<DOC>
[109th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:26657.wais]
WOMEN AND CANCER: WHERE ARE WE IN PREVENTION, EARLY DETECTION AND
TREATMENT OF GYNECOLOGIC CANCERS?
=======================================================================
HEARING
before the
SUBCOMMITTEE ON CRIMINAL JUSTICE,
DRUG POLICY, AND HUMAN RESOURCES
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
__________
SEPTEMBER 7, 2005
__________
Serial No. 109-128
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
index.html
http://www.house.gov/reform
______
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut HENRY A. WAXMAN, California
DAN BURTON, Indiana TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio
TODD RUSSELL PLATTS, Pennsylvania DANNY K. DAVIS, Illinois
CHRIS CANNON, Utah WM. LACY CLAY, Missouri
JOHN J. DUNCAN, Jr., Tennessee DIANE E. WATSON, California
CANDICE S. MILLER, Michigan STEPHEN F. LYNCH, Massachusetts
MICHAEL R. TURNER, Ohio CHRIS VAN HOLLEN, Maryland
DARRELL E. ISSA, California LINDA T. SANCHEZ, California
GINNY BROWN-WAITE, Florida C.A. DUTCH RUPPERSBERGER, Maryland
JON C. PORTER, Nevada BRIAN HIGGINS, New York
KENNY MARCHANT, Texas ELEANOR HOLMES NORTON, District of
LYNN A. WESTMORELAND, Georgia Columbia
PATRICK T. McHENRY, North Carolina ------
CHARLES W. DENT, Pennsylvania BERNARD SANDERS, Vermont
VIRGINIA FOXX, North Carolina (Independent)
------ ------
Melissa Wojciak, Staff Director
David Marin, Deputy Staff Director/Communications Director
Rob Borden, Parliamentarian/Senior Counsel
Teresa Austin, Chief Clerk
Phil Barnett, Minority Chief of Staff/Chief Counsel
Subcommittee on Criminal Justice, Drug Policy, and Human Resources
MARK E. SOUDER, Indiana, Chairman
PATRICK T. McHenry, North Carolina ELIJAH E. CUMMINGS, Maryland
DAN BURTON, Indiana BERNARD SANDERS, Vermont
JOHN L. MICA, Florida DANNY K. DAVIS, Illinois
GIL GUTKNECHT, Minnesota DIANE E. WATSON, California
STEVEN C. LaTOURETTE, Ohio LINDA T. SANCHEZ, California
CHRIS CANNON, Utah C.A. DUTCH RUPPERSBERGER, Maryland
CANDICE S. MILLER, Michigan MAJOR R. OWENS, New York
GINNY BROWN-WAITE, Florida ELEANOR HOLMES NORTON, District of
VIRGINIA FOXX, North Carolina Columbia
Ex Officio
TOM DAVIS, Virginia HENRY A. WAXMAN, California
J. Marc Wheat, Staff Director and Chief Counsel
Michelle Powers, Counsel
Malia Holst, Clerk
Richard Butcher, Minority Professional Staff Member
C O N T E N T S
----------
Page
Hearing held on September 7, 2005................................ 1
Statement of:
Karlan, Dr. Beth, president, Society of Gynecologic
Oncologists; Dr. Mark Jay Rosenfeld, scientist/researcher;
Sheryl Silver, sister of Johanna Silver; and Kolleen
Stacey, ovarian cancer survivor............................ 71
Karlan, Dr. Beth......................................... 71
Rosenfeld, Dr. Mark Jay.................................. 78
Silver, Sheryl........................................... 86
Stacey, Kolleen.......................................... 94
Trimble, Dr. Edward L., M.D., M.P.H., head of the surgery
section, Division of Cancer Treatment and Diagnosis,
National Cancer Institute; Dr. Ed Thompson, M.D., M.P.H.,
Chief of Public Health Practice, Centers for Disease
Control and Prevention; and Dr. Richard Pazdur, M.D.,
Director, Division of Oncology Drug Products, Center for
Drug Evaluation and Research, U.S. Food and Drug
Administration............................................. 15
Pazdur, Dr. Richard...................................... 33
Thompson, Dr. Ed......................................... 24
Trimble, Dr. Edward L.................................... 15
Letters, statements, etc., submitted for the record by:
Karlan, Dr. Beth, president, Society of Gynecologic
Oncologists, prepared statement of......................... 74
Pazdur, Dr. Richard, M.D., Director, Division of Oncology
Drug Products, Center for Drug Evaluation and Research,
U.S. Food and Drug Administration, prepared statement of... 36
Rosenfeld, Dr. Mark Jay, scientist/researcher, prepared
statement of............................................... 80
Silver, Sheryl, sister of Johanna Silver, prepared statement
of......................................................... 89
Souder, Hon. Mark E., a Representative in Congress from the
State of Indiana, prepared statement of.................... 4
Stacey, Kolleen, ovarian cancer survivor, prepared statement
of......................................................... 96
Thompson, Dr. Ed, M.D., M.P.H., Chief of Public Health
Practice, Centers for Disease Control and Prevention,
prepared statement of...................................... 26
Trimble, Dr. Edward L., M.D., M.P.H., head of the surgery
section, Division of Cancer Treatment and Diagnosis,
National Cancer Institute, prepared statement of........... 18
WOMEN AND CANCER: WHERE ARE WE IN PREVENTION, EARLY DETECTION AND
TREATMENT OF GYNECOLOGIC CANCERS?
----------
WEDNESDAY, SEPTEMBER 7, 2005
House of Representatives,
Subcommittee on Criminal Justice, Drug Policy, and
Human Resources,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:45 a.m., in
room 2154, Rayburn House Office Building, Hon. Mark E. Souder
(chairman of the subcommittee) presiding.
Present: Representatives Souder, Burton, Cannon, Issa,
Foxx, Waxman, Cummings, Watson, Sanchez, Ruppersberger, and
Norton.
Staff present: Marc Wheat, staff director and chief
counsel; Michelle Powers, counsel; Malia Holst, clerk; Kristin
Amerling, minority general counsel; Tony Haywood and Naomi
Seller, minority counsels; Richard Butcher, minority
professional staff member; Earley Green, minority chief clerk;
Cecelia Morton, minority office manager; and Christopher Davis,
minority investigator.
Mr. Souder. The subcommittee will come to order.
Good morning and thank you all for being here.
Today's hearing will examine the Federal efforts targeting
gynecologic cancers, specifically where we are in the areas of
education, research, prevention, and treatment. The hearing
will also provide an opportunity for medical and research
specialists, patients, and family members to discuss the
relevant issues involved in gynecologic cancers and where more
work is needed.
This month marks Gynecologic Cancer Awareness Month, as
well as National Ovarian Cancer Awareness Month. According to
the American Cancer Society, over 79,000 women are diagnosed
every year with cancers affecting the reproductive organs. If
diagnosed in the early stages, the survivability rate is as
high as 95 percent. Nonetheless, this year alone, more than
27,000 women will die from gynecologic cancer.
Any woman is at risk for developing a gynecologic cancer.
The most deadly gynecologic malignancy is ovarian cancer.
Patients with ovarian cancer often report that they had
symptoms for months before diagnosis, but early signs of this
cancer are frequently mistaken for more common digestive
disorders. As a result, most ovarian cancer cases are diagnosed
at an advanced stage, where the chances of survival drop to
only 20 percent. This year, out of the more than 22,000 new
diagnoses of ovarian cancer, more than 16,000 women will die
from the disease.
The most common gynecologic cancer is uterine cancer, which
will afflict more than 40,000 women this year and kill over
7,000 women. While there have been advances in therapy for
uterine cancer, including the innovative new surgical
treatments, women are largely unaware of the risk factors
contributing to this disease, which include obesity,
hypertension, diabetes, and inappropriate estrogen use.
However, if a women is diagnosed early, surgical therapy is
usually adequate for a cure.
Where there is effective screening, there has been a
significant reduction in deaths from certain gynecological
cancers; over the last 50 years, routine use of the pap test to
screen for cervical cancer has reduced deaths from that disease
by 74 percent. However, there are no widely accepted and
effective screening tests for other gynecologic cancers. This
leaves women vulnerable to late diagnosis, and lower chances of
recovery.
Even with effective screening, the American Cancer Society
estimates that cervical cancer will kill more than 3,700 women
this year. The primary cause of virtually all cervical cancers
is human papillomavirus [HPV], which is transmitted through
sexual contact. More women will die from this disease than from
AIDS, among non-injection drug users. Although Federal agencies
are working on vaccines developed to prevent HPV infection,
current proposed vaccines do not address all strains of HPV.
Moreover, the FDA has yet to comply with Public Law 106-
554, signed by President Clinton in 2000, requiring that
condoms be accurately labeled to reflect the fact that condoms
do not protect women from HPV infections. The Gynecologic
Cancer Foundation's 2005 State of the State Report on
Gynecologic Cancers notes that both women and men do not fully
understand the association between HPV infection and its severe
health consequences.
It is inexcusable that Federal agencies have yet to comply
with a law passed more than 5 years ago and, in the meantime,
thousands of women continue to die from this preventable
disease. The cost to comply with the law requiring accurate
condom labeling is quite low. The benefit is measured in terms
of women's lives. There is simply no justification for the FDA
and the White House Office of Management and Budget dragging
their feet on this critical public health matter.
I am surprised that the FDA's testimony today makes no
reference to their progress in complying with this law since
the FDA last appeared before this subcommittee on this very
issue on March 11, 2004. Perhaps the FDA witness is not
prepared to address this matter this morning, but I would ask
that FDA provide a full explanation on this matter in 5 days,
and we will be happy to forward FDA's response to all
subcommittee members. I hope the other agencies represented
here today will address these issues in oral testimony.
There is an evident need to raise awareness among patient
and medical communities about all aspects of gynecologic
cancers, including prevention, symptoms, screening, and
treatment. A recent poll commissioned by the Gynecologic Cancer
Foundation found that the majority of women believe that they
are at risk for developing gynecologic cancers, and fear them
even more than lung cancer, which is the leading cause of
cancer deaths among women. More than a third of women say they
have little knowledge about gynecologic cancers, and in fact, a
staggering 47 percent of them could not name any symptoms of
gynecologic cancers.
Parallel to the important education needs is the necessity
for innovative research and therapy development.
I hope the outcome of this hearing is a better picture of
what efforts the Federal agencies are making to raise awareness
among practitioners and among patient and medical communities
of gynecologic cancers, and where there are unmet needs. In
particular, I hope the agencies address their critical role in
protecting the public from HPV infection and preventing more
cervical cancer deaths. I also hope we can learn the status of
current funding paths for innovative and cutting edge research
for gynecologic cancers, and whether we are meeting the
challenges to deliver new therapies.
Finally, I hope the first-hand experience and perceived
needs of those who deal with gynecologic cancers as patients,
family members, doctors, and researchers provide us with a
better understanding of how to address gynecologic cancers.
I am now going to turn this hearing over to Congressman
Cannon to chair the hearing. His daughter passed away from
cancer late last year at the age of 25, and he is particularly
interested in innovative research issues. I will be in and out
of the hearing this morning, and I appreciate his leadership in
this field and his willingness to chair the hearing.
[The prepared statement of Hon. Mark E. Souder follows:]
[GRAPHIC] [TIFF OMITTED] T6657.001
[GRAPHIC] [TIFF OMITTED] T6657.002
[GRAPHIC] [TIFF OMITTED] T6657.003
Mr. Cannon [presiding]. Thank you, Mr. Chairman.
First of all, I would like to thank Chairman Souder for
holding this hearing today. This is an issue affecting millions
of Americans currently: 1 in 2 men and over 1 in 3 women will
be diagnosed with cancer. In 2000, more than 1.2 million new
cancer diagnoses were expected and 550,000 died from the
disease. Nearly 10 million people in the United States alone
were living with cancer in 2001, up from 3 million in 1971, and
the American Cancer Society estimates that in 2005 nearly 1.4
million new cases of cancer will be diagnosed.
While we say that we are winning the war on cancer, the
statistics don't seem to represent that. Although I am pleased
to hear that we are making progress in the length of survival
of those with cancers, we need to eliminate the incidents of
cancer and completely cure this illness. Tremendous strides in
research and treatments are being made; however, there are
numerous challenges in getting those treatments to patients
effectively and efficiently. There are some serious gaps in
research and failures to optimize research to produce new
treatments. Drug approval takes years, withholding potentially
life-saving drugs and treatments from patients.
We need to look at all of these areas and optimize research
among agencies, fill the gaps in research, and incentivize
entrepreneurial research and produce life-saving treatments.
Today we will specifically hear from our witnesses
regarding gynecological cancers, including the role of human
papillomavirus and cervical cancer. Most Americans are not
aware that HPV is one of the most common sexually transmitted
diseases and that at any one time approximately 10 percent of
women have a cancer-causing HPV infection. These HPV types
cause nearly all cervical cancers, and this year about 11,000
women will be diagnosed with cervical cancer.
Additionally, as many of you may know, the Gynecological
Cancer Foundation reported that men and women do not completely
recognize the association between HPV and its severe health
consequences. We need to better educate the public on the
health risks of HPV and gynecological cancers. Although PAP
test is the standard procedure to check for cervical cell
changes, it is my understanding that it does not test for
uterine or other gynecological cancers. I am anxious to learn
how we are doing in developing tests for these other cancers.
Many of us have been personally affected by cancer,
unfortunately. We now have reached a time that I believe we can
all say we know someone who has been diagnosed with this
devastating disease.
I thank all of our witnesses for appearing today, and I
look forward to hearing your testimony about where we are on
cancer research and what we need to do to win the war on
cancer.
I would now like to recognize Mr. Cummings for an opening
statement.
Mr. Cummings. Thank you very much, Mr. Chairman. And I am
very pleased that we are holding this hearing.
Breast, lung, and colon cancers are the most frequently
diagnosed cancers among women in the United States. The
gynecologic cancers, including cervical, ovarian, and uterine
cancers, also account for a significant number and percentage
of cancer diagnoses and deaths among U.S. women.
The American Cancer Society reports that approximately
79,000 U.S. women are diagnosed with cancers affecting the
reproductive organs each year. Although the survivability rate
is as high as 95 percent when these cancers are detected in the
early stages, each year 27,000 U.S. women die from gynecologic
cancers.
Fifty years ago, cervical cancer was the leading cause of
cancer death among women in the United States and around the
world. Thanks to advances in cancer screening and treatment,
most notably widespread use of the Pap test, the threat of
mortality from cervical cancer has been dramatically reduced in
the United States. Nevertheless, thousands of women are newly
diagnosed each year, and the American Cancer Society estimates
that more than 3,000 women will die from it in 2005.
Unfortunately, despite improved screening rates, enabled by
congressionally authorized CDC screening programs, unequal
access to screening remains a problem that contributes to
significant disparities in cervical cancer death rates, along
the lines of race, educational level, income, and age. Although
racial and ethnic disparities have decreased sharply, there is
more progress that must be made.
Women who belong to racial and ethnic minority groups still
are disproportionately represented among the new cases of
cervical cancer. Asian, African-American and Hispanic women
have significantly higher mortality rates from cervical cancer
than White women. Women with less than a high school education
are less likely to have testing than more highly educated
women. And despite the peek incidents of cervical cancer among
women 40 to 55 years of age, women in this age group are less
likely to have been screened than younger women. African-
American women are 60 percent more likely to have cervical
cancer and 33 percent more likely to die from it, as compared
to White women.
The great tragedy in the American Cancer Society's
estimates of the thousands of lives that will be lost to
cervical cancer is that these deaths are avoidable. The
Department of Health and Human Services notes in its Healthy
People 2005 Initiative that the likelihood of cervical cancer
survival is nearly 100 percent if early detection is followed
by appropriate treatment and followup. But costs remains a
barrier to access Pap tests and DNA tests for HPV.
Used together, these tests can accurately determine whether
a woman is or is not at risk for cervical cancer or precursor
conditions. Genital HPV infection is a necessary precursor for
cervical cancer and the main cause of the disease. In recent
years we have seen vigorous efforts from certain quarters to
force the FDA to relabel condoms to indicate that condoms are
ineffective in preventing transmission of HPV. These efforts,
if they succeed, are likely to undermine progress in preventing
not only HPV infection and the development of cervical cancer,
but also the spread of other sexually transmitted diseases,
including HIV.
The American Cancer Society specifically recognizes HIV and
chlamydia as risk factors for development of cervical cancer,
and condoms are widely recognized as a primary intervention for
prevention of HIV and chlamydia. The best available scientific
evidence, moreover, supports the conclusion that condoms
significantly reduce the risk of genital HPV infection and,
therefore, development of cervical cancer.
In July of this year, a study entitled, ``The Effect of
Consistent Condom Use on the Risk of Genital HPV Infection
Among Newly Sexually Active Young Women,'' was presented to the
International Society of Sexually Transmitted Disease Research.
The study found that condoms significantly reduce the risk of
HPV acquisition among female university students who use them
100 percent of the time, as well as among those who use them
between 55 percent and 99 percent of the time during the course
of an 8-month study.
The bottom line, then, is that cervical cancer can be
prevented, detected, treated, and cured, and health screening
and condom use are essential components of a sound, realistic
public health strategy for combating cervical cancer and the
spread of sexually transmitted diseases. Unfortunately,
ovarian, uterine, and other gynecologic cancers are less
susceptible to prevention and early detection, and mortality
rates, as a result, are much higher.
But great progress has been made in developing treatments
that are highly effective when these cancers are detected at an
early stage. We must therefore support efforts to promote
awareness of risk factors for ovarian, uterine, and other
gynecologic cancers, as well as research that can lead to
development of new and better diagnostic and therapeutic tools.
That is precisely the aims of Johanna's Law, legislation
pending the House and Senate named for the sister of Sheryl
Silver, who will tell her sister's story during panel two of
today's hearing. I am proud to be an original co-sponsor of
this important bill in the House, and I sincerely hope that
this hearing serves to improve the prospects for enacting this
legislation.
Finally, Mr. Chairman, it is worth reiterating that we have
made enormous strides in reducing cervical cancer deaths over
the past few decades. Ensuring that cervical cancer death rates
continue to go down for women in all parts of American society
and working to duplicate that success with other gynecologic
cancers are important objectives that we should fully support.
Expanding access to screening and treatment for women at risk
should remain the foundation of a public health strategy that
puts health and wellness before ideology and science, and
before politics.
I want to thank you for holding the hearing. I sincerely
hope that it will lead to further advances toward eliminating
gynecologic cancers as a cause of illness and death for women
in these United States.
With that, I yield back.
Mr. Cannon. Thank you, Mr. Cummings.
Let me just add that you point out that we want to solve
this for American society, and that is our goal. But if we
solve it in America, we solve it for large parts of the world,
including the many, many women who die of cervical cancer in
Africa because their partners and spouses have not only brought
back AIDS and other diseases, but HPV, and that ends up being a
principal cause of death in Africa. If we can solve some of
these problems here in America, it is cheap and easy to solve
them in other parts of the world, and that is why I think this
is such an important hearing.
Are there other members who wish to make an opening
statement?
Mr. Issa. Yes, Mr. Chairman.
Mr. Cannon. Let me come over here.
Mr. Issa. Thank you, Mr. Chairman. And I would ask that my
complete statement be placed in the record.
Mr. Chairman, I want to thank you on behalf of the
thousands of women fighting this fierce battle against
gynecological cancer. As you know, this bill has been
previously introduced in early Congresses, it has been
something that we wanted to get on the front burner for 4 years
plus, and I think your leadership is really making a difference
in getting this bill moved and moved quickly. As you know,
there are 220 plus Members of Congress who have co-sponsored
this. As a general rule, that means that you have enough votes
to pass it on the House floor, and I am hoping that today is an
important step toward that.
I won't repeat the good words that have been said by
previous speakers, but I would like to simply add a couple of
items. First of all, this is a cancer in which awareness can
save lives. Cervical, ovarian, and uterine cancer really is, to
a great extent, about what we don't know and, to be candid, as
we will hear in the second panel, to a great extent what
doctors don't know.
The story of Johanna is the story of misdiagnosis. It is
the story not of an underserved population, a poor person or a
minority; it is somebody who had professional care, and that
care failed to save her life. And it has failed to save her
life not out of malice, but out of a lack of the kind of
information that we hope the funding we provide on a Federal
level can do.
I do think that it is important. I was not an original
cosponsor of this in previous Congresses, but came on board as
the principal author, along with Sander Levin and others,
because of an awareness that came into my office. If I may
share this personally, last year I discovered first-hand the
importance of early diagnosis when my legislative director,
Paige Anderson, who is with us here today because of early
diagnosis. She is one of the lucky ones. She stands here today
a cancer survivor.
However, it was not until early diagnosis that she even
learned of HPV, cervical cancer, and the importance of early
Pap smears and pelvic exams. Unfortunately, her story is the
story that is going to repeat itself until this legislation not
only passes, but that we fully fund it and start bringing about
the kind of awareness of this cancer that, candidly, we have
had success stories in other areas.
This is a bipartisan bill, and I would particularly like to
thank, once again, Sander Levin, who was the author of it in a
previous Congress; Kay Granger; Rosa DeLauro; and Congressman
Dan Burton, who will speak in a few moments. They really made a
difference in previous Congresses in moving this, and now,
together, we are very happy to be able to move this.
Last, but not least, I want to recognize Dr. Beth Karlan.
Dr. Karlan is the president of the Society of Gynecological
Oncologists. She practices medicine at Cedars Sinai Medical
Center in my home State of California. But beyond being a
doctor, a researcher, a professor, and mother, Dr. Karlan has
been an inspiration and motivator in the fight for
gynecological cancers, and she is also the person whose efforts
saved my staff person, Paige Anderson's, life. So I am looking
forward to seeing the energy that she brings to the Congress,
just as the energy that she has brought to her practice.
And with that I yield back.
Mr. Cannon. Thank you, Mr. Issa.
Are there other Members who would like to make an opening
statement? Ms. Watson. The gentlelady is recognized for 5
minutes.
Ms. Watson. Thank you, Mr. Chairman, for having this most
critical hearing. I too had cancer visited on my family: my
sister, 18 months older than I, had cervical cancer and did not
survive.
It reminds me of a discussion we had in our legislature
maybe 20 years ago, when we were startled to learn in the
1980's that most of the cancer testing for breast cancer was
done on men. So about seven of the women in both Houses--I was
in the Senate--and my colleagues in the Assembly ganged
together and we said we will not vote for the budget in a block
unless you put $28 million in for research on breast cancer on
women.
And we got it in. We had to gang up; we had to terrorize.
UCLA's Dr. Love worked with us and reported on the status of
the research over the years. The women--and particularly
minority women--who had breast cancer, by the time we finished
up, were all dead. So we really forged ahead.
I was heading Health and Human Services for 17 years, and
we forged ahead on the studies. But we required in the State of
California that every woman over 40 have a mammogram yearly. We
had to drop that down to 20 because we found that breast cancer
was spreading faster among African-American women--we didn't
know why--at an earlier age. And by the time we would get to
them and we would try to follow them and profile, they were
gone as well.
So in 2005 we cannot stress that we really have not made
that much progress. So I do hope, listening to the panels, that
you will encourage us--and particularly women--and let us know
the intensity of the effort. Are we putting enough resources
in? And what are America's priorities when it comes to fighting
cancer? We have new kinds of cancers appearing every day. And,
particularly in my State of California, skin cancer is becoming
very prevalent. So we must keep pace; we must keep focused; we
must keep allotting the necessary resources.
And I want to tie it in to the tragedy that we are all
going through in the Gulf Coast. We need to place a priority on
health; health of all Americans. And I just have to say this:
When we talk about homeland security, it is not the land I am
worried about; it is the people on the land. If they are
weakened by disease, contagious diseases and cancer, we have no
defense; we have no security. So I hope that our subcommittee
will keep the focus going on the health delivery system, and
specifically on the prevention and detection of cancer.
Thank you, Mr. Chairman.
Mr. Cannon. Thank you.
Other members who wish to make an opening statement? Mr.
Burton. The gentleman is recognized for 5 minutes.
Mr. Burton. I have a very, very brief statement. First of
all, I want to thank Darrell Issa and Sander Levin for
sponsoring this; I think it is very important and you should be
congratulated for that. I want to thank Chairman Souder. He
just added his name as a cosponsor of the bill, so we are up to
221 or whatever it is, so we should be able to get this passed.
I want to also thank Kolleen Stacey and Sheryl Silver for being
here. They have been doing yeoman's service for this cause for
a long time, and I personally really appreciate it.
My wife was misdiagnosed and died about 3 years ago because
of misdiagnosis on her cancer, and I just hope that part of the
solution that we finally realize is making sure that the
doctors across this country are educated in how to deal with
analyzing the various kinds of cancer that women have. One of
the big problems we have right now is, unfortunately, some of
the doctors misdiagnose, and because of that the cancers spread
too rapidly before we find out about it, and that is what
happened with my wife.
So I thank you very much for sponsoring this bill, Darrell,
and thanks for having this hearing. And I look forward to
hearing the testimony.
Mr. Cannon. The gentleman yields back. I want to thank the
gentleman. This is actually sort of a hard topic to talk about,
isn't it, Mr. Burton?
Other Members who wish to make an opening statement? Mr.
Ruppersberger.
Mr. Ruppersberger. Thank you, Mr. Chairman.
Mr. Cannon. The gentleman is recognized for 5 minutes.
Mr. Ruppersberger. This is an extremely important issue,
and I hope this hearing today will really call attention to us
and to what we need to do to bring this issue to the forefront.
As we all know, gynecologic cancers, if detected early, can
help the issue, and it is very important to do this.
But we do need to understand that early detection is
sometimes not possible, where the symptoms demonstrated by
afflicted women are identified as something else. And we must
continue to be at the forefront of science and technology when
it comes to diagnosing and treating these types of cancers. If
adequate resources, expertise, and manpower exists, there is no
excuse for delay.
I am looking forward to the testimony today from our
witnesses in an effort to again raise the awareness about this
type of cancer among patients and doctors, and how we, as
Members of Congress, can help.
Thank you, Mr. Chairman.
Mr. Cannon. The gentleman yields back.
Mr. Waxman. The gentleman is recognized for 5 minutes.
Mr. Waxman. Thank you very much, Mr. Chairman.
I welcome our witnesses today, and I am pleased we are
holding this hearing.
Over the last 30 years, the rate of lung cancer among women
in the United States has more than doubled. The rate of breast
cancer has increased by 20 percent. But the rate of cervical
and uterine cancers has dropped in half. And the racial
disparities in diagnosis of these cancers have also
substantially narrowed.
Credit for progress against cervical cancer goes largely to
a single preventive health intervention: the Pap smear. By
diagnosing precancerous lesions, this test permits eradication
of the problem before cancer develops. By any accounting, the
Pap smear ranks as one of the most major advances in women's
health of the 20th century. Yet, there is much more to be done
to combat gynecological cancers. Cervical cancer kills 4,000
women each year; ovarian cancer kills nearly 15,000.
The key to progress is to continue implementing sound
public health practices and supporting crucial research. To
start, we must make sure that all women have access to routine
cervical screening. An estimated 60 percent of cervical cancer
cases occur among women who did not get routine Pap smears. We
also must make sure that women who screen positive for
gynecological cancers have access to needed medical treatment.
This is not something to be taken for granted. The President's
proposed cuts to the Medicaid program threaten the basic access
to care for women around the country, and, if passed, they
could expect it to lead to more suffering and death from
cancer.
We must take advantage of new technology. And we will hear
today about vaccines that seem to be very, very promising and
very successful in their tests. We need to pursue progress at
the same time we resist calls to politicize policy decisions on
women's health. And there are two ongoing ideological campaigns
that could seriously undermine the progress that the public
health system has made. The first is the call to require
warning labels on condoms stating that they don't protect
against HPV. This policy makes no sense.
The National Institutes of Health and CDC have both
concluded that condoms reduce the risk of cervical cancer. That
is the benefit, the health benefit outcome that we are all
concerned about. In addition, the most recent scientific
evidence indicates condoms do reduce the risk of HPV
acquisition among women. In a carefully designed study of HPV
and condoms by researchers at University of Washington,
consistent condom use reduced the risk of HPV among young women
by 70 percent.
A second attempt to politicize science involves early
efforts to reject HPV vaccine. A spokeswoman from one right-
wing group has expressed concern that giving the HPV vaccine to
young women could be potentially harmful because they may see
it as a license to engage in premarital sex.
It is a good thing that this sort of reasoning did not
prevail when the Pap smear was invented. We would not have seen
the major decrease in cervical cancer rates over the last three
decades. The HPV vaccine offers the potential of saving
thousands of lives. We should follow the advice of experts, not
ideologs, in determining who should receive this intervention.
After all, it is science that has guided our success in
cervical cancer, and science will lead the way to continuing
success.
I have looked at the list of witnesses. I think that we
have a good two panels before us. I particularly want to single
out Dr. Beth Karlan, who is my constituent, and welcome her to
our hearing today, and also all of the witnesses that are here
to make their presentations.
Thank you, Mr. Chairman.
Mr. Cannon. The gentleman yields back. Thank you.
I would now like to recognize the Honorable Sandy Levin of
the 12th Congressional District of Michigan, who will introduce
Sheryl Silver, the sister of Johanna Silver.
Mr. Levin.
Mr. Levin. Thank you. My thanks to everyone on the panel
for your eloquent statements.
My opportunity today is to introduce Sheryl Silver, who is
on the second panel, and I will do just briefly so you can move
on to the distinguished people here on the first panel.
Several years ago Sheryl Silver was in touch with us and in
touch with me. It was the aftermath of the death of her sister,
and she decided to take that tragedy in the life of her family
and see if she could impact the lives of others. And for these
years that has been, I think, her main preoccupation, as well
as her mother, who is here today, and other members of the
family.
What she brought to our attention is what has been repeated
here, that wasn't well enough known: that as to gynecologic
cancers, early detection almost invariably works and late
detection is almost invariably fatal. So we introduced the
legislation and there was a lot of interest shown across the
isle and across the Rotunda. So I am here today to introduce
Sheryl, who has been so dedicated to this cause, Johanna's Law,
named after her sister.
Last session, Darrell Issa and I talked. He was very much
moved by the experience within his own office, and we set upon
a course to try to maximize the chances of passage of this
legislation.
So let me just finish by suggesting the challenge here. One
is for us in this Congress to prove that one person in our
country can indeed make a difference, and it is up to us to do
that. And, second, I think it is our charge to take personal
experiences so eloquently and personally expressed here, and
take personal experiences and place them into public action.
And if we fail to do that, we have failed in our
responsibilities as elected officials.
I am glad you are holding this hearing. I think we all
appreciate the expression of personal backgrounds of personal
experiences. We appreciate the interest of the scientists who
are here. And I hope very much, to all of you, that the result
of this hearing today will be action on the floor of the Senate
and the House. We have enlisted Senators in this effort, and I
think now, after you hear this, the responsibility will be
ours.
Thank you for letting me proceed out of turn, and I wish
you the best of luck.
Mr. Cannon. Thank you, Mr. Levin. Let me just make a
personal note. I appreciate your initiative on this action,
your support. I truly believe that individuals make the
difference, so I appreciate your introduction, your initiative,
and thank you for being here with us.
Mr. Levin. Thank you very much. Thank you to all of you.
Mr. Cannon. I would just also add thanks to Mr. Issa. I am
a co-sponsor of this bill, and I think it is great legislation.
Thank you.
A couple of procedural matters. I ask unanimous consent
that all members have 5 legislative days to submit written
statements and questions for the hearing record, and that any
answers to written questions provided by the witnesses be also
included in the record. Without objection, so ordered.
I also ask unanimous consent that all exhibits, documents,
and other materials referred to by Members may be included in
the record, and that all Members be permitted to revise and
extend their remarks. Without objection, so ordered.
Our first panel is composed of Dr. Edward Trimble, Head of
the Surgery Section, Division of Cancer Treatment and Diagnosis
at the National Cancer Institute; Dr. Ed Thompson, Chief of
Public Health Practice at the Centers for Disease Control and
Prevention; and Dr. Richard Pazdur, Director of the Division of
Oncology Drug Products, Center for Drug Evaluation and
Research, U.S. Food and Drug Administration.
It is our custom as an oversight committee to swear all of
our witnesses in. Would you mind rising while I administer the
oath?
[Witnesses sworn.]
Mr. Cannon. You may be seated. The record should reflect
that each member of the first panel agreed in the affirmative
to that oath.
Dr. Trimble, thank you for joining us, and you are
recognized for 5 minutes. Before you begin, let me just point
out that, since we are probably going to have quite a bit of
questioning, the 5-minute limit is not fixed, we don't get
lightening from heaven, but if it goes beyond, I may tap just
to remind you to draw your comments to a conclusion. And then
we may go a second round of questioning.
But for the panel members, I intend to enforce the 5-minute
rule fairly strictly, so that people who are waiting have a
chance to ask questions. But, again, we may go to a second
round or more of questioning if those here would deserve.
Dr. Trimble, you are recognized for 5 minutes.
STATEMENTS OF DR. EDWARD L. TRIMBLE, M.D., M.P.H., HEAD OF THE
SURGERY SECTION, DIVISION OF CANCER TREATMENT AND DIAGNOSIS,
NATIONAL CANCER INSTITUTE; DR. ED THOMPSON, M.D., M.P.H., CHIEF
OF PUBLIC HEALTH PRACTICE, CENTERS FOR DISEASE CONTROL AND
PREVENTION; AND DR. RICHARD PAZDUR, M.D., DIRECTOR, DIVISION OF
ONCOLOGY DRUG PRODUCTS, CENTER FOR DRUG EVALUATION AND
RESEARCH, U.S. FOOD AND DRUG ADMINISTRATION
STATEMENT OF DR. EDWARD L. TRIMBLE
Dr. Trimble. I am honored to testify on the topic of
gynecologic cancer for the National Cancer Institute. Over the
past century, we have made major progress toward the defeat of
cervical cancer in the United States. Today I would like to
talk to you about some of the exciting work NCI is doing to
eliminate the scourge of gynecologic cancer in the United
States and around the world.
NCI scientists developed a new vaccine approach to prevent
the transmission of HPV. We have licensed this technology to
two large pharmaceutical companies who have recently reported
that the vaccines were almost 100 percent effective in
preventing spread of the virus. We have also been working to
make screening for cervical cancer less expensive, more
reliable, and more available. Even with the arrival of HPV
vaccines, we will need to continue screening for many years to
come.
In one of our most exciting projects, NCI is working with
the CDC, the University of Alabama at Birmingham, and the
Mississippi State Health Department to improve screening for
cervical cancer among poor rural women in the Mississippi Delta
who have had some of the highest rates of cervical cancer in
the United States for the last 50 years.
Again in collaboration with the CDC, as well as with the
U.S. Department of Agriculture and the American Cancer Society,
NCI is implementing TEAM-UP, a national pilot program to
increase cervical cancer screening among never or rarely
screened women in eight underserved Appalachian States.
We are also making major strides toward the elimination of
death and suffering from ovarian cancer. We are currently
evaluating screening for ovarian cancer among 70,000 women
through our PLCO trial. Our laboratories are developing new
screening tests for ovarian cancer. One of the most promising
is the identification of proteomics, protein expression in the
blood, as a screen for ovarian cancer.
The NCI discovered and developed paclotaxol, or Taxol,
which is now one of the standard drugs used to treat ovarian
cancer. We have just completed the largest treatment trial,
5,000 women, ever conducted in ovarian cancer with the help of
investigators across the United States, Canada, and five other
international partner countries.
We have established four specialized programs of research
excellence to foster translational research in ovarian cancer.
We are also working to strengthen our research portfolio in
endometrial cancer, which is the most common female pelvic
malignancy. The identification of new targets and treatments
will lead us to new strategies to prevent women from developing
endometrial cancer and to avoid the need for hysterectomy.
We have also developed an extensive educational program
focused on gynecologic cancers. Our Cancer Information Service
Partnership collaborates with local, State, and other Federal
agencies to conduct outreach on cervical cancer, particularly
in medically underserved populations. For example, NCI has
joined with county and local officials to raise awareness,
provide education, and build a community-based sustainable
cancer control infrastructure for urban American Indian women
in Los Angeles. We also collaborate with the CDC in addressing
the needs of underserved populations using our 1-800-4-CANCER
number to refer thousands of eligible women to low-cost and no-
cost CDC services.
We have an extensive educational program focused on
gynecologic cancer, including Web sites and educational
material for both patients and medical professionals, available
in English and Spanish.
Ending pain and suffering from gynecologic cancer is among
the highest priorities of the NCI. We are working to implement
the recommendations of the Gynecologic Cancer Progress Review
Group. We have also undertaken, in partnership with the CDC,
the American Cancer Society, the International Agency for
Research on Cancer, the World Health Organization, the Society
of Gynecologic Oncologists, and the Gynecologic Cancer
Foundation, a global initiative on women's cancer so that we
can lift the burden of gynecologic cancer from women around the
world.
That concludes my oral testimony. You have additional
material in my written testimony. I would be happy to answer
any questions.
[The prepared statement of Dr. Trimble follows:]
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Mr. Cannon. Thank you, Mr. Trimble. And I note that the
light was still yellow when you finished. I appreciate that
testimony.
The other members of the panel don't have to be so careful.
We actually are interested in what you say.
Dr. Thompson, you are recognized for 5 minutes, or as much
time as you would like to use.
STATEMENT OF DR. ED THOMPSON
Dr. Thompson. Thank you, Mr. Chairman. I am Dr. Ed
Thompson, a specialist in preventive medicine and Chief of the
Public Health Practice at the Centers for Disease Control and
Prevention. It is an honor to be in front of this committee
again. We appreciate the commitment of this committee to this
important issue.
I would also like to thank Mr. Levin for referring to the
members of this panel as distinguished. But we are
distinguished by the degrees that we hold and by the positions
that we occupy. The next panel will bring before you people who
are distinguished by their personal courage, by their
commitment to this important cause; and they are far more
distinguished than we.
Gynecological cancers, cancers of the female reproductive
organs--including, most importantly, those of the uterus, its
endometrium, and cervix, the ovaries, and also, to a lesser
extent, vaginal and vulvar cancer--are some of the most
important cancers that affect women in this country. According
to the most recent CDC and National Cancer Institute data--and
as you have observed, Mr. Chairman--more than 71,000 women in
the United States were diagnosed with a cancer affecting the
reproductive organs in 2002, and approximately 27,000 women in
the United States died from some form of gynecological cancer
in that year.
Endometrial cancer may be the most common gynecological
cancer; ovarian cancer the most deadly. Cervical cancer is the
one cancer for which we currently have an effective and
approved screening tool; and we will speak more about that in a
moment as well.
At CDC, we are actively engaged in providing most current
cancer prevention and control strategies at the community
level, primarily through State and local health departments.
These efforts reach hundreds of thousands of women every year
in the United States. Our efforts are directed largely toward
surveillance screening, where recommended, public education and
awareness, health care provider education, epidemiology, and
behavioral research. I would like to tell you about a few of
our cancer initiatives, in particular those directed against
cervical cancer. But by no means are we limiting our activities
to those against cervical cancer.
The CDC's National Breast and Cervical Cancer Early
Detection Program, which was established by Congress in 1991,
has received growing support that helps low-income, uninsured,
and underinsured women gain access to lifesaving screening
programs. The national program currently provides screening
support in all 50 States, the District of Columbia, four U.S.
territories, and to 13 Indian tribes.
Since 1991, this program has provided more than 2.9
Papanicolaou tests and detected more than 1500 invasive
cancers. Testament to the benefit of prevention and early
detection is the fact that more than 74,500 cancer precursor
lesions had been detected or treated since the program's
inception. The program represents a national infrastructure of
more than 22,000 health care providers designed to reach those
most in need.
Now, each year, between 10,000 and 12,000 women will be
diagnosed with cervical cancer, and approximately 3,700 women
will die from cervical cancer in the United States in 2005. The
sad thing is that, in a very real way, every one of these 3,700
deaths is preventable and every one represents a failure of our
American public health system.
We have achieved some success with cervical cancer
mortality, reducing it by more than 70 percent over the last
five decades, so that cervical cancer, once the No. 1 cause of
cancer deaths among U.S. women, is now 14th. This is in large
part due to widespread application of the Pap test to detect
cervical abnormalities.
But as has been noted, approximately half of the cervical
cancers that are diagnosed today in this country occur in women
who have never received a Pap test. Another 10 percent occur in
women who have not been screened within the past 5 years. So we
are still not using this remarkable tool as effectively as it
needs to be.
CDC also manages the National Comprehensive Cancer Control
Program, which provides supports to develop comprehensive
cancer control plans in all 50 States across the Nation. These
plans serve as blueprints for developing and implementing
cancer control activities. As an example, the California and
the Florida Departments of Health, through this program, have
identified and implemented strategies in their Statewide cancer
control plans to identify the burden of ovarian and/or cervical
cancer in local communities, strategies which include promoting
referrals of ovarian cancer patients to clinical trials,
promoting education and awareness within communities, and
supporting ovarian cancer research.
In Alabama, the ovarian initiative focuses on enhancing the
public's understanding of hereditary factors that increase the
risk of developing ovarian cancer. And West Virginia's Raising
Ovarian Cancer Awareness Initiative enlists ovarian cancer
experts to speak with women in high-incidence counties about
the symptoms of ovarian cancer and the importance of
gynecological exams. Since implementing the program, the State
has been able to demonstrate a 40 percent increase in
participants' knowledge of the symptoms and risk factors for
ovarian cancer.
In addition, CDC's national program of cancer registries
collects information about incidents, diagnosis, treatment, and
mortality. This data helps us to understand both the
epidemiology of cancer occurrence and, in some cases, our
effectiveness in bringing women to treatment.
In conclusion, gynecological cancers constitute a serious
health problem in this country that CDC, along with our fellow
Federal agencies, takes extremely seriously. Our role at CDC is
focused on risk reduction, early detection, identifying and
improving barriers to appropriate clinical practice, and to
enhancing survivorship for women. There is much work to be done
in all of these areas. I look forward to the opportunity to
answer any questions that you may have.
[The prepared statement of Dr. Thompson follows:]
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Mr. Cannon. Thank you, Dr. Thompson. We appreciate that.
Dr. Pazdur. Is that an appropriate pronunciation?
Dr. Pazdur. Pazdur.
Mr. Cannon. Pazdur.
STATEMENT OF DR. RICHARD PAZDUR
Dr. Pazdur. Mr. Chairman, members of the subcommittee, I am
Dr. Richard Pazdur, M.D., FDA's Director of the Office of
Oncology Drug Products within the Office of New Drugs at the
Center for Drug Evaluation and Research [CDER]. I am pleased to
be here today to discuss prevention, early detection, and
treatment of gynecological cancers.
The FDA's mission is to promote and protect the public
health by helping to assure the safety and efficacy of human
drugs and medical devices. Let me begin by informing you of
recent structural changes within the FDA that are intended to
provide a stronger and more consistent approach to the review
process for drugs used to diagnose, treat, and prevent cancer.
In July 2005, the FDA created a new Office of Oncology Drug
Products. This office has three divisions that will review
applications for safety and effectiveness: the Division of Drug
Oncology Products, Biological Oncology Products, and Medical
Imaging and Hematology Products. Also, the Office will develop
and lead a comprehensive oncology program to facilitate
coordination of oncology activities across all FDA centers and
ensure ongoing outreach and collaboration between the FDA, the
National Cancer Institute, and other cancer-related
organizations.
The Office expects to improve the consistency of review and
policy toward oncology drugs and bring together a critical mass
of oncologists who will help guide the development of these new
therapies. Although many details of this new structure are
still evolving, I am pleased to be working with many talented
and dedicated scientists who comprise this new office.
The access process for cancer drugs usually starts with a
sponsor seeking to develop a new cancer drug. A sponsor is
usually a pharmaceutical company or a research scientist at the
university or at the National Cancer Institute at the National
Institutes of Health. Before clinical testing begins,
researchers analyze the drug's main physical and chemical
properties in the laboratory and studies its pharmacological
and toxic effects in laboratory animals. If the laboratory and
animal studies show promise, the sponsor submits an
investigational new drug application to the FDA prior to
initiating testing in patients.
New therapies for the treatment of gynecological cancer are
being investigated. Hundreds of clinical trials in ovarian,
cervical, endometrial, and other gynecological cancers are
publicly listed. The FDA has several programs to expedite drug
development and expand access to unapproved therapies. All of
these programs have been instrumental in shortening the time to
marketing approval for cancer drugs and biologics.
Under the Accelerated Approval Rule, the FDA can approve
treatments for serious or life-threatening conditions that
demonstrate the potential to address unmet medical needs on the
basis of a ``surrogate endpoint'' that is reasonably likely to
predict clinical benefit. A surrogate endpoint is a measure of
drug effect--for example, tumor shrinkage--that does not by
itself show direct clinical benefit such as decreased pain or
longer survival, but is thought to lead to such benefit.
Priority new drug applications and effectiveness
supplements are those that could have important therapeutic
impacts. The FDA's goal is to review a priority product within
6 months, rather than the standard review time of 10 months.
The fast track refers to a process for frequent and timely
interaction between sponsors and the FDA during drug
development. The fast track programs are designed to facilitate
the development and to expedite the review of new drugs and
biologics to treat serious or life-threatening conditions that
demonstrate the potential to address unmet medical needs.
We are currently in the early stages of planning a workshop
for oncology experts, radiation oncology, statisticians,
industry representatives, and patient advocates to discuss
endpoints related to ovarian cancer, and hope to hold this
meeting sometime in early 2006. A steering committee including
representation from the FDA, the NCI, the American Society of
Clinical Oncology, and the American Association for Cancer
Research is planning these workshops.
The FDA's Office of Special Health Issues works with
patients with life-threatening diseases. Patients usually call
to obtain information about unapproved treatments currently
being researched. We direct callers to public information about
clinical trials for which they might be eligible and provide
additional sources of information to patients and their family
members.
The formation of the NCI-FDA Interagency Oncology Task
Force, in 2003, was an important strategic step toward
achieving FDA's goal of increasing availability and the use of
safe and effective treatments for cancer, and the NCI's goal of
eliminating pain and suffering and death from cancer by 2015.
The purpose of this Task Force is to leverage the expertise and
capabilities of both agencies to help streamline and accelerate
the overall development of the diagnostic, preventative, and
therapeutic interventions of cancer.
Finally, we want to mention the FDA's Critical Path
Initiative. There is growing concern that many of the new basic
science discoveries made in recent years may not yield quickly
more effective, affordable, and safe medical products for
patients because the current medical product development path
is becoming increasingly challenging, inefficient, and costly.
During the past several years, the number of new drugs and
biologic applications submitted to the FDA has declined. The
number of innovative medical devices applications has also
decreased. In contrast, the cost of product development has
soared over the last decade.
A new product development tool kit--containing powerful new
scientific and technical methods such as animal or computer
predictive models, biomarkers for safety and effectiveness, and
new clinical evaluation techniques--are urgently needed to
improve predictability and efficiency along with all critical
path from the laboratory to commercial product development. The
FDA is in the final stages of developing a critical path
opportunity list based on the input and ideas contributed both
by external stakeholders and the FDA reviewers.
The FDA is working with the NCI, industry, academia,
patient and other organizations to ensure that cancer patients
have timely and important information about available cancer
drugs, including those for gynecological cancer indications.
Thank you for this opportunity to testify. I will be happy
to answer any questions the subcommittee might have.
[The prepared statement of Dr. Pazdur follows:]
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Mr. Cannon. Thank you.
May I begin the questioning by asking you members of the
panel, generally, are you familiar with Abasian statistics or
its evolving cousin, complexity theory? Mr. Trimble. Are you
experts in either of those areas?
Dr. Trimble. I am not expert. I do have statistical
colleagues at the NCI who are very qualified in those topics.
Mr. Cannon. Dr. Thompson.
Dr. Thompson. I can answer an unqualified no, I am not an
expert in either of those, although, likely, we do have
colleagues at CDC who can provide additional information if
needed.
Mr. Cannon. Dr. Pazdur.
Dr. Pazdur. Likewise, I am not a statistician; however, the
FDA obviously has a complete cadre of statistical analysis.
Mr. Cannon. Are you all familiar with some of the concepts
embedded in Abasian theory or complexity theory? Just generally
familiar?
Dr. Trimble. I would have to tell you, Mr. Chairman, that I
am sufficiently familiar with it to get myself into real
trouble if I attempt to explain anything according to those
lines.
Mr. Cannon. You are probably a lot better than I am. I ask
that question because it seems to me that we have the
opportunity in America today to make some dramatic changes in
the way we do things and improve things. Let me go through a
series of questions for each of you.
I met with Dr. Eschenbach from the National Cancer
Institute. I think he is a remarkably delightful, interesting
person, but the delightful part doesn't extend to the gravitas
that he brings to bear on these subjects. He is highly
committed and I have enjoyed my conversations with him along
these lines. NCI and NIH are to be commended for the extensive
database work they have done in developing databases on ongoing
clinical trials. This is a terrific step forward.
But, Dr. Trimble, is there any database you are aware of
that lists off-label use of currently approved drugs or devices
for medical treatment?
Dr. Trimble. There is a compendium which lists the
available data to support off-label use of drugs in various
clinical situations.
Mr. Cannon. Would that be like a study that somebody
reported, so it is a compendium of studies?
Dr. Trimble. That is correct.
Mr. Cannon. Is there a centralized Internet database that
physicians or patients can refer to that outlines current
treatment protocols for a given medical condition?
Dr. Trimble. The NCI's PDQ database lists standard
recommendations based on a comprehensive review of the
literature for cancer prevention, screening, treatment,
treatment of symptoms, palliative of care and end of life care.
Mr. Cannon. Tell me a little bit about where that database
comes from, how it is developed, and how new protocols get into
the system.
Dr. Trimble. The NCI convenes panels that are independent
panels. They include both representatives from academic
institutions as well as from NCI and from other Federal
agencies. They review the current literature on a regular
basis. Some panels meet yearly, some meet every 3 months,
depending on the volume of literature. They then draft
statements which summarize the literature, which reference the
literature, and those statements are placed on the NCI's PDQ
Web site so that it is widely available.
Mr. Cannon. You know, we have this mammoth number of highly
educated doctors in America. Sometimes they don't actually
recognize the problems. But when we have this huge group of
people that are well educated, tend to be academic, tend to be
clinicians, but with a creative mind-set, is it possible in
your mind to capture that capability, that academic ingenuity
out there in some form that would allow protocols that doctors
are using to be brought into a database so that other doctors
could look at those protocols and then develop sort of an
Abasian context in improved treatments?
Dr. Trimble. Well, as I said, the PDQ database makes or
summarizes what is----
Mr. Cannon. Let me just make a distinction. The problem
with PDQ is that this is a bureaucratic and long process, as
opposed to a database process or a process that grows from
practitioners up. Is it possible to shift gears away from the
long process that says this is OK and to a process that says we
would like to know what you are doing out there, we would like
to compare it to what other people are doing, and we would like
that information to be made available to other doctors?
Dr. Trimble. We have made an effort to reach out to the
community in a pie project for certain cancers to find out how
these cancers are being treated in the community, what is the
effective treatment upon outcome upon quality of life; and we
are analyzing that data currently to see how effective it is
and to see whether we should be expanding this program to other
cancer sites.
Mr. Cannon. You are probably familiar with the development
of childhood cancer responses. When I was very young, my best
friend's younger brother was found to have leukemia, and we
thought he would be dead within 3 months. It turns out there
was a treatment that somebody had identified, tried on the
young boy, and he wasn't cured, but he didn't die. This
happened four or five times in my childhood, where he became
critical, was ready to die, and then a new treatment came
forward. As a result, I saw him 6 months ago; he has a family,
he is happy and in his fifties now. So we have a case of
success.
What happened there--and I have talked to a number of
people throughout the pediatric world--is that there was so
little focus on pediatric medicine, especially oncology, that
what we had was a high level of communication. And that high
level of communication meant that it started out with
telephones, later went to faxes and to e-mail. It meant that
people who discovered something that might work communicated it
to everybody else, everybody else tried it, and those things
that really worked tended to be focused on and then became the
base of treatment. That has been incredibly effective; not just
in the single case that I am aware of, but the view of all
people involved in childhood oncology recognize that as a great
source of success.
We have the ability to communicate those things on all
levels and for all cancers much more rapidly. Is anybody
looking at that at NIH or NCI that you are aware of, Mr.
Trimble, to try and replicate with the massive increase in
technology the great successes we had in that one area?
Dr. Trimble. Certainly, the progress that we have made in
pediatric cancer has been tremendous, and we are trying to see
if we can replicate that progress. There are a number of things
that the pediatric oncology community has done which are
admirable.
For example, probably 90 percent of children less than age
12 diagnosed with cancer are treated at pediatric cancer
hospitals. This is in contrast, for example, to adult cancers,
where only 5 percent or 10 percent of patients are treated at
NCI-designated cancer centers. So the fact that the pediatric
oncology community has been able to concentrate the care of
children with cancer in specialized cancer hospitals has been
tremendous.
They have also----
Mr. Cannon. Excuse me. The access to data is radically
greater today for all cancers, including adult cancers as
opposed to child cancers. In other words, I don't want to
understand why we are successful with childhood cancers. I
think I get that. The question is is it possible to systematize
access to data so that we do it much more rapidly.
Dr. Trimble. Well, another area which has made the
pediatric cancer world so successful is that more than 70
percent of children with cancer go on clinical trials. So we
capture data on how they are treated, their response to
treatment, and their quality of life. We are trying to increase
the number of adult patients going on clinical trials. In
addition, we are trying to extend our database so that we can
capture more information on all adults who are diagnosed with
cancer.
Mr. Cannon. I apologize for that diversion. Have you
finished on that point?
Dr. Trimble. Yes, I did.
Mr. Cannon. OK. In the case of my daughter--let me just ask
the panel of this generally.
I think we should do a second round of questions. On this
committee there is a tendency to go longer for the chairman and
the ranking member. I am not going to abuse that too much.
But in the case of my daughter, she had a rare cancer that
maybe 30 young women typically a year get in America. I called
a friend of mine, as my daughter was going through the MRI, who
is a radiologist, and said after she is done, would you mind
taking a look at the pictures, and he said, hold on a second.
And then he said, OK, I am looking at them now.
I said, how could you be looking at them; she is in the MRI
machine right now. And he was not at the same site. So he said,
well, the miracle of modern science. And then the next words
out of his mouth were, ``Oh, this is bad.'' Not exactly the
kind of thing you want to hear from a doctor.
Now, if he had been sitting--it was in her knee and he said
it's involved in the tendons, and that is bad. Now, what she
had was clear cell sarcoma of the tendons and aponeurosis. But
he didn't remember the whole name; he just remembered having
bumped into this rare cancer that was associated with tendons.
And if he typed into the freaking machine that he had in front
of him, if he had a database that allowed him to type in
sarcoma in tendons, the treatment for my daughter would have
been radically different. Just a simple little information
context there.
Now, we have done radical things in information. My
favorite on earth is Napster. You need to think about Napster,
because that was a peer-to-peer system that allowed anybody to
get online and identify information that was out there. In
particular, it means that a doctor can make information
available.
You are telling me how you want to structure data so that
it is available and put people in clinical trials. We have
people who are essentially in clinical trials because they have
cancer and they are being treated by people who understand
information and systems. In my daughter's case, she worked for
the guy later on who actually did the MRI that I had mentioned
earlier, so when the cancer came back, she did a number of
MRIs, because it didn't cost anything and because her boss was
a very gracious guy and a good friend.
Now, in the course of her disease, there were no
treatments. We found one treatment of a person in Japan who had
the disease and had remission. But there are no accepted
protocols for her disease. That meant that we tried various
different kinds of things with medical guidance, including
using the most standard or common treatment for malaria
throughout the world today, which is an herb that the Chinese
came up with.
Today, there are millions of people taking that herb with
no side effects, so we tried it on her. But we had no guidance;
the idea of how much to give her or how often to give it to
her. So we experimented with it for 6 weeks. We didn't really
understand it, but going back now we see that in her case the
MRIs before she took it and after she took it indicate that
there was a dramatic slowing of the growth of the tumor.
Now, that information seems to me to be quite important to
somebody else who has the same kind of disease. And the only
way you can get that information, the only way is by having
access to her records. So if you have a database that is like a
Napster directory and you can find clear cell sarcoma of the
tendons as aponeuroses and see who has treated what and then
say, wait a minute, here is something that might have an
effect, that could actually save people's lives.
There is no way to get that data in our current system. You
can go online and you can see all the--well, I shouldn't say
that. There are many people who have used this and they have
their ideas about how to use this, but there is no context
where you can give it scientific integrity, where people can
build on the ideas.
What I am asking you--and let me just leave it at this
point with this panel and then we will go to Mr. Cummings--is
does it make sense to create in our data-rich environment a
context for practitioners, medical doctors, people who are
trained in medicine, to identify the best treatments that are
out there, and then build upon those and create a database as
we did in pediatric oncology, and move from that base forward?
This is not, are your institutions going to do it? The question
is, does that make sense? Because we probably have to make some
changes here for you guys to be able to do that. But does it
make sense?
If I could ask the three of you to respond to that, I will
then yield back and defer to my friend, Mr. Cummings.
Dr. Thompson. Mr. Chairman, you have just identified one of
the primary reasons why Secretary Leavitt is committed for the
Department of Health and Human Services to work toward
developing an electronic patient record system in this country.
It would provide the sorts of database that would allow the
sort of research you are talking about to be done. It is not
something that we now have on a large scale basis.
You have identified one institution that had that aspect of
it and was able to use it very well, but we don't yet have it
standardized; we don't have it in enough places. We have not
yet solved the problems of privacy and confidentiality that
must be solved.
But if we can develop a common patient record that is
electronic and accessible in the ways you just described, it
will not only provide better direct patient care with the
medical knowledge that we have now, it will allow the type of
research you have just described.
Dr. Pazdur. I think you hit on the head some really
important areas here, and one of them being treatment of
patients that are not on clinical trials. We do a great job, I
think, of collecting data, and perhaps too much data, on
patients that are on clinical trials, and one of the real
issues is how does a drug work once it gets out there in a
post-marketing situation as well as in the treatment in off-
label uses such as in rare diseases where there are not going
to be large clinical trials.
So a database that reflects how the drug is actually used
in the intended indications as well as in off-label uses I
think would be an extreme important step to provide guidance,
especially in areas where you have relatively rare and unusual
tumors, because considering the frequency of some tumors, they
are very important tumors, but somebody is not going to do a
large size clinical trial, just due to the rarity of some of
these diseases.
Dr. Trimble. The only additional point I would add is that
we desperately need a system to track who has been screened for
cancer, for example. We have no national database to tell us
who has had a Pap smear within the last 10 years, who has had a
mammogram; do we know one place where we can capture the images
of those mammograms so we can compare them.
Mr. Cannon. Thank you. Let me make a distinction and a
comment. The distinction is you are thinking in terms of
clinical trials. And what we have are many, many, many
practitioners who use protocols sometimes, who adapt protocols
for the use of their patients, and who are accumulating huge
amounts of data. The question is not how do we make this all
fit into a clinical trial, but how we capture the data from the
practitioners. If you would think about that.
Dr. Thompson, Secretary Leavitt is actually from Utah,
interestingly, and he may not appreciate actually how good we
are in Utah, but there is a company in Utah that is the leading
light in these kinds of issues, and I am going to get you the
name of it, it is called NexLight, or sometimes eBridge. They
have developed an incredibly thorough system for managing
patient data using all the rules of HIPAA and other
requirements and allowing the staff.
And I am going to get you a card on that and ask for, in a
written request, your response as to what that kind of a
program could do for allowing us in America to accumulate data
on individuals based upon their consent, their understanding of
the law and their consent, and giving access by those patients
to people like doctors or people running clinical studies or
other scientists so that we can actually move that issue
forward.
I am going to ask some more questions, but I will save
those until the next round.
Mr. Cummings, if you have questions, you are recognized for
5 minutes.
Mr. Cummings. Yes.
Dr. Thompson, in your opinion, what do we need to do to
increase access to the existing interventions like Pap smears?
You know, the sad part is that we have people dying.
Dr. Thompson. It is. And what we need to do is to learn to
use the science we now have more effectively so that it reaches
everybody. The Congress took an important step in 1991 in
enacting the legislation that created the Breast and Cervical
Cancer Screening Program, because what this does more than
anything else is make it true in this country that today no
woman should be without cervical cancer screening or breast
cancer screening simply because she lacks the ability to pay
for it, because any woman at or below 250 percent of the
Federal poverty level qualifies for this program and can
receive screening services through it.
So cost should not be a barrier. And yet we know we are
still not reaching all of the women we should. The figures that
I cited to you I think are figures we should be proud of. We
are reaching many women and they are low-income women. But we
know some things that are troubling to us, and we want to work
to make them different.
This is not published information, it is simply what we
have observed in looking at some of the States implementing it,
but we know, in the State of Ohio, for instance, that they tell
us that although they are utilizing the program effectively,
the women in the upper half of that income range, 250 percent
and below of the Federal poverty level, are the ones who seem
to be taking advantage of the program, and women in the lower
half, the very lowest of the low-income women, seem to be less
often reached by the program. So we are looking and need to be
looking at things that influence women's choices as to how they
use these programs, whether they know about them.
We have now gone passed the point where it is laboratory
research that is needed. In these areas it is the sorts of
behavioral research that will help us learn why people do and
don't use medical programs and things that may be necessary to
facilitate that. That is the sort of research that CDC engages
in along with our colleagues at the National Institutes of
Health. But the bottom line, the answer to your question, we
have simply got to learn how to bring these techniques to the
people that need the most and often are the ones who know the
least about them.
Mr. Cummings. The program is one going back to 1991, so it
is about, I guess, 15 year anniversary. That is a long time.
And I am just wondering, do you know how that research is done?
Is it focus groups? You know, one of the things that I do
believe is that people who have similar experiences in life
probably shed the best light on other people in like
circumstances.
And I am just wondering. Sometimes I think what happens is
that, say, for example, if I wanted to know about why do women
in the lower economic rung of the ladder did not access, I
would go and talk to other women. I sure wouldn't go to a man;
I would go to a woman. Sometimes I just find that a lot of our
government programs don't do that. A lot of times we don't go
to people who could probably help us with it.
For example, in my community there is a big glaucoma
problem. And my mother, having lost sight in one of her eyes
with glaucoma, I am in tune; I get it. So I am always talking
to people about their eyes. But some kind of way I think we
also need to use people who see the light, perhaps, to help
spread the word. And I was just wondering how much we do of
that, too. That is, people who may fall into those categories
and have a relationship, therefore, and can spread that word.
You follow what I am saying?
Dr. Thompson. Yes, sir, I do. And this is an area in which
we in the medical professions maybe are coming a bit late to
the idea that we should ask those who we are trying to reach
how best to reach them. But we are doing that now. And at CDC
in particular we have established a new center, it is the
National Center for Health Marketing.
That doesn't mean we are selling people things, it means we
are literally marketing health. And we are doing research by
asking people, both in studies and in focus groups, how it is
that you make your decisions about how you seek your health
care of all sorts and how we can improve your ability to do
that. So we are beginning to use those techniques of
approaching the community we are trying to reach much more
extensively.
Mr. Cummings. Now, as far as doctors are concerned, they
know about these options that women have with regard to free
screenings and whatever. Do you think that plays a major role?
Are you following me? Somebody comes to the doctor. Do you
think because they know this is something available, that they
make women aware of it?
Dr. Thompson. My colleagues can probably address this
better than I. But although we as doctors believe we know
everything, the truth is most of us don't know enough even
about our own specialties, and all have things that we can
learn. So professional education is a part of CDC's programs. I
know it is also part of the National Cancer Institute's
approach.
Mr. Cummings. Dr. Trimble.
Dr. Trimble. We have seen data showing that obstetricians
and gynecologists are the most likely to recommend that women
undergo Pap smears and mammography. They are followed by family
practitioners. Unfortunately, many adult internal medicine
specialists are less likely to do a pelvic exam or obtain a Pap
smear.
So as Dr. Thompson mentioned, we need to redouble our
professional educational efforts. In addition, the routine Pap
smear screening has now been instituted as a mark of quality in
health care provider organizations, so we think that this will
increase the recommendation of Pap smears for all women.
Mr. Cummings. Dr. Pazdur, you know that rising costs and a
lack of commitment to applied science in emerging various new
drugs and devices to treat cancer and other deadly diseases.
What can be done to encourage applied science research and
technology?
Dr. Pazdur. Well, I think this is one of the considerations
that the FDA had in establishing the critical pathway, because
there is a tremendous funding of discovery of drugs. But I
think where we have been lacking in the whole drug development
area has been in the clinical and the development of drugs
after they may have been initially discovered, and that is the
clinical development of the drugs and the preclinical
development.
And that is why we are working with the NCI and have this
project. What are paradigms that can be shifted from
conventional evaluation of drugs to facilitate bringing drugs
that are safe and effective, not compromising safety and
efficacy--we never want to do that--but expedite drugs
cognizant of the fact that they have to be safe and effective;
looking at new non-clinical ways to develop in animal models.
For example, what would be a minimum data package that
could be accepted to bring drugs into a life-threatening
situation; what are different statistical tools that could be
used to give us confidence that a drug is safe and effective,
rather than the traditional statistical methods that have been
used? So I think this is an area that is an extremely important
area that we want to focus on, because we are cognizant of that
and really need to work not only in the FDA but with our
external stakeholders, not only in government, not only in
industry, but with the academic and patient community.
Mr. Cummings. Thank you.
Mr. Cannon. The gentleman yields back.
Mr. Issa, did you have questions?
Mr. Issa. Yes, Mr. Chairman.
Mr. Cannon. The gentleman from California is recognized for
5 minutes.
Mr. Issa. Thank you.
Dr. Trimble, you mentioned in your opening statement the
vaccine for HPV, and my understanding is there are 150 or so
different strains, if you will. How many is it effective
against?
Dr. Trimble. Well, there are a variety of HPV subtypes.
Only a subset, perhaps 20 or 30, seem to be bad actors in terms
of going on to cause cancer. The two companies that are
developing the vaccine have gone furthest with the prophylactic
vaccine and have focused on the most common subtypes, 16 and
18, which are responsible for a majority of cervical cancers
around the world and in the United States.
Mr. Issa. And I would like to concentrate my questions not
on, if you will, the new discovery side of it for a moment,
because Johanna's Law really is about awareness, with $5
million going toward and $10 million per year going initially
toward demonstration projects to try to improve early
diagnosis.
My first question--and I will take any of them, but I
think, Dr. Trimble, I would start with you--is it enough? Is
this the amount of money that you believe would start saving
lives in large enough numbers, or are we kidding ourselves? And
even with the leveraging of public-private partnerships, will
we need more?
Dr. Trimble. Well, I concentrate my own work on promoting
gynecologic cancer research and developing trials in
gynecologic cancer, so obviously from my own perspective I
always like to see more money focused on gynecologic cancer.
And it should be said that about 5 percent of the NCI's budget
is, as we know, earmarked and goes toward gynecologic cancer
research. And there is a lot of basic science research as well
that is specific to gynecologic cancers, but may well influence
us and help us develop new treatments, new screening tests.
So I think it is a very hard question for me to answer.
Yes, I would love to see more money going into gynecologic
cancer; on the other hand, we have a limited pot of money and
there are a lot of other cancers that we have to study as well.
Mr. Issa. Dr. Thompson, maybe in your case, right now I
would say there are tens of millions of dollars a day worth of
free air time warning the people of New Orleans and the south,
but particularly New Orleans, not to drink the water and the
contamination. I don't know how many people are going to heed
that warning.
It does seem a little strange that we are all going to be
aware, unless of course, we are in the affected area, where we
don't have a television. But maybe somebody will go in and tell
the person who doesn't have a television or water what they
need to do. From your experience, is this a sufficient first
step to have a real impact both on the misdiagnosis side and on
the need for testing side?
Dr. Thompson. Well, certainly we will never have spent
enough on cancer prevention and cancer detection until no one
dies of cancer. But at the same time there are other priorities
that we have to balance back and forth.
I think certainly the concept of educating particularly
providers about the latest techniques, about the latest
knowledge, about how to appropriately screen, how to evaluate
symptomotology is always worth the effort. Whether this will
accomplish the end I think we will only know when we attempt it
and then we evaluate whether or not we have accomplished it,
and if not, what is then required to finally accomplish it.
Mr. Issa. Last question, and I am staying on the same
subject of money. My understanding is it takes about three
quarters of a billion dollars to bring a new drug to market.
Any one drug coming to market, from your experience--and Dr.
Pazdur might be the best to answer this--any one drug probably
would save, at a maximum, 3,000 to 5,000 deaths a year for
nearly $1 billion, perhaps more; $15, $20 million, would you
say, any of you from your experience, that an effective
awareness campaign could save 3,000, to 10,000 lives a year
between the three cancers? Would you say, on balance, that this
$15 million--as compared to the $1 billion of one new drug--
could save as many or more lives?
Dr. Pazdur. The answer to your question is yes. Obviously,
prevention and early detection of cancer is always better than
the treatment of advanced disease, even early stage disease.
But especially when one takes a look at advanced disease,
patients that have metastatic disease, where most of the drugs
in oncology are being developed, most of those situations have
to be considered palliative types of therapies, unfortunately.
So efforts to really eradicate cancer and to truly make an
impact on the burden of cancer really needs to be addressed in
the early stage awareness, getting the community to see their
physicians. Doctors know generally what to do; however, if the
patients are not coming to them, that is where the gap could
be, and I think that is a need for community recognition of the
disease and the importance of getting screened, etc.
Mr. Issa. Thank you, Mr. Chairman.
Mr. Cannon. The gentleman yields back.
Ms. Watson. The gentlelady is recognized for 5 minutes.
Ms. Watson. Thank you, Mr. Chairman.
This question goes to Dr. Trimble. In your testimony you
state that an effective vaccine in combination with cervical
cancer screening is expected to reduce cervical cancer rates by
90 percent in the United States.
I am finding out that there are those who began to oppose
the HPV vaccine. A spokesperson for the Family Research Council
said that giving the HPV vaccine to young women could be
potentially harmful because they might see it as a license to
engage in premarital sex. So from a public health perspective,
does the Government typically withhold vaccines because of the
unsubstantiated claims that they will affect people's attitudes
and behaviors?
Dr. Trimble. Well, let me start by seeing if Dr. Thompson
would like to comment in terms of the--I know the CDC has a
vaccine advisory committee which carefully measures the risks
and benefits associated with vaccines and makes
recommendations, so perhaps Dr. Thompson----
Ms. Watson. Fine.
Dr. Thompson. First, Ms. Watson, let me thank you for the
imagery you used earlier about homeland security being not
about the land, but about the people on the land. With your
permission, I am going to use that with attribution,
occasionally.
Ms. Watson. Please do.
Dr. Thompson. As my colleague has said, CDC has a process
for evaluating the usage of vaccines. Now, the first issue is
whether it becomes licensed, and there my colleagues from the
FDA must make the decision. But once a vaccine is licensed, we
have a committee, it is called the Advisory Committee on
Immunization Practices, that meets regularly. It consists
primarily of scientific experts, but also of public health
practitioners.
I had the privilege of serving on that committee myself for
4 years before coming to CDC. And it also makes provision,
extensive provision, for public input and public comment. Based
then on the science and the policy implications of the use of a
vaccine, they make scientifically informed decisions
recommending to CDC, and from CDC thus to the Department of
Health and Human Services, what use the vaccine should be put
for.
That process is ongoing now. The ACIP has already addressed
the issue of HPV vaccine in some of its meetings in
anticipation of licensure, and will be doing so again. So it is
critically important that persons interested in this issue
bring their concerns to the committee through the public
comment process and make sure that their voice is heard.
Ms. Watson. The encouraging words that you used were based
on science.
Dr. Thompson. That is correct.
Ms. Watson. Not based on ideology or negative attitudes. We
have been accused in our public school system--I was a member
of the board in Los Angeles--when we passed out condoms upon
request to block the spread of AIDS, we were accused of
encouraging young people to engage in sex.
I carried the needle exchange bill for 8 years--it was
passed after I left--and was accused and made to sit on the hot
seat because there were those attitudes out there that
everything we did was encouraging people to have sex. So I am
assured by your response that you operate based on the facts
and on empirical evidence gained from your scientific research
when you make these decisions, correct?
Dr. Thompson. I can assure you, both from having been on it
and knowing the people that are on it now, that the ACIP bases
its decisions on scientifically verifiable fact and will not
deviate from it.
Ms. Watson. From a public health standpoint--and this is
back to Dr. Trimble--we in Government, we decisionmakers must
put policies out there that will help the public and reduce the
risks that they face, even if it goes against some people's
religious beliefs. I am a Roman Catholic, and I support choice,
I support condoms, I support all kinds of other things that
will reduce the risk to the public. So I just wanted to make
that statement real clearly. And I appreciate, Dr. Thompson,
your response.
Thank you, Mr. Chairman.
Mr. Cannon. Thank you. Without objection, I think we will
go through another round of questioning.
Let me just followup on what Ms. Watson was just asking.
What rate of vaccination is that 90 percent figure you talked
about predicated upon? In other words, what percentage of women
and girls does such an outlook presume will be vaccinated?
Dr. Trimble. I am not sure where the 90 percent figure came
from. My impression is that we may well have said that the rate
of cervical cancer has fallen so dramatically in the United
States with the introduction of Pap smears, but I am not sure
that we discussed in our testimony the projections for vaccine
adoption and implementation in the future.
Mr. Cannon. Thank you. Just along those lines, I am going
to ask a couple of questions that my colleagues wanted to ask
but are not here.
For the FDA, your testimony references cervical cancer only
once. This subcommittee informed your agency that we are very
interested in issues that the FDA failed to address in our
hearing on cervical cancer last year. Your agency was provided
with questions that we expected to be addressed, specifically
on the matter of the agency's failure to comply with Public Law
106-554, signed by President Clinton in 2000, requiring that
condoms be accurately labeled to reflect the fact that condoms
do not protect women from HPV infections. Why aren't you
addressing this issue?
Dr. Pazdur. I personally can't answer that issue. The
condoms are handled and the approval of condoms are handled by
the Center for CDRH, so I do not have personal knowledge of
that area. We will provide to the committee a written response
to this question within 5 days.
Mr. Cannon. Thank you.
Since Public Law 106-554 was enacted requiring accurate
condom labeling, more women have died of cervical cancer than
from AIDS among non-injection drug users. The FDA has still not
complied with this law. Can you tell this committee why it has
taken so long to act on this critical public health matter and
require accurate condom labeling?
Dr. Pazdur. Here again I will reference my previous answer,
that we will provide an answer to the committee in writing.
Mr. Cannon. Thank you. It is not a personal thing, but
institutionally we did have a hearing, and we expect a
response. Thank you.
Now I would like to move on to other issues. Are any of you
familiar with protein testing to identify whether a woman or,
for that matter, man has had HPV and which of the HPV viruses
the individual has had?
Dr. Trimble. There are currently approved by the FDA tests
for women to evaluate whether they have an active infection of
HPV and some subtyping of the various high-risk types is
available for that. In addition, we do have some serological
studies which evaluate antibodies in blood that can show a
history of HPV infection.
Mr. Cannon. Are those definitive; can you say to a woman
you have not had or you have had a HPV infection based upon
those studies?
Dr. Trimble. Certainly the tests for active HPV infection
does have a false negative rate, so one would need to do a
series of tests over weeks to months to say for sure that a
woman does not have an active infection at this point in time.
The serological tests can fade over the years, so you may no
longer have an immunological memory of having HPV, although in
one point in life you may have had it.
Mr. Cannon. For you, Dr. Trimble, but also for CDC, it
would seem to be important that if you had a test that could
identify what HPV a person has had in his or her system, would
that be significant in the cost of identifying and treating
people that may have or get cervical cancer?
Dr. Trimble. Certainly with the development of accurate HPV
tests, we have begun to study whether we should or could modify
the existing screening program so as to screen first with a HPV
typing and then only followup with Pap smears in people who
were found to have HPV infection. This might well work for
women let us say 25 and older in whom HPV is rare.
Among younger women, though, HPV infections are common, so
one would not want to start with a primary HPV screening test
because there would be many false positives. And the vast
majority of individuals, both men and women, who are exposed to
HPV quickly resolve that infection and have no adverse health
effects from the HPV infection.
Mr. Cannon. But when you say no adverse health effects,
doesn't it take years of the infection to create a cancerous
lesion?
Dr. Trimble. Well, we think that the average age of
infection is probably less than age 20, and the median age for
diagnosing cancer is around 65. So, yes, there are years to
decades.
Mr. Cannon. Thank you.
Dr. Thompson.
Dr. Thompson. We do currently, through CDC's breast and
cervical cancer screening program, provide for the use of HPV
DNA testing in certain clinical situations where it can be used
as an adjunct to Pap testing. But at this point it has not yet
been determined that it is a useful tool for across-the-board
screening.
So we use it in very special circumstances, such as when a
woman has had a low-grade abnormality detected by a Pap smear.
And after a period of time she has had negative colposcopy, we
can then use HPV DNA screening and Pap screening to determine
what sorts of followup are necessary. So in some circumstances
we use it even today.
Mr. Cannon. You know, there have been some terrific
transformations in science. I read 2 or 3 weeks ago in Time
magazine about Craig Ventner, who is traveling the world in a
yacht and testing the DNA set every 20 miles or so, and he is
able to do this because the cost of decoding DNA has fallen
dramatically, from about $10 a pair, when we started the Human
Genome Project, apparently, now down to like less than a penny
a pair to decode. So it is cost-effective for him to do that
even on his boat. And I think there are new technologies that
are going to bring that down by another order or two orders of
magnitude.
It seems to me that this is an area where we need to change
our thinking about how we are looking at disease, because the
cost of decoding what is going on is so much, almost
infinitely, lower than it has been. Could the three of you
respond to how your agencies are dealing with the lowered cost
of protein identification, DNA or RNA and other proteins, and
what that means for the future of science? And what it might
mean for complexity, how we ought to start looking at these
diseases in an environment of Abasian or complex theory.
Dr. Trimble, Dr. Thompson, then Dr. Pazdur.
Dr. Trimble. Well, certainly cost is an important issue.
The Gates Foundation, for example, has made a large
contribution or earmarked a large contribution of money to help
develop inexpensive HPV diagnostic tests for use in the
developing world. And we have had some discussions with the
Gates Foundation, as that research progress, as to whether we
might be able to use some of those inexpensive diagnostics in
the public health sector.
At present, we only have a few tests which have been
approved by the FDA, and some individuals have commented that
the prices attached to them, prices placed on them by the
companies which market them, make them less than optimal for
use in the public health setting. But we obviously have no
influence over the price of a proprietary diagnostic.
Mr. Cannon. Thank you. I have a friend who complains that
in every other sector of the economy innovation means lower
prices, except in the medical sector, where prices skyrocket.
That is an issue, but perhaps maybe the issue really is--and if
I could skip over you just for a moment, Dr. Thompson, because
this is probably an issue of most importance to you and what
you are doing--but what do we do about the cost of getting
approval when the nature of the ideas that are coming before
the FDA is changing? In other words, you know more about what
you are dealing with when you have decoded a protein than you
do when you are dealing with a substance which may be toxic,
but it may also affect disease.
Dr. Pazdur. I think what you are really talking about is a
concept which we refer to as enrichment, and that could the
fields that you are referring to, proteomics and genomics,
really identify a population of patients that are more likely
to respond to a therapy. For example, if you have a DNA chip
which identifies a subgroup of cervical cancer patients or
ovarian cancer patients that are more likely to respond to a
given therapy, that is a great step forward, because obviously
these drugs are toxic drugs, for the most part, and you could
spare people that have a very reduced chance of benefiting it
from receiving drugs that they are not going to benefit from.
Likewise, you are going to select a group of patients that are
most likely to benefit.
Mr. Cannon. What you just said is perfectly agreeable, but
what I asked is slightly different. What are you doing at the
FDA to encourage the identification of proteins and then your
process for approving those proteins based upon what they are,
as opposed to what historically we have done with toxicity? In
other words, you may have a patient who responds better, as you
have just pointed out, because of proteins that he or she has.
On the other hand, you may have causative agents that you
can identify, like HPV viruses, for which you may have
serological remnants, or you might have an active culture. What
are you doing at FDA to help speed up that process, where we
are not dealing with the likelihood of death, but we are
dealing with the likelihood of certainty that an agency is
present?
Dr. Pazdur. What we are doing in the area of genomics, we
have specific groups of people that are working on guidances on
how this data should be submitted to the agency. Obviously,
this is an evolving field of science. So we are working with
industry, inviting them to come in, share their data with us.
We are organizing conferences, discussing how this data will
have an influence on subsequent clinical trials. We are well
aware of the scientific advance. It is an evolving science that
has to really have a partnership with the FDA and both the
academic community as well as the commercial community.
Mr. Cannon. You call this an evolving area of science. It
is not. That is what you called a transition of understanding
what germs were over 100 years before we got vaccines that we
actually understood why they worked. This is a revolution; this
is an explosion; this is a transformation. And what you are
talking about is a process that makes it a lot more expensive
and, by the way, impedes the health care of Americans and
people worldwide.
May I suggest that the FDA needs to think differently about
this? Because it is not the same as what has been, and much of
what has happened can be left up to practitioners who
specialize and who deal with the issues. So what I view the FDA
here as is a big door, a big hurdle, a big cost increaser that
needs some thought.
I know you are thinking about it, but your answers are
answers that are in the context of a bureaucratic and outcome-
oriented context, rather than how to help people's health,
which is what the focus ought to be. You really need a
transformation of thinking at the FDA.
And I know you have done many things. I am a big fan of the
FDA. I have been a big opponent of reimported drugs and things
like that. But the FDA needs to evolve at a rate that is
somewhat maybe lagging, but at least near the rate that the
transformation in science is happening.
I don't mean to lecture so much, but it is an area of deep
frustration.
And, Dr. Thompson, clearly this is a matter of great
importance to you and your agency. Do you have some comments?
Dr. Thompson. Well, in public health it is really simple:
the lower the cost of a screening test or an intervention, the
more people we can provide with the benefit of it. So it is up
to our colleagues in the regulatory sector, in the research
sector to develop and certify these products, but once they
reach our hands, the less they cost, the more people we can
serve with them.
Mr. Cannon. Thank you.
Mr. Burton, I have one more question, but did you want to
ask questions of this panel?
Mr. Burton. I just have one question, but go ahead.
Mr. Cannon. Let me just point out what our discussion has
been and where I think, as a community, we need to be headed.
Much of the answering of the questions I have asked has related
to controlled clinical trials, and I have continued to come
back to what a practitioner does with his patients and what his
experience is, and what we can accumulate from that process. It
is a paradigm shift. It is a dramatic paradigm shift, but it is
a shift that makes pretty significant sense, especially when
you view the world from the point of view of the tools we have
that are capable of helping us accumulate data.
Of course, I have to say my questions may have, at some
times, been harsh, and I apologize for that, but it is an
awfully personal thing. But your agencies are really wonderful
agencies, and there is no criticism of the agencies, it is just
a road I hope you would see to get to the next position. And
all three of your agencies have a piece of this and you are
doing remarkable work, but the cost of medicine is
skyrocketing. The access to medicine is diminishing.
When I was elected to Congress, 65 percent of Americans had
employer-based health insurance; today, 45 percent of Americans
have that. And the answer is either we go to a controlled,
socialized single payer system, which 65 percent of Americans
now want, by the way, understanding that means socialism--as
opposed to 45 percent when I first got elected; the numbers
have inverted themselves--or we go to a system where the
American way actually succeeds, and that is open markets, free
access to information, choice by consumers, choice based upon
access to information. In some cases that is a matter of cost;
in the case of my daughter, it was a matter of life and death.
It was an ignorant set of doctors who prescribed badly, didn't
know what they were doing.
What happened to my daughter was an abomination, and it was
an abomination that I couldn't fix. I mean, I am a Member of
Congress; I was a Member of Congress then. I didn't have access
to the information to figure out what was going on with my
daughter. Now, that has been ameliorated somewhat in recent
times, but we still have problems in that area.
Here, the three of your institutions are very different and
represent different elements of the puzzle. But we have a huge
cost hurdle that is transforming the rights and choices of
Americans in a way that I think is wrong. So as you look at
this, may I just suggest when a patient and his doctor or her
doctor has access to information, they will make better
decisions.
We have ways of massively expanding information, and one of
them, just to be thinking about, when we passed AHSEA, we had 2
million people in America that got involved in that act, that
became activists. I suspect you have 5 or 10 million today,
because the number of people that are using nutritional
supplements has increased significantly. And if you go to the
NNFA, which is the National Nutritional Foods Association, Web
site, nnfa.org, they have an incredible presence. They reach
many people.
And if the CDC said here is a set of questions we would
like to know about your health and here is how we will protect
the data, I suspect you would have millions of people who would
respond. In other words, if you think about how you get data,
you can get it much more cheaply than we have ever done before.
The cost of obtaining data from individuals has plummeted, just
like the cost of decoding a DNA pair has plummeted.
So if you would think in those terms, I suspect you would
see that there are great opportunities for improved health in
America, for improved control by individuals of their health in
America, and for a system that protects without impeding,
without causing death and destruction, which in fact often
happens with our medical system. That is probably not your
fault, it is actually largely doctors who are ignorant of what
they are doing. But it would be nice to allow patients to have
some access.
And I have ranted here, but I would like you all to think
about that. We are going to followup with some written
questions.
Now, Mr. Ruppersberger, I know that you are next, but I
think Mr. Burton only had one question. Would you mind if we go
to him for that question and then come back to you?
The gentleman from Indiana is recognized for 5 minutes.
Mr. Burton. Thank you, Mr. Chairman. I will just be real
brief here.
First of all, I presume that you gentlemen would be
supportive of Johanna's Law. That authorizes $15 million over 3
years for public service announcements and $55 million over 3
years for grants to establish local and national nonprofits and
community-based health centers to test different outreach and
education strategies. I am sure you know all that.
Are our health agencies doing anything in this area right
now? Do they have any kind of an outreach program or
educational program for gynecological cancers in women?
Dr. Trimble. The NCI does have an extensive educational
program, both for the lay public as well as health
professionals, focused on gynecological cancer. We work closely
with our Cancer Information Service and the CDC in terms of
disseminating that information.
Mr. Burton. The reason I asked is when my wife was
suffering from cancer, I never saw any manifestation of that.
Can you tell me, real quickly, how much money is being put into
that program?
Dr. Trimble. I will have to get back to you with the amount
of money that we put into cancer information, but it is a large
portion of our budget and our activities.
Mr. Burton. I would like to have that. Thank you.
Mr. Cannon. The gentleman yields back.
Mr. Ruppersberger. The gentleman is recognized for 5
minutes.
Mr. Ruppersberger. Mr. Chairman, thank you.
There have been a lot of issues discussed here today. I
think one of the frustrations that we have sometimes in
Congress is that we raise some issues and then there is not
implementation. And I would hope that we could benefit from
this panel, and I know that the chairman feels very strongly
about this issue because of some of his unfortunate personal
situations that we really implement and move forward.
In order to avoid any repetition, there is one issue that I
think hasn't been addressed, so I will just ask that to the
panel and that is all I have.
In the past, the NIH and CDC has found that there was
evidence that condoms can reduce the risk of cervical cancer,
but there wasn't enough data to determine if condoms prevented
the spread of HPV. Earlier studies were insufficient to answer
this question because they asked people to recall past condom
use, they didn't track people's behavior over time or they
didn't know people's STD status before the study.
Now a recent study has addressed many of these issues.
Researchers tracked young women over time and gathered precise
data on condom use and sexual behavior. The study found that
consistent condom use reduced the risk of HPV acquisition among
women by 70 percent and reduced the risk of cervical HPV by 80
percent.
My question to anyone on the panel, if anyone has an
opinion: Do you think this is the kind of study that the FDA
should take into account when considering labels for condoms?
Dr. Pazdur. Here again, I have not reviewed the study, but
obviously I think we should take account of all information. I
can't make a commitment to you on a specific study without
obviously seeing the data that is presented, but from your
description of it it is something that we would be very
interested in looking at and including into product labeling.
Mr. Ruppersberger. I am not just saying looking at. I would
recommend that you look at the study and if we are going to
have momentum and move forward on this entire issue, I think
these are things that we just shouldn't talk about at a
hearing; we need to get the research done and follow through.
Dr. Pazdur. By ``look at'' I meant evaluate appropriately.
Mr. Ruppersberger. And then deal with FDA.
Dr. Pazdur. Correct.
Mr. Ruppersberger. Thank you.
Mr. Cannon. The gentleman yields back.
Mr. Issa, did you have further questions?
Mr. Issa. Yes.
Mr. Cannon. The gentleman is recognized for 5 minutes.
Mr. Issa. Thank you.
I would like to followup on a question Mr. Burton asked. If
there is a lot of money being spent on outreach, why is it that
it doesn't get to the end of the pipeline? Because Johanna's
Law and this authorization for funding specifically is the
result of an observation that it doesn't get to the end of the
pipeline.
So where is it being spent if we can't see it where we
believe it should end up? Is it just that it is being spent
elsewhere or something? It is befuddling to both Mr. Burton and
myself.
You could just not answer, and we will assume that is no,
it isn't getting there, and we can move on. But go ahead.
Dr. Thompson. We can give you the figures as to how much
CDC spends on programs aimed at preventing or early detection
in all of the different kinds of gynecologic cancer. That is
not going to answer your question, however; it will just tell
you relative amounts of dollars spent.
Our focus at CDC has been primarily on provider and patient
education, but it has been limited. It has been limited
primarily to demonstration projects trying to gain a little
more knowledge about how we can most effectively use those
dollars. We do not yet have a large-scale campaign that is
population-based and nationwide. It has been very focused.
Mr. Issa. So, following up, should this bill become law, it
would enable you to take that next step; certainly not
nationwide, but it would give you the tools to do that, is that
correct?
Dr. Thompson. Certainly from the standpoint at CDC,
legislation that provides resources to expand our programs
would give us the opportunity to expand them. But, at this
point, HHS currently has not established a position formally on
this particular piece of legislation, but its provisions and
the concepts embodied in it are certainly those that I think we
could all support.
Mr. Issa. OK.
I would yield to the gentleman from Indiana.
Mr. Burton. Let me just say that I watch old movies and
stuff on television, and I see advertisements and stuff all the
time, public service announcements saying, you know, prostrate
cancer is a growing thing; gentlemen, get tested for that. And
I just can't understand when I never--and when my wife was
suffering from cancer, I never saw any ads, never saw any
public service announcements, never saw anything.
And I was just talking to this young lady back here, who is
a cancer survivor, and she says she has a master's degree, and
when she tried to go to the Web site to find information about
the cancer she was suffering from, she and her husband, they
had to go through all kinds of hoops to get the information.
And it seems that if our health agencies have money in the
pipeline to educate the public about these various forms of
cancer, it would be manifested in television ads or newspaper
ads.
I just saw this ad in the Roll Call magazine that was paid
for by Angelina Jolie. You know, it just seems people would be
educated to know, especially about the kind of cancer that is
not readily discernible.
I mean, if you guys are spending money on telling people
about this, I sure haven't seen it, and my wife died 3 years
ago. So I would just like to know, if you are spending the
money, where in the world is it going?
Dr. Trimble. We would be happy to get you the information
on the budget that NCI spends on educating the public and
professionals about gynecologic cancer. But, nonetheless, the
size of that budget is substantially less than that of, say,
what major corporations use to promote new products. So in many
cases we can't afford to buy TV time on national network TV.
That said, I think we make a very energetic effort to make
sure that our Web site is as comprehensive as possible; that we
have publications which are available in low literacy form,
both in English and Spanish; that we have a 1-800-4-CANCER
number with cancer information services available around the
country that can help people find appropriate care, to find
clinical trials, to find contact for support organizations.
We know we need to do more, but we have developed a close
working relationship between NCI and CDC, between NCI and CDC
and the professional societies and advocacy groups so that we
can multiply our investments and make sure that the information
gets as widely as possible.
Mr. Burton. Well, let me just say that maybe you need to
hire an ad agency or somebody to come up with some ads that
could be put in public service announcements so people could be
made aware of these things. My wife was misdiagnosed, and I
think it was because even the doctor didn't have the kind of
educational background to tell her what she should do.
I just think if we are spending money in that area, and I
hope we pass Johanna's Law to help augment this, but if we are
spending money in that area, we ought to make sure the public
can see it in one way or another. So you should just take that
back as a recommendation. And I would like to see, if you could
send it to us, a list of the ways that you are spending the
money to inform the public, because I haven't seen it, and I
would like to see it. Thank you.
Mr. Issa. Mr. Chairman, I would ask unanimous consent for 1
additional minute.
Mr. Cannon. Without objection, so ordered.
Mr. Issa. Mr. Chairman, I would yield to you for that
minute.
Mr. Cannon. Thank you. If the gentleman would yield back, I
will just make my final comments. The gentleman yields back.
Thank you.
Mr. Trimble in particular, but others, have any of you been
involved with the rulemaking relating to making federally
funded studies available? That is an issue for another time and
another panel, but of course goes right to the heart of access
for information.
Just a final question. Actually, we want a commitment from
each of you on behalf of your agencies, so you have to be
careful. You are not limited to what you are able to actually
do, but you know your internal circumstances. FED has made some
commitment along these lines that I am sure you are aware of.
I want from each of you a commitment, those of you who can
give it, on behalf of your agencies that you will work together
and with Congress, with my office, to work on the issue of
making more information available, developing databases that
appropriately can have information available to doctors,
researchers, and others, especially in the context of the
lowered cost of database access and the lowered cost of protein
decoding.
If we could start with Mr. Trimble, whatever you could
commit to, I would appreciate.
Dr. Trimble. Well, I know this is a high priority of Dr.
von Eschenbach, our Director, is making information more widely
available, as well as building on the Nation's expertise in
informatics. And as part of that he has established a cancer
bioinformatics project called CIBIG. And I think that there are
a number of components to that, but one of them would include
the emphasis that you, Congressman Cannon, have put on, in
terms of gaining data from the way an individual doctor, an
individual patient, their experiences so other people are aware
of that and can learn from that.
Mr. Cannon. Thank you. I appreciate the clarity of that
commitment. I actually spoke to Dr. von Eschenbach about this.
I believe that he clearly understands the benefit of capturing
data from practitioners. So I appreciate that.
Dr. Thompson.
Dr. Thompson. As I mentioned earlier, the Department of
Health and Human Services is already solidly behind the
development of an electronic patient record which would
facilitate many of the things that you are describing. At the
level of CDC, our commitment to this is, I think, demonstrated
best by the establishment only a few months ago of a new center
called the National Center for Public Health Infomatics, which
will address this and other needs for health information to be
more readily collected and more readily available.
Mr. Cannon. Thank you. And I assume that includes also a
commitment to work with other agencies and to get clinical
information from practitioners available to others.
Dr. Thompson. Yes, sir, it does, particularly the
electronic medical record effort is one that is cross-cutting
throughout the Department of Health and Human Services, and all
of the divisions of the Department are potentially involved in
this.
Mr. Cannon. Thank you.
Dr. Pazdur. As I stated in my testimony, we have an
Interagency Task Force that is a joint effort between the FDA
and the NCI, and I think that this is an excellent project for
that task force really to capitalize on. It is not solely an
FDA problem; it is not solely an NCI problem; it is not solely
a CDC problem; but something for us to work on together. And I
think that task force provides at last a framework to begin the
process that you have outlined.
Mr. Cannon. And is this a fairly substantial commitment on
the part of FDA, from your perspective?
Dr. Pazdur. Yes, it is.
Mr. Cannon. Thank you.
I find myself sitting here frowning through this hearing.
That is because this is a rotten subject to be talking about,
especially if you have had the kind of loss that Mr. Burton and
I have had. And I hope that frown has not been viewed as
negative. What your institutions are doing is incredibly
important. You are remarkably effective. We don't want to
change the world, but we want to help you all adapt and we want
to create the legal context for that adaptation.
Let me just say finally, before we leave, Mr. Rosenfeld,
would you mind raising your hand? This is a molecular biologist
over here, a friend of mine and a brilliant human being. You
may want to meet him as you go out and get his card, or stay
and listen to his testimony, which I think is going to be
remarkably interesting. He was a molecular biologist before I
think that was popular, and has been a leader in some of these
areas, particularly in cervical cancer and the identification
of proteins related to that.
So, with that, unless there are further questions, we
appreciate your time. This panel is dismissed.
If we could have the second panel join us.
We had a question from a witness regarding the
appropriateness of videotaping, that is, a family member
videotaping the testimony. Without objection, the chair is
inclined to allow that. So, without objection, so ordered. The
family may videotape the hearing.
And, if you would like, without objection, Ms. Silver, you
can have her put a chair up here so she can videotape the
table, if you would like. Without objection, so ordered.
All right, now, if we could have you raise your right
hands.
[Witnesses sworn.]
Mr. Cannon. The clerk will note that all members of the
panel have nodded in the affirmative.
We will just go member by member, starting with Dr. Karlan.
We appreciate your being here, and you are recognized for 5
minutes.
STATEMENTS OF DR. BETH KARLAN, PRESIDENT, SOCIETY OF
GYNECOLOGIC ONCOLOGISTS; DR. MARK JAY ROSENFELD, SCIENTIST/
RESEARCHER; SHERYL SILVER, SISTER OF JOHANNA SILVER; AND
KOLLEEN STACEY, OVARIAN CANCER SURVIVOR
STATEMENT OF DR. BETH KARLAN
Dr. Karlan. Thank you, sir. Chairman Cannon and members of
the subcommittee, thank you for inviting me to testify at
today's hearing. I am honored and heartened by the interest of
this subcommittee in this important issue.
My name, as you heard, is Beth Karlan, and I practice
medicine at Cedar Sinai Medical Center in Los Angeles. There, I
am the director of the Women's Cancer Research Institute, the
Division of Gynecologic Oncology, and the Gilda Radner
Hereditary Cancer Detection Program. I am also professor of
Obstetrics and Gynecology at the UCLA Geffen School of
Medicine.
This year I was elected to serve as the 37th president of
the Society of Gynecologic Oncologists [SGO]. Our
organization's purpose is to improve the care of women with
gynecologic cancer by encouraging research and disseminating
knowledge. Our overall effort is focused on raising the
standards of practice in the prevention and treatment of
gynecologic malignancies through cooperation with other
organizations that share our interest in women's health care,
oncology, and related fields. SGO members make us the leading
organization of gynecologic oncologists in the United States.
At the outset, I want to clearly state my belief that
Congress can take action that in the immediate future will save
the lives of thousands of women. Today in the United States,
one women will be diagnosed with a gynecologic cancer every 7
minutes. That is over 200 women just today and close to 80,000
women this year. If detected early, a majority of these cancers
can be cured.
But, frankly, many women don't know what symptoms to worry
about and, therefore, they are unable to ask the right
questions of their health care providers. Complaints such as
bloating, abdominal or low back pain, or constipation may
bother all of us occasionally. But when these symptoms are
persistent and progressive for as little as 2 weeks, they
should alert a woman to see her physician and ask about
gynecologic cancer. With the help of the Federal Government, we
can make this happen. We can make this happen.
I would like to bring to your attention H.R. 1245, the
Gynecologic Cancer and Awareness Act of 2005, commonly referred
to as Johanna's Law. This legislation would serve to increase
the education and awareness about the early warning signs of
gynecologic cancer. That is the purpose of Johanna's Law: so no
woman has to face a diagnosis of gynecologic cancer late in her
disease just because she did not know the associated symptoms,
risks, or where to turn.
As a clinician and surgeon, I can recount hundreds of
stories of women who came into my care too late because they
did not recognize the warning signs their bodies were sending
to alert them to the presence of cancer. These anecdotes,
however, are validated by a recent poll of 800 women across
America that was conducted by Research America in conjunction
with SGO's foundation, the Gynecologic Cancer Foundation. This
poll surveyed women about their knowledge of gynecologic
cancers and is submitted as an attachment to my written
testimony.
Here are just a few of the astonishing statistics: 47
percent of women surveyed could not name one symptom of a
gynecologic cancer, not one; and almost 60 percent of women
surveyed could not name one step they could take to decrease
their personal risk of developing a gynecologic cancer.
Mr. Chairman, these statistics do not lie. We need to make
a difference, and we can make it now. We have achieved much,
but women are still dying. Congress's commitment to expanding
the boundaries of medical research has been a vital weapon in
our war against gynecologic cancer, and for that we are
immensely grateful. However, there is still a tremendous gap
between the science and the realities of clinical care. All of
our scientific advances are useless if women do not know when,
where, or how to access care.
Representatives Issa, Levin, Granger, and DeLauro have
introduced Johanna's Law, which is cosponsored by many members
of this committee. In fact, there are now 221 co-sponsors of
this important legislation. Under Johanna's Law, the Department
of Health and Human Services would conduct public education and
awareness programs to get facts about the early warning signs
of gynecologic cancer into the hands of women of this country.
I cannot over-stress the importance of arming women with
the basic facts about gynecologic cancers. Education is our
front line defense in the battle against these killers of
women. Your support will make this education and awareness
possible.
Once again, thank you for the opportunity to testify here
today. I am constantly inspired and humbled by the strength and
determination shown by women with cancer who are just trying to
survive. I believe your leadership on this issue will give even
more women the full lives they so richly deserve.
Thank you, and I look forward to answering your questions.
[The prepared statement of Dr. Karlan follows:]
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Mr. Cannon. Thank you, Dr. Karlan. Among those women are my
five remaining daughters and wife who appreciate your
testimony, and there are some startling statistics there.
Dr. Rosenfeld, you are recognized for 5 minutes.
STATEMENT OF DR. MARK JAY ROSENFELD
Dr. Rosenfeld. I am grateful to the subcommittee for the
opportunity to discuss my professional experiences and opinions
on progress against gynecologic cancers. I come from a
different perspective than most here. No. 1, I am a researcher;
No. 2, most of my work has occurred not only in the United
States, but the bulk of it in places like China.
Given the time constraints, I have made much of my
presentation a written one, and covers such issues as the
financial incentives that perpetuate inefficient and costly
diagnostic methods; the need for disruptive or analytic or
diagnostic technologies to achieve pervasive high-quality and
inexpensive medical care; and whether cervical cancer vaccines
can actually achieve significant use in our lifetime.
Perhaps not an intended topic at this meeting, but the ways
in which we have pursued cancer for several decades have, over
all, been a failure, in my opinion. There have been some clear
successes. With the possible exception of Pap smears,
gynecologic cancers are not blatantly prominent among these.
Perhaps the greatest improvement, as actually has been
mentioned, has been treating childhood cancers. Overall, our
inability to lower the cancer death rate, despite expensive
efforts spanning more than 35 years since the war on cancer
began, shows the need for major change in strategy.
I am now going to somewhat digress--although it is in my
written presentation--digress from what I had originally
prepared because of comments made by people. For example, Dr.
Thompson talked about the 2.9 million Pap smears that had been
done to achieve the finding 1,500 patients with invasive
cancers. That is great, because that cost $75 million and an
average of $40,000 to $60,000 to find each of those cancers.
Now, I am happy that these people were discovered. I hope
that they were treated; I hope that it was successful. On the
other hand, that is a lot of money. And it is a lot of money
that if we could be more efficient in terms of the way in which
we pursue our medicine and the way in which we pursue our
diagnostics, then we could reach more people.
This gets into questions such as we discussed a few minutes
ago, or actually throughout this entire proceeding, and that is
how do we reach people? We can only reach people if we have the
kind of technologies, if we have the kind of methods that will
allow us to reach them for a good economic price. Most of the
democratic side, in fact all are not here right now, but, on
the other hand, they had talked literally about that, the black
community, and reaching the black community.
I talk in my written work about the financial incentives
that perpetuate inefficient and costly diagnostic methods. Look
at the Pap smear industry. It is a $7 billion industry. I am
not condemning Pap smears. But if something new, something
revolutionary, something disruptive came along--and there are
those things on the horizon as we speak--how do we contend with
that? These people are making a living.
So either consciously or subconsciously, they are going to
buck the trend because they are spending $2 billion per
gynecologic exam in this country that leads to a Pap smear.
There is $1.2 billion being spent on average each year now for
Pap smears alone. When you have a Pap smear that is
questionable, you go to colposcopy. Colposcopy is a microscopic
examination of the cervix; $3.6 billion is being spent there.
Yet, over 80 percent of colposcopies, fortunately for the
patient, show that the patient has nothing wrong. We just spend
over $2 billion for nothing, in a sense.
Things need to be done. There is a need for disruptive
technologies. Bringing down costs is mandatory. We have to
shift in a grander way to earlier detection and treatment. This
is something that I push very aggressively in China.
And I think that if you look at the war on cancer, speaking
more generally, but also to gynecologic cancers, we have to
concentrate more on less advanced states, where treatment
effects may be better. For example, when we go to FDA approval
and we are looking at a new drug, what is happening with a new
drug is that, typically, the patient that is being treated is
the sickest patient.
Now, I am not saying sick patients should or should not be
treated, but the sickest patient with a drug is oftentimes a
patient that won't respond anyway; and maybe a person who is
not as sick could benefit more from that drug. This is
something that really needs to be looked at very, very
seriously.
In any case, I am rather passionate about changing the
system, and hopefully during my question and answer period I
can help you in terms of what else I have to offer. Thank you.
[The prepared statement of Dr. Rosenfeld follows:]
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Mr. Cannon. Thank you for recognizing the light. We
probably wouldn't have tapped you silent, given the kind of
information you were giving, but we will come back, I can
assure you, with questions to give you more opportunity to
explain some of these things.
Ms. Silver, you are recognized for 5 minutes.
STATEMENT OF SHERYL SILVER
Ms. Silver. Thank you so much, Mr. Chairman, for your
leadership, for holding this hearing today, for your passion
for this issue. I am so sorry for your loss, and I express my
deepest condolences.
And to so many of you on this committee who have also been
personally touched by cancer and who have led this fight for
us, we are so grateful to you, Mr. Issa, our lead sponsor in
the 109th Congress; to Mr. Burton, who has been such an
advocate for us; Mrs. DeLauro; Mrs. Granger; and, of course,
Mr. Levin, the original author of Johanna's Law. We are just
indebted to all of you for taking up this fight for us, and for
millions of American women at risk. That is really the issue
here.
And as the person who first proposed Johanna's Law, I
suppose I should give my name: Sheryl Silver. I am the founder
and president of Johanna's Law Alliance for Women's Cancer
Awareness. Most proudly, I am the younger sister of Johanna
Silver Gordon, after whom this legislation is named.
I feel a responsibility on behalf of millions of grieving
family members in this country who have lost hundreds of
thousands of their mothers, sisters, daughters, and other loved
ones, to sound an alarm today. I know everyone in this room is
supportive, and we are grateful for that, but there will be
many who read and hear this testimony.
So I want to go on record today as saying we have a
national tragedy that is not being addressed adequately. Unlike
the tragedy of September 11th and Hurricane Katrina, which
thankfully have only happened once in this Nation's history,
this is a tragedy that is going on year after year in this
country, as we lose, this year, nearly 30,000 women to
gynecologic cancers. Nearly 10 times the number of Americans we
lost on September 11th we are now losing every single year.
In just the last 10 years we have lost over 250,000 of our
mothers, sisters, daughters, and other loved ones. Although we
are grateful for its progress and absolutely for the 221
cosponsors in the House, the time to act is now. In just the
nearly 3 years since I proposed it, over 75,000 more women in
this country have run out of time, run out of medical options
and died, and left behind millions of us grieving for the rest
of our lives.
And what magnifies the tragedy of these deaths, and all of
them from these cancers, is that they are not inevitable. A
diagnosis does not have to be a death sentence, as we have
heard today. Diagnosed at the earliest stage, ovarian, uterine,
and cervical cancer--which account for over 90 percent of all
new diagnoses in this country every year--these three cancers
all have 5 year survival rates greater than 90 percent, with
women diagnosed early commonly going on to live normal, long,
healthy lives.
And yet thousands of women, tens of thousands are diagnosed
after this earliest stage every year in this country. With
ovarian cancer, the problem is particularly common. Eighty
percent of women are diagnosed after the cancer has progressed
to more advanced and less survivable stages.
And a common ingredient in those late-stage diagnoses are
the delays that occur simply because women don't recognize or
know the symptoms of the disease or its risk factors, and so
are not seen quickly enough, appropriately enough. This is
exactly the life-threatening information gap that contributed
to my sister's late diagnosis and death.
Despite being the daughter of a physician, the sister yet
of two other physicians, and a health-conscious woman who saw
her gynecologist annually for pelvic exams and Pap smears, who
ate nutritiously, exercised regularly, did everything she knew
of to live a long, healthy life, despite that, the one thing my
sister did not know is that persistent heartburn, bloating, and
constipation were common symptoms of ovarian cancer. She
assumed they were to do with a minor gastric problem. She took
antacids.
When the symptoms persisted, she made an appointment to see
a gastroenterologist; waited several weeks as a new patient for
that first appointment, never thinking the delay may be life-
threatening. And by the time she saw her gynecologist and
appropriate tests were performed, she was immediately scheduled
for major surgery that led to the shocking diagnosis of stage
3C ovarian cancer, of only four stages, a late stage. She was
only given a prognosis of 12 to 18 months to live; and with
aggressive surgery, multiple surgeries, treatments,
chemotherapy, different kinds of chemotherapy, clinical trials.
We searched for everything. She went to leading cancer
centers, she had great insurance, access to care at UCLA, MD
Anderson. But nothing helped because she was diagnosed so late.
And she spent the last 8 months of her life tethered to an IV
pole for her basic nutrition and hydration, and eventually pain
medication 24 hours a day to dull her agony. This is a horrible
way for a dynamic and loving and health-conscious woman to lose
her life.
But we are not here because my sister was an unlucky,
uninformed woman. I didn't propose Johanna's Law 3 years ago
because of that. I proposed it because this tragedy is
happening day after day, year after year in this country,
unchecked. And whatever we are doing, it is not enough, because
the death toll from this group of cancers is not going down.
Two years ago the death toll from ovarian cancer went up.
It may go up further as this population ages. Our Nation is an
aging population, and women over 50 are at higher risk for both
ovarian and uterine cancer. So we have to do more to improve
early detection and develop better treatments, all of it, or
else we will see this death toll continue to climb.
Last week--I am going to also cut my testimony short. I am
already over that time. Let me just say the following, and I
will submit, if I may, my written testimony in its entirety.
Last week our President said the Federal Government's job
is to save lives because every life is precious. I absolutely
agree. And we have already lost too many of our precious
mothers, daughters, sisters, and other loved ones and dear
friends, simply because they didn't get the information in
time.
This is not the behavior of a compassionate Nation. We know
that acting quickly can spare needless suffering, just as we
know that acting quickly in the wake of Hurricane Katrina--and
this Congress can move quickly when it needs to, as it did last
Friday in granting major funding for relief. We know that
moving quickly in the case of natural disasters will spare
needless suffering and death.
And the coalition of doctors, nurses, cancer survivors, and
family members who have advocated for Johanna's Law these last
2 plus years, we do it because we all believe that we can
improve early detection; we can save lives by educating women.
They will take action given the facts.
So I beg this Congress, we have the best chance we have
ever had because we have over half the members already co-
sponsoring. Please let the legacy of the 109th Congress be that
in addition to responding to the challenges of terrorism,
homeland security, natural disasters, and other challenges
facing this Nation, this was the Congress that finally took the
action so long needed and created the urgently and desperately
needed program of gynecologic cancer education.
By doing that you will not only save lives by improving
early detection, you will finally give a measure of healing to
millions of us in this country who grieve the loss of our loved
ones and who will know, by the existence and the passage of
Johanna's Law, that our loved ones did not suffer and die in
vain, but that their stories and our retelling of their
tragedies have finally been the catalyst to create this long
overdue and urgently needed national program of gynecologic
cancer education.
I thank you for your patience and indulgence. Thank you.
[The prepared statement of Ms. Silver follows:]
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Mr. Cannon. Thank you.
Ms. Stacey.
STATEMENT OF KOLLEEN STACEY
Ms. Stacey. Good morning Chairman Cannon and committee
members. Good morning Mr. Burton, my Congressman. I want to
thank you, Mr. Burton, for everything that you have done for me
as a survivor. I am very honored to be here to speak to you
about something very dear to my heart, Johanna's Law.
Last year I went to an advocacy training meeting and I
heard Sheryl Silver speak about her sister Johanna and her
motives for Johanna's Law. That speech gave me hope that some
day something will be done to make women and health care
professionals more aware of the signs and symptoms of
gynecological cancers.
Sheryl, I want to thank you for taking the initiative to
propose a bill long overdue.
Johanna's story and mine were so much the same that it gave
me cold chills. Unfortunately, thousands of other women have
the same story, caused in great part by a lack of knowledge of
the symptoms of ovarian cancer. The need for education and
awareness is crucial. Johanna's Law will provide that campaign
that will definitely save lives.
For the last 8 years I have suffered through numerous
surgeries, reoccurrences, countless hours of chemotherapy and
radiation. Why? Could this suffering have been prevented, or at
least lessened?
I learned, after diagnosed, that I had all the symptoms. I
wasn't aware that indigestion, heartburn, pressure on the
bladder, unusual bleeding were symptoms of ovarian cancer. Nor
did I know that a Pap smear didn't screen for ovarian cancer. I
visited doctors for each one of those symptoms, but no one put
it all together.
It took an entire year for me to be diagnosed correctly. By
then the cancer was stage 3C, an advanced stage of ovarian
cancer, with only a 38 percent chance of a complete cure. Had
it been discovered in an early stage, I would have had a 90
percent chance of complete cure.
Today, 8 years later, nothing has changed. I still meet
with women who did not learn about the signs and symptoms until
after diagnosed. Together, Congress, we can do this. We can
educate people until scientists come up with an early detection
test.
I may look good to you today, at least I hope so, however,
that hasn't always been the case. Time won't permit me to go
into all the details of my experiences over the last 8 years,
but let me tell you what I have gone through just this year
alone. I had a PET scan last December that showed a tumor in my
lymph node in my neck. Surgery was scheduled for January to
remove the tumor.
It turned out to be much worse than the doctors expected.
On January 7th I woke up with incisions up and down my neck,
stapled. I had two drainage tubes coming out, six radiation
catheters, all hanging out my neck. I could tell people were
frightened to look at me. They were shocked by the way I
looked. My friend said, you have a good Frankenstein look
going, Kolleen.
Then I saw the fear in my family's eyes and I was
immediately scared too. I was then told that my cancer had
spread, and the surgeon had to remove two nerve clusters and my
juggler vein.
Just 4 weeks after surgery and radiation treatments, a
followup PET scan was done. My cancer had spread again. We had
no choice but to be aggressive with treatment. I just finished
chemo 2 weeks ago. I felt like giving up. This isn't fun.
My family is tired of seeing me with pain. I live with a
terrorist every day. I have multiple side effects that will be
with me the rest of my life. My quality of life has
dramatically changed. I have an equilibrium problem that makes
me unable to walk in the dark.
I have numbness in my feet and hands, continuous pain,
constant fatigue, and I was forced to go on disability. Being
on disability affects my pride. This year, the 8th year, I
wanted to give up, but I knew I could not. I have to fight for
my family and for other women that are going through this
horrible experience. Cancer isn't just a physical condition,
but also an emotional roller coaster for me, my family and my
friends. I could not have done it without their love and
support.
In closing, I would like to leave you with a feeling of
hope. As children, we hope to grow up to be big and strong. As
adults, we hope to be healthy and live a long, happy life. If
we are not healthy, we hope that our experience will help the
people around us to make the right decision.
Congress, by passing Johanna's Law, each of you has a
chance to make the right decision and give hope back to me, to
women, and grieving families that have been victims of this
deadly disease. This year, 28,000 women will die from
gynecologic cancers.
Thank you.
[The prepared statement of Ms. Stacey follows:]
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Mr. Cannon. Thank you, Ms. Stacey. It is hard to believe
all that by talking about it or hearing about it. Thank you for
sharing that with us.
My sense is that we are going to make great progress with
Johanna's Law. I am pretty sure the House will pass it.
Unfortunately, we had to pass the bankruptcy bill eight times
before the Senate got around to it. In this case we may have
more. I think there is some kind of prohibition against
speaking ill of the other body, so let me just say we have high
hopes that they will be reasonable on this issue and move
relatively quickly.
I view Johanna's Law as part of a larger context. You were
all here and listened to me talking with the people that
control the purse strings in America for much of what is going
on here and control, to a large degree, the research, so I
would like your comments as we go through this on that
research.
But, Dr. Karlan, if we could start with you. You are a
practitioner. You run a research institute. You are one of
those people that is--I think most doctors really view
themselves as scientists anyway. But you really straddle both
worlds; you treat people and you run a research institute.
Can you comment on what we talked about, what the earlier
panel dealt with to some degree, about the role of
practitioners, what it would mean to health care generally if
we had access to more information from practitioners and their
patients as to treatments, and how best practices could be
spread and how new ideas could be generated? Is that something
you have thought about and would you like to comment on that?
Dr. Karlan. I clearly thought about it in the last 2 hours
during this panel, but I think previously we at times exchange
the anecdotal observations that you described so clearly
earlier with regards to your daughter's response on the MRI to
her Chinese herb. I think sharing those observations are often
seminal on the research side of things. One takes that
observation and then asks how and why, as well as sharing it
with others.
I think that the information system that you described is
one that we do colloquially in our communities, we do it
through the society at our annual meetings where we talk about
our patient experiences or the amazing survival or the things
we have seen, and exchange those stories. I think an
information database as you described could perhaps allow us to
collate those anecdotes, begin to make observations that would
have better power by seeing are they consistent or is it
anecdotal to that person's immune system or other aspects of
her genetic makeup, and then translate that. As a clinician-
scientist, I look at those observations and try to understand
the molecular biology as to why they occurred.
So, yes, that type of information, where every single
patient, and not to at all make patients' experiences and take
it out of the human nature, but allow those data points to be
captured so we can learn more and more from every single
patient's experience, because I do think that is going to be
our future. But individualized care, molecularly directed and
targeted care, and we are going to need those data, that
opportunity to move that forward.
Mr. Cannon. Are you familiar at all with complexity theory
or Abasian statistics? That is a mean question, but I don't
mean it to be.
Dr. Kaplan. Not in any great detail, sir.
Mr. Canon. But from your point of view, having dealt with
many patients and with clinical studies, you get the sense of
how, if you had much data, you could sort that and bring a
great deal of decision-enhancing information to bear on any
given patient.
Dr. Kaplan. Absolutely.
Mr. Cannon. Thank you.
Dr. Kaplan. I think that is what we are all dealing with
now with genomics, proteomics, that we have enormous amounts of
data, but we need to mine that data so that we find those gold
cores, that ore that allows us to see the light, see how the
dots are appropriately connected. So we need all those
patient----
Mr. Cannon. Exactly. That is exactly it. Thank you.
I wish the prior panel were all here. Thank you for staying
with us.
But, yes, thank you, that is exactly the point. And while I
suspect all doctors may not be as smart or as attractive as
you, almost all doctors actually care about their patients and
want to see better processes, better treatment, better devices
available for their health.
And in the case of my daughter, by the way, there were like
100 studies, animal studies on the artemisinin that we used
that showed pretty dramatic success. But no bridge from those
studies to practice. How do you dose a human being? Whether
that drug would have worked or not, I don't know. There was
some obvious evidence that it was working to some degree, but
we are not building at all on that experience for other people
who have this or similar diseases, despite the fact that there
are some really very powerful, profound studies out there with
animals, and yet no opportunity to translate that to others.
Thank you very much, Dr. Karlan.
Dr. Rosenfeld, we have talked somewhat about some of these
issues. Do you have other things you wanted to talk about in
response to the other panel, or would you rather that I ask you
questions?
Dr. Rosenfeld. I am used to questions from you. Ask me a
question.
Mr. Cannon. You talked about disruptive technologies in
your presentation. And clearly, with the earlier panel, we
talked about the effect of the disruptive technologies that
have resulted in a much lowered cost of identifying proteins.
Can you talk a little bit about what has happened in that
field, where we are headed, and what that means for patients in
America? Ms. Silver talked about 250,000 mothers and sisters in
America. We are talking 20 or 30 times that many people
worldwide. So if you would talk a little bit about what
progress in America means to the rest of the world, I would
appreciate that also.
Dr. Rosenfeld. Sure. Disruptive technology actually has its
own definition, it is an innovation that, due to its
revolutionary nature, can actually replace an existing or
dominant technology. We already know of those things in other
contexts. For example, everybody knows what a CD is. My kid
doesn't know what a vinyl record is. So a point made there.
A disruptive technology oftentimes, also, if you read, for
example, Clayton Christianson, who has written extensively
about that, from the Harvard School of Business----
Mr. Cannon. And a good Utah boy, I might add.
Dr. Rosenfeld. You better believe it. You can tell I am
from Utah too.
A disruptive technology oftentimes also does several
things. No. 1, it very frequently brings down costs. An example
that comes to mind, of course, is the computer industry. You
get a lot more bang for the buck today from a computer than the
little 8088 that I bought in 1981.
In any case, disruptive technologies are also interesting
in the sense that they have odd origins. Oftentimes they don't
come from academia. For example, the CD, although it was from
an MIT professor, it actually came through a private enterprise
route. And the reason is that academic institutions are
oftentimes interested or follow down a path which are called
evolutionary technologies; that is, you build A to B to C of
the same technology. Where a disruptive technology is a
revolution.
Now, with that in mind, what is on the horizon, what is
actually working now? And please realize that I am very, very
interested in health care delivery to rural populations, to
developing nation populations. So, from my perspective, I want
to see people everywhere get the kind of health care that is
only affordable now at some of the big medical centers or the
big reference laboratories.
But with regards to, for example, DNA and DNA analyses,
right now the current methods used to look at, for example, PCR
DNA to look at human papillomavirus in a laboratory, to set up
that laboratory would cost you $100,000 for the device alone.
Set up the lab and so on, you are in for another $100,000. You
have to run it with specially trained personnel, etc., etc.,
etc.
There is now disruptive technology that will allow that
same DNA analysis to be done on a device that would retail
probably for a couple hundred dollars, for chemistries that
will allow you to do this for a couple pennies per patient. And
that is the kind of disruptive technologies I am talking about.
These technologies will allow you to do things anywhere.
Mr. Cannon. So the common lab today, a current lab with PCR
technology, it costs something like a penny a pair to decode?
Dr. Rosenfeld. Well, it is not a penny a pair, but by the
time--I can actually, if you want me to produce this, I can
actually give you a spreadsheet; I have this broken down. But
to do a patient in a laboratory with all costs right now would
probably cost in the neighborhood of tens of dollars to do an
analysis: do you have HPV; do you have ovarian cancer. Those
kinds of things would cost a lot of money. And what I am
talking about is now the technology is in place for doing this
for pennies; and away from offices and away from laboratories.
Mr. Cannon. And when you say pennies, you are talking about
the whole analysis, not each pair.
Dr. Rosenfeld. Yes, I am talking the whole analysis.
Mr. Cannon. So if you are decoding several pairs, you are
talking about a fraction, a very small fraction of a penny per
pair.
Dr. Rosenfeld. In fact, there is a meeting tomorrow at
Johns Hopkins University in that regard I will be participating
in.
Mr. Cannon. So what does that mean for the FDA or for the
CDC or for NIH or for the National Cancer Institute in terms of
this massively plummeting cost of decoding proteins in
comparison with what should be available to Americans and the
rest of the world in terms of treatment? What should happen?
How should that transformation drive treatment technology?
Dr. Rosenfeld. Well, I mean, it is obvious. If it is
disruptive technology that has brought down cost, we should be
able to deliver whatever that is to the patient for cheaper.
So, for example, if it is to diagnose cervical disease, I
should be able to diagnose cervical disease for a couple of
dollars instead of tens of dollars.
And, by the same token, if we are talking, though, the FDA,
CDC, I don't hold them blameless, but the FDA, with regard to
that bureaucracy, they are going to have to start looking at
things differently. Things have to be done differently, because
I don't think we can afford not only to neglect new technology,
but we can't afford to approve technologies the way in which
our infrastructure is set up as we speak.
Mr. Cannon. We have three people who have had a daughter or
a wife or a sister die of cancer here in the group and a cancer
survivor with us, and we are talking about clinical testing and
protocols that get set at a high level, when what you are
telling me is we have now in place technology that enables a
physician at the lowest level to be doing things that could
only be done at the most expensive labs on Earth less than a
decade ago.
Doesn't that seem to you--in fact, you, in your earlier
testimony said something--I made a little note somewhere. You
are fairly critical, I think, of the FDA and its reaction, and
I suspect that the key here is the historic context of the FDA
versus the transformed future of medicine.
Dr. Rosenfeld. It is time for the FDA to change. The world
has changed. It is time for them to change. They are operating
on a system that is predicated, in my opinion, on the way in
which things used to be done prior to the advent of molecular
biology. The FDA still has not even adjusted to molecular
biology as a term. There is one molecular biology test in the
entire planet that is FDA approved, one, with regards to
gynecologic cancers.
Mr. Cannon. Wow.
Dr. Rosenfeld. And not only that, the technology for that
one HPV--it is an HPV test--is 20-year-old molecular biology
technology. There is lots of new stuff, there is lots of good
stuff. There is molecular testing that could be done for
ovarian as we speak, and it is not in the pipeline.
Mr. Cannon. I want to explore this for a bit. But first I
would like to get some bona fides on the table. Would you mind
giving us your academic background, what you are doing in
China, the committees you are serving on? I know that is a long
list, but you don't have to do it all, just some of the high
points.
Dr. Rosenfeld. OK, if I talk about China, remember I am a
loyal American.
I have graduate degrees from both the University of Utah
and the University of British Columbia. I am a molecular
biologist, also a geneticist. I am former faculty at the
University of Utah School of Medicine. Our department used to
be called the Cellular, Viral, and Molecular Biology
Department.
I went into private enterprise actually because I feel very
strongly about the direction that I feel medicine needs to
take, and have been involved with innovative technologies as a
consequence. I have been involved predominantly with
gynecologic cancers and, in particular, cervical cancer, and I
hold one distinction, and that is that I actually sit on the
China State Council on Medical Reform. I am the only American.
And I am very proud of that because China has made great
strides with regards to reforming their medical system. They
want a system that really works for people, and that is
something that I think is, from my perspective, I am apolitical
on that; if they want to do it, I am willing to help. And just
because it is fun, I also breed giant pandas when I am in
China. I am in charge of giant panda reproduction at Peking
University.
That is my background on reproduction endocrinology.
Mr. Cannon. Do you also work with the Mandalay? Do you also
work with the pandas----
Dr. Rosenfeld. Oh, the Mandalay Bay fiasco? Yes.
Mr. Cannon. I didn't know it was a fiasco. That is because
of the trust that the Chinese have in your judgment.
Dr. Rosenfeld. Yes. I am also the English version--if you
go on the net, the English version of the China 5 year cancer
policy, I am actually the author.
Mr. Cannon. So you spend a lot of time in China. Why?
Dr. Rosenfeld. What?
Mr. Cannon. You spend a lot of time in China working on
cervical cancer. Is there a reason for that?
Dr. Rosenfeld. Cervical cancer in particular, because China
is probably the epicenter for cervical cancer. Last year, for
example, over 90,000 died of cervical cancer. And I have been
on wards where I have seen, on a given afternoon, as many as 70
women with terminal invasive cervical disease. So China is a
place that is necessary if one is to get a handle on
gynecologic cancers, in particular cervical.
The other reason is that I really do have a true commitment
to taking technology and introducing it into rural and
developing regions, and working with the Chinese has been good
from that perspective. So, for example, I am down in Guangxi
Province, which is a remote area of China, and looking at
whether or not we can indeed deliver such things as molecular
biology services in the middle of nowhere.
However, the spillover, I think, is great, and that is
this, that the commitment is that this be provided also here.
So, for example, when we heard discussions earlier today about
the need for Black populations to be able to achieve pervasive
early detection screening, I believe that can only be achieved
if we change the diagnostic paradigm, and that is the kind of
technologies that I work with.
Mr. Cannon. I know the Chinese Cancer Institute is among
the highest quality in the world, with highly trained people,
and they are not compromising that at all. But China has a
problem: they don't have the wealth that America has, so they
can't do things the way America does them and still reach
people in China, which is really Johanna's Law. How do we do
things in America? Well, we are going to spend a lot of money
on it.
Dr. Rosenfeld. That is a plus.
Mr. Cannon. But the Chinese are different. Would you talk
about that, why that is a plus?
Dr. Rosenfeld. It is a plus because we are spoiled and they
are not. And the plus is this: again, I said it earlier, and
that was 2.9 million people, we spend $75 million, $60,000 per
cancer. We are willing to spend that kind of money. We throw
money left and right in health care. That has been a problem
here. We throw money out for research, but where is the
accountability in the end?
There is a wonderful article that I actually photocopied
and put in, called ``Why We Are Losing the War on Cancer and
How to Win It.'' Read that. That is what is wrong with cancer
in the United States, and that is why the Chinese don't have
that problem. You know, they are very practical-minded. How did
they deliver the most to a country that is three or four times
the size of our country, and for little money?
Mr. Cannon. It seems to me there are probably three
disruptive technologies or things that have happened in
America.
And, Dr. Karlan, I would appreciate your comments on this
as well.
In the first place, you are talking about DNA decoding,
that technology and how that has plummeted in price. That is
dramatic. I don't know how you can state how dramatic it is,
because everything that derives from it is unanticipated. You
never thought in terms of looking for a genetic marker for a
disease when the cost was tens of thousands of dollars. But
now, if you are talking about pennies, it means a different
kind of thing; it is a whole new mind-set.
In the second place we have what I call the Napster
phenomenon, that is, I am a big fan of Napster, I wanted them
to have a model where people paid. We don't want them to rob
music. They wanted a model where they paid. But that kind of
peer-to-peer technology is disruptive, I think it is fair to
say. And when you add that to the other kinds of database
technologies we have, the informatics approach, where you
organize information, as opposed to the peer-to-peer work,
where information organizes itself, it seems to me you have
another two kinds of transformations.
And then the third kind of thing that is happening is that
as people are aware of these transformations, wholly new ways
of viewing medical problems are arising. And those are
principally coming, I think, from medical practitioners, but
they are also coming from a lot of other folks, because as
nutritionists, as dieticians, as people that like nutritional
supplements, as drug companies look at off-label uses, you are
getting this incredible increase.
So you take a drug that you know the toxicity of, that may
be very effective for one thing, and you say what are the
molecules. And, of course, we can tell what those molecules are
better now because of these other technologies. Then you can
look at what the chain of reactions is within a body and do
some significant predicting. In other words, as a derivative of
these other things, you have this massive number of people who
are empowered then to do creative things.
Is it important to the two of you in particular that we
create a data context for that to happen? And if you are aware
enough of the difference between a database like the
informatics database that has been testified about earlier and
a peer-to-peer database, I would like your comments on that.
And what else can we do to help this tide or this dam that has
broken and now is flooding down, what else can we do to help
that be channeled and effective for improving treatments for
people?
Let us start with Dr. Karlan, if you would, and then Dr.
Rosenfeld.
Dr. Karlan. Thank you, Mr. Chairman. I think you have
eloquently outlined the breakthroughs, the shifts in paradigm
that have resulted from the human genome project, and then the
advances in informatics that allow us to look at gigabytes of
data and suddenly see the tree and get through it and see the
next steps forward.
Johanna's Law, though, processes and tries to take the
disconnect between our breakthroughs in the laboratory and what
we see on the corner. Shoppers, come in and get your Pap smears
now. How do we bring these advances to all of our kitchen
tables before we get cancer? When you get cancer, then you
start logging on, you do extensive searches.
Mr. Cannon. Almost everybody in America uses Google. And to
the degree you can make information available--and there are
many forms of that--then you have the ability for people to
educate themselves, so you don't have to suffer with four or
five different symptoms, you go to four or five different
doctors, and way too late you find out that you have one
problem that is causing them all.
Dr. Karlan. But I think Mr. Burton hit on it earlier. When
you start to have the symptoms, when you start to have the
problems, when you begin to ask those questions, then you go to
Google.
Mr. Cannon. Right. Exactly.
Dr. Karlan. But how do you process that information? How do
women----
Mr. Cannon. Let me make a suggestion. I understand what you
are saying, and I want Johanna's Law to pass. But I want some
other transformations in the medical system, which I would like
your opinion on, because I believe, to your point now, to the
degree that people understand that there are transformations in
medicine, then they will look. Mr. Burton laid it out very
well: The problem is how do you look in the right place and
know what you are actually looking for? But the transformations
that derive, that is, as you see from a database, from other
sources, new treatments and new opportunities, then people say,
``What are my symptoms?'' And they will go back.
So I think it is actually an iterative process. In other
words, I am not just ignoring Johanna's Law here. I am saying,
how do we make it all come together in a system?
Go ahead.
Dr. Karlan. No. Again, as we get these new technologies, a
better basic understanding, if you would allow me, why some
people live and others do not survive their cancer, and we
communicate better that cancer is not a death sentence, we will
then also open up that door.
And I will digress, if you allow me, one moment. We did an
outreach project in Los Angeles, in the inner city church
system, where the pastor was very much in support of Pap
smears, and we did see and treat; get your Pap before mass, go
to mass, come out, have your treatment. And we published those
data about the findings of Pap smears. It was predominantly a
Latina population.
Afterwards, the pastor was very interested in the women who
did not participate; came to church every single Sunday, but
did not partake in this problem. We did these focus groups in
Spanish with social workers, not with the physicians
themselves. And there was this pervasive fear of a passive
coping mechanism of why do I want to find out if I have cancer?
Cancer is a death sentence.
So to your point again, informatics, genomics, targeted
therapies, when we can better use Johanna's Law to communicate
cancer is a curable disease--the article that you referred to.
When we look at heart disease as the paradigm, where have we
been able to see the death rate from heart disease plummet? It
is because we have educated people so effectively about
lowering your cholesterol, taking your aspirin, exercising,
watching your weight, watching your diet.
We need to do something similar for cancer; understand what
we need to do to prevent it. And the way we are going to get
that information, the way we are going to be able to roll out
the molecular tests that are being developed is by integrating
all these data effectively and seeing how to move forward.
Mr. Cannon. And you struck me with what you said earlier.
You talked about gigabytes of data. In other words, you are
talking about big, big, big numbers or data points that you are
crunching to identify this, which means you really have to have
another paradigm shift, which is a paradigm toward complexity
and toward the kind of computing that is now so cheap, that
will allow you to sort the massive number of data points and
come up with indicators of where we should go.
Dr. Karlan. Yes. And thank goodness our computational
colleague scientists, who understand Abasian theory much better
than I myself, can put together these four-dimensional type of
networks that allow us to look at those massive volumes of
data.
Mr. Cannon. We are actually looking now, as we speak, at
trying to get funded a complexity center in Utah, which is not
just my home State, but a place where a lot of this activity is
going on. So I am going to take that comment as in support of a
massive computer that would be shared by University of Utah's
Medical Center and various other places around the country.
We have talked a lot, but, Dr. Rosenfeld, do you want to
followup and comment on those things?
Dr. Rosenfeld. Yes. I actually have a couple comments. No.
1, technologies are in place now, for example, for a lot of
gynecologic cancers, that you could, on your way into the mall,
literally have your finger pricked and an analysis instantly
done. And from that analysis you could find out such things as
ovarian status; you could find out such things as your Pap
status, that is, whether or not you have not only HPV, but
whether or not that has progressed to cervical dysplasia.
Now, that goes to what Dr. Karlan was saying, and that is
why some of these people who went to church did not
participate. I contend a lot of them do not want to participate
because a gynecologic examination, whether you like it or not,
means you have to get up in stirrups, and it is very
uncomfortable or discomforting for patients. And there is some
good information on that.
So if we are able to diagnose new ways, and not only new
ways in terms of the technique, but new ways in the sense that
you don't have to at least initially go for a gynecologic exam,
then I think that we are going to be able to obtain much
broader reach of people and get disease at its earliest stages.
I will say one last thing, and that is that we can get--and
we have done this already--we can get as little as one molecule
and find that one molecule, which means that we can find
disease in perhaps its earliest state. And if we find it in its
earliest state, it is the easiest to treat.
Mr. Cannon. Thank you.
Mr. Burton, would you like----
Mr. Burton. Yes, Mr. Chairman.
Mr. Cannon. The gentleman from Indiana is recognized for 5
minutes.
Mr. Burton. I am sorry, I have to leave in just a few
minutes. So I appreciate you yielding to me, Mr. Chairman.
First of all, I was reading part of this article that you
referred to, ``Why We Are Losing The War on Cancer and How To
Win It.'' And I promise you I will read it all. But I wasn't
aware that in 2004 cancer will claim or did claim some 563,700
people. That is an amazing figure to me.
I am glad Dr. Trimble is still here. Are you awake, doctor?
Your eyes are closed. I just want to make sure you are still
with us.
The President signed a proclamation on August 29th making
this month National Ovarian Cancer Awareness Month, and he said
because the early signs of ovarian cancer are easy to miss and
often resemble the signs of other conditions, it is important
for women to talk with their doctors about detection and be
aware of the risk factors and symptoms of this cancer. That is
true of so many cancers, not just ovarian cancer.
And I would like to go back to what I said to you, doctor,
a while ago, and I am really glad you are still here. You know,
it is one thing to come up with technical advances that will
help in the war against cancers of various types. It is another
thing for people to know about them. There has to be some
balance between the technology advances and the research that
is taking place, and the people knowing what in the world to
do.
It really bothers me from a personal standpoint--and, you
know, as I said, three members of the panel have had people die
from cancer, and we have people out here who have suffered from
cancer or had loved ones die from cancer, and they simply
didn't know the signs.
There should be a significant part of the budget--we give
our health institutions billions and billions of dollars every
single year for research. That research amounts to nothing if
the people who are affected by cancer don't know that it works
and don't know how to utilize it. And you say you don't have
money in there for public service announcements and that sort
of thing. That is nonsense.
I mean, if you could find that 90 percent of the people are
going to survive more than 5 years if they know how to deal
with their cancer and you don't tell them about it, that is
almost criminal. In fact, I think it is criminal. Why are we
spending these billions and billions and billions of dollars,
and people like my wife or these other people we are talking
about, aren't even aware of what they can do to protect
themselves, or their doctor? Her doctor misdiagnosed her, for
God's sake.
I should have sued her for malpractice, but when you are in
politics, you can't do that because it is all over the papers
you are trying to take advantage of somebody. So we didn't do
that. But my wife died. And everybody I have talked to said had
she been aware of her early signs, she would be alive probably
today, 3 years later.
I just have to tell you--and I hope you will take this
message back, because I was looking at your background here.
You are the Head of the Surgery Section, Division of Cancer
Treatment and Diagnosis at the National Cancer Institute. For
God's sake, go back and tell them to spend some money on
advertising and telling people what the hell is going on.
[Applause.]
Mr. Burton. That is what Johanna's Law is all about, and
that is why I am glad we are having this hearing today. And I
wish there were a lot more Members of Congress here. But to do
all this research and spend all these billions and billions of
dollars--I don't want to beat a dead horse--and to not have
public service announcements so people know that bloating and
constipation, bleeding, and different kinds of things are signs
of some form of cancer so they can go get checked out, it just
boggles my mind.
You know, there just has to be some balance there. So we
have talked about, just a minute ago, maybe introducing a
resolution, a congressional resolution saying that the National
Institutes of Health and National Cancer Institute should spend
a certain percentage of their budget on advertising so people
are aware of the various kinds of cancer they may be subject
to.
[Applause.]
Mr. Burton. And I think we will probably introduce that
legislation, but it is unnecessary, because all you guys have
to do over there is say, hey, look, we have to make sure the
public is informed.
And I want to tell you, in my district right now we did
some public service announcements this week about the
hurricane, and every television station was very anxious to put
on public service announcements informing people what was
available to them to help them survive. And with 563,000 people
dying in 1 year from cancer, you would think we would spend
part of our budget telling them what it is all about,
especially since we are doing all this research.
Anyhow, that is all I have to say, Mr. Chairman, except I
do want to say one thing that is a little bit humorous. Your
curriculum vitae, Doctor, is very impressive, but it is nothing
compared to the woman sitting right next to you. She has got 33
pages, and that is only since 1999. I am so impressed with you.
Are you married?
Dr. Karlan. Twenty-five years.
Mr. Burton. I am just teasing. You tell your husband he is
very lucky to have such an intelligent woman at his side. I
understand he is a psychologist, too.
But let me just say, Mr. Chairman, I really appreciate your
giving me the time to do this. And I hope that the people at
our health agencies and the National Cancer Institute will take
this to heart. Spend some money on telling people. And if you
do public service announcements, just get them produced. Get an
ad agency to produce them. I promise you, you get them to me in
Indiana, they will be shown. I will get them shown. You just
get them produced. Thank you.
Mr. Cannon. The gentleman yields back. Thank you for your
comments.
Mr. Issa, did you have questions?
Mr. Issa. Yes, Mr. Chairman.
Mr. Cannon. The gentleman is recognized for 5 minutes.
Mr. Issa. Thank you, Mr. Chairman.
Dr. Rosenfeld, you talked about the pin prick blood test.
How much is that per each examination?
Dr. Rosenfeld. Right now, the pin prick, just so you
understand what it is, Congressman Cannon had referred earlier
to an immune or protein test for cervical disease, and we have
one actually working now. Our actual cost of doing it at the
moment--realize that we haven't gone through the FDA hurdle.
And, by the way, it is $802 million, on average, for a drug or
tests, not three-quarters of a billion. So it is even higher.
Mr. Issa. I have been in Congress for 5 years, so that is
about how far out of date I am on all my facts.
Dr. Rosenfeld. Oh. But, anyway, it is costing us 14 cents.
Mr. Issa. What is it going to cost the patient if it
becomes FDA approved?
Dr. Rosenfeld. Well, in our discussions we are hoping a
couple bucks, literally. Again, realize that everything I do
centers around low resource settings, so that my eye is on the
economy.
Mr. Issa. I appreciate that. That sounds very promising,
and we look forward to--it is too bad we lost our FDA guy. We
really could have put him on the spot on that one.
Dr. Karlan, California is sort of the starting home of
HMOs, and health maintenance organizations were designed to do
things early, provide care early in order to spend less money,
and the theory was that you actually got less expensive health
care by doing certain things early.
How do you accomplish that in the--let me back up a little.
In order to accomplish that, which is a truism, I think, that
we all understand from the last couple of hours here, in
gynecological cancer, how can we take the dollars that we are
authorizing in this bill and leverage those in public-private
partnerships to get that effect?
Dr. Karlan. As you said, we have a lot of experience with
the prepaid health care system in California, and I go back to
Mr. Burton's impassioned words a few moments ago: we need to
get the message out there. There was a recent study published a
few months ago in the Journal of the National Cancer Institute
looking within the Kaiser system.
They looked at specifically cervix cancer, and they looked
at women in the Kaiser system who had access to paid health
care, and if they had Pap smears in the 4 to 12 months prior to
the diagnosis of cervix cancer. About two-thirds of them had
been in the system. Eighty percent of them had actually come in
for an outpatient visit three times or more and did not get a
Pap smear.
So I guess my comment about public service announcements,
getting the information out there, new technologies is what
they call inreach. Instead of outreach, inreach assessment.
When you come in for your vision care--because you look at
where gynecologic cancers hit in women, let us say, in the
perimenopause, menopause, and older, and you say what types of
needs are those women accessing the health care for, and remind
them to get a Pap smear. At Kaiser it is almost a four vital
sign. When you go in to get your prescription checked, they
will ask you, ``Here is information about gynecologic care,
have you had your Pap smear?''
There has to be this access, this education of both the
women as well as health care providers. I think we have heard
over and over again ob-gyns are more likely to think about
gynecologic cancers, but so many women, especially after they
finish childbearing, their primary care physicians are not
their obstetrician-gynecologist, and they may go misdiagnosed
for months to years.
There was recently a study published out of California
looking at the Medicare records, and those women who were
diagnosed with ovarian cancer--and they looked at their doctor
visits in the 4 to 12 months prior to the diagnosis of ovarian
cancer, and 40 percent of them went to the doctor. Forty
percent of women with ovarian cancer went to the doctor 4 to 12
months before their diagnosis with a complaint of one of the
main symptoms, bloating, abdominal, low back pain, or
constipation, and never had it worked up. So that is an
enormous impact we can make right there.
Lower cost. If you make an early diagnosis, costs a lot
less to cure someone with stage 1 disease. And then not only
the financial cost, the human cost: they live a full life, they
are cured of their disease.
Kolleen was very brave today both to come here and to take
the time to share with us her story. If she was diagnosed at
stage one, it would have been 8 years ago, she would have been
cured.
So I think that is an enormous way to lower cost: find them
early; we don't have to pay for the lengthy treatments. And for
that we do need continued research, continued focus on newer
technologies.
Mr. Issa. Mr. Chairman, I will put most of the rest of my
questions in for the witnesses to answer, but could I ask just
one more on the record?
Mr. Cannon. Certainly.
Mr. Issa. Thank you, Mr. Chairman.
Dr. Karlan, you and I, as Californians, but you as a health
care professional, have been in California during this entire
period after we mandated a woman's right to get to an Ob-Gyn
directly. Can you give me--because even though it is not in
this law, but it is an area of concern--how much has it
accomplished? It was very controversial at the time.
General practitioners, among others, said, ``Hey, we can
handle this, we can handle the referral; we can prescreen.''
And, of course, the HMO--which used to be a nice word and now
is pejorative normally--fought it, but it became law. How has
that impacted in California, for the benefit of those who may
be in States that don't have this?
Dr. Karlan. The legislation that Mr. Issa is referring to,
of course, is that every woman in the State of California has
the right to see her obstetrician-gynecologist as her primary
health care provider. And I will have to go back and look at
actual numbers, because I don't know how it has enhanced the
use of mammography screening, Pap smear screening, and early
detection, because those would be the benchmarks that I would
look at. We know that obstetrician-gynecologists are more
cognizant of those screening practices.
I think when we look at the roll-out of Johanna's Law and
making sure that we get the right information into women's
hands before they have symptoms, I think that opportunity in
California, that when you come in for your prenatal care there
is information already out there, that while you are sitting
there waiting in doctors' offices it is inevitable, that these
are things, and whether it is a PSA loop, I mean, there are
many ways people learn, whether it is visually, auditory, or
the written word that we can use that opportunity by working
with the American College of Ob-Gyn, the Society of Gynecologic
Oncologists and its foundation, the Gynecologic Cancer
Foundation can help put together the messaging that would be
the ability to be accessed.
But I don't have actual benchmark numbers, to answer the
question, at this time, but I will look into getting that for
you.
Mr. Cannon. Thank you. The gentleman yields back.
Let me just wrap up, and after I go through a list of
things, if any of the panel members want to comment, I would
appreciate that.
It seems to me that we have come to the conclusion that
there are some disruptive technologies. I have described them
as protein decoding, cost declining dramatically, and as
databases with the capability of making information available
in either the structured form like the informatics kind of
database or the peer-to-peer kinds of databases. And then,
finally, those two things lead us to a point where scientists
and MDs and other people can be freed to be innovators because
they have more information available to innovate.
We have other things going on in the world today that I
think are important as it relates. For instance, we have the
availability of information. NIH just withdrew a rule that
would require federally funded research to be available
publicly. I suspect what we need to do there is--and the reason
they did that is because the publishers of those journals had
to pay the cost of preparation.
So what we probably need to do is increase the Federal
funding for research to include the cost of publication so
those publications can be made available. And then hopefully a
Napster type micropayment system could be set up so that they
can make money on selling their information and people in
America and worldwide have the ability to access that
information.
In addition, we need a kind of patient information
environment where a patient can make--and this is what the CDC
is working on, and Secretary Leavitt at HHS--his information
available, subject to certain rules, to certain types of
people, M.D.s and scientists, so that it is a controlled
environment. That is just a technological breakthrough that we
need and we need to put in place. In fact, I mentioned there is
a company in Utah that is doing that called NexLight.
I think, in addition to that, Dr. Karlan, you were talking
about the gigabytes. You need the kind of computers to drive
the issue so that you can come up to, even in the cases of an
individual who may have a problem, to go through gigabytes of
data to come up with the data points that may help him is well
within our reach. The cost of supercomputing has plummeted, but
we need to probably focus on a center for complexity studies
that would provide that kind of availability.
Finally, we need public awareness so that people can
identify their problems and then, in my view, in addition to
that, drill down themselves to find out the kind of information
that would be available in this world where we make information
available so that an individual can find more and more about
his or her particular problems.
And in that world of changes that have happened around us
or that need to happen, it seems to me that the FDA needs to
come up with new processes to accommodate how we do that. That
means physicians need to have the ability to treat patients
with best practices that they learn online; they need to be
able to innovate and come up with, based upon their own
analysis and based upon a context rich in information and rich
in analysis, they need to be able to come up with their own
innovations; and they have to be able to do that relatively
quickly so that their individual patients can be treated as
opposed to creating protocols and tests that were fine in an
earlier time.
Because when you have an $800,000 to $1 million cost for a
new drug, that means you have massive interests who all have a
huge reason to keep the threshold high and to keep alternatives
that may be cheaper, that may be more readily available, that
may be innovated by a doctor with access to information. You
want to keep those people out, you want to keep the thresholds
up. And what that means is worse health for Americans, worse
health for people all over the world, a stifling of creativity
instead of an improved safety. And safety was the purpose of
the FDA at a time when we were doing a lot of guessing.
And I think, Dr. Karlan, you were talking about following
the chain of reactions that a protein causes. We know a lot
about those chains, and in a complex environment where we have
lots of information, we can have much better guessing. So the
nature of what FDA does has to change. The nature of what the
National Cancer Institute does has to change. The nature of
what NIH does and the CDC does all have to change to
accommodate these disruptive technologies.
I want to thank you all for being here. The suffering
caused by cancer is phenomenal and personal, and I appreciate
the roles that you all have played in this hearing today and in
the cause of transforming our system so that we get the kind of
treatments we deserve in America. Thank you all for being here.
The committee is now adjourned.
[Whereupon, at 2:10 p.m., the subcommittee was adjourned.]
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