[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]



 
      NCI CANCER RESEARCH: TODAY'S PROGRESS; TOMORROW'S CHALLENGES

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             SECOND SESSION

                               __________

                             MARCH 23, 2010

                               __________

                           Serial No. 111-108


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov


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                    COMMITTEE ON ENERGY AND COMMERCE

                 HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan            JOE BARTON, Texas
  Chairman Emeritus                    Ranking Member
EDWARD J. MARKEY, Massachusetts      RALPH M. HALL, Texas
RICK BOUCHER, Virginia               FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
BART GORDON, Tennessee               NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois              ED WHITFIELD, Kentucky
ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
BART STUPAK, Michigan                JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York             ROY BLUNT, Missouri
GENE GREEN, Texas                    STEVE BUYER, Indiana
DIANA DeGETTE, Colorado              GEORGE RADANOVICH, California
  Vice Chairman                      JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California               MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania       GREG WALDEN, Oregon
JANE HARMAN, California              LEE TERRY, Nebraska
TOM ALLEN, Maine                     MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois       SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas           JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington               TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin             MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas                  MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York          PHIL GINGREY, Georgia
JIM MATHESON, Utah                   STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin 
    Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE BRALEY, Iowa
PETER WELCH, Vermont
                         Subcommittee on Health

                FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan            NATHAN DEAL, Georgia,
BART GORDON, Tennessee                   Ranking Member
ANNA G. ESHOO, California            RALPH M. HALL, Texas
ELIOT L. ENGEL, New York             BARBARA CUBIN, Wyoming
GENE GREEN, Texas                    JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado              STEVE BUYER, Indiana
LOIS CAPPS, California               JOSEPH R. PITTS, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois       MARY BONO MACK, California
TAMMY BALDWIN, Wisconsin             MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas                  MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York          SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah                   JOHN SULLIVAN, Oklahoma
JANE HARMAN, California              TIM MURPHY, Pennsylvania
CHARLES A. GONZALEZ, Texas           MICHAEL C. BURGESS, Texas
JOHN BARROW, Georgia
DONNA M. CHRISTENSEN, Virgin 
    Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     1
Hon. Donna M. Christensen, a Representative in Congress from the 
  Virgin Islands, opening statement..............................     9
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, prepared statement......................................    11
Hon. Zachary T. Space, a Representative in Congress from the 
  State of Ohio, opening statement...............................    15
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, prepared statement..............................    19
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, prepared statement......................................    24
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, prepared statement.........................   116

                               Witnesses

Anna D. Barker, Ph.D., Deputy Director, National Cancer Institute    27
    Prepared statement...........................................    31
    Answers to submitted questions...............................   129
Kristin Fitzgerald, Naperville, Illinois.........................    63
    Prepared statement...........................................    66
Megan Gordon Don, M.H.S., Chair, Deadly Cancer Coalition, 
  Director of Government Affairs, Pancreatic Cancer Action 
  Network........................................................    74
    Prepared statement...........................................    77
    Answers to submitted questions...............................   137
Robert S. DiPaola, M.D., Member, American Association of Cancer 
  Research, and Director, Cancer Institute of New Jersey.........    86
    Prepared statement...........................................    88
    Answers to submitted questions...............................   139
Jeff Allen, Ph.D., Executive Director, Friends of Cancer Research    94
    Prepared statement...........................................    96
    Answers to submitted questions...............................   143

                           Submitted Material

Statement of the International Myeloma Foundation, submitted by 
  Ms. Capps......................................................     4
Statement of the Lung Cancer Alliance............................   118
Statement of the Association of American Cancer Institutes.......   124


      NCI CANCER RESEARCH: TODAY'S PROGRESS; TOMORROW'S CHALLENGES

                              ----------                              


                        TUESDAY, MARCH 23, 2010

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The Subcommittee met, pursuant to call, at 2:05 p.m., in 
Room 2322 of the Rayburn House Office Building, Hon. Frank 
Pallone, Jr. [Chairman of the Subcommittee] presiding.
    Members present: Representatives Pallone, Eshoo, Green, 
Capps, Schakowsky, Baldwin, Christensen, Castor, Space, Waxman 
(ex officio), Shimkus, Buyer, Burgess, Gingrey and Barton (ex 
officio).
    Also present: Representative Biggert.
    Staff present: Sarah Despres, Public Health Counsel; Anne 
Morris, Professional Staff; Stephen Cha, Professional Staff; 
Alvin Banks, Special Assistant; Aarti Shah, Minority 
Professional Staff; Clay Alspach, Minority Counsel; and Ryan 
Long, Minority Professional Staff.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. I call the hearing to order.
    Let me mention that votes were just called, so we will try 
to do--maybe we will see if we can get in the three people that 
are here, or at least myself and Mr. Shimkus, and then we will 
have to take a break and come back.
    But let me say today, as you know, we are having a hearing 
on NCI Research: Today's Progress; Tomorrow's Challenge, and 
basically examining the cancer research efforts at the National 
Cancer Institute. It is a very important topic that is of great 
interest to many of my colleagues. Many of my colleagues have 
been asking us to have this hearing for some time.
    Cancer is an ugly word. It is an even uglier disease. 
Unfortunately, cancer touches us all and everyone in this room 
has had either direct or indirect contact with cancer. Either a 
mother, a father, a brother, a sister, in almost all cases a 
friend has been diagnosed with some form of cancer. And some 
have fought the odds and survived. Others tragically have lost 
the battle. The bottom line is, far too many of us have lost 
people we care deeply about to this horrible illness. Cancer is 
the second leading cause of death in the United States. In 
fact, it accounts for almost every one in four deaths. Half of 
all men and one-third of all women will develop cancer during 
their lifetimes, and today, millions of people are living with 
cancer or have had cancer.
    The issue is a very emotional and personal one for me. In 
the spring of 2008, my mother was diagnosed with pancreatic 
cancer, and she passed away late that same year. Pancreatic 
cancer is obviously one of the diseases that we are looking at 
today in particular.
    Fortunately, we have made great progress in cancer research 
over the last decades. Just 40 years ago, there were only 3 
million cancer survivors. Today, 3 percent of the U.S. 
population has survived cancer. We have new therapies that 
specifically target the malignant tumors in an attempt to 
lessen the impact of the therapy on the patients. We have 
better screening and early detection methods which help 
identify cancer in the stages when it is more successfully 
treatable.
    With the support of Congressional efforts over the next 2 
years, NCI will grant $1.3 billion to cancer researchers across 
the country, and this money will go to fund additional grants 
for first-time investigators, thereby providing additional 
opportunities for the next generation of investigators and 
ensuring that the pipeline for new researchers remains stable. 
This additional funding will also go to initiatives that are 
expected to propel us forward in our understanding of cancer in 
the near future including efforts on the cancer genome atlas. I 
want to find out more about that today obviously. Also, 
research on personalized cancer care and new therapy 
development, collaborative cancer care work, just to name a 
few.
    Nevertheless, we face serious challenges regarding rare and 
deadly cancers. Cancers that have been termed the deadliest 
cancers have a 5-year survival rate of less than 50 percent. 
These cancers include ovary, brain, myeloma, stomach, 
esophagus, lung, liver and, of course, pancreas. Pancreatic 
cancer is the deadliest cancer with a 5-year survival rate of 
only 5 percent. Combined, the deadly cancers make up half of 
all cancer deaths yet they receive a fraction of the research 
funding as compared to other cancers. It is clear that we still 
know far too little about these cancers. We have no or limited 
early detection and screening. By the time one of these cancers 
is diagnosed, it has often progressed too far for treatment to 
be successful. And I know some of our witnesses here today will 
speak to these issues and we look forward to their comments and 
recommendations.
    As I think you know, we are a legislative subcommittee and 
so when we have oversight hearings like this, they are designed 
to try to see whether we should be legislating, so I want 
everyone to keep that in mind in terms of their recommendations 
as we move forward today.
    Mr. Pallone. And now I would like to recognize our ranking 
member, Mr. Shimkus.
    Mr. Shimkus. Thank you, Chairman Pallone, for holding this 
important hearing about the progress and the challenges we face 
in tracking rare forms of cancer.
    I want to thank all the witnesses for being here today to 
help educate members on this issue.
    I have long been a supporter of cancer research but my 
former legislative director, Ray Fitzgerald's, battle with 
gastric cancer brought this issue much closer to my heart. As 
Chairman Pallone said, everybody has personal stories and 
experiences.
    I want to thank Ray's wife, Kristin, and their three young 
girls, Nora, Maggie and Lucy, who I think are hiding somewhere 
not disrupting--oh, they are back there--for testifying before 
the committee today. They were an inspiration to me and many 
others as they publicly shared the highs and lows of Ray's 
cancer. Kristin has continued to work tirelessly to expand 
efforts in the field of gastric cancer. I know her knowledge on 
the subject here today will help the committee advance efforts 
in that area. Also just for the record, she is a former 
congressional staffer, having worked for Harris Faywall, who is 
well known in the health legislative area, Judy Biggert and now 
our Republican leader, John Boehner. I also would like to thank 
Dr. Barker for being here today from the National Cancer 
Institute. I commend you and the NCI on the many things you do 
to make cancer curable, and I look forward to your 
institutional knowledge on what we can do from the federal side 
to progress our efforts in research on rare forms of cancer.
    With that, Mr. Chairman, I yield back my time.
    Mr. Pallone. Thank you, Mr. Shimkus.
    I think we have time for Mr. Gingrey, the gentleman from 
Georgia.
    Mr. Gingrey. Mr. Chairman, I will waive my opening.
    Mr. Pallone. You want to waive? OK.
    Ms. Capps, our vice chair.
    Mrs. Capps. Thank you, Mr. Chairman. Before I make a brief 
statement, I wish to insert for the record written testimony of 
the International Myeloma Foundation regarding NCI Cancer 
Research: Today's Progress, Tomorrow's Challenges.
    [The information follows:]

    [GRAPHIC] [TIFF OMITTED] T6020A.001
    
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    [GRAPHIC] [TIFF OMITTED] T6020A.004
    
    Mr. Pallone. Without objection, so ordered.
    Let me--it has been very busy and crazy around here the 
last few days so I overlooked, and I do want to mention that 
not only is Lois Capps our vice chair and one of the hardest 
working members of this subcommittee but also she has taken a 
particular interest in this subject, asked that we have this 
hearing today, and I think is also developing legislation----
    Mrs. Capps. Yes.
    Mr. Pallone [continuing]. On some of this, so thank you.
    Mrs. Capps. Thank you, Mr. Chairman, and thank you to our 
witnesses and to all of you for being here.
    It is so appropriate in my opinion that we are holding this 
particular hearing just 2 days after our historic passage of 
comprehensive health reform legislation. After all, while our 
witnesses today will be able to highlight just how advanced and 
cutting-edge cancer research is in the United States, now 
passage of legislation will finally mean that more American 
patients can take advantage of the treatment and the therapies 
that you all have developed.
    I am eager to learn from our witnesses today about the 
direction of cancer research and how we can develop better 
policies in Congress that mesh with the work that you are 
doing. I think we know now that collaboration is key and it is 
important that legislation and funding are geared toward 
facilitating collaboration.
    We also know that research is incomplete unless we also 
include research on best practices for providing cancer care in 
the clinical setting. I am particularly interested in that 
phase of it, but I see it as a collaboration with what you are 
doing. While it isn't the focus of today's hearing, I urge the 
chairman to consider holding a hearing in the near future to 
discuss this issue of cancer care as well.
    With the passage of health reform, a lot of us are getting 
back to our other health care priorities that we have held 
long, and this is one of mine. I am proud to be working with 
Chairman Pallone and several members of this committee to 
prepare a House companion to one of Senator Ted Kennedy's 
priorities, the 21st Century Cancer ALERT Act. This bill will 
put emphasis on enabling federal research dollars to model the 
trends of modern cancer research. Additionally, it will focus 
on patients as survivors and the concept of living with cancer. 
With the right types of investment, we can truly put an end to 
the days of cancer as a death sentence as it has been for so 
many of our loved ones.
    I look forward to continuing to work with the committee to 
advance this legislation, and I hope we can use what we learn 
today to perfect the language that we are developing, and with 
that, I yield back, Mr. Chairman.
    Mr. Pallone. I think, Mr. Buyer, there is maybe 3 or 4 
minutes left. Do you want to go now or would you rather----
    Mr. Buyer. I will reserve.
    Mr. Pallone. OK. Then we will go in recess until we have--
oh, Donna, did you want to do your statement? The gentlewoman 
from the Virgin Islands, Mrs. Christensen.

       OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A 
       REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS

    Mrs. Christensen. Thank you, Chairman Pallone and Ranking 
Member Shimkus. Thank you for holding this hearing.
    You know, there is not one of us here whose life has not 
been touched by cancer, and in my 21 years of practice, my 
patients with cancer have given me some of the highest highs, 
like an elderly lady with early-found colon cancer who is still 
surviving many years later, and some of the lowest lows such as 
women with breast cancer who came so very late that nothing 
could be done, and African Americans, while we may not have the 
highest incidence of many cancers, have the shortest survival 
rates and the highest deaths of any other population group in 
this country and so this hearing is very important to me 
personally and as chair of the Congressional Black Caucus's 
Health Brain Trust. If we look at some other population groups, 
cancer has already surpassed heart disease as a leading cause 
of death for Asian Americans and Pacific Islanders.
    There has been a lot of progress that we are very proud of 
in cancer research at the National Cancer Institute, and all of 
NIH is to be commended for the transdisciplinary programs, the 
linking of genomics and cancer and advances in molecular 
biology and technologies. I don't know where the balance should 
be but I do hope that the role of environmental and behaviors 
is given adequate attention as well.
    Of great concern given the disparities that exist in 
African American and the projections for even greater incidence 
of cancer in the future is how are we going to be able to 
ensure that the new diagnostic and treatment modalities reach 
everyone and reduce rather than exacerbate the disparities that 
now exist. So I would like to know what progress is being made 
and including racial ethnic minorities and women adequately in 
clinical trials, and just as important, how many principal 
investigators are at minority-serving institutions, which is 
what would really help to increase our participation, which is 
very critical to reducing the longstanding disparities.
    I would like to welcome you, Dr. Barker, and the other 
panelists on the second panel. We look forward to your 
testimonies. Thank you.
    Mr. Pallone. Thank you, Dr. Christensen.
    So we will now recess, and I think there are three votes so 
I guess maybe 45 minutes, maybe less. The subcommittee hearing 
is in recess.
    [Recess.]
    Mr. Pallone. The subcommittee will reconvene. Now, I know 
that there were some that did not have a chance to do openings 
so we will have that now for those of you who didn't. I think 
next was the gentlewoman from Florida, Ms. Castor.
    Ms. Castor. In the interest of time, I would really like to 
hear the witnesses so I will submit my opening statement for 
the record. Thank you, Mr. Chairman.
    [The information was unavailable at the time of printing.]
    Mr. Pallone. Thank you.
    The gentleman from Texas, our ranking member.
    Mr. Barton. Mr. Chairman, I will put my statement in the 
record. I agree, we need to get to the witness, but thank you 
for giving me the opportunity.
    [The prepared statement of Mr. Barton follows:]

    [GRAPHIC] [TIFF OMITTED] T6020A.005
    
    [GRAPHIC] [TIFF OMITTED] T6020A.006
    
    [GRAPHIC] [TIFF OMITTED] T6020A.007
    
    Mr. Pallone. Thank you.
    Ms. Eshoo.
    Ms. Eshoo. Thank you, Mr. Chairman. I will put my full 
statement in the record, but let me thank you for having this 
hearing today.
    I am pleased that our subcommittee has the stamina to push 
forward, especially on this important hearing because cancer is 
the second leading cause of death in our country, and it is 
really amongst the most dreaded words that anyone can ever 
hear. Everyone in this room and beyond this room has been 
affected by this disease in some way, shape or form, either 
themselves, someone in their family, a colleague, a child, a 
grandparent, an aunt, an uncle, a neighbor. So really, so many 
of us, I believe, we are all like one diagnosis away from 
something.
    There are several bills, Mr. Chairman, that members have 
authored in the committee, and what I would urge you to do is 
to put together a compendium of these bills from both sides of 
the aisle and really see what we can move in this Congress. 
Sometimes bills don't have to be gigantic to really have an 
impact, especially in a specific area. So----
    Mr. Pallone. Would the gentlewoman yield?
    Ms. Eshoo. Certainly.
    Mr. Pallone. Let me just mention that--I mean, not that we 
are making excuses but as you know, there was so much of the 
legislation that many of you have introduced on both sides of 
the aisle was either in the health care reform or impacted by 
the health care reform, and I think what we are going to do 
during the break, you know, the 2 weeks, is to try to sift 
through all that and see what is still relevant and not 
included in the bill, you know, once we go through 
reconciliation and then get back to all of you and say, OK, 
these are the things that we need to consider now between now 
and the end of the session.
    Ms. Eshoo. That would really be wonderful, Mr. Chairman. 
Thank you.
    And I just want to add how proud I am that in my 
Congressional district that we have a National Cancer 
Institute-designated cancer center at Stanford University and 
the work is really extraordinary, so the investments in this 
are amongst the best we can make as a society.
    I look forward to hearing from the witnesses and thank all 
the people that have been advocates for years and years and 
years. Hang in there. We all need each other and we have got to 
get more done on this. Thank you.
    [The information was unavailable at the time of printing]
    Mr. Pallone. I thank the gentlewoman.
    The gentleman from Ohio, Mr. Space.
    Mr. Space. Thank you, Mr. Chairman. I too waive my oral 
statement orally and submit it for the record.
    [The prepared statement of Mr. Space follows:]

    [GRAPHIC] [TIFF OMITTED] T6020A.008
    
    [GRAPHIC] [TIFF OMITTED] T6020A.009
    
    Mr. Pallone. Thank you, and I think that concludes our 
opening statements. Did you want to say something?
    Mr. Shimkus. Mr. Chairman, I ask unanimous consent that 
Congresswoman Judy Biggert be allowed to make an introduction 
of a former staffer on the second panel, and Judy.
    Mr. Pallone. Without objection, so ordered.
    Ms. Biggert. Thank you, Chairman Pallone, and Ranking 
Member Shimkus for giving me this opportunity to address the 
subcommittee. I am honored to introduce to the subcommittee 
today Kristin Fitzgerald, who not only is a constituent of mine 
from Naperville, Illinois, but she is also a valued former 
member of my staff and the staff of the Education and 
Workforce, now the Labor Committee. But it is not Kristin's 
expertise as an outstanding Congressional staff member that 
brings her to this subcommittee today. Rather, it is her 
experience in seeking treatment and a cure for a rare cancer 
that afflicted her late husband and dear friend of mine and 
Ranking Member Shimkus, Ray Fitzgerald. Kristin kept me, Mr. 
Shimkus and the rest of us on Capitol Hill informed via daily 
e-mails as to what was happening with her husband's treatment, 
and we felt like we were able to be with her every day during 
that difficult time. Unfortunately, just over a year ago, Ray 
passed away from gastric cancer a mere six months after he was 
diagnosed.
    After seeing firsthand the strengths and weaknesses of the 
cancer treatment system here in America, Kristin has used her 
knowledge of government to advocate for improvements in the 
dissemination of best practices at the NCI and other research 
facilities across the country. I believe that her ideas have 
the power to speed cancer research by better leveraging and 
coordinating our current efforts. Given the excellent work that 
she did in my staff, I have no doubt that she is up to the 
task. And with that, I would yield back.
    Mr. Pallone. Thank you. Kristin is actually going to be on 
our second panel.
    Before we go to our witnesses, though, let me just mention 
that our chairman, Chairman Waxman here is here, and if he 
would like to give an opening statement, we haven't begun with 
the witnesses yet.
    Mr. Waxman. Thank you very much, Mr. Chairman. I thank you 
for holding this hearing and giving us the opportunity to hear 
from the National Cancer Institute and other witnesses about 
the Institution's cancer research efforts.
    Cancer is a complex disease. We know that genetic, 
environmental and other factors all contribute to an 
individual's risk for developing cancer, so discovering cures 
and developing effective treatments are complex, difficult and 
expensive endeavors as well. We have made tremendous progress 
in reducing cancer deaths and new cancer cases due in large 
part to scientific advances over the last decade. However, 
cancer remains the second leading cause of death in this 
country and may soon overtake heart disease as the Nation's 
number one killer. One and a half million people are diagnosed 
with cancer each year. Eleven million people are cancer 
survivors. Cancer is particularly devastating for members of 
certain communities. Racial and ethnic minorities experience 
disproportionately high rates of cancer cases and death. All 
these individuals, their families and friends know all too well 
the tremendous physical, emotional and financial toll of this 
disease.
    In the past 5 years, we have made strides in combating 
certain forms of cancer such as breast and cervical cancer. 
Other cancers pose new challenges. For example, while 
colorectal cancer rates have decreased overall, the number of 
people under 50 with this type of cancer is on the rise, and 
eight types of cancer, those that we often don't hear much 
about, account for half of all cancer deaths. I know these so-
called deadly cancers are of particular interest to the 
chairman, Mr. Shimkus and other members of the subcommittee.
    Today we have an opportunity to learn more about cancer 
research conducted and supported by the NCI to better 
understand where we are and where we hope to go in making 
advances to beat this terrible disease. This research spans the 
continuum of discoveries starting at the laboratory bench, then 
translating scientific breakthroughs into clinical application 
and finally testing for safety and efficacy to determine if new 
innovations really work at the patient's bedside.
    In every regard and throughout the world, NCI is considered 
the preeminent institution for biomedical research on cancer. 
The research funded by NCI will enable us to discover and 
ultimately deliver the best possible prevention, detection, 
diagnosis and treatment tools to all Americans. As we will 
hear, there is much to be excited about and, of course, there 
remains much work to do. I want to thank Dr. Barker and all of 
our witnesses for being here today, and I look forward to their 
testimony. Thank you.
    [The prepared statement of Mr. Waxman follows:]

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    Mr. Pallone. Thank you, Chairman Waxman.
    Mr. Green, would you like to make an opening?
    Mr. Green. Thank you, Mr. Chairman, and I would like to 
have my full statement in the record, but I can't get away 
without--I represent a district in Houston and we have there 
great NCI facilities at the University of Texas, Health Science 
Center, Baylor College of Medicine and of course the University 
of Texas M.D. Anderson Cancer Center. I thank NCI for what you 
are doing because I see it every day when I am home, so thank 
you.
    I ask unanimous consent to place my full statement in the 
record.
    [The prepared statement of Mr. Green follows:]

    [GRAPHIC] [TIFF OMITTED] T6020A.014
    
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    [GRAPHIC] [TIFF OMITTED] T6020A.016
    
    Mr. Pallone. Without objection, so ordered. And all 
statements by members in full will be put in the record if they 
so desire.
    Let me move to our first panel and only witness, who is Dr. 
Anna D. Barker, deputy director of the National Cancer 
Institute. Welcome, and thank you for being here today. I am 
not going to go through the drill. You know how we operate, so 
I recognize you for an opening statement.

 STATEMENT OF ANNA D. BARKER, PH.D., DEPUTY DIRECTOR, NATIONAL 
                        CANCER INSTITUTE

    Ms. Barker. Thank you very much, Mr. Chairman and members 
of the subcommittee. It is my great pleasure to be here, and I 
want to thank you for the opportunity to testify today and for 
holding this hearing. The timing couldn't be more appropriate, 
I think.
    I am the deputy director of the National Cancer Institute. 
I also have the singular pleasure actually of directing the 
strategic science initiatives for the Cancer Institute, and I 
will be talking about a couple of those today that I think you 
will find of some interest. It is really an exciting time in 
cancer research, as you heard earlier today. I would like to 
highlight a few of the advances in my testimony today and we 
can discuss them later, but I think we have unprecedented 
opportunities now to really increase progress against this 
disease that still tragically affects almost all of us in one 
way or another.
    So an unprecedented convergence of advances in molecular 
biology and advanced technologies is beginning to transform our 
understanding of the mechanisms of cancer, and that is 
incredibly important. Cancer is a disease of changes in our 
genes, so if I don't deliver any other message today, maybe we 
can take that away. Some of these genes are inherited. You 
can't choose your parents. But some of them, actually most of 
them are actually acquired as a consequence of the way we lives 
our lives. As you will hear, we are systematically identifying 
these genomic changes in cancer, which is allowing us to 
finally identify the molecular basis of subclasses of cancer 
and develop targeted interventions. That is quite a step.
    These discoveries really represent a paradigm shift. It 
will take time but knowing the molecular makeup of a cancer 
will allow a patient to be treated according to their tumor's 
signature. As the cost of sequencing the human genome continues 
to fall, and it is falling almost daily, and bioinformatics 
facilitates the availability of an electronic medical record 
that captures all of a patient's data in this next decade, and 
beyond, we are going to transform the way cancer is diagnosed, 
treated and prevented.
    NCI is leading this revolution through programs that range 
from studies that define specific changes in the genomes of 
cancer patients to nanotechnology-based diagnostics that can 
detect miniscule amounts of cancer in a patient. I would like 
to tell you a little bit about a few of these programs in this 
limited time that I have, but I think the programs I am going 
to tell you about will change our definition of cancer, allow 
us to better understand why certain cancers have poor outcomes 
and provide new approaches to control all cancers.
    Led by Dr. Francis Collins and myself in 2005, the NCI and 
the NHGRI, which is the National Human Genome Research 
Institute, launched a groundbreaking collaboration called The 
Cancer Genome Atlas--I will refer to it from now as TCGA, which 
you should remember--to ultimately identify and catalog all of 
the relevant genomic changes in most types of cancer. This is 
an enormous undertaking. The Cancer Genome Atlas is one of 
those paradigm-shifting programs that I mentioned earlier. It 
employs state-of-the-art genomic characterization and 
sequencing technologies, engages a network of multidisciplinary 
centers, which is actually composed of tens of institutions and 
hundreds of experts in genomics in cancer biology and deposits 
all of the data in a public database. TCGA is the largest and 
most comprehensive analysis of the molecular basis of cancer 
ever undertaken and the project has already faced and overcome 
a large number of technical and scientific challenges in the 
first three years.
    We launched TCGA with a study of glioblastoma, which is the 
most prevalent human brain tumor in adults, and ovarian cancer 
and squamous cell cancer of the lung had followed soon 
thereafter. In 2008, the first major results of the TCGA pilot 
program produced a map of these three key pathways that are 
disrupted in GBM and defined the four specific molecular 
subtypes of this cancer, paving the way for identifying the 
right patient for the right drug. The availability of a 
highest-quality, multidimensional data set on a statistically 
valid set of high-quality samples is bringing new investigators 
and teams forward to study GBM in large numbers. This is one of 
the goals of TCGA, so we are bringing tons of people to the 
table to study this cancer.
    We are about to do the same thing for high-grade serous 
ovarian cancer, which is responsible for most ovarian cancer 
and a major contributor to the overall 5-year survival rate of 
only 31 percent. These data are being finalized for 
publication. I haven't talked to anybody about the data but I 
am going to tell you a few things that no one else will know. 
First, at one level, ovarian cancer looks quite different from 
GBM at the genomic level but in another way it looks quite 
similar. Ovarian cancer is a study of genome instability with a 
highly disrupted genome. It is a disease of copy number change, 
which actually means a disrupted genome. This instability is 
likely driven by nearly wholesale changes in only three genes. 
There are three distinct molecular subtypes of ovarian cancer 
confirmed at multiple levels of the genome. The distinct 
pathways disrupted in ovarian cancer where there are signatures 
can predict survival duration. That is quite a finding. 
Overall, the tumor is driven by defects in genes that are 
responsible for repairing damaged DNA, and there are a number 
of other rare genes that may represent new targets for drug 
development. The data is going to open a whole range of new 
windows of exploration for diagnosis and treatment of ovarian 
cancer that I predict will change the future for ovarian cancer 
patients hopefully on an accelerated schedule.
    The value of TCGA will ultimately be measured in many 
advances but perhaps one of the most striking is the value of 
the integration and analysis of multidimensional data about the 
many cancers it will study. Using ARRA funds, we are currently 
expanding the scope of TCGA to explore 20 additional cancers 
over the next 5 years, 10 in the next 2 years. Many of these 
studies will include the rare and deadly cancers that you will 
all be asking me about later.
    One additional comment I would like to make is that one of 
the rate-limiting steps in TCGA has been the availability of 
rare cancer samples and very high-quality cancer samples, and 
we are hoping to work with the advocacy community to fix that 
problem. Achieving high-quality biospecimens for the country is 
a major challenge. This is the foundation for personalized 
cancer medicine. It is also a problem in terms of the way 
standard of care is practiced in this country and it is also a 
problem with most of the tumor samples in the country where 
only about 30 percent of those samples are available and can be 
used in a high-quality study like TCGA. NCI has launched 
something called the cancer Human Biobank to deal with that 
issue, so we are going to have a national biobank.
    The other program that I wanted to highlight just for the 
last minute is basically what we are doing in nanotechnology. 
Nanotechnology, as you know, is allowing us to measure things 
at levels we only dreamed about a few years at 1 to 100 
nanometers, roughly the size of a water molecule to the size of 
a bacterium. Recently, we have been able to show with 
nanotechnology that you can measure in this particular case 
cancer changes roughly six times more sensitively than some of 
the diagnostic tests that we are using today. Northwestern 
University reported just 2 weeks ago using a barcode assay in 
DNA, they can actually detect prostate cancer at a level that 
is unheard of, and we believe going forward we will be able to 
use that kind of information to detect these cancers much, much 
earlier.
    Another recent breakthrough that was only published 
yesterday from the Nanotechnology Alliance for Cancer, which 
was started by NCI 5 years ago, we are now able to know that 
there is a piece of the genome actually called RNAI that 
actually blocks the expression of certain genes. We haven't 
been able to deliver that. It gets actually degraded in the 
body. We had a nanotechnology investigator from California, 
actually from Cal Tech, report just yesterday that they have 
been able to deliver this to patients and it is going into 
phase II trials. Again, this is another breakthrough from the 
nanotechnology program that NCI started about 5 years ago.
    At NCI, we are really proud of the progress we are making 
in these advanced technology programs. We are excited by the 
opportunities that lie ahead and challenged by the daunting 
amount of work that we have yet to do. We are dedicated to 
achieving a future where the shadow of cancer is removed from 
our lives and those of our children and our grandchildren. This 
increasingly seems to me like an achievable mission and a 
vision for every American that we can achieve hopefully in this 
next decade. NCI and NIH and are committed to moving us all 
forward toward this future, and I have never been more excited 
about believing that we will achieve this future for every 
patient, for every family and everyone touched by cancer, 
including my own. I have lost all of my family to cancer. I 
have been in this field for my entire career. I lost my 
grandmother to pancreatic cancer, two additional relatives to 
pancreatic cancer, my mother to breast cancer, my sister to 
breast cancer and my father to lung cancer.
    Thank you.
    [The prepared statement of Dr. Barker follows:]

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    Mr. Pallone. Thank you, Dr. Barker. We are going to take 
questions from the panel beginning with me, and I have to say 
that as much as I am tired and I know many of us are from the 
long weekend, I am also very excited by your testimony. You 
mentioned nanotechnology, which I think is so important for the 
future. We just had a--well, not just but within the year or so 
I went to an all-day conference at Rutgers on nanotechnology 
and some of the things that were really interesting that they 
were doing, and when you were talking about your relatives, I 
feel the same way, you know, my mother with pancreatic cancer, 
father-in-law with brain cancer. These deadly cancers are just 
around us, you know.
    When I went to Johns Hopkins with my mom, I was surprised 
to find out how much of a hereditary factor there was. Now, I 
don't think it was that significant. I think they said 10 or 11 
percent that they could say were hereditary, which isn't really 
that much, but the first day we arrived and they were looking 
at my mom, they took myself and my brother into a separate room 
and said by the way, there is a certain hereditary factor here, 
and they put us in some kind of a genetic bank or something to 
get back to us if there are breakthroughs because of the 
genetic factor, and I was of course--the first question they 
asked, Do you have a history of this in your family, and my 
mother actually was adopted so we had absolutely no information 
to relate to them other than her. But I know that all these 
things you mentioned are so important, really. I can't stress 
that enough.
    I mentioned in the opening about this genome atlas that I 
guess examines genetic material of various tumors and looks 
into gene mutations and different things genetically, and I 
know that you have some new findings in that respect with 
regard to ovarian cancer, but this atlas I guess from what I 
understand gets updated and may be expanded, I suppose, to 
include some of these other deadly cancers, so I wanted to ask 
you, you said it is going to be expanded to include 20 
additional forms of cancer over the next 5 years and NCI will 
look at half of these within the next 2 years. So tell me, what 
is the basis for selecting the 20 additional cancers that you 
research and what is the timeline for that selection? How is 
that process gone about?
    Ms. Barker. It is an excellent question. It turns out that 
as I said, the biggest issue we have with doing these very 
sophisticated studies is the availability of the samples. So as 
you can imagine, we are looking everywhere for samples, and to 
give you some feel for how difficult this was for GBM, 
glioblastoma, which is this adult brain tumor we did first, we 
had to look everywhere in the United States and outside the 
United States to get enough samples to actually do that study. 
It turns out that only about 30 percent of those samples 
qualify, and that is not a bad number for most of the samples 
in the country right now. Why is that? Well, people collected 
these samples for many years. They weren't thinking a lot about 
when they collected the samples the advanced technologies we 
would be using today. So in terms of selecting cancers for the 
atlas, the first priority is, are the samples there, are they 
available, and so we are doing very well. We are moving ahead 
on lung cancer. We are just introducing kidney cancer into The 
Cancer Genome Atlas, already have actually. Colon cancer is 
already being introduced into the atlas. We have cervical 
cancer and potentially gastric cancer to come into the atlas. 
Now, the latter one obviously is a rare tumor and so we are 
having to look in many, many areas to find these samples. By 
and large, or at least as we move forward, we think that we 
will also be able to prospectively collect samples and that 
will be driven mostly by which tumors are prevalent and which 
ones we can actually lay our hands on in the most rapid 
fashion, but we can collect tumors prospectively now and 
actually make sure that they meet our very stringent criteria. 
So going forward, we are going to use a combination of 
retrospective samples and prospective samples.
    But it turns out to be the biggest barrier we have. I mean, 
who would have guessed going into this that this--what most 
scientists would have considered a trivial issue is non-trivial 
and it is going to be actually the basis for personalized 
medicine overall so as a country we have to face up to the fact 
that we have to start treating our patient samples as well as 
we treat our patients, if not better, because they are going to 
actually define what personalized cancer medicine can be. So at 
NCI we started a lot of initiatives including best practices 
for how you collect samples and store them and actually what 
the stewardship is going to be of those samples. We think it is 
critically important.
    Mr. Pallone. I would just ask you, I know that I and 
several members, maybe all the members of the committee, are 
interested in tracking any progress that you make on this 
cancer genome atlas, and keep us abreast of your efforts as you 
go along because this is of interest to me and to all of us. We 
appreciate it.
    The gentleman from Illinois, Mr. Shimkus.
    Mr. Shimkus. Thank you, Mr. Chairman.
    Dr. Barker, welcome and we are glad to have you here. The 
budget request this year is $5.26 billion. It is a $163 million 
increase over fiscal year 2010. Add to that $1.26 billion 
provided by the stimulus bill. How do you go about apportioning 
out--we as members have disease groups all the time that 
descend upon us, and it is a sad kind of a food fight. So how 
do you apportion research dollars to cancer, the various 
cancers?
    Ms. Barker. With great difficulty.
    Mr. Shimkus. Like we do, I think.
    Ms. Barker. I think at the last count there were a little 
over 400 survivors' groups, I think, relative to cancer of one 
sort or another, and so what we try to do is to look at what is 
really promising in terms of what is going to enable cancer 
research that will actually be translatable to patients and 
backing into that what is really going to inform the biological 
space that will allow that to happen. I mean, if you think 
about what is really required for cancer, it is to understand 
the mechanisms that actually drive this disease and that is 
understanding the biology, and that has taken some time and we 
have built a really strong base for that. So what we try to do 
at NCI is obviously about half of our portfolio is driven by 
what we call individual investigator-initiated research, which 
is the strongest part of what we still do in science today. It 
is innovative. It is driven by innovation and individuals' 
ideas. The rest of our portfolio is dedicated to things like 
our cancer centers, our specialized programs of research 
excellence, our clinical trials infrastructure, et cetera. So 
cancer is a very, very big problem in the country so there is a 
fair amount of infrastructure that we have established in the 
early 1970s, actually the early 1960s.
    The other thing we try to do is the area that I lead up, 
the NCI, through the Center of Scientific Initiatives, we try 
to focus on areas that we think are enormously promising like 
cancer genomics or nanotechnology or proteomics, the 
biospecimen issue, cancer bioinformatics. These are all things 
that we have tried to focus on over the last several years.
    Mr. Shimkus. If I can, because I have only got a couple 
more questions that I want to ask, but I appreciate that. But I 
want to follow up on----
    Ms. Barker. So balance, I guess, is my answer.
    Mr. Shimkus. I know, I expected not an easy answer of how 
you do it.
    In the appropriations bills of last year, we addressed both 
sides of the Hill. We encouraged NCI to put a high priority on 
GI cancers in people age 40 and under and for NCI to consider 
developing an interconnected gastrointestinal cancer 
biorepository. Where are we at on that, and can you give us any 
response as far as what progress has been made, what factors 
are you considering to determine if a GI repository should be 
developed? What else can we do? Obviously that is a particular 
focus of this hearing and my interest.
    Ms. Barker. I think the GI spores are really well under way 
and they are collecting their samples and so we will have 
samples from this specific cancer, so I think that is going 
alone fine. The other thing that we have done just recently is, 
we held a meeting just last week on infectious agents in 
cancer, and as you know, gastric cancer especially is related 
to H. pylori, an infestation of a bacterium in the gut, but not 
all stomach cancer is caused by H. pylori, and you heard about 
one of those today, I am guessing. So we are trying to also now 
investigate other areas that are related to intestinal cancers 
other than just the kinds of normal things we have been looking 
at over the years, specifically, infectious agents.
    Mr. Shimkus. What about the cancer Human Biobank, which 
seems very promising? Can you talk about that?
    Ms. Barker. Yes. We had hoped to--we were planning on 
launching that probably next year, but with the aid of the ARRA 
funding, we were able to launch it in 2009 with about $60 
million. So it is under way. We expect it to be well under way 
in the next 3 years. Certainly by the end of the ARRA period we 
will have it well under way and samples are already beginning 
to flow in. The infrastructure is being created. So thanks to 
the ARRA funds, we were able to get it under way at least a 
year earlier than we would have been able to do it before.
    Mr. Shimkus. And I appreciate your quick answers. I still 
have 20 seconds left.
    There are some difficult biological materials to obtain in 
this process. Can you identify some of those?
    Ms. Barker. Well, any of the rare tumors basically. I mean, 
the rare tumors are really hard to get. Sometimes it is because 
of standard of care. Sometimes it is because people hang on to 
their samples; they are very precious and they don't want to 
share them. So I would say any time that we can encourage and I 
think really engage the advocacy groups to help us to collect 
these samples, that is where we should be focusing.
    Mr. Shimkus. Thank you, Mr. Chairman.
    Mr. Pallone. Our vice chair, Ms. Capps.
    Mrs. Capps. Thank you.
    I found myself, Dr. Barker, getting goose bumps while you 
were giving your testimony. I think it is very stunning what 
you were telling us, and I would like to have you use my time 
to talk more. The whole notion of personalized medicine is kind 
of floating around there. You are kind of pinpointing it so we 
can know, but you mentioned Cancer Genome Atlas, and is that 
what Mr. Shimkus asked you about?
    Ms. Barker. That is what the chairman is talking about.
    Mrs. Capps. Yes, and the Human Biobank would be part of 
that atlas?
    Ms. Barker. Separate ideas and separate concepts and 
separate initiatives but very much related to each other 
because the cancer Human Biobank will collect these samples and 
make them available to The Cancer Genome Atlas.
    Mrs. Capps. And then I guess the part that is so intriguing 
to me, you could talk on and on, hours, I suppose, just about 
that----
    Ms. Barker. And I am Irish, so you don't want to do that.
    Mrs. Capps. But maybe another time. I have a feeling we are 
just getting into this, and I feel myself wanting very much to 
be educated.
    I want to try something on you because there is a--we found 
that there is a piece of our health reform language that is 
about research on cancer, and the part that intrigues me is the 
Cures Action Network, another new initiative. I am just quoting 
from the language of the legislation. ``New initiative created 
in the legislation, an effort to help translate promising 
discoveries into cures with an emphasis on priority health 
issues where incentives for development are inadequate guided 
by''--this is all to be--``guided by a board of scientific 
experts and venture capitalists, individuals who have 
experience identifying promising projects. These experts are 
teamed with advocates who can represent the needs of patients. 
How would you see what you do there? I sort of call that pure 
research, if you will, and then also with the atlas and those 
samples, how can these results, your results, be translated 
more quickly to treatment and cures?
    Ms. Barker. So I think it is an end-to-end solution. I 
mean, basically you are starting with the samples. You are 
going through The Cancer Genome Atlas identifying all of these 
pathways that are disrupted. It allows you now to sort of 
attack that valley of death where things get lost and we don't 
have a real opportunity to take things to the next step. I 
think it is a very exciting idea.
    Mrs. Capps. Will you be doing that or do you see yourself 
collaborating? I don't mean you personally but----
    Ms. Barker. Probably both. We do a lot in translational 
research already but this allows actually--if I understand it 
correctly, it allows for more direct relations and public-
private partnerships to occur, which is something that is 
missing now in terms of really moving these new treatments into 
patients. I think that is long overdue and I think we can make 
good use of both the mechanisms and obviously the resources.
    Mrs. Capps. So we need to stay in touch with you. I am 
suggesting this to my chairman at the same time. This is a work 
in progress, both where you are and also this is a brand-new 
piece of legislation, to find out those ways that those 
connections should be made and using the advocacy groups 
because they are so useful to all of us.
    Ms. Barker. Right.
    Mrs. Capps. And then connecting to the private sector.
    Ms. Barker. Once you know which of these pathways is 
disrupted and which of these pathways are driving a specific 
cancer, then you are going to have to be able to make a new 
intervention or a drug, and The Cancer Genome Atlas is already 
sending the private sector in a new direction to discover new 
drugs. We are already seeing changes in the way that they are 
actually doing business. So the government is actually having a 
lot to do with sort of redirecting the way discovery is going 
to occur in the future.
    Mrs. Capps. Again, it is very exciting. I have 48 seconds 
left that is yours. What else would you like to tell us in that 
very short time?
    Ms. Barker. Well, you can't say much in these prepared 
statements so the couple things I would say is that The Cancer 
Genome Atlas is an example of something that is really changing 
science. I mean, it really is bringing hundreds of people 
together to look at a disease as complex as cancer and 
integrate all the data and make it available.
    Mrs. Capps. Let me just interrupt. Say there is someone who 
walks into a doctor's office and they take a biopsy and it 
comes back, and that is the point that I think we all can 
relate to. How does what you are talking about connect there in 
any way?
    Ms. Barker. So in a few years--when we started The Cancer 
Genome Atlas it was a couple hundred million dollars to 
sequence a cancer genome. It is now down to tens of thousands 
of dollars, and I would predict in as little as 5 years it is 
going to be down to less than $5,000. You get your genome 
sequenced, and we are going to know what the disruptions are 
and we are going to know what subclass of cancer that you have 
and you will get the right drug. You will not be treated with a 
generic sort of treatment. You will get the right drug for your 
subclass.
    Mrs. Capps. And you will have it in the bank, or someplace 
it will be?
    Ms. Barker. Well, if we can move ahead quickly on the 
things that you just talked about in terms of developing these 
new treatments, absolutely. So I think it is going to change 
the way medicine is practiced completely.
    Mrs. Capps. Stunning. That is all I can say. We have to do 
this more, Mr. Chairman. Thank you.
    Mr. Pallone. I realize that this is a subject of great 
interest and we will look into possibly doing additional 
hearings. We only have 6 months left, though, before the end of 
the session.
    The ranking member, the gentleman from Texas, Mr. Barton.
    Mr. Barton. Thank you, Mr. Chairman.
    Thank you, Doctor, for appearing. Dr. Andy von Eschenbach 
is not only a professional acquaintance but a personal friend 
and has helped me in treatment decisions for members of my 
family, so he is somebody that I have a lot of respect for. He 
has told me that with the proper approach and proper funding, 
we could actually find a cure for cancer in the next 15 years. 
Do you share that view?
    Ms. Barker. I think it depends on how we define ``cure.'' I 
think what will happen in this field, and Andy and I have 
discussed this on many occasions, is we are going to learn 
enough about these cancers to actually be able to treat them 
and have people live normal lives, and if you call that a cure, 
then that is a cure, but I think if you can stop the growth of 
a cancer, and let us just say even the cancer comes back, much 
as you see with AIDS patients, if you now can go in with 
another treatment that is equally effective and someone gets 
another 10 years, let us say, which is what is happening with 
breast cancer patients today, for example, then you are going 
to live out your life normally and die from something else. So 
that is the road we are on with cancer. Cancer is an 
extraordinarily complex disease, probably the most complex 
disease we have ever undertaken, but we are going to understand 
it well enough to be able to control the pieces that need to be 
controlled on a time frame that will allow you, I think, to 
live a fairly normal life. So I think that is the future.
    Mr. Barton. Now, I don't have the article in front of me 
but several months ago I believe Newsweek had a cover story 
about the war against cancer and was the wrong battle being 
fought. The article was not necessarily negative but it did 
raise some questions. Are you familiar with that article?
    Ms. Barker. Yes.
    Mr. Barton. What is your general view of that? It implied 
to me that we are spending a lot of money and kind of doing 
things the conventional way, which is somewhat contrary to what 
you just discussed with Congresswoman Capps.
    Ms. Barker. Well, those that know me know that I do very 
little in a conventional way. I mean, most of the programs that 
we started at NCI are pretty unconventional, whether it is 
nanotechnology or The Cancer Genome Atlas or some of the other 
things we have done. You know, this happens three or four times 
a year that we have a national story that says, you know, why 
aren't we winning the war on cancer, and, you know, I think it 
varies from time to time as to what the issues are, but I think 
we do have to look at these diseases differently. If we can 
actually balance the amount of individual investigator-
initiated research with some of these larger programs, I think 
we will proceed faster. So I think we have to come up with sort 
of piece coexistence of programs that enable everybody in 
individual investigator-initiated grants.
    Mr. Barton. But you do have a mechanism with NCI to review 
that type of----
    Ms. Barker. Yes.
    Mr. Barton. So there are people thinking about different 
ways to do things?
    Ms. Barker. Yes. I think it is the biggest change that we 
are going to have in cancer research and ultimately in the way 
products are developed for cancer patients. The one thing I 
didn't say but maybe it is obvious to everybody on the 
subcommittee is that cancer is digital, it is knowable, it is 
information. Think about it. I mean, you know, you pick up this 
device or another now and it is turning over every 5 years or 
it seems like every 2 months you are getting a new device. 
Well, once we digitize cancer, which is what we are doing with 
The Cancer Genome Atlas, going back to the Human Genome 
Project, that is what the Human Genome Project taught us, that 
DNA is digital, so as you begin to learn the information about 
cancer, you are going to be able to move much more rapidly, I 
think, and I think if cancer is knowable and we can decipher 
all the genes that cause these cancers and make them available 
to everybody, that is going to move the field exponentially.
    Mr. Barton. Now, one of the things that we did in the NIH 
Reauthorization Act several years ago was create a common fund 
that requires a certain amount of money each year to go into 
this fund and requires those that wish to take advantage of 
grants from that fund to work across different areas of NIH. 
That fund has been in existence now I believe for 2 years, 
maybe 3. Is that type of approach something that would tend to 
help the approaches that you are focusing on at NCI?
    Ms. Barker. They are very similar, and some of them have 
actually come from the common fund or enabled the common fund 
as many of the NIH institutes actually work in this way. I 
think the common fund is a great idea. I know Dr. Collins is 
now looking for new ideas for the common fund, so yes, they are 
very complementary and I really commend you for the common fund 
and the idea. It has been very, very helpful.
    Mr. Barton. And my last question, we are bombarded every 
year on this committee with requests from advocacy groups for 
special bills for specific diseases and specific cancers, and 
each group, whether it is the breast cancer group or the 
cervical cancer group or the prostate cancer group or the 
autism group or the Alzheimer's group or you name it, the heart 
group, theirs is always in their minds the priority that we 
should fund. What is your advice to the Congress on how we 
should handle those kinds of bills?
    Ms. Barker. So we see the same groups, and I think 
increasingly I believe that understanding the biological space 
or understanding the biology that drives cancer and other 
diseases is going to be critical to everybody. So I think that 
what we do--and we are learning so much now from The Cancer 
Genome Atlas that says that, for example, GBM, the pathways 
that are disrupted in GBM are going to look like the same 
pathways only a bit different in terms of the quantity of the 
genes and the exact numbers of genes that are actually 
disrupted in ovarian cancer so there are going to be some 
interesting overlaps here that are going to tie these cancers 
together. So I would encourage us all to begin to unravel that 
mystery that is cancer as opposed to, you know, what is 
prostate cancer, what is breast cancer, what is this cancer, 
what is that cancer. I think that is all going to converge and 
it is starting to converge now. So we need to work together to 
fill in the biological space and find out what drives cancer, 
and I believe it is going to help all these diseases.
    Mr. Shimkus. Will the gentleman yield?
    Mr. Barton. Yes, I would be happy to yield.
    Mr. Shimkus. Just to follow up. Thank you, Dr. Barker. In 
talking about again the cancer Human Biobank, how do we 
envision researchers across the board having access and using 
that? It is kind of tied to the same question based upon 
research. Because a lot of the advocacy groups are also doing 
research that I am not sure how--if we are getting access to 
that information or how that all works out. Can you in the last 
minute of----
    Ms. Barker. So in the last minute--it is a complex issue. 
The cancer biobank is just getting underway. The Human Biobank 
is just getting underway. But what we want to do is, we will 
have to prioritize access because some of the samples will be 
quite precious. So what we envision is having a board for the 
biobank that will actually prioritize requests and make samples 
available and information available on a priority basis but we 
generally will also offer services to investigators who are 
just looking for or need samples and so I think both of those 
will be possible in the biobank.
    Mr. Shimkus. And how do we incentivize people? We will have 
testimony in the next panel of someone with a rare cancer who 
when they had the availability there was no place to go. How do 
we encourage a place to go?
    Ms. Barker. For?
    Mr. Shimkus. I am not a doctor, but the tissues from this 
stuff. Some of these rare diseases, they are rare. It happens, 
it is gone and then you have no place to get the tissue to go 
to.
    Ms. Barker. Well, I have proactively--for The Cancer Genome 
Atlas, the first three choices were rare tumors basically: 
squamous cell carcinoma of the lung, ovarian cancer and GBM, 
GBM being the toughest. We spend a lot of time thinking about 
and working on these highly lethal tumors, and we will do more. 
The Cancer Genome Atlas will allow us now to look at these 
tumors. We are going to need help with getting the samples, and 
this is where the advocacy groups can really play a role, and I 
spoke just recently with the Deadly Cancer Coalition and we are 
working with several of those groups now to get those samples 
into The Cancer Genome Atlas. So I think it is working.
    Mr. Barton. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you.
    The gentlewoman from the Virgin Islands, Mrs. Christensen.
    Mrs. Christensen. Thank you, Mr. Chairman. Thank you, Dr. 
Barker.
    It is very exciting. It was very exciting to read and to 
listen to your testimony today. You focus a lot on of course 
the genomics and the molecular biology, but when you talk about 
bringing all of the experts together and all the data together, 
does that also include experts on environmental and 
psychosocial? Does that come into the discussion as well?
    Ms. Barker. Yes, because we are collecting data. I mean, I 
didn't have time to mention but all the samples we are using 
are actually from patients that are extraordinarily well 
characterized. They have to be to get into The Cancer Genome 
Atlas. So we have survival data on these patients, exposure 
data, et cetera. So as we go through these processes and learn 
more and more about these cancers, we will be able to begin to 
dissect out some of the questions relative to environmental 
exposures. I know Dr. Collins is planning a larger initiative 
in that regard to look at longitudinal data in terms of looking 
specifically at lifetime exposures in patients. We don't have 
that capability right now.
    Mrs. Christensen. Thank you. A Dr. Foege, I guess is how 
that name is pronounced at CDC, is quoted as saying, ``The 
challenge to genomics is to overcome the inequitable allocation 
of benefits, the tragedy that would befall us if we made the 
promise of genetics only for those who could afford it and not 
for all of society.'' So how do we incorporate population-level 
considerations of personalized cancer medicine and ensure that 
the emphasis on molecularly targeted therapies won't exacerbate 
the health disparities?
    Ms. Barker. I have lots of friends who always ask me this 
question--Harold Friedman from New York, who was at the NCI and 
actually founded our disparities program. I honestly think that 
this is going to do a lot to remove many of those barriers 
because one thing we are finding actually is that early on I 
think people assumed that maybe if you take the African 
American population, for example, that their cancers look the 
same as other cancers, and in fact, it is likely not to be the 
case. So we are studying these cancers now and we have cohorts 
of these cancers where we will be able to determine if there 
are differences, if there are inherited differences and if 
there are population differences. We are also working across 
borders with several countries. Almost all the countries now 
have actually--The Cancer Genome Atlas has become very popular. 
It is being cloned in lots of countries now. There is a meeting 
going on in Spain today that I was supposed to be at, but the 
United States, we are actually providing all these countries 
with the construct for how we are doing this. So there are 
going to be lots and lots of data on many countries including 
Africa where we will be able to sort out a lot of these 
differences. So I think actually this could reduce the digital 
divide and I think it will because I think we are going to know 
enough to do what is right for all these populations, not just 
for some.
    Mrs. Christensen. And are you doing anything, any specific 
research on the more aggressive forms of breast cancer that 
black women are disproportionately likely to get? I noticed 
that in your plan you say you are using ARRA money to look at 
health disparities and really target these kinds of issues.
    Ms. Barker. Right. So you are talking primarily about 
triple-negative breast cancer, which is a devastating cancer 
and it is quite high in African American women and quite 
devastating, and we have a number of programs in the NCI 
looking at that. We just launched a new program which I don't 
have time to talk about last week actually called the I-SPY 2 
trial which is actually a program to look at breast cancer in 
the neoadjuvant setting. Patients are going to have surgery. 
Many of those patients will be triple-negative breast cancer 
patients but the idea is to use an adaptive trial and test a 
large number of agents which we have not been able to do before 
and move drugs through very quickly. So I think we have got a 
lot of attention on that disease right now.
    Mrs. Christensen. Great. We could probably look that up on 
your Web site?
    Ms. Barker. Yes.
    Mrs. Christensen. One last question. I notice that you have 
a center to reduce cancer health disparities at the NCI. I 
would like to just know how do you relate and interact with the 
National Center for Minority Health and Health Disparities 
research.
    Ms. Barker. Very close interactions, and I think our center 
for reducing health disparities is a real flagship for all of 
the initiatives that are ongoing around cancer and disparities, 
and everything from our centers, you know, where we are 
actually training and bringing in new investigators, minority 
investigators especially, to some of the special research 
programs. It is really quite a success.
    Mrs. Christensen. Thank you.
    Thank you, Mr. Chairman.
    Mr. Pallone. The gentleman from Indiana is recognized for 8 
minutes. Mr. Buyer.
    Mr. Buyer. I thank the gentleman.
    Ma'am, when you were holding up your cell phone, I couldn't 
help but sense that as you talked about the genome and how fast 
our discoveries are moving, I am going to ask a question. I 
don't know the answer to this but I am going to do a systems 
analytical, and this would be our delivery systems. Sometimes 
our delivery systems can be caught in time. It is logistics, it 
is who is doing what in the preparation of what you described 
as that proper drug. So if you take yourself back actually 
maybe 15 years ago, some of the larger pharmaceutical companies 
did some discoveries and they held the drugs and they realized 
that they couldn't keep up and some would then spin them off 
either into the compound pharmacies or some nuclear pharmacies 
and they would be responsive to some cancer hospital or clinic 
or particular doctor, and so we have a unique delivery system 
on how that proper mix is getting there. Is that delivery 
system keeping pace in order for us to do that specialized 
proper care as you envision?
    Ms. Barker. Well, that is a tough question.
    Mr. Buyer. I don't know the answer to it either.
    Ms. Barker. Well, I think I do know the answer. I mean, I 
think the answer is, as of now I think we are keeping pace 
pretty well because the targeted drugs we are using in cancer 
research today, drugs like Gleevec and Avastin, are getting to 
patients. I think the bigger question is, when we have hundreds 
of these kinds of drugs and you are going to be hard-pressed to 
know everything there is about every one of these drugs, will 
people keep pace then. I think that information is going to 
change and the amount of information available is going to 
change at a pace that will allow people to keep up. But I think 
delivery is going to be the major challenge. I don't disagree 
with that. I think it is a huge systems challenge.
    Mr. Buyer. I asked that question from a systems analytical 
approach. We have a regulatory--all these regulations that are 
in place. Take, for example, a doctor that--you said the 
personalized sampling increasing personalized care. So when the 
doctor now knows what my patient's needs and requirements are, 
sends off to someone for a particular proper drug mix and it is 
then placed into the delivery system whether it is FedEx or 
UPS. Now it comes under some other regulatory schematic and 
maybe it is held in FedEx, it is brought in overnight and it is 
now held in a different place because of the regs and it has a 
time--sensitive in time. And now it may sit there for 2 days, 
and by the time doc gets it, how stale is the mix with regard 
to toxicity? You know what I am saying? I look at our system 
here and you say OK, the more we personalize, the better care 
we can get, but are we doing what we need to do because by the 
time that proper mix gets, is it going to do what the doc 
wants. This is my question.
    Ms. Barker. Well, I am not funded for FedEx but I can tell 
you right now that the delivery of drugs in this country is a 
very high priority for the pharmaceutical companies that 
actually send them to physicians, and the delivery thereof is 
highly monitored by physicians because everybody knows that 
many of these drugs are actually not terribly stable. They have 
to be kept at certain temperatures, et cetera. I don't think we 
see that problem very often but to your point, as you have more 
and more of these, it could become more of an issue. So it is a 
systems problem.
    Mr. Buyer. That is why I am asking the question. If this is 
where we are going, when you say what is our over-the-horizon 
vision, will our delivery system match your vision. Maybe I 
should----
    Ms. Barker. No, and I think--in oncology we have been 
working on that for many years and I think, you know, because 
we do have an oncology community, especially a community of 
physicians that are very, very good at keeping track of the 
information. I think it will morph according but it is going to 
be a huge challenge, I mean, for all diseases, not just cancer 
actually.
    Mr. Buyer. I yield to Mr. Shimkus. Are you good? I yield 
back my time. Thank you.
    Ms. Barker. You are welcome.
    Mr. Pallone. Thank you. Recognize the gentlewoman from 
Florida, Ms. Castor, for 8 minutes.
    Ms. Castor. Thank you, Chairman Pallone, very much.
    Dr. Barker and everyone at the National Cancer Institute, 
thank you very much for all that you are doing on cancer 
research and that vital--it is fundamental to American families 
and the struggles they have every day with cancer, and as my 
colleague said, there is just no one that has been unaffected.
    I am particularly enthused about your focus on genomics. I 
represent the Tampa Bay area that is home to the Moffitt Cancer 
Center, and they are really at the forefront of the national 
genomics project and have been educating me over the past few 
years, and let me tell you, even the Recovery Act money now, 
the NCI money, the Recovery Act that has gone to even greater 
research dollars and jobs, kind of high-wage jobs we want in 
our community and this new emphasis on genomics, and we also 
get support through the defense bill to even bolster the NCI 
funding. Moffitt launched their database in 1999 and they have 
been gathering that genomic data, the genetic profiles and the 
clinical history data for each enrolled patient, and I guess 
the next big step was to reach out to other researchers and 
other hospitals and begin that important partnership on the 
biorepository. So we are spreading out across Florida through 
the Moffitt, and I would like you to expand a little bit more 
on that data collection and the sample collection. I know the 
Moffitt, we have got 50,000 cancer patients so far have 
consented to have their clinical data and molecular profiles 
added to the database and that is going to be accessible to 
physicians, researchers and the patient themselves. They call 
it the total cancer care database that then flows into the 
personalized treatment that you are talking about.
    But could you drill down farther on the details of 
collection and the challenges that we are going to face? You 
did mention in passing the protocols, ensuring that the sample 
meets your standards. Talk a little bit about that in the data 
collection.
    Ms. Barker. So first of all, I just have to say that Dr. 
Bill Dalton at the Moffitt Center is one of the prime examples 
of a state that has actually put their whole state ahead. I 
think of the curve here. It is an amazing amount of work that 
they have done and they have actually taken a lot from The 
Cancer Genome Atlas directly and implemented it in Florida, a 
very commendable effort.
    In terms of some of the specifics, I mean, we have 
established at the NCI a set of best practices guidelines which 
I think have enormous merit for all investigators to be held 
accountable to, and so we are working on that, but I think in 
terms of the specimens themselves, they are very prescribed 
SOPs, or standard operating procedures, for how long in the 
operating room, you know, when it goes into storage, how it's 
stored, how you access it, the kind of bioinformatics platforms 
that you need to keep track of the samples, the consent that 
goes with the samples, and in this era of genomics they are 
quite different consents for patients than they were before. So 
there is an enormous amount of information. Moffitt has all of 
that, and they have been using our standard operating 
procedures now for a couple of years.
    Ms. Castor. So you have got how many research institutes 
that are part of genomics data gathering right now?
    Ms. Barker. Well, there are literally hundreds of those, 
but for The Cancer Genome Atlas, there are probably 20 
different institutions that are contributing.
    Ms. Castor. And then is it their responsibility to use your 
framework and the SOPS----
    Ms. Barker. Yes.
    Ms. Castor [continuing]. To continue the outreach to gather 
those samples?
    Ms. Barker. That is correct, and what you want is a 
standardized approach so we are all talking about the same 
things when we get to experimentation. Now, I thought you were 
going to ask a different question, and that is----
    Ms. Castor. What did you think I was going to ask?
    Ms. Barker. That is that there is something about these 
samples--we are actually doing some research on what causes 
changes in samples. We don't know. I mean, patients undergo 
anesthesia, all kinds of things in the OR. We don't know what 
impact that has. We have undertaken some research at NCI to try 
to figure that out. It is an interesting problem.
    Ms. Castor. How often does that occur? Is that standard, 
happening throughout all the samples?
    Ms. Barker. Well, it is actually--we have just undertaken 
that research in the last 2 years. No one has ever asked the 
question before. No one has ever said, what is the impact of 
anesthesia on a cancer sample, I mean, until I hired a 
pathologist to come to NCI, who I have known for a very long 
time, and the first question she asked me was, how do you know 
the anesthesia patients get is not actually responsible for the 
biomarkers you are measuring versus the biology itself. Nobody 
ever asked that question before. So we are doing research now 
to answer that question but it is a very important question, 
along with several other questions that we are trying to 
answer, so it is an interesting set of questions driven now by 
personalized cancer medicine because we want to know what those 
samples are actually telling us about the biology.
    Ms. Castor. And as you build this digitized database, I 
guess it is the molecular footprint for each of these cancers?
    Ms. Barker. Right.
    Ms. Castor. And then you have control factors based on all 
sorts of considerations. Can you state again in plain language 
what that means? Maybe go back to the latest ovarian cancer 
findings, what that means to a patient now and in the future.
    Ms. Barker. So what that will mean is that take ovarian 
cancer. We have identified three subclasses of ovarian cancer, 
very clear molecular subclasses. So we are going to know which 
drugs work on which subclasses. We already have survival data 
that says these drugs predict survival and these subclasses, at 
least two of the subclasses, so you are going to know as a 
patient what you should get, and you are also going to know as 
a physician whether or not anyone should get any drug 
basically. You know, right now we generically treat everybody 
with the same drug. If you have ovarian cancer, you either get 
a platinum-based drug or you get Taxol, and you may benefit 
from one, you might benefit from both, you may benefit from 
neither. So now we are going to be able to tell you which of 
these you are going to benefit from and the physician will have 
some idea about the expected longevity. As we go forward, I 
think you are going to see more and better cancer therapeutics 
for those specific subclasses, and that is the whole goal of 
The Cancer Genome Atlas. So patients can benefit very quickly 
by actually being put on the right drugs, I mean, going into 
the right clinical trials, putting patients in the right trials 
and then ultimately treating patients with the right drugs.
    Ms. Castor. And they benefit by submitting their samples?
    Ms. Barker. Yes, and increasingly every patient coming in 
for any diagnosis of cancer should have their sample collected, 
stored and kept, period.
    Ms. Castor. Well, again, thank you very much for what you 
are doing. I will pass along to Dr. Dalton that you have kudos 
of the Moffitt.
    Ms. Barker. He is a great catalyst.
    Ms. Castor. Thank you.
    Mr. Pallone. Thank you. Now, we have our last series of 
votes, a 15-minute and a 2-minute--I am sorry, a 15-minute and 
two 5-minutes.
    Mr. Gingrey, you are next and you have 8 minutes. Do you 
want to try to use it?
    Mr. Gingrey. Why don't I take a shot at it, Mr. Chairman?
    Mr. Pallone. All right. You are recognized. The other 
members, if you want to go vote and then we will----
    Mr. Gingrey. I think if you don't mind, Mr. Chairman, and I 
appreciate, I will go ahead. This is so interesting, I hate to 
lose my train of thought.
    Dr. Barker, thank you so much for being with us and sharing 
this information. I have a medical background, but I can tell 
you, on this issue I don't know any more, maybe less than my 
colleagues on the subcommittee. You talked a good bit about the 
state of the art in regard to the TCGA and being able to figure 
out subsets. You just mentioned, I think, in ovarian cancer and 
being able to tailor specific drug therapy depending on the 
subset, which I think is fantastic, and this is a great thing 
and I am glad that we are continuing to fund it, and I will 
certainly continue to support that.
    I want to take it maybe a step further into the future and 
maybe you are already there, you haven't talked about it yet, 
but, you know, there was a study in the New England Journal of 
Medicine last year, I think it was called the REVEAL study. Are 
you familiar with that, Dr. Barker?
    Ms. Barker. Yes.
    Mr. Gingrey. Well, let me continue down that line then. In 
that study, it was on the impact of educating about genomic 
predispositions had on a patient's emotional state. Now, let me 
make it a little more personal and anecdotal. I had a first 
cousin deceased several years ago of Lou Gehrig's disease, 
amyotrophic lateral sclerosis, and he had a wife and three sons 
and a great life until he got this disease and it took him 3 or 
4 years to die from Lou Gehrig's disease. Now, there will come 
a day, maybe it is already here and I want you to tell us about 
it, where every individual will go in for an annual routine 
screening physical examination, and instead of just having 
several tubes of blood drawn and checking for blood type and 
different things and maybe an X-ray and an EKG, that they will 
have an opportunity to have their own genomes studied and maybe 
a printout that would suggest well, you are 20 years old, Mr. 
Jones, and your likelihood of developing Lou Gehrig's disease 
or Huntington's chorea or prostate cancer at some time in your 
life is a certain statistic or to a woman, same thing with 
breast cancer and ovarian cancer. But it is no assurance that 
that will happen to them, it is just a statistical likelihood 
or chance. How much of this information should be given to 
patients and what effect would it have on their lives in regard 
to something like, let us say, Lou Gehrig's disease which has 
no cure or Huntingdon's chorea, which has no cure? Should they 
know this? Is this something that people want to know or would 
it drive them nuts to have that information, say, 40 years 
before the occurrence of the disease?
    Ms. Barker. So you raise an excellent point. I think we 
have reached a point in our society where advanced technologies 
are ahead of the extent to which we have actually incorporated 
this into our thinking and our planning. Genetic counseling is 
something that we are investing in but probably not enough, and 
I think we are going to have to do a lot more and I think 
genetic counseling will become very much a practice of medicine 
in the future. I am a bit of futurist so I believe that what is 
going to happen is that you will get your genome. I think you 
will know that your probabilities of getting certain diseases 
are, but as you point out, the chances are really going to be 
dependent on the environmental exposure you receive and dozens 
of other factors and so many people inherit predisposition for 
breast cancer, don't get breast cancer, and frankly, all the 
inherited genes that we know about in cancer today are 
responsible for only probably less than 5 percent of all 
cancers.
    So I do think that people will want to know, and I think as 
we go forward, and I think the whole idea here is, we will 
develop prospective strategies for dealing with that both in 
terms of genetic counseling and ultimately interventions. So we 
haven't talked much about prevention today but I think as you 
understand the genomics of these diseases, you will be able to 
go in and figure out ways to prevent them. Now, it is going to 
take some time but I think it is going to catalyze a whole new 
field here of, you know, sort of genomics-based prevention, and 
that is what I am in favor of. But as you know, there are 
companies already today that are giving people their genomes, I 
mean, at least your germline DNA, the changes that you 
inherited, and they do have genetic counselors. There are two 
or three of these companies now. And we are kind of watching 
that to see what impact that is having on patients.
    Mr. Gingrey. Well, in the couple of minutes that I have 
left, let me ask your opinion on this. Do you think ultimately 
that this will reduce the cost of medicine or that it 
ultimately will drive it up drastically?
    Ms. Barker. Well, I don't know the answer to the question 
but my guess is that there will be a blip as in all things and 
people will take a very high interest in this, and we just 
discussed, they will then realize that there are certain 
strategies that you have to undertake to mitigate you risk but 
that is pretty much what you can do until we can develop 
interventions to actually either prevent the disease or treat 
the disease effectively. So I think there may be some blip once 
everybody--you know, I think it is not going to be that long 
until everybody can get their genomes sequenced. So I think 
there will be a period when people have a high level of 
interest but I am guessing that will become integrated into our 
society and we will ease off. So I think in the long run it 
will reduce the cost of health care.
    Mr. Gingrey. Well, I think in the long run it will too, and 
I think I agree with you on that.
    The final point that I wanted to ask you about of course is 
the issue of discrimination, and of course as people get this 
information at a very young age and go out into the job market, 
how do we protect them from the possibility of being 
discriminated against because they have a high risk of 
developing breast cancer or colon cancer or whatever and as 
employers look at that or have access to that information? It 
would be so important to make sure that we protect that 
information.
    Ms. Barker. And we do. I mean, I didn't mention that all of 
the data in The Cancer Genome Atlas is protected at a second 
level. If you want any access to patient data, you have to 
actually apply for it, and any good, you know, sort of 
validated investigator can access that data. We are also 
protecting the patients' data through informed consent, and of 
course, ultimately the Nation is protecting that data though 
GINA and many people have worked tirelessly to pass that bill a 
few years ago. So I think we have anticipated this. That 
doesn't mean that there might not be somebody who falls through 
the cracks here but we have done everything we can but we are 
going to have to stay ahead of this so that as more and more of 
this information becomes available, that opportunity doesn't 
become too much of a temptation for people to actually abuse 
their privileges in that regard.
    Mr. Gingrey. Dr. Barker, thank you. My time is about up, 
and I thank you so much.
    Mr. Chairman, I yield back.
    Mr. Pallone. Thank you. Now, I don't think there is any 
time left on the floor so I suggest everyone go over there. But 
Ms. Eshoo wanted to be recognized.
    Ms. Eshoo. Thank you, Mr. Chairman. Unfortunately, I can't 
come back after votes because I have to attend an Intelligence 
Committee meeting, but I want to thank you, Dr. Barker. I am 
going to submit my questions to you.
    I just want to make an observation, and that is that I 
think that there needs to be a healthy balance all the way 
around. You used that word in the beginning of your testimony. 
But also about advocates and advocacy. I remember a time where 
the NIH was reluctant for whatever reasons, maybe it was 
whatever was going on at the time with HIV/AIDS. It was the 
Congress that pushed it and they pushed the money into it in 
order to make things happen, especially to help care for the 
people that were afflicted, which we thought was going to be a 
pandemic at the time. So I have a lot of regard for the 
advocacy groups, and there is one that is going to be 
testifying today on behalf of pancreatic cancer. I think what I 
would like to know more about at some point is where the 
balance is between the atlas, the samples, what we are doing 
with it, The Cancer Genome Atlas, but also the funding of the 
rest as we do that, because I think that there is a correlation 
between low investment in research and poor survival rates, and 
I don't think anyone can really get around that. We have never 
made a low and gotten a big bang for it.
    So I think we need to explore these things and I hope, Mr. 
Chairman, we will invite Dr. Barker back because there is a 
great deal of hope riding on you and I think in your words we 
found a great deal of hope. Thank you, Mr. Chairman.
    Ms. Barker. Thank you.
    Mr. Pallone. Thank you. We stand in recess until these 
votes.
    [Recess.]
    Mr. Pallone. The subcommittee will reconvene. I think we 
have at least one more member who would like to ask Dr. Barker 
some questions. I yield to the gentleman from Texas, Dr. 
Burgess.
    Mr. Burgess. Thank you, Mr. Chairman. I apologize for 
missing the earlier part of the hearing. As you know, we have 
several things happening simultaneously. That almost never 
happens up here on Capitol Hill, but today it did.
    You know, one of the things that has come up from time to 
time--we had the FDA in last week or the week before. There was 
a significant amount of funding coming to the National 
Institute of Health out of the stimulus bill last year. As I 
recall, that was a $10 billion amount that came to the NIH. 
What portion of that came to the National Cancer Institute?
    Ms. Barker. About $1.28 billion.
    Mr. Burgess. And can you give us an idea of where that 
funding is now? Has it all been allocated? Is there research 
now underway as a result of that? Where are we in the process 
with that?
    Ms. Barker. Most of the funds have been allocated, probably 
the lion's share of the funds have been allocated, and we will 
spend about $849 million obligated in 2009 and the remainder 
will be obligated in 2010. The funds went for special 
initiatives like The Cancer Genome Atlas, for example, where we 
invested in acquiring the samples and actually building the 
database and then Dr. Collins actually also invested money in 
sequencing these tumors. So some of the money went into the 
cancer Human Biobank. Much of the money went into, as you might 
imagine, individual investigator-initiated grants, and some of 
the money went into supplements to existing grants for 
investigators who had special projects. We funded quite a 
number of the innovation grants that actually came in, and 
overall, the lion's share of the funds as they usually do go to 
individual investigators but we were able to fund several 
infrastructure, you know, kinds of programs like The Cancer 
Genome Atlas and also a lot of translational science, new 
clinical trials. This is probably the boost for cancer research 
that I have ever seen, I think the biggest and most catalytic 
action I have ever seen in cancer research. It has stimulated 
more thinking and more activities that I have seen in 35 years, 
and I think it is going to have a huge impact downstream.
    Mr. Burgess. When you fund these research projects, was 
this money that was all allocated to be spent over 1 year's 
time or have you funded a research project that may go on over 
multiple years?
    Ms. Barker. Well, as you know, people are encouraged to 
spend their money in 2 years and to actually maximize the 
numbers of people that are hired newly and minimize the number 
of people who had to be let go in some of these institutions, 
but some of the grants will be extended over a couple of 
additional years, especially those that require longer-term 
objectives be met. So generally speaking, we are encouraging 
people to spend the money in the 2-year period allotted but 
there are certain kinds of studies that could proceed another 
couple of years if they have permission to do so.
    Mr. Burgess. What about the sustainability of research? It 
is an odd way to get money to get a big chunk of dollars like 
that. Obviously you have to make a commitment to scientists who 
are going to stay with you. What do you expect to see in the 
funding stream and the appropriations process over the next 
several years? How are we going to make that pitch to the 
appropriators? As I recall, we did the NIH reauthorization in 
2006. It was a base of $30 billion with an increase of 5 
percent, so roughly $1.5 billion a year over the 6 years of the 
authorization. We are coming to the end of that time. Has that 
been adequate in the way of funding, and now with this 
additional money that is coming in? Are we going to have other 
projects that need to be sustained? What do we look for in the 
future?
    Ms. Barker. Well, I think the additional of $10 billion to 
NIH was an extraordinarily wise strategic move on the part of 
Congress and the President. I think it will be extraordinarily 
difficult, as you would expect, to reduce the numbers of 
investigators, to reduce the number of programs coming out of 
the ARRA period. So I think the decisions will be tough ones 
but I am hopeful that the pace of research and the pace at 
which things are moving right now in terms of moving us towards 
a health care system that I think will be much more responsive 
in terms of reducing costs because we know what the disease is 
and how to treat it than continuing on the paths that we are 
on. I think it is one of the best investments we have ever made 
actually.
    Mr. Burgess. And I don't disagree, but putting a bunch of 
money in, you are going to come up--you probably have some 
things that are in clinical trials. How do you see the 
interaction with the FDA going forward? You are going to have a 
lot of stuff that has to go through the FDA. And I can actually 
remember having this discussion with Andy von Eschenbach when 
he was at NCI before he was at FDA, and he was concerned about 
the FDA's ability to keep up with the pace of research, and 
this was back in 2004 and 2005 that he was doing when he was at 
NCI. So how do you see this playing out? Is the FDA going to be 
able to keep up with the pressure that you are going to putting 
on with the demand for approval of new drugs and new therapies 
and new techniques?
    Ms. Barker. So Andy von Eschenbach, the same year you 
talked to him talked to me and said we need to put together an 
interagency oncology task force with FDA. We did that. And that 
task force has been working now for almost 7 years now, and I 
would say that--and we have been working on the science that is 
required to enable FDA to actually, you know, review these 
drugs and devices accordingly. So many of our things fail 
because there hasn't been enough science done to actually 
inform the process. So what we have tried to do over the last 6 
or 7 years is to sort of identify the regulatory science that 
has to be done, to work with them to determine what is a 
clinical trial going to have to look like, what do the 
biomarkers have to do to perform in a regulatory sense. We made 
a lot of progress in that regard, and so I think FDA--and there 
is a new announcement even a few weeks ago between the 
Secretary and Dr. Collins of a new relationship between FDA and 
NIH to do exactly what we have been doing, and that is, to 
really enhance this regulatory pathway by actually informing 
the science up front. So I think it is a relationship that has 
been built and will continue to be built, and I think FDA is 
anticipating this influx of new agents. For example, we work 
with them on nanotechnology products and so they are actually 
coming along and I think are on the same page with where we 
are.
    Mr. Burgess. I am going to run out of time.
    Mr. Pallone. You are out of time.
    Mr. Burgess. How do you----
    Mr. Pallone. You can't ask any more questions. Your time is 
over. Let us move on.
    Ms. Schakowsky.
    Ms. Schakowsky. Thank you, Mr. Chairman. I thank you, Dr. 
Barker, and actually all the witnesses who have been patient 
and waited with us.
    This is really just thrilling, the genomics and the 
nanotechnology and the next generation. I am just wondering if 
we have all the personnel we need. I have had concerns that 
once an upcoming scientist leaves NIH for the private sector 
they don't often come back, and I wondered if this is a concern 
at NCI. What impact does it have on NCI's ability to advance 
promising research? Is this a problem where there is a brain 
drain at all?
    Ms. Barker. So I think it is always going to be a problem 
because I don't think in our country we are placing enough 
emphasis in high schools and even earlier on science and 
mathematics, and that is a problem. We need to do more about 
that. I just came from China last November, and looking at the 
number of computational scientists they are training, for 
example, we are those computational scientists, and fortunately 
we can partner with these countries. But at NCI what we have 
attempted to do over the last 7 years is actually really look 
at the first-time investigator coming in for a grant. We pull 
out those applications. We call them star R1s. And we 
preferentially fund those young investigators. So I think we 
are doing fine in terms of funding young investigators. I think 
where we are going to fall short is having individuals who know 
how to work in teams and actually areas like mathematics, as I 
said before, because the amount of data that we are creating, 
terabytes every week, has to be analyzed and we have very few 
individuals that we have trained to analyze this quantity of 
data. We don't have many Google experts in the biomedical 
research enterprise. So I think we are doing fine but I think 
we really need to be very proactive about this and our 
universities and our high schools and even in our grade schools 
have to start thinking about putting science and mathematics 
back on the agenda, the top of the agenda, so they can bring 
the best and brightest into this field. I can't imagine if I 
were entering college today, I mean, I cannot imagine what an 
exciting future they are looking at.
    Ms. Schakowsky. Exactly.
    Ms. Barker. It is absolutely stunning. You know, the 
choices are amazing but these kids all grew up with their 
computer games and game theory and those are the kids that will 
be able to analyze the data.
    Ms. Schakowsky. Right, and they are used to changing 
technologies and being early adopters and being flexible. I 
think that we need to do a better sales job about just what is 
possible and soon in the fields of science. I was told by the 
Northwestern University in my hometown that were it not for 
Chinese students that postgraduate programs in science and math 
would probably have to shut down, and now the foreign students 
that we certainly want to come in go home. They are taking the 
skills that they learn here and going back home.
    Ms. Barker. In large numbers.
    Ms. Schakowsky. Yes, and so I appreciate your emphasizing 
the STEM programs. I think we all have to get behind that. But 
I think if we could just paint a picture of the kinds of 
achievements that are possible for them as individuals, the 
kinds of teams that they could be working on that are going to 
deliver cures, it is just incredible. So I thank you for all 
your work, and Mr. Chairman, I yield back.
    Ms. Barker. My pleasure.
    Mr. Pallone. I think that completes our questions. Thank 
you for bearing with us and for your input. I know members talk 
about doing further hearings on this subject. We will certainly 
look at it. I don't know what exactly we can do but I do 
appreciate you being here today. You may get some additional 
written questions within the next 10 days or so from the clerk, 
and if you do, I would ask that you respond to them. Thanks a 
lot.
    Ms. Barker. I really appreciate the opportunity. Thanks to 
all.
    Mr. Burgess. Mr. Chairman, may I just make an inquiry? Do 
we get at the committee level--it seems like in years past the 
NCI used to produce an annual report? Is that made available to 
the committee?
    Ms. Barker. Yes.
    Mr. Burgess. Mr. Chairman, could I just ask that we all get 
a copy of the most recent report? I think it would be----
    Mr. Pallone. Is it something that is very voluminous?
    Ms. Barker. No.
    Mr. Pallone. You can get hard copies?
    Ms. Barker. It is quite short.
    Mr. Pallone. All right. Let us get some hard copies. Thank 
you.
    Ms. Barker. All right. We will follow up with that. Thank 
you.
    Mr. Pallone. I ask the second panel to come forward, if you 
would. Thank you for bearing with us. Let me introduce each of 
the members of this panel. Beginning on my left, she was 
introduced before, is Ms. Kristin Fitzgerald from Naperville, 
Illinois. Thanks for being with us today. And then we have 
Megan Gordon Don, who is the chair of the Deadly Cancer 
Coalition and director of government affairs for the Pancreatic 
Cancer Action Network. And then from New Jersey is Dr. Robert 
DiPaola, who is a member of the American Association of Cancer 
Research and director of the Cancer Institute of New Jersey. 
And last is Jeff Allen, who is the executive director of the 
Friends of Cancer Research. We ask you each to give us a 5-
minute statement, if you will. That becomes part of the hearing 
record and after that our own questions for 5 minutes each. As 
I mentioned, we may give you some written questions in the next 
10 days or so.
    So let us start with Ms. Fitzgerald. Thank you so much.

 STATEMENTS OF KRISTIN FITZGERALD, NAPERVILLE, ILLINOIS; MEGAN 
GORDON DON, M.H.S., CHAIR, DEADLY CANCER COALITION, DIRECTOR OF 
GOVERNMENT AFFAIRS, PANCREATIC CANCER ACTION NETWORK; ROBERT S. 
DIPAOLA, M.D., MEMBER, AMERICAN ASSOCIATION OF CANCER RESEARCH, 
 AND DIRECTOR, CANCER INSTITUTE OF NEW JERSEY; AND JEFF ALLEN, 
     PH.D., EXECUTIVE DIRECTOR, FRIENDS OF CANCER RESEARCH

                STATEMENT OF KRISTIN FITZGERALD

    Ms. Fitzgerald. Mr. Chairman, members of the subcommittee, 
I want to thank you for the opportunity to testify at today's 
hearing.
    My name is Kristin Fitzgerald. As a former health staffer, 
I have participated in many Congressional hearings. This is, 
however, my first time on this side of the dais, and I greatly 
appreciate the opportunity to speak to the challenges facing 
cancer research. I am here today not only on my own behalf, but 
that of my husband, Ray Fitzgerald, who as you have heard was a 
staffer for Congressman Shimkus.
    Ray died last January of gastric, or stomach, cancer. Until 
his diagnosis in May of 2008, Ray was a healthy 36-year-old 
man. He had no risk factors for cancer. He had never smoked, 
drank infrequently, and lived a healthy lifestyle. With a large 
Irish family before him, there were only four unrelated 
incidences of cancer before him. Nothing would ever have put 
him at high risk of a cancer diagnosis.
    Ray's cancer symptom was burping, which appeared for a 
period of 2 months before his cancer was diagnosed. When Ray 
was diagnosed, his cancer was an advanced stage IV. His gastric 
tumor had spread throughout the lining of his stomach and 
progressed to his esophagus and throughout his liver. We were 
told that there was no hope of a cure but that chemotherapy 
could reduce the cancer for a time. That time was 8 months.
    This is not an abnormal scenario for gastric cancer. It is 
the second deadliest cancer worldwide. It very often presents 
in Stage IV, and is always incurable at that point. Ray 
however, was 40 years younger than the average gastric cancer 
patient, and thus the grim prognosis impacted not just Ray, but 
myself and our three young daughters, Nora, Maggie and Lucy. 
Nora and Maggie are here.
    It is my belief that Ray's diagnosis and prognosis is our 
worst cancer nightmare: diagnosis of a deadly cancer with very 
few warning signs at an advanced stage where a cure is 
impossible. It is a death sentence. And if we think it can't or 
won't happen to us, we are wrong. Ray was one of us, or at 
least in your case, your staff. And as I have learned, it could 
even be happening to one of us right now, and we would never 
know it.
    After Ray died, I spent some time talking with Ray's 
doctors to see how this kind of scenario can be prevented so 
that more young dads and moms aren't violently stolen from 
their families by cancer. As a former health staffer, I assumed 
that gastric cancer research was ongoing and would utilize 
Ray's tumor specimen and facts about his age and health status 
to find a cure for this deadly cancer. However, far too little 
is being done to research gastric cancer and other 
gastrointestinal, or GI, cancers that have a similar deadly 
prognosis. CBS News analyzed the disparity in research dollars 
in May of 2009. For each cancer death, the most federal 
research dollars are spent on cancer of the cervix at $18,000 
per fatality and breast at $14,000 per fatality, contrasted by 
the least funded, which is gastric cancer at $1,100 per cancer 
fatality.
    GI cancers are some of the deadliest cancers in the United 
States with deaths attributed to the digestive system second 
only to those in the respiratory system. Four out of the five 
lowest 5-year cancer survival rates for metastatic cancer are 
GI, pancreas, liver, esophagus and stomach. And GI cancers are 
rising, particularly in young people. A recent NCI article 
documented the rise in gastroesophageal cancers of the stomach 
and esophagus. This article compared the incidence rates in two 
4-year periods, 1975 through 1979 and 2000 through 2004. 
Overall, there was a 44 percent increase in these cancers. 
Within gastroesophageal cancers there was an explosion of a 
particular type, adenocarcinoma, which is what Ray had. The 
increase in adenocarcinoma was 465 percent, with a 190 percent 
increase in young white males. And the situation for young 
people with GI cancers is particularly grim. Because GI cancers 
are considered to be diseases of middle or advanced age, the 
diagnosis in people under 40 is often delayed. As a result, the 
disease is usually in an advanced stage with a poor prognosis 
by the time the diagnosis is established. And their very age 
works against them. The strength and relative health of their 
bodies is passed on to their cancers, making them even more 
aggressive than in older patients. As a result, GI cancers in 
young people tend to be fatal.
    Yet, unlike other deadly cancers, gastric cancer and many 
other GI cancers do not have a national clinical registry and 
tissue bank to utilize tumor tissue and clinical records for 
research purposes. In my view, this is intolerable. Congress 
and NCI can and should do more to ensure that researchers can 
have access to the tools they need to prevent and diagnose 
these cancers before it is too late. Though these cancers are 
growing, they are poor candidates for wide-scale screening 
programs due to the smaller population of people impacted and 
the invasive nature of screening available.
    More research is essential in order to understand the 
unique characteristics of the disease in younger people and 
develop a screening test based on molecular markers to allow 
for earlier detection. In order to accomplish this research, 
NCI must develop a coordinated national GI cancer tissue 
biorepository and accompanying research project to focus 
research in this area and make tumor tissue available for 
research purposes.
    Last year the Labor, HHS, and Education Appropriations 
Report included language asking NCI to do just that. To date, 
this has not yet been accomplished. Congress must act to ensure 
that these cancers can be detected and cured so that more lives 
are not lost.
    Ray was a wonderful man and his spirit will live on always. 
However, it is my belief that Congress should fund a research 
project, tissue bank and registry so that the physical legacy 
of a patient like Ray can live on forever, giving eternal gifts 
to researchers and scientists throughout the world.
    Members of the subcommittee, thank you for your time and 
consideration. I am happy to answer any questions.
    [The prepared statement of Ms. Fitzgerald follows:]

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    Mr. Pallone. Thank you so much.
    Ms. Don.

                 STATEMENT OF MEGAN GORDON DON

    Ms. Don. Mr. Chairman and members of the subcommittee, my 
name is Megan Gordon Don and I am here on behalf of the 
Pancreatic Cancer Action Network as well as the Deadly Cancer 
Coalition. I appreciate the opportunity to testify today 
regarding deadly cancers and the state of cancer research.
    I am going to give you some background on the research 
problems associated with deadly cancers and why the Deadly 
Cancer Coalition was formed as well as provide you with four 
key recommendations for the committee's consideration. While a 
number of cancers have achieved 5-year survival rates of over 
80 percent since passage of the National Cancer Act in 1971, 
and the average 5-year survival rate for all cancers has 
increased during that time from 50 percent to 66 percent, 
significant challenges still remain for other types of cancer. 
In fact, there are eight major cancers that have yet to reach 
the 1971 benchmark. Nearly half of the over 562,000 cancer 
deaths in 2009 were caused by these same eight forms of cancer, 
which are ovarian, brain, myeloma, stomach, esophageal, lung, 
liver and pancreatic. I have provided for the record a fact 
sheet on these cancers, which we refer to as the deadly 
cancers.
    As grim as the statistics are now for deadly cancers, the 
future looks even worse. According to an article in the June 
2009 edition of the Journal of Clinical Oncology, cancer 
incidence is not only projected to dramatically increase in the 
next 20 years, but some of the deadliest cancers will be among 
those of the greatest relative increase in incidence.
    In contrast to many of the other cancers with significantly 
better survival rates, research into the deadly cancers has 
been relatively underfunded, and as a result, these cancers 
have no early detection or treatment tools or the available 
treatments are still considered controversial. While there has 
been some work through the TCGA, as Dr. Barker highlighted, for 
three of the deadly cancers, and while NCI has expressed 
interest in expanding TCGA to more deadly cancers, biomarkers 
have yet to be identified or validated for the majority. Also, 
survival for these cancers is measured in weeks and months, not 
years.
    Research into deadly cancers has also faced many hurdles 
including low priority status, little accountability, low 
average funding, little understanding of the research 
complexities by grant reviewers, deadly research grants are 
rarely reviewed by experts in the field, and a shortage of 
available tissue.
    Our coalition started with the premise that all cancer 
patients deserve at least a 50-50 chance of survival. And, at a 
minimum, survival from all types of cancers should be above the 
starting line that was established nearly 40 years ago. The 
fact that there are a set of cancers that have not reached that 
starting line, in most cases are not even close, indicates that 
the time has come to establish a targeted effort to focus on 
the greatest challenges with the greatest need: deadly cancers. 
These challenges are not insurmountable but it will take 
leadership, vision and a change in the current research 
paradigm at NCI. Specifically, we are calling for an increase 
in funding, the creation of a targeted deadly cancer program to 
provide structure and accountability, a dedicated grant 
program, and expert review of grants.
    I want to note that our recommendations are not about 
telling NCI how to do the science. We are calling for an 
increase in funding because the data clearly shows that deadly 
cancers are currently not research priorities at NCI.
    I would like to call the subcommittee's attention to two 
charts that I have provided for the record. The first shows NCI 
funding for the top five cancer killers. Lung and pancreatic 
are two of the most deadly, and they also have the lowest 
funding levels. Looking at the survival rates, you also see 
that survival is the lowest. This chart demonstrates in very 
dramatic fashion that there is a clear correlation between low 
investment in research and poor survival rates, and vice versa. 
The second chart shows that less than 18 percent of NCI's 
funding has gone to the deadly cancers, and yet over half of 
the cancer deaths are caused by the eight deadly cancers. 
Across all types of cancer combined, the NCI spent just over 
$7,000 per cancer death in 2008. For the deadly cancers, NCI 
devoted only about $2,500. Taken together, these charts clearly 
demonstrate that the status quo is not working for the deadly 
cancers and some sort of targeted funding is needed.
    Mr. Chairman, creating structure and accountability is 
absolutely essential to making progress. Therefore, a second 
recommendation is to create a targeted cancers program that 
includes strong accountability measures such as requiring the 
NCI director to develop a strategic plan to increase survival 
rates for the deadly cancers. Furthermore, we call for annual 
reports to Congress showing progress against the strategic plan 
to further ensure accountability.
    Our third recommendation is to establish a new targeted 
grants program to create a protected pool of research funds for 
the deadliest cancers. This additional grant opportunity will 
help to compensate for the limited existing data on deadly 
cancers which put these grant applications at a competitive 
disadvantage with the better researched cancers and allow these 
grants to be evaluated in a way that would foster more funding 
opportunities for both experienced and young investigators in 
order to attract more scientists to this field of study. Grant 
review committees would include scientific experts in the 
specific disease areas of interest, another critical point for 
deadly cancers in our fourth and last recommendation. We have 
presented the idea for a targeted cancers program to the NCI 
and have also been working with the House and Senate sponsors 
of the ALERT Act.
    Chairman Pallone, on behalf of the Deadly Cancer Coalition, 
I would like to commend you and Representative Capps for your 
work on the ALERT Act. It captures many of the recommendations 
outlined above. Additionally for the pancreatic cancer 
community, passage of H.R. 745, the Pancreatic Cancer Research 
and Education Act, introduced by Representatives Anna Eshoo and 
Ginny Brown-Waite, is another important step to tackling the 
changes I have discussed.
    Mr. Chairman, in conclusion, I want to thank you and 
members of the subcommittee again for allowing me the time to 
testify. The Deadly Cancer Coalition believes that the time has 
come to create a new research paradigm at NCI that will lead to 
the institute tackling the hardest and most complex problems. 
It is by solving the hardest problems that we will likely see 
the greatest rewards for the entire field of cancer research. I 
am happy to answer any questions.
    [The prepared statement of Ms. Don follows:]

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    Mr. Pallone. Thank you.
    Dr. DiPaola.

                 STATEMENT OF ROBERT S. DIPAOLA

    Dr. DiPaola. Good afternoon, Mr. Chairman and members of 
the subcommittee. My name is Dr. Robert DiPaola. I am director 
of the Cancer Institute in New Jersey, our State's only NCI-
designated comprehensive cancer center. The mission of CINJ, 
similar to 65 other NCI-designated centers nationwide, is to 
reduce cancer incidence, morbidity and mortality through 
multidisciplinary cancer research including researchers in the 
laboratory collaborating with physician researchers in the 
clinic. I am also a member of the American Association of 
Cancer Research, AACR, which is dedicated to advancing cancer 
research, to prevent and cure cancer through research, 
education, communication and collaboration. Thank you for 
convening this hearing and recognizing that cancer research is 
critical to making and translating the discoveries needed to 
reduce the toll that cancer takes on the people and the economy 
of our Nation. Through its oversight and legislative 
activities, this committee has played an important role in 
advancing cancer research, and I commend Chairman Pallone and 
all the members of the committee for their achievements and 
ongoing commitment to this national priority.
    Today we estimate, as you have heard, one in two men and 
one in three women will develop cancer in their lifetimes. This 
year alone, almost 1.5 million Americans will be diagnosed with 
cancer and more than half a million Americans are expected to 
die of the disease. That is approximately 1,500 people a day, 
one per minute. The toll on the economy is staggering and 
predicted to increase with the increased risk of cancer to our 
aging Baby Boomer population if there is not dramatic 
intervention supporting the need to increase the investment in 
cancer research.
    The Nation's prior investment in cancer research is reaping 
benefits to millions of Americans. According to the ACS, as you 
just heard, the 5-year survival rate for cancer has improved. 
The overall 5-year survival rate improved to approximately 66 
percent compared to 50 percent in earlier years but we now need 
to go further, especially for rare and aggressive cancers. An 
example of a major advance that is providing for accelerated 
progress is the sequencing of the human genome and The Cancer 
Genome Atlas, as you just heard from Dr. Barker, which is now 
allowing us to answer difficult questions more rapidly. 
Research to improve diagnosis, treatment and prevention of 
cancer can improve patient outcome.
    Currently, only approximately 5 to 10 percent of drugs that 
are first tested in cancer clinical trials are ultimately 
approved. We now have the models to improve this rate including 
a better understanding of molecular pathways that allow a more 
targeted and individualized approach. Much of the progress made 
in this country against cancer has been the result of 
organizations such as the AACR and of research in cancer care 
done at NCI-designated cancer centers. A culture of 
collaboration is also a hallmark of NCI-designated cancer 
centers in which collaboration between laboratory and clinical 
researchers and collaboration with other research institutions, 
industry and other cancer centers is encouraged.
    At CINJ, as an example, with NCI's support, we have been 
able to foster a consortium model with researchers at multiple 
institutions in the State including the best researchers at 
CINJ, Rutgers and Princeton universities. These efforts 
recently have led to the discovery of critical metabolic 
pathways involved in tumor cell starvation and survival and 
translated these laboratory findings into several clinical 
trials that are now ongoing and available for patients with 
both common and more rare cancers that are attempting to better 
starve tumor cells.
    Another area of funded research important to improve 
outcomes for patients is comparative effectiveness research 
which seeks to optimize emerging and existing therapies. For 
example, a team of researchers in epidemiology recently 
published a landmark study that better defines the use of 
hormone therapy for men with early stages of prostate cancer. 
Other novel therapeutic trials with NCI support include a 
recently opened clinical trial to look at harnessing our immune 
system to tackle pancreatic cancer and other cancers, in this 
case administering in pancreatic cancer a new vaccine 
combination directly into the tumor, now offering many patients 
in need a new clinical trial option.
    Other efforts to foster collaboration include the work of 
the AACR that underpins many efforts and groups such as Stand 
Up To Cancer. This new initiative provides large grants awarded 
to multidisciplinary research dream teams.
    Cancer's economic burden is staggering. The NIH estimates 
that in 2008 the overall cost to society was more than $200 
billion. Fortunately, we are at a most promising time in cancer 
research, as you have heard, but much more remains to be done. 
I think we have the potential to accelerate through this 
tipping point in time by supporting a new era of cancer 
treatment and prevention and gain on our investment to reduce 
the toll of cancer on the people and the economy of our Nation. 
Thank you.
    [The prepared statement of Dr. DiPaola follows:]

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    Mr. Pallone. Thank you, Dr. DiPaola.
    Dr. Allen.

                    STATEMENT OF JEFF ALLEN

    Mr. Allen. Good afternoon, Chairman Pallone, Mr. Shimkus 
and members of the subcommittee. It is an honor to testify 
before you today. I am Dr. Jeff Allen, executive director of 
Friends of Cancer Research, a cancer research advocacy 
organization and think tank based in the Washington, D.C., 
area. I would like to thank the staff of this committee, who 
have worked tirelessly in putting together this hearing.
    The foundation of Friends of Cancer Research, Dr. Ellen 
Sigal, could not be here today as she is with a loved one right 
now who is being treated for a rare cancer. Dr. Sigal started 
this organization 15 years ago after having lost a sister to 
breast cancer, her father to prostate cancer and mother to 
pancreatic cancer. This is as personal for her as it is for 
you, Mr. Chairman, and likely everyone in this room including 
myself, who have been deeply affected by this terrible disease. 
It is with this in mind that I am here today to express what we 
feel needs to be done to end the suffering that millions of 
cancer patients and their families experience every year. 
Exceptional progress has been made in the treatment of cancers, 
due in large part to the investments in biomedical research. 
However, significant hurdles stand in the way of ending the 
burden of cancer.
    Today it is estimated that it requires over $1 billion, 12 
to 15 years and 1,000 patient volunteers to get a single drug 
to market. Chairman Pallone, 15 years to translate a new 
discovery to a therapeutic today by today's rates would mean a 
loss of almost 8.5 million Americans, approximately the 
population of your home State of New Jersey.
    The funding allocation to biomedical research as a part of 
the American Recovery and Reinvestment Act presented a renewed 
opportunity for American investigators to carry out research 
projects that otherwise may not have been possible. However, in 
order to truly halt the devastating impact of cancer, a 
comprehensive approach is needed. First, increased 
collaboration across all sectors is needed to turn the next 
corner of scientific advancement. The NCI continues to be an 
engine-driving process but we must also acknowledge the need 
for collaboration with other agencies. For example, increased 
scientific capacity at the FDA is needed to ensure that the 
discoveries being made at the NCI get to patients as safely and 
efficiently as possible.
    Second, the historic health reform bill passed this week 
takes many important steps to ensure that breakthroughs from 
research are available, accessible and affordable to all 
Americans. This includes the expansion of comparative 
effectiveness research, which can help to provide improved 
information for patients and their health care providers. While 
it will take careful thinking to finalize many of the details 
moving forward, we look forward to working with members of this 
committee and others to ensure the success of these programs.
    Finally, we must also tear down the silos that exist in 
biomedical research and focus on the common goal of reducing 
the cancer burden. Classifying and studying cancers based on 
their molecular characteristics as opposed to just their tumor 
site is in many cases the direction that science is leading. It 
is through the success of research that common molecular 
targets for abnormal growth have been identified in multiple 
cancers. While this adds to complexity, it also creates 
opportunities for shared success. This is not to diminish the 
important work of targeted focus but we must let our work 
support and inform those fighting for the common goal on our 
alternative fronts. The time of scientific opportunity is upon 
us. In order to ensure that multiple integral components of the 
health care system are prepared for the future of cancer 
research, we must act now.
    We respectfully ask that members of this committee, the 
Congress and the Administration be steadfast in their 
commitment to ending cancer. I cannot emphasis enough the need 
for collaboration. The advocacy community and entire research 
community must embrace our common goal and support science and 
collaboration that will enhance the battle against cancer on 
all fronts. It is our responsibility to represent patients' 
needs and what must be done to end the burden of all diseases. 
Thank you.
    [The prepared statement of Mr. Allen follows:]

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    Mr. Pallone. Thank you, Dr. Allen. I thank all of you, 
really. I want to particularly mention Ms. Fitzgerald. I 
remember when your husband passed away last year and how sad it 
was and a difficult time for Mr. Shimkus in particular, and I 
just wanted to thank you for sharing Ray's and your family's 
story with us today. Thank you.
    I am going to recognize myself first. You know, I wanted to 
ask, I guess, Ms. Fitzgerald and Ms. Don, you know, you both 
described progress in our fight against cancer but that it has 
been limited progress with certain types of deadly cancers like 
pancreatic, stomach and esophageal cancer, and of course, I 
mentioned my mother, and one of the things that--I will try to 
be brief, but what happened was, I started doing research and I 
actually went on your Pancreatic Cancer Action Network site 
almost daily during that period of maybe 7 or 8 months from 
when she was diagnosed to when she passed away, and of course, 
the one thing that I kept finding out was that the problem was 
no early diagnosis. In other words, by the time you find out 
about pancreatic cancer, it is usually too late. In her case, 
though, there was a little bit of an early diagnosis because 
she had jaundice, and I basically found out from your Web site 
that that is one of the few cases where they do find it a 
little early if the person gets jaundice and that is because 
the tumor presses on something, I guess the bile ducts or 
whatever, and the person turns yellow, which is what happened 
to her, and then she did have an opportunity. They call it the 
Whipple operation. And I have talked to a lot of people, even 
Members of Congress, who had the operation.
    But what I wanted to ask you is, is that one of the 
reasons, and if not, what are the reasons why pancreatic cancer 
or a lot of these other deadly cancers are so challenging to 
researchers? Is the lack of an early diagnosis the main problem 
or what is it from a research perspective?
    Ms. Don. It is actually twofold. One is the fact that we 
don't have early detection tools and the second is that 
pancreatic cancer in particular is a particularly difficult 
disease to diagnose. The pancreas is located deep in your body 
so it is not something that a doctor can feel on examination. 
As you mentioned, there really aren't that many early warning 
signs. It is usually lower back pain or jaundice, and typically 
with jaundice, the tumor is pushing on the bile duct and 
typically that is too late. So if your mother was a candidate 
for the Whipple surgery, then that was actually fantastic news 
because most patients are not. Only 15 percent of pancreatic 
cancer patients are currently eligible for the Whipple 
procedure, which is a very, very difficult surgical procedure 
where they take out almost all of your digestive tract to get 
to your pancreas. So if only 15 percent of patients are 
eligible for the surgery, then that means that another problem 
is that it is very difficult to get tissue because you only get 
issue when you do surgery.
    Mr. Pallone. Oh, you are saying because only 15 percent 
actually have the surgery, you just don't get much tissue to 
work with?
    Ms. Don. Right.
    Mr. Pallone. Of course, most of those don't last more than 
a year or two anyway, even when they have the Whipple, but I 
see your point.
    Ms. Don. Pancreatic cancer also has a very high recurrence 
rate. Of the people who have surgery, 80 percent will have a 
recurrence within 5 years.
    Mr. Pallone. Right. That is what they tell us. So now, is 
this lack of early warning the biggest problem not only with 
pancreatic but also with a lot of these other deadly cancers or 
that is just pancreatic?
    Ms. Don. No, it is----
    Mr. Pallone. And Ms. Fitzgerald can chime in too if she 
wants.
    Ms. Don. It is a similar problem across many of the 
cancers, and most of the deadly cancers we find at very late 
stages, so getting the cancers at earlier stages would be 
helpful but we also don't have treatments for them once we get 
them. As I mentioned, the best treatment for pancreatic cancer 
is a surgical procedure that even in the best case, 80 percent, 
still don't make it more than 5 years.
    Mr. Pallone. Ms. Fitzgerald.
    Ms. Fitzgerald. I think it is a combination. There are very 
few symptoms in many of the GI-tract cancers, gastric cancer. 
You know, like I mentioned, my husband's symptom was burping 
which is, you know, pretty often reflux or something of the 
kind----
    Mr. Shimkus. Ray did that all the time.
    Ms. Fitzgerald. But there are few symptoms, and I think it 
is also in the case of gastric cancer, a rapid progression. So 
you have very few symptoms, you have a rapid progression 
throughout the GI tract and then straight--because the stomach 
pumps out all your--you know, it gets your food and it pumps 
out your nutrients. It goes straight to your blood so it goes 
straight to your liver, so it is a rapid progression and right 
to basically all of your blood and so it goes throughout your 
body, and I think that is really similar on a number of the GI 
cancers, that they progress right to the liver.
    Mr. Pallone. So is the problem then--in other words, is the 
reason why National Cancer Institute or others don't do a lot 
of research because they just figure that with all these 
problems and the difficulty of determining early diagnosis and 
cures, it is just not worth the investment? I don't want to put 
it that way but is that what is going on? They would rather 
spend money on other things where they think they can make more 
progress? Is that what we are getting?
    Ms. Don. I think that from our perspective, and obviously I 
can't speak for NCI but from our perspective, it has been a 
case of we have gotten to a point where we encourage 
researchers to go after the lowest hanging fruit, and NCI funds 
the safe bets.
    Mr. Pallone. Because this way they can show they are 
spending money, they want to show results.
    Ms. Don. That, and there is a limited amount of money.
    Mr. Pallone. But in a sense, I mean, at one level it makes 
sense because then they can show they have results. On the 
other level, they may be spending money on things that aren't 
as deadly and don't need--I mean, you see my point. In other 
words, why not spend money on the areas where we have such 
problems rather than the ones where we don't.
    Ms. Don. And that is our central point, that we really 
believe the time has come where we have to challenge NCI to 
tackle the hardest problems, and the hardest problems are 
really the deadly cancers where we have made the least amount 
of progress. That doesn't mean there is not worthwhile research 
to be done on other cancers, on breast cancer and colon cancer 
and prostate and the others, but there is definitely a set of 
cancers that have not gotten the same amount of attention or 
really any sufficient attention, and it is time to focus 
efforts there.
    Mr. Pallone. Thank you.
    Mr. Shimkus.
    Mr. Shimkus. Thank you. And I want to thank Dr. Barker for 
staying here and listening to the testimony. That doesn't 
always happen here in Congressional hearings, and I think it is 
to your credit. And I also now can see why the funding issue 
that we struggle with is very similar to the funding struggles 
that you have.
    Ms. Don, kind of on the same line, but the question would 
be, NCI's efforts towards establishing The Cancer Genome Atlas, 
which was discussed at length, I think, how is that going to 
help research towards the deadly cancers, the pancreatic and 
gastrointestinal and others?
    Ms. Don. Well, we certainly appreciate and want to 
acknowledge Dr. Barker in particular for all of her work to try 
and ensure that deadly cancers are included. I mean, the three 
places where they started were three of the deadly cancers, and 
she has absolutely reached out to the deadly cancer community 
to try and get more deadly cancers included. I think the issue 
is that The Cancer Genome Atlas is one piece of a very large 
puzzle of things that we need to be doing for these cancers. It 
is a very important piece, as is nanotechnology, but we also 
need to be doing additional things to be able to understand the 
bigger picture and so we fully support TCGA moving forward, and 
from the Pancreatic Cancer Action Network's perspective, we 
absolutely hope pancreatic cancer is included and we can figure 
out a way to deal with the tissue issue with pancreatic cancer, 
but we need to focus on other efforts too.
    Mr. Shimkus. Great. Thank you.
    Kristin, again, welcome. We all miss Ray. And your 
daughters have been precious in the back. Let me ask you a 
question on the issue of federally coordinated national 
cooperation. Why is that so important in cases like stomach 
cancer that develop in young people?
    Ms. Fitzgerald. First, I just want to publicly thank you 
and your staff for your tireless advocacy on behalf of Ray, and 
I know that he would be incredibly happy that we were here at 
the Commerce Committee, his favorite committee, and this is a 
Congressional family. Ray's family was Congressional, many of 
whom are here, and I just want to thank you for helping and I 
know that it would mean a lot to him that we are helping to 
prevent this from happening to other people.
    I think that I would say that NCI federally coordinating 
cooperation and collaboration on the case of GI cancers like 
gastric cancer and esophageal cancer is one of what I would 
think would be their truest missions, which in the case of 
someone like Ray where they are younger and they have a more 
rare cancer, that is a time where there really isn't a sample 
size that you need at any one institution. There are many 
institutions that are doing their best to really make a 
difference in curing people that have gastric cancer but they 
might see a handful of patients that are young like Ray, so in 
really attacking that question of what is happening in these 
cases with gastric and esophageal cancers that are happening in 
young people, collaboration is absolutely essential. Otherwise 
they just won't be able to make the kind of gains that they 
need. And they need--in the case of gastric cancer, they need a 
place to store tissue. They don't have a biorepository where 
they can store things. They need to be able to share that so 
they can make the research happening at any one institution 
benefit from the kinds of tissues that are coming into other 
institutions. They need a clinical registry which is 
coordinated on a federal level, all the kind of things that 
they can use to determine the kinds of influences that are 
contributing to these cancers. The coordination on a federal 
level helps to be able to solve that problem because of the 
smaller sample size at all the institutions that are working so 
hard.
    And probably most importantly, they need a coordinated 
federal research project because there are difficulties in 
obtaining gastric cancer tumors. When you are diagnosed with 
gastric cancer, you can't have surgery if you are stage IV like 
Ray because that would delay your chemotherapy and you would 
probably die. So you have to have mechanisms in order to 
develop a better tissue sample before it is treated with 
chemotherapy, and those are the kinds of things that NCI can 
perfect and disseminate throughout the United States because 
you are not having an endoscopy at a cancer center most likely. 
You don't think you are going to find cancer. And so even the 
community centers need to be able to get a sample size of the 
tissue that is untreated in order to have the kinds of things 
they need to make the truest gains in research. So it is 
probably in my view one of the areas where NCI can most be 
effective is coordinating all these fantastic cancer centers 
that are doing their very best in these areas and really making 
those gains.
    Mr. Shimkus. Thank you, and I have got limited time, but 
the 5-year survival rate for GI cancer is?
    Ms. Fitzgerald. Well, for metastatic cancer, five of the 
worst survival rates, and I put them in my testimony, are GI. I 
think it is 1.7 for pancreatic. Liver is, I think, 2.2, 2.4 for 
esophageal, 3.4 for GI cancer. So, you know, folks with 
metastatic cancer, which is where it is often found for those 
GI cancers, they are not living.
    Mr. Shimkus. Which is compared to some of the others where 
we have 95 percent early diagnosis, and I know they are 
different, but that is part of this debate.
    My time is up but I just want to, if I can, Mr. Chairman, 
just go to Dr. DiPaola and Dr. Allen. Because we have had a big 
debate on this terminology and hopefully this terminology is 
maybe not the same, or I am trying to get--comparative 
effectiveness research, which in the health care debate we talk 
about funding. Comparative effectiveness research, I hope, I 
gather from what you are doing, is finding the right response 
for the right disease, kind of like Dr. Barker talked about on 
the genome and the right medicine or whatever to affect that. 
What is your definition of comparative effectiveness research? 
Is it for directed research or is it not for a funding process, 
is it?
    Dr. DiPaola. It is a great question, and this comes up a 
lot. In terms of comparative effectiveness research, what we 
are really trying to do is do research to try to understand 
with many of the therapies that we have how to have better 
outcomes for patients, so how to take the therapies that we do 
have and appropriately use them to maximize their effect and 
outcomes for patients.
    Mr. Shimkus. Not possibly minimize care based upon the 
cost?
    Dr. DiPaola. I think that it should be focused on outcomes.
    Mr. Shimkus. Dr. Allen.
    Mr. Allen. Thank you. At Friends of Cancer Research, we 
spend a lot of time looking at this issue for really about the 
last 2 years, and in conjunction with the cancer community put 
together a policy white paper that I am happy to leave copies 
for the members of the committee if you are interested. But 
what this outlined was really from a broad perspective what can 
be obtained through comparative effectiveness research, largely 
focusing on the need for creating additional information, and I 
think we are in a fortunate position as far as the national 
infrastructure that is available in this country from the 
cancer research centers funded by NCI to be able to collaborate 
better to create additional information that then can be a 
starting point for comparative effectiveness research but it is 
important as this funding is being allocated to fund 
comparative effectiveness research moving forward that we 
capitalize on the strengths of the different agencies to be 
able to really get to the answers to the questions that we are 
looking for and so comparative effectiveness and personalized 
medicine can actually go hand and hand and inform each other 
better.
    Mr. Shimkus. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you.
    Next is our vice chair, Ms. Capps.
    Mrs. Capps. Thank you. Thank you, each of you, for your 
testimony. I had to miss some of the oral testimony but I am 
glad I could read the written statements that you made and I 
appreciate it very much. I have two questions, one to ask you, 
Dr. DiPaola, quite specific to the Cancer Institute of New 
Jersey. Then I have a more generic question to ask each of you.
    So if I could ask you, Dr. DiPaola, your testimony 
described the work of the Cancer Institute and the work of the 
consortia. Can you just briefly highlight the issues involved 
in setting this up and the way this could be replicated in 
other areas of the country, how it could be streamlined perhaps 
as a model?
    Dr. DiPaola. Sure, absolutely, and I think that the 
consortia model is being done throughout the country, you know, 
and I gave an example in terms of what we are doing. CINJ as an 
NCI-designated center does have a consortia model, meaning 
there can be members, great researchers from additional 
institutions, especially local institutions, that would 
basically allow us to share their science, work together and 
translate that science into clinical trials for patients. Right 
now we work together with many of the researchers at Rutgers 
and now even Princeton, and what I had described in my 
testimony was an example of that that has actually led to a 
better understanding on how to better starve tumor cells and 
has led to additional grant funding because of this team 
approach. Additionally, it has led to clinical trials that are 
operating right now that are taking that biology and that 
understanding from researchers from multiple institutions and 
putting it into designing new clinical trials.
    Mrs. Capps. Thank you, and because of Dr. Barker's previous 
testimony, I can see the connection with NCI and then to you 
and then perhaps other consortia around the country too. I see 
a really good model.
    Finally, I know that it has been mentioned already that our 
recovery dollars have been a real boost to the NCI. The 
downside of that is that it is one-time or limited-time 
funding. I would like each of you to respond to this question. 
We all know that NIH has essentially been flat-funded during a 
good portion of the past decade. In your experiences, how has 
this affected cancer research, and particularly research on the 
deadly cancers, and briefly, how can we avoid that in the 
future? Just down the panel, if you will start, Ms. Fitzgerald.
    Ms. Fitzgerald. I think that NIH and NCI are doing their 
very best.
    Mrs. Capps. I know they are.
    Ms. Fitzgerald. It is a difficult balance. I think one of 
the things that I would like to see is factoring in incidence 
but then factoring in mortality. You know, maybe there is a 
large portion of the United States that gets a particular 
cancer but if they have treatments, they are a little bit 
better off than, for example, my husband, who there just wasn't 
treatment available and so factoring in that, when you get this 
cancer, then you die, that to me should mean that there is a 
priority there in the federal research. So to the extent that 
new dollars come into the pot, that those are--and even with 
the existing dollars, they are apportioned in a way that 
includes looking at those kinds of statistics.
    Mrs. Capps. Thank you.
    Ms. Don.
    Ms. Don. So 2 percent of NCI's $5 billion budget goes to 
pancreatic cancer research. When you talk about ARRA funds, 
there are approximately 208 projects for all of the eight 
deadly cancers for a total of about 5.7 percent of NCI's ARRA 
budget. So we look at it, if these eight cancers are causing 
half of all cancer deaths, we are not trying to say that it 
should be X percentage or X number of dollars that should go to 
these cancers but it seems like there should be more than 18 
percent of the overall budget, 2 percent in the case of 
pancreatic, less than 6 percent of ARRA funds going to the 
cancers where we have the worst survival rates, and as I stated 
earlier, I think that part of the problem is that given the 
flat funding, NCI has been looking for the safest bets instead 
of the most difficult research and the deadly cancers clearly 
are some of the most difficult and complex research.
    Mrs. Capps. Let me shift the tone for you, Dr. DiPaola, 
given your testimony. Is there a way that the consortia could 
come partway to meet that diagnosis that has been given by the 
two previous, you know, how can the deadly cancers that need so 
much, is there a way that what you do can help meet the needs 
that they propose?
    Dr. DiPaola. Yes, I do think so. You know, as we especially 
work in teams, you know, teams of researchers that are really 
discovering new pathways and the biology and align them with 
the clinical researchers that are able to take it in the clinic 
or for clinical trials that are therapeutic or for new 
biomarkers that might be useful in diagnosis. I think as we 
support those teams coming together on a regular basis, we 
speed up that process so that that biology, which is cancer 
biology, can apply towards really any cancers, and especially 
rarer cancers. I can tell you that I spent this morning being 
part of a session at NCI, a symposium where we looked at a new 
biology focused on that area of metabolism actually called 
autophagy, and what was commented in the symposium was that 
that biology actually applies even best to the most aggressive 
cancers, so now what would be important, which we did there, 
was we had laboratory researchers presenting with clinical 
researchers is translate that to many different cancers but it 
is that same important biology.
    Mrs. Capps. That is important.
    Dr. Allen.
    Mr. Allen. Thank you. Well, I think like any situation 
where there is a budget, there comes hard choices. But I think 
that with NCI leading the way, it must be encouraged to look at 
what other components of the health care system can provide 
data so that cancer research is an ongoing and learning 
process. We need to look at the data that is available through 
other federal health-related agencies, and even as Ms. 
Fitzgerald mentioned earlier, with so many cancer patients 
being treated in a community setting, how cancer treatment can 
actually be research so that we learn more about the products 
we are even using now, because when they come to market, we 
don't really fully understand, particularly the impact that 
these products might have in different populations that weren't 
involved in the original clinical trials. So there is a degree 
of creativity in trying to capitalize and generate as much data 
as possible so that we are in a learning process continuously.
    Mrs. Capps. Thank you, each of you.
    Mr. Pallone. The gentleman from Texas, Mr. Burgess.
    Mr. Burgess. Thank you, Mr. Chairman. You know, I think it 
is interesting on a historical note, this building that we are 
in, the Rayburn Building, Mr. Rayburn did die of pancreatic 
cancer and the diagnosis was just as Ms. Don described it. He 
came down with back pain, came back to Texas, was hospitalized 
probably back then under the care of an orthopedist for a while 
without much help to his problem, and ultimately succumbed to 
his disease. So I don't think things were a whole lot different 
in 1961 than they are in 2010. It is useful to reflect.
    Dr. Allen, I just wanted to ask you on the issue that has 
come up of course with The Cancer Genome Atlas and the issue of 
personalized medicine as far as treatment but what about 
prospectively? What about looking ahead at someone's risk? What 
if there were a way to screen people to understand where their 
risks were? Is that something that is on the horizon out there 
from a genetic standpoint, not just from the family history, 
not just from the things we typically associate but you have 
companies out there now sequencing human genomes for $987. Is 
that a useful part of what lies ahead for the next generation 
of researchers and doctors?
    Mr. Allen. I think it is quite possible. The challenge is 
that right now at this point in time we may not fully 
understand what some of that information could lead to down the 
road or what it actually means at a point in time or quite 
frankly what to do in order to act and when a problem is 
identified. But I think this also goes back to the earlier 
question about how we try and gather long-term longitudinal 
data so that we understand the outcomes associated with some of 
those genetic tests that are detected. Ms. Castor described 
really a large project that is going on at the Moffitt Cancer 
Center that is trying to do just that. As patients come in and 
are diagnosed with cancer, they are enrolled in a long-term 
database that allows for a great deal of follow-up. So not 
everyone can be enrolled in a clinical trial throughout their 
lifetime but if there is a way that we can try and capture more 
data about each individual person, share this across multiple 
centers and agencies, then we may be able to get to some of 
these longer-term answers much quicker.
    Mr. Burgess. Where are you in that process? My father 
trained at Mayo Clinic back in the late 1940s. Part of his 
master's thesis was on esophageal cancer. Mayo Clinic has 
tissue from every patient they have ever seen since patient 
number one. Is there an effort to sort of consolidate and be 
collaborative of this mass of data that is out there?
    Mr. Allen. I think there are some very good efforts 
underway. The challenge is the problem is so complex. One 
program that the NCI would be able to tell you more about is 
their cancer bioinformatics grid which looks to align clinical 
trial data from multiple centers across the country. This helps 
to essentially increase your patient base as well so hopefully 
like the others at the table mentioned, when you have smaller 
cancer populations enrolling for those trials is an increased 
challenge so kind of connecting the data between others is 
underway. I think the challenge is that the data sources are do 
disparate right now that it is very difficult to align what you 
gain from a clinical trial versus perhaps administrative 
records like CMS that have more of a longitudinal look to 
things rather than a point in time kind of where clinical trial 
is a little shorter span.
    Mr. Burgess. Well, with other areas in medicine, 
particularly with the push to electronic health records, we 
talk about particularly for hospital-acquired infections, for 
example, deidentifying and aggregating data so that trends can 
be spotted sooner than perhaps in the past. Is this type of 
work going on as far as surveillance of cancer? It seems like 
The Cancer Genome Atlas being developed, this would be 
something that people would want to do and in fact would be a 
priority.
    Mr. Allen. Absolutely, and I think there is a great deal of 
interest in doing that. It is underway. It is expensive. But 
right now I think the biggest challenge, it is frequently done 
in isolated different centers so you mentioned the Mayo Clinic, 
which has a fantastic model and example and achieved many 
successes from it. But in order to really harness the power of 
this, it would be nice to try and adopt that and allow it to 
link in to other systems that are doing very much the same 
thing so that we increase the pool, so to speak, the means to 
the end will be much faster.
    Mr. Burgess. Dr. DiPaola, is that something that you are 
doing in New Jersey?
    Dr. DiPaola. Absolutely. In fact, you know, one of the 
areas that we have increased dramatically over the last follow-
up years was our bioinformatics area, and they are working with 
NCI in their efforts so that we do a better job in having 
clinical data associated with all of the issue and genetic 
data.
    Mr. Burgess. What about the concept Ms. Fitzgerald raised? 
A lot of, particularly, well, in this case not early stage 
gastric cancer is diagnosed at an endoscopy center or an 
ambulatory surgery center, kind of different from the days when 
I trained, whoever was in the hospital, and it was not as big a 
challenge to collect tissue and get it down to the lab. Is 
there an effort being made to get collaboration from the 
endoscopy centers and ambulatory surgery centers for just this 
type of data collection?
    Dr. DiPaola. There is. You just pointed out some of the 
things and challenges we need to overcome, and especially when 
things are in these trials including multidisciplinary 
approach, not only multidisciplines in terms of lab and 
clinical researchers but different disciplines in terms of 
surgery and radiation oncology and medical oncology.
    Mr. Burgess. But it does seem, Ms. Fitzgerald was telling 
her story and we have the other paper where it talks about the 
incidence of adenocarcinoma of the esophagus increasing. I 
mean, I have heard that story different names and different 
places but the same story, advanced-stage esophageal cancer 
being diagnosed at an ambulatory surgery center or endoscopy 
center if the incidence is indeed increasing, and this is not--
I mean, this is the third time I have this story told. I did 
practice medicine but not GI. It just seems like that is 
something we should be perhaps a little bit more aggressive 
about, about getting the word out to our clinicians who are 
doing the endoscopies out in the field.
    Ms. Fitzgerald. I don't think that the technology exists to 
get the kind of tumor sample that they want, right now, 
anyways. I mean, I think that it is important to get that 
little biopsy but what they really need is they need that whole 
tumor with those properties before it is treated and so they 
need, like, a little hole punch that goes all the way down and 
gets more of those tumor properties, and I think NCI is working 
on that but I am not sure that it is totally the kinds of 
tissue that we need for the kind of research that we need to 
do. I am not sure that that technology is totally available.
    Mr. Burgess. But, I mean, 15 years ago we were doing that 
for breast disease for estrogen receptors in the hospital. They 
weren't large tissue samples with ovarian malignancy.
    Ms. Fitzgerald. And they haven't been disseminated, and I 
think the other part of it too is that in terms of clinical 
trials, many patients do not qualify for clinical trials 
because they are late-stage diagnosis. For example, my husband 
could not qualify for that so I think clinical trials are 
really important in terms of driving some of the funding but I 
think in the case of pancreatic cancer and some of these other 
cancers like gastric cancer, you simply are not going to be 
able to participate because you don't qualify and so there has 
to be a way of obtaining those kinds of tissue samples too.
    Mr. Pallone. OK. We are 3 minutes now.
    Mr. Burgess. Sorry.
    Mr. Pallone. That is all right.
    The gentlewoman from Illinois, Ms. Schakowsky.
    Ms. Schakowsky. Well, first of all, let me just express my 
condolences to you, Ms. Fitzgerald. As has been said, there is 
really not a family that hasn't been affected. My 38-year-old 
daughter-in-law died of cancer 5 years ago. I admire your 
incredible composure. I am still not as good at talking about 
it as you were today. You are great.
    Here is what I want to really understand from this 
testimony. One is the issue just of diagnosis. If there is not 
really major symptoms of some of these deadly diseases, then 
inevitably when they are diagnosed, they have moved along. So 
maybe this has all been said in the testimony but it is not 
just what we do about the cure. Yet your husband was burping. I 
mean, who doesn't, right? So what would drive--let us say he 
went for an annual checkup. What do we do about diagnosis?
    Ms. Fitzgerald. You have to have a molecular screen on a 
cellular level. You have to have a blood test that could pick 
him up because there is no other way that you can prevent it 
because there is not a large enough population for these 
cancers that they will ever have the invasive screening 
procedures necessary that there would be for like colon or 
breast cancer. You just won't have an endoscopy screening 
program in the United States like you have a mammography or a 
colonoscopy program.
    Ms. Schakowsky. Right.
    Ms. Fitzgerald. You have to have that science. You have to 
understand that molecular change that somebody on their regular 
visit to their general practitioner has a blood draw and 
catches that and either gets put into a screening program or, 
you know, catches the cancer and takes it out. You know, that 
is the only thing that would be able to get somebody in this 
kind of a situation.
    Ms. Don. If I may comment, that is absolutely true. The 
other thing is that we do need more awareness for the symptoms 
that we know about. For example, in pancreatic cancer, we are 
beginning to see that there may be some evidence that otherwise 
healthy mean who all of a sudden have diabetes may actually 
have pancreatic cancer, and when they see their general 
practitioner their general practitioner isn't thinking about 
pancreatic cancer, they are thinking about treating their 
diabetes, and so we need to get more information out there 
about even back pain. We need to get more information out there 
so that more physicians are thinking about some of these other 
cancers from very seemingly benign symptoms and we absolutely 
need a good early detection test but we also need to get 
information out as it becomes available.
    Ms. Schakowsky. Thank you.
    Dr. DiPaola.
    Dr. DiPaola. I absolutely agree with the other speakers. I 
guess what I would say is that, you know, with the research 
that is going on looking at the biology of the cancer that 
leads to an understanding of what potential markers we could 
assess, which might be early diagnostic markers.
    Ms. Schakowsky. Meaning when we take a blood sample or 
something?
    Dr. DiPaola. I think that we need to continue to work 
toward discovery of even better markers as we learn the biology 
of cancer even more, and the problem is that once we understand 
that in the laboratory to really apply it in the clinic. We 
need to conduct very large clinical trials to validate that, 
and that becomes difficult, especially in rarer tumors, and I 
think having partnerships and collaborations to conduct those 
types of trials is going to be critically important. So even if 
we found and there are a number of potential markers to prove 
it and make sure that it is doing what it should be doing, we 
need these larger clinical trials.
    Ms. Schakowsky. So if cancer were present but it is not one 
of these common ones, is our goal to develop now some kind of a 
simple one-size-fits-all diagnostic tool that is a blood test 
of some sort or, I don't know, urine, whatever, I don't know, 
that would at least say there is some abnormality that is worth 
looking at?
    Dr. DiPaola. Well, I mean, the goal would always be to 
define the best and the simplest. I think----
    Ms. Schakowsky. But are we looking for that? Are we 
anywhere close to that?
    Dr. DiPaola. Absolutely. I mean, I think there are a lot of 
leads and it stems from understanding the biology better. I do 
think that kind of the partnership between the labs that are 
looking at the biology and these potential markers with the 
clinic need to continue to work together, but it will 
ultimately require validation in these larger clinical trials 
where many people need to be enrolled to really understand 
this.
    Ms. Schakowsky. But is the thought, though, that some 
manifestation of the disease is more likely to show up? You 
seem to imply that even then in some of the rarer forms of 
cancer that it may not necessarily show up in some kind of a 
mass test.
    Dr. DiPaola. No, I think that there is a lot of potential 
based on the biology and understanding new markers. There are 
new imaging modalities that are coming up all the time, so our 
ability to do things with greater technology have a lot of hope 
and I think our ability to collaborate so that we can conduct 
larger trials to prove or disprove and develop these different 
technologies is going to be important but I do think we need to 
look further, some relying on, as you have heard, the current 
symptoms and current imaging modalities for many of these 
cancers is just not enough and so we are relying on new science 
and discoveries, new markers and developing them all the way 
through clinical trials to prove them and use them in the best 
possible way.
    Ms. Schakowsky. Thank you. Thank you all.
    Mr. Pallone. Thank you.
    Mr. Shimkus. Before you could, could I----
    Mr. Pallone. I yield to the gentleman.
    Mr. Shimkus. Thank you, and I will be brief. Kind of 
following up on my colleague from Illinois's comments, I think 
part of that genome discussion I think earlier, one of my 
takeaways is that if we identify in essence an individual 
genome, and I would have thought that they would never change. 
Obviously there are changes that may occur, and then if people 
have that as part of their medical record, then you may get a 
better heads-up than before. Is that fair to say?
    Dr. DiPaola. Absolutely. If you can start identifying 
populations that are at risk for certain cancers, then as you 
develop even, you know, the existing and the newer modalities 
whether they be imaging or new biomarker potential diagnostic 
tests, you would apply them more individualized and 
appropriate, especially for the higher populations.
    Mr. Shimkus. And I guess the other takeaway is that we do--
as we know, we always have the disease groups here. This 
funding issue causes people to struggle, and it is very 
compelling when you talk about mortality rates and where should 
dollars go. Now, we would hope that NCI would take that into 
consideration as they make these decisions versus intervention 
by us or other people. I was never one to want to direct 
funding because you want it to go to the scientists and you 
want them to apportion based upon due diligence, but there is a 
question about should mortality be given a higher priority, and 
that is kind of a takeaway and I don't know what we do from 
that.
    And last, I got an e-mail. Kristin, folks who are watching, 
they are saying you are doing a great job and they appreciate 
your strength and fortitude.
    Thank you, Mr. Chairman.
    Mr. Pallone. Thank you.
    Let me say before we conclude, it is very obvious to me and 
I am sure to everyone in the room that there is a great deal of 
interest on this panel in everything you have discussed, and I 
know it was mentioned that Ms. Capps and I are trying to put 
together some legislation and there is already, I think that 
you mentioned the pancreatic cancer bill that is already out 
there. I mean, there are different things out there. So first 
of all, I will say we are probably going to have a lot of 
follow-up written questions to all of you just because we have 
so many questions. I know, for example, you both described the 
need for improved collaboration to ensure that scientific 
advances at NCI and others actually translate to safe and 
effective treatments, and I want to follow up with my staff 
about the three types of collaboration you discussed within the 
biomedical research community and with industry partners, so 
that is one thing I know we are going to get back to you on. 
But I am sure there are going to be others. So thank you so 
much. We really appreciate it. Usually we get back to you 
within 10 days or so with any written questions that we have, 
and I really appreciate your testimony.
    And without objection, the Subcommittee hearing is 
adjourned.
    [Whereupon, at 5:50 p.m., the Subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

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