    [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

        [GRAPHIC] [TIFF OMITTED] T6020A.002

        [GRAPHIC] [TIFF OMITTED] T6020A.003

        [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:]

        [GRAPHIC] [TIFF OMITTED] T6020A.010

        [GRAPHIC] [TIFF OMITTED] T6020A.011

        [GRAPHIC] [TIFF OMITTED] T6020A.012

        [GRAPHIC] [TIFF OMITTED] T6020A.013

        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

        [GRAPHIC] [TIFF OMITTED] T6020A.015

        [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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