDA's Critical Path 
Initiative. There is growing concern that many of the new basic 
science discoveries made in recent years may not yield quickly 
more effective, affordable, and safe medical products for 
patients because the current medical product development path 
is becoming increasingly challenging, inefficient, and costly. 
During the past several years, the number of new drugs and 
biologic applications submitted to the FDA has declined. The 
number of innovative medical devices applications has also 
decreased. In contrast, the cost of product development has 
soared over the last decade.
    A new product development tool kit--containing powerful new 
scientific and technical methods such as animal or computer 
predictive models, biomarkers for safety and effectiveness, and 
new clinical evaluation techniques--are urgently needed to 
improve predictability and efficiency along with all critical 
path from the laboratory to commercial product development. The 
FDA is in the final stages of developing a critical path 
opportunity list based on the input and ideas contributed both 
by external stakeholders and the FDA reviewers.
    The FDA is working with the NCI, industry, academia, 
patient and other organizations to ensure that cancer patients 
have timely and important information about available cancer 
drugs, including those for gynecological cancer indications.
    Thank you for this opportunity to testify. I will be happy 
to answer any questions the subcommittee might have.
    [The prepared statement of Dr. Pazdur follows:]

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    Mr. Cannon. Thank you.
    May I begin the questioning by asking you members of the 
panel, generally, are you familiar with Abasian statistics or 
its evolving cousin, complexity theory? Mr. Trimble. Are you 
experts in either of those areas?
    Dr. Trimble. I am not expert. I do have statistical 
colleagues at the NCI who are very qualified in those topics.
    Mr. Cannon. Dr. Thompson.
    Dr. Thompson. I can answer an unqualified no, I am not an 
expert in either of those, although, likely, we do have 
colleagues at CDC who can provide additional information if 
needed.
    Mr. Cannon. Dr. Pazdur.
    Dr. Pazdur. Likewise, I am not a statistician; however, the 
FDA obviously has a complete cadre of statistical analysis.
    Mr. Cannon. Are you all familiar with some of the concepts 
embedded in Abasian theory or complexity theory? Just generally 
familiar?
    Dr. Trimble. I would have to tell you, Mr. Chairman, that I 
am sufficiently familiar with it to get myself into real 
trouble if I attempt to explain anything according to those 
lines.
    Mr. Cannon. You are probably a lot better than I am. I ask 
that question because it seems to me that we have the 
opportunity in America today to make some dramatic changes in 
the way we do things and improve things. Let me go through a 
series of questions for each of you.
    I met with Dr. Eschenbach from the National Cancer 
Institute. I think he is a remarkably delightful, interesting 
person, but the delightful part doesn't extend to the gravitas 
that he brings to bear on these subjects. He is highly 
committed and I have enjoyed my conversations with him along 
these lines. NCI and NIH are to be commended for the extensive 
database work they have done in developing databases on ongoing 
clinical trials. This is a terrific step forward.
    But, Dr. Trimble, is there any database you are aware of 
that lists off-label use of currently approved drugs or devices 
for medical treatment?
    Dr. Trimble. There is a compendium which lists the 
available data to support off-label use of drugs in various 
clinical situations.
    Mr. Cannon. Would that be like a study that somebody 
reported, so it is a compendium of studies?
    Dr. Trimble. That is correct.
    Mr. Cannon. Is there a centralized Internet database that 
physicians or patients can refer to that outlines current 
treatment protocols for a given medical condition?
    Dr. Trimble. The NCI's PDQ database lists standard 
recommendations based on a comprehensive review of the 
literature for cancer prevention, screening, treatment, 
treatment of symptoms, palliative of care and end of life care.
    Mr. Cannon. Tell me a little bit about where that database 
comes from, how it is developed, and how new protocols get into 
the system.
    Dr. Trimble. The NCI convenes panels that are independent 
panels. They include both representatives from academic 
institutions as well as from NCI and from other Federal 
agencies. They review the current literature on a regular 
basis. Some panels meet yearly, some meet every 3 months, 
depending on the volume of literature. They then draft 
statements which summarize the literature, which reference the 
literature, and those statements are placed on the NCI's PDQ 
Web site so that it is widely available.
    Mr. Cannon. You know, we have this mammoth number of highly 
educated doctors in America. Sometimes they don't actually 
recognize the problems. But when we have this huge group of 
people that are well educated, tend to be academic, tend to be 
clinicians, but with a creative mind-set, is it possible in 
your mind to capture that capability, that academic ingenuity 
out there in some form that would allow protocols that doctors 
are using to be brought into a database so that other doctors 
could look at those protocols and then develop sort of an 
Abasian context in improved treatments?
    Dr. Trimble. Well, as I said, the PDQ database makes or 
summarizes what is----
    Mr. Cannon. Let me just make a distinction. The problem 
with PDQ is that this is a bureaucratic and long process, as 
opposed to a database process or a process that grows from 
practitioners up. Is it possible to shift gears away from the 
long process that says this is OK and to a process that says we 
would like to know what you are doing out there, we would like 
to compare it to what other people are doing, and we would like 
that information to be made available to other doctors?
    Dr. Trimble. We have made an effort to reach out to the 
community in a pie project for certain cancers to find out how 
these cancers are being treated in the community, what is the 
effective treatment upon outcome upon quality of life; and we 
are analyzing that data currently to see how effective it is 
and to see whether we should be expanding this program to other 
cancer sites.
    Mr. Cannon. You are probably familiar with the development 
of childhood cancer responses. When I was very young, my best 
friend's younger brother was found to have leukemia, and we 
thought he would be dead within 3 months. It turns out there 
was a treatment that somebody had identified, tried on the 
young boy, and he wasn't cured, but he didn't die. This 
happened four or five times in my childhood, where he became 
critical, was ready to die, and then a new treatment came 
forward. As a result, I saw him 6 months ago; he has a family, 
he is happy and in his fifties now. So we have a case of 
success.
    What happened there--and I have talked to a number of 
people throughout the pediatric world--is that there was so 
little focus on pediatric medicine, especially oncology, that 
what we had was a high level of communication. And that high 
level of communication meant that it started out with 
telephones, later went to faxes and to e-mail. It meant that 
people who discovered something that might work communicated it 
to everybody else, everybody else tried it, and those things 
that really worked tended to be focused on and then became the 
base of treatment. That has been incredibly effective; not just 
in the single case that I am aware of, but the view of all 
people involved in childhood oncology recognize that as a great 
source of success.
    We have the ability to communicate those things on all 
levels and for all cancers much more rapidly. Is anybody 
looking at that at NIH or NCI that you are aware of, Mr. 
Trimble, to try and replicate with the massive increase in 
technology the great successes we had in that one area?
    Dr. Trimble. Certainly, the progress that we have made in 
pediatric cancer has been tremendous, and we are trying to see 
if we can replicate that progress. There are a number of things 
that the pediatric oncology community has done which are 
admirable.
    For example, probably 90 percent of children less than age 
12 diagnosed with cancer are treated at pediatric cancer 
hospitals. This is in contrast, for example, to adult cancers, 
where only 5 percent or 10 percent of patients are treated at 
NCI-designated cancer centers. So the fact that the pediatric 
oncology community has been able to concentrate the care of 
children with cancer in specialized cancer hospitals has been 
tremendous.
    They have also----
    Mr. Cannon. Excuse me. The access to data is radically 
greater today for all cancers, including adult cancers as 
opposed to child cancers. In other words, I don't want to 
understand why we are successful with childhood cancers. I 
think I get that. The question is is it possible to systematize 
access to data so that we do it much more rapidly.
    Dr. Trimble. Well, another area which has made the 
pediatric cancer world so successful is that more than 70 
percent of children with cancer go on clinical trials. So we 
capture data on how they are treated, their response to 
treatment, and their quality of life. We are trying to increase 
the number of adult patients going on clinical trials. In 
addition, we are trying to extend our database so that we can 
capture more information on all adults who are diagnosed with 
cancer.
    Mr. Cannon. I apologize for that diversion. Have you 
finished on that point?
    Dr. Trimble. Yes, I did.
    Mr. Cannon. OK. In the case of my daughter--let me just ask 
the panel of this generally.
    I think we should do a second round of questions. On this 
committee there is a tendency to go longer for the chairman and 
the ranking member. I am not going to abuse that too much.
    But in the case of my daughter, she had a rare cancer that 
maybe 30 young women typically a year get in America. I called 
a friend of mine, as my daughter was going through the MRI, who 
is a radiologist, and said after she is done, would you mind 
taking a look at the pictures, and he said, hold on a second. 
And then he said, OK, I am looking at them now.
    I said, how could you be looking at them; she is in the MRI 
machine right now. And he was not at the same site. So he said, 
well, the miracle of modern science. And then the next words 
out of his mouth were, ``Oh, this is bad.'' Not exactly the 
kind of thing you want to hear from a doctor.
    Now, if he had been sitting--it was in her knee and he said 
it's involved in the tendons, and that is bad. Now, what she 
had was clear cell sarcoma of the tendons and aponeurosis. But 
he didn't remember the whole name; he just remembered having 
bumped into this rare cancer that was associated with tendons. 
And if he typed into the freaking machine that he had in front 
of him, if he had a database that allowed him to type in 
sarcoma in tendons, the treatment for my daughter would have 
been radically different. Just a simple little information 
context there.
    Now, we have done radical things in information. My 
favorite on earth is Napster. You need to think about Napster, 
because that was a peer-to-peer system that allowed anybody to 
get online and identify information that was out there. In 
particular, it means that a doctor can make information 
available.
    You are telling me how you want to structure data so that 
it is available and put people in clinical trials. We have 
people who are essentially in clinical trials because they have 
cancer and they are being treated by people who understand 
information and systems. In my daughter's case, she worked for 
the guy later on who actually did the MRI that I had mentioned 
earlier, so when the cancer came back, she did a number of 
MRIs, because it didn't cost anything and because her boss was 
a very gracious guy and a good friend.
    Now, in the course of her disease, there were no 
treatments. We found one treatment of a person in Japan who had 
the disease and had remission. But there are no accepted 
protocols for her disease. That meant that we tried various 
different kinds of things with medical guidance, including 
using the most standard or common treatment for malaria 
throughout the world today, which is an herb that the Chinese 
came up with.
    Today, there are millions of people taking that herb with 
no side effects, so we tried it on her. But we had no guidance; 
the idea of how much to give her or how often to give it to 
her. So we experimented with it for 6 weeks. We didn't really 
understand it, but going back now we see that in her case the 
MRIs before she took it and after she took it indicate that 
there was a dramatic slowing of the growth of the tumor.
    Now, that information seems to me to be quite important to 
somebody else who has the same kind of disease. And the only 
way you can get that information, the only way is by having 
access to her records. So if you have a database that is like a 
Napster directory and you can find clear cell sarcoma of the 
tendons as aponeuroses and see who has treated what and then 
say, wait a minute, here is something that might have an 
effect, that could actually save people's lives.
    There is no way to get that data in our current system. You 
can go online and you can see all the--well, I shouldn't say 
that. There are many people who have used this and they have 
their ideas about how to use this, but there is no context 
where you can give it scientific integrity, where people can 
build on the ideas.
    What I am asking you--and let me just leave it at this 
point with this panel and then we will go to Mr. Cummings--is 
does it make sense to create in our data-rich environment a 
context for practitioners, medical doctors, people who are 
trained in medicine, to identify the best treatments that are 
out there, and then build upon those and create a database as 
we did in pediatric oncology, and move from that base forward? 
This is not, are your institutions going to do it? The question 
is, does that make sense? Because we probably have to make some 
changes here for you guys to be able to do that. But does it 
make sense?
    If I could ask the three of you to respond to that, I will 
then yield back and defer to my friend, Mr. Cummings.
    Dr. Thompson. Mr. Chairman, you have just identified one of 
the primary reasons why Secretary Leavitt is committed for the 
Department of Health and Human Services to work toward 
developing an electronic patient record system in this country. 
It would provide the sorts of database that would allow the 
sort of research you are talking about to be done. It is not 
something that we now have on a large scale basis.
    You have identified one institution that had that aspect of 
it and was able to use it very well, but we don't yet have it 
standardized; we don't have it in enough places. We have not 
yet solved the problems of privacy and confidentiality that 
must be solved.
    But if we can develop a common patient record that is 
electronic and accessible in the ways you just described, it 
will not only provide better direct patient care with the 
medical knowledge that we have now, it will allow the type of 
research you have just described.
    Dr. Pazdur. I think you hit on the head some really 
important areas here, and one of them being treatment of 
patients that are not on clinical trials. We do a great job, I 
think, of collecting data, and perhaps too much data, on 
patients that are on clinical trials, and one of the real 
issues is how does a drug work once it gets out there in a 
post-marketing situation as well as in the treatment in off-
label uses such as in rare diseases where there are not going 
to be large clinical trials.
    So a database that reflects how the drug is actually used 
in the intended indications as well as in off-label uses I 
think would be an extreme important step to provide guidance, 
especially in areas where you have relatively rare and unusual 
tumors, because considering the frequency of some tumors, they 
are very important tumors, but somebody is not going to do a 
large size clinical trial, just due to the rarity of some of 
these diseases.
    Dr. Trimble. The only additional point I would add is that 
we desperately need a system to track who has been screened for 
cancer, for example. We have no national database to tell us 
who has had a Pap smear within the last 10 years, who has had a 
mammogram; do we know one place where we can capture the images 
of those mammograms so we can compare them.
    Mr. Cannon. Thank you. Let me make a distinction and a 
comment. The distinction is you are thinking in terms of 
clinical trials. And what we have are many, many, many 
practitioners who use protocols sometimes, who adapt protocols 
for the use of their patients, and who are accumulating huge 
amounts of data. The question is not how do we make this all 
fit into a clinical trial, but how we capture the data from the 
practitioners. If you would think about that.
    Dr. Thompson, Secretary Leavitt is actually from Utah, 
interestingly, and he may not appreciate actually how good we 
are in Utah, but there is a company in Utah that is the leading 
light in these kinds of issues, and I am going to get you the 
name of it, it is called NexLight, or sometimes eBridge. They 
have developed an incredibly thorough system for managing 
patient data using all the rules of HIPAA and other 
requirements and allowing the staff.
    And I am going to get you a card on that and ask for, in a 
written request, your response as to what that kind of a 
program could do for allowing us in America to accumulate data 
on individuals based upon their consent, their understanding of 
the law and their consent, and giving access by those patients 
to people like doctors or people running clinical studies or 
other scientists so that we can actually move that issue 
forward.
    I am going to ask some more questions, but I will save 
those until the next round.
    Mr. Cummings, if you have questions, you are recognized for 
5 minutes.
    Mr. Cummings. Yes.
    Dr. Thompson, in your opinion, what do we need to do to 
increase access to the existing interventions like Pap smears? 
You know, the sad part is that we have people dying.
    Dr. Thompson. It is. And what we need to do is to learn to 
use the science we now have more effectively so that it reaches 
everybody. The Congress took an important step in 1991 in 
enacting the legislation that created the Breast and Cervical 
Cancer Screening Program, because what this does more than 
anything else is make it true in this country that today no 
woman should be without cervical cancer screening or breast 
cancer screening simply because she lacks the ability to pay 
for it, because any woman at or below 250 percent of the 
Federal poverty level qualifies for this program and can 
receive screening services through it.
    So cost should not be a barrier. And yet we know we are 
still not reaching all of the women we should. The figures that 
I cited to you I think are figures we should be proud of. We 
are reaching many women and they are low-income women. But we 
know some things that are troubling to us, and we want to work 
to make them different.
    This is not published information, it is simply what we 
have observed in looking at some of the States implementing it, 
but we know, in the State of Ohio, for instance, that they tell 
us that although they are utilizing the program effectively, 
the women in the upper half of that income range, 250 percent 
and below of the Federal poverty level, are the ones who seem 
to be taking advantage of the program, and women in the lower 
half, the very lowest of the low-income women, seem to be less 
often reached by the program. So we are looking and need to be 
looking at things that influence women's choices as to how they 
use these programs, whether they know about them.
    We have now gone passed the point where it is laboratory 
research that is needed. In these areas it is the sorts of 
behavioral research that will help us learn why people do and 
don't use medical programs and things that may be necessary to 
facilitate that. That is the sort of research that CDC engages 
in along with our colleagues at the National Institutes of 
Health. But the bottom line, the answer to your question, we 
have simply got to learn how to bring these techniques to the 
people that need the most and often are the ones who know the 
least about them.
    Mr. Cummings. The program is one going back to 1991, so it 
is about, I guess, 15 year anniversary. That is a long time. 
And I am just wondering, do you know how that research is done? 
Is it focus groups? You know, one of the things that I do 
believe is that people who have similar experiences in life 
probably shed the best light on other people in like 
circumstances.
    And I am just wondering. Sometimes I think what happens is 
that, say, for example, if I wanted to know about why do women 
in the lower economic rung of the ladder did not access, I 
would go and talk to other women. I sure wouldn't go to a man; 
I would go to a woman. Sometimes I just find that a lot of our 
government programs don't do that. A lot of times we don't go 
to people who could probably help us with it.
    For example, in my community there is a big glaucoma 
problem. And my mother, having lost sight in one of her eyes 
with glaucoma, I am in tune; I get it. So I am always talking 
to people about their eyes. But some kind of way I think we 
also need to use people who see the light, perhaps, to help 
spread the word. And I was just wondering how much we do of 
that, too. That is, people who may fall into those categories 
and have a relationship, therefore, and can spread that word. 
You follow what I am saying?
    Dr. Thompson. Yes, sir, I do. And this is an area in which 
we in the medical professions maybe are coming a bit late to 
the idea that we should ask those who we are trying to reach 
how best to reach them. But we are doing that now. And at CDC 
in particular we have established a new center, it is the 
National Center for Health Marketing.
    That doesn't mean we are selling people things, it means we 
are literally marketing health. And we are doing research by 
asking people, both in studies and in focus groups, how it is 
that you make your decisions about how you seek your health 
care of all sorts and how we can improve your ability to do 
that. So we are beginning to use those techniques of 
approaching the community we are trying to reach much more 
extensively.
    Mr. Cummings. Now, as far as doctors are concerned, they 
know about these options that women have with regard to free 
screenings and whatever. Do you think that plays a major role? 
Are you following me? Somebody comes to the doctor. Do you 
think because they know this is something available, that they 
make women aware of it?
    Dr. Thompson. My colleagues can probably address this 
better than I. But although we as doctors believe we know 
everything, the truth is most of us don't know enough even 
about our own specialties, and all have things that we can 
learn. So professional education is a part of CDC's programs. I 
know it is also part of the National Cancer Institute's 
approach.
    Mr. Cummings. Dr. Trimble.
    Dr. Trimble. We have seen data showing that obstetricians 
and gynecologists are the most likely to recommend that women 
undergo Pap smears and mammography. They are followed by family 
practitioners. Unfortunately, many adult internal medicine 
specialists are less likely to do a pelvic exam or obtain a Pap 
smear.
    So as Dr. Thompson mentioned, we need to redouble our 
professional educational efforts. In addition, the routine Pap 
smear screening has now been instituted as a mark of quality in 
health care provider organizations, so we think that this will 
increase the recommendation of Pap smears for all women.
    Mr. Cummings. Dr. Pazdur, you know that rising costs and a 
lack of commitment to applied science in emerging various new 
drugs and devices to treat cancer and other deadly diseases. 
What can be done to encourage applied science research and 
technology?
    Dr. Pazdur. Well, I think this is one of the considerations 
that the FDA had in establishing the critical pathway, because 
there is a tremendous funding of discovery of drugs. But I 
think where we have been lacking in the whole drug development 
area has been in the clinical and the development of drugs 
after they may have been initially discovered, and that is the 
clinical development of the drugs and the preclinical 
development.
    And that is why we are working with the NCI and have this 
project. What are paradigms that can be shifted from 
conventional evaluation of drugs to facilitate bringing drugs 
that are safe and effective, not compromising safety and 
efficacy--we never want to do that--but expedite drugs 
cognizant of the fact that they have to be safe and effective; 
looking at new non-clinical ways to develop in animal models.
    For example, what would be a minimum data package that 
could be accepted to bring drugs into a life-threatening 
situation; what are different statistical tools that could be 
used to give us confidence that a drug is safe and effective, 
rather than the traditional statistical methods that have been 
used? So I think this is an area that is an extremely important 
area that we want to focus on, because we are cognizant of that 
and really need to work not only in the FDA but with our 
external stakeholders, not only in government, not only in 
industry, but with the academic and patient community.
    Mr. Cummings. Thank you.
    Mr. Cannon. The gentleman yields back.
    Mr. Issa, did you have questions?
    Mr. Issa. Yes, Mr. Chairman.
    Mr. Cannon. The gentleman from California is recognized for 
5 minutes.
    Mr. Issa. Thank you.
    Dr. Trimble, you mentioned in your opening statement the 
vaccine for HPV, and my understanding is there are 150 or so 
different strains, if you will. How many is it effective 
against?
    Dr. Trimble. Well, there are a variety of HPV subtypes. 
Only a subset, perhaps 20 or 30, seem to be bad actors in terms 
of going on to cause cancer. The two companies that are 
developing the vaccine have gone furthest with the prophylactic 
vaccine and have focused on the most common subtypes, 16 and 
18, which are responsible for a majority of cervical cancers 
around the world and in the United States.
    Mr. Issa. And I would like to concentrate my questions not 
on, if you will, the new discovery side of it for a moment, 
because Johanna's Law really is about awareness, with $5 
million going toward and $10 million per year going initially 
toward demonstration projects to try to improve early 
diagnosis.
    My first question--and I will take any of them, but I 
think, Dr. Trimble, I would start with you--is it enough? Is 
this the amount of money that you believe would start saving 
lives in large enough numbers, or are we kidding ourselves? And 
even with the leveraging of public-private partnerships, will 
we need more?
    Dr. Trimble. Well, I concentrate my own work on promoting 
gynecologic cancer research and developing trials in 
gynecologic cancer, so obviously from my own perspective I 
always like to see more money focused on gynecologic cancer. 
And it should be said that about 5 percent of the NCI's budget 
is, as we know, earmarked and goes toward gynecologic cancer 
research. And there is a lot of basic science research as well 
that is specific to gynecologic cancers, but may well influence 
us and help us develop new treatments, new screening tests.
    So I think it is a very hard question for me to answer. 
Yes, I would love to see more money going into gynecologic 
cancer; on the other hand, we have a limited pot of money and 
there are a lot of other cancers that we have to study as well.
    Mr. Issa. Dr. Thompson, maybe in your case, right now I 
would say there are tens of millions of dollars a day worth of 
free air time warning the people of New Orleans and the south, 
but particularly New Orleans, not to drink the water and the 
contamination. I don't know how many people are going to heed 
that warning.
    It does seem a little strange that we are all going to be 
aware, unless of course, we are in the affected area, where we 
don't have a television. But maybe somebody will go in and tell 
the person who doesn't have a television or water what they 
need to do. From your experience, is this a sufficient first 
step to have a real impact both on the misdiagnosis side and on 
the need for testing side?
    Dr. Thompson. Well, certainly we will never have spent 
enough on cancer prevention and cancer detection until no one 
dies of cancer. But at the same time there are other priorities 
that we have to balance back and forth.
    I think certainly the concept of educating particularly 
providers about the latest techniques, about the latest 
knowledge, about how to appropriately screen, how to evaluate 
symptomotology is always worth the effort. Whether this will 
accomplish the end I think we will only know when we attempt it 
and then we evaluate whether or not we have accomplished it, 
and if not, what is then required to finally accomplish it.
    Mr. Issa. Last question, and I am staying on the same 
subject of money. My understanding is it takes about three 
quarters of a billion dollars to bring a new drug to market. 
Any one drug coming to market, from your experience--and Dr. 
Pazdur might be the best to answer this--any one drug probably 
would save, at a maximum, 3,000 to 5,000 deaths a year for 
nearly $1 billion, perhaps more; $15, $20 million, would you 
say, any of you from your experience, that an effective 
awareness campaign could save 3,000, to 10,000 lives a year 
between the three cancers? Would you say, on balance, that this 
$15 million--as compared to the $1 billion of one new drug--
could save as many or more lives?
    Dr. Pazdur. The answer to your question is yes. Obviously, 
prevention and early detection of cancer is always better than 
the treatment of advanced disease, even early stage disease. 
But especially when one takes a look at advanced disease, 
patients that have metastatic disease, where most of the drugs 
in oncology are being developed, most of those situations have 
to be considered palliative types of therapies, unfortunately.
    So efforts to really eradicate cancer and to truly make an 
impact on the burden of cancer really needs to be addressed in 
the early stage awareness, getting the community to see their 
physicians. Doctors know generally what to do; however, if the 
patients are not coming to them, that is where the gap could 
be, and I think that is a need for community recognition of the 
disease and the importance of getting screened, etc.
    Mr. Issa. Thank you, Mr. Chairman.
    Mr. Cannon. The gentleman yields back.
    Ms. Watson. The gentlelady is recognized for 5 minutes.
    Ms. Watson. Thank you, Mr. Chairman.
    This question goes to Dr. Trimble. In your testimony you 
state that an effective vaccine in combination with cervical 
cancer screening is expected to reduce cervical cancer rates by 
90 percent in the United States.
    I am finding out that there are those who began to oppose 
the HPV vaccine. A spokesperson for the Family Research Council 
said that giving the HPV vaccine to young women could be 
potentially harmful because they might see it as a license to 
engage in premarital sex. So from a public health perspective, 
does the Government typically withhold vaccines because of the 
unsubstantiated claims that they will affect people's attitudes 
and behaviors?
    Dr. Trimble. Well, let me start by seeing if Dr. Thompson 
would like to comment in terms of the--I know the CDC has a 
vaccine advisory committee which carefully measures the risks 
and benefits associated with vaccines and makes 
recommendations, so perhaps Dr. Thompson----
    Ms. Watson. Fine.
    Dr. Thompson. First, Ms. Watson, let me thank you for the 
imagery you used earlier about homeland security being not 
about the land, but about the people on the land. With your 
permission, I am going to use that with attribution, 
occasionally.
    Ms. Watson. Please do.
    Dr. Thompson. As my colleague has said, CDC has a process 
for evaluating the usage of vaccines. Now, the first issue is 
whether it becomes licensed, and there my colleagues from the 
FDA must make the decision. But once a vaccine is licensed, we 
have a committee, it is called the Advisory Committee on 
Immunization Practices, that meets regularly. It consists 
primarily of scientific experts, but also of public health 
practitioners.
    I had the privilege of serving on that committee myself for 
4 years before coming to CDC. And it also makes provision, 
extensive provision, for public input and public comment. Based 
then on the science and the policy implications of the use of a 
vaccine, they make scientifically informed decisions 
recommending to CDC, and from CDC thus to the Department of 
Health and Human Services, what use the vaccine should be put 
for.
    That process is ongoing now. The ACIP has already addressed 
the issue of HPV vaccine in some of its meetings in 
anticipation of licensure, and will be doing so again. So it is 
critically important that persons interested in this issue 
bring their concerns to the committee through the public 
comment process and make sure that their voice is heard.
    Ms. Watson. The encouraging words that you used were based 
on science.
    Dr. Thompson. That is correct.
    Ms. Watson. Not based on ideology or negative attitudes. We 
have been accused in our public school system--I was a member 
of the board in Los Angeles--when we passed out condoms upon 
request to block the spread of AIDS, we were accused of 
encouraging young people to engage in sex.
    I carried the needle exchange bill for 8 years--it was 
passed after I left--and was accused and made to sit on the hot 
seat because there were those attitudes out there that 
everything we did was encouraging people to have sex. So I am 
assured by your response that you operate based on the facts 
and on empirical evidence gained from your scientific research 
when you make these decisions, correct?
    Dr. Thompson. I can assure you, both from having been on it 
and knowing the people that are on it now, that the ACIP bases 
its decisions on scientifically verifiable fact and will not 
deviate from it.
    Ms. Watson. From a public health standpoint--and this is 
back to Dr. Trimble--we in Government, we decisionmakers must 
put policies out there that will help the public and reduce the 
risks that they face, even if it goes against some people's 
religious beliefs. I am a Roman Catholic, and I support choice, 
I support condoms, I support all kinds of other things that 
will reduce the risk to the public. So I just wanted to make 
that statement real clearly. And I appreciate, Dr. Thompson, 
your response.
    Thank you, Mr. Chairman.
    Mr. Cannon. Thank you. Without objection, I think we will 
go through another round of questioning.
    Let me just followup on what Ms. Watson was just asking. 
What rate of vaccination is that 90 percent figure you talked 
about predicated upon? In other words, what percentage of women 
and girls does such an outlook presume will be vaccinated?
    Dr. Trimble. I am not sure where the 90 percent figure came 
from. My impression is that we may well have said that the rate 
of cervical cancer has fallen so dramatically in the United 
States with the introduction of Pap smears, but I am not sure 
that we discussed in our testimony the projections for vaccine 
adoption and implementation in the future.
    Mr. Cannon. Thank you. Just along those lines, I am going 
to ask a couple of questions that my colleagues wanted to ask 
but are not here.
    For the FDA, your testimony references cervical cancer only 
once. This subcommittee informed your agency that we are very 
interested in issues that the FDA failed to address in our 
hearing on cervical cancer last year. Your agency was provided 
with questions that we expected to be addressed, specifically 
on the matter of the agency's failure to comply with Public Law 
106-554, signed by President Clinton in 2000, requiring that 
condoms be accurately labeled to reflect the fact that condoms 
do not protect women from HPV infections. Why aren't you 
addressing this issue?
    Dr. Pazdur. I personally can't answer that issue. The 
condoms are handled and the approval of condoms are handled by 
the Center for CDRH, so I do not have personal knowledge of 
that area. We will provide to the committee a written response 
to this question within 5 days.
    Mr. Cannon. Thank you.
    Since Public Law 106-554 was enacted requiring accurate 
condom labeling, more women have died of cervical cancer than 
from AIDS among non-injection drug users. The FDA has still not 
complied with this law. Can you tell this committee why it has 
taken so long to act on this critical public health matter and 
require accurate condom labeling?
    Dr. Pazdur. Here again I will reference my previous answer, 
that we will provide an answer to the committee in writing.
    Mr. Cannon. Thank you. It is not a personal thing, but 
institutionally we did have a hearing, and we expect a 
response. Thank you.
    Now I would like to move on to other issues. Are any of you 
familiar with protein testing to identify whether a woman or, 
for that matter, man has had HPV and which of the HPV viruses 
the individual has had?
    Dr. Trimble. There are currently approved by the FDA tests 
for women to evaluate whether they have an active infection of 
HPV and some subtyping of the various high-risk types is 
available for that. In addition, we do have some serological 
studies which evaluate antibodies in blood that can show a 
history of HPV infection.
    Mr. Cannon. Are those definitive; can you say to a woman 
you have not had or you have had a HPV infection based upon 
those studies?
    Dr. Trimble. Certainly the tests for active HPV infection 
does have a false negative rate, so one would need to do a 
series of tests over weeks to months to say for sure that a 
woman does not have an active infection at this point in time. 
The serological tests can fade over the years, so you may no 
longer have an immunological memory of having HPV, although in 
one point in life you may have had it.
    Mr. Cannon. For you, Dr. Trimble, but also for CDC, it 
would seem to be important that if you had a test that could 
identify what HPV a person has had in his or her system, would 
that be significant in the cost of identifying and treating 
people that may have or get cervical cancer?
    Dr. Trimble. Certainly with the development of accurate HPV 
tests, we have begun to study whether we should or could modify 
the existing screening program so as to screen first with a HPV 
typing and then only followup with Pap smears in people who 
were found to have HPV infection. This might well work for 
women let us say 25 and older in whom HPV is rare.
    Among younger women, though, HPV infections are common, so 
one would not want to start with a primary HPV screening test 
because there would be many false positives. And the vast 
majority of individuals, both men and women, who are exposed to 
HPV quickly resolve that infection and have no adverse health 
effects from the HPV infection.
    Mr. Cannon. But when you say no adverse health effects, 
doesn't it take years of the infection to create a cancerous 
lesion?
    Dr. Trimble. Well, we think that the average age of 
infection is probably less than age 20, and the median age for 
diagnosing cancer is around 65. So, yes, there are years to 
decades.
    Mr. Cannon. Thank you.
    Dr. Thompson.
    Dr. Thompson. We do currently, through CDC's breast and 
cervical cancer screening program, provide for the use of HPV 
DNA testing in certain clinical situations where it can be used 
as an adjunct to Pap testing. But at this point it has not yet 
been determined that it is a useful tool for across-the-board 
screening.
    So we use it in very special circumstances, such as when a 
woman has had a low-grade abnormality detected by a Pap smear. 
And after a period of time she has had negative colposcopy, we 
can then use HPV DNA screening and Pap screening to determine 
what sorts of followup are necessary. So in some circumstances 
we use it even today.
    Mr. Cannon. You know, there have been some terrific 
transformations in science. I read 2 or 3 weeks ago in Time 
magazine about Craig Ventner, who is traveling the world in a 
yacht and testing the DNA set every 20 miles or so, and he is 
able to do this because the cost of decoding DNA has fallen 
dramatically, from about $10 a pair, when we started the Human 
Genome Project, apparently, now down to like less than a penny 
a pair to decode. So it is cost-effective for him to do that 
even on his boat. And I think there are new technologies that 
are going to bring that down by another order or two orders of 
magnitude.
    It seems to me that this is an area where we need to change 
our thinking about how we are looking at disease, because the 
cost of decoding what is going on is so much, almost 
infinitely, lower than it has been. Could the three of you 
respond to how your agencies are dealing with the lowered cost 
of protein identification, DNA or RNA and other proteins, and 
what that means for the future of science? And what it might 
mean for complexity, how we ought to start looking at these 
diseases in an environment of Abasian or complex theory.
    Dr. Trimble, Dr. Thompson, then Dr. Pazdur.
    Dr. Trimble. Well, certainly cost is an important issue. 
The Gates Foundation, for example, has made a large 
contribution or earmarked a large contribution of money to help 
develop inexpensive HPV diagnostic tests for use in the 
developing world. And we have had some discussions with the 
Gates Foundation, as that research progress, as to whether we 
might be able to use some of those inexpensive diagnostics in 
the public health sector.
    At present, we only have a few tests which have been 
approved by the FDA, and some individuals have commented that 
the prices attached to them, prices placed on them by the 
companies which market them, make them less than optimal for 
use in the public health setting. But we obviously have no 
influence over the price of a proprietary diagnostic.
    Mr. Cannon. Thank you. I have a friend who complains that 
in every other sector of the economy innovation means lower 
prices, except in the medical sector, where prices skyrocket. 
That is an issue, but perhaps maybe the issue really is--and if 
I could skip over you just for a moment, Dr. Thompson, because 
this is probably an issue of most importance to you and what 
you are doing--but what do we do about the cost of getting 
approval when the nature of the ideas that are coming before 
the FDA is changing? In other words, you know more about what 
you are dealing with when you have decoded a protein than you 
do when you are dealing with a substance which may be toxic, 
but it may also affect disease.
    Dr. Pazdur. I think what you are really talking about is a 
concept which we refer to as enrichment, and that could the 
fields that you are referring to, proteomics and genomics, 
really identify a population of patients that are more likely 
to respond to a therapy. For example, if you have a DNA chip 
which identifies a subgroup of cervical cancer patients or 
ovarian cancer patients that are more likely to respond to a 
given therapy, that is a great step forward, because obviously 
these drugs are toxic drugs, for the most part, and you could 
spare people that have a very reduced chance of benefiting it 
from receiving drugs that they are not going to benefit from. 
Likewise, you are going to select a group of patients that are 
most likely to benefit.
    Mr. Cannon. What you just said is perfectly agreeable, but 
what I asked is slightly different. What are you doing at the 
FDA to encourage the identification of proteins and then your 
process for approving those proteins based upon what they are, 
as opposed to what historically we have done with toxicity? In 
other words, you may have a patient who responds better, as you 
have just pointed out, because of proteins that he or she has.
    On the other hand, you may have causative agents that you 
can identify, like HPV viruses, for which you may have 
serological remnants, or you might have an active culture. What 
are you doing at FDA to help speed up that process, where we 
are not dealing with the likelihood of death, but we are 
dealing with the likelihood of certainty that an agency is 
present?
    Dr. Pazdur. What we are doing in the area of genomics, we 
have specific groups of people that are working on guidances on 
how this data should be submitted to the agency. Obviously, 
this is an evolving field of science. So we are working with 
industry, inviting them to come in, share their data with us. 
We are organizing conferences, discussing how this data will 
have an influence on subsequent clinical trials. We are well 
aware of the scientific advance. It is an evolving science that 
has to really have a partnership with the FDA and both the 
academic community as well as the commercial community.
    Mr. Cannon. You call this an evolving area of science. It 
is not. That is what you called a transition of understanding 
what germs were over 100 years before we got vaccines that we 
actually understood why they worked. This is a revolution; this 
is an explosion; this is a transformation. And what you are 
talking about is a process that makes it a lot more expensive 
and, by the way, impedes the health care of Americans and 
people worldwide.
    May I suggest that the FDA needs to think differently about 
this? Because it is not the same as what has been, and much of 
what has happened can be left up to practitioners who 
specialize and who deal with the issues. So what I view the FDA 
here as is a big door, a big hurdle, a big cost increaser that 
needs some thought.
    I know you are thinking about it, but your answers are 
answers that are in the context of a bureaucratic and outcome-
oriented context, rather than how to help people's health, 
which is what the focus ought to be. You really need a 
transformation of thinking at the FDA.
    And I know you have done many things. I am a big fan of the 
FDA. I have been a big opponent of reimported drugs and things 
like that. But the FDA needs to evolve at a rate that is 
somewhat maybe lagging, but at least near the rate that the 
transformation in science is happening.
    I don't mean to lecture so much, but it is an area of deep 
frustration.
    And, Dr. Thompson, clearly this is a matter of great 
importance to you and your agency. Do you have some comments?
    Dr. Thompson. Well, in public health it is really simple: 
the lower the cost of a screening test or an intervention, the 
more people we can provide with the benefit of it. So it is up 
to our colleagues in the regulatory sector, in the research 
sector to develop and certify these products, but once they 
reach our hands, the less they cost, the more people we can 
serve with them.
    Mr. Cannon. Thank you.
    Mr. Burton, I have one more question, but did you want to 
ask questions of this panel?
    Mr. Burton. I just have one question, but go ahead.
    Mr. Cannon. Let me just point out what our discussion has 
been and where I think, as a community, we need to be headed. 
Much of the answering of the questions I have asked has related 
to controlled clinical trials, and I have continued to come 
back to what a practitioner does with his patients and what his 
experience is, and what we can accumulate from that process. It 
is a paradigm shift. It is a dramatic paradigm shift, but it is 
a shift that makes pretty significant sense, especially when 
you view the world from the point of view of the tools we have 
that are capable of helping us accumulate data.
    Of course, I have to say my questions may have, at some 
times, been harsh, and I apologize for that, but it is an 
awfully personal thing. But your agencies are really wonderful 
agencies, and there is no criticism of the agencies, it is just 
a road I hope you would see to get to the next position. And 
all three of your agencies have a piece of this and you are 
doing remarkable work, but the cost of medicine is 
skyrocketing. The access to medicine is diminishing.
    When I was elected to Congress, 65 percent of Americans had 
employer-based health insurance; today, 45 percent of Americans 
have that. And the answer is either we go to a controlled, 
socialized single payer system, which 65 percent of Americans 
now want, by the way, understanding that means socialism--as 
opposed to 45 percent when I first got elected; the numbers 
have inverted themselves--or we go to a system where the 
American way actually succeeds, and that is open markets, free 
access to information, choice by consumers, choice based upon 
access to information. In some cases that is a matter of cost; 
in the case of my daughter, it was a matter of life and death. 
It was an ignorant set of doctors who prescribed badly, didn't 
know what they were doing.
    What happened to my daughter was an abomination, and it was 
an abomination that I couldn't fix. I mean, I am a Member of 
Congress; I was a Member of Congress then. I didn't have access 
to the information to figure out what was going on with my 
daughter. Now, that has been ameliorated somewhat in recent 
times, but we still have problems in that area.
    Here, the three of your institutions are very different and 
represent different elements of the puzzle. But we have a huge 
cost hurdle that is transforming the rights and choices of 
Americans in a way that I think is wrong. So as you look at 
this, may I just suggest when a patient and his doctor or her 
doctor has access to information, they will make better 
decisions.
    We have ways of massively expanding information, and one of 
them, just to be thinking about, when we passed AHSEA, we had 2 
million people in America that got involved in that act, that 
became activists. I suspect you have 5 or 10 million today, 
because the number of people that are using nutritional 
supplements has increased significantly. And if you go to the 
NNFA, which is the National Nutritional Foods Association, Web 
site, nnfa.org, they have an incredible presence. They reach 
many people.
    And if the CDC said here is a set of questions we would 
like to know about your health and here is how we will protect 
the data, I suspect you would have millions of people who would 
respond. In other words, if you think about how you get data, 
you can get it much more cheaply than we have ever done before. 
The cost of obtaining data from individuals has plummeted, just 
like the cost of decoding a DNA pair has plummeted.
    So if you would think in those terms, I suspect you would 
see that there are great opportunities for improved health in 
America, for improved control by individuals of their health in 
America, and for a system that protects without impeding, 
without causing death and destruction, which in fact often 
happens with our medical system. That is probably not your 
fault, it is actually largely doctors who are ignorant of what 
they are doing. But it would be nice to allow patients to have 
some access.
    And I have ranted here, but I would like you all to think 
about that. We are going to followup with some written 
questions.
    Now, Mr. Ruppersberger, I know that you are next, but I 
think Mr. Burton only had one question. Would you mind if we go 
to him for that question and then come back to you?
    The gentleman from Indiana is recognized for 5 minutes.
    Mr. Burton. Thank you, Mr. Chairman. I will just be real 
brief here.
    First of all, I presume that you gentlemen would be 
supportive of Johanna's Law. That authorizes $15 million over 3 
years for public service announcements and $55 million over 3 
years for grants to establish local and national nonprofits and 
community-based health centers to test different outreach and 
education strategies. I am sure you know all that.
    Are our health agencies doing anything in this area right 
now? Do they have any kind of an outreach program or 
educational program for gynecological cancers in women?
    Dr. Trimble. The NCI does have an extensive educational 
program, both for the lay public as well as health 
professionals, focused on gynecological cancer. We work closely 
with our Cancer Information Service and the CDC in terms of 
disseminating that information.
    Mr. Burton. The reason I asked is when my wife was 
suffering from cancer, I never saw any manifestation of that. 
Can you tell me, real quickly, how much money is being put into 
that program?
    Dr. Trimble. I will have to get back to you with the amount 
of money that we put into cancer information, but it is a large 
portion of our budget and our activities.
    Mr. Burton. I would like to have that. Thank you.
    Mr. Cannon. The gentleman yields back.
    Mr. Ruppersberger. The gentleman is recognized for 5 
minutes.
    Mr. Ruppersberger. Mr. Chairman, thank you.
    There have been a lot of issues discussed here today. I 
think one of the frustrations that we have sometimes in 
Congress is that we raise some issues and then there is not 
implementation. And I would hope that we could benefit from 
this panel, and I know that the chairman feels very strongly 
about this issue because of some of his unfortunate personal 
situations that we really implement and move forward.
    In order to avoid any repetition, there is one issue that I 
think hasn't been addressed, so I will just ask that to the 
panel and that is all I have.
    In the past, the NIH and CDC has found that there was 
evidence that condoms can reduce the risk of cervical cancer, 
but there wasn't enough data to determine if condoms prevented 
the spread of HPV. Earlier studies were insufficient to answer 
this question because they asked people to recall past condom 
use, they didn't track people's behavior over time or they 
didn't know people's STD status before the study.
    Now a recent study has addressed many of these issues. 
Researchers tracked young women over time and gathered precise 
data on condom use and sexual behavior. The study found that 
consistent condom use reduced the risk of HPV acquisition among 
women by 70 percent and reduced the risk of cervical HPV by 80 
percent.
    My question to anyone on the panel, if anyone has an 
opinion: Do you think this is the kind of study that the FDA 
should take into account when considering labels for condoms?
    Dr. Pazdur. Here again, I have not reviewed the study, but 
obviously I think we should take account of all information. I 
can't make a commitment to you on a specific study without 
obviously seeing the data that is presented, but from your 
description of it it is something that we would be very 
interested in looking at and including into product labeling.
    Mr. Ruppersberger. I am not just saying looking at. I would 
recommend that you look at the study and if we are going to 
have momentum and move forward on this entire issue, I think 
these are things that we just shouldn't talk about at a 
hearing; we need to get the research done and follow through.
    Dr. Pazdur. By ``look at'' I meant evaluate appropriately.
    Mr. Ruppersberger. And then deal with FDA.
    Dr. Pazdur. Correct.
    Mr. Ruppersberger. Thank you.
    Mr. Cannon. The gentleman yields back.
    Mr. Issa, did you have further questions?
    Mr. Issa. Yes.
    Mr. Cannon. The gentleman is recognized for 5 minutes.
    Mr. Issa. Thank you.
    I would like to followup on a question Mr. Burton asked. If 
there is a lot of money being spent on outreach, why is it that 
it doesn't get to the end of the pipeline? Because Johanna's 
Law and this authorization for funding specifically is the 
result of an observation that it doesn't get to the end of the 
pipeline.
    So where is it being spent if we can't see it where we 
believe it should end up? Is it just that it is being spent 
elsewhere or something? It is befuddling to both Mr. Burton and 
myself.
    You could just not answer, and we will assume that is no, 
it isn't getting there, and we can move on. But go ahead.
    Dr. Thompson. We can give you the figures as to how much 
CDC spends on programs aimed at preventing or early detection 
in all of the different kinds of gynecologic cancer. That is 
not going to answer your question, however; it will just tell 
you relative amounts of dollars spent.
    Our focus at CDC has been primarily on provider and patient 
education, but it has been limited. It has been limited 
primarily to demonstration projects trying to gain a little 
more knowledge about how we can most effectively use those 
dollars. We do not yet have a large-scale campaign that is 
population-based and nationwide. It has been very focused.
    Mr. Issa. So, following up, should this bill become law, it 
would enable you to take that next step; certainly not 
nationwide, but it would give you the tools to do that, is that 
correct?
    Dr. Thompson. Certainly from the standpoint at CDC, 
legislation that provides resources to expand our programs 
would give us the opportunity to expand them. But, at this 
point, HHS currently has not established a position formally on 
this particular piece of legislation, but its provisions and 
the concepts embodied in it are certainly those that I think we 
could all support.
    Mr. Issa. OK.
    I would yield to the gentleman from Indiana.
    Mr. Burton. Let me just say that I watch old movies and 
stuff on television, and I see advertisements and stuff all the 
time, public service announcements saying, you know, prostrate 
cancer is a growing thing; gentlemen, get tested for that. And 
I just can't understand when I never--and when my wife was 
suffering from cancer, I never saw any ads, never saw any 
public service announcements, never saw anything.
    And I was just talking to this young lady back here, who is 
a cancer survivor, and she says she has a master's degree, and 
when she tried to go to the Web site to find information about 
the cancer she was suffering from, she and her husband, they 
had to go through all kinds of hoops to get the information. 
And it seems that if our health agencies have money in the 
pipeline to educate the public about these various forms of 
cancer, it would be manifested in television ads or newspaper 
ads.
    I just saw this ad in the Roll Call magazine that was paid 
for by Angelina Jolie. You know, it just seems people would be 
educated to know, especially about the kind of cancer that is 
not readily discernible.
    I mean, if you guys are spending money on telling people 
about this, I sure haven't seen it, and my wife died 3 years 
ago. So I would just like to know, if you are spending the 
money, where in the world is it going?
    Dr. Trimble. We would be happy to get you the information 
on the budget that NCI spends on educating the public and 
professionals about gynecologic cancer. But, nonetheless, the 
size of that budget is substantially less than that of, say, 
what major corporations use to promote new products. So in many 
cases we can't afford to buy TV time on national network TV.
    That said, I think we make a very energetic effort to make 
sure that our Web site is as comprehensive as possible; that we 
have publications which are available in low literacy form, 
both in English and Spanish; that we have a 1-800-4-CANCER 
number with cancer information services available around the 
country that can help people find appropriate care, to find 
clinical trials, to find contact for support organizations.
    We know we need to do more, but we have developed a close 
working relationship between NCI and CDC, between NCI and CDC 
and the professional societies and advocacy groups so that we 
can multiply our investments and make sure that the information 
gets as widely as possible.
    Mr. Burton. Well, let me just say that maybe you need to 
hire an ad agency or somebody to come up with some ads that 
could be put in public service announcements so people could be 
made aware of these things. My wife was misdiagnosed, and I 
think it was because even the doctor didn't have the kind of 
educational background to tell her what she should do.
    I just think if we are spending money in that area, and I 
hope we pass Johanna's Law to help augment this, but if we are 
spending money in that area, we ought to make sure the public 
can see it in one way or another. So you should just take that 
back as a recommendation. And I would like to see, if you could 
send it to us, a list of the ways that you are spending the 
money to inform the public, because I haven't seen it, and I 
would like to see it. Thank you.
    Mr. Issa. Mr. Chairman, I would ask unanimous consent for 1 
additional minute.
    Mr. Cannon. Without objection, so ordered.
    Mr. Issa. Mr. Chairman, I would yield to you for that 
minute.
    Mr. Cannon. Thank you. If the gentleman would yield back, I 
will just make my final comments. The gentleman yields back. 
Thank you.
    Mr. Trimble in particular, but others, have any of you been 
involved with the rulemaking relating to making federally 
funded studies available? That is an issue for another time and 
another panel, but of course goes right to the heart of access 
for information.
    Just a final question. Actually, we want a commitment from 
each of you on behalf of your agencies, so you have to be 
careful. You are not limited to what you are able to actually 
do, but you know your internal circumstances. FED has made some 
commitment along these lines that I am sure you are aware of.
    I want from each of you a commitment, those of you who can 
give it, on behalf of your agencies that you will work together 
and with Congress, with my office, to work on the issue of 
making more information available, developing databases that 
appropriately can have information available to doctors, 
researchers, and others, especially in the context of the 
lowered cost of database access and the lowered cost of protein 
decoding.
    If we could start with Mr. Trimble, whatever you could 
commit to, I would appreciate.
    Dr. Trimble. Well, I know this is a high priority of Dr. 
von Eschenbach, our Director, is making information more widely 
available, as well as building on the Nation's expertise in 
informatics. And as part of that he has established a cancer 
bioinformatics project called CIBIG. And I think that there are 
a number of components to that, but one of them would include 
the emphasis that you, Congressman Cannon, have put on, in 
terms of gaining data from the way an individual doctor, an 
individual patient, their experiences so other people are aware 
of that and can learn from that.
    Mr. Cannon. Thank you. I appreciate the clarity of that 
commitment. I actually spoke to Dr. von Eschenbach about this. 
I believe that he clearly understands the benefit of capturing 
data from practitioners. So I appreciate that.
    Dr. Thompson.
    Dr. Thompson. As I mentioned earlier, the Department of 
Health and Human Services is already solidly behind the 
development of an electronic patient record which would 
facilitate many of the things that you are describing. At the 
level of CDC, our commitment to this is, I think, demonstrated 
best by the establishment only a few months ago of a new center 
called the National Center for Public Health Infomatics, which 
will address this and other needs for health information to be 
more readily collected and more readily available.
    Mr. Cannon. Thank you. And I assume that includes also a 
commitment to work with other agencies and to get clinical 
information from practitioners available to others.
    Dr. Thompson. Yes, sir, it does, particularly the 
electronic medical record effort is one that is cross-cutting 
throughout the Department of Health and Human Services, and all 
of the divisions of the Department are potentially involved in 
this.
    Mr. Cannon. Thank you.
    Dr. Pazdur. As I stated in my testimony, we have an 
Interagency Task Force that is a joint effort between the FDA 
and the NCI, and I think that this is an excellent project for 
that task force really to capitalize on. It is not solely an 
FDA problem; it is not solely an NCI problem; it is not solely 
a CDC problem; but something for us to work on together. And I 
think that task force provides at last a framework to begin the 
process that you have outlined.
    Mr. Cannon. And is this a fairly substantial commitment on 
the part of FDA, from your perspective?
    Dr. Pazdur. Yes, it is.
    Mr. Cannon. Thank you.
    I find myself sitting here frowning through this hearing. 
That is because this is a rotten subject to be talking about, 
especially if you have had the kind of loss that Mr. Burton and 
I have had. And I hope that frown has not been viewed as 
negative. What your institutions are doing is incredibly 
important. You are remarkably effective. We don't want to 
change the world, but we want to help you all adapt and we want 
to create the legal context for that adaptation.
    Let me just say finally, before we leave, Mr. Rosenfeld, 
would you mind raising your hand? This is a molecular biologist 
over here, a friend of mine and a brilliant human being. You 
may want to meet him as you go out and get his card, or stay 
and listen to his testimony, which I think is going to be 
remarkably interesting. He was a molecular biologist before I 
think that was popular, and has been a leader in some of these 
areas, particularly in cervical cancer and the identification 
of proteins related to that.
    So, with that, unless there are further questions, we 
appreciate your time. This panel is dismissed.
    If we could have the second panel join us.
    We had a question from a witness regarding the 
appropriateness of videotaping, that is, a family member 
videotaping the testimony. Without objection, the chair is 
inclined to allow that. So, without objection, so ordered. The 
family may videotape the hearing.
    And, if you would like, without objection, Ms. Silver, you 
can have her put a chair up here so she can videotape the 
table, if you would like. Without objection, so ordered.
    All right, now, if we could have you raise your right 
hands.
    [Witnesses sworn.]
    Mr. Cannon. The clerk will note that all members of the 
panel have nodded in the affirmative.
    We will just go member by member, starting with Dr. Karlan. 
We appreciate your being here, and you are recognized for 5 
minutes.

     STATEMENTS OF DR. BETH KARLAN, PRESIDENT, SOCIETY OF 
  GYNECOLOGIC ONCOLOGISTS; DR. MARK JAY ROSENFELD, SCIENTIST/
   RESEARCHER; SHERYL SILVER, SISTER OF JOHANNA SILVER; AND 
            KOLLEEN STACEY, OVARIAN CANCER SURVIVOR

                  STATEMENT OF DR. BETH KARLAN

    Dr. Karlan. Thank you, sir. Chairman Cannon and members of 
the subcommittee, thank you for inviting me to testify at 
today's hearing. I am honored and heartened by the interest of 
this subcommittee in this important issue.
    My name, as you heard, is Beth Karlan, and I practice 
medicine at Cedar Sinai Medical Center in Los Angeles. There, I 
am the director of the Women's Cancer Research Institute, the 
Division of Gynecologic Oncology, and the Gilda Radner 
Hereditary Cancer Detection Program. I am also professor of 
Obstetrics and Gynecology at the UCLA Geffen School of 
Medicine.
    This year I was elected to serve as the 37th president of 
the Society of Gynecologic Oncologists [SGO]. Our 
organization's purpose is to improve the care of women with 
gynecologic cancer by encouraging research and disseminating 
knowledge. Our overall effort is focused on raising the 
standards of practice in the prevention and treatment of 
gynecologic malignancies through cooperation with other 
organizations that share our interest in women's health care, 
oncology, and related fields. SGO members make us the leading 
organization of gynecologic oncologists in the United States.
    At the outset, I want to clearly state my belief that 
Congress can take action that in the immediate future will save 
the lives of thousands of women. Today in the United States, 
one women will be diagnosed with a gynecologic cancer every 7 
minutes. That is over 200 women just today and close to 80,000 
women this year. If detected early, a majority of these cancers 
can be cured.
    But, frankly, many women don't know what symptoms to worry 
about and, therefore, they are unable to ask the right 
questions of their health care providers. Complaints such as 
bloating, abdominal or low back pain, or constipation may 
bother all of us occasionally. But when these symptoms are 
persistent and progressive for as little as 2 weeks, they 
should alert a woman to see her physician and ask about 
gynecologic cancer. With the help of the Federal Government, we 
can make this happen. We can make this happen.
    I would like to bring to your attention H.R. 1245, the 
Gynecologic Cancer and Awareness Act of 2005, commonly referred 
to as Johanna's Law. This legislation would serve to increase 
the education and awareness about the early warning signs of 
gynecologic cancer. That is the purpose of Johanna's Law: so no 
woman has to face a diagnosis of gynecologic cancer late in her 
disease just because she did not know the associated symptoms, 
risks, or where to turn.
    As a clinician and surgeon, I can recount hundreds of 
stories of women who came into my care too late because they 
did not recognize the warning signs their bodies were sending 
to alert them to the presence of cancer. These anecdotes, 
however, are validated by a recent poll of 800 women across 
America that was conducted by Research America in conjunction 
with SGO's foundation, the Gynecologic Cancer Foundation. This 
poll surveyed women about their knowledge of gynecologic 
cancers and is submitted as an attachment to my written 
testimony.
    Here are just a few of the astonishing statistics: 47 
percent of women surveyed could not name one symptom of a 
gynecologic cancer, not one; and almost 60 percent of women 
surveyed could not name one step they could take to decrease 
their personal risk of developing a gynecologic cancer.
    Mr. Chairman, these statistics do not lie. We need to make 
a difference, and we can make it now. We have achieved much, 
but women are still dying. Congress's commitment to expanding 
the boundaries of medical research has been a vital weapon in 
our war against gynecologic cancer, and for that we are 
immensely grateful. However, there is still a tremendous gap 
between the science and the realities of clinical care. All of 
our scientific advances are useless if women do not know when, 
where, or how to access care.
    Representatives Issa, Levin, Granger, and DeLauro have 
introduced Johanna's Law, which is cosponsored by many members 
of this committee. In fact, there are now 221 co-sponsors of 
this important legislation. Under Johanna's Law, the Department 
of Health and Human Services would conduct public education and 
awareness programs to get facts about the early warning signs 
of gynecologic cancer into the hands of women of this country.
    I cannot over-stress the importance of arming women with 
the basic facts about gynecologic cancers. Education is our 
front line defense in the battle against these killers of 
women. Your support will make this education and awareness 
possible.
    Once again, thank you for the opportunity to testify here 
today. I am constantly inspired and humbled by the strength and 
determination shown by women with cancer who are just trying to 
survive. I believe your leadership on this issue will give even 
more women the full lives they so richly deserve.
    Thank you, and I look forward to answering your questions.
    [The prepared statement of Dr. Karlan follows:]

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    Mr. Cannon. Thank you, Dr. Karlan. Among those women are my 
five remaining daughters and wife who appreciate your 
testimony, and there are some startling statistics there.
    Dr. Rosenfeld, you are recognized for 5 minutes.

              STATEMENT OF DR. MARK JAY ROSENFELD

    Dr. Rosenfeld. I am grateful to the subcommittee for the 
opportunity to discuss my professional experiences and opinions 
on progress against gynecologic cancers. I come from a 
different perspective than most here. No. 1, I am a researcher; 
No. 2, most of my work has occurred not only in the United 
States, but the bulk of it in places like China.
    Given the time constraints, I have made much of my 
presentation a written one, and covers such issues as the 
financial incentives that perpetuate inefficient and costly 
diagnostic methods; the need for disruptive or analytic or 
diagnostic technologies to achieve pervasive high-quality and 
inexpensive medical care; and whether cervical cancer vaccines 
can actually achieve significant use in our lifetime.
    Perhaps not an intended topic at this meeting, but the ways 
in which we have pursued cancer for several decades have, over 
all, been a failure, in my opinion. There have been some clear 
successes. With the possible exception of Pap smears, 
gynecologic cancers are not blatantly prominent among these. 
Perhaps the greatest improvement, as actually has been 
mentioned, has been treating childhood cancers. Overall, our 
inability to lower the cancer death rate, despite expensive 
efforts spanning more than 35 years since the war on cancer 
began, shows the need for major change in strategy.
    I am now going to somewhat digress--although it is in my 
written presentation--digress from what I had originally 
prepared because of comments made by people. For example, Dr. 
Thompson talked about the 2.9 million Pap smears that had been 
done to achieve the finding 1,500 patients with invasive 
cancers. That is great, because that cost $75 million and an 
average of $40,000 to $60,000 to find each of those cancers.
    Now, I am happy that these people were discovered. I hope 
that they were treated; I hope that it was successful. On the 
other hand, that is a lot of money. And it is a lot of money 
that if we could be more efficient in terms of the way in which 
we pursue our medicine and the way in which we pursue our 
diagnostics, then we could reach more people.
    This gets into questions such as we discussed a few minutes 
ago, or actually throughout this entire proceeding, and that is 
how do we reach people? We can only reach people if we have the 
kind of technologies, if we have the kind of methods that will 
allow us to reach them for a good economic price. Most of the 
democratic side, in fact all are not here right now, but, on 
the other hand, they had talked literally about that, the black 
community, and reaching the black community.
    I talk in my written work about the financial incentives 
that perpetuate inefficient and costly diagnostic methods. Look 
at the Pap smear industry. It is a $7 billion industry. I am 
not condemning Pap smears. But if something new, something 
revolutionary, something disruptive came along--and there are 
those things on the horizon as we speak--how do we contend with 
that? These people are making a living.
    So either consciously or subconsciously, they are going to 
buck the trend because they are spending $2 billion per 
gynecologic exam in this country that leads to a Pap smear. 
There is $1.2 billion being spent on average each year now for 
Pap smears alone. When you have a Pap smear that is 
questionable, you go to colposcopy. Colposcopy is a microscopic 
examination of the cervix; $3.6 billion is being spent there. 
Yet, over 80 percent of colposcopies, fortunately for the 
patient, show that the patient has nothing wrong. We just spend 
over $2 billion for nothing, in a sense.
    Things need to be done. There is a need for disruptive 
technologies. Bringing down costs is mandatory. We have to 
shift in a grander way to earlier detection and treatment. This 
is something that I push very aggressively in China.
    And I think that if you look at the war on cancer, speaking 
more generally, but also to gynecologic cancers, we have to 
concentrate more on less advanced states, where treatment 
effects may be better. For example, when we go to FDA approval 
and we are looking at a new drug, what is happening with a new 
drug is that, typically, the patient that is being treated is 
the sickest patient.
    Now, I am not saying sick patients should or should not be 
treated, but the sickest patient with a drug is oftentimes a 
patient that won't respond anyway; and maybe a person who is 
not as sick could benefit more from that drug. This is 
something that really needs to be looked at very, very 
seriously.
    In any case, I am rather passionate about changing the 
system, and hopefully during my question and answer period I 
can help you in terms of what else I have to offer. Thank you.
    [The prepared statement of Dr. Rosenfeld follows:]

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    Mr. Cannon. Thank you for recognizing the light. We 
probably wouldn't have tapped you silent, given the kind of 
information you were giving, but we will come back, I can 
assure you, with questions to give you more opportunity to 
explain some of these things.
    Ms. Silver, you are recognized for 5 minutes.

                   STATEMENT OF SHERYL SILVER

    Ms. Silver. Thank you so much, Mr. Chairman, for your 
leadership, for holding this hearing today, for your passion 
for this issue. I am so sorry for your loss, and I express my 
deepest condolences.
    And to so many of you on this committee who have also been 
personally touched by cancer and who have led this fight for 
us, we are so grateful to you, Mr. Issa, our lead sponsor in 
the 109th Congress; to Mr. Burton, who has been such an 
advocate for us; Mrs. DeLauro; Mrs. Granger; and, of course, 
Mr. Levin, the original author of Johanna's Law. We are just 
indebted to all of you for taking up this fight for us, and for 
millions of American women at risk. That is really the issue 
here.
    And as the person who first proposed Johanna's Law, I 
suppose I should give my name: Sheryl Silver. I am the founder 
and president of Johanna's Law Alliance for Women's Cancer 
Awareness. Most proudly, I am the younger sister of Johanna 
Silver Gordon, after whom this legislation is named.
    I feel a responsibility on behalf of millions of grieving 
family members in this country who have lost hundreds of 
thousands of their mothers, sisters, daughters, and other loved 
ones, to sound an alarm today. I know everyone in this room is 
supportive, and we are grateful for that, but there will be 
many who read and hear this testimony.
    So I want to go on record today as saying we have a 
national tragedy that is not being addressed adequately. Unlike 
the tragedy of September 11th and Hurricane Katrina, which 
thankfully have only happened once in this Nation's history, 
this is a tragedy that is going on year after year in this 
country, as we lose, this year, nearly 30,000 women to 
gynecologic cancers. Nearly 10 times the number of Americans we 
lost on September 11th we are now losing every single year.
    In just the last 10 years we have lost over 250,000 of our 
mothers, sisters, daughters, and other loved ones. Although we 
are grateful for its progress and absolutely for the 221 
cosponsors in the House, the time to act is now. In just the 
nearly 3 years since I proposed it, over 75,000 more women in 
this country have run out of time, run out of medical options 
and died, and left behind millions of us grieving for the rest 
of our lives.
    And what magnifies the tragedy of these deaths, and all of 
them from these cancers, is that they are not inevitable. A 
diagnosis does not have to be a death sentence, as we have 
heard today. Diagnosed at the earliest stage, ovarian, uterine, 
and cervical cancer--which account for over 90 percent of all 
new diagnoses in this country every year--these three cancers 
all have 5 year survival rates greater than 90 percent, with 
women diagnosed early commonly going on to live normal, long, 
healthy lives.
    And yet thousands of women, tens of thousands are diagnosed 
after this earliest stage every year in this country. With 
ovarian cancer, the problem is particularly common. Eighty 
percent of women are diagnosed after the cancer has progressed 
to more advanced and less survivable stages.
    And a common ingredient in those late-stage diagnoses are 
the delays that occur simply because women don't recognize or 
know the symptoms of the disease or its risk factors, and so 
are not seen quickly enough, appropriately enough. This is 
exactly the life-threatening information gap that contributed 
to my sister's late diagnosis and death.
    Despite being the daughter of a physician, the sister yet 
of two other physicians, and a health-conscious woman who saw 
her gynecologist annually for pelvic exams and Pap smears, who 
ate nutritiously, exercised regularly, did everything she knew 
of to live a long, healthy life, despite that, the one thing my 
sister did not know is that persistent heartburn, bloating, and 
constipation were common symptoms of ovarian cancer. She 
assumed they were to do with a minor gastric problem. She took 
antacids.
    When the symptoms persisted, she made an appointment to see 
a gastroenterologist; waited several weeks as a new patient for 
that first appointment, never thinking the delay may be life-
threatening. And by the time she saw her gynecologist and 
appropriate tests were performed, she was immediately scheduled 
for major surgery that led to the shocking diagnosis of stage 
3C ovarian cancer, of only four stages, a late stage. She was 
only given a prognosis of 12 to 18 months to live; and with 
aggressive surgery, multiple surgeries, treatments, 
chemotherapy, different kinds of chemotherapy, clinical trials.
    We searched for everything. She went to leading cancer 
centers, she had great insurance, access to care at UCLA, MD 
Anderson. But nothing helped because she was diagnosed so late. 
And she spent the last 8 months of her life tethered to an IV 
pole for her basic nutrition and hydration, and eventually pain 
medication 24 hours a day to dull her agony. This is a horrible 
way for a dynamic and loving and health-conscious woman to lose 
her life.
    But we are not here because my sister was an unlucky, 
uninformed woman. I didn't propose Johanna's Law 3 years ago 
because of that. I proposed it because this tragedy is 
happening day after day, year after year in this country, 
unchecked. And whatever we are doing, it is not enough, because 
the death toll from this group of cancers is not going down.
    Two years ago the death toll from ovarian cancer went up. 
It may go up further as this population ages. Our Nation is an 
aging population, and women over 50 are at higher risk for both 
ovarian and uterine cancer. So we have to do more to improve 
early detection and develop better treatments, all of it, or 
else we will see this death toll continue to climb.
    Last week--I am going to also cut my testimony short. I am 
already over that time. Let me just say the following, and I 
will submit, if I may, my written testimony in its entirety.
    Last week our President said the Federal Government's job 
is to save lives because every life is precious. I absolutely 
agree. And we have already lost too many of our precious 
mothers, daughters, sisters, and other loved ones and dear 
friends, simply because they didn't get the information in 
time.
    This is not the behavior of a compassionate Nation. We know 
that acting quickly can spare needless suffering, just as we 
know that acting quickly in the wake of Hurricane Katrina--and 
this Congress can move quickly when it needs to, as it did last 
Friday in granting major funding for relief. We know that 
moving quickly in the case of natural disasters will spare 
needless suffering and death.
    And the coalition of doctors, nurses, cancer survivors, and 
family members who have advocated for Johanna's Law these last 
2 plus years, we do it because we all believe that we can 
improve early detection; we can save lives by educating women. 
They will take action given the facts.
    So I beg this Congress, we have the best chance we have 
ever had because we have over half the members already co-
sponsoring. Please let the legacy of the 109th Congress be that 
in addition to responding to the challenges of terrorism, 
homeland security, natural disasters, and other challenges 
facing this Nation, this was the Congress that finally took the 
action so long needed and created the urgently and desperately 
needed program of gynecologic cancer education.
    By doing that you will not only save lives by improving 
early detection, you will finally give a measure of healing to 
millions of us in this country who grieve the loss of our loved 
ones and who will know, by the existence and the passage of 
Johanna's Law, that our loved ones did not suffer and die in 
vain, but that their stories and our retelling of their 
tragedies have finally been the catalyst to create this long 
overdue and urgently needed national program of gynecologic 
cancer education.
    I thank you for your patience and indulgence. Thank you.
    [The prepared statement of Ms. Silver follows:]
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    Mr. Cannon. Thank you.
    Ms. Stacey.

                  STATEMENT OF KOLLEEN STACEY

    Ms. Stacey. Good morning Chairman Cannon and committee 
members. Good morning Mr. Burton, my Congressman. I want to 
thank you, Mr. Burton, for everything that you have done for me 
as a survivor. I am very honored to be here to speak to you 
about something very dear to my heart, Johanna's Law.
    Last year I went to an advocacy training meeting and I 
heard Sheryl Silver speak about her sister Johanna and her 
motives for Johanna's Law. That speech gave me hope that some 
day something will be done to make women and health care 
professionals more aware of the signs and symptoms of 
gynecological cancers.
    Sheryl, I want to thank you for taking the initiative to 
propose a bill long overdue.
    Johanna's story and mine were so much the same that it gave 
me cold chills. Unfortunately, thousands of other women have 
the same story, caused in great part by a lack of knowledge of 
the symptoms of ovarian cancer. The need for education and 
awareness is crucial. Johanna's Law will provide that campaign 
that will definitely save lives.
    For the last 8 years I have suffered through numerous 
surgeries, reoccurrences, countless hours of chemotherapy and 
radiation. Why? Could this suffering have been prevented, or at 
least lessened?
    I learned, after diagnosed, that I had all the symptoms. I 
wasn't aware that indigestion, heartburn, pressure on the 
bladder, unusual bleeding were symptoms of ovarian cancer. Nor 
did I know that a Pap smear didn't screen for ovarian cancer. I 
visited doctors for each one of those symptoms, but no one put 
it all together.
    It took an entire year for me to be diagnosed correctly. By 
then the cancer was stage 3C, an advanced stage of ovarian 
cancer, with only a 38 percent chance of a complete cure. Had 
it been discovered in an early stage, I would have had a 90 
percent chance of complete cure.
    Today, 8 years later, nothing has changed. I still meet 
with women who did not learn about the signs and symptoms until 
after diagnosed. Together, Congress, we can do this. We can 
educate people until scientists come up with an early detection 
test.
    I may look good to you today, at least I hope so, however, 
that hasn't always been the case. Time won't permit me to go 
into all the details of my experiences over the last 8 years, 
but let me tell you what I have gone through just this year 
alone. I had a PET scan last December that showed a tumor in my 
lymph node in my neck. Surgery was scheduled for January to 
remove the tumor.
    It turned out to be much worse than the doctors expected. 
On January 7th I woke up with incisions up and down my neck, 
stapled. I had two drainage tubes coming out, six radiation 
catheters, all hanging out my neck. I could tell people were 
frightened to look at me. They were shocked by the way I 
looked. My friend said, you have a good Frankenstein look 
going, Kolleen.
    Then I saw the fear in my family's eyes and I was 
immediately scared too. I was then told that my cancer had 
spread, and the surgeon had to remove two nerve clusters and my 
juggler vein.
    Just 4 weeks after surgery and radiation treatments, a 
followup PET scan was done. My cancer had spread again. We had 
no choice but to be aggressive with treatment. I just finished 
chemo 2 weeks ago. I felt like giving up. This isn't fun.
    My family is tired of seeing me with pain. I live with a 
terrorist every day. I have multiple side effects that will be 
with me the rest of my life. My quality of life has 
dramatically changed. I have an equilibrium problem that makes 
me unable to walk in the dark.
    I have numbness in my feet and hands, continuous pain, 
constant fatigue, and I was forced to go on disability. Being 
on disability affects my pride. This year, the 8th year, I 
wanted to give up, but I knew I could not. I have to fight for 
my family and for other women that are going through this 
horrible experience. Cancer isn't just a physical condition, 
but also an emotional roller coaster for me, my family and my 
friends. I could not have done it without their love and 
support.
    In closing, I would like to leave you with a feeling of 
hope. As children, we hope to grow up to be big and strong. As 
adults, we hope to be healthy and live a long, happy life. If 
we are not healthy, we hope that our experience will help the 
people around us to make the right decision.
    Congress, by passing Johanna's Law, each of you has a 
chance to make the right decision and give hope back to me, to 
women, and grieving families that have been victims of this 
deadly disease. This year, 28,000 women will die from 
gynecologic cancers.
    Thank you.
    [The prepared statement of Ms. Stacey follows:]

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    Mr. Cannon. Thank you, Ms. Stacey. It is hard to believe 
all that by talking about it or hearing about it. Thank you for 
sharing that with us.
    My sense is that we are going to make great progress with 
Johanna's Law. I am pretty sure the House will pass it. 
Unfortunately, we had to pass the bankruptcy bill eight times 
before the Senate got around to it. In this case we may have 
more. I think there is some kind of prohibition against 
speaking ill of the other body, so let me just say we have high 
hopes that they will be reasonable on this issue and move 
relatively quickly.
    I view Johanna's Law as part of a larger context. You were 
all here and listened to me talking with the people that 
control the purse strings in America for much of what is going 
on here and control, to a large degree, the research, so I 
would like your comments as we go through this on that 
research.
    But, Dr. Karlan, if we could start with you. You are a 
practitioner. You run a research institute. You are one of 
those people that is--I think most doctors really view 
themselves as scientists anyway. But you really straddle both 
worlds; you treat people and you run a research institute.
    Can you comment on what we talked about, what the earlier 
panel dealt with to some degree, about the role of 
practitioners, what it would mean to health care generally if 
we had access to more information from practitioners and their 
patients as to treatments, and how best practices could be 
spread and how new ideas could be generated? Is that something 
you have thought about and would you like to comment on that?
    Dr. Karlan. I clearly thought about it in the last 2 hours 
during this panel, but I think previously we at times exchange 
the anecdotal observations that you described so clearly 
earlier with regards to your daughter's response on the MRI to 
her Chinese herb. I think sharing those observations are often 
seminal on the research side of things. One takes that 
observation and then asks how and why, as well as sharing it 
with others.
    I think that the information system that you described is 
one that we do colloquially in our communities, we do it 
through the society at our annual meetings where we talk about 
our patient experiences or the amazing survival or the things 
we have seen, and exchange those stories. I think an 
information database as you described could perhaps allow us to 
collate those anecdotes, begin to make observations that would 
have better power by seeing are they consistent or is it 
anecdotal to that person's immune system or other aspects of 
her genetic makeup, and then translate that. As a clinician-
scientist, I look at those observations and try to understand 
the molecular biology as to why they occurred.
    So, yes, that type of information, where every single 
patient, and not to at all make patients' experiences and take 
it out of the human nature, but allow those data points to be 
captured so we can learn more and more from every single 
patient's experience, because I do think that is going to be 
our future. But individualized care, molecularly directed and 
targeted care, and we are going to need those data, that 
opportunity to move that forward.
    Mr. Cannon. Are you familiar at all with complexity theory 
or Abasian statistics? That is a mean question, but I don't 
mean it to be.
    Dr. Kaplan. Not in any great detail, sir.
    Mr. Canon. But from your point of view, having dealt with 
many patients and with clinical studies, you get the sense of 
how, if you had much data, you could sort that and bring a 
great deal of decision-enhancing information to bear on any 
given patient.
    Dr. Kaplan. Absolutely.
    Mr. Cannon. Thank you.
    Dr. Kaplan. I think that is what we are all dealing with 
now with genomics, proteomics, that we have enormous amounts of 
data, but we need to mine that data so that we find those gold 
cores, that ore that allows us to see the light, see how the 
dots are appropriately connected. So we need all those 
patient----
    Mr. Cannon. Exactly. That is exactly it. Thank you.
    I wish the prior panel were all here. Thank you for staying 
with us.
    But, yes, thank you, that is exactly the point. And while I 
suspect all doctors may not be as smart or as attractive as 
you, almost all doctors actually care about their patients and 
want to see better processes, better treatment, better devices 
available for their health.
    And in the case of my daughter, by the way, there were like 
100 studies, animal studies on the artemisinin that we used 
that showed pretty dramatic success. But no bridge from those 
studies to practice. How do you dose a human being? Whether 
that drug would have worked or not, I don't know. There was 
some obvious evidence that it was working to some degree, but 
we are not building at all on that experience for other people 
who have this or similar diseases, despite the fact that there 
are some really very powerful, profound studies out there with 
animals, and yet no opportunity to translate that to others.
    Thank you very much, Dr. Karlan.
    Dr. Rosenfeld, we have talked somewhat about some of these 
issues. Do you have other things you wanted to talk about in 
response to the other panel, or would you rather that I ask you 
questions?
    Dr. Rosenfeld. I am used to questions from you. Ask me a 
question.
    Mr. Cannon. You talked about disruptive technologies in 
your presentation. And clearly, with the earlier panel, we 
talked about the effect of the disruptive technologies that 
have resulted in a much lowered cost of identifying proteins. 
Can you talk a little bit about what has happened in that 
field, where we are headed, and what that means for patients in 
America? Ms. Silver talked about 250,000 mothers and sisters in 
America. We are talking 20 or 30 times that many people 
worldwide. So if you would talk a little bit about what 
progress in America means to the rest of the world, I would 
appreciate that also.
    Dr. Rosenfeld. Sure. Disruptive technology actually has its 
own definition, it is an innovation that, due to its 
revolutionary nature, can actually replace an existing or 
dominant technology. We already know of those things in other 
contexts. For example, everybody knows what a CD is. My kid 
doesn't know what a vinyl record is. So a point made there.
    A disruptive technology oftentimes, also, if you read, for 
example, Clayton Christianson, who has written extensively 
about that, from the Harvard School of Business----
    Mr. Cannon. And a good Utah boy, I might add.
    Dr. Rosenfeld. You better believe it. You can tell I am 
from Utah too.
    A disruptive technology oftentimes also does several 
things. No. 1, it very frequently brings down costs. An example 
that comes to mind, of course, is the computer industry. You 
get a lot more bang for the buck today from a computer than the 
little 8088 that I bought in 1981.
    In any case, disruptive technologies are also interesting 
in the sense that they have odd origins. Oftentimes they don't 
come from academia. For example, the CD, although it was from 
an MIT professor, it actually came through a private enterprise 
route. And the reason is that academic institutions are 
oftentimes interested or follow down a path which are called 
evolutionary technologies; that is, you build A to B to C of 
the same technology. Where a disruptive technology is a 
revolution.
    Now, with that in mind, what is on the horizon, what is 
actually working now? And please realize that I am very, very 
interested in health care delivery to rural populations, to 
developing nation populations. So, from my perspective, I want 
to see people everywhere get the kind of health care that is 
only affordable now at some of the big medical centers or the 
big reference laboratories.
    But with regards to, for example, DNA and DNA analyses, 
right now the current methods used to look at, for example, PCR 
DNA to look at human papillomavirus in a laboratory, to set up 
that laboratory would cost you $100,000 for the device alone. 
Set up the lab and so on, you are in for another $100,000. You 
have to run it with specially trained personnel, etc., etc., 
etc.
    There is now disruptive technology that will allow that 
same DNA analysis to be done on a device that would retail 
probably for a couple hundred dollars, for chemistries that 
will allow you to do this for a couple pennies per patient. And 
that is the kind of disruptive technologies I am talking about. 
These technologies will allow you to do things anywhere.
    Mr. Cannon. So the common lab today, a current lab with PCR 
technology, it costs something like a penny a pair to decode?
    Dr. Rosenfeld. Well, it is not a penny a pair, but by the 
time--I can actually, if you want me to produce this, I can 
actually give you a spreadsheet; I have this broken down. But 
to do a patient in a laboratory with all costs right now would 
probably cost in the neighborhood of tens of dollars to do an 
analysis: do you have HPV; do you have ovarian cancer. Those 
kinds of things would cost a lot of money. And what I am 
talking about is now the technology is in place for doing this 
for pennies; and away from offices and away from laboratories.
    Mr. Cannon. And when you say pennies, you are talking about 
the whole analysis, not each pair.
    Dr. Rosenfeld. Yes, I am talking the whole analysis.
    Mr. Cannon. So if you are decoding several pairs, you are 
talking about a fraction, a very small fraction of a penny per 
pair.
    Dr. Rosenfeld. In fact, there is a meeting tomorrow at 
Johns Hopkins University in that regard I will be participating 
in.
    Mr. Cannon. So what does that mean for the FDA or for the 
CDC or for NIH or for the National Cancer Institute in terms of 
this massively plummeting cost of decoding proteins in 
comparison with what should be available to Americans and the 
rest of the world in terms of treatment? What should happen? 
How should that transformation drive treatment technology?
    Dr. Rosenfeld. Well, I mean, it is obvious. If it is 
disruptive technology that has brought down cost, we should be 
able to deliver whatever that is to the patient for cheaper. 
So, for example, if it is to diagnose cervical disease, I 
should be able to diagnose cervical disease for a couple of 
dollars instead of tens of dollars.
    And, by the same token, if we are talking, though, the FDA, 
CDC, I don't hold them blameless, but the FDA, with regard to 
that bureaucracy, they are going to have to start looking at 
things differently. Things have to be done differently, because 
I don't think we can afford not only to neglect new technology, 
but we can't afford to approve technologies the way in which 
our infrastructure is set up as we speak.
    Mr. Cannon. We have three people who have had a daughter or 
a wife or a sister die of cancer here in the group and a cancer 
survivor with us, and we are talking about clinical testing and 
protocols that get set at a high level, when what you are 
telling me is we have now in place technology that enables a 
physician at the lowest level to be doing things that could 
only be done at the most expensive labs on Earth less than a 
decade ago.
    Doesn't that seem to you--in fact, you, in your earlier 
testimony said something--I made a little note somewhere. You 
are fairly critical, I think, of the FDA and its reaction, and 
I suspect that the key here is the historic context of the FDA 
versus the transformed future of medicine.
    Dr. Rosenfeld. It is time for the FDA to change. The world 
has changed. It is time for them to change. They are operating 
on a system that is predicated, in my opinion, on the way in 
which things used to be done prior to the advent of molecular 
biology. The FDA still has not even adjusted to molecular 
biology as a term. There is one molecular biology test in the 
entire planet that is FDA approved, one, with regards to 
gynecologic cancers.
    Mr. Cannon. Wow.
    Dr. Rosenfeld. And not only that, the technology for that 
one HPV--it is an HPV test--is 20-year-old molecular biology 
technology. There is lots of new stuff, there is lots of good 
stuff. There is molecular testing that could be done for 
ovarian as we speak, and it is not in the pipeline.
    Mr. Cannon. I want to explore this for a bit. But first I 
would like to get some bona fides on the table. Would you mind 
giving us your academic background, what you are doing in 
China, the committees you are serving on? I know that is a long 
list, but you don't have to do it all, just some of the high 
points.
    Dr. Rosenfeld. OK, if I talk about China, remember I am a 
loyal American.
    I have graduate degrees from both the University of Utah 
and the University of British Columbia. I am a molecular 
biologist, also a geneticist. I am former faculty at the 
University of Utah School of Medicine. Our department used to 
be called the Cellular, Viral, and Molecular Biology 
Department.
    I went into private enterprise actually because I feel very 
strongly about the direction that I feel medicine needs to 
take, and have been involved with innovative technologies as a 
consequence. I have been involved predominantly with 
gynecologic cancers and, in particular, cervical cancer, and I 
hold one distinction, and that is that I actually sit on the 
China State Council on Medical Reform. I am the only American.
    And I am very proud of that because China has made great 
strides with regards to reforming their medical system. They 
want a system that really works for people, and that is 
something that I think is, from my perspective, I am apolitical 
on that; if they want to do it, I am willing to help. And just 
because it is fun, I also breed giant pandas when I am in 
China. I am in charge of giant panda reproduction at Peking 
University.
    That is my background on reproduction endocrinology.
    Mr. Cannon. Do you also work with the Mandalay? Do you also 
work with the pandas----
    Dr. Rosenfeld. Oh, the Mandalay Bay fiasco? Yes.
    Mr. Cannon. I didn't know it was a fiasco. That is because 
of the trust that the Chinese have in your judgment.
    Dr. Rosenfeld. Yes. I am also the English version--if you 
go on the net, the English version of the China 5 year cancer 
policy, I am actually the author.
    Mr. Cannon. So you spend a lot of time in China. Why?
    Dr. Rosenfeld. What?
    Mr. Cannon. You spend a lot of time in China working on 
cervical cancer. Is there a reason for that?
    Dr. Rosenfeld. Cervical cancer in particular, because China 
is probably the epicenter for cervical cancer. Last year, for 
example, over 90,000 died of cervical cancer. And I have been 
on wards where I have seen, on a given afternoon, as many as 70 
women with terminal invasive cervical disease. So China is a 
place that is necessary if one is to get a handle on 
gynecologic cancers, in particular cervical.
    The other reason is that I really do have a true commitment 
to taking technology and introducing it into rural and 
developing regions, and working with the Chinese has been good 
from that perspective. So, for example, I am down in Guangxi 
Province, which is a remote area of China, and looking at 
whether or not we can indeed deliver such things as molecular 
biology services in the middle of nowhere.
    However, the spillover, I think, is great, and that is 
this, that the commitment is that this be provided also here. 
So, for example, when we heard discussions earlier today about 
the need for Black populations to be able to achieve pervasive 
early detection screening, I believe that can only be achieved 
if we change the diagnostic paradigm, and that is the kind of 
technologies that I work with.
    Mr. Cannon. I know the Chinese Cancer Institute is among 
the highest quality in the world, with highly trained people, 
and they are not compromising that at all. But China has a 
problem: they don't have the wealth that America has, so they 
can't do things the way America does them and still reach 
people in China, which is really Johanna's Law. How do we do 
things in America? Well, we are going to spend a lot of money 
on it.
    Dr. Rosenfeld. That is a plus.
    Mr. Cannon. But the Chinese are different. Would you talk 
about that, why that is a plus?
    Dr. Rosenfeld. It is a plus because we are spoiled and they 
are not. And the plus is this: again, I said it earlier, and 
that was 2.9 million people, we spend $75 million, $60,000 per 
cancer. We are willing to spend that kind of money. We throw 
money left and right in health care. That has been a problem 
here. We throw money out for research, but where is the 
accountability in the end?
    There is a wonderful article that I actually photocopied 
and put in, called ``Why We Are Losing the War on Cancer and 
How to Win It.'' Read that. That is what is wrong with cancer 
in the United States, and that is why the Chinese don't have 
that problem. You know, they are very practical-minded. How did 
they deliver the most to a country that is three or four times 
the size of our country, and for little money?
    Mr. Cannon. It seems to me there are probably three 
disruptive technologies or things that have happened in 
America.
    And, Dr. Karlan, I would appreciate your comments on this 
as well.
    In the first place, you are talking about DNA decoding, 
that technology and how that has plummeted in price. That is 
dramatic. I don't know how you can state how dramatic it is, 
because everything that derives from it is unanticipated. You 
never thought in terms of looking for a genetic marker for a 
disease when the cost was tens of thousands of dollars. But 
now, if you are talking about pennies, it means a different 
kind of thing; it is a whole new mind-set.
    In the second place we have what I call the Napster 
phenomenon, that is, I am a big fan of Napster, I wanted them 
to have a model where people paid. We don't want them to rob 
music. They wanted a model where they paid. But that kind of 
peer-to-peer technology is disruptive, I think it is fair to 
say. And when you add that to the other kinds of database 
technologies we have, the informatics approach, where you 
organize information, as opposed to the peer-to-peer work, 
where information organizes itself, it seems to me you have 
another two kinds of transformations.
    And then the third kind of thing that is happening is that 
as people are aware of these transformations, wholly new ways 
of viewing medical problems are arising. And those are 
principally coming, I think, from medical practitioners, but 
they are also coming from a lot of other folks, because as 
nutritionists, as dieticians, as people that like nutritional 
supplements, as drug companies look at off-label uses, you are 
getting this incredible increase.
    So you take a drug that you know the toxicity of, that may 
be very effective for one thing, and you say what are the 
molecules. And, of course, we can tell what those molecules are 
better now because of these other technologies. Then you can 
look at what the chain of reactions is within a body and do 
some significant predicting. In other words, as a derivative of 
these other things, you have this massive number of people who 
are empowered then to do creative things.
    Is it important to the two of you in particular that we 
create a data context for that to happen? And if you are aware 
enough of the difference between a database like the 
informatics database that has been testified about earlier and 
a peer-to-peer database, I would like your comments on that. 
And what else can we do to help this tide or this dam that has 
broken and now is flooding down, what else can we do to help 
that be channeled and effective for improving treatments for 
people?
    Let us start with Dr. Karlan, if you would, and then Dr. 
Rosenfeld.
    Dr. Karlan. Thank you, Mr. Chairman. I think you have 
eloquently outlined the breakthroughs, the shifts in paradigm 
that have resulted from the human genome project, and then the 
advances in informatics that allow us to look at gigabytes of 
data and suddenly see the tree and get through it and see the 
next steps forward.
    Johanna's Law, though, processes and tries to take the 
disconnect between our breakthroughs in the laboratory and what 
we see on the corner. Shoppers, come in and get your Pap smears 
now. How do we bring these advances to all of our kitchen 
tables before we get cancer? When you get cancer, then you 
start logging on, you do extensive searches.
    Mr. Cannon. Almost everybody in America uses Google. And to 
the degree you can make information available--and there are 
many forms of that--then you have the ability for people to 
educate themselves, so you don't have to suffer with four or 
five different symptoms, you go to four or five different 
doctors, and way too late you find out that you have one 
problem that is causing them all.
    Dr. Karlan. But I think Mr. Burton hit on it earlier. When 
you start to have the symptoms, when you start to have the 
problems, when you begin to ask those questions, then you go to 
Google.
    Mr. Cannon. Right. Exactly.
    Dr. Karlan. But how do you process that information? How do 
women----
    Mr. Cannon. Let me make a suggestion. I understand what you 
are saying, and I want Johanna's Law to pass. But I want some 
other transformations in the medical system, which I would like 
your opinion on, because I believe, to your point now, to the 
degree that people understand that there are transformations in 
medicine, then they will look. Mr. Burton laid it out very 
well: The problem is how do you look in the right place and 
know what you are actually looking for? But the transformations 
that derive, that is, as you see from a database, from other 
sources, new treatments and new opportunities, then people say, 
``What are my symptoms?'' And they will go back.
    So I think it is actually an iterative process. In other 
words, I am not just ignoring Johanna's Law here. I am saying, 
how do we make it all come together in a system?
    Go ahead.
    Dr. Karlan. No. Again, as we get these new technologies, a 
better basic understanding, if you would allow me, why some 
people live and others do not survive their cancer, and we 
communicate better that cancer is not a death sentence, we will 
then also open up that door.
    And I will digress, if you allow me, one moment. We did an 
outreach project in Los Angeles, in the inner city church 
system, where the pastor was very much in support of Pap 
smears, and we did see and treat; get your Pap before mass, go 
to mass, come out, have your treatment. And we published those 
data about the findings of Pap smears. It was predominantly a 
Latina population.
    Afterwards, the pastor was very interested in the women who 
did not participate; came to church every single Sunday, but 
did not partake in this problem. We did these focus groups in 
Spanish with social workers, not with the physicians 
themselves. And there was this pervasive fear of a passive 
coping mechanism of why do I want to find out if I have cancer? 
Cancer is a death sentence.
    So to your point again, informatics, genomics, targeted 
therapies, when we can better use Johanna's Law to communicate 
cancer is a curable disease--the article that you referred to. 
When we look at heart disease as the paradigm, where have we 
been able to see the death rate from heart disease plummet? It 
is because we have educated people so effectively about 
lowering your cholesterol, taking your aspirin, exercising, 
watching your weight, watching your diet.
    We need to do something similar for cancer; understand what 
we need to do to prevent it. And the way we are going to get 
that information, the way we are going to be able to roll out 
the molecular tests that are being developed is by integrating 
all these data effectively and seeing how to move forward.
    Mr. Cannon. And you struck me with what you said earlier. 
You talked about gigabytes of data. In other words, you are 
talking about big, big, big numbers or data points that you are 
crunching to identify this, which means you really have to have 
another paradigm shift, which is a paradigm toward complexity 
and toward the kind of computing that is now so cheap, that 
will allow you to sort the massive number of data points and 
come up with indicators of where we should go.
    Dr. Karlan. Yes. And thank goodness our computational 
colleague scientists, who understand Abasian theory much better 
than I myself, can put together these four-dimensional type of 
networks that allow us to look at those massive volumes of 
data.
    Mr. Cannon. We are actually looking now, as we speak, at 
trying to get funded a complexity center in Utah, which is not 
just my home State, but a place where a lot of this activity is 
going on. So I am going to take that comment as in support of a 
massive computer that would be shared by University of Utah's 
Medical Center and various other places around the country.
    We have talked a lot, but, Dr. Rosenfeld, do you want to 
followup and comment on those things?
    Dr. Rosenfeld. Yes. I actually have a couple comments. No. 
1, technologies are in place now, for example, for a lot of 
gynecologic cancers, that you could, on your way into the mall, 
literally have your finger pricked and an analysis instantly 
done. And from that analysis you could find out such things as 
ovarian status; you could find out such things as your Pap 
status, that is, whether or not you have not only HPV, but 
whether or not that has progressed to cervical dysplasia.
    Now, that goes to what Dr. Karlan was saying, and that is 
why some of these people who went to church did not 
participate. I contend a lot of them do not want to participate 
because a gynecologic examination, whether you like it or not, 
means you have to get up in stirrups, and it is very 
uncomfortable or discomforting for patients. And there is some 
good information on that.
    So if we are able to diagnose new ways, and not only new 
ways in terms of the technique, but new ways in the sense that 
you don't have to at least initially go for a gynecologic exam, 
then I think that we are going to be able to obtain much 
broader reach of people and get disease at its earliest stages.
    I will say one last thing, and that is that we can get--and 
we have done this already--we can get as little as one molecule 
and find that one molecule, which means that we can find 
disease in perhaps its earliest state. And if we find it in its 
earliest state, it is the easiest to treat.
    Mr. Cannon. Thank you.
    Mr. Burton, would you like----
    Mr. Burton. Yes, Mr. Chairman.
    Mr. Cannon. The gentleman from Indiana is recognized for 5 
minutes.
    Mr. Burton. I am sorry, I have to leave in just a few 
minutes. So I appreciate you yielding to me, Mr. Chairman.
    First of all, I was reading part of this article that you 
referred to, ``Why We Are Losing The War on Cancer and How To 
Win It.'' And I promise you I will read it all. But I wasn't 
aware that in 2004 cancer will claim or did claim some 563,700 
people. That is an amazing figure to me.
    I am glad Dr. Trimble is still here. Are you awake, doctor? 
Your eyes are closed. I just want to make sure you are still 
with us.
    The President signed a proclamation on August 29th making 
this month National Ovarian Cancer Awareness Month, and he said 
because the early signs of ovarian cancer are easy to miss and 
often resemble the signs of other conditions, it is important 
for women to talk with their doctors about detection and be 
aware of the risk factors and symptoms of this cancer. That is 
true of so many cancers, not just ovarian cancer.
    And I would like to go back to what I said to you, doctor, 
a while ago, and I am really glad you are still here. You know, 
it is one thing to come up with technical advances that will 
help in the war against cancers of various types. It is another 
thing for people to know about them. There has to be some 
balance between the technology advances and the research that 
is taking place, and the people knowing what in the world to 
do.
    It really bothers me from a personal standpoint--and, you 
know, as I said, three members of the panel have had people die 
from cancer, and we have people out here who have suffered from 
cancer or had loved ones die from cancer, and they simply 
didn't know the signs.
    There should be a significant part of the budget--we give 
our health institutions billions and billions of dollars every 
single year for research. That research amounts to nothing if 
the people who are affected by cancer don't know that it works 
and don't know how to utilize it. And you say you don't have 
money in there for public service announcements and that sort 
of thing. That is nonsense.
    I mean, if you could find that 90 percent of the people are 
going to survive more than 5 years if they know how to deal 
with their cancer and you don't tell them about it, that is 
almost criminal. In fact, I think it is criminal. Why are we 
spending these billions and billions and billions of dollars, 
and people like my wife or these other people we are talking 
about, aren't even aware of what they can do to protect 
themselves, or their doctor? Her doctor misdiagnosed her, for 
God's sake.
    I should have sued her for malpractice, but when you are in 
politics, you can't do that because it is all over the papers 
you are trying to take advantage of somebody. So we didn't do 
that. But my wife died. And everybody I have talked to said had 
she been aware of her early signs, she would be alive probably 
today, 3 years later.
    I just have to tell you--and I hope you will take this 
message back, because I was looking at your background here. 
You are the Head of the Surgery Section, Division of Cancer 
Treatment and Diagnosis at the National Cancer Institute. For 
God's sake, go back and tell them to spend some money on 
advertising and telling people what the hell is going on.
    [Applause.]
    Mr. Burton. That is what Johanna's Law is all about, and 
that is why I am glad we are having this hearing today. And I 
wish there were a lot more Members of Congress here. But to do 
all this research and spend all these billions and billions of 
dollars--I don't want to beat a dead horse--and to not have 
public service announcements so people know that bloating and 
constipation, bleeding, and different kinds of things are signs 
of some form of cancer so they can go get checked out, it just 
boggles my mind.
    You know, there just has to be some balance there. So we 
have talked about, just a minute ago, maybe introducing a 
resolution, a congressional resolution saying that the National 
Institutes of Health and National Cancer Institute should spend 
a certain percentage of their budget on advertising so people 
are aware of the various kinds of cancer they may be subject 
to.
    [Applause.]
    Mr. Burton. And I think we will probably introduce that 
legislation, but it is unnecessary, because all you guys have 
to do over there is say, hey, look, we have to make sure the 
public is informed.
    And I want to tell you, in my district right now we did 
some public service announcements this week about the 
hurricane, and every television station was very anxious to put 
on public service announcements informing people what was 
available to them to help them survive. And with 563,000 people 
dying in 1 year from cancer, you would think we would spend 
part of our budget telling them what it is all about, 
especially since we are doing all this research.
    Anyhow, that is all I have to say, Mr. Chairman, except I 
do want to say one thing that is a little bit humorous. Your 
curriculum vitae, Doctor, is very impressive, but it is nothing 
compared to the woman sitting right next to you. She has got 33 
pages, and that is only since 1999. I am so impressed with you. 
Are you married?
    Dr. Karlan. Twenty-five years.
    Mr. Burton. I am just teasing. You tell your husband he is 
very lucky to have such an intelligent woman at his side. I 
understand he is a psychologist, too.
    But let me just say, Mr. Chairman, I really appreciate your 
giving me the time to do this. And I hope that the people at 
our health agencies and the National Cancer Institute will take 
this to heart. Spend some money on telling people. And if you 
do public service announcements, just get them produced. Get an 
ad agency to produce them. I promise you, you get them to me in 
Indiana, they will be shown. I will get them shown. You just 
get them produced. Thank you.
    Mr. Cannon. The gentleman yields back. Thank you for your 
comments.
    Mr. Issa, did you have questions?
    Mr. Issa. Yes, Mr. Chairman.
    Mr. Cannon. The gentleman is recognized for 5 minutes.
    Mr. Issa. Thank you, Mr. Chairman.
    Dr. Rosenfeld, you talked about the pin prick blood test. 
How much is that per each examination?
    Dr. Rosenfeld. Right now, the pin prick, just so you 
understand what it is, Congressman Cannon had referred earlier 
to an immune or protein test for cervical disease, and we have 
one actually working now. Our actual cost of doing it at the 
moment--realize that we haven't gone through the FDA hurdle. 
And, by the way, it is $802 million, on average, for a drug or 
tests, not three-quarters of a billion. So it is even higher.
    Mr. Issa. I have been in Congress for 5 years, so that is 
about how far out of date I am on all my facts.
    Dr. Rosenfeld. Oh. But, anyway, it is costing us 14 cents.
    Mr. Issa. What is it going to cost the patient if it 
becomes FDA approved?
    Dr. Rosenfeld. Well, in our discussions we are hoping a 
couple bucks, literally. Again, realize that everything I do 
centers around low resource settings, so that my eye is on the 
economy.
    Mr. Issa. I appreciate that. That sounds very promising, 
and we look forward to--it is too bad we lost our FDA guy. We 
really could have put him on the spot on that one.
    Dr. Karlan, California is sort of the starting home of 
HMOs, and health maintenance organizations were designed to do 
things early, provide care early in order to spend less money, 
and the theory was that you actually got less expensive health 
care by doing certain things early.
    How do you accomplish that in the--let me back up a little. 
In order to accomplish that, which is a truism, I think, that 
we all understand from the last couple of hours here, in 
gynecological cancer, how can we take the dollars that we are 
authorizing in this bill and leverage those in public-private 
partnerships to get that effect?
    Dr. Karlan. As you said, we have a lot of experience with 
the prepaid health care system in California, and I go back to 
Mr. Burton's impassioned words a few moments ago: we need to 
get the message out there. There was a recent study published a 
few months ago in the Journal of the National Cancer Institute 
looking within the Kaiser system.
    They looked at specifically cervix cancer, and they looked 
at women in the Kaiser system who had access to paid health 
care, and if they had Pap smears in the 4 to 12 months prior to 
the diagnosis of cervix cancer. About two-thirds of them had 
been in the system. Eighty percent of them had actually come in 
for an outpatient visit three times or more and did not get a 
Pap smear.
    So I guess my comment about public service announcements, 
getting the information out there, new technologies is what 
they call inreach. Instead of outreach, inreach assessment. 
When you come in for your vision care--because you look at 
where gynecologic cancers hit in women, let us say, in the 
perimenopause, menopause, and older, and you say what types of 
needs are those women accessing the health care for, and remind 
them to get a Pap smear. At Kaiser it is almost a four vital 
sign. When you go in to get your prescription checked, they 
will ask you, ``Here is information about gynecologic care, 
have you had your Pap smear?''
    There has to be this access, this education of both the 
women as well as health care providers. I think we have heard 
over and over again ob-gyns are more likely to think about 
gynecologic cancers, but so many women, especially after they 
finish childbearing, their primary care physicians are not 
their obstetrician-gynecologist, and they may go misdiagnosed 
for months to years.
    There was recently a study published out of California 
looking at the Medicare records, and those women who were 
diagnosed with ovarian cancer--and they looked at their doctor 
visits in the 4 to 12 months prior to the diagnosis of ovarian 
cancer, and 40 percent of them went to the doctor. Forty 
percent of women with ovarian cancer went to the doctor 4 to 12 
months before their diagnosis with a complaint of one of the 
main symptoms, bloating, abdominal, low back pain, or 
constipation, and never had it worked up. So that is an 
enormous impact we can make right there.
    Lower cost. If you make an early diagnosis, costs a lot 
less to cure someone with stage 1 disease. And then not only 
the financial cost, the human cost: they live a full life, they 
are cured of their disease.
    Kolleen was very brave today both to come here and to take 
the time to share with us her story. If she was diagnosed at 
stage one, it would have been 8 years ago, she would have been 
cured.
    So I think that is an enormous way to lower cost: find them 
early; we don't have to pay for the lengthy treatments. And for 
that we do need continued research, continued focus on newer 
technologies.
    Mr. Issa. Mr. Chairman, I will put most of the rest of my 
questions in for the witnesses to answer, but could I ask just 
one more on the record?
    Mr. Cannon. Certainly.
    Mr. Issa. Thank you, Mr. Chairman.
    Dr. Karlan, you and I, as Californians, but you as a health 
care professional, have been in California during this entire 
period after we mandated a woman's right to get to an Ob-Gyn 
directly. Can you give me--because even though it is not in 
this law, but it is an area of concern--how much has it 
accomplished? It was very controversial at the time.
    General practitioners, among others, said, ``Hey, we can 
handle this, we can handle the referral; we can prescreen.'' 
And, of course, the HMO--which used to be a nice word and now 
is pejorative normally--fought it, but it became law. How has 
that impacted in California, for the benefit of those who may 
be in States that don't have this?
    Dr. Karlan. The legislation that Mr. Issa is referring to, 
of course, is that every woman in the State of California has 
the right to see her obstetrician-gynecologist as her primary 
health care provider. And I will have to go back and look at 
actual numbers, because I don't know how it has enhanced the 
use of mammography screening, Pap smear screening, and early 
detection, because those would be the benchmarks that I would 
look at. We know that obstetrician-gynecologists are more 
cognizant of those screening practices.
    I think when we look at the roll-out of Johanna's Law and 
making sure that we get the right information into women's 
hands before they have symptoms, I think that opportunity in 
California, that when you come in for your prenatal care there 
is information already out there, that while you are sitting 
there waiting in doctors' offices it is inevitable, that these 
are things, and whether it is a PSA loop, I mean, there are 
many ways people learn, whether it is visually, auditory, or 
the written word that we can use that opportunity by working 
with the American College of Ob-Gyn, the Society of Gynecologic 
Oncologists and its foundation, the Gynecologic Cancer 
Foundation can help put together the messaging that would be 
the ability to be accessed.
    But I don't have actual benchmark numbers, to answer the 
question, at this time, but I will look into getting that for 
you.
    Mr. Cannon. Thank you. The gentleman yields back.
    Let me just wrap up, and after I go through a list of 
things, if any of the panel members want to comment, I would 
appreciate that.
    It seems to me that we have come to the conclusion that 
there are some disruptive technologies. I have described them 
as protein decoding, cost declining dramatically, and as 
databases with the capability of making information available 
in either the structured form like the informatics kind of 
database or the peer-to-peer kinds of databases. And then, 
finally, those two things lead us to a point where scientists 
and MDs and other people can be freed to be innovators because 
they have more information available to innovate.
    We have other things going on in the world today that I 
think are important as it relates. For instance, we have the 
availability of information. NIH just withdrew a rule that 
would require federally funded research to be available 
publicly. I suspect what we need to do there is--and the reason 
they did that is because the publishers of those journals had 
to pay the cost of preparation.
    So what we probably need to do is increase the Federal 
funding for research to include the cost of publication so 
those publications can be made available. And then hopefully a 
Napster type micropayment system could be set up so that they 
can make money on selling their information and people in 
America and worldwide have the ability to access that 
information.
    In addition, we need a kind of patient information 
environment where a patient can make--and this is what the CDC 
is working on, and Secretary Leavitt at HHS--his information 
available, subject to certain rules, to certain types of 
people, M.D.s and scientists, so that it is a controlled 
environment. That is just a technological breakthrough that we 
need and we need to put in place. In fact, I mentioned there is 
a company in Utah that is doing that called NexLight.
    I think, in addition to that, Dr. Karlan, you were talking 
about the gigabytes. You need the kind of computers to drive 
the issue so that you can come up to, even in the cases of an 
individual who may have a problem, to go through gigabytes of 
data to come up with the data points that may help him is well 
within our reach. The cost of supercomputing has plummeted, but 
we need to probably focus on a center for complexity studies 
that would provide that kind of availability.
    Finally, we need public awareness so that people can 
identify their problems and then, in my view, in addition to 
that, drill down themselves to find out the kind of information 
that would be available in this world where we make information 
available so that an individual can find more and more about 
his or her particular problems.
    And in that world of changes that have happened around us 
or that need to happen, it seems to me that the FDA needs to 
come up with new processes to accommodate how we do that. That 
means physicians need to have the ability to treat patients 
with best practices that they learn online; they need to be 
able to innovate and come up with, based upon their own 
analysis and based upon a context rich in information and rich 
in analysis, they need to be able to come up with their own 
innovations; and they have to be able to do that relatively 
quickly so that their individual patients can be treated as 
opposed to creating protocols and tests that were fine in an 
earlier time.
    Because when you have an $800,000 to $1 million cost for a 
new drug, that means you have massive interests who all have a 
huge reason to keep the threshold high and to keep alternatives 
that may be cheaper, that may be more readily available, that 
may be innovated by a doctor with access to information. You 
want to keep those people out, you want to keep the thresholds 
up. And what that means is worse health for Americans, worse 
health for people all over the world, a stifling of creativity 
instead of an improved safety. And safety was the purpose of 
the FDA at a time when we were doing a lot of guessing.
    And I think, Dr. Karlan, you were talking about following 
the chain of reactions that a protein causes. We know a lot 
about those chains, and in a complex environment where we have 
lots of information, we can have much better guessing. So the 
nature of what FDA does has to change. The nature of what the 
National Cancer Institute does has to change. The nature of 
what NIH does and the CDC does all have to change to 
accommodate these disruptive technologies.
    I want to thank you all for being here. The suffering 
caused by cancer is phenomenal and personal, and I appreciate 
the roles that you all have played in this hearing today and in 
the cause of transforming our system so that we get the kind of 
treatments we deserve in America. Thank you all for being here.
    The committee is now adjourned.
    [Whereupon, at 2:10 p.m., the subcommittee was adjourned.]
    [Additional information submitted for the hearing record 
follows:]

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