[Senate Hearing 110-984]
[From the U.S. Government Publishing 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
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
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.
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\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.]