[Senate Hearing 110-984]
[From the U.S. Government Printing Office]






                                                        S. Hrg. 110-984

                 CANCER: CHALLENGES AND OPPORTUNITIES 
                          IN THE 21ST CENTURY

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                                   ON

       EXAMINING CANCER RELATING TO CHALLENGES AND OPPORTUNITIES 
                          IN THE 21ST CENTURY

                               __________

                              MAY 8, 2008

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions


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                                 senate





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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

               EDWARD M. KENNEDY, Massachusetts, Chairman

CHRISTOPHER J. DODD, Connecticut     MICHAEL B. ENZI, Wyoming
TOM HARKIN, Iowa                     JUDD GREGG, New Hampshire
BARBARA A. MIKULSKI, Maryland        LAMAR ALEXANDER, Tennessee
JEFF BINGAMAN, New Mexico            RICHARD BURR, North Carolina
PATTY MURRAY, Washington             JOHNNY ISAKSON, Georgia
JACK REED, Rhode Island              LISA MURKOWSKI, Alaska
HILLARY RODHAM CLINTON, New York     ORRIN G. HATCH, Utah
BARACK OBAMA, Illinois               PAT ROBERTS, Kansas
BERNARD SANDERS (I), Vermont         WAYNE ALLARD, Colorado
SHERROD BROWN, Ohio                  TOM COBURN, M.D., Oklahoma

           J. Michael Myers, Staff Director and Chief Counsel

                 Ilyse Schuman, Minority Staff Director

                                  (ii)









                            C O N T E N T S

                               __________

                               STATEMENTS

                         THURSDAY, MAY 8, 2008

                                                                   Page
Kennedy, Hon. Edward M., Chairman, Committee on Health, 
  Education, Labor, and Pensions, opening statement..............     1
Murkowski, Hon. Lisa, a U.S. Senator from the State of Alaska, 
  statement......................................................     3
 Hutchison, Hon. Kay Bailey, a U.S. Senator from the State of 
  Texas, statement...............................................     5
Harkin, Hon. Tom, a U.S. Senator from the State of Iowa, prepared 
  statement......................................................     7
Burr, Hon. Richard, a U.S. Senator from the State of North 
  Carolina, statement............................................     8
Brown, Hon. Sherrod, a U.S. Senator from the State of Ohio, 
  statement......................................................     8
    Prepared statement...........................................     9
Edwards, Elizabeth, J.D., Senior Fellow, Center for American 
  Progress, Washington, DC.......................................    11
Armstrong, Lance, Chairman and Founder, Lance Armstrong 
  Foundation, Austin, TX.........................................    13
    Prepared statement...........................................    15
Case, Steve, Chairman and CEO, Revolution Health, Washington, DC.    18
    Prepared statement...........................................    20
Benz, Edward J., Jr., M.D., President, Dana Farber Cancer 
  Institute, Boston, MA..........................................    38
    Prepared statement...........................................    41
Simon, Gregory C., J.D., President, FasterCures, Washington, DC..    44
    Prepared statement...........................................    45
Moddelmog, Hala, M.A., CEO, Susan G. Komen Foundation, Dallas, TX    51
    Prepared statement...........................................    54

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Enzi, Hon. Michael B., a U.S. Senator from the State of 
      Wyoming, prepared statement................................    68
    Mikulski, Hon. Barbara A., a U.S. Senator from the State of 
      Maryland, prepared statement...............................    69
    Obama, Hon. Barack, a U.S. Senator from the State of 
      Illinois, prepared statement...............................    70

                                 (iii)

  

 
                 CANCER: CHALLENGES AND OPPORTUNITIES 
                          IN THE 21ST CENTURY

                              ----------                              


                         THURSDAY, MAY 8, 2008

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 9:04 a.m. in Room 
SH-216, Hart Senate Office Building, Hon. Edward M. Kennedy, 
chairman of the committee, presiding.
    Present: Senators Kennedy, Dodd, Harkin, Murray, Reed, 
Brown, Burr, and Murkowski.
    Also Present: Senator Hutchison.

                  Opening Statement of Senator Kennedy

    The Chairman. Well, there are many important hearings that 
are taking place in the U.S. Congress probably this year. I 
think, for many of us on this committee, this really is one of 
the most important.
    Not only is it related to something that families across 
this country are concerned about, but we also have three very 
extraordinary individuals in our first panel, others that will 
follow who really represent the best in terms of knowledge and 
understanding and commitment on this issue. So today is a very 
special day for our committee and for many of us on this 
committee who had a long-time interest and association with 
trying to deal with the challenges of cancer.
    I will make a brief opening statement. I will ask Senator 
Murkowski if she would make a brief opening statement. We have 
some time issues, then we will listen to, hear from our 
witnesses.
    We are honored today to have such distinguished guests. We 
welcome Elizabeth Edwards, a dear friend. My wife, Vicki, and I 
have enjoyed the times that we have spent with Elizabeth, John, 
and the Edwards family. Elizabeth is currently an inspiration 
to me, and I know she is for millions of Americans, as she 
shares with the Nation her spirit of determination, her hope, 
optimism, and we admire her very much.
    We also welcome Lance Armstrong. America cheered you on to 
seven Tour de France victories, cheered you in your battle with 
cancer. Now you are doing the cheerleading, urging us to do all 
we can to find the cure.
    We are honored to welcome Steve Case. We know that he was a 
pioneer at AOL and in our transition to a high-tech economy. 
Today, he has dedicated those same talents and extraordinary 
abilities to fight against cancer.
    So each one comes to this issue from different paths, with 
a variety of experiences and insights to offer, but we have a 
common commitment to do all we can to stand with those facing 
cancer and to find a cure. So I thank you all for the enormous 
difference you are making on this issue and for being with us 
today.
    Thirty-seven years ago, a Republican president and a 
Democratic Congress came together in a new commitment to find a 
cure for cancer. At the time, cancer was the second-leading 
cause of death in the Nation. Americans lived in fear that they 
or someone they loved would be lost to this dreadful disease.
    In 1971, in response to these serious concerns, we passed 
the National Cancer Act with broad bipartisan support and 
launched the war on cancer. Since then, significant progress 
has been made. New methods to prevent and treat cancer have led 
to more beneficial and more humane ways of dealing with the 
illness.
    The expansion of basic research, the use of large-scale 
clinical trials, the development of new drugs, and the enhanced 
focus on early detection have led to breakthroughs unimaginable 
only a generation ago. And as a result, today cancer is no 
longer the automatic death sentence that it was a generation 
ago.
    But despite the impressive achievements in fighting cancer, 
our society now faces a perfect storm of conditions, have 
expanded the number of our citizens suffering from cancer--the 
aging of our population, the new environmental issues, 
increased life expectancy, and unhealthy behavior. As a result, 
today cancer is still the second-highest cause of death in 
America.
    Clearly, we need a new way forward in battling this 
frightening disease. We must build on what the Nation has 
already accomplished and launch a new war on cancer for the 
21st century. We stand on the threshold of unprecedented new 
advances in life sciences, such as much earlier diagnosis based 
on molecular evidence and astonishing new treatments tailored 
to an individual's own DNA and capable of blocking the gene's 
effects.
    To make the promise of this new century of discovery a 
reality, we must see the patients' DNA tests are free from any 
fear that their genetic information will be used against them 
to deny them health insurance or even jobs. Congress took a 
major step last month towards unlocking the potential of this 
new era of approving comprehensive protections against genetic 
discrimination in health insurance and employment, and 
President Bush is about to sign it into law.
    To launch this new war on cancer, we must first give new 
urgency to efforts to find cures for cancer. We have learned 
over the years that cancer is, in fact, not a single disease. 
Knowledge gained from molecular biology now suggests that 
cancers vary not only from type to type, but from person to 
person, with each individual having specific cancer that is at 
least partially unique.
    Second, an equal priority must be to lift the horizons of 
science to detect and prevent the disease before it develops. 
We can now look at each other's genes to prevent cancers before 
they happen. We can tap modern technologies that can detect and 
destroy cancer cells in their earliest stages before they 
destroy a life. We can continue to work on vaccines that will 
eradicate a threat over a lifetime.
    Third, we can treat patients with modern therapies that 
enable them to survive their cancers and lead full lives. 
Modern medicine allows individualized care for the specific 
biological, social, and emotional needs of each affected 
person.
    And finally, we need to integrate our current fragmented 
and piecemeal system of addressing cancer. Front and center in 
our current system are the troubling divisions that separate 
research, prevention, and treatment. Our current system treats 
these three aspects of cancer care as being inherently 
separate, rather than what they really are--different aspects 
in the continuum of comprehensive cancer care. The net effect 
of this fragmentation is the development of marked disparities 
in research, market innovation, and access to care and quality 
of care.
    In sum, we need an entirely new model--for research, 
prevention, for treatment, and we are here today to begin that 
effort. We must move from a ``magic bullet'' approach to a 
mosaic of care in which advance becomes part of a larger 
picture of cancer care.
    We have today an esteemed group of witnesses to start what 
I hope will be an ongoing conversation on cancer in our Nation 
and the world.
    Senator Murkowski.
    Senator Murkowski. Thank you, Mr. Chairman.
    The Chairman. We are joined, I see, by Senator Hutchison, 
and we are delighted to welcome our principal co-sponsor of 
this legislation. Someone who has been enormously involved and 
active in this and many other health issues, and we are 
delighted.

                     Statement of Senator Murkowski

    Senator Murkowski. Mr. Chairman, I want to thank you. I 
want to thank Senator Enzi for scheduling this hearing this 
morning.
    I want to welcome those on our first panel. Clearly, a 
very, very distinguished panel, leaders in this area, and we 
appreciate all that you do and your efforts on behalf of those 
afflicted with cancer and your efforts to make sure that we win 
this battle.
    Mr. Chairman, you mentioned the war on cancer that was 
launched by President Nixon back in 1971. That was a long time 
ago, 36 years ago. It has been about $79 billion ago. And the 
war on cancer continues.
    We are very, very proud, and we are very thankful for the 
more than 10 million cancer survivors nationwide. The great 
researchers, the great scientists that have helped us achieve 
progress in many, many areas. But as we all know, the war 
continues.
    Cancer accounts for one in four deaths in the United 
States. But we do know that we have seen some good news. We 
have seen some progress. Researchers have made impressive 
strides in battling certain types of cancers. It is estimated 
that 99 percent of prostate cancer patients will survive at 
least 5 years, and 9 out of 10 breast cancer patients will, 
too. This is compared to about a 70 percent rate for prostate 
cancer, 75 percent for breast cancer back in the mid-1970s.
    We are making gains. We have come a long way. I think we 
all acknowledge that there is so much more to do.
    Those of us on the HELP Committee, quite frequently say, 
``an ounce of prevention is worth a pound of cure.'' I believe 
very strongly that education on the cause, the risks of those 
factors--whether it is tobacco use, alcohol--looking at what it 
is that we can do to outreach, to focus on prevention, to help 
motivate and enable individuals to get screened for cancer 
early, to make healthy lifestyle choices.
    You look at Lance Armstrong here in the middle. Talk about 
healthy lifestyle choices, and yet, cancer comes along. We 
recognize that with a limited exception of pap tests, 
mammograms, pelvic and colorectal and prostate exams, Medicare 
and most State Medicaid programs do not cover preventive and 
screening services for cancer. This is unfortunate because we 
do recognize that there are relatively low-cost screenings.
    In the State of Alaska, where so many of our Alaska Natives 
are afflicted with oral cancer, we know that early and lower-
cost screenings could greatly improve the early diagnosis and 
dramatically increase a patient's chance for survival.
    Now, while our cancer research is yielding significant 
improvements in the diagnosis, in the treatment, and the 
prevention of many forms of the disease, we have to appreciate 
that Federal funding for cancer research is not doing what we 
need. It is declining. And we cannot forget the advances that 
have been made and then the years that it takes for the drug 
developments to occur.
    We certainly recognize this in the drug Herceptin that is 
used in the treatment of the ``Her-2 positive'' form of breast 
cancer. Initial discovery was made in 1979, and it wasn't until 
1998 that Herceptin was approved by the FDA for use in breast 
cancer patients. We can and we must continue to bring the life-
saving drugs to market to build on the progress that we know.
    I want to specifically mention the Lance Armstrong 
Foundation and some of the specific efforts that we have seen 
in Alaska. You have helped us in an outreach to our Alaska 
Native communities by funding the ``Traditional Food Guide for 
Alaska Native Cancer Survivors.'' This is a full-color 142-page 
nutrition guide that has been published by the Alaska Native 
Tribal Health Consortium cancer program, and it highlights the 
traditional foods that should be eaten by cancer patients.
    Keep in mind that the high rate of cancer that we are 
seeing amongst Alaska Natives, are out in villages. You have 
access to some of the food that you see in the grocery store, 
but a lot of it is the traditional subsistence food. Are the 
berries safe? Is this type of fish safe or not safe? What part 
of the moose do you eat?
    I learned in this guide that the nose of the moose is OK, 
but the lips are not where you should be going if you have 
cancer. We appreciate that the Lance Armstrong Foundation has 
helped us with this food guide. We understand that the first 
order of 3,000 copies has already been distributed and 
completely gone. We appreciate your help with that.
    I also want to make sure that I recognize the important 
work that tens of thousands of volunteers do every day at 
national and State organizations, such as the Susan G. Komen 
Foundation, the American Cancer Society, the Lance Armstrong 
Foundation. These are all critical to us as we fight the war 
against cancer.
    We all know someone that has been impacted by cancer in 
some way. We have lost too many loved ones to not ensure that 
NIH and NCI have the funding necessary to find the cure for all 
of these diseases.
    Again, I thank you, Mr. Chairman, for your leadership in 
this. Senator Hutchison, for yours. I look forward to the 
comments from the very distinguished panel.
    The Chairman. Senator Hutchison, we thank you for being 
here and welcome a comment from you.

                     Statement of Senator Hutchison

    Senator Hutchison. Thank you very much, Mr. Chairman and 
all of the members here.
    I just want to say a few things. First, I will be anxious, 
Lance, to see the Texas version of nutritional eating for 
cancer survivors and what parts of the armadillo----
    Mr. Armstrong. No, the longhorn. You should not eat the 
horns on the longhorn.
    Senator Hutchison. Thank you very much. I was hoping that 
you would----
    Mr. Armstrong. But, I am not even a nutritionist.
    [Laughter.]
    Senator Hutchison. Let me just say a couple of things. 
First of all, I am so pleased and honored to join with Senator 
Kennedy in the initiative that will look at where we are. I 
think that Senator Kennedy and Senator Murkowski have covered 
some of the major reasons why we are here. I think it is time 
for us to step back from what Congress has already done, and 
that is double the NIH funding with, I might say, great help 
from Senator Harkin, who is at this table. It was Senator 
Harkin and Senator Specter who led the way for the doubling of 
the funding for NIH, and I thank you for that.
    I was one of the 25 or so women who sat in Nancy Brinker's 
living room back in the, I guess, early 1980s that became the 
foundation for the Susan G. Komen Foundation. I have worked on 
and followed the progress on breast cancer research for a long 
time, and I am pleased that Hala Moddelmog from the foundation 
is going to be one of the witnesses today.
    I want to also say that my brother has multiple myeloma. I 
have also championed the blood diseases, and I know about the 
progress and what isn't being done in that field.
    I have watched Elizabeth Edwards be such a great role model 
for America, the way you have accepted and kept a smile on your 
face, she's just been the most amazing person going through the 
treatment at the time. It is an inspiration for all of us.
    And Lance Armstrong, oh my gosh. You know, I want to say 
that Lance Armstrong--of course, I am proud that he is a Texan. 
To have been the inspiration to cancer survivors that he is, to 
show that not only can you survive cancer, but you can become 
the best in your field in sports in the world, and you can do 
it six times----
    Mr. Armstrong. Seven.
    [Laughter.]
    Senator Hutchison [continuing]. And be a cancer survivor. 
Seven? What? Seven. Oh, I underestimate you all the time, 
Lance. Seven times he can be the world champion.
    What I love the most is that he has now taken on a new 
effort. He led the effort in Texas to pass a $3 billion bond 
issue just for cancer research and treatment, and he could have 
rested on his laurels. He could have gone to Hollywood, or I 
guess he wouldn't be going to France again. But he is doing 
even more to say that we can beat this if we just keep working.
    He has led the effort for the bond issue, which we are now 
going to begin to process, doing things like Lisa mentioned in 
Alaska. It is beyond what anyone could have ever hoped for, and 
I am so proud to be here with you and to lead this effort with 
Senator Kennedy.
    Let me just say that what Senator Kennedy and I are going 
to do, and this hearing is going to be a big part of it, is try 
to remove the barriers that we see today. We know that there 
could be more progress and coordination in cancer research, 
that there is so much going on, but it is not being coordinated 
well enough to produce the results that we need.
    We need to reduce the disparities in cancer treatment 
because we know there are certain sectors of our country that 
are being under-treated maybe because they don't have access to 
the early detection and prevention knowledge. We want to make 
sure that we are doing that.
    Enrollment in clinical trials, making sure that those 
clinical trials are covered by insurance. This is going to be 
what I think we are going to be looking at.
    We look forward to hearing from the witnesses on both 
panels. I will have to be leaving, but I will be coming back 
and listening throughout the testimony because we are going to 
renew our war on cancer. And I look forward to the Kennedy-
Hutchison bill, and we are going to make this happen.
    Thank you very much.
    The Chairman. Thank you very much.
    We had planned to move ahead because we have scheduling 
issues, but I see my colleagues. If I could ask them to keep it 
less than 2 minutes and urge a word from Tom Harkin, who has, 
as Senator Hutchison, been such a leader in this whole area.
    Would that be good? A couple of minutes should be about it. 
Hopefully, none of our other colleagues will come in, and we 
won't tell them if they do come on in.
    Tom, thank you.

                      Statement of Senator Harkin

    Senator Harkin. Mr. Chairman, thank you very much for your 
kind words, and Senator Hutchison. I just want to thank our 
panel.
    I will just ask that my statement be made a part of the 
record.
    [The prepared statement of Senator Harkin follows:]

                  Prepared Statement of Senator Harkin

    I thank the chairman for calling this important hearing. 
And I want, in particular to welcome my friends Elizabeth 
Edwards and Lance Armstrong to the committee.
    Elizabeth, in addition to being an outstanding advocate for 
screening and early detection, you have set an amazing example 
for every person fighting cancer--an example of courage, 
tenacity, and a truly indomitable spirit. We thank you for 
coming, today.
    Lance, you became a national hero for winning the Tour de 
France 7 years in a row. You have become a national treasure as 
America's No. 1 advocate for cancer research, detection, and 
treatment. I want to thank you, again, for testifying at my 
cancer field hearing in Iowa City in July 2006.
    I have been very pleased to secure funding every year since 
2004 for a unique partnership between the Lance Armstrong 
Foundation and the Centers for Disease Control and Prevention. 
That partnership has resulted in the National Action Plan for 
Cancer Survivorship, which is charting the course for our 
entire Nation in how best to prevent secondary cancers and 
recurrence of cancer, and how to improve the quality of life 
for survivors.
    This is personal with me. I have lost four of my five 
siblings to cancer. And, with better detection and screenings, 
perhaps my siblings would have had a better outcome.
    I believe passionately in doing our best to prevent cancer, 
by encouraging appropriate lifestyle choices, including good 
nutrition and smoking cessation. I am equally passionate about 
the need to do a better job of detecting cancer as early as 
possible.
    In 1990, I secured the first funding for the National 
Breast and Cervical Cancer Early Detection Program. And I've 
championed that funding every year since. It currently stands 
at $200 million annually.
    In 2005, I secured funding for a Colorectal Cancer 
Screening Demonstration Program in five communities around the 
country. Colorectal cancer is the second most deadly form of 
cancer, killing nearly 55,000 Americans each year. We know that 
screening is extremely effective: you detect polyps and remove 
them, and this dramatically reduces the risk of this type of 
cancer.
    The Colorectal Cancer Screening Demonstration Program has 
been a huge success on a small scale. This year, I intend to 
make this demonstration program permanent, and to double its 
reach in the coming year.
    Of course, the biggest issue with regard to cancer 
prevention and research is money. Right now we are waging a war 
on cancer on a shoestring budget. In truth, over the last 5 
years, we have been funding a retreat in the war on cancer. And 
that is a national shame.
    Between 1998 and 2003, Senator Arlen Specter and I teamed 
up to nearly double funding for the National Cancer Institute. 
Because of the President's misplaced priorities--funding the 
war in Iraq, not the war on cancer--National Cancer Institute 
funding has fallen short of biomedical inflation every year for 
the last 5 years. The President has proposed an increase of 
less than $5 million for 2009. As I said, that is simply 
shameful.
    And, make no mistake, this kind of neglect has 
consequences.
    At the National Cancer Institute, only 11 percent of 
research grants are being funded. This is the highest 
percentage of rejections in decades. They are rejecting many 
grants of exceptional quality. Projects seen as risky--even if 
they have great potential for breakthroughs--are much less 
likely to be funded.
    We have got to do better.
    We need a surge in the war on cancer.
    We need a surge in funding for screening and prevention.
    We need a surge in embryonic stem cell research relevant to 
cancer.
    I intend to do everything I can to increase funding this 
year. And I agree wholeheartedly with Lance Armstrong: Cancer 
funding should be an issue in the election this year. We need 
to know where every candidate for President and Congress stands 
on the issue of funding the war on cancer.

    Senator Harkin. I just want to thank our panelists for 
their courage, their tenacity, and the example that they show 
everyone on how to fight cancer and that indomitable spirit 
that the two of you have. Also, for Mr. Case, in challenging 
accepted ways of thinking and trying to get us to think 
differently about how we do some of these things.
    So, all three of you, thank you very much for your 
leadership in this area.
    The Chairman. Senator Burr.

                       Statement of Senator Burr

    Senator Burr. Mr. Chairman, I will join my colleague, Mr. 
Harkin, and be brief. I want to welcome Mrs. Edwards, who is a 
great advocate for healthcare from North Carolina. We welcome 
you here today. Lance Armstrong, who is just a fabulous athlete 
and a great spokesperson. And Steve Case, an unbelievably 
successful business person.
    I want to encourage my colleagues if you haven't read in 
detail Steve Case's testimony, I would ask you to do so. I just 
want to read one part that I think really hits home.

          ``The policies now in place limit collaboration and 
        slow innovation by making it difficult for NCI to 
        partner with for-profit companies.''

    This identifies an absolute key that we have got to figure 
out, and Steve, I just want to thank you for your testimony. It 
is very out-of-the-box compared to how we think in Washington, 
and I encourage my colleagues to pay particular attention to 
his statement.
    I thank all three of you for being here.
    The Chairman. Thank you very much.
    Senator Brown.

                       Statement of Senator Brown

    Senator Brown. Thank you, Mr. Chairman, and thanks to all 
three of you on the panel, especially to Elizabeth Edwards. 
Your op-ed in the New York Times recently was just phenomenal. 
My wife, who is a terrific admirer of yours, as you know, sends 
her regards.
    A couple of real quick issues that Senator Hutchison 
touched on in the health disparity issue. The death rate for 
African-American men from prostate cancer is 240 percent higher 
than it is for white men. African-American women have a lower 
incidence of breast cancer than white women but are more likely 
to die of the disease.
    We know these health disparities are so, so serious. That 
is a big part of what Senator Kennedy's bill needs to address 
and will address.
    Another issue, and real briefly, I am introducing 
legislation this week called the Access To Cancer Clinical 
Trials Act. I have found out in a series of roundtables I have 
done around Ohio in the last year-plus that an insurer--you 
will buy an insurance policy to insure yourself on the premise 
that the policy covers medically necessary routine care. Then 
you enroll in a clinical trial. Suddenly, your insurer refuses 
to cover your routine healthcare costs while you are in the 
clinical trial.
    In essence, you are in a clinical trial. They drop the 
coverage you have for the rest of your standard care, which is 
quite a disincentive to enroll in a clinical trial, which 
obviously threatens your own health too often as a cancer 
patient and sets back medical science. It is something that 
clearly we need to fix. That is a small part of the efforts we 
need to put forward with something we should do.
    Mr. Armstrong, thank you. Mr. Case, nice to see you. And 
thank you, Elizabeth.
    [The prepared statement of Senator Brown follows:]

                  Prepared Statement of Senator Brown

    Thank you, Mr. Chairman, for focusing on convening this 
important hearing.
    In one way or another, cancer has touched all of our lives. 
A loved one, a neighbor, a friend, a role model . . . someone 
we know is fighting cancer.
    As it stands, cancer is a vicious enemy, a brutal fact of 
life.
    We are making progress, and someday we will put cancer in 
its place. We will prevent it and we will cure it.
    Medical research is the lynchpin. And needless barriers to 
research are a deadly setback.
    I'm introducing legislation today that confronts one of 
those barriers: unjustifiable out-of-pocket costs.
    Here's what happens: An insurer sells you a policy on the 
premise that the policy covers medically necessary routine 
care. Virtually all health plans do.
    Then you enroll in a clinical trial.
    Suddenly, your insurer refuses to cover routine health care 
costs, even if those costs have nothing to do with the clinical 
trial itself.
    It deters people from enrolling in clinical trials, which 
thwarts medical research and chokes off hope for patients who 
have exhausted all their other options.
    I am introducing the Access to Cancer Clinical Trials Act 
to prevent insurers from establishing illogical, unethical, 
insupportable coverage exclusions for routine care . . . care 
that is not associated with a clinical trial, but that happens 
to coincide with it.
    This bill is a true Ohio effort--Ohio Congresswoman Debra 
Pryce, a leader in the area of cancer research, has championed 
this legislation in the House.
    I am introducing the Senate companion to advance her vision 
and pave the way for more cancer clinical trials.
    Our bill obligates health plans to pay for routine care 
costs when a cancer patient enrolls in a clinical trial.
    These are costs that would normally be covered if a cancer 
patient were not participating.
    The legislation is very specific in its definition of 
routine care costs to make it clear that clinical trial-related 
care would still be covered by the trial itself, as would the 
costs of any complications related to the trial.
    It is equally clear in stopping health plans from treating 
cancer patients like second class citizens, dashing their hopes 
and compromising the public health.
    Last year, Sheryl Freeman and her husband, Craig, of 
Dayton, OH, visited my office in Washington, DC.
    Sheryl had multiple myloma. Sheryl and Craig brought to my 
attention the problems they were having with their insurance 
company.
    Sheryl was a retired school teacher and was covered under 
Craig's insurance plan.
    Craig has been a Federal employee for 20 years and has one 
of the best health plans in the country.
    Yet when Sheryl tried to enroll in a clinical trial, her 
insurance company would not cover the routine costs of her 
care.
    In addition to her clinical trial in Columbus, Sheryl 
needed to visit her oncologist in Dayton at least once a week 
for standard cancer monitoring, which included scans and blood 
tests.
    But her insurance company would not cover these services if 
she enrolled in a clinical trial.
    Sheryl wanted to take part in a clinical trial because she 
hoped it would help her. She hoped that it might save her life, 
give her more time, or advance cancer research.
    Rather than devoting her energy toward combating cancer, 
Sheryl spent the last months of her life haggling with her 
insurance company.
    The delays and denials from Sheryl's insurance company 
probably affected her treatment and her survival.
    Sheryl died on December 9 of last year. This story should 
have ended differently.
    Sheryl and Craig should not have had to sacrifice their 
precious time together trying to get the care she deserved, the 
care she paid for when she signed up for health insurance.
    On Monday of this week, I met another cancer patient, Merle 
Farnsworth, from Beverly, OH.
    Merle has lymphoma. For him, clinical trials signify hope. 
Hope for the future, hope for others who are fighting cancer, 
hope for a cure.
    As we take a closer look at cancer today, I will be 
thinking of Merle and Sheryl. No one should be robbed of hope 
by an insurance loophole. No one.
    Thank you, Mr. Chairman.

    The Chairman. We will ask Elizabeth Edwards if she would 
lead off. There are many parts of your biography, all of your 
biography was left out. One additional part that I will add for 
Elizabeth Edwards is that tonight she has been--will celebrate 
being elected as the recipient of the Mother of the Year award.
    [Applause.]
    The Chairman. So, congratulations to you on that as well.

STATEMENT OF ELIZABETH EDWARDS, J.D., SENIOR FELLOW, CENTER FOR 
               AMERICAN PROGRESS, WASHINGTON, DC

    Mrs. Edwards. Thank you all. Thank you to Senator Enzi, who 
is not here, for this hearing; to Senator Kennedy for your role 
not just today, but, of course, for decades in being a leader 
on these issues; Senator Murkowski for your interest in it; and 
Senator Hutchison for your co-sponsorship of this bill--or I 
guess sponsorship of this bill is enormously important. Senator 
Harkin, obviously an enormous voice with respect to all sorts 
of healthcare issues.
    I want to tell a story before I begin that actually 
involves Connie Schultz, Senator Brown's wife. I was in 
Cleveland in March 2007, giving a speech at a luncheon, and 
Connie was there. It was a very nice event.
    Afterwards, a number of people spoke to me. One woman who 
was very well-dressed, leaned over, spoke to me and said, 
whispered in my ear--she didn't want anyone to hear--whispered 
in my ear that she had a lump in her breast. She was really 
afraid for herself and for her children because she had no 
health insurance and, therefore, could not get it tested.
    We tried--she ran off before--I guess to get back to work 
before we were able to hook her and Connie up so that she could 
get the treatment and the great services that they have in 
Cleveland and make certain that that one gap was filled.
    It says some bad things about us, of course, that we have a 
system where a working mother can't get healthcare that she is 
going to need in order to be able to continue to provide for 
those children. It also says something kind of good about our 
spirit, I think. That this woman, despite all of the hurdles 
that she had in front of her, believed that if she just 
whispered in the right person's ear, something could change.
    Since March 2007 and hearing that woman's whisper in my 
ear, I have been trying, and this is--I want to thank you so 
much for giving me the opportunity now to whisper for her in 
the right person's ears. Those are your ears because you have 
the capacity to make a difference in the life of that woman and 
so many women who are like her.
    I speak a lot about healthcare policy now. I am a senior 
fellow with the Center for American Progress. This is an issue 
that doesn't know political boundaries. It knows moral 
boundaries, and we have an obligation as human beings, to make 
certain that we answer this call.
    Senator Murkowski said one in four Americans dies of 
cancer, one in four of us. If you look around the room and 
imagine how many of us that is, it is a necessity that we 
respond to this demand. The fact that it is nonpartisan is 
indicated by the fact that the first war on cancer was led by 
President Nixon with a Democratic Congress, all believing we 
needed to respond.
    Believe me, in addition to my occupation, I also, of 
course, am--I have metastatic breast cancer. It will 
undoubtedly be the reason that I die, when I do. I have a real 
interest in the treatments and making certain that those 
happen. Making certain that we pay attention to metastasis in 
our research as an important part of the process, the part of 
the process that usually takes us, when it does.
    I want to talk today about the fact that it doesn't matter 
what kind of services we have if we don't have access to them. 
And the impediments to access are often--or some of them are 
whether or not we have insurance. Some of them are demographic, 
our economic status. Some of them are geographic. If we live in 
rural areas, it is more difficult for us to get services. These 
are things that need to be addressed.
    I want to make three points in my testimony today. One is 
that health insurance matters. The quality of coverage, of 
course, matters. Health insurance itself is really a crucial 
part of this. Probably the most preventable cause of 
unnecessary suffering in our healthcare system is the lack of 
adequate health insurance. That was what this woman was 
complaining to me about.
    Compared to those with health insurance, uninsured people 
with cancer are more likely to be diagnosed late, less likely 
to have access to needed care, and more likely to die within 
the 5-year period. They are also less likely to have their 
lives prolonged. It is likely to be tied to the ability to get 
access, both demographically and geographically.
    As Senator Brown was mentioning these disparities, if you 
are a black woman today--we have made all this progress that we 
have been talking about, which is great. If you were a black 
woman in 1988, your chances of survival were essentially the 
same as they are today if you have advanced breast cancer. They 
haven't changed in 20 years. Now if you are a white woman, they 
have changed. You have a chance of living about 2 years longer 
because of the improvements that have been made because of the 
research. These are not available widely.
    I have a friend. You must know I am a North Carolinian, 
right?
    There are, of course, right and wrong ways to insure us. It 
is really important that we build, I think, and I hope that 
your programs will build on the existing successful system of 
employer-based coverage until we are able to subsidize 
everybody. I hope that there would be a someday when we are 
able to do that, but until we do, what has worked for us is an 
employer-based system. We need to make certain that that 
remains in place.
    Because people who are uninsured--47 million of us are 
uninsured, another 15 million or so who are underinsured--are 
largely uninsured because we don't have coverage through our 
employer.
    Among those 47 million who are uninsured, a million have 
cancer. And they are the ones we know about. Obviously, there 
are a lot of them who are not getting diagnosed. Assume if you 
have a one in four chance of getting cancer, you are probably 
talking more about 12 million of them, who will eventually die 
of cancer if they do not get the treatment that they need and 
some if they do.
    Anyway, so we want to build on it. People should have the 
option of keeping that coverage if they want. Also from 
choosing from private plans, individual private plans, if that 
is what they choose to do. I would like them to have the 
quality of the services available to Members of Congress. I 
know that when my husband was in the Senate, served on this 
committee, I was afforded very good coverage. Which meant that 
although I had to be very afraid of having cancer, I didn't 
have to be afraid of not being insured.
    Also, I would like to see us build on our public health 
system. You were talking earlier, Senator Murkowski, about 
Medicare and Medicaid and the need to make certain that these 
systems provide the kind of comprehensive coverage that we 
need. Short of comprehensive insurance reform, we also need to 
make certain that we are bolstering those public health systems 
and the policies, the insurance that is available through 
those, and filling the gaps in eligibility and in screenings 
and other kind of coverage, which currently exist in those 
systems.
    We know how to lengthen and improve the lives of people 
with cancer, but we've chosen, as a Nation, to turn our backs 
on some of us who have the disease. I urge you to reform 
healthcare responsibly and morally and aggressively and save 
millions of us. Save that woman in Cleveland who whispered in 
my ear.
    Thank you.
    The Chairman. Very good. Thank you very much.
    Mr. Armstrong.

   STATEMENT OF LANCE ARMSTRONG, CHAIRMAN AND FOUNDER, LANCE 
                ARMSTRONG FOUNDATION, AUSTIN, TX

    Mr. Armstrong. Thank you all. Thank you for having all of 
us here. Senator Kennedy, Senator Hutchison, Senator Murkowski, 
thank you. And to the other Senators as well, thank you.
    My journey to this place began 11 years ago, when, for 
those of you who don't know, I was diagnosed with advanced 
testicular cancer that had spread throughout my body--the 
abdomen, the lungs, and the brain. It was obviously a surprise 
to me at the time because I assumed that I was a healthy, fit 
person, and I had never even had a broken bone, tendonitis. A 
common cold was very rare for me.
    Then, all of a sudden, this happened and really turned my 
life upside down. Of course, it ended up being a bit of a 
blessing in that it gave me a new sense of perspective on my 
life. It became my life's work, and it became my life's mission 
to make sure that this disease is diminished in our lifetime.
    I was fortunate enough in 2002 to be appointed by President 
Bush to the President's Cancer Panel and to serve 6 years and 
to listen to testimony from doctors and researchers and nurses 
and survivors and family members all over the world. And listen 
to their stories, listen to their passion. It taught me a lot.
    This issue is big, and this issue is complicated. This 
issue, as we will talk about today, is literally hundreds of 
diseases. This is not one disease. I think America in general 
has this perception that let us just go and cure cancer. When, 
in fact, why am I sitting here today as somebody who feels like 
he has been cured, meanwhile down the street, a 45-year-old man 
will die of colon cancer? Because it is a different disease, 
and it is treated differently and operated on differently and 
monitored differently and researched differently.
    We have to be realistic. The numbers are stunning. Five 
hundred sixty-thousand Americans die every year, 1 American 
every minute, 1.4 million Americans diagnosed every year, 12 
million Americans living with cancer in this country today. 
Those are big numbers.
    In fact, if you consider where does this disease rank, why 
are we talking about this? Well, we are talking about it 
because it is the No. 1 killer in this country for people under 
the age of 85, which says that it is worthwhile.
    A couple of other things with regard to the scope of the 
disease is the economic impact of this illness. Today, in 2008, 
the economic impact of this disease is hundreds of billions of 
dollars on our society in terms of loss of productivity, loss 
of life, loss of efficiency.
    It is projected that by the time--I have an 8-year-old son. 
It is projected that by the time he graduates college this 
disease will cost our society and our economy a trillion 
dollars every year. That is a number that, when compared to $6 
billion or $7 billion in Federal funding at the NCI, seems to 
me to be out of line.
    The other and, I think for me, the most important 
comparison here is the disparity in cancer care. Simply put, 
the 560,000 deaths that we have every year in this country, a 
full third of them could be prevented. We could save close to 
200,000 American lives every year if we simply applied the 
information and the technology and the knowledge that we have 
to the people that need it the most.
    To me, and I am not the smartest guy on this panel by any 
stretch of the imagination, but if we have something in-house 
and there is somebody down the street that needs it, and we are 
not walking down the street and giving it to him, we are 
failing. And so, I would also--I would stress that.
    Having been around this fight for 10 or 11 years now, I 
have come to learn a thing or two, and I think the thing that 
sums it up for me the best is to discuss this epidemic as a 
continuum, what we call the cancer continuum. That, to me, 
really boils down to six areas, and those are prevention, 
screening and early detection, access to the best healthcare 
and medical care, scientific research, survivorship, and end-
of-life care.
    All of them have to be looked at when we talk about this 
issue, and I think that is what is so great about this new 
piece of legislation is that it really is a comprehensive look 
at the continuum. I mean, if it is prevention, we have to 
discuss tobacco and tobacco abuse. We have to discuss sun and 
sunscreen, et cetera, et cetera. We have to discuss other 
potential environmental factors, at least explore them.
    Screening and early detection, we know--everybody in this 
room knows, I think, that the earlier you catch this disease, 
the better off you are. The chances for cure are so much 
higher.
    Access to care, as I said, if we have the information and 
the technology and the science to cure people, regardless of 
the color of their skin, the neighborhood they live in, the 
language they speak, we should do that.
    Scientific research, the fact that we have in the last few 
years been cutting the budget at the National Cancer Institute 
and the National Institutes of Health in the midst of a growing 
and oncoming epidemic, a perfect storm of an aging population, 
a sedentary youth population, and a disease that is really not 
going away, we are making a big mistake.
    Survivorship--very, very important to understand that with 
12 million of us living with this disease in this country, I 
fully understand what it means to be a survivor, and I also 
understand what it means to thrive after my disease. Making 
sure that I am aware and that everybody else, all 12 million of 
us, are aware of our future health risks, future potential side 
effects, secondary diagnoses, other potential problems. We have 
to make sure that anybody, especially for us, a cancer survivor 
maintains a high quality of life. And so, survivorship is 
important.
    Ultimately and unfortunately, if somebody is going to pass 
away, that they pass with dignity and with pride and with the 
way that they want to go. Now, we don't ever want to end up 
there.
    To close it up, I will tell a little story. I have been 
walking around these halls for almost a decade, probably close 
to a decade. And I have met with most of you guys and gals, and 
we have had, I think, some great success. I have got to tell 
you, the most poignant moment that I ever had, Mr. Kennedy, was 
when I was in your office. And we were discussing this very 
issue. And I never know if people are passionate about this or 
not because sometimes in DC that is the MO.
    As we were discussing this issue, you started to talk about 
your son, and the next thing I know--and you sort of hesitated 
and you paused, and you got a little choked up, and I thought, 
``Oh, my God. Senator Kennedy is shedding a tear,'' and when he 
is talking about his son. You pointed to the picture on the 
wall, and there was Junior skiing down that slope. And you 
said, ``That is my son, the cancer survivor.''
    I had the good fortune to meet your son last night, and it 
is an honor to have met him. It is an honor to be here with you 
to share your passion.
    This is a major fight. This is a major war, and this is 
something, as I said, it doesn't care if you are a Republican 
or you are Democrat, if you are young or you are old, you are 
black or you are white, Native American, you are rich or you 
are poor. It comes, and it comes hard. It is ruthless and it is 
relentless.
    And for us to win, we also have to be ruthless and 
relentless. I encourage all of us to do that. Renew the war on 
cancer. Renew a comprehensive war on cancer and ultimately make 
sure that our kids and our grandkids don't have to face this.
    Thank you.
    [The prepared statement of Mr. Armstrong follows:]
                 Prepared Statement of Lance Armstrong
    Mr. Chairman, members of the committee, thank you for inviting me 
to testify before the Senate Committee on Health, Education, Labor, and 
Pensions today. I am honored to be here with you. Chairman Kennedy, I 
applaud you and Senator Enzi for your leadership in renewing our 
Nation's focus on cancer.
    Much has happened in the 37 years since Congress passed the 
National Cancer Act. Chairman Kennedy, I know you played a key role in 
the passage of that historic legislation. Our National War on Cancer 
has made much progress since 1971. Thousands of lives have been saved 
and we have improved the lives of many more. Still, we can and must do 
better.
    After I was diagnosed with cancer in 1996, I founded the Lance 
Armstrong Foundation (LAF), a 501(c)(3) national nonprofit organization 
based in Austin, TX. The LAF engages Americans to pursue an agenda 
focused on preventing cancer, ensuring access to screening and care, 
improving the quality of life for people affected by cancer, and 
investing in needed research. The LAF is committed to making cancer a 
national priority through our advocacy initiatives.
    The facts are staggering. Five hundred and sixty-five thousand 
Americans will die of cancer in 2008--more than 1,500 people a day. One 
point four million Americans will hear the words, ``you have cancer'' 
this year. Cancer is already the leading cause of death for Americans 
under the age of 85, but it is certain to become the leading cause of 
death for all Americans in the next decade as the ``Baby Boomer'' 
generation ages.
    I was honored to be asked by President Bush to serve two terms on 
the President's Cancer Panel. The Panel was established by the National 
Cancer Act of 1971 to monitor the development and execution of the 
activities of the National Cancer Program, and report directly to the 
President. Before my second term expired this year, I had the privilege 
of working with national cancer experts such as Dr. Harold Freeman, Dr. 
LaSalle Lefall and Dr. Margaret Kripke.
    During my 6 years on the Panel, I contributed to the creation of 
four sets of recommendations to the President of which I am very proud. 
I feel that as much as I contributed, I've learned even more in the 
process. Traveling the country as a member of the Panel, I learned that 
as a Nation, we know what it takes to save lives. What we know and what 
we do are two different things.
    Through my service on the President's Cancer Panel, I have seen 
first-hand the toll this disease takes on America and recognized it for 
the epidemic that it truly is. The recommendations made to the 
President by this Panel are ones that I stand behind and fully support. 
In fact, my foundation has made them cornerstones of our policy 
platform and our advocacy efforts. But sadly, one of my biggest 
frustrations throughout my service on the Panel is that very few of the 
recommendations we made ever came to fruition.
    We have the ability and power to improve access to quality health 
care for cancer patients while lowering the personal costs of 
treatment. We can also cure many who have cancer and improve their 
quality of life.
    Tragically, we do not use all available policy and regulatory tools 
at our disposal to optimize what we can control; nor do we deploy 
sufficient resources to stimulate scientific discovery and translation 
which hold enormous promise. Thanks to your leadership, we have an 
opportunity to renew our efforts in four key areas.
                             access to care
    Nearly 47 million Americans lack health insurance, and about 16 
million more are underinsured. Study after study has shown that those 
who lack insurance or are underinsured have higher cancer mortality 
rates than those who have insurance and therefore better access to 
care. Healthcare coverage and financial concerns should not dictate who 
lives, who dies, and who suffers unnecessarily. Yet all too often, it 
does.
    Quality cancer care means ensuring that people with cancer have 
access to treatment that has been proven successful and is appropriate. 
It means services are delivered in a patient-centered, timely, and 
technically competent manner. And, it depends on good communication and 
shared decisionmaking between the patient and provider in a culturally 
sensitive manner across the continuum of care and throughout the 
remainder of life. We do not take full advantage of what we already 
know about delivering high quality cancer care.
    It is fundamentally and morally untenable that a world-class 
athlete who has been diagnosed with testicular cancer should have a 
better chance of surviving than an African-American resident of Harlem 
who has been given the exact same diagnosis. Yet minority and poor 
populations carry a disproportionate burden of the negligent cancer 
care in the United States--even when adjusting for socioeconomic 
factors.
                            quality of life
    We must improve the quality of life for people affected by cancer. 
Providing access to quality cancer care and improving quality of life 
are intertwined.
    In 1971, there were 3 million cancer survivors in the United 
States. At that time, cancer was largely a death sentence. Today there 
are 12 million Americans living with the disease. Addressing the needs 
of this growing population is critical.
    Quality of life means different things to different people. Broadly 
speaking, quality of life for those living with cancer may encompass 
physical well being, including symptom management; psychological and 
social issues; emotional well-being; and spiritual considerations.
    Cancer survivors should be provided access to treatment summaries 
and survivorship care plans. Patients starting treatment should be 
provided written documentation that details all elements of their 
treatment and those completing primary treatment should be provided 
with a comprehensive care summary and follow-up plan that is clearly 
and effectively explained. These resources allow cancer survivors to 
play a critical role in their treatment decisions and provide much-
needed documentation of their treatment history. This service should be 
uniformly reimbursed by third-party payors of health care.
    Psychosocial support is absolutely critical to the quality of life 
of cancer patients and survivors, yet the healthcare system's provision 
thereof is often abysmal or nonexistent. We must ensure that clinicians 
incorporate psychosocial management as an integral part of treatment.
    Cancer survivors are at increased risk of experiencing employment 
and insurance discrimination. Signing the Genetic Information 
Nondiscrimination Act (GINA) into law will go a long way to provide 
protections against the use of genetic information in health insurance 
coverage and employment decisions. Even with the passage of GINA, the 
fact that cancer survivors are consistently denied health coverage due 
to pre-existing condition classifications must also be addressed.
    Pain management and palliative care for cancer patients and 
survivors is in need of improvement. Pain is the number one symptom 
cited in cancer as well as a host of other diseases, yet it is 
continually left under-treated. The appropriate management of severe 
symptoms such as pain, nausea and vomiting is not only central to 
quality of life, but it also has implications for the efficiency of the 
health care system.
                           cancer management
    Managing cancer involves activities that aim to prevent or cure 
cancer and increase survival and enhance quality of life for those who 
develop the disease. We must deliver the knowledge we have gained 
through research into strategies and services to the general public.
    We can have a measurable impact if we just apply what we know. We 
have the tools to detect many of the more common cancers earlier, when 
they are most treatable.
    The U.S. Preventive Services Task Force (USPSTF) first recommended 
that Americans 50 and older be screened for colon cancer in 1996. If 
colorectal cancer is discovered early, before it has spread, the 5-year 
survival rate is 90 percent. If colorectal cancer is discovered after 
it has spread to distant parts of the body, only 10 percent of patients 
survive 5 years.
    If all adults 50 and older were screened for colon cancer, we could 
save approximately 30,000 lives per year, cutting the death rate from 
this disease in half. Yet today, 12 years after the USPSTF first 
recommended this screen, we still have no Federal screening program for 
low-income and uninsured Americans.
    Timely and regular mammography screening would prevent up to 30 
percent of all deaths from breast cancer in women over the age of 40. 
Pap tests and the widespread use of the HPV vaccine can prevent 
virtually all deaths from cervical cancer.
    Yet today, the National Breast and Cervical Cancer Early Detection 
program, administered by the Centers for Disease Control and 
Prevention, only reaches 20 percent of eligible women between the ages 
of 50-64 with current levels of funding.
    We also need a unified and evidenced-based national cancer 
prevention and cessation campaign to reduce the use of tobacco 
products. Almost one out of every three cancer deaths in the United 
States--170,000 people a year--is the result of tobacco use. These 
deaths are entirely preventable.
                                research
    Simply applying what we already know about cancer prevention and 
early detection is not enough. For many Americans who die every day 
from terminal cancers, such as lung and pancreatic cancer, there is 
little known about how to effectively detect their disease early enough 
to decrease mortality.
    For these people, research could provide the answer. We need to 
accelerate our investment in research on better detection methods for 
the deadliest cancers. We must improve treatment options so they will 
only attack the cancer cells and reduce the overall damage to the 
patient. And we need to develop treatments to control and manage 
cancer, much as high cholesterol and heart disease are managed 
conditions today. This is all within the realm of medical science, but 
it will take a renewed and constant effort to become reality.
    Unfortunately, our Nation's commitment to cancer research has 
fallen flat over the past few years. National Cancer Institute (NCI) 
funding for cancer research has been level since 2005. I applaud the 
Senate for taking a bold step by passing the Harkin-Specter amendment 
to the Budget in March, supporting a 10 percent increase in funding for 
the National Institutes of Health (NIH) for fiscal year 2009. It is my 
hope that this initial first step will allow Congress to get our 
national investment in biomedical research back on track through the 
appropriations process.
    This is not a time when we should be decreasing our investment in 
extraordinary Federal research opportunities. Federal investments in 
cancer research have yielded remarkable results. Several drugs 
developed and/or tested by NIH-supported scientists have been proven 
effective in treating and sometimes preventing certain types of cancer. 
New, more precise ways to treat cancer are also emerging, such as drugs 
that target abnormal proteins in cancer cells and leave healthy tissue 
alone.
    Investing more money in cancer research is necessary, but not 
sufficient. We must also use strategies that improve the incentives for 
scientists, restructure the enterprise to encourage collaborative team 
science, and support best practices and common sense in clinical trials 
and the translation of discoveries into practice.
    The Federal Government faces significant challenges in coordinating 
research to improve cancer treatment, building effective cancer 
prevention programs, deploying quality cancer care delivery systems, 
and paying for quality care for cancer patients who depend on Federal 
health care programs.
    In light of these challenges, we need a broad-based national cancer 
plan that aligns our research priorities with those for cancer 
prevention, early detection, treatment and survivorship. The NCI is 
doing great work in conducting cancer research, but our national plan 
must be broader than just cancer research. Too much knowledge sits on a 
shelf, never translated from the laboratory to the clinic. And 
effective evidence-based strategies for prevention and early detection 
remain underutilized costing America hundreds of thousands of lives.
    Our national cancer plan should be a multi-disciplinary, cross 
agency approach that leverages the strengths of the various Federal 
agencies and remains accountable for developing results in 
comprehensive cancer control and care. Ultimately, we need strong 
leadership that responds to the needs of the American public, can 
implement the plan, is backed with the resources to achieve the goals, 
and has the authority to facilitate communication and collaboration 
across diverse Federal agencies that are engaged in cancer research, 
prevention, and care.
    In 1999, after I won the Tour de France for the first time, I 
testified on Capitol Hill before the Joint Economic Committee about the 
promise of biotechnology. At that time, I indicated that I was a living 
example of what cancer research can do. If I had been diagnosed in 1971 
rather than 1996, I would have likely died from the cancer that had 
invaded my body.
    During that same hearing, my doctor, Dr. Larry Einhorn, testified 
that cancer was the scourge of the 20th century and if we don't 
accelerate our efforts, it will be the scourge of the 21st as well. Our 
national war against cancer has made some progress since I testified 9 
years ago, but we still have a long way to go to eliminate suffering 
and death due to this disease.
    It has been 37 years since the United States first declared war 
against cancer. I applaud the committee for your interest in renewing 
the fight against this disease and look forward to working with you, 
Senator Hutchison and other Members of Congress on this effort. We have 
new knowledge and new tools ready for deployment. And through your 
leadership, we can change the way our country is fighting cancer in the 
21st century.

    The Chairman. Good.
    Mr. Case.

 STATEMENT OF STEVE CASE, CHAIRMAN AND CEO, REVOLUTION HEALTH, 
                         WASHINGTON, DC

    Mr. Case. Well, first of all, it is a great honor to be 
here. Thank you for your leadership on this issue. I think your 
legislation is exactly the kind of thing that we need to bring 
a more innovative, collaborative, kind of out-of-the-box 
approach to this.
    I am a little humbled to be on this panel with a world 
champion, a seven-time world champion. I am certainly not a 
world champion, and I am also certainly not Mother of the Year. 
I am just an entrepreneur, and I spent about 20 years just 
trying to make the Internet part of everyday life and try to 
usher in a more--a digital age. I must admit, for those 20 
years, I didn't spend much time thinking about cancer. I was 
focused on all kinds of other issues.
    I got a call at midnight 7 years ago from my brother, who 
had a diagnosis of a brain tumor and a week later was told that 
he probably only had about 6 months to live. We asked, the 
family, what causes this kind of tumor, and the answer was 
nobody really knows. And we asked what the treatment options 
were and people said, ``Well, there really aren't any that have 
been particularly effective'' and asked what the prognosis was. 
As I said, it was just sort of a death sentence.
    He said, and we said, that is just not good enough. He was 
an investment banker and took a lot of companies like 
amazon.com and Electronic Arts and other public, and Silicon 
Valley, and said we need to bring an entrepreneurial 
technology-driven approach to bear here, and he started an 
organization, which carries on, called Accelerate Brain Cancer 
Cure, ABC2.org. It is focused on driving innovation, focused on 
driving collaboration, focused on more entrepreneurship in this 
field.
    Coincidentally, this week, we have Brain Tumor Action Week. 
Sunday, we kicked it off with a Race for Hope down Pennsylvania 
Avenue, and I was joined by 8,000 other people talking about 
this issue and shining a spotlight on this issue and trying to 
raise additional funds for this issue.
    I am not here to talk about brain cancer. Obviously, it is 
something I care deeply about. I think part of the problem we 
have now, 37 years into this war, is everybody is kind of 
focused on their particular silo, focused on their particular 
issue. What seems to be lacking, which is what I think your 
legislation is trying to address, is more strategic framework. 
Taking a step back and instead of looking at this as a series 
of little pieces of the puzzle, we should be integrating that 
puzzle in a more comprehensive, strategic framework.
    That is really what I think is desperately needed. Coming 
at this relatively fresh. Bringing sort of an entrepreneurial 
approach. And certainly understanding technology and seeing how 
the Internet developed over the past few decades, it feels like 
that is what we need in this space.
    The kind of leadership the Congress took with the 
Internet--in terms of some of the funding of DARPA and the 
flexibility it gave DARPA--because it desired to invest in this 
issue in the broadest possible context with the greatest level 
of flexibility because our national security was at risk.
    Or when we set out with NASA to put a man on the moon, we 
said we need to do this quickly. We don't want to put a lot of 
restrictions on the groups focusing on this issue. We want to 
give them maximum flexibility and encourage them to think out 
of the box. Indeed, those investments led to a lot of other 
spin-off benefits in terms of our economy with satellite 
technology and Internet companies and so forth. I think there 
are some long-term benefits that go well beyond this.
    It strikes me that it is exactly the right time to 
recognize that this war on cancer is not working at least the 
way we hoped it would. It requires a fresh approach. It is a 
little bit like your personal computer when it has slowed down 
and not working so well. You have to reboot it. You turn it off 
and turn it back on for kind of a fresh start, and that is what 
I think we need here, and a new approach that really is enabled 
by technology, free of bureaucracy, fueled by entrepreneurship, 
and really facilitated by collaboration.
    There are lots of great initiatives that are in place. Some 
of the testimony you will hear this morning talks about them. I 
would just urge you to focus on this strategic framework, less 
on these particular issues, and more on the broader context. 
Think of it more as an opportunity to build a platform for 
innovation.
    Particularly, whatever you end up ultimately deciding in 
terms of how much of the national resources should be put 
against this effort, make sure a significant portion is really 
set aside for strategic initiatives not focused on any one of 
these specific issues, but these broader issues such as what is 
happening with the cancer genome atlas or the bioinformatics 
networks, sort of an Internet for cancer research, or a 
biomarker database--broad efforts that really apply to all 
cancer.
    Then over time, I think it can apply more broadly to 
healthcare as well because the other thing I have noticed, as I 
have learned more about this, is even though we call it a 
healthcare system, it really isn't a system at all. It is sort 
of a kind of confused--and it really isn't even that much about 
health. It is more about disease care. We need an ethic, as 
several of you talked about, that really focuses on keeping 
people healthy and prevention and wellness, earlier detection 
of things so you can catch these things earlier when people do 
have these difficult life-threatening diseases, obviously with 
cancer being the centerpiece of that.
    Just being able to deal with that in a much more 
thoughtful, much more personalized way and recognize that it is 
less about where the cancer starts and more about a systems 
approach even to the human body and approaching it in that kind 
of context.
    I applaud the effort to really kind of reboot our efforts 
on cancer, restart those efforts, and bring a much more 
strategic approach. I would urge you to resist the efforts from 
our organization, ABC2.org, and many others to focus resources 
specifically on specific diseases. Obviously, we care about 
that. What seems to be missing after 37 years is this broader 
strategic framework and far more of those dollars need to--if 
there are any earmarks, it really should be for the strategic 
initiatives that can benefit all cancers and over time benefit 
our healthcare system more generally as opposed to the 
parochial interest of any particular organization.
    Thank you.
    [The prepared statement of Mr. Case follows:]
                    Prepared Statement of Steve Case
    Thank you, Chairman Kennedy for this opportunity to share my 
thoughts with this subcommittee, and for your commitment to this 
important issue.
    My name is Steve Case. I co-founded America Online and spent two 
decades helping to make the Internet part of everyday life. Now I am 
the Chairman of Revolution, a company I started to give consumers more 
choice, control and convenience in important aspects of their lives. We 
are particularly focused on health care, and recently launched a new 
company called Revolution Health. In addition, I serve as the Chairman 
of Accelerate Brain Cancer Cure, ABC \2\, an organization I founded 
with my late brother Dan to drive collaboration and innovation in the 
field of brain cancer.
    ABC \2\ was formed with the belief that the entrepreneurial model 
that has enabled so many technological innovations offers the best hope 
to increase the number of potential therapies discovered and move them 
rapidly into the clinic for patients. ABC \2\ takes an innovative, 
results-oriented approach to giving researchers the active support they 
need to make critical breakthroughs, and helps fund outstanding and 
novel translational research aimed at discovering new treatments to end 
the pain and suffering from brain cancer.
    ABC \2\ continues to play an active role not only in research, but 
also in advocacy. This past Sunday, as a kick off to Brain Tumor Action 
Week, I joined more than 7,000 patients, survivors, and family members 
who gathered on Pennsylvania Avenue to raise funds for research and 
increase awareness. I was inspired by the lasting commitment of those 
who have lost loved ones to brain cancer and also by the more than 200 
survivors who kicked off the race.
    From 1950 to 2001, the death rate from heart disease fell 60 
percent, but during that same period of time, the death rate for cancer 
has not changed. I think it is clear to all of us that the 37-year-old 
war on cancer has not had the impact that was envisioned.
    My brother Dan was afflicted with glioblastoma multiforme (GBM), 
the most common form of brain cancer. Unfortunately, the prognosis for 
someone with a GBM is grim, with less than 50 percent of patients 
surviving more than a year following their diagnosis.
    However, I am encouraged by new research emerging, much of which is 
being developed through collaborations between top brain cancer 
institutions, biotechnology companies, the National Cancer Institute 
(NCI) and the FDA. For example, a new therapeutic option was presented 
recently--bevacuzumab--that appears to effectively cut off the blood 
supply to brain tumors and shrink them dramatically. While this 
treatment will not cure brain cancer, it appears to delay the disease, 
improve quality and quantity of life, and bide time for the next 
breakthrough.
    Bevacuzumab serves as a positive example of what we can accomplish 
when researchers, investors, and patients work together under an 
entrepreneurial model. The lessons learned from the development of this 
treatment should be applied broadly and should signal the need for a 
new strategic approach to cancer research and treatment.
    Indeed, I am not here today to argue for more money for brain 
cancer research. Rather, I am here to share my views on cancer more 
generally--and suggest how we might be able to apply some of the 
lessons learned from building the Internet to fighting cancer.
    All too often, the battle for research money ends up pitting cancer 
groups against each other, in what they perceive to be a zero sum 
game--some will win, and others will lose. The fact of the matter is we 
are all in this together, and all of us will benefit from a more 
strategic, networked, technology-driven approach to cancer research.
    There was a time when information services operated autonomously--
but it was only when they were brought together by the Internet that we 
made real strides. Similarly, our focus in cancer must shift to a more 
integrated approach--recognizing that even the way we label cancers may 
very well turn out to be misguided, as we learn more about pathways and 
invent new more personalized, more targeted ways to treat patients.
    Should we invest more in cancer research? Yes, absolutely, for the 
reasons you'll hear today from my distinguished colleagues. The big 
breakthroughs aren't likely to come just from spending more money--they 
will come from changing how we spend money.
    As is too often the case in business, ineffective approaches may be 
perpetuated simply because it was the way it was done before. While 
such an approach represents a comfortable path for many in large 
organizations, it also inevitably discourages innovation and 
institutionalizes inefficiencies. Since the mid-19th century we have 
classified cancer based on where it appears in the body rather than 
based on its molecular composition. This system has resulted in the 
creation of silos around cancer research, where scientists typically 
focus only on one type of cancer and rarely collaborate. In addition, 
it has created a climate where cancer advocates are all too often 
pitted against each other for limited research dollars.
    We need to come together as one community committed to tackling 
cancer--and move away from the model that treats cancer based on where 
it appears in the body and toward a model where we focus on signaling 
pathways, new technologies, biomarkers and novel clinical trials.
    The National Cancer Institute has already made significant strides 
in this direction with the creation of the Cancer Genome Atlas--an 
attempt to discover the genetic underpinnings of cancer. By 
understanding cancer based on its genetic underpinnings, we are 
discovering that what we thought was one disease--breast or lung 
cancer--are actually several unique ailments. The Cancer Genome Atlas 
is currently analyzing brain, lung, and ovarian cancers, but should 
expand this vital work to all types of cancer. This will be a powerful 
tool which will better enable us to classify different types of cancers 
and improve treatment of the disease.
    A key component of this new approach will be to increase funding of 
biomarker research. Biomarker research will redefine how diseases are 
classified--not simply looking at their symptoms, but at their biologic 
underpinnings. What were thought to be single diseases are being split 
into separate ailments. If we better understand the pathways for 
different types of cancer, we will be able to target treatments more 
effectively.
    As part of this strategic approach, we need to eliminate the 
restrictions that prevent NCI from pursing the most effective 
collaborative models. Congress is well-
intentioned but--in my view--somewhat misguided in earmarking large 
portions of the NCI budget to specific cancers, which deprives the NCI 
from being able to adopt a more strategic approach. Similarly, while 
there is always the risk of abuse, the policies now in place limit 
collaboration and slow innovation by making it difficult for the NCI to 
partner with for-profit companies. We didn't preclude NASA from working 
with for-profit companies when we wanted to reach the moon, similarly, 
we should not prevent NCI from pursuing the most effective model to 
find a cure for cancer.
    We also need to think differently about managing risk. We are so 
good in this country about reporting when something wrong happens, but 
too often fail to highlight our progress. When it comes to cancer we 
need post-approval surveillance of therapeutics to report the positive 
outcomes, not just the side effects. We need to learn from each 
encounter cancer patients have with their doctors and act on that 
information. The technology is in place to allow us to share this 
information in order to improve treatment. If retailers can analyze 
data at each of their cash registers, there is no reason why America 
can't do the same with its cancer doctors.
    Although there is much work still to be done to fight cancer there 
is reason to be hopeful. Some breakthrough collaborative projects are 
in place, and the initial results are encouraging. For example, I 
already mentioned the Cancer Genome Atlas, exactly the kind of 
networked strategic approach we need more of. Another project that 
could result in real breakthroughs is the National Cancer Institute 
Nanotechnology Initiative. These represent good first cross-
disciplinary steps, but a much larger commitment to these sorts of 
strategic, collaborative initiatives is needed.
    As we focus on systems and technology and collaboration, as we 
must, let's not forget that this is all about people--about patients, 
and their families. Our health care system has been organized around 
the payers for the past half century--not around consumers. We need to 
put consumers--patients--back at the center of our health care system. 
For example, cancer patients need to be more empowered with 
information, and have the opportunity to take an even more active role 
in managing their care. This was one of the lessons I learned on a 
personal level, when my brother was battling his cancer.
    My brother passed away, but the work of the organization he started 
lives on. I am proud of the strides we have made in driving 
collaboration and innovation in cancer research. As I spent more time 
learning about the health care system, I concluded that more needed to 
be done--and that I needed to put my money where my mouth was. That led 
me to start a new company, Revolution Health. We are just getting 
started, and we recognize there is a long journey ahead, but we are 
hopeful that we can play a small role in improving our Nation's health 
care system. Our focus is on getting consumers more actively involved 
in thinking about and managing their health and the health of their 
loved ones, so they can live healthier, happier, and longer lives. Our 
efforts to really engage consumers, along with the creative efforts of 
many, many organizations, will hopefully set us on a path towards a 
health care system driven by consumers, shaped by market forces, and 
powered by technology.
    I would like to thank the committee for giving me the opportunity 
to join you today to share both my personal and professional 
experiences--and passion--around revolutionizing health care, and 
fighting cancer. I applaud your commitment and stand ready to assist 
you and the cancer research community to hasten the search for cures.

    The Chairman. Thank you all. Enormously interesting, 
valuable testimony. All very different and all on target.
    I think most of us understand that we are living in the 
life science century. I mean, the opportunities that are out 
there in terms of these breakthroughs are virtually unlimited, 
with the mapping of the human genome. Senator Harkin, again, 
was so involved and engaged in that.
    The opportunity from metabolical and health and research 
are really unlimited. I think we also have a sense of we can't 
legislate, as all of you have pointed out, that you are going 
to have a cure for cancer. We understand that. We also 
understand the American people have an interest. This affects 
so many families.
    If Government is about anything, it is also about trying to 
reflect what people's concerns are, and they are concerned 
about this disease, and they want some additional focus and 
attention. They want to try and bring the best of not only the 
research, but I think, as all of you have outlined, the newer 
kind of approach that is going to marshal all of the elements 
that this cancer brings and to do it in an innovative and 
creative way.
    That seems to me what we are hearing from all of you, and 
certainly what we have heard about before. I am interested in 
your own thinking about the areas that are of greatest concern 
to you--I, for one, am a parent of two children who had had 
rather devastating lung cancer, which is a killer, and another 
the osteosarcoma, the cancer of the leg bone, which was 
dangerous--the good fortune of having early diagnosis, getting 
ahead of the curve.
    I mean, I am absolutely convinced that that made all the 
difference just in the early kind of treatment and how we are 
going to be able to do that for people. As Elizabeth Edwards 
talks about the early kind, making sure, and others have talked 
about access. If you are not going to get the access, you are 
sure not going to get that early diagnosis.
    What is your own experience regarding the importance of 
that early diagnosis, of trying to find out? Maybe you can talk 
a little bit about those preventive aspects of it, and then a 
dash about these breakthroughs that we are having now in terms 
of being able to get early detection.
    It seems to me if we get this early kind of detection, 
early kind of assessment of this and continue to bring the 
focus and attention to this, continue to do these clinical 
trials, but have these early kinds of detection and prevention 
aspects of it, we can really make a very large and substantial 
difference within the broader context.
    Elizabeth, do you want to talk a little bit about this?
    Mrs. Edwards. Well, what we have to do is remove the 
impediments to early diagnosis, to early screenings. There are, 
of course, way too many of those. The largest impediment is 
insurance. The percentage of women who are diagnosed with Stage 
3 or Stage 4 cancers, which means they have metastasized to 
some other part of your body, and that decreases your chances 
of survival, is 2.5 times larger for women who are uninsured 
than it is for people who have insurance.
    Those statistics are repeated in each kind of the cancers 
that people at this table represent and the other kinds of 
cancers not represented there. Your chances of survival are so 
much greater before metastasis. Lung cancer that has 
metastasis, you have a 3 percent chance of survival. Colon 
cancer before metastasis, 90 percent chance of survival. After 
metastasis, 10 percent chance of survival.
    Not to mention, and something that is important, as Lance 
was pointing out, the effect--the economic effect. The 
treatments are less debilitating, less expensive, less 
disruptive if the diagnosis is early. We need to make certain 
that people have access. Sometimes it is demographic in terms 
of whether or not they have the finances to pay for insurance 
or whether they have an employer who pays for it. That is 
something you can solve.
    Another one of the reasons, geographic, we see it in North 
Carolina, I know, because we have a large rural area. I am 
certain Senator Murkowski sees it in Alaska as well. In rural 
communities, it is much harder to get the kind of effective 
screenings. We have better and better--I will use my own 
disease--mammograms, for example, but they are not available 
unless you drive lots of hours to get to them.
    Some of the kinds of investments that we make, they may 
seem expensive on the front end. The truth of the matter is 
that every dollar we spend on the front end saves us $5 on the 
back end at a minimum, and probably more as time goes on and 
increases the quality of the life of the people who are going 
to suffer from this disease until we find out what it is that 
causes it.
    I am convinced we are going to find the answers to these, 
but not without the investment. And I want to applaud what 
Steve Case said, the investment that looks beyond what we 
normally--the protocols that we are normally following right 
now.
    I also want to comment on something that Susan G. Komen is 
doing, and that is they have invested like $600 million in 
basically allowing people to do just what Steve was talking 
about, and that is give the wild ideas a chance, basically. The 
way that we fund research right now doesn't allow that to 
happen. But you are precisely right. We need the early 
detection that saves us money, allows us to make the investment 
in some of these other things.
    I have to ask the indulgence of the committee in order to 
be feted later. If you do not mind my leaving?
    The Chairman. No. No, no. We are very grateful for you 
arranging your program and enormously appreciative of your 
presence and the eloquence of your comments on this. We will 
excuse you and give our very best to the Senator.
    Mrs. Edwards. Thank you, Senator Kennedy.
    The Chairman. We will follow the 6-minute rule here. My 
time will be up, and I will recognize Senator Murkowski.
    Senator Murkowski. Well, thank you, Mr. Chairman.
    Mrs. Edwards, as you leave, I want to again acknowledge all 
that you do and your efforts to remove these impediments, and 
they are very, very real. We look forward to working with you 
on that.
    We have in the State of Alaska some geographic issues that 
we deal with when we talk about the impediments to access, and 
our geography is simply never going to change. And in my 
lifetime, we are probably not going to have any more 
significant roads added to our road system than we currently 
have.
    About 30 years ago-plus, my mother was involved in an 
effort to provide for a mobile mammography unit and recognizing 
that you are pretty limited if you are just sticking to the 
road system. For the past 30 years, every summer, they put a 
mobile mammography unit on a barge. It goes up and down the 
river system, stopping in the little villages where you might 
have only 80 people. We are providing for a level of screening 
that we are bringing to them.
    In the communities that are not accessible by river and not 
accessible by road, every now and again, we can get the Air 
Guard to do a mission and to fly one of their aircraft out 
there. We put the mobile mammography unit in, and what we are 
seeing in terms of removing that impediment to access is that 
the screening rates among the Alaska Native women are greatly 
increasing. And as we are able to screen, we are better able to 
diagnose earlier.
    I look at that as an example of how in a big State with 
real impediments to access, we are reaching women, but we need 
to be doing more things like this in rural America. We need to 
be going to the people. We have got to be more creative.
    Mr. Case, I so appreciate your testimony about the 
collaboration and how we change the way we view the disease and 
the approach to the disease and the research that goes with it. 
I was at Johns Hopkins a couple of years ago, touring through 
the facility there, talking to the doctors and talking to the 
researchers. I had an opportunity to look specifically at what 
was going on with ALS.
    You want to talk about silos, we are pretty siloed in this 
system. Over there, your grant depends entirely on what you are 
able to produce in your research. And if you share it with 
anybody else, then your future grant opportunity is potentially 
jeopardized.
    I may have information that perhaps hasn't allowed me to 
break through, but if I were to share it with another 
researcher who is working on Parkinson's or another disease, we 
do not allow for a level of collaboration that can promote, I 
think, the kinds of breakthroughs that we are all hoping and 
praying for.
    We have got to do more in terms of breaking through these 
impediments that we have put in front of us. A question on 
that, and how we can enter into more of these public/private 
partnerships and the need for NCI to do that. Do you have any 
great ideas as to what we can do now to further enhance that 
type of a public-partnership approach?
    Mr. Case. It is obviously complicated, and I am still 
learning about it. It seems to me that we have focused too much 
on different silos, as we have discussed, and really defining 
the problem incorrectly. We are drilling for oil in a 
particular hole and telling people exactly where they are 
supposed to drill and exactly how they are supposed to drill. 
Maybe we should be drilling somewhere else, or maybe we should 
figure out another way to drill, or maybe we shouldn't be 
drilling at all and should be focusing on alternate energy. 
Using that as an analogy.
    I think we forced the system over the past few decades into 
these little, focused silos and then put all kinds of 
restrictions, understandably, given a fear of abuse or trying 
to correct for abuse. A lot of restrictions that basically 
impede innovation and impede progress and impede collaboration. 
I think it does require a clean-slate approach. That is why I 
used the analogy of DARPA and NASA.
    When there really was a need to do something and do 
something quickly, the tendency was to put the resources there 
and provide a fair degree of flexibility and let people do 
things that are a little bit out of the box. Right now, we have 
moved it too much towards being risk averse, and as a result, 
we are not seeing the level of innovation that we thought.
    Some of this goes back to how you define the problem. To 
the extent that you are looking at it, say, from a context of 
brain cancer or ALS specifically, you are missing the broader 
dynamic in terms of what is really happening with the brain. 
And similarly, you need a more systems-based approach to health 
in general.
    Going back to early detection, we do some things on the 
philanthropic side, such as ABC \2\ and the Case Foundation, 
also do some things on the for-profit side, funding interesting 
companies that are doing entrepreneurial things. The one 
company we provided some seed funding to is a company called 
BrainScope. It is still in development.
    The reason I was interested in that was they initially were 
focused on this little device--it is almost like an iPod--to 
basically diagnose concussions on the field. They are working 
with the NFL on something like that. We also thought there may 
be an opportunity over time to use it to detect other things, 
including, maybe even over time, brain tumors.
    Using the same device that is right now focused on 
concussions could be used in terms of traumatic brain injury on 
the battlefield, but could be used for brain tumors? Nobody, 
looking at this from a brain tumor context, would ever have 
come up with this idea, but defining the problem differently 
and having an entrepreneurial, technology-driven approach to it 
may end up providing some leverage not just in the area it was 
targeted, but more broadly.
    I think it really is kind of taking a step back, and that 
is why I do, as I have said several times, applaud this 
legislation, applaud the effort just to take a fresh approach. 
Nobody knows exactly how it is going to turn out. What we do 
know is that what we have tried over the last 37 years hasn't 
gotten to where we want to go, and it is time to try a new 
approach.
    It is going to require more flexibility. It is going to 
require more collaboration. And it is going to require more 
innovation, which is going to be hard because, basically, we 
are going to have to trust people to do the right things in the 
right ways and give them the tools to really think out of the 
box.
    Senator Murkowski. Thank you, Mr. Chairman.
    The Chairman. Thank you very much.
    Senator Harkin.
    Senator Harkin. Again, thank you both very much. Thank you, 
Mr. Chairman, for your great leadership in this area.
    I just want to focus on a couple of things. First, the 
early screening and detection. We do the research, and as you 
said, Mr. Case, we have got to think anew about how we do that 
research and fund it, and proceed on that. We also have to 
focus on the immediate problems of not only access, but early 
screening, detection, treatment, survivorship.
    Last year, Lance, you were here when we introduced that 
bill in May 2007, the Cancer Screening, Treatment, and 
Survivorship Act, for that very purpose. It was sent to the 
Finance Committee, and I haven't seen it since. I was hoping we 
might get sequential or referral or joint referral to this 
committee, too, because it has Medicaid in it. As you pointed 
out, if we can get to people early, their survival rate is 
tremendous. If you don't, then it is very low.
    What we have done--just since we did that--we now have five 
centers, as you know, in the United States for colorectal 
screening. And those have really helped in terms of 
survivorship, finding early detection for polyps, and just in 
the last couple of years has done a great job. But there are 
only five centers.
    Here it is. Since 2005, we screened 2,300 uninsured men and 
women ages 52 to 64, 272 polyps were identified and removed, 70 
individuals that have been diagnosed with colorectal cancer are 
now in treatment. That is just out of 2,300, over 10 percent. 
Just think how many more people are running around out there if 
they had early detection of colorectal screening would be 
saved. We know they can do that.
    The same is true also of breast cancer screening. In 1990, 
I funded the first money for early detection program for breast 
and cervical cancer. We started with $30 million a year. It is 
now up to $200 million a year. Since that time, 3.1 million 
women have been provided more than 7.5 million screening 
examinations, diagnosed 33,000 breast cancers, 2,000 invasive 
cervical cancers, and 1,006 pre-cancerous cervical lesions.
    All of this early detection, but still, we are still only 
able to reach 20 percent of the eligible women in this country. 
And again, it seems to me that we have to focus on early 
detection and early screening. I know that was some of your 
points that you were making on that.
    I had five siblings, and four of my siblings died of 
cancer. The two that I focused the most on are the breast 
cancers. My two sisters died at an early age of breast cancer. 
Why? They didn't have early screening. They were fairly low 
income. They lived in rural areas or places where they didn't 
have early screening, and by the time it was detected, it was 
way too late. If it had been detected earlier, it would have 
been a different story.
    Somehow, we have got to get more of our funding and more 
focus on that early detection, treatment, and survivorship that 
you talked about. I don't know that I have a real potent 
question for you other than just any other thoughts you have on 
that and what we should be doing? We use, of course, the 
Centers for Disease Control and Prevention to get out there. 
They know how to do these things. Again, they have a lot on 
their plate, too. Developing vaccines and fighting flu 
epidemics and threats of terrorism, that type of thing.
    Still, CDC and our public health infrastructure, they 
have--the structure is there to do it. We haven't funded it. We 
haven't built it up, but we just need, I think, to focus more 
on it. I just wondered if you had any more thoughts on that, on 
the early detection, treatment, and survivorship aspects of 
this?
    Mr. Armstrong. Well, first of all, thank you for all of 
your help. You have been such an ally of ours, and we 
appreciate it.
    Secondly, I feel a little as if I am not qualified to talk 
about screening and early detection because I simply was 
probably the exact opposite of that. I was a young, hard-headed 
athlete that, as I said earlier, thought he was invincible. I 
am not sure that I could have waited any longer. It is a little 
ironic that I get to speak to that.
    It is a fact. And again, sitting on the President's Cancer 
Panel, spending the better part of a decade dealing with this, 
we know that that works. If you just simply look at colorectal 
cancer and what we discussed on the last piece of legislation 
you were talking about, 56,000 deaths a year to this disease, 
which is a big number in terms of this whole problem. If every 
one of those 56,000 people were screened properly, we would 
probably save 99 percent of those people.
    Yet, you will hear that screening is expensive or early 
detection is potentially expensive. Ultimately, people will be 
diagnosed, and they will be treated, and treatment could last a 
long time. As Elizabeth said, it could become very expensive. 
While we save a dime, ultimately, we are going to end up 
spending a dollar. Economically, it doesn't make any sense.
    Morally and ethnically, obviously, it doesn't make sense 
because when you are losing 56,000 Americans a year to that 
particular disease, that is too many.
    The other thing I will say--and Steve touched on this, 
too--is the imaging aspect of this. If you go back to look--I 
mean, I don't know. I wasn't around in the 1800s, but when they 
thought you had a problem, they looked at you, and they said, 
``I think you have a problem.''
    Then it came along, and imaging improved, and the 
technology behind that improved. We have the X-ray and we have 
the CT scan, and then we have the MRI, and now you have methods 
to really detect any disease and a lot of diseases. And that 
even goes further towards blood tests or tumor markers in the 
blood, things like that, where you can really monitor disease 
and monitor progress, No. 1.
    For myself, if I ever felt like I was getting sick again, I 
wouldn't go get an MRI or a CAT scan. I would walk to the 
doctor's office and take a simple blood test and have my tumor 
marker checked, and I would know. My gauge is there. Most 
people don't have that opportunity. So the patient is confused. 
The doctor is confused because they can't monitor the work that 
they are doing. That all will develop over time.
    All of that stuff, again, we have to encourage and we have 
to fund and we have to implement across the population, not 
just the proper communities or the haves, but also, 
unfortunately, to the people that some refer to as the have-
nots.
    Again, it is a simple solution to a complicated problem. We 
know these things. If you go back to the continuum and you talk 
about prevention, in any community, we know what works--reduce 
tobacco, sun, better diet, and exercise. We know those work. 
Let us fix that problem.
    If you go to screening and early detection, we know that 
that works. We know that, morally, it makes sense. 
Economically, it makes sense. Let us do that.
    The access issue is, I know, more complicated and on the 
Federal level, but needs to be researched and ultimately needs 
to be solved. A key word that I think we have been using in the 
last 5 minutes is collaboration. Collaboration will work on a 
lot of these levels, and somehow we have to find a way to solve 
that access piece through collaboration, and then on and on and 
on. We have some answers to the easy questions. We are just not 
doing it.
    I think, ultimately, the last thing I will say to this is 
the reason that I think we are not doing this is because this 
is a complacent disease. This disease and its constituents in 
our society has grown complacent to this disease. People are 
used to cancer. People are used to losing--and while it is sad, 
and everybody is upset in the family and in the community, we 
have grown used to losing people to this disease.
    If the bird flu comes along and five people die and we give 
$7 billion, people think, ``Oh, my God. We are all going to get 
the bird flu.'' Or any other kind of ailment or illness or 
plague that comes along. This disease is an old problem, and we 
have lost our focus on the problem, I think. As I said earlier, 
I think it is going to require a renewed fight, a renewed 
vision, and Steve talked about that.
    We might need to overhaul some things, and people don't 
like to hear that the system is broken. Don't tell them that I 
said the system might be broken. Some things have to change.
    Senator Harkin. Thank you. I appreciate that very much. 
Thanks.
    Mr. Armstrong. We will see you at----
    Senator Harkin. I will do the first couple of hours. Then I 
will wave good-bye.
    [Laughter.]
    The Chairman. Senator Burr.
    Senator Burr. Thank you, Mr. Chairman. Again, thank you to 
both of you for your willingness to be here.
    Lance, let me go right to something you have repeated over 
and over again. The system does not pay for maintaining 
wellness or preventing illness. It focuses on paying for sick 
care.
    Listen, I am not sure that there is any way you can 
summarize how the system is broken better than that right 
there, and I think the fundamental problem in our healthcare 
structure in this country today is that we have a system that 
is designed to trigger when people get sick. It is not designed 
to try to prevent illness or to encourage healthy decisions.
    It is pretty tough to say that you can go in and you can 
change the architecture, Steve, as you said, and just fix the 
things that are broken without the overall architecture being 
redesigned in a way. Steve, you brought up several times DARPA, 
and I am not sure that everybody here knows what DARPA is.
    I am amazed how few people understand how unique the DARPA 
model is, but more importantly, how it reassesses risk. Let me 
ask you, could you take the DARPA model, and bring that fully 
into healthcare and make it work, in your estimation?
    Mr. Case. I think to a large extent. It depends on how you 
define it. The way I think of DARPA was at a time of national 
crisis, really, around security issues, particularly in the 
middle of the past century, the sense was that we really needed 
to have a focused effort that gave people working on that the 
resources necessary and the flexibility to make decisions and 
to do whatever it took to be successful on that mission. I 
think that approach is certainly applicable.
    Now, that approach did lead to some seed investments, 
including in some different companies, and over time led to the 
creation of the Internet. That, then, had significant economic 
benefits and, I think, quite a number of other benefits. The 
Internet wouldn't exist today if there wasn't a concern raised 
50 years ago around security that led to the creation of DARPA 
and the DARPANET, which became the Internet, which now has 
become a part of everyday life.
    It really required this kind of SWAT team effort in saying 
here is the mission. Here are the resources to accomplish the 
mission, and we are not going to tell you what you can't do. We 
are going to tell you what you need to accomplish. That kind of 
effort is hard to do these days. I recognize that.
    Senator Burr. As you know, with the DARPA model, had they 
determined 2 years into the research, you can't do it, it can't 
be accomplished, DARPA had the ability to cut the funding off 
right there and to redirect those efforts into another 
breakthrough area. Are we ready for that in health research?
    Are we ready for somebody to head down that trail, thinking 
that they have identified that marker, as Lance referenced, 
only to find out it is a dead end? To be able to redirect the 
money, do you think there are people within the health 
community and the patient, the consumer community, as you put 
it, who are ready for us to take that type of approach?
    Mr. Case. Well, my view is many of the people in the 
community that I have talked to--and again, I am no expert in 
this--recognize the system is broken, and have their own 
particular formula in terms of how to fix it. There is always 
going to be some institutional resistance to major change. That 
is always going to be the case. People are always going to tend 
to cling to the status quo because that is sort of their 
comfort zone.
    Broadly, it is recognized that some major change is needed, 
some disruptive approach is needed. We need to bring more of an 
out-of-the-box approach. I think it really becomes an issue of 
political will, more than anything else. That is why I support 
this legislation and applaud your efforts to try to put 
something forward that is a little bit more out of the box and 
does put some pressure on the system.
    There are a lot of good ideas. I read some of the materials 
on the next panel, a lot of good prescriptions from FasterCures 
and others, about approaches that might make sense going 
forward. The ideas are out there. The question is how do we 
take those great ideas and embrace them and champion them and 
fund them and not be overly prescriptive in terms of how you 
implement some of those programs? That is where we tend to get 
into trouble.
    We have too much of a culture now around health, as I said 
earlier, that is risk averse. Worried about what might go 
wrong. The focus needs to be on what might instead go right.
    Senator Burr. Well, there is no bigger advocate up here 
than Senator Kennedy for health IT. Yet we still can't seem to 
get a bill produced because individuals are concerned with 
privacy issues that could easily be addressed through de-
identifying the data. Yet by pooling the data together we can 
glean areas that show great promise for us to produce research 
in.
    I remember years ago when Trent Lott helped me--and I think 
others on this committee--create an Institute of Biomedical 
Imaging at the National Institutes of Health, and the National 
Institutes of Health didn't want it at the time. We weren't 
putting the money into the potential breakthroughs on the 
imaging side so we could make earlier detections. Yet now we 
are in a State where we look and say one of the most crucial 
things is that we get people in and detect problems at the 
earliest possible point because we know our chances of survival 
are greater the earlier we detect a cancer.
    I think we have pushed the envelope against the system. Let 
me assure all of you that it will take a continued persistence 
on the part of you and on the part of Congress because we will 
go into areas where people are very uncomfortable with the 
change, whether that is in the peer review process that we have 
currently at NIH, or whether, Lance, it is in restructuring a 
healthcare system that actually creates an incentive for 
individuals to make healthy decisions versus a system that is 
only triggered when you get sick.
    I, for one, am willing to tackle it, and I look forward to 
continuing our conversations with both of you.
    I thank you, Mr. Chairman.
    The Chairman. Thank you.
    Mr. Case has to leave shortly. We have three Senators here 
that haven't had a chance. Do you think--could I ask each of 
them to take a couple of minutes or maybe----
    Mr. Case. I am happy to stay. This is more important than 
my other commitment.
    The Chairman. Well, thank you. Maybe they will each have a 
question for you, and then I know, as I mentioned, you will 
sort of have to go along. So we will do Senator Dodd, Senator 
Murray, Senator Brown.
    Senator Dodd. Mr. Chairman, I will be brief. I was late 
getting here this morning, and I apologize for getting here 
late. Thank you both, and thank Elizabeth Edwards as well. 
Thank you, Mr. Chairman. Once again, you have been at the 
forefront of this for your entire career here.
    Can you hear me all right? Let me just quickly--a couple of 
quick questions for you. One is we have been trying for a long 
time to get the legislation to regulate, have the FDA regulate 
the use of tobacco. Talking about these issues here, I can't 
resist asking the question since you are here and can give us 
your thoughts on that.
    We are talking about managing cancer, but obviously, until 
we are able to regulate one of the major causes of cancer, we 
have a problem. I would like you to address that issue, if you 
would.
    And second, a related issue is palliative care and also 
pain management issues. I am working with Senator Hatch on a 
pain management issue right now, and I know it is a major 
issue. You have, Mr. Armstrong, dealt with this one way. 
Different people deal with it different ways. It seems to me a 
major question as well, and I wonder if you might just address 
those three issues.
    Mr. Armstrong. Well, the first being tobacco?
    Senator Dodd. Yes.
    Mr. Armstrong. Of the years that I spent on the President's 
Cancer Panel, if you asked me to sum it up in one word, what 
would be the one thing that you just kept hearing over and over 
and over those years and years and years, tobacco use and abuse 
would be the No. 1 thing. I mean, across the field, which 
unfortunately translates most of the time into a lung cancer 
situation, whereas basically an orphan disease is tremendously 
underfunded and underserved.
    Tobacco is what it is. It is an addictive drug that is 
marketed and targeted to the youth of America. If you consider 
that the budget of the National Cancer Institute is $6 billion, 
big tobacco in the United States alone, just to market that 
drug, $15 billion a year in marketing, most of it directed to 
our children.
    As a father of three and as a cancer survivor, that is 
troubling. Listen, certainly people have the right to make 
their own decisions and choose unhealthy habits if they want. 
But, something isn't right with those numbers. I think that has 
to change. I am not a Senator or a policymaker. I don't know 
the solution.
    The science will show that tobacco is, No. 1, obviously 
awfully addictive. And No. 2, more times than not, is awfully 
deadly. I think as a society that we have to address that in 
some way.
    The second question was about?
    Senator Dodd. Was palliative care and pain management 
issues.
    Mr. Armstrong. Yes, as I said, I don't know--in the 
beginning, I talked about the continuum of this disease, and it 
starts all the way from prevention all the way to end of life. 
Palliative care is something that has to be addressed. It is 
the sixth area in the continuum, in my opinion.
    If people continue to slip through the cracks of this 
continuum and ultimately are not going to survive, they deserve 
to die in peace and surrounded by friends and family and with a 
whole heck of a lot of pride and know that they tried 
everything that they could to live and that they are ready to 
pass on. That is part of it.
    Certainly, they don't deserve to die in pain or in a 
sterile hospital room or wherever that might be. They deserve 
the best, the best passing that they can. It is a very, you 
know--listen if you consider that we are talking about an idea, 
but in reality, you are talking about 560,000 Americans. I have 
sat up here for 1 hour and 20 minutes. Since I have sat here, 
80 people have faced that situation, 80. Today, there is going 
to be 1,500 of them that face that situation.
    It is a real concern, and it is something that we have to 
acknowledge. Ultimately, it is something that we want to erase 
or we want to at least reverse.
    Senator Dodd. Steve, do you have any quick comments on that 
at all, on the tobacco, FDA regulation of it?
    Mr. Case. Not really, other than sharing your view and 
Lance's view that it is obviously a problem. It has been known 
for decades it is a key cause of disease and a key cost to the 
healthcare system. So just continuing on kind of ``business as 
usual'' just clearly does not make sense.
    That is an instance where we know there is a problem. We 
know what the solution is. We just need to be bold in taking 
action. I know there are a number of employers that are 
actually looking at ways they can modify even their insurance 
programs to try to have a carrot-and-stick kind of approach. 
Everybody has to do whatever they can do to try to encourage 
healthy behaviors. There is obviously nothing more obvious than 
trying to prevent people from smoking.
    Mr. Armstrong. Can I just add one thing to that? That is 
something that I have been very passionate about and just 
selfishly because I don't like to walk into a restaurant or a 
store and sit next to somebody that is smoking. I raced for 15 
years in Europe, and I was around enough cigarette smoke to 
last me a lifetime.
    I think local communities or States that are smoke free is 
the way to go. It is really an issue of public health and 
really an issue of fairness. When you walk into a restaurant, I 
mean, why would one person be allowed to exercise their own 
freedom and jeopardize the health and wellness of 10 others? 
That is an issue of fairness.
    That should not be--if it is a single mother of three that 
is waiting tables at a bar or restaurant, and she has got to be 
around that? That is not fair. If you want to smoke, fine. Step 
outside and have your cigarette and come back in.
    I think when you talk about tobacco, obviously, there is 
the issue itself. There are the side effects and the secondary 
effects that that particular drug or that particular habit 
imposes and inflicts on other people. I have asked long and 
hard and asked all of the presidential candidates whether or 
not America should be smoke free, and I think that the 
consensus is that it is better left to the cities and the 
States.
    As you see, now you have a city like New York City or 
Austin, TX, or Los Angeles, or States like Iowa or States like 
Wisconsin----
    Senator Dodd. And in Europe. Europe is doing----
    Mr. Armstrong. I was going to say, now you have a country 
like Ireland, a country like--I mean, for God's sake, Paris, 
France, is smoke free now.
    [Laughter.]
    Senator Dodd. Is it 3,000 young people a day, I think, that 
start smoking? I think is that number right?
    Mr. Armstrong. I don't know the number, but that is a 
startling number. I can tell you that I asked--on one of the 
panels, I asked one of the experts at what point are you 
addicted? They reckoned that after about 100 cigarettes, you 
are addicted.
    So, you do the math, and you have spent--I don't know what 
cigarettes cost. I haven't bought any ever. You have spent $10 
or $20 or $30, and you are hooked forever. It is one of the 
hardest drugs to kick. We have to address this, especially with 
our kids. If we are marketing to the kids of America, that is 
not right.
    Mr. Case. It also ties in obviously with the healthcare 
system issues generally. It is unbelievable that we spent $2 
trillion in healthcare, one sixth of the economy, keeps going 
up. You look at the underlying cause and that is clearly a 
contributor.
    It is bad enough that the secondhand smoke is annoying you 
in a restaurant, in fact, it is worse that you are actually 
indirectly subsidizing other people's unhealthy decisions.
    The Chairman. Senator Murray.
    Senator Dodd. Thank you.
    Senator Murray. Thank you very much, Mr. Chairman. Thank 
you to both of you for coming and for your passion on this 
issue.
    I come from the State of Washington, and cancer research is 
something that is very important in my home State. Fred 
Hutchinson Cancer Research Center in Seattle doing great 
developments on everything from transplantation, targeted cell 
treatment, gene therapy. We have the Seattle Cancer Care 
Alliance, which is doing some fascinating research on proton 
beam therapy. This is something I think all of us really care 
about, and we are excited about a lot of the opportunities.
    We heard a lot about prevention, absolutely agree. New 
research to find new cures. The one issue that doesn't get a 
lot of attention, which I would like to ask you about, is 
survivors. It is great. We have cancer survivors, but are we 
doing enough to address the issues that they face, whether it 
is psychological, whether it is getting back into the workplace 
and being accepted, quality of life, secondary cancers?
    What should we be looking at in terms of that population 
that we are not focused on today?
    Mr. Armstrong. Well, I think we, at the Lance Armstrong 
Foundation, have made--that has been the bulk of our priority 
the last 5 or 6 years. I had the good fortune of being with 
Ellen Stovall last night for the National Coalition of Cancer 
Survivorship benefit. She is really the pioneer in this field.
    In the last decade, we have done a lot. I think, initially, 
cancer was a death sentence, and so nobody worried about if you 
live. If you lived, just be glad you lived. It is not like that 
anymore because the numbers are straightforward. There are 12 
million of us in this society that are living with this 
disease.
    There are a lot of things to consider, the economic issues, 
the personal, the emotional, the professional issues. Fertility 
is a big issue for both men and women. All of these things have 
to be addressed. As I said in my opening statement, to me, it 
boils down to quality of life. Regardless of whether or not you 
have had cancer or not, we all deserve a high quality of life.
    All of these things have to be looked at, and certainly a 
cancer survivor deserves to have children. A cancer survivor 
deserves to continue on with their job and not be discriminated 
against in that aspect. They deserve to--you know what, if they 
want to go out and run a marathon, they deserve to do that. If 
they want to go out and get back on their bike for some crazy 
reason and win seven Tours, they deserve to do that.
    All of that stuff, and some of it is scientific, has to be 
looked at as to how we preserve that quality of life. Let's 
face it, chemotherapy is chemotherapy. Ideally, in 10 or 20 or 
30 years, you look at chemotherapy and you go, ``Jesus Christ, 
did we really do that to people?'' The fact of the matter is, 
is that the drugs are toxic, and there are inevitably side 
effects in and around those drugs.
    The best example would be my situation. I started on 
standard treatment for testicular cancer. If I had continued on 
with standard treatment, I never would have gotten on my bike 
again. I switched doctors after one cycle. I ended up in 
Indianapolis, and my doctor, Dr. Larry Einhorn, who essentially 
cured the disease 30 years ago, he said, ``Lance, do you think 
you ever want to race again?''
    I thought, ``Well, I would like to live. But, I guess if I 
get that part down, yes, maybe I will race again.'' He said, 
``Well, then we need to switch your treatment.'' The downside 
to that was that I had to be an in-patient and essentially stay 
in the hospital for the entire time.
    That simple decision of him taking me off standard 
treatment and putting me on an alternative treatment that took 
away bleomycin, which is highly toxic to the lungs and would 
have prohibited me from ever doing an endurance sport, that 
decision, that day, that minute, preserved my career.
    Now that is a scientific answer because we know now that 
bleomycin is toxic to the lungs and causes scarring, and I 
never would have--I would have had trouble getting up stairs. 
That is--selfishly for me, I am glad he did that. I am glad he 
asked that question, and I am glad I stayed in the hospital.
    There are other issues that are equally, if not more 
important. Again, fertility is a huge, huge issue for both 
young men and young women or anybody that wants to have a 
child. Then the emotional stuff and the insurance issues and 
professional reasons. It all boils down to quality of life.
    People who were used to a quality of life that they had 
before the disease, that should not change. In fact, you might 
argue that they should have a higher quality of life because 
they appreciate that life so much more.
    Senator Murray. Thank you. Thank you very much, Mr. 
Chairman.
    The Chairman. Senator Brown.
    Senator Brown. Thank you, Mr. Chairman.
    Mr. Armstrong, I want to ask you a couple of questions. 
Earlier this week, I was at the James Cancer Center in 
Columbus, OH, and met with a fellow named Merle Farnsworth, who 
is in his 60s, has cancer, is in the midst of a clinical trial, 
and had his insurance cut off when he enrolled in the clinical 
trial.
    Our understanding is, some 20 percent of people in clinical 
trials, cancer clinical trials, have had serious problems with 
their insurance companies. They are not only fighting their 
disease, they are fighting their insurance company, and we know 
we want to change that.
    Talk to me, if you would, what--the thousands of patients 
that have participated in clinical trials through the years, 
what are those trials, can you sort of tell me what those 
trials have meant to you and your healthcare?
    Mr. Armstrong. I know a lot--at least, I think--about 
clinical trials. I have spoken to them a lot. If my time in 
this fight has--the one thing that I have heard the most is the 
tobacco issue. The second most common thing that I have heard 
would be clinical trials.
    Everybody in this field agrees that if we could enroll more 
people in clinical trials, we would have much greater success. 
The proof is actually in the pudding in that if you consider 
childhood cancers 20, 30 years ago had very low participation 
in clinical trials, and the death rate consequently was very 
high. That has completely changed. I think the latest number is 
80 or 90 percent of our children--not children, our children--
are enrolled in clinical trials, and the cure rate directly 
reflects that.
    Meanwhile, in the adult population, I think the latest 
percentage is 3 to 5 percent of adults are in clinical trials, 
and of course, the death rate also reflects that. A very tricky 
situation. I don't know the answer.
    Again, many of these things boil down to fairness. If 
somebody is willing, in my opinion--and let me just say that I 
was not on a clinical trial. I am the product of somebody that 
was on a clinical trial. I am grateful for the pioneers that 
came before me and said I will try that. I have got nothing to 
lose. I am going to die. Let us try it. And therefore gave life 
to tens of thousands of young men in this country.
    That has to be respected. Scientifically, if you asked, if 
you put the 100 best researchers in the room and you said, 
``OK, what do we need to do,'' and they all agreed that we have 
to increase participation in clinical trials, and that has to 
be funded and that has to be provided to everybody, then my 
answer would be, well, we have to do that.
    Of course, nobody wants to fight the disease and fight an 
insurance company. That is incredibly frustrating. The facts 
are there, and I would fall back on the facts.
    Senator Brown. You had said earlier that you had served two 
terms on the President's Cancer Panel, but that few of the 
recommendations made by the panel ever came to fruition. Talk 
about that. Why weren't they?
    Mr. Armstrong. Well, it was a very interesting time sitting 
on the President's Cancer Panel because it is called the 
President's Cancer Panel, and most of the people before I would 
go--and this is slightly off the subject, but I will answer the 
question. Before I would go, they would say, ``When you are 
there, tell the President this is what I would like to see.'' I 
never saw the President at the President's Cancer Panel 
meeting, but that is not the point.
    Other people that would come to testify would say, ``Tell 
the President this.'' They really feel like the line between 
them and change is that direct. Again, I said earlier that I 
think that this issue has grown complacent. I am not foolish 
and I know that in our society we are conflicted as to how we 
allocate money, how we allocate resources, where we decide to 
fight. This is not a priority in our society to fight.
    Regardless--and I will remind you that the role of the 
President's Cancer Panel is to oversee the actions of the 
National Cancer Institute. Whatever plans we put together or 
wanted to implement, the fact is that they have to be given 
proper priority and they have to be given proper funding, and 
we don't have that.
    All great ideas, but if we don't have the funding because 
the funding is going elsewhere or priorities are elsewhere, 
then they won't be acted upon.
    Senator Brown. OK, thank you.
    One last comment, Mr. Chairman. I was on the Health 
Subcommittee in the House of Representatives 15 years ago, when 
it was then-Chairman Waxman who, in those days, brought six or 
seven executives, CEOs from tobacco companies. The famous 
picture in the paper, they all raised their right hand and then 
were a little close to going over the edge on the truth talking 
about nicotine addiction.
    The one thing that hit me during that hearing was that--as 
we talked about 400,000 people die a year from smoking--the 
tobacco companies, no matter what they said, have to find 
400,000 new customers every year just to stay even. That is why 
they have had such focus over the years--in spite of Senator 
Kennedy's and others' efforts, to--on going after and marketing 
to children.
    Then you take that further, and it is those same CEOs when 
I asked them some questions that they were willing to take down 
their billboards near schoolyards and doing certain things like 
that here, I asked them if they would be willing to do that 
around the world, and they just went down the line and said, 
``no.'' That is a whole other issue of what our tobacco 
companies have done internationally, but you know that.
    The Chairman. Thank you.
    I want to thank all of our panelists, Mrs. Edwards, Mr. 
Armstrong and Mr. Case. This has been enormously helpful and 
valuable. Really very constructive and very, very positive. A 
lot of good recommendations and suggestions, and we would like 
to follow up with you. We will follow up with you. We are 
grateful for you taking the time and joining with us. Thank you 
very much.
    Our second panel--Mr. Edward Benz, who is president of Dana 
Farber Cancer Institute in Boston; Greg Simon, who is president 
of the FasterCures; and Hala Moddelmog, who is CEO of Susan G. 
Komen for the Cure.
    Mr. Benz has been president of the Dana Farber Cancer 
Institute, Boston since 2000, active NIH-funded researcher, 
over 200 published articles, past president of the American 
Society of Hematology, the American Society of Clinical 
Investigation, and American Association of Cancer Institutes, 
currently an associate editor of the New England Journal of 
Medicine.
    Gregory Simon is president of FasterCures, whose goal is to 
save lives by saving time in the discovery, development, and 
delivery of treatments and cures for serious diseases. He was 
domestic policy advisor for Vice President Gore 1993 to 1997, 
then went on to become CEO at Simon Strategies, a consulting 
firm in biotechnology, healthcare, and information technology.
    And Hala Moddelmog, who is president and CEO of Susan G. 
Komen for the Cure, former Fortune 500 exec, and joined the 
Komen in 2006. Under her leadership, the foundation has 
implemented a new grant mechanism to improve the discovery and 
delivery of cures, now pledged to invest $2 billion in the 
coming decade in strategically important research and community 
outreach programs.
    Thank you all very much, and we will start with Dr. Benz.

STATEMENT OF EDWARD J. BENZ, JR., M.D., PRESIDENT, DANA FARBER 
                  CANCER INSTITUTE, BOSTON, MA

    Dr.  Benz. Thank you very, very much, Senator Kennedy. If 
you will permit me a moment of local pride? Thank you for so 
much that you do for Boston and New England and healthcare in 
the entire country.
    Thank you, Senator Murkowski, and to all of the Senators 
here for taking on this incredibly important issue and for your 
sustained support of biomedical research and better healthcare.
    With your permission, I would like to speak to you from 
several perspectives today. First, as president of the Dana 
Farber Cancer Institute and director of the Dana Farber Harvard 
Cancer Center, I represent tens of thousands of our patients, 
our supporters, our staff who are absolutely dependent on and 
committed to what you are trying to accomplish with this what I 
hope will be the decisive battles in the war on cancer.
    As president of the American Association of Cancer 
Institutes, I represent the directors of the 92 comprehensive 
cancer centers around the country, and we are pledging our 
support, help, and assistance in any way as you try to figure 
out the best way to lead this country forward to conquer and to 
control cancer.
    I would like to speak to you today from two other contexts 
that matter as much or more to me. First, as a physician and as 
a scientist, I have spent my life trying to understand the 
inner workings of cells and how they affect disease, cause 
disease, and how they might be turned around so that they stop 
doing that. As a physician, I have had the joy of telling 
people with blood-forming cell cancers that they have been 
cured and the agony of telling people that they weren't going 
to make it.
    But most importantly, I am here today as the son, the 
brother, and husband of cancer survivors. Like so many of you, 
I wake up every day wondering if that cancer is gone forever or 
if the other shoe is going to drop. We are all in this 
together, whether we work in the field, whether we are 
advocates, whether we are patients.
    You know the numbers. There are 1.4 million people in this 
country, roughly, who will be diagnosed with cancer this year. 
Over 500,000 will die of those cancers.
    The good news, as you and others who have testified today 
have pointed out, is that we have 12 million cancer survivors 
that, in contrast to the year when I entered medical school in 
1968, when the chances of living with cancer for 5 years were 
around 30 percent, almost 0 percent for a child with leukemia, 
it is now almost 2 out of 3 patients can expect to live 5 very 
good years or longer of life with a cancer diagnosis, and over 
80 percent of children can expect to be cured if they have 
childhood leukemia.
    That is the good news. The other good news is that we in 
the field are incredibly excited that from a scientific point 
of view, from the point of view of the tools that are available 
in information technologies, in systems research, that we can 
make the decisive push to make cancer a disease that can be 
cured or at the very least can be rendered to be a very 
controllable chronic disease compatible with long-term good 
quality of life.
    I and my colleagues in medicine, in nursing, in pharmacy, 
in healthcare in general, are also very frustrated and very 
worried because we think at a time when science is giving us 
the opportunities to make the decisive difference that the 
trends in this country in both healthcare and research policy 
and financing are going to prevent us from taking advantage of 
those incredible opportunities.
    The Human Genome Project, which was made possible by the 
doubling of the NIH budget, that very visionary thing that I 
know so many of you supported, was an initiative made for the 
study and cure of human cancers. There is no other set of 
diseases that depends as much on the information that we get 
from the Human Genome Project as the 400 diseases that we call 
cancer.
    Coming out of that project already are incredibly powerful 
new forms of therapy like Herceptin, like Gleevec, two drugs 
that are highly targeted. Not the kind of chemotherapy that Mr. 
Armstrong described that are so extremely toxic, but drugs that 
are, if you will, smart bombs that go directly to the Achilles 
heel of particular forms of cancer.
    In the intervening years, we have developed a number of 
additional drugs, and we are finding that progress is much 
slower. Some of that is because the biology of cancer is very 
difficult.
    A cancer cell differs from a normal cell by mutations, 
changes in about 200 or 300 genes out of that cell's genome. 
Our genome has 30,000 genes in it, roughly. The difference is 
incredibly subtle. Far less than 1 percent of the genes that 
are changed are the ones that are called cancer.
    On the other hand, figuring out which of those 300 changes 
is the one that if you could turn it around or stop it would 
cure cancer is an incredibly daunting task. Cancers also trick 
the body into allowing the cancer to go. Cancers are very 
subversive cells. They evade and defeat the mechanisms that we 
have in place to protect ourselves from cancer.
    As we think about what needs to be done to control and 
conquer cancer, I believe, and I think I share this view with 
my colleagues, that we need both a better way of doing what we 
already know how to do. That was very much the focus of the 
last panel, one that we fully endorse and support.
    If we were to use, to the maximum that we know how to use 
it, preventive strategy--smoking cessation, diet, exercise, 
oral health checks for oral cancers, mammograms, colonoscopy, 
fecal occult blood stool testing--we clearly, in the short 
term, could reduce deaths and suffering from cancer enormously.
    We also have to balance that and have a balanced portfolio 
of research. Because there are many forms of cancer for which 
we don't have yet good preventive or early diagnostic methods, 
nor do we have the treatments that could be used if we were to 
detect those cancers. We need better ways to provide therapies 
that are more effective, that are less toxic, that are usable 
in patients as they become older. Older patients don't tolerate 
our existing therapies quite as well as younger patients.
    We need better tests--biomarkers we call them in the 
field--blood tests or breath tests or urine tests that would 
tell you that a cancer is developing. Better methods of imaging 
so that we can see a tumor and know precisely where it is, when 
the tumor might be 1,000 or 10,000 cells in size rather than 
over a billion, which is the typical size of a tumor when it is 
detected even very early. There are already a billion tumor 
cells in the body.
    All of that is going to require basic biological research. 
It is going to require applied research, focused on the various 
forms of cancer. It is going to require clinical research and 
clinical trials because what good does it do if we learn all 
those things and do not have a good way of finding out whether 
they matter and are going to be beneficial in people? At some 
point, we have to be able to study these new agents, the new 
strategies in people.
    We need health services research and nursing research. 
Nursing research focuses on the experience of the patient as 
the patient progresses through an illness. Many of the advances 
that we have made are due to improvements in the quality of 
life, the way the cancer chemotherapy and surgery and radiation 
are tolerated, the way that pain is palliated during treatment.
    Health services research has to be part of the portfolio 
because if we were, for example, to initiate a widespread 
program for colorectal cancer screening, which method would be 
the best and the most cost-effective and the most likely to 
detect the cancers that are likely to kill us?
    Which test could we find that would be better than the PSA 
test--a good, but highly imperfect test for screening for 
prostate cancer--that would tell us not just who has prostate 
cancer, but which of those patients has the prostate cancer 
that needs the kind of radical surgery and radiation and drug 
treatment that we give probably to more patients today than we 
should because we simply don't know which patients are going to 
die if we don't do that.
    I am here today to advocate that as we look at this 
holistic view, which I think is visionary on your part, this 
holistic view of cancer--access, the best use of our existing 
strategies for early detection, for prevention, for making sure 
that all patients can access the state-of-the-art in 
treatment--that I also need to be the one who reminds us that 
we know so little about so many forms of cancer that we must 
also make research part of each and every initiative and 
intervention, whether that research is in the form of public 
health research, basic biological research, nursing and 
clinical research, or epidemiology to assess the changes in 
risk factors. The demographics of cancer are changing rapidly.
    Fortunately, lung cancer has actually begun to decline from 
smoking. But lung cancer in nonsmoking women is increasing. Why 
is that? What are we going to do about it? What new strategies 
for detection and treatment for that newer form of cancer that 
is emerging need to be done?
    We will always be contending with the mechanisms that make 
cancer happen as our population ages and lives in an 
increasingly more complex and toxic environment.
    In closing, I just want to thank you profoundly, for all of 
the groups that I represent, for your vision and commitment. I 
want to urge that as we look at all of the ways that we need to 
attack cancer as a national problem, a public health problem, a 
problem for individuals and families, that we find a holistic 
way, as Steve Case mentioned, to encourage our scientists and 
investigators to use every opportunity for us to learn, even as 
we treat the cancers that we face today, so that we will 
constantly be improving what we have to offer to patients and 
to their families with cancer.
    Thank you very, very much.
    [The prepared statement of Dr. Benz follows:]
            Prepared Statement of Edward J. Benz, Jr., M.D.
    On behalf of Dana-Farber Cancer Institute, an NCI-designated 
comprehensive cancer center located in Boston, MA, thank you for 
inviting me to testify at today's hearing on comprehensive cancer 
legislation. As a comprehensive cancer center director, I, and the 
colleagues and patients that I represent, have a deep interest in all 
aspects of the forthcoming cancer legislation. My distinct role today, 
however, is to reflect on the essential need for fundamental and 
applied cancer research. I have had the privilege to serve as the co-
chair of a recently-formed Research Working Group, a panel of 
physicians, scientists, advocates and policy specialists convened to 
provide expertise and formulate recommendations to revolutionalize the 
cancer research enterprise. We appreciate the chance to share those 
recommendations with you now.
                 a vision of the future of cancer care
    The world of cancer care is changing before our eyes. The era when 
treatments were focused on the organ where a cancer originates is 
coming to an end. In the not-too-distant future, patients may receive 
therapies geared to the specific molecular characteristics of their 
disease. These customized treatments could include agents able to block 
the particular genes and proteins that have gone awry in the cancer 
tissue. Such agents will be supplemented by others that choke off the 
blood supply to tumors, limiting their size, and by vaccines that 
mobilize the body's natural immune defenses against cancer. Still other 
agents could take aim at the tumor's ability to spread to other parts 
of the body. The effect of such treatments could be tracked by imaging 
technology capable of showing, in precise detail, the extent of death 
of tumor tissue.
    Other changes might be just as dramatic. The same knowledge that 
would enable us to halt the genetic machinery of cancer could lead to 
agents that can prevent cancer in people at risk for it. We'll hope to 
have a better handle on why some populations--for genetic, cultural, or 
economic reasons--have a greater likelihood of getting cancer and lower 
rates of successful treatment. We expect to know the safety issues 
associated with each form of treatment and have effective protocols for 
minimizing them. We'll ensure that the environment in which patients 
are treated--hospital, clinic, or home--is as responsive to patients' 
needs and well-being as possible.
    Ambitious as all this might sound, the fact is, some elements are 
already in place, and more are coming on line every year. The 
completion of the Human Genome Project has spurred the development of 
several ``targeted'' therapies that take aim at specific malfunctioning 
or misbehaving genes. The best-known of these are Herceptin, which has 
benefited thousands of women with a specific type of breast cancer, and 
Gleevec, which is now the standard of care for many patients with 
chronic myelogenous leukemia and the digestive tract cancer known as 
gastrointestinal stromal tumor (GIST), for which there previously was 
no effective therapy for many patients. Blood vessel-blocking drugs 
known as angiogenesis inhibitors, such as Avastin, have become part of 
the regular arsenal of therapies against several kinds of cancer, 
including colon cancer. In recent weeks, a study has found that in 
patients with metastatic melanoma--a condition for which no effective 
treatment exists--Gleevec can drive the disease into remission if the 
cancer cells contain a key genetic mutation, or abnormality. These 
optimistic projections for the future could only happen if we are able 
to build on the research momentum generated by the human genome project 
and other advances, which will only happen if research funding growth 
is restored to at least its historical pace.
                       the many forms of research
    The groundwork for all these advances has been laid by an 
unprecedented degree of research--most of it government-funded--at 
academic and private institutions across the United States and 
overseas. A great deal of this exploration has occurred at the level of 
basic science--in which investigators study the fundamental workings of 
normal and cancer cells--and clinical science--where potential 
therapies are tested in human patients--but this represents only a 
portion of the full spectrum of cancer research. Equally robust efforts 
are under way in the areas of cancer prevention, patient safety, 
quality of care, quality of life, nursing, health disparities, and 
treatment outcomes. Much of this work necessarily takes place in health 
centers, but much is done in cooperation with community groups such as 
employers, religious organizations, tenants' groups, and neighborhood 
associations.
    The reason for this broad focus is that cancer is truly a multi-
dimensional problem--first and foremost, a matter of individual health, 
but one that affects people's loved ones, finances, occupation, 
education, and community, and one that reverberates on a local, State, 
and national level. Just as cancer needs to be attacked biologically on 
a variety of fronts, so does cancer research need to concern itself 
with all the implications of the disease and its treatment. We will not 
be able to truly defeat cancer unless we grapple with the entire array 
of issues associated with the disease.
                        cancer's continuing toll
    Despite significant and steady gains against cancer--seen most 
clearly in a slow but uninterrupted decline in U.S. cancer death rates 
over the past 3 years--the disease continues to take a devastating 
toll. In 2008, there will be 1.44 million new cases of cancer in the 
United States (not including more than 1 million new cases of basal and 
squamous cell skin cancer) and an estimated 565,650 cancer-related 
deaths, according to the American Cancer Society. The number of new 
cases, which stood at 1.25 million in 2002, is rising each year as the 
American population ages. Nor are the physical, emotional, and 
financial costs of the disease spread evenly across the population: the 
National Cancer Institute states that the burdens of cancer are 
``unfairly shouldered by the poor, the elderly, and minority 
populations.'' Financially, the annual bill for cancer care in this 
country exceeds $200 billion.
                         laying the foundation
    Clearly, an immense amount of work remains before cancer can be 
declared ``conquered.'' Research over the past two-plus decades has 
provided a scientific and social foundation from which we as a nation 
can launch a truly decisive assault on the disease. We know in 
intricate detail the genes and combinations of genes that cause tumors 
to form and drive their growth. We know, with equal specificity, the 
body's responses to the formation and spread of cancer. We have devised 
ways, in many instances, of blocking these genetic malefactors and the 
proteins they're responsible for--including the use of sub-microscopic 
nanoparticles or lab-made proteins that home in on key genes and stifle 
their activity.
    In other facets of the cancer riddle, researchers have developed 
effective communication techniques and public-service campaigns for 
informing people--at home, on the job, where they shop, and where they 
go to school--about how to reduce the risk of cancer. Hospitals have 
designed systems for ensuring that when patients are treated for 
cancer, they're treated in the safest possible environment with 
powerful safeguards against medication errors. Investigators are 
compiling examples of ``best practices''--determining which treatment 
approaches are most successful and advocating for them to become the 
standard of care. Other scientists are cataloging the ways that diet 
and behavior influence people's risk of developing cancer. Still others 
are charting racial, ethnic, and socioeconomic disparities in people's 
risk of contracting cancer and their likelihood of receiving proper 
treatment for it.
    The cumulative effect of this work--in the lab, the clinic, and the 
community--is to place the Nation's cancer research enterprise on the 
brink of dramatic gains against the disease in the years ahead. In many 
respects, the work undertaken thus far can be viewed as a down payment 
on the new generation of therapies now taking shape.
                             areas of focus
    In surveying the state of cancer research in the United States, the 
Research Working Group has identified a number of problem areas that 
are impeding optimal progress. Our recommendations offer ways of 
rectifying those problems and reinvigorating the Nation's overall 
cancer research effort. We have divided our study into seven broad 
categories, which we summarize below.
I. Translational Research
    The National Cancer Institute-supported effort to convert basic 
scientific findings into new and better therapies is not keeping pace 
with the advances in knowledge and technology over the past 40 years in 
cancer research. Among our recommendations to remedy this situation 
are: a special funding program to advance a select number of especially 
promising early research opportunities; joint NCI/industry funding of 
collaborative early translational research projects; and increased NCI 
interaction with foundations and advocacy groups to advance this type 
of research.
II. Clinical Research
    Clinical trials are becoming increasingly complex to conduct, and 
the NCI's per-patient reimbursements are insufficient to cover the 
costs of such trials. Among our recommendations: additional Medicare 
payments to cover the additional time and resources involved in 
enrolling patients in trials; and group and individual health insurance 
mandates to cover the routine costs of participation in trials.
III. National Collection of Tissues/Biospecimens
    Cutting-edge cancer research is impaired by the absence of either a 
centralized network of biospecimen and tissue collection banks, or 
consistent standards for retention and storage of such specimens. Among 
our recommendations: establishment of a National Cancer Biospecimen 
Network by linking existing public and private biospecimen and tissue 
collection banks; and guarantees of protections against genetic 
discrimination.
IV. Prevention and Early Detection Research
    Despite the launching in 2000 of the Early Detection Research 
Network by the NCI, only a few biomarkers--substances in blood or other 
fluids that serve as telltale signs of cancer--are routinely used in 
oncology today. Discovery of new ones is hampered by the limitations of 
current technology. Among our recommendations: a standard process for 
developing, testing, and proving the value of biomarkers; support for 
high-quality biorepositories of samples of cancerous tissue across all 
stages of development and representative of all cancer sites; and 
Federal and private health insurance coverage of new biomarker tests.
V. Young Investigator and Oncology Nurse Workforce
    Teaching and mentoring the next generation of investigators is one 
of cancer scientists' most important jobs, but many of today's 
brightest young researchers are finding it increasingly difficult to 
establish independent careers in biomedical research and are leaving 
the field. Equally disturbing trends are threatening the vitality of 
the oncology nursing workforce, which is critical to quality care for 
patients. Among our recommendations: more stable funding streams to 
allow individuals and institutes to better plan projects and careers; 
more opportunities for non-U.S. citizens to emigrate and compete for 
training, postdoctoral and research awards; and fully funding for 
Federal nurse loan repayment and scholarship programs.
VI. Collaboration
    There is a lack of collaboration among NCI-funded cancer centers 
and programs, and a variety of barriers discourage partnerships between 
publicly and privately funded researchers. Pharmaceutical and 
biotechnology firms have little financial incentive to develop 
treatments for rare cancers. Among our recommendations: expansion of 
the Bayh-Dole Act to permit cancer-related partnerships between 
academia, nonprofit organizations, and private companies; and remove 
some restrictions on international sites that participate in NCI-funded 
trials.
VII. Federal Funding
    Ten years ago, the Nation made a bold, 5-year investment in the 
National Institutes of Health and the National Cancer Institute, the 
primary Federal vehicle for advancing cancer research. Between 1998 and 
2003, NIH appropriations for cancer research essentially doubled, far 
outpacing the historic norm of 8.2 percent average annual increases. 
Since that period, however, the budget for such appropriations has been 
flat or declined. As the accompanying chart shows, had the 5-year 
doubling never occurred and the 8.2 percent average been maintained 
each year since 1998, the appropriations budget would be significantly 
higher than it is today. Funding cuts for extramural research have been 
even more dramatic if one takes into account the allocations made for 
other NCI obligations. The result of this fall-off is that many 
experienced researchers are struggling to obtain funding for more 
conservative, less-ambitious projects, while young investigators are 
increasingly abandoning the field. Without a renewed commitment to 
funding, the potential for new treatments, cures, and prevention 
strategies for cancer will continue to recede. Among our 
recommendations: consistent and sustained Federal funding for research; 
support programs to improve the accuracy, completeness and 
accessibility of cancer data; and establish an office for rare cancers 
to ensure that research needs are met.
                               conclusion
    Decades of research have brought us to the point where some of the 
most dramatic advances in the history of the disease's treatment are 
coming into sight. The American public has made an investment in cancer 
research unequalled by that of any other nation, in the hope that such 
research will lead to better treatments and long-term cures. We have 
the opportunity, now, to honor that investment by ensuring a level of 
funding that will bring the promise of current cancer science to 
fruition.
    The Research Working Group encourages the Members of the Senate 
Committee on Health, Education, Labor, and Pensions to provide the 
financial, regulatory, and legislative tools to carry the War on Cancer 
to its decisive stage.

    The Chairman. Thank you very much, Doctor.
    Mr. Simon.

 STATEMENT OF GREGORY C. SIMON, J.D., PRESIDENT, FASTERCURES, 
                         WASHINGTON, DC

    Mr. Simon. Thank you, Senator Kennedy, it is an honor to be 
here today. I would also like to thank Senator Enzi, who is not 
here, for reaching out to invite me to testify. I would like to 
thank all of the Senators for your interest in this very 
important topic.
    I also want to say that our organization is only 5 years 
old, and there are many people in this town who have fought 
long and hard to have the war on cancer succeed. I want to 
thank one of those people who is here today, Ellen Siegel, who 
is the head of Friends of Cancer Research and is an 
indefatigable fighter in the war against cancer.
    FasterCures is a nonprofit center of the Milken Institute. 
We are independent. We are nonpartisan. We do not accept funds 
from drug companies, biotech companies, or device companies so 
we can maintain our independence. Our mission is to save lives 
by saving time, time in the research, discovery, and 
development of cures for diseases of all kinds.
    Given the human and financial cost that we suffer from 
cancer and the emotional and economic gain we would enjoy from 
curing cancer, no one can say that our current investment of 
money, human capital, and technology amounts to a war on 
cancer, much less an effort to win the war. It is not just our 
investment that is lacking, it is also our strategy.
    To paraphrase former Secretary Rumsfeld, we cannot fight 
this war with the strategy we have. We have to fight this war 
with the strategy we need. The strategy we have is derived from 
the 20th century model that underpins the NIH, which is based 
on a system whose goal is to study human biology. As a result 
of that system, we are not soldiers in a war against cancer, we 
are students majoring in cancer.
    In the 21st century, our strategy to fight cancer must be 
based on a system designed to cure diseases. What would this 
change? Everything. It would change how, where, and why we 
invest money in cancer research. It would change how we use and 
share data, biospecimens, intellectual property, human 
resources, and designed clinical trials. It would change the 
daily purpose of research from what Michael J. Fox calls 
``careeriosity'' to outcomes-focused research designed to cure 
patients.
    It would target the biggest questions in cancer research 
with a unified team effort rather than a fragmented 
bureaucratic infrastructure. It would require us to give the 
FDA the budget, the people, and the tools necessary to review 
expeditiously and thoroughly the new therapies that are so 
desperately awaited by so many of our loved ones and friends.
    It would require us to link, not separate, our researchers 
in academia, Government, nonprofit, and for-profits in new 
efforts like the Reagan-Udall Foundation. It would require us 
to ensure that all Americans enjoy the benefit of new cures and 
treatments so that where someone lives does not determine 
whether they live.
    In my hometown of Blytheville, AR, my father contracted 
cancer at the age of 91. There were no cancer doctors in 
Blytheville, AR. They came over twice a week from Memphis. That 
was the bad news. The good news was you couldn't get cancer on 
Monday, Wednesday, or Friday because the doctors were only 
there on Tuesday and Thursday. We have to provide access to 
these new cures to all of our citizens regardless of geography 
and social and economic status.
    The first and greatest challenge to curing cancer in the 
21st century is to believe we can do it. We have to be willing 
to challenge long-held assumptions about the nature and purpose 
of medical research and to share and show a renewed commitment 
to supporting medical research through meaningful investments 
of financial and human capital.
    A long time ago, a young leader of America, standing in 
Rice Stadium in Texas issued a challenge. I would like to 
paraphrase that challenge. Why choose to cure cancer? Why 
choose that as our goal? Some might say, ``why climb the 
highest mountain? Why, years ago, fly the Atlantic? Why, years 
ago, walk on the moon? Why does Rice University play Texas?''
    We choose to cure cancer not because it is easy, but 
because it is hard. Let us choose to do it, and let us choose 
to do it right.
    Thank you very much.
    [The prepared statement of Mr. Simon follows:]
              Prepared Statement of Gregory C. Simon, J.D.
                            i. introduction
    I want to thank the Senate Committee on Health, Education, Labor, 
and Pensions (HELP) for the opportunity to present testimony today. My 
name is Greg Simon,\1\ and I am the President of FasterCures/The Center 
for Accelerating Medical Solutions, based in Washington, DC.
---------------------------------------------------------------------------
    \1\ Throughout my own career, I have focused on efforts to advance 
medical and scientific discovery. Before joining FasterCures, I served 
as the Chief Domestic Policy Advisor to Vice President Al Gore from 
1993 to 1997, specifically on economic, science, and technology issues. 
In that role, I oversaw a number of initiatives, including the programs 
of the National Institutes of Health, National Cancer Institute, Food 
and Drug Administration (FDA), the Human Genome Project, and the 
development of the regulatory framework for biotechnology products. I 
also had the honor of serving on the staff of a congressional 
committee. From 1985 to 1991, I was Staff Director of the 
Investigations and Oversight Subcommittee of the House of 
Representatives Committee on Science, Space, and Technology.
---------------------------------------------------------------------------
    FasterCures is dedicated to saving lives by saving time. Our 
mission is to identify ways to accelerate the discovery and development 
of new therapies for the treatment of deadly and debilitating diseases 
both in the United States and around the globe. The organization was 
founded in 2003 under the auspices of the Milken Institute to 
aggressively catalyze systemic change in cure research and to make the 
complex machinery that drives breakthroughs in medicine work for all of 
us faster and more efficiently. During our relatively brief history, 
FasterCures has worked with a broad range of individuals and 
organizations to eliminate barriers to efficiency and effectiveness in 
our systems of disease prevention, treatment, research, and 
development.
    FasterCures is independent and non-partisan. We do not accept 
funding from companies that develop pharmaceuticals, biotechnology 
drugs, or therapeutic medical devices. Our primary mission is to 
improve the lives of patients by improving the research environment, 
research resources, and research organizations.
                    ii. are we in a war with cancer?
    Our Nation incurs an enormous human and financial cost due to 
cancer every day. It is expected that cancer will claim over 565,000 
Americans in 2008, more than 1,500 people each day. One in two men and 
one in three women are likely to develop cancer in their lifetime. The 
annual bill for cancer care in this country exceeds $200 billion. The 
economic benefit our Nation would enjoy with a 1-percent reduction in 
cancer mortality would be $500 billion (Murphy and Topel, 2006). Yet 
our national investment in cancer research is going down and is nowhere 
near commensurate with the costs we bear or the gains we could expect 
if we made progress in curing cancer.
    With those harsh facts as background, no one can claim that our 
historical and current investments in cancer research or our cancer 
research strategy itself rises to a level that justifies claiming that 
we are at war with cancer.
    We are not soldiers in a war against cancer; we are students 
majoring in cancer.
    We are not investing the financial resources, human capital, and 
technological infrastructure needed to be ``at war'' with cancer, much 
less to win that war.
            iii. reorienting the cancer research enterprise
    What is behind the slow momentum in clinical discovery and 
application? There are many factors, but among them are structural 
obstacles that have arisen from the ways in which the biomedical 
research enterprise has grown and evolved along with the Nation's 
increasing investment in science over the past 50 years. Shortly after 
World War II, the National Institutes of Health (NIH) created a 
research enterprise system whose central organizing principle was the 
study of human biology. Without a doubt, the value of this basic 
research has revolutionized our understanding of diseases and opened 
doors of scientific promise beyond anyone's imagination. It is not 
entirely sufficient to develop a therapy for a patient.
    In addition to this system of studying diseases, we need to create 
a medical research enterprise whose central organizing principle is 
curing diseases. Cancer research can be the pathfinder for this new 
form of biomedical research enterprise. If we can address these 
problems for cancer, there will be enormous value to the rest of our 
disease research system.
              iv. breaking down barriers to curing cancer
    The challenges in our current system may not allow us to realize 
the opportunities in cancer research. The past few decades have brought 
enormous breakthroughs in the fundamental knowledge necessary to 
understand, prevent, diagnose, and treat cancer. Yet it still takes an 
average of 17 years to translate these discoveries into effective 
treatments. To truly organize our research enterprise around curing 
cancer, we need to forge solutions to the barriers that stand in our 
way.
1. Transform the Existing Fragmented, Bureaucratic Research 
        Infrastructure Into a Collaborative Network
    Our research environment has created an entire bureaucracy that 
fuels a quest for research publications, a need for perpetual grant 
seeking, and an intellectual property protection system that has 
resulted in a lottery ticket approach to scientific findings. Changing 
the infrastructure and reward systems within academic research 
institutions is difficult. There is fierce competition for funds, 
publications, and patents which serve as a disincentive to 
institutionalized communication and data exchange between basic and 
clinical researchers. Scientists have inadequate opportunities for 
cross-disciplinary training and practice.
2. Move Toward a Systems Research Approach
    Currently, we have a highly specialized, reductionist approach to 
scientific inquiry. There is little funding or reward available for 
high-risk research. The system tends to focus on individual 
organizational challenges instead of collaborative approaches to ``big 
picture'' problems.
    Cancer is a systems problem. It requires the collaboration of 
multi-disciplinary teams from many institutions and perspectives. At 
every turn this collaboration is discouraged. NIH grants are still 
primarily focused on principal investigators, not teams. Universities 
throw up legal and financial objections to collaborations with other 
universities. Major medical journals only give real credit to the first 
and last authors listed on a paper, thereby discouraging researchers 
from collaborating for fear they will not receive credit and therefore 
not move along the road to tenure--one more bad side effect of 
organizing the system to study disease rather than cure it.
3. Ensure Scientific Research is More Outcomes Focused
    In funding deliberations at the NIH there is little emphasis on 
specific goals or milestones to cure disease or on achieving specific 
clinical results. Researchers often insist that science cannot be 
managed, and that the role of the NIH is to provide ever increasing 
funds and not to direct how those funds will be used. NIH program 
officers exercise little oversight over the use of NIH funds except to 
be sure that researchers are doing the work for which they were funded. 
As a result, the time from initial discovery to dissemination and 
commercialization is often measured in decades--an outcome simply 
unacceptable to the citizens who fund this research and expect to 
benefit from its fruits.
    The NIH Director and the National Cancer Institute (NCI) Director 
have the authority to start using new goal-oriented funding methods 
that can accelerate medical research. The National Institutes of Health 
Research Reform Act of 2006 gave the NIH Director the authority to:

          ``. . . allocate funds for the national research institutes 
        and centers to award grants, contracts, or engage in other 
        transactions, for high-impact, cutting edge research that 
        fosters scientific creativity and increases fundamental 
        biological understanding leading to the prevention, diagnosis, 
        and treatment of diseases and disorders.''

    Institute Directors, including the head of NCI, have authority 
under the act to use those allocated funds in novel and creative ways 
to spur innovation and cutting-edge research.
    The obstacle to using this authority is a classic Catch-22. Critics 
argue against more money for NIH and NCI because of concerns that the 
budget doubling did not lead to breakthroughs. Using the same old 
mechanisms to fund low-risk research will not lead to breakthroughs. No 
one will use the new authority to fund new high-risk research because 
there is so little money available for the traditional basic research.
    We need not only to allow but to require the NIH to invest in 
cutting-edge technologies through goal-oriented, contract funding 
mechanisms. Intelligence agencies have the ability to invest in start-
up companies through their venture capital firm, In-Q-Tel. The Defense 
Department and NASA have ``other contracting authority'' to do the 
same. Why shouldn't the NIH be allowed to, and directed to, invest in 
the best private sector research tools and approaches, and leverage 
private sector resources in the same way?
    We should integrate, not segregate, translational and clinical 
research. The message must be clear to all those engaged in NIH-funded 
research, inside and outside the walls of the Institutes, that the 
ultimate goal of all research is to improve health and cure disease. 
Translational research, by definition, requires joining basic research 
to a therapy that will help a patient. This translation process 
requires that each researcher understand the source and the ultimate 
use of the knowledge they are part of creating.
4. Clarify the Purpose of and Measures of Success for Clinical Trials
    Human clinical trials are absolutely critical to medical progress. 
Recruiting volunteers to participate remains one of the costliest 
aspects of the drug development process. Reducing the length of a 
clinical trial by just 1 month by improving patient recruitment could 
not only save lives, but also generate additional revenue to reinvest 
in the research and discovery of new therapies.
    The clinical trial challenges are especially acute in some cancers 
where clinical trials are viewed as the last hope and often viewed as 
the only therapeutic option. Staying on the current path is simply not 
an option if we want to accelerate the search for cancer cures. Some of 
the ways we can do this include:

     Creating a national Web-based registry of individuals 
willing to participate in clinical trials;
     Orchestrating a major public relations effort to highlight 
the critical role patients play in the search for cures and to give 
them the information they need to get involved;
     Partnering with community physicians to educate them about 
clinical trials, develop new incentives for their participation, and 
create ``mini-CROs'' to ease their administrative burden; and
     Institutionalizing methods for making research protocols 
more patient-centered such as revamping the informed consent process.

    By enrolling in clinical trials to test potential new therapies--as 
well as by providing tissue samples, blood, or medical histories--
patients can provide critical information and resources, without which 
the search for cures could slow to a halt. FasterCures has focused on 
all three of these tools for discovery under our Patients Helping 
Doctors (PHD) program.
5. Establish Standards for Biospecimen Collection
    We cannot develop therapies for us without first conducting 
research on tissues taken from us. The availability of high-quality 
biospecimens allows a researcher to conduct a wide range of analyses 
that not only allow for a better understanding of the genetic and 
molecular changes involved in the progression of diseases, but can also 
be used for assessing the effectiveness of novel drugs and therapeutics 
in a particular patient population. &
    Progress in cancer research will be impeded if we cannot create a 
network of biospecimen repositories and standardize the collection and 
storage process. The lack of standards for molecular-based biomedical 
research as well as standards for the collection of tissue samples, 
genomic data, and information exchange across private and public 
sectors curtails collection of much-needed biospecimens. It also means 
that many of the samples already collected are simply not useful.
    We need to support private and public efforts to strengthen the 
network of biobanks. Biobanks are a critical resource for such 
molecular-based biomedical research. The data, biospecimens--such as 
tissue or blood--and molecular components that they collect, test for 
quality, and then distribute to researchers are absolute requirements 
in the pathway to developing modern diagnostics and cures for human 
disease.
    The NCI needs to overcome the resistance of local cancer centers 
and create a unified system of tissue collection and preservation to 
accelerate medical research.&
6. Create Platforms to Address Big Scientific Challenges&
    The ``knowledge economy'' has affected all aspects of our lives--
except for the most important, our health. In order to build a 
knowledge economy in health research, we need to find pragmatic models 
that link researchers and their knowledge into networks that can 
identify and solve the big problems in cancer research.
    The NCI is beginning to address this reality through programs like 
the ``HapMap,'' The Cancer Genome Atlas, the NCI Alliance for 
Nanotechnology in Cancer, the Cancer Bioinformatics Grid program 
(caBIG), and the Translational Research Working Group. These efforts 
are harbingers of the future direction cancer research must take to 
create the information infrastructure, databases, and standards 
necessary to progress.
7. Transform the NIH Intramural Research Program to Focus on 
        Translational Research
    All of the research being funded by NIH and conducted at NIH needs 
to be as efficient as possible. Clearly, additional funds are needed 
and the impact of declining NIH budgets is already sending a rippling 
effect across the research infrastructure. We need to be sure that 
existing programs are maximizing their potential.&
    The NIH Intramural Research Program (IRP) is a unique national 
resource. It includes a large cadre of scientists, clinicians, and 
technicians, supported by long-term and stable funding, an expansive 
infrastructure, and close proximity to the NIH leadership. It was 
established over 50 years ago, at a time when there was only a small 
extramural biomedical research community, and thus its function was 
unique: both to support multidisciplinary research and train the next 
generation of researchers. However, as the extramural biomedical 
research community has developed over time, the IRP's mission and 
activities are no longer clearly distinct from those of the extramural 
community.
    There is broad consensus that, given its size, scope, and 
resources, the NIH IRP should not simply be a duplication or extension 
of the extramural biomedical research enterprise. Rather, it should 
take on distinctive and strategic research programs that respond to 
pressing needs and opportunities more in line with its special status. 
It should function more nimbly, be more responsive to change, and take 
better advantage of its long-term funding stability and low level of 
competing demands. Moreover, the juxtaposition of extensive basic and 
clinical research communities provides great opportunities both for 
multidisciplinary and translational research, and both should become 
more clearly central to the IRP 's mission.
    Moreover, the IRP should become more outcomes-focused, meaning it 
should strategically seek solutions to clinical problems through 
combining bench work, animal models, and human studies. Its focus on 
basic questions should be more clearly supportive of solving pressing 
medical problems. The ultimate success of the IRP should be measured 
both in terms of the quality of the science it conducts and its clear 
accomplishments contributing to improved health.
    To achieve this vision, the culture, expectations, and paradigm of 
the IRP should be realigned. Such a transformation will require 
congressional and administrative action and leadership. The NIH 
Director must be supportive of reform and granted the authority to 
implement widespread change in the IRP. Leadership should be assessed 
on its ability to push a priority-setting and review strategy that is 
more strategic and consistent, coordinating and facilitating the 
collaboration of the various institutes and centers, and focused more 
on quality control, assurance, and accountability, as well as on basic, 
translational, and clinical research progress.
8. Develop a Responsive Peer-Review System
    Our current systems for reviewing and funding research, however, 
have become in many ways highly conservative, placing heavy emphasis on 
established researchers and high success rates in research outcomes, 
instead of clinical outcomes. Novel, high-risk proposals do not fare 
well in a system driven to maximize positive results to get scarce 
grant funds. The peer-review system is also oriented around evaluating 
individual proposals and identifying flawed ideas--not around 
prioritizing research projects for a particular purpose.
    NIH is the largest pillar on which the academic peer-review system 
currently rests, and the impact of any effort at NIH to revamp the 
system would be wide-ranging. Even simple procedural changes could 
significantly improve the quality of proposal evaluation (and 
evaluators) and give more innovative research a better shot at 
competing for funds.
    We believe that assumptions about the integrity and validity of NIH 
's peer-review system need to be tested to ensure that it is as 
responsive as possible to scientific and health priorities.
    The review system should be designed to identify the most promising 
areas of scientific exploration in terms of their potential to 
contribute to improved human health and well-being. This includes basic 
science studies of normal function and development in both humans and 
in animal models, translational research that develops drugs or other 
therapies, and clinical trials that test interventions in patients.
    All types of research across this spectrum are critical to the 
Nation's health. FasterCures, however, has concerns that despite 
incremental improvements to the system over the past few decades, some 
major challenges remain. These challenges will not be sufficiently 
addressed by simply re-reviewing the composition and organization of 
the current system.
9. Encourage Innovative Research Approaches and New Models of Research 
        Funding
    Together, the public and private sectors can transform our research 
and healthcare system from the current model to an integrated, 
information-based, high-quality, health-sustaining model that will 
extend and improve the quality of life for patients with cancer in the 
21st Century.
    Free of the imperatives of publication and career advancement in 
academia and the bottomline imperatives of the private sector, disease 
research organizations are ideally positioned to make relatively high-
risk investments that could significantly move a field of disease 
research forward and increase the likelihood that other parties will 
invest as well. Venture philanthropy groups such as the Multiple 
Myeloma Research Foundation, Susan G. Komen for the Cure, Prostate 
Cancer Foundation, and the newly created Melanoma Research Alliance 
have been at the forefront of creating new models of collaboration and 
public-private partnerships that can ``de-risk'' the costly process of 
therapy development.
    At FasterCures, we work with many of these groups both in the 
cancer and non-cancer arenas. They have a unique ability to move 
research forward by targeting research in areas that will help 
translate basic scientific discoveries into therapies, such as 
biomarkers, target and pathway validation, animal models, and small 
pilot clinical trials. They also:

     Bring a business mindset to the conduct of research;
     Create funding mechanisms that enable or even require 
academic researchers to work with industry partners;
     Provide access to a patient--community and resources--by 
creating patient registries, biorepositories, and networks of trained 
clinical trials sites;
     Explore new indications for existing drugs;
     Employ high-throughput screening to help industry identify 
better investment opportunities;
     Facilitate access to scientific experts and clinicians;
     Educate industry about the state of understanding of and 
research into a specific disease;
     Advocate with the Food and Drug Administration (FDA) for 
approval of new treatments; and
     Serve as a ``Good Housekeeping Seal of Approval'' 
validating particular researchers or paths of inquiry.
10. Collaborate With, and Support for, the FDA
    In the past 10 years, we have witnessed dramatic advances in 
science that impact the practice of medicine, including the mapping of 
the human genome, and advances in computational tools and broadband 
communications. Electronic health records will likely change the 
practice of medicine and hopefully clinical research in the coming 
decade, and offer substantial benefits to monitoring adverse events.
    Despite these advances, the FDA's ability to harness these advances 
has been hampered because the budget has not kept pace. In fact, it is 
currently at a level that is the same in real dollars as in 1996. Each 
year, FDA receives minimal new dollars and yet their costs increase, 
missions evolve, scope of science expands, and inflation erodes this 
budget. In addition, new initiatives of the FDA such as the Critical 
Path Initiative have not been given full financial support. The budget 
is holding the FDA back and preventing the agency from maximizing the 
benefits of these historical advances in science for the American 
public.
    The FDA plays a central role in American medicine--protecting and 
promoting the public's health. The agency must ensure that products are 
safe, but also effective. It must help speed lifesaving drugs to 
patients, yet ensure those same patients have the safest drugs 
possible. We ask a lot of the FDA and we expect a lot. But we don't 
support it a lot. The FDA, charged with protecting 300 million people, 
has a budget that mirrors that of the school budget in Montgomery 
County Maryland.
    FDA needs increased appropriations from Congress and should not be 
forced to rely on industry user fees which the FDA is largely 
restricted from using on post-approval activities. Many of the 
improvements recommended by the recent Science Board Report, Institute 
of Medicine report, and included in several legislative proposals will 
simply not be possible without additional resources. New initiatives of 
the FDA such as the Critical Path Initiative and the Reagan-Udall 
Foundation have not been given full financial support--or in the case 
of the Reagan-Udall Foundation any support. We cannot fund the fight 
against cancer because we cannot end the fights about funds inside the 
Beltway.
                   v. ensuring access to cancer care
    Our efforts to deliver good cancer care show the same mismatch to 
the challenge of defeating cancer that we find in our investments and 
our research strategy. We offer the best care at major cancer centers 
and academic health centers that are successful at getting Federal 
grants. Unfortunately, most people do not receive their cancer care at 
such centers. Many people are treated at local oncology practices and 
community cancer centers, where resources and cancer doctors are scarce 
and, regrettably, cancer guidelines for best care are often even 
scarcer.
    We must ensure that where people live does not determine whether 
they live. All cancer patients should have access to the best standards 
of care possible. One approach starts with the NCI Community Cancer 
Centers Program, a 3-year pilot program to test the concept of a 
national network of community cancer centers to expand cancer research 
and deliver the latest, most advanced cancer care to a greater number 
of Americans in the communities in which they live.
    The program brings more Americans into a system of high-quality 
cancer care, increases participation in clinical trials, reduces cancer 
healthcare disparities, and improves information sharing among 
community cancer centers. We should expand the pilot program to include 
community cancer centers beyond the NCI-designated cancer centers.
                             vi. conclusion
    The first and greatest challenge to curing cancer in the 21st 
Century is to believe it can be done. We have not given ourselves a 
chance to prove it is possible because our system is not focused on 
curing diseases like cancer. We have created an elaborate and 
complicated system of studying diseases that affects the way we make 
grants, give tenure, publish data, do clinical trials, create and use 
intellectual property and train young investigators. If we are to 
create a 21st Century system to cure diseases, we have to be willing to 
challenge long-held assumptions about the nature and purpose of medical 
research and to show a renewed commitment to supporting medical 
research through meaningful investments of financial and human capital.
                                 ______
                                 
Summary--Presented by Gregory C. Simon, J.D., President, FasterCures\1\
    Are We in a War with Cancer? We are not soldiers in a war against 
cancer; we are students majoring in cancer. We are not investing the 
financial resources, human capital, and technological infrastructure 
needed to be ``at war'' with cancer, much less to win that war.
---------------------------------------------------------------------------
    \1\ FasterCures is dedicated to saving lives by saving time. Our 
mission is to identify ways to accelerate the discovery and development 
of new therapies for the treatment of deadly and debilitating diseases 
both in the United States and around the globe. The organization was 
founded in 2003 under the auspices of the Milken Institute to 
aggressively catalyze systemic change in cure research and to make the 
complex machinery that drives breakthroughs in medicine work for all of 
us faster and more efficiently. FasterCures is independent and non-
partisan. We do not accept funding from companies that develop 
pharmaceuticals, biotechnology drugs, or therapeutic medical devices. 
Our primary mission is to improve the lives of patients by improving 
the research environment, research resources, and research 
organizations.
---------------------------------------------------------------------------
    Reorienting the Cancer Research Enterprise. The central organizing 
principle of the National Institutes of Health (NIH) is to study human 
biology. This has led to great advances in knowledge of human health 
and disease; but it is not a good system for developing therapies for 
patients. We need to create a medical research enterprise whose central 
organizing principle is curing diseases. If we can address these 
problems for cancer, there will be enormous value to the rest of our 
disease research system.
    Breaking Down Barriers to Curing Cancer. To truly organize our 
research enterprise around curing cancer, we need to forge solutions to 
the barriers that stand in our way.

    1. Transform the existing fragmented, bureaucratic research 
infrastructure into a collaborative network.
    2. Move toward a systems research approach.
    3. Ensure scientific research is more outcomes-focused.
    4. Clarify the purpose of and measures of success for clinical 
trials.
    5. Establish standards for biospecimen collection.
    6. Create platforms to address big scientific challenges.&
    7. Transform the NIH Intramural Research Program to focus on 
translational research.
    8. Develop a responsive peer-review system.
    9. Encourage innovative research approaches and new models of 
research funding.
    10. Increase collaboration with, and support for, the FDA.

    Ensuring Access to Cancer Care. We must ensure that where people 
live does not determine whether they live. All cancer patients should 
have access to the best standards of care possible.
    The first and greatest challenge to curing cancer in the 21st 
Century is to believe it can be done. We have not given ourselves a 
chance to prove it is possible because our system is not focused on 
curing diseases like cancer. We have created an elaborate and 
complicated system of studying diseases that affects the way we make 
grants, give tenure, publish data, do clinical trials, create and use 
intellectual property, and train young investigators. If we are to 
create a 21st Century system to cure diseases, we have to be willing to 
challenge long-held assumptions about the nature and purpose of medical 
research and to show a renewed commitment to supporting medical 
research through meaningful investments of financial and human capital.

    STATEMENT OF HALA MODDELMOG, M.A., CEO, SUSAN G. KOMEN 
                     FOUNDATION, DALLAS, TX

    Ms. Moddelmog. Thank you, Mr. Chairman. Senator Kennedy, 
Senator Murkowski, and Senator Burr, thank you so much for 
having me.
    I come here today as a cancer survivor, as a wife, as a 
mother, as the leader of the largest breast cancer organization 
in the world, and it is important, and I am proud to be here 
for Susan G. Komen for the Cure. It is much more important that 
I am here in concert with the other groups who work on this 
disease day in and day out. They appreciate what you have done. 
We all appreciate what you will do in this fight.
    I guess there is a chance that some of the past attempts 
that we have had to work on cancer in Congress may have been 
thwarted because it was about specific body parts. Again, I am 
especially glad that today I feel like we are coming here 
together to talk about this. The balkanization of body parts is 
not necessary, and the thing that is necessary is treating this 
as an inhibitor.
    Twenty-five years ago, Susan G. Komen for the Cure was 
started by Nancy Brinker with a promise to her sister that she 
would do everything in her power to end this disease. A billion 
dollars later, 25 years later, it is with great happiness, of 
course, that I can report that with breast cancer, if it is 
found early--and it is about this early detection that I want 
to talk a bit today--that 98 percent of the women live. Twenty-
five years ago, it was 77 percent.
    The problem is that there are so many cancers that don't 
have any effective early detection methods, and that is what we 
have to stop and we have to start to do. The early detection in 
many cases is really the closest thing that we have to a cure. 
We can't really let anything get in the way of fighting this 
critical battle for biomarkers, these blood tests that Dr. Benz 
mentioned, the things that make it easy to detect early and 
actually save people's lives.
    We have been talking about this a bit as a colossal cancer 
crusade. It is time to launch that crusade. It is time to 
conquer cancer. It is time to unleash the amazing power of 
science, of technology, of medicine to find these early 
breakthroughs, the early breakthroughs and early detection.
    We want to be able to think about detection that it could 
be as simple as an injection, where the treatment is so 
targeted that we don't have to worry about the toxic effects. 
Here is where we have to stop and remind ourselves about the 
fact that the early detection methods we have today are not 
being sought out and not being offered to literally millions of 
Americans.
    We, unfortunately, at Komen have the opportunity to talk to 
many people who don't have insurance, who are having access 
issues. One thing that I want to urge, as we talk about the 
surge in the science and we talk about the biomarkers and we 
talk about moving ahead, that we talk about at the same time 
the access issues. Because if we don't talk about them 
together, the gaps we have in disparities of care will only 
widen, and I know we know those gaps are there.
    It has already been said several times today in several 
different ways, but 1,500 people, 1,500 Americans die every day 
from cancer. Sixty percent--you are 60 percent more likely to 
die if you are uninsured. That is an access issue. The price 
tag for this is $219 billion a year. If we had access for 
everybody, the price tag would be even bigger.
    The early breast and cervical act has been discussed here 
today, and it is a wonderful act, and we are very happy about 
it. The truth of the matter is it is only funded at 20 percent 
for people that are eligible to get it. Even with the 
legislation that we have in place, we don't have the funding 
for even the methodologies that we have today. If we don't stop 
and work on the access issue at the same time we work on the 
science, we will be missing an opportunity.
    I have to tell you a couple of things that will sound 
pretty shocking, I am afraid. We have had some rural doctors 
sort of whisper in our ears that there are many times that a 
woman in communities where healthcare is not readily available 
will get a double mastectomy because that woman can't come to 
the hospital for chemo. She either can't get there because she 
doesn't have the transportation, or if she does have the 
transportation, she can't take the time off from work because 
she is working a minimum wage job and she won't be able to feed 
her kids, and/or there are no opportunities for childcare for 
her kids.
    When people are choosing mutilation of their bodies versus 
the treatment that, again, is available today, we really have 
to stop and understand that piece again as the science surges.
    Another thing that happens in our world and another thing 
that gets told to us is that there are cultural barriers that 
prevent this access. In some cases, even when the money is 
there and the ability to get the care is there, Latina women 
will tell us that they don't want to know about breast cancer 
because they are afraid that their husbands will leave them. 
Again, as we talk about access, again, as we talk about 
biomarkers and the science, we also have to work on the 
cultural issues.
    As Elizabeth Edwards said, we at Komen are spending our 
research dollars on what we hope and believe is innovative 
research. We have actually just assigned quite a bit of money, 
grants, upwards of $7.5 million that charge groups with being 
co-PIs, having people work collaboratively from separate 
institutions. It is an issue that has already been brought up 
today. It is about trying to drive incentives that fix the 
research system, and that is something we are committed to at 
Komen as well.
    One of the other things that I have discovered when I have 
had the opportunity to travel around the world with Komen is 
that the power in health diplomacy, the power to export what we 
learn from our health system and from our care and from our 
science is transformative. I take a lot of pride that what we 
are doing here today, what you are doing here today will create 
things for us that we can export around the world, and we will 
be thanked and loved for that. I have seen it personally when 
we have had the opportunity to do it.
    As advocates, we certainly can't deny the complexity of the 
disease. We can't forget about that. We don't mean to sound 
naive. If you think back to the panel who was here before with 
Steve Case and the fact that America has been founded on 
solving complex issues, founded on getting creative, founded on 
technologically driven solutions, we believe and this gives us 
faith that we can do this. We are not afraid of the complexity, 
and as advocates, we are going to push forward.
    One thing that I also want to say is that, ironically, 
yesterday I had the opportunity to meet two extraordinary women 
who were Stage 4. I have to say that my reaction was that I was 
embarrassed and ashamed that we are not faster, that we are not 
doing something bigger, that we are not doing something bolder.
    These women were angry. They were sad. Their main message 
was do something about this for my children. It would have been 
a really difficult night to go to sleep having faced that, but 
knowing that we were going to all have an opportunity to come 
here today and have an opportunity to work with you and what 
you are trying to do made me feel not as distressed.
    This is big. We appreciate it. We love what you are trying 
to do, and anything that we can do, all of the cancer 
organizations, we stand ready to do it.
    With your indulgence, I would like to just do one more 
thing. I am going to ask our entire audience to stand up, 
please. Now I am going to ask every other person to sit down. 
If you can't figure it out, there are some women who can show 
you how at the front. Every other person sits down.
    OK. For those that are standing, that is roughly the number 
of people that will be diagnosed with cancer in their lifetime. 
One in two men, one in three women. For the people that are 
sitting down, if you look to your right and you look to your 
left, that is your sister, it is your mother, it is your 
brother, your friend, or your child.
    Thank you for this visual.
    [The prepared statement of Ms. Moddelmog follows:]
               Prepared Statement of Hala Moddelmog, M.A.
    Mr. Chairman, Ranking Member, and members of the committee, thank 
you for the opportunity to testify before you today about the need for 
comprehensive legislation to address our Nation's cancer crisis. My 
name is Hala Moddelmog, and I am President and CEO of Susan G. Komen 
for the Cure. While I am here in my role as President and CEO of Komen 
for the Cure, I speak on behalf of every cancer patient who has a stake 
in finding a cure for this disease and every patient advocate who has 
dedicated his or her life to ending cancer forever. I am a breast 
cancer survivor. I joined Komen in September 2006--5 years to the week 
after my surgery--after a successful career in corporate America, most 
recently as president of a major food service company. Of all the jobs 
I've ever had, this--I firmly believe--is the most important of my 
life. I wake up every day with a purpose: to help put an end to a 
disease that has affected me and so many others, a disease that cost 
the lives of countless mothers. It is important for us to remember, on 
Mothers Day this weekend, how many mothers have been lost to breast 
cancer and all cancers, how many children have lost their mothers to 
this terrible disease.
    Now is a turning point for the cancer community--we have come 
together to offer our suggestions and have advocated in unity for 
change. We are committed to moving beyond strategies that have focused 
on specific cancers and have limited attempts by Congress to 
comprehensively address all cancers. We are committed to speaking with 
a renewed and resounding single voice that calls for action now to end 
for all time the ugly reality of this disease, which kills 1,500 
Americans every day. Because of this, any legislative effort will be 
that much more powerful, that much more comprehensive, and that much 
more effective.
                 mission of susan g. komen for the cure
    Susan G. Komen for the Cure began with a promise from Nancy G. 
Brinker to her dying sister Suzy that she would do everything in her 
power to end breast cancer forever. In 1982, that promise became Susan 
G. Komen for the Cure and launched the global breast cancer movement. 
Today, Komen for the Cure is the world's largest grassroots network of 
breast cancer survivors and activists fighting to save lives, empower 
people, ensure quality care for all and energize science to find the 
cures. Thanks to events like the Komen Race for the Cure, in its first 
25 years, Komen for the Cure invested $1 billion to fulfill its 
promise, becoming the largest source of nonprofit funds dedicated to 
the fight against breast cancer in the world. To continue this 
progress, Komen for the Cure has pledged to invest another $2 billion 
by 2017.
    With $100 million in scientific research grants awarded this year, 
we are well on our way to meeting our $2 billion goal. This is the 
largest single-year investment in research in the organization's 26-
year history and represents a landmark 30 percent increase over last 
year's award total of $77 million. With this year's slate of 143 
grants, Komen for the Cure has fully activated new funding mechanisms 
designed to speed the discovery and delivery of the cures for breast 
cancer. The 2008 slate funds projects designed to promote breast cancer 
research collaboration and cost efficiencies, arrive at reliable and 
replicable research results more quickly, motivate bright young 
investigators to commit to breast cancer research careers and keep 
career researchers intensely focused on breast cancer. We've made it 
clear that our money will fund projects that focus on ways to 
significantly reduce breast cancer incidence and mortality within the 
next 10 years.
    While we invest in research to discover the cures of the future, we 
must ensure that everyone has access to the best cures we have today. 
We accomplish this through the community grant programs of our network 
of 122 affiliates in the United States. Last year Komen for the Cure 
provided community grants to over 1,600 organizations, totaling over 
$70 million. These funds provided over 180,000 women with free or low-
cost mammograms, helped 18,000 with the physical, emotional, and 
financial effects of breast cancer treatment, and helped over 4,000 
people enroll in breast cancer clinical trials. Many affiliates fund 
treatment assistance programs that help breast cancer patients with 
day-to-day chores and provide monetary assistance with rent, utilities, 
and co-pays. Sadly, for women with advanced breast cancer, Komen grants 
help provide the legal assistance necessary to help these women put 
their affairs in order.
    Through the newly formed sister organization, the Susan G. Komen 
for the Cure Advocacy Alliance, Komen for the Cure is taking the next 
logical next step in its evolution: expanding its reach in the health 
policy arena. The Komen Advocacy Alliance is directly engaging 
policymakers and opinion leaders to advocate for increased funding for 
cancer research and greater access to cancer screening and treatment. 
Our goal is to expand on the long history of Komen for the Cure's 
commitment to saving lives through public policy advocacy.
                         the cancer ``crisis''
    I am honored to be testifying today about the need for 
comprehensive legislation to address the cancer crisis our Nation is 
facing. We are facing a cancer crisis. A crisis in our investment in 
prevention and early detection of cancers; a crisis in our dedication 
to innovative cancer research; and a crisis in patient access to the 
highest quality cancer care and treatment.
    Approximately 40 percent of Americans will be diagnosed with cancer 
at some point in their lives. More than 1.4 million new cancer cases 
will be diagnosed in the United States in 2008, and approximately 
565,000 Americans will die from cancer this year. The National 
Institutes of Health (NIH) estimates the annual costs of cancer to be 
$219 billion. Yet, despite a few highly successful cancer therapies, 
the fundamental goal of the ``War on Cancer'' launched in the 1970s--to 
diminish death and suffering--remains largely unrealized. In the 35 
years since the declaration of the War on Cancer, scientific research 
has produced an abundance of extraordinary knowledge about the 
biochemical mechanisms that cause cancer. This new scientific knowledge 
has led to only a modest reduction in overall age-
adjusted cancer mortality rates, especially compared to the plummeting 
mortality rates for cardiovascular disease and stroke. Cancer now 
exceeds heart disease as the leading cause of death among people under 
85 years old.
    Through our Komen Community Challenge tour, a nationwide year-long 
campaign designed to bring communities and policymakers together to 
close the gaps in access to care, I have heard firsthand from patients, 
family members, and lawmakers just how severe this cancer crisis is. 
The impact of cancer on the lives of ordinary citizens is 
extraordinary, but often unimaginable to those who have not lived 
through it.
    One of the more poignant moments of the Komen Community Challenge 
was in California. In Sacramento, actor Ricardo Chivara joined us at a 
rally to motivate the California legislature to expand access to early 
detection programs. Ricardo shared his reasons for being a breast 
cancer activist. He said, ``I personally know that cancer does not only 
affect the victim, it also affects his or her entire family. Mothers 
with breast cancer have an uncertain future for themselves and their 
children. Sick mothers cannot nurture and guide their children. Mothers 
suffering from breast cancer sometimes can't even make it to the 
grocery store to buy food to make dinner, or help you with that 
evening's homework. I remember on more than one occasion having to ride 
my bike several blocks with a $20 bill to the grocery store to buy 
food, put it in my back pack, and ride back home. I was 12. I remember 
my older sister balancing my mother's check book and paying all the 
medical bills, because my mother was vomiting from just having received 
chemo[therapy]. My sister was 15.'' Ricardo lost his mother, Elizabeth 
Ries Chivara to breast and cervical cancer when he was 16 years old, 
and he is an activist because he does not want to see other children 
suffer the way he and his sisters did.
    In California, we also met Jamie Ledezma, a deputy district 
attorney from Fresno, who was 27 years old and 14 weeks pregnant when 
she was diagnosed with breast cancer on Valentines Day. Determined not 
to let her cancer diagnosis stop her dream of being a mother, Jamie 
underwent 6 months of chemotherapy during her pregnancy. Her son Blake 
was born healthy, with a full head of hair, and he accompanied his 
mother to Sacramento to help lobby California legislators. When Blake 
was a just a month and a half old, Jamie underwent a bilateral 
mastectomy. Jamie has a significant family history of breast cancer and 
tested positive for BRCA1. She is a breast cancer activist because she 
wants to ensure that legislation, such as the recently-passed Genetic 
Information Nondiscrimination Act, benefits her family.
    In Massachusetts just last month, we met Cristina Moya, a lawyer 
who moved to the United States in 2000 from the Dominican Republic. In 
April 2005, she found a lump in her breast. She waited 2 months to see 
a specialist, who assured her that she had nothing to worry about. She 
did worry, because she had lost her sister to breast cancer and her 
mother to ovarian cancer. Two months later, she saw yet another 
specialist, who again told her she had nothing to worry about. She 
continued advocating for herself, and finally in January 2006, 9 months 
after she found the lump, she was diagnosed with breast cancer. She was 
fortunate to have health insurance and was treated at Dana-Farber 
Cancer Institute, where she had a patient navigator to help her through 
her treatment. Now she works as a case manager at Jamaica Plain Child 
Care Center. As a volunteer with the Boston Public Health Commission, 
Cristina trains women on breast health and the importance of early 
detection and screening. She said, ``I want to help other women, 
especially women in the Latina community. In many parts of my 
community, cancer is considered a punishment from God. Women need to 
know this is a disease that you get treated. No shame should be 
associated with it.''
    Cancer is a devastating diagnosis. I learn this every day in my own 
life, and every time I meet survivors and family members of survivors. 
From our work with activists, scientists, States and the Federal 
Government, Komen for the Cure believes that the fundamental gaps in 
the paradigm of cancer research and care are based on:

     Lack of investment in early detection of cancer;
     Inadequate funding for cancer research and barriers that 
is difficult to translate basic research into patient treatments; and
     Inconsistent access to high quality cancer care.

    To discover and deliver the cures for cancer, we must address these 
gaps.
                 early detection of cancer saves lives
    Komen has long believed that early detection is critical to 
successfully treating cancer and has been a champion of early detection 
programs. Timely mammography screening of women over age 40 could 
reduce mortality by 20 to 35 percent. Moreover, the 5-year survival 
rate for women with early-stage breast cancer is 98 percent; for women 
with distant metastatic disease, the figure plummets to 27 percent. 
Early detection of prostate and colon cancers is similarly beneficial 
for patients: the 5-year survival for colon cancer is 90 percent when 
detected early, and the 5-year survival rate for prostate cancer 
approaches 100 percent due to early diagnosis and improvements in 
treatment.
    There is no doubt that early detection saves lives. The single most 
important factor in the relative success of a cancer treatment regimen 
is often the stage at which the cancer is diagnosed. However, despite 
the expansion of screening programs in recent years as the result of 
greater awareness of the importance of early detection, 45 percent of 
all women over 40--the age after which the National Cancer Institute 
(NCI) recommends an annual mammogram--still do not receive an annual 
mammogram. Screening for colorectal cancer is similarly disturbing. 
Despite the high survival rate of patients when colorectal cancer is 
discovered early, only 39 percent of cases are diagnosed at the early, 
localized stage. According to the American Cancer Society, of the 
49,960 people expected to die of colorectal cancers in 2008, 
appropriate testing could save more than half.
    In the breast cancer community, we have advanced screening and 
imaging techniques which can accurately identify the early stages of 
cancer. For many other cancers there are no such early detection 
modalities. Ovarian cancer is a particularly devastating example: there 
is no screening diagnostic, thus a diagnosis is most often made after 
the cancer has spread when a symptomatic patient presents to her 
physician. According to the American Cancer Society, when ovarian 
cancer is detected locally, the survival rate is 92 percent; however, 
only 19 percent of cases are detected at this stage, and the overall 5-
year survival rate is only 45 percent. Survival rates are even more 
disturbing for lung and pancreatic cancers. In addition to improved 
education and outreach for current diagnostic screening, the wave of 
the future lies in the discovery of biomarkers and the development of 
effective early detection diagnostics for all cancers. Armed with these 
biomarkers and early detection tools, we must also apply our knowledge 
of genomic and molecular data to the development of targeted, low-
toxicity medications and dosing regimens that are tailored to an 
individual patient's genetic makeup.
    Personalized medicine holds enormous potential to advance oncology 
care and treatment. With the discovery and clinical uptake of targeted 
diagnostics and therapeutics, we could save countless lives and reduce 
untold suffering. We must dedicate substantial resources to the 
development of biomarkers and to the delivery of personalized medicine.
Continued Commitment to NIH Funded-Research
    Previous investments in research have allowed us to make 
significant progress toward discovering and delivering the cures for 
cancer. The ``doubling'' of the National Institutes of Health (NIH) 
budget from 1998-2003 fostered incredible advances in our understanding 
of the molecular etiology of the disease. Yet, since 2003, the NIH has 
been consistently flat funded. When adjusted for inflation, flat 
funding translates to an actual decline in NIH purchasing power. 
According to the NCI, when funding is adjusted to reflect the 
Biomedical Research and Development Price Index, the NCI has 
experienced a significant loss in purchasing power each year since 
2004, resulting in a 19 percent--or $1 billion--loss for fiscal year 
2008. We cannot engage in cutting edge science and maintain our status 
as the global leader in biomedical research without adequate NIH 
funding.
    Susan G. Komen for the Cure is particularly concerned with funding 
for young researchers. According to recent statistics from ``A Broken 
Pipeline: Flat Funding of the NIH Puts a Generation of Science at 
Risk,'' only one in four NIH grants is awarded to a first-time grantee. 
Young investigators are often the source of the most innovative, 
creative ideas in science, but we are losing a generation of young 
researchers due to chronic under-funding of the NIH. The NIH must re-
evaluate its commitment to young researchers by creating dedicated 
funding streams for young scientists, establishing mentoring programs 
and restructuring the grant review process to encourage funding for 
high risk proposals sponsored by young, but highly qualified, 
investigators.
    Komen for the Cure is also concerned that the proliferation of 
basic scientific knowledge about cancer has not been matched by the 
capacity of the American cancer research enterprise to translate that 
knowledge into improved diagnosis and treatment. For example, the NCI-
supported translational research enterprise is not keeping pace with 
the enormous opportunities presented by advances in knowledge and 
technology in the last four decades of cancer research. Advances in 
basic science are critical, but just as important is the translation of 
those discoveries into treatments and therapies to benefit patients. To 
improve the translational research framework at NIH and NCI, we should 
expand methods for identification of the most promising early 
translational research opportunities, streamline intellectual property 
agreements to facilitate collaborative research, and develop standards 
for storage and access to biospecimens to assist translational 
researchers. The Institute should also provide opportunities for young 
researchers to engage in translational research.
    Komen for the Cure also encourages the establishment of public-
private partnerships to advance translational research. Komen believes 
strongly that collaboration is the best way to advance scientific 
discoveries. Collaboration eliminates duplication of effort and allows 
individuals to benefit from the pioneering ideas of others. Komen for 
the Cure's own recent focus on partnerships and sponsored programs has 
resulted in highly visible and productive relationships with the 
American Association for Cancer Research, with whom we are partnering 
to create public efforts that address disparities in general cancer 
research, cancer prevention and breast cancer research; and with the 
American Society of Clinical Oncology, with whom we are creating 
programs to look at the quality of cancer care across all regions of 
this country. Komen also led an effort to bring all key opinion leaders 
in breast cancer together for the first Collaborative Breast Cancer 
Summit, held in November 2007. The meeting facilitated discussion 
around eliminating duplication of effort, sharing information and 
resources and creating collaborative programs to fund broad 
initiatives. Partnerships between the NIH and private industry, non-
profit organizations, universities, and others could be equally 
beneficial as we work toward finding a cure for cancer. Komen 
encourages the development of incentives to foster collaborative 
efforts as well as the removal of barriers that hinder such 
relationships.
              ensuring access to high quality cancer care
    Komen for the Cure has dedicated itself to ensuring that all women 
have access to high quality cancer care. We believe that all women 
deserve access to the highest quality treatment and care, regardless of 
race, ethnicity, socio-economic status or geographic location. 
Unfortunately, many of these factors do play a role in the quality of 
care a patient receives--for breast cancer, and for all cancers. For 
every person with cancer who has benefited from early detection and the 
best available care, there are many others who have not, and will not, 
benefit from the advances we have made over the past 25 years. For 
example, African-American women have a 35 percent higher rate of 
mortality from breast cancer than Caucasian women, despite overall 
lower rates of incidence of breast cancer. Only 38 percent of Hispanic 
women over the age of 40 receive regular mammograms. Those who live in 
rural communities may have to travel long distances for screening or 
treatment. And, for all cancers combined, uninsured patients are 60 
percent more likely to die than their insured counterparts.
    Last fall, the Wall Street Journal profiled Shirley Loewe, who was 
working as a hairdresser when she was diagnosed with breast cancer in 
2003. Unfortunately, Shirley did not have health insurance and went to 
the wrong clinic for her screening and diagnosis. As a result, she was 
unable to access Medicaid to help with her treatment. After 3 years of 
delays in treatment and care patched together through multiple sources, 
Shirley succumbed to the disease last summer, leaving her daughter Niko 
Ferguson and her children without their mother and grandmother. Niko 
runs in the Komen Denver Race for the Cure in honor of her mother. 
Sadly, Shirley is only one of many deserving patients who do not have 
access to cancer care.
    Komen's first annual ``State of Breast Cancer Report,'' which was 
released in 2007, found that disparities in care were pervasive 
throughout the continuum of cancer: from unequal representation in 
clinical trials to disparities in access to early detection services 
and high quality treatment. A recent study showed that ethnic and 
racial minorities make up only 10 percent of participants in clinical 
trials testing cancer drugs. Low-income women and women living in rural 
areas have difficulty getting to mammography facilities and often do 
not receive regular screening mammograms. Language barriers and lack of 
insurance prevent many other women from receiving appropriate treatment 
for their cancer.
    These disparities are not unique to breast cancer and must be 
addressed if we are to find and deliver the cure to every deserving 
American. We must provide access to high quality care to every cancer 
patient. To ensure that research is applicable to both genders and to 
all ages and racial minorities, the NIH should promote participation in 
clinical trials by addressing the financial and regulatory barriers 
that make it challenging for oncologists to offer clinical trials in 
their practices, including encouraging inclusion of minorities and 
other under-represented groups as a condition of reimbursement for 
clinical trials. To ensure equal access to early detection and 
screening services, we must continue to educate about the importance of 
early detection and consistently fund early detection programs and 
early detection research. To ensure access to high quality treatment of 
cancer, we should strive toward culturally sensitive and coordinated 
oncology care. Patient navigation services are one critical component 
to addressing barriers to quality cancer care, particularly for 
minority and underserved patients who often do not speak English, have 
low literacy skills, are uninsured and/or live long distances from 
treatment centers. These patients have difficulty accessing quality 
care and have trouble coordinating their cancer care, leading to 
disjointed treatment, inadequate patient-doctor communication, 
difficulty with follow-up appointments and poor adherence to treatment 
regimens. Patient navigators help patients ``navigate'' the maze of 
doctors, insurers and patient support groups.
    Thank you for this opportunity to testify. I have offered only a 
few of the many suggestions, changes and improvements we must make to 
address the Nation's cancer crisis. On behalf of Komen for the Cure and 
the many cancer patient advocacy groups who are working tirelessly to 
find a cure for cancer, let us together meet the challenge of directing 
our research efforts toward the detection of cancer at its earliest 
stages when our chances of stopping it are the highest. Komen's mission 
is to reduce mortality from breast cancer, but we cannot improve the 
survival rate from breast cancer, or all cancers for that matter, 
without investment in early detection of cancer biomarkers. We must 
devote time, energy and resources to discovering breakthrough, next 
generation measures for the early detection of cancer and for 
predicting its behavior before the cancer has spread. We must also 
continue the promising research on developing tailored therapies to 
treat individual advanced cancers that have already spread. 
Personalized medicine is the cornerstone to successful treatment of 
cancer. An accurate diagnosis at the earliest possible moment is 
critical to successful treatment.
    A second challenge is to ensure that every cancer patient in 
America has access to high quality, affordable care that meets the 
highest standards set by experts and physician societies. It is 
unconscionable that we cannot guarantee every American access to 
lifesaving medical care and unacceptable that we have not addressed 
this issue.
    We come here today to respectfully challenge you to join us, along 
with the rest of the cancer community, to act boldly, comprehensively, 
across all fronts--research, prevention, early detection, access and 
treatment--to win the fight against cancer, and with it, save the lives 
of millions of Americans.

    The Chairman. Thank you very much, Hala, for your 
testimony. I couldn't agree more about the potential in terms 
of what progress, shared progress in the world would mean. We 
have seen at other times when America has been at its best, 
particularly in the areas of food, for example, medicines.
    You look at what happened when the tsunami hit, where we 
were so involved, and the opinions about America went up, just 
soared. We obviously weren't there just for the poll results, 
but people do have enormous appreciation, as we all would 
understand, as they are trying to provide help and assistance 
to their children and to their families.
    Let me come back to Dr. Benz and Mr. Simon. When we had the 
war on cancer, there was that legitimate discussion and debate 
and editorials about we can't legislate the cure. We understand 
that. Those that actually opposed the legislation at that time 
saying that they were opposing it because that is really what 
they were attempting to do, which is not what we were doing.
    We had reached the judgment decision that about two thirds 
of the funds were going to be basic and about a third were 
going to be both clinical and more targeted. That was basically 
a reflection of some of the deep interest that many, many 
families had, many Americans had, maybe mistakenly, that they 
ought to have at least some voice in the allocations of 
resources.
    If they are going to be affected by the HIV and AIDS or 
they are going to beat breast cancer, they want some additional 
kind of input and impact on this, some additional kind of focus 
and attention. Looking back, there were some failures, but 
there also were some successes. Heart disease, stroke, HIV, 
some results on it. With the others, basic research were going 
to be peer reviewed.
    Now I don't know what is out there. I think all of us are 
very conscious of the fact that we can't have the ``disease of 
the month,'' and solving all of our problems. At least I happen 
to believe that people care and care deeply about some of these 
issues. We ought to have a broad context, but we should also 
give some degree, I can't say precisely what percent, by 
looking into some of these areas that are of particular concern 
to families.
    There has been a strong effort by Dr. Zerhouni to try and 
bring together these various disciplines, and that was included 
in the NIH in the last year. He hasn't gotten a lot of 
resources to be able to do that, but at least he is attempting 
and particularly in the areas of clinical research, which I 
think are very interesting. Strong support, and I hope we can 
get him some additional help and assistance in this.
    What is your own kind of sense? We have seen, Dr. Benz, you 
are familiar with this and as a participant. I know Mr. Simon 
has got some real concerns. The concerns have been expressed by 
members of this committee as well. Obviously, we are all trying 
to come at this in the way that we can get the best opportunity 
for making progress with these diseases and to try to do it 
with the greatest degree of support.
    Dr. Benz.
    Dr. Benz. Thank you for the question. It is a great 
question.
    First, I will just mention that one of my present roles is 
to be advisor to Dr. Zerhouni and his advisory board for 
clinical research. I chair that committee and have watched what 
he has been trying to do, and I think it is exemplary of what 
we face in terms of the systems we have in place now and the 
need to look hard at those systems to break down the kinds of 
barriers that artificially divide basic and clinical research, 
artificially divide research on pancreatic cancer from research 
on breast cancer.
    I will answer your question first as a scientist and tell 
you that science is completely changing the way we classify 
tumors. Perhaps the most important classification is in what 
category should your tumor be in terms of how it is treated?
    The drug Gleevec that we have mentioned several times here, 
the prototype of a new targeted, less toxic form of therapy was 
developed for a disease called chronic myelogenous leukemia. 
That drug turns out to be highly effective in a form of sarcoma 
called GIST sarcoma, which previous to the use of Gleevec was 
completely untreatable unless caught at a very early stage--
treatable surgically.
    It now appears that a form of melanoma might be treatable 
by that drug and yet another form of lung cancer. Now these are 
minorities of each group of patients, relatively small 
percentages of each group of patients. In the aggregate, a 
large number of patients benefit enormously from this drug 
because the important way to classify tumors, from the point of 
view of should you get Gleevec, is not by: is it pancreatic 
cancer, is it lung cancer, is it melanoma? It is by what is its 
molecular signature?
    I think all of the advocacy groups--I shouldn't presume to 
speak, but having worked with them--are of this belief as well, 
that whatever should be invested in going after the particular 
form of cancer that matters most to you and your family, there 
needs to be this fundamental research into the basic aspects of 
all cancers because these cancers share certain things in 
common and from a point of view of effective therapies probably 
are as likely to get a good treatment for breast cancer from a 
study of pancreatic cancer or vice versa as from focused 
therapy just on that.
    The other part of it, where I do think advocacy for 
specific forms of cancer is incredibly important, is when it 
comes time to take those advances into the clinic and to make 
sure that patients, as you heard from the bill that Senator 
Brown is advocating and that we put through in some States like 
Massachusetts, about half of the States, that the barriers and 
disincentives for patients going on clinical research just have 
to be dropped.
    Only 5 percent of cancer patients go on clinical trials, 
and you need to advocate that if your interest is breast 
cancer, that breast cancer patients have access to the newest 
strategies and drugs or we won't be able to change--whatever we 
have learned from science, we won't be able to change the way 
that breast cancer is treated.
    We can do this, as both of my colleagues up here have said. 
I am convinced that we have the science in hand to learn what 
we need to know. We need to do the science. I am convinced that 
we can develop therapies for these disorders. The next big 
question is will we get them out there in the field, where they 
are going to make a difference?
    The Chairman. Mr. Simon.
    Mr. Simon. Senator Kennedy, FasterCures has pulled together 
a group of over 30 nonprofits in 20 different diseases to ask 
them ``what is holding you back?'' We put them in one room, and 
they usually aren't people who go to the same meetings. So you 
have breast cancer in with ALS patients, multiple sclerosis, 
and Parkinson's.
    What they all found out was that all their problems were 
the same, regardless what disease they were dealing with. Those 
problems were the culture of research, lack of collaboration, 
lack of standards for tissue collection, lack of funding for 
translational research, lack of sharing of intellectual 
property at the right time, lack of training people for 
research and medicine.
    It is not a disease-by-disease problem. We can't cure any 
of the diseases we are wrestling with, with the system we have. 
We need to devise a system that can cure diseases, and it will 
help us cure any disease. Cancer can be the avant-garde for 
this because cancer is one of the diseases where we know the 
most about the cause and the progress and what we need to be 
working on.
    The foundation that has been laid through basic research is 

highly valuable, and my remarks should not at all be 
interpreted to be diminishing the role of basic research. But 
basic research is just that, it is basic. We have to build a 
bridge from that to the patient. That bridge is not being 
funded. That bridge is not being staffed. That bridge is not 
being rewarded.
    All of these excellent ideas that Dr. Benz talks about do 
not get the funds they deserve. Why? Because as money goes 
down, the established investigators who have been getting 
grants for years and years want to keep getting grants. That is 
why the average age of someone who gets their first NIH grant 
is 42 years old. The average age people do the work for which 
they get a Nobel Prize is 33 years old.
    We are wasting our human resources by the way we run our 
research system. When we do have breakthroughs, we need to have 
a flexible system that can move resources quickly into that 
area, and health is the last sector where we are using 
information technology to share knowledge.
    They know more about your car when you go in with computer 
diagnostics than they know about you when you go into a 
hospital. They learn more about what goes on on the Internet 
everyday on Facebook than we know about what is going on in 
clinical trials in Bethesda. They are not sharing the 
information.
    The Chairman. Well, I am all with you on health IT, and I 
make the case on that. We are all into that. But all of us can 
make the case that if you get additional kinds of grants for 
well-qualified research that we are going to do better.
    The question comes back that I hear you, though, is a 
fundamental kind of sense that the idea that we are doing peer-
reviewed research is not working? I don't know. That is the 
basic concept of our research here, and it has been.
    Now, if that is your point, that is what I want to hear. If 
that isn't working, I don't know what the substitute is. I am 
not getting a lot from you to tell me what it is. I don't--my 
own sense is we are short on the--we have seen the investment. 
Now we have got the possibility, as I mentioned earlier in the 
comment, I am a strong believer this is the life science 
century. It is unlimited, and we are only funding whatever 
percent, 18 or 19 percent of the qualified grants on these 
kinds of issues. We all ought to do more.
    The point about it is are those basic underlying grants 
that are going--if peer review isn't working--where we are 
trying to take the best in terms of researchers and scientists 
that have related information and knowledge about these subject 
matters and bringing them together to review these 
applications. I am sure there are a lot of things that could be 
corrected and improved on. If we are not for peer review, I 
don't know what we ought to be for, particularly if we are 
starting out on a new course.
    Mr. Simon. Well, let me address that, Senator. No. 1, peer 
review has two parts. One part is, is this proposal 
scientifically rigorous? The other part, which gets short-
changed all the time, is, is this meaningful? Does this help 
patients?
    If something is scientifically rigorous, then it often 
rises to the top of the heap even if something that is equally 
scientifically rigorous is next to it but has more merit, and 
we have to be able to do both. We have to have strong science, 
but we have to start asking will this help people?
    The second part is the DARPA example. DARPA doesn't do it 
through peer review. They find a problem. They ask people to 
fix it. They have a project manager for 2 years, and they make 
a go/no-go decision at the end of 2 years. We don't do that in 
medicine.
    The Chairman. Yes, well, that is entirely different from 
peer review. DARPA, I am familiar with DARPA. I am familiar 
with space, the going to the moon. I am familiar with those. 
But that is an entirely different concept than the peer-
reviewed research.
    Now if you are talking about getting sound science and 
grants that meet the best in terms of scientific capability and 
also have the best opportunity to have an impact to improve 
patients, I am with you. I am with you. I think we ought to be 
there. If we are not there, if that is an area that you think 
is missing in terms of the totality on it, I think that that 
does make sense and maybe we are not there. If that is what you 
are talking about, I think that makes sense.
    I am just concerned about if we are not--getting into the 
questions about undermining peer review, if we start talking 
about that, we are talking about an entirely different kind of 
an approach. I don't know a lot of science or science 
researchers or researchers that think we ought to throw the 
peer review over the side.
    Dr. Benz. Senator.
    Mr. Simon. I wouldn't propose that, Senator, not at all. It 
is just we need to do more risky things than most peer-review 
committees are willing to do, and we need the money to do those 
things.
    Dr. Benz. Senator, if I might, with your permission, 
comment briefly, as someone who has been on both sides of peer 
review? In fact, I have a grant, and I just got my peer review 
score back. It is right on the cusp for funding. My view of 
peer review might change depending on what the council says.
    I don't think the issue or the problem is with peer review. 
I think it would be very unfortunate if peer review, as the 
mechanism for evaluating the quality of the science, were 
replaced by something else because, like you, I can't imagine 
what would be better.
    Peer review, like all human systems, has its flaws. Having 
served on study sessions, chaired study sessions, sat on the 
council--which is the second level of peer review, actually at 
several of the NIH institutes--what I can tell you is peer 
reviewers do extremely well and sincerely with what they are 
charged with doing. The problem in the peer-review system, in 
my view, right now is what rules and what criteria are the peer 
reviewers asked to evaluate?
    If the primary mechanism for funding is the individual 
research grant in which individual productivity, individual 
accomplishment is a major parameter, we are going to fund 
things that favor individual accomplishment at probably the 
expense of the kind of collaboration.
    I can offer you a quick example from the Dana Farber. In 
our strategic plan in 2003, we decided we needed to create 
these connections and these overlaps between the clinic and 
basic research and collaborations and platforms, you know, 
create what Steve Case might have called the wires and the 
wireless signals in the Internet because that is where the 
action is.
    We did that, and we funded it. But we funded it with 
philanthropy, and we funded it with institutional dollars that 
we were able to generate from our own operations because there 
was no effective, at the time, NIH mechanism for funding that. 
It is what we ask the peer reviewers to do that I think we 
should examine, not the process of peer review itself.
    The Chairman. This is very interesting, and I yield. I have 
taken too much time. We ought to try--this is very important, 
and we ought to try and sharpen that up, I think, if we are 
going down this pathway. I think these are good suggestions, 
and we ought to try and work with Dr. Zerhouni and others on 
this as well. We are, I think, interested.
    Thank you very much.
    Senator Murkowski. Thank you, Mr. Chairman.
    It gets back to the buzz word of the last panel in which 
everyone was talking about collaboration, and how do you take 
what you have learned from this study and what you have gained 
from this and learn and share that so that the benefit is 
greater? Again, just the focus on collaboration.
    Ms. Moddelmog, I want to talk just a moment about your 
focus, your emphasis on the early detection and the screening. 
We know, it is clearly demonstrated that this is effective, 
this saves lives. This really makes a difference. Through the 
National Early Detection Breast and Cervical Cancer Program, we 
have seen so much good come out of that. Yet we recognize that 
only about 20 percent of the women that are eligible are 
actually taking advantage of that or utilizing that.
    In the State of Alaska, I have had the opportunity to speak 
with those in the State that have the Breast and Cervical 
Cancer Early Detection Program and I have asked them what the 
problem is here? How do we get more women in for the screening? 
What is it that we need to do? Is it the geographical access 
that I talked about earlier?
    One of the comments that struck me at that time was that 
there are women who don't want to come in for the screening for 
fear of the diagnosis because they know that they don't have 
the money to do anything once they get the bad news. Maybe if I 
just don't go through the screening, I don't have to hear it 
and I don't have to deal with it.
    Then you live with that uncertainty until that uncertainty 
just takes over your life, and it is something that when we 
talk about access and we talk about the issues that prevent 
access and healthcare insurance and how we make that 
meaningful. To me, that is so incredibly sad to know that a 
woman would not take that step for the screening because she 
knows that once she hears what the reality is, she has no 
ability to deal with it after that.
    How do we, in your opinion, deal with this? How significant 
is that aspect of the lack of access when it comes to early 
detection and screening? Is it because of the fear of the other 
side?
    Ms. Moddelmog. Well, you have hit on two issues that are 
extremely important. One is the cultural issue, which I would 
like to address a little bit, and the other is really the 
financial issue. I will start with the cultural issue because 
it does get back to the fact that women, a lot of times, don't 
want to know.
    As a matter of fact, we did a study that we have just named 
the mortality report, and we went to the eight pockets in 
America that have the highest mortality rate from breast cancer 
to study these groups and find out what are the barriers that 
make their mortality rate so high.
    I am sorry to report that in these areas of our country, 
the mortality rates from breast cancer are third-world 
mortality rates. They are the same kinds of numbers that you 
are going to find in the developing world. We went in to do a 
film of women, and we thought that we were going to be talking 
to women who were interested in trying to take care of 
themselves. We ended up naming the film ``I Don't Want To 
Know'' because they felt disempowered to do anything about it.
    When you get back to the financial part of it, again, the 
Breast and Cervical Early Detection Program, it is not only 
that 20 percent of women are not availing themselves of it, 
only 20 percent of it is funded. There is a financial gap there 
already. On top of that, there are some loopholes in some of 
the States in terms of if you are not screened at the 
appropriate place through the CDC with the Breast and Cervical 
Early Detection Program, then you are not eligible for 
treatment in that State.
    That is a gap that we have talked about on the Hill for 
several years now, and we have actually been able in some of 
the particular States to get that gap closed. There are several 
States in our union--probably about half, as a matter of fact--
where if you don't get screened in the right place, then you 
are not eligible for treatment. And women know this.
    You have really hit on something that is very troubling. 
Again, it gets back to my--really the part of the premise of 
the talk here is that as the science surges and as we put our 
efforts behind it, if we don't mindfully close the gap on 
disparities, our mortality rates may not change that much. 
Because the people who are getting care today will be the same 
people getting the care tomorrow.
    We could close the gap on mortality with what we have 
today, much less what is coming up. The personalized medicine, 
targeted treatments, we couldn't be more excited about. Just 
like all politics is local, all cancer is personal. If we don't 
have access for the people that don't have it today, they are 
not going to get it when we have the fancier treatments.
    Senator Murkowski. Well, let me ask--and I will throw it 
out to any one of the three of you, or all three of you--if you 
are fortunate enough to live in Seattle and have access to the 
Fred Hutchinson Cancer Center and you have the experts there, 
or you are back here on the East Coast and you have access to 
the levels of care that you have at the Dana Farber, good for 
you. But what about the rest of those of us that live in the 
outlying areas that don't have access to these incredible 
facilities?
    How good of a job are we doing in getting what we are 
learning from some of the great research that is out there into 
the smaller communities, where you may have one oncologist that 
is available for the whole community here? What are we doing to 
make sure that they have access to the best possible care? Or 
do you just have to say you have got to figure out a way 
financially, and everything else, your support system, to get 
you to where it is known that it is a better cancer treatment 
center? What do you do?
    Dr. Benz. Well, Senator, we know a few things that speak to 
your point and the need for us to do this better. About 15 
percent of patients diagnosed with cancer in the United States 
will have their care given in something that looks, feels like 
an organized cancer center. It may not be quite as 
sophisticated and large as a Fred Hutchinson or a Dana Farber, 
but with quite expert care.
    What happens to the other 85 percent? Where do they end up? 
And what difference does it make?
    Well, it turns out it does make a difference, although the 
data are a little hard to pin down and haven't been rigorously 
published. There is enough persuasive data out there to suggest 
that your cancer outcomes, at least for particular forms of 
cancer that have been looked at, will be better if you are in 
the more sophisticated care facility. Not a surprising finding, 
but one that is true and says that the expertise and the 
availability of facilities and specialized care does matter for 
the cancer patient.
    For the rest, a number of our cancer centers--and this is 
one of the efforts of the American Association of Cancer 
Institutes--have been looking at ways to partner with community 
practices, to reach out to smaller cancer centers, to try to 
find better ways to use the improved communication tools we 
have right now.
    When those succeed, we do see that it has a positive 
impact. They are just not succeeding often enough.
    Senator Murkowski. Are we doing it enough?
    Dr. Benz. We are not doing it enough. There are limits on 
how an individual cancer center can do it because of the 
funding. There are barriers, even things like the Stark laws 
that limit how much information you can share if you do not 
have an economic connection between the cancer center or, say, 
a practice or a community hospital. You are limited in what 
kinds of information you can share because so much healthcare 
information--I know that Senator Kennedy knows this--is tied to 
billing information. You cannot share financials if you are 
collaborating but don't have a ``business'' relationship.
    There are the issues you have heard about, put so 
eloquently, that even when you correct for all this, there are 
still these enormous cultural issues of people being reluctant 
to come to cancer center care. There is a belief too widespread 
in our community that coming to a cancer center is what you do 
at the end of the road, not what you do as the first, most 
important decision you make about your treatment for cancer. 
What is your first line of treatment and evaluation going to 
be?
    We need this. I have often thought that it would be 
interesting to see what happens if all of the people who 
advertise and market on TV and billboards and in the magazines 
and on the Internet volunteered to use a certain percentage of 
their marketing to make people aware of how important it is to 
get their cancer screening, do their early prevention, and get 
to a cancer expert early in their care. We need something like 
that. In addition to the facilities and resources, I think we 
could find a way to do that. We need the patients to demand to 
get their care there.
    Mr. Simon. The NCI has a community cancer center program. 
It is a pilot program. It is a 3-year pilot, and it has about 
$15 million.
    The problem is cancer doesn't have pilots. That program is 
only going to reach 10 hospitals in the United States of 
America over the next 3 years. It is already showing very good 
success in getting people into clinical trials at a rate of 60 
percent, which is far above what it normally is. But you are 
talking about only 150 patients who were recruited. We have 
some good ideas. We need to expand them.
    As everybody here does, I am sure, I get several calls a 
month to have people connected to the best cancer care. When my 
own sister-in-law, who lives on a military base, was diagnosed 
with breast cancer, there was one doctor on the military base, 
and it took a number of calls to get a second opinion off the 
base, at which point the military doctor wanted to drop her as 
a patient because she got a second opinion.
    That is not right. In the area where they were living, 
there were very, very few other options. We have got to spread 
the cure as far as the disease is.
    Senator Murkowski. Thank you, Mr. Chairman. I don't have 
any further questions of the panel. I truly respect the 
dedication that each one of you have in your respective areas.
    Ms. Moddelmog, I have written down your comment about the 
balkanization of body parts, and how that has been an inhibitor 
in our real advancement on our war against cancer. It is a 
comment that I am going to be taking away from this hearing and 
will remember for a while. It has been very instructive.
    Again, Mr. Chairman, thank you for your leadership on this 
issue.
    The Chairman. Thank you all. You have stimulated, as you 
can tell, a lot of thinking and a lot of good recommendations 
and suggestions, and we will be back in touch with you, follow 
up on these matters.
    We will keep the record open here for 10 days. We are very 
grateful to all of you. The committee will stand in recess.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

                   Prepared Statement of Senator Enzi

    Good morning and thank you for joining us today. Cancer is 
an important and relevant topic for discussion this morning, as 
cancer is the second leading cause of death in the United 
States and approximately 1.2 million Americans develop cancer 
each year. It is a devastating disease and federally funded 
research is critical to better understand the causes and 
methods to treat cancer. The more we know, the sooner we will 
be able to call cancer curable.
    Investing in Cancer research is something that I strongly 
support. Hearing ``You have cancer'' from your doctor used to 
be considered a death sentence. Today when the same phrase is 
uttered, there is less fear and more hope. Federal research has 
led to remarkable advances. Nonetheless, when President Nixon 
declared war on cancer, no one ever imagined that 37 years 
later we would still have such large obstacles to overcome.
    Today, we are here to discuss the challenges and 
opportunities we face in the 21st Century with the prevention, 
treatment and cure of cancer. This is a large task that the 
United States has initiated and I believe that we need to 
continue to fund research for cancer to better understand what 
the causes are, how best to treat each type of cancer and one 
day have a cure for the cancers that we were unable to prevent. 
While cancer research should continue, it is clear that it 
should not be at the cost of another disease. Congress should 
leave the funding decisions to the scientists and experts. That 
is, the funds should follow the research, and not respond to 
the advocacy of one disease over the other.
    We have seen time-and-again examples of research that has 
resulted in victories for diseases that the funds were not 
directed to. If research entities are not able to benefit from 
flexible funding streams, chances are we would not have been 
able to capitalize on those opportunities.
     To more quickly supply new therapies to cancer patients we 
need a functioning and modern FDA. Last year we built upon the 
critical path initiative at the FDA with the creation of the 
Reagan-Udall Foundation. The inclusion of this foundation was 
heralded by patient groups as an important component of the 
bill and as having the potential to speed development and 
evaluation of drugs. This foundation would develop tools to 
speed drug development through better disease models and tests 
to detect rare adverse events.
     However, this research initiative has been denied the 
relatively small amount of money it needs to begin to work. It 
is hard to imagine why the majority side of the House 
Appropriations Committee would deny the necessary $1 million 
for this initiative. As we think of ways to speed therapies to 
patients, fully funding the FDA and allowing them to move 
forward on cross cutting critical path research is a wise use 
of money.
     Furthermore, I must remind the committee that victory over 
cancer is not just about research, but it is also about 
prevention and treatment. For that, we need real reform to 
provide better access to care for all Americans, suffering from 
any disease or medical condition. I have introduced a bill, Ten 
Steps to Transform Health Care in America, that includes the 
steps that I think will greatly reduce some of the impediments 
that prevent patients from accessing health care. The focus of 
today's discussion is on research, but I want to remind folks 
that research is only one piece of a bigger picture--we also 
need to focus our efforts on prevention through early 
screenings and treatments. Not only should everyone have access 
to early screenings and treatments, but we also need to ensure 
that all Americans that already have health insurance are 
utilizing the cancer screenings available to them. These 
foundations are essential to effective health care delivery for 
all Americans.
    I can imagine that cancer has affected most of the people 
in this room. Healthcare, and specifically preventative 
measures, must be a priority for every American and promoting 
that message through my position in Congress is very important 
to me. When my wife, Diana, was diagnosed with colon cancer, I 
was grateful for the commitment our Nation has made to 
biomedical research. She was able to benefit from these 
discoveries and treatments, while my father was not as 
fortunate--he passed away from lung cancer. It pained me to see 
my family in such physical and emotional pain while they were 
struggling in their battles against cancer. Yet, it reaffirmed 
my commitment to providing flexible Federal research dollars to 
support the research that was already there, rather than direct 
funding to a disease that was not yet in the research stages to 
result in a discovery or cure. I would want any other family 
suffering from the pain associated with any life-threatening or 
debilitating condition or disease to have the same research 
opportunities.
    I look forward to hearing the views and thoughts of our 
panelists today. I hope to better understand where the current 
gaps are in our system, concerning the prevention treatment and 
research of cancer. I also hope to hear about the current 
successes we have seen with the support the Federal Government 
is providing today. Not only research, but legislative 
successes over the years have resulted in better care for 
individuals living with cancer. I thank the witnesses for 
taking the time to discuss this important issue and welcome 
them to this important discussion.

                 Prepared Statement of Senator Mikulski

    Good morning. Thank you Mr. Chairman for the opportunity to 
talk about an issue that has touched the lives of almost 
everyone in this room--cancer--and discuss the challenges and 
opportunities that lay ahead of us in the 21st Century.
    Welcome to our panel of witnesses: Elizabeth Edwards, 
Senior Fellow, Center for American Progress; Lance Armstrong, 
Founder, Lance Armstrong Foundation; Edward Benz, M.D., 
President, Dana Farber Cancer Institute; Greg Simon, President, 
FasterCures; Hala Moddelmog, CEO, Susan G. Komen Foundation; 
and Steve Case, Chairman and CEO, Revolution LLC.
    All of you are committed to the war against cancer 
dedicating your careers to finding new cancer therapies and 
treatments, providing patients with quality comprehensive 
cancer care, making personal sacrifices to be activists and 
advocates, and speaking for the millions of people living with 
cancer. I look forward to hearing your testimony and having an 
open dialogue about this important public health issue.
    Cancer is the second most common cause of death in the 
United States accounting for 1 of every 4 deaths; exceeded only 
by heart disease. An estimated 27,000 new cases of cancer will 
be diagnosed this year in my home state of Maryland.
    Research is the best weapon we have in this fight. That's 
why I fought to double funding for the National Institutes of 
Health from $13.6 billion in 1998 to $27 billion in 2003. 
Funding for the National Cancer Institute doubled at that time 
as well from $2.5 billion in 1998 to $4.6 billion in 2003. 
Since the doubling of the NIH budget in 2003, I have supported 
increases for NIH every year. I'm concerned like many of you 
that funding is not keeping up with inflation. President Bush's 
fiscal year 2009 budget provides the NIH with $29.5 billion 
flat funded at the fiscal year 2008 level. This will mean fewer 
advances in research and a longer wait for a potential cure for 
cancer.
    Breast cancer is still the leading cause of cancer deaths 
for women 20-60 years old with an estimated 41,000 deaths this 
year in the United States. That's why I have fought to make 
sure that women's health is protected.
    I created Breast and Cervical Cancer Early Detection 
Programs in 1991 to make sure women without health insurance 
have access to life-saving tests like mammograms and can get 
the treatment they need. I also fought to pass the Breast and 
Cervical Cancer Treatment Act to help these women get the 
treatment they need if diagnosed with breast or cervical 
cancer. In addition, I created the Mammography Quality 
Standards Act in 1992. Before this law there were no national 
quality standards and no inspections done. Now, when women get 
a mammogram they know it is safe and that it meets the quality 
standards.
    We have made strides in the areas of cancer research, 
prevention, and treatment. However, there is still a great deal 
of work that must be done. I look forward to hearing from our 
witnesses today to hear about the challenges and opportunities 
that lay ahead of us. Each one of us can make a difference 
together. We can make change.

                  Prepared Statement of Senator Obama

    Mr. Chairman, I want to start by commending you and Senator 
Enzi for convening this important hearing this morning. I would 
also like to thank Elizabeth Edwards, Lance Armstrong and Steve 
Case for making the time to come to Washington to share their 
powerful stories and insights. We are also quite fortunate to 
hear the expert recommendations from Dr. Edward Benz, Greg 
Simon and Hala Moddelmog about steps we can take as a nation to 
improve the care of Americans with cancer.
    As many of you know, this Nation launched its war against 
cancer by signing into law the War Against Cancer Act in 1971, 
with Senator Kennedy's leadership. Since that time, America has 
made tremendous strides in the war against cancer and has 
become a true world leader in this area. This Nation's ground-
breaking ``bench-to-bedside'' research has led to better 
diagnostic tools and many life-saving treatments and cures. 
Equally important, because of the attention and tireless 
energies of cancer advocacy groups, Americans are more aware 
and knowledgeable than ever about this disease and how to 
prevent it. We've won many battles already, with the number of 
adults and children surviving cancer steadily increasing every 
decade. This war is far from over, and the downward trend in 
funding for cancer research is constraining our ability to move 
forward.
    Over the past 5 years, President Bush and the Congress have 
cut or frozen Federal funding for cancer, signaling a troubling 
change in Federal funding priorities. A recent survey by the 
American Cancer Society Cancer Action Network found that the 
vast majority of Americans, 69 percent, believe that the fight 
against cancer should be a top or high priority for the Federal 
Government, and that cancer funding should be increased. Sadly, 
this has not been the case.
    Further, the American public believes, as I believe, that 
we should also prioritize research to discover prevention and 
early detection tools that do not yet exist for the most deadly 
cancers, such as pancreatic and ovarian cancer. Three in four 
Americans, 76 percent, believe this is extremely urgent or very 
urgent in the fight against cancer.
    I could go on with a laundry list of statistics for you, 
but I won't. The bottom line is that the number of Americans 
being diagnosed with cancer is rising, and even today, despite 
many new tests and treatments, too many Americans are 
needlessly suffering and dying from this disease. Even as we 
focus on these troubling facts, we can never forget that 
although we talk about the ``War Against Cancer,'' we are not 
just talking about the disease. We are talking about our 
families, friends and loved ones, those who are cancer 
survivors, and those that have fallen victim to this terrible 
disease.
    Each of us has a personal story to tell about cancer, and 
it is these stories that touch our hearts, and keep each one of 
us focused, committed, and determined to stamp out cancer. Many 
of you know that my mother had ovarian cancer, dying just 6 
months after she was diagnosed, and that is my story. As such, 
I stand with you today, pledging to partner with you, and doing 
everything possible to make sure we win this fight.
    To that end, I want to mention one bill that I have 
introduced to help us in the fight against cancer--The Genomics 
and Personalized Medicine Act. I re-introduced this bill with 
my colleague Senator Burr in April 2007, and we have been 
working to move this important legislation through this 
committee. Researchers are already applying genetics and 
genomics science to identify and develop new and more effective 
tools for developing better cancer diagnostic tests, treatments 
and cures. We in the Congress need to do more to expand and 
accelerate work in this area, and our bill does just that. I 
know that a number of you have touched on the promise of 
genomics and I look forward to partnering with you as we move 
forward on this issue.
    In closing, I commend and thank each of you for 
participating in this hearing and providing us with a better 
understanding of opportunities and challenges regarding cancer 
treatments and cures, and providing specific suggestions for 
direction and funding for critical research at the National 
Cancer Institute and other institutes and agencies. We've made 
many important advances, and we can't let the flawed funding 
priorities of President Bush stop our progress. Increased 
funding will translate to increased awareness and education and 
research, which will lead to earlier detection, better 
treatments, and most importantly, cures.
    All of this will lead to a new story to tell about cancer, 
a story about extraordinary scientific and medical advancement, 
about a once-feared disease that no longer threatens, and about 
the lives of so many patients--including fathers and mothers 
and sisters and brothers--that have been prolonged and saved. I 
look forward to telling this story, and I thank you once again 
for your efforts to make sure this is a story that I will tell 
in my lifetime. Thank you.
    [Whereupon, at 11:35 a.m., the hearing was adjourned.]