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+
+ - WOMEN'S HEALTH: RAISING AWARENESS OF CERVICAL CANCER
+
+[House Hearing, 106 Congress]
+[From the U.S. Government Publishing Office]
+
+
+
+
+ WOMEN'S HEALTH: RAISING AWARENESS OF CERVICAL CANCER
+
+=======================================================================
+
+ HEARING
+
+ before the
+
+ SUBCOMMITTEE ON
+ HEALTH AND ENVIRONMENT
+
+ of the
+
+ COMMITTEE ON COMMERCE
+ HOUSE OF REPRESENTATIVES
+
+ ONE HUNDRED SIXTH CONGRESS
+
+ FIRST SESSION
+
+ __________
+
+ MARCH 16, 1999
+
+ __________
+
+ Serial No. 106-4
+
+ __________
+
+ Printed for the use of the Committee on Commerce
+
+
+
+
+
+ U.S. GOVERNMENT PRINTING OFFICE
+ 55-639CC WASHINGTON : 1999
+------------------------------------------------------------------------------
+ For sale by the U.S. Government Printing Office
+ Superintendent of Documents, Congressional Sales Office, Washington, DC 20402
+
+
+
+ ------------------------------
+
+ COMMITTEE ON COMMERCE
+
+ TOM BLILEY, Virginia, Chairman
+
+W.J. ``BILLY'' TAUZIN, Louisiana JOHN D. DINGELL, Michigan
+MICHAEL G. OXLEY, Ohio HENRY A. WAXMAN, California
+MICHAEL BILIRAKIS, Florida EDWARD J. MARKEY, Massachusetts
+JOE BARTON, Texas RALPH M. HALL, Texas
+FRED UPTON, Michigan RICK BOUCHER, Virginia
+CLIFF STEARNS, Florida EDOLPHUS TOWNS, New York
+PAUL E. GILLMOR, Ohio FRANK PALLONE, Jr., New Jersey
+ Vice Chairman SHERROD BROWN, Ohio
+JAMES C. GREENWOOD, Pennsylvania BART GORDON, Tennessee
+CHRISTOPHER COX, California PETER DEUTSCH, Florida
+NATHAN DEAL, Georgia BOBBY L. RUSH, Illinois
+STEVE LARGENT, Oklahoma ANNA G. ESHOO, California
+RICHARD BURR, North Carolina RON KLINK, Pennsylvania
+BRIAN P. BILBRAY, California BART STUPAK, Michigan
+ED WHITFIELD, Kentucky ELIOT L. ENGEL, New York
+GREG GANSKE, Iowa THOMAS C. SAWYER, Ohio
+CHARLIE NORWOOD, Georgia ALBERT R. WYNN, Maryland
+TOM A. COBURN, Oklahoma GENE GREEN, Texas
+RICK LAZIO, New York KAREN McCARTHY, Missouri
+BARBARA CUBIN, Wyoming TED STRICKLAND, Ohio
+JAMES E. ROGAN, California DIANA DeGETTE, Colorado
+JOHN SHIMKUS, Illinois THOMAS M. BARRETT, Wisconsin
+HEATHER WILSON, New Mexico BILL LUTHER, Minnesota
+JOHN B. SHADEGG, Arizona LOIS CAPPS, California
+CHARLES W. ``CHIP'' PICKERING,
+Mississippi
+VITO FOSSELLA, New York
+ROY BLUNT, Missouri
+ED BRYANT, Tennessee
+ROBERT L. EHRLICH, Jr., Maryland
+
+ James E. Derderian, Chief of Staff
+ James D. Barnette, General Counsel
+ Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
+
+ ______
+
+ Subcommittee on Health and Environment
+
+ MICHAEL BILIRAKIS, Florida, Chairman
+
+FRED UPTON, Michigan SHERROD BROWN, Ohio
+CLIFF STEARNS, Florida HENRY A. WAXMAN, California
+JAMES C. GREENWOOD, Pennsylvania FRANK PALLONE, Jr., New Jersey
+NATHAN DEAL, Georgia PETER DEUTSCH, Florida
+RICHARD BURR, North Carolina BART STUPAK, Michigan
+BRIAN P. BILBRAY, California GENE GREEN, Texas
+ED WHITFIELD, Kentucky TED STRICKLAND, Ohio
+GREG GANSKE, Iowa DIANA DeGETTE, Colorado
+CHARLIE NORWOOD, Georgia THOMAS M. BARRETT, Wisconsin
+TOM A. COBURN, Oklahoma LOIS CAPPS, California
+ Vice Chairman RALPH M. HALL, Texas
+RICK LAZIO, New York EDOLPHUS TOWNS, New York
+BARBARA CUBIN, Wyoming ANNA G. ESHOO, California
+JOHN B. SHADEGG, Arizona JOHN D. DINGELL, Michigan,
+CHARLES W. ``CHIP'' PICKERING, (Ex Officio)
+Mississippi
+ED BRYANT, Tennessee
+TOM BLILEY, Virginia,
+ (Ex Officio)
+
+ (ii)
+
+
+ C O N T E N T S
+
+ __________
+ Page
+
+Testimony of:
+ Cox, John Thomas, Student Health Services, University of
+ California at Santa Barbara................................ 82
+ Eshoo, Hon. Anna G., a Representative in Congress from the
+ State of California........................................ 6
+ Gatscha, Rosemarie, Cytology Manager, American Society of
+ Clinical Pathologists...................................... 91
+ Lee, Nancy C., Associate Director for Science, Center for
+ Disease Control and Prevention............................. 22
+ Lenhart, Sharyn, Immediate Past President, American Medical
+ Women's Association........................................ 88
+ Lowey, Douglas R., Deputy Director, National Cancer Institute 27
+ Mack, Hon. Connie, a United States Senator from the State of
+ Florida.................................................... 8
+ Piker, Linda Grace, Cervical Cancer Survivor................. 73
+ Trimble, Edward L., Head Surgery Section, National Cancer
+ Institute.................................................. 26
+ Valdiserri, Ronald O., Deputy Director, Center for Disease
+ Control and Prevention..................................... 16
+Material submitted for the record by:
+ Center for Cervical Health, prepared statement of............ 101
+ Center for Disease Control, responses to questions for the
+ record..................................................... 132
+ Lowey, Douglas R., Deputy Director, National Cancer
+ Institute, letter dated April 8, 1999, enclosing response
+ for the record............................................. 105
+ Trimble, Edward L., Head Surgery Section, National Cancer
+ Institute, letter dated April 8, 1999, enclosing response
+ for the record............................................. 103
+
+ (iii)
+
+
+
+ WOMEN'S HEALTH: RAISING AWARENESS OF CERVICAL CANCER
+
+ ----------
+
+
+ TUESDAY, MARCH 16, 1999
+
+ House of Representatives,
+ Committee on Commerce,
+ Subcommittee on Health and Environment,
+ Washington, DC.
+ The subcommittee met, pursuant to notice, at 2:57 p.m., in
+room 2123, Rayburn House Office Building, Hon. Michael
+Bilirakis (chairman) presiding.
+ Members present: Representatives Bilirakis, Stearns,
+Greenwood, Bilbray, Ganske, Coburn, Lazio, Bryant, Brown,
+Green, Barrett, Capps, Towns, and Eshoo.
+ Staff present: Lori Wall, majority counsel; Marc Wheat,
+majority counsel; Mike Flood, legislative clerk; John Ford,
+minority counsel, and Kristi Guillory, minority legislative
+fellow.
+ Mr. Bilirakis. The hearing will come to order.
+ Today the subcommittee will hold the first in a series of
+hearings on women's health concerns by focusing on the issue of
+cervical cancer, its causes, and its treatments. Each year
+approximately 15,000 women are diagnosed with cervical cancer
+in the United States, and almost 5,000 die annually from the
+disease. Troubling evidence also shows a higher incidence of
+cervical cancer among minority and disadvantaged populations.
+The tragedy of these statistics is compounded by the fact that
+cervical cancer is readily treatable if caught at an early
+stage.
+ Last year I sponsored legislation which was enacted into
+law to reauthorize the National Breast and Cervical Cancer
+Early Detection Program at the Centers for Disease Control and
+Prevention. This women's health initiative had strong
+bipartisan support, including the subcommittee's ranking
+member, Mr. Brown, the full committee chairman, Tom Bliley, and
+the full committee ranking member John Dingell.
+ Today we will learn about recent progress in the fight
+against this terrible disease. We know that the primary risk
+factor and leading cause of cervical cancer is the human
+papillomavirus or HPV, a sexually transmitted disease. Experts
+estimate that 24 million Americans are infected with HPV, and
+the incidence of this virus may be increasing.
+ The good news is that the human immune system can normally
+clear the virus within 18 months. As a result, many women do
+not realize they have contracted HPV and they never suffer any
+health consequences from it. Unfortunately, that is not always
+the case. It is critical that all women understand the threat
+of cervical cancer and the importance of regular Pap smear
+exams. We must increase awareness of how it is transmitted and
+the importance of early detection. We must also improve methods
+of detecting the presence of pre-cancerous lesions that develop
+into cervical cancer.
+ Later this year I will be participating in a women's health
+fair in my congressional district. I encourage my colleagues to
+help educate the public about this disease and other women's
+health concerns. In that regard, I want to commend the efforts
+of Senator Connie Mack of my home State of Florida, and
+Representatives Juanita Millender-McDonald, Rick Lazio, and Tom
+Coburn in sponsoring a resolution to raise awareness of
+cervical cancer.
+ Let me also thank our witnesses for taking the time to join
+us today, and again extend a special welcome to my Florida
+colleague, Senator Connie Mack. Connie, do you have the time to
+wait for the opening statements before testifying?
+ Senator Mack. Sure.
+ Mr. Bilirakis. Okay. I first want to applaud the work that
+you and Priscilla have done in the fight against cancer. You
+certainly will be missed in the Senate, but I trust your
+leadership in these issues will continue.
+ I now recognize the ranking member, Mr. Brown of Ohio.
+ Mr. Brown. Thank you, Mr. Chairman, for arranging this
+hearing. I would also like to thank Senator Mack and
+Congresswoman Eshoo for their fine work, and our other
+distinguished panelists today. While I am pleased that the
+subcommittee will hear from a wide range of witnesses, I am
+disappointed that it was not possible to include a
+representative from the College of American Pathologists. This
+organization, representing some 16,000 physicians, offers a
+unique perspective on the detection, diagnosis, and treatment
+of cervical cancer. Their input would have been extremely
+valuable.
+ The tragedy of cervical cancer is twofold. It is tragic
+that hundreds of thousands of women confront this disease, a
+profoundly debilitating and deadly illness. It is tragic that
+cervical cancer remains such a virulent killer, when it is
+within our power to prevent it. Cervical cancer is a national
+and international public health issue. It accounts for 6
+percent of cancers diagnosed in women in the United States,
+taking nearly 5,000 lives. Worldwide, more than 470,000 new
+cases are diagnosed each year.
+ In both industrialized and non-industrialized nations,
+cervical cancer takes its greatest toll on those individuals
+least able to fight back, minority populations and the economic
+disadvantaged. Cervical cancer deaths can be virtually
+eliminated through behavioral changes, early detection, and
+timely access to treatment, all of which hinge on public
+awareness. Public awareness fuels change. It can generate the
+individual and collective actions necessary to achieve a
+meaningful reduction in cervical cancer rates.
+ The public needs to know that safe behaviors and proper
+screening can reduce cervical cancer death rates dramatically.
+We need to get them the facts about screening test accuracy,
+new detection methods, and treatment breakthroughs, so they can
+play an active role in prevention and treatment decisions. We
+need to emphasize the potential inherent in a national
+commitment to combat this disease.
+ The public needs to know about initiatives like the CDC's
+Breast and Cervical Cancer Early Detection Program, which has
+reached millions of uninsured women with free screening tests.
+Public awareness can help us gather the resources needed for
+CDC and its State and local partners to do more than scratch
+the surface of this problem. As currently funded, the CDC
+program reaches only 15 percent of uninsured women. We can do
+much better than that.
+ We need to spread the word about initiatives like H.R.
+1070, legislation introduced by Ms. Eshoo, which would ensure
+proper treatment for women who are screened under the CDC
+program and diagnosed with cancer. Diagnosis is a cruel and
+fiscally irresponsible exercise when women diagnosed with
+cancer have no access to treatment, as happens all too often in
+this society.
+ Finally, we must all become more sensitive to potential
+barriers blocking proper cervical cancer screening. Pap smears
+have dramatically reduced cervical cancer deaths, and it is
+critical that we do everything in our power to ensure their
+continued availability.
+ In that context, we must be vigilant in evaluating the
+adequacy of Federal reimbursement for Pap smears. Medicare and
+Medicaid reimbursement directly affects access for two
+populations particularly vulnerable to cervical cancer: low-
+income individuals and the elderly. Since private reimbursement
+is often based on Federal payment rates, our actions indirectly
+affect millions of women with employer-sponsored or individual
+insurance coverage. It is imperative that Federal reimbursement
+accurately reflect the true costs of performing and evaluating
+Pap smears.
+ Inadequate data on cervical cancer incidence rates is one
+of our greatest obstacles, a problem to which too little
+attention is paid. Our current data lumps different
+subpopulations together, potentially masking wide variations in
+cervical cancer rates. It is critical to understand these
+differences in order to target prevention and treatment
+initiatives appropriately. Knowledge fuels advocacy, and in the
+case of cervical cancer, advocacy will save countless lives.
+That is why today's hearing on cervical cancer awareness is so
+valuable.
+ Mr. Bilirakis. I thank the gentleman. The Chair recognizes
+the gentleman from Oklahoma, Dr. Coburn.
+ Mr. Coburn. Thank you Mr. Chairman. I, too, want to
+congratulate you on having this hearing. This is a subject
+matter which, unfortunately, I know way too much about. Last
+year I treated over 200 women with carcinoma in situ of the
+cervix. Seven of those had invasive carcinoma. But there were
+thousands that went through our clinic that had cervical
+dysplasia.
+ Not only is the knowledge not out there, the government
+entities, in terms of this disease, have done a miserable job,
+in my estimation, of raising public awareness of this. We are
+not just talking about cervical cancer. There are studies now
+that show that the human papillomavirus can be transmitted from
+the mother in utero to her child; that, in fact, you can
+culture newborn children about 40 percent of the time with this
+virus. It is theoretically possible that a young woman never
+exposed could die of carcinoma of the cervix because she
+contracted that virus in utero or at birth.
+ There are many studies that are ongoing now to look at
+these issues. My fear and my worry is not that we will make
+awareness of these issues possible, but that we will somehow
+average and marginalize the best public health policy for
+preventing this disease.
+ I look forward to the testimony that we have and I yield
+back my time.
+ Mr. Bilirakis. I thank the gentleman. The gentlelady from
+California, Ms. Capps.
+ Mrs. Capps. Thank you Mr. Chairman. I appreciate that you
+are holding this hearing today on such an important topic,
+raising awareness of cervical cancer, and I want to welcome all
+of the witnesses.
+ Senator Mack, I know that you are representing Priscilla as
+well.
+ My colleague, Anna Eshoo, a leader in this area, I look
+forward to hearing from you.
+ I want to particularly welcome one of our expert panelists
+today, Dr. J. Thomas Cox, who is a constituent of mine from the
+University of California at Santa Barbara. An accomplished OB-
+GYN, Dr. Cox oversees student health services at UCSB, where he
+runs a program that screens thousands of women for cervical
+cancer each year. He is an expert in the area of cervical
+cancer treating, and will today share his broad knowledge on
+the problems associated with present cervical cancer screening
+and opportunities to improve this system. I am so proud that
+Dr. Cox is here to represent the medical expertise worldwide
+and at UCSB in the 22nd district of California.
+ As a nurse, I have seen firsthand how important it is to
+raise awareness of cervical cancer, especially since it is so
+highly treatable if caught early. The vast majority of cases of
+cervical cancer are caused by the human papillomavirus,
+otherwise known as HPV, a sexually transmitted agent that
+infects the cells of the cervix and slowly causes cellular
+changes that can result in cancer. Women are often infected
+with HPV in their teens, 20's or 30's, though the disease can
+take up to 20 years after the HPV infection starts before the
+development of the disease begins. It starts with an in situ
+stage that can be treated, but then as it progresses to an
+invasive disease, it can often be fatal.
+ Cervical cancer prevention efforts worldwide have focused
+on screening women at risk of the disease through Pap smears
+and treating pre-cancerous lesions. Where screening quality and
+coverage have been high, these efforts have reduced invasive
+cervical cancer by as much as 90 percent, and that is a
+remarkable number. Since pre-cancerous and very early cervical
+cancers are nearly 100 percent curable, this test can prevent
+nearly all deaths from cervical cancer.
+ In reading the remarks that Dr. Cox has prepared for
+today's presentation, I learned that the decrease in the rate
+of cervical cancer in the United States is so dramatic that Pap
+smear screening is one of the few interventions to receive an
+``A'' recommendation from the U.S. Preventive Services Task
+Force, and that is quite an endorsement. Pap smears have
+changed the way we approach the problem of cervical cancer, but
+even with all of our medical advances, there is so much more
+work to do. Women need more education about cervical cancer and
+the associated risk factors, including this link with HPV.
+ Our challenge now is to provide those who have been slow to
+seek out screening, very often low-income women, with screening
+opportunities and with access to treatment. And so, just this
+week, I was honored to join with Congresswoman Anna Eshoo and
+Congressman Rick Lazio in introducing the Breast and Cervical
+Cancer Treatment Act. This bipartisan bill gives States the
+option to provide Medicaid coverage to uninsured or
+underinsured women who have been diagnosed through the National
+Breast and Cervical Cancer Early Detection Program, a screening
+program for low-income, uninsured, or underinsured women. Women
+who are screened through this program often cannot afford
+treatment. All of the screening in the world won't help if
+women who are diagnosed with the disease do not have access to
+quality treatment for their condition.
+ So I look forward to learning more from our experts today
+as we seek to raise the awareness of cervical cancer, its
+causes, and its treatments. And I hope that we can all work
+together to enact the Breast and Cervical Cancer Treatment Act
+as quickly as possible.
+ I yield back the balance of my time.
+ Mr. Bilirakis. I thank the gentlelady. Does the gentleman
+from Florida, Mr. Stearns, have a quick opening statement?
+ Mr. Stearns. A quick opening statement.
+ Mr. Bilirakis. You are recognized.
+ Mr. Stearns. Thank you, Mr. Chairman. I appreciate you
+holding this important hearing, and, of course, I look forward
+to hearing from our distinguished Senator, who is retiring. I
+appreciate the opportunity to see him again.
+ The average age at diagnosis is 45, but can occur in women
+20 to 30 years old. We are not sure what causes cervical
+cancer, but we do know that there are a number of pre-disposing
+factors. These include multiple sex partners, early sexual
+activity, and early child bearing. But the good news is that
+routine Pap smears are very effective in detecting abnormal
+cells, and if detected in time, can be treated with promising
+results.
+ I look forward to the hearing, Mr. Chairman, and I
+appreciate Senator Mack being here.
+ [The prepared statement of Hon. Cliff Stearns follows:]
+Prepared Statement of Hon. Cliff Stearns, a Representative in Congress
+ from the State of Florida
+ Thank you, Chairman Bilirakis, for holding this very important
+hearing that deals with a very serious women's health issue.
+ I look forward to hearing from our distinguished panel of
+witnesses. In particular, I look forward to hearing from my own
+Senator, Connie Mack.
+ When we think about the various cancers that can afflict women, we
+rarely focus on cervical cancer. Yet, 2-3 percent of all women over the
+age of 40 will develop some form of cervical cancer. That translates to
+about 5,000 deaths per year.
+ The average age at diagnosis is 45, but can occur in women 20-30
+years old. We are not sure what causes cervical cancer, but we do know
+that there are a number of predisposing factors. These include:
+multiple sex partners, early sexual activity, or early childbearing
+(less than 16 years of age).
+ Another factor that must be mentioned is that women who were
+exposed to the drug DES (diethylstilbestrol) might be at greater risk
+of developing certain types of cervical cancer due to this exposure.
+ The good news is that routine pap smears are very effective in
+detecting abnormal cells and if detected in time can be treated with
+promising results. Because there are no discernible symptoms in the
+early stages, it is vital that women see their physician on an annual
+basis since early intervention with proper treatment can save 80% of
+women. Once this disease progresses and spreads to other organs the
+survival rate drops significantly.
+ I look forward to hearing from our witnesses and believe that
+through hearings such as this we can educate the public about this
+disease and the need for medical check ups on a regular basis.
+
+ Mr. Bilirakis. I thank the gentleman. Unless it is
+imperative that the latecomers make an opening statement, I
+would like to go ahead. Greg, do you have a quick opening
+statement?
+ Mr. Ganske. In deference to the chairman, I will submit my
+opening statement.
+ Mr. Bilirakis. I appreciate that.
+ Well, let's go into the first panel then. Joining Senator
+Connie Mack in the first panel is a lady who I always refer to
+as to the conscience of this subcommittee. She is a very
+effective Congresswoman with a fantastic heart. Anna, you are
+recognized.
+
+STATEMENTS OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN CONGRESS
+ FROM THE STATE OF CALIFORNIA; AND HON. CONNIE MACK, A UNITED
+ STATES SENATOR FROM THE STATE OF FLORIDA
+
+ Ms. Eshoo. Thank you very much, Mr. Chairman. Is this on?
+Now it is. We are more accustomed to the microphones at the
+other side of the table here.
+ Mr. Chairman and members of the committee, our
+distinguished ranking member, it is a special privilege for me
+to give testimony today to the subcommittee that I am a member
+of, and how proud I am to be a member of the committee. This is
+an all important issue, and I think that the entire Nation
+should be grateful today that this hearing is taking place.
+ I am especially proud to be seated next to Senator Mack,
+and I want to salute him for his outstanding service in the
+Congress of the United States. Everyone will miss your
+leadership and your service here. I want to express my
+gratitude to him and to California Representative Juanita
+Millender-McDonald for their leadership on the cervical cancer
+public awareness resolution.
+ Resolutions are important because I think they set the
+foundation on which legislation can follow, and so I am very
+pleased to be a part of that resolution because it raises
+public awareness. And we know that we can make a difference
+when we set our minds to it, to raise the awareness of people
+in the country, and in this case about cervical cancer, with
+special regards to its risks, certainly the prevention, and
+most importantly, treatment.
+ Why? Because 70 percent of women in a recent study in our
+country did not even know what causes cervical cancer. Less
+than a quarter of them had ever even heard of HPV, which is the
+leading cause of this disease. Cervical cancer is a killer. I
+should say that again. Cervical cancer is a killer. Of the
+15,000 women who are diagnosed with cervical cancer each year,
+5,000 will die. That is a huge, huge number of human beings.
+And we know that we can do something about this. That is a
+mortality rate of over 30 percent. In this enlightened Nation,
+we know we can do better. In fact, we must.
+ But even more tragic is the fact that this disease is
+actually preventable. Since the introduction of the Pap smear,
+as Congressman Lois Capps just stated, since 45 years ago,
+cervical cancer in our country has dropped 75 percent.
+According to the National Cancer Institute, the 5-year survival
+rate is 91 percent when cervical cancer is detected and treated
+at an early stage.
+ In 1990, Congress took a very important step. I wasn't here
+then, but to those of you that were, I salute you, because you
+took a very important step in the fight against this deadly
+disease by passing the Breast and Cervical Cancer Mortality
+Prevention Act. The law authorized a cervical cancer screening
+program for low-income, uninsured, or underinsured women
+through the CDC. It was a very important first step, but it was
+only a first step. Because while the current program covers
+screening services, it does not cover treatment for women who
+are found to be positive through the program.
+ Representative Rick Lazio, Congresswoman Capps, and myself
+introduced last week a bill that would address this. The bill,
+H.R. 1070, would establish an optional State Medicaid benefit
+for the coverage of certain women who are screened and
+diagnosed through the CDC program. I don't really think, Mr.
+Chairman, that the Federal Government should be saying to
+women, ``We are willing to help you be screened and then you
+are left to your own devices when it comes to treatment.'' So
+this is what the bill seeks to close the gap on.
+ I set a goal with Representative Lazio when we introduced
+this last week--and we missed you, Lois, there, and we
+understand why you couldn't be--that by Mother's Day we would
+have 218 co-sponsors on a bipartisan basis in the House. And I
+hope, Mr. Chairman, that you will have a hearing on the bill. I
+think that this is something that we can, indeed, get done for
+the American people.
+ So, this providing breast and cervical cancer treatment to
+women who cannot afford it otherwise, we believe should be a
+Federal priority. We know that there is not Republican cancer
+or Democratic cancer. When we go home to our constituents, we
+should have an united voice and a united front on this.
+ So, we will look forward to taking the next step, not only
+on the resolution, but on the bill, and I want to thank you,
+Mr. Chairman, for your leadership always, and our distinguished
+ranking member, Sherrod Brown. I think it is the real privilege
+of my congressional career to be part of this committee,
+because we can really make a difference in people's lives. So
+thank you for giving me this opportunity.
+ [The prepared statement of Hon. Anna G. Eshoo follows:]
+Prepared Statement of Hon. Anna G. Eshoo, a Representative in Congress
+ from the State of California
+ Thank you Mr. Chairman. As a member of this distinguished
+committee, I am extremely proud that we are tackling the issue of
+cervical cancer. As a witness for the hearing, I am grateful for the
+opportunity to contribute my insight into how we, in Congress, might
+help to fight this battle.
+ I also want to express my gratitude to my colleague from
+California, Rep. Juanita Millender-McDonald, and Senator Connie Mack
+for their leadership on the Cervical Cancer Public Awareness
+Resolution.
+ This resolution seeks to raise public awareness of cervical cancer
+among women, specifically with regard to risks, prevention and
+treatment.
+
+ For instance, 70% of women in a recent survey did not know
+ what causes cervical cancer and less than a quarter had even
+ heard of the human papilloma virus (HPV), which is the leading
+ cause of the disease.
+ I am an original cosponsor of the Millender/Mack resolution because
+I know that knowledge saves lives.
+ Cervical cancer is a killer.
+
+ Of the 15,000 women who are diagnosed with cervical cancer
+ each year, 5,000 will die. That is a mortality rate of over
+ 30%.
+ But even more tragic is the fact that this disease is preventable.
+
+ Since the introduction of the Pap smear test 45 years ago,
+ cervical cancer in the U.S. has dropped 75%.
+ According to the National Cancer Institute, the five-year
+ survival rate is 91% when cervical cancer is detected and
+ treated at an early stage.
+ In 1990, Congress took the first step in the fight against this
+deadly disease by passing the Breast and Cervical Cancer Mortality
+Prevention Act.
+
+ This law authorized a cervical cancer screening program for
+ low-income, uninsured or uninsured women through the Centers
+ for Disease Control (CDC).
+ But this was only the first step. While the current program covers
+screening services, it does not cover treatment for women who are found
+to be positive through the program.
+ A bill Rep. Rick Lazio and I introduced last week would fill that
+gap.
+ Our bill, the Breast and Cervical Cancer Treatment Act (H.R. 1070)
+would establish an optional state Medicaid benefit for the coverage of
+certain women who were screened and diagnosed through the CDC program.
+ Our bill would replace the current system of providing treatment
+through an ad hoc patchwork of providers, volunteers, and local
+programs scrambling to find treatment dollars with a consistent,
+reliable source of health care coverage.
+ Mr. Chairman, we have the technology to fight cervical cancer. But
+we must pair this with the will to help women fight the battle. Because
+women with life threatening diseases should be concentrating their
+energies on treatment, not payment.
+ Mr. Chairman, the federal government should not be in the business
+of telling women, ``We've helped you find out you have cancer, now
+you're on your own.''
+ With over 80 bipartisan cosponsors of the bill already, Congress
+has sent a message that this bill--the Lazio/Eshoo Breast and Cervical
+Cancer Treatment Act--should be a federal priority.
+ Providing breast and cervical cancer treatment to women who can not
+otherwise afford it, should be a federal priority.
+ So I ask you today, Mr. Chairman, to not allow this to be the only
+hearing this subcommittee holds on cervical cancer. Hold a hearing on
+H.R. 1070 and take the next step toward helping women fight cervical
+cancer.
+ Thank you Mr. Chairman for this opportunity to testify before my
+own distinguished subcommittee on this very important issue. I look
+forward to hearing from the other witnesses.
+
+ Mr. Bilirakis. Thank you very much.
+ Ms. Eshoo. I see the red light and I'll shut my microphone
+off.
+ Mr. Bilirakis. Thank you very much. Knowing you, Anna, and
+having worked with you these many years, I expect you'll
+probably have 218 co-sponsors by your timeline.
+ It is a great privilege to yield now to Senator Mack.
+
+ STATEMENT OF HON. CONNIE MACK
+
+ Senator Mack. Well, Mr. Chairman, let me add my voice to
+others in expressing not only my gratitude for the opportunity
+to speak before this committee, but also to thank you for
+highlighting this particular issue. Some of you probably
+remember that I was diagnosed with melanoma back in 1989, right
+after I was elected to the Senate. I don't have to worry about
+that today, because it was detected early. That early detection
+probably took place because of the death of my younger brother
+Michael, who died of the same cancer. It made me so aware of it
+that I was, as I have said before, Priscilla and I check each
+other like two baboons looking for--you get the message. I am
+alive today because of early detection.
+ Many of you know that my wife Priscilla was diagnosed with
+breast cancer a number of years ago, and she is a survivor
+today because she detected the breast cancer early. Most of you
+don't know, in fact, probably all of you don't know, that our
+daughter Debbie was diagnosed with cervical cancer back in
+1990. She is a survivor today because of early detection. She
+was aware of the cancers in our family, and as families become
+sensitive to that, they are aware of the types of actions they
+ought to be taking on their own to protect themselves.
+ So, I commend you for holding this hearing because, I will
+tell you, just as a result of doing the hearing, someone is
+going to hear that message. Priscilla and I have already
+experienced it, and I suppose that you have as well; that
+people will come up to you and say, ``Because I heard such and
+such, I did such and such, and as a result today, I am cancer-
+free.''
+ So, I not only commend the chairman, but all of you who
+have shown such an interest in this disease. I commend all of
+you.
+ According to the American Cancer Society, nearly 1,000
+women in Florida will be diagnosed with cervical cancer in
+1999. This year Florida will have the third largest number of
+new cases of cervical cancer.
+ Yet, despite significant progress being made in the war on
+cancer, not all segments of the U.S. population have benefited
+to the fullest extent from the advances made in the
+understanding of cancer. According to the U.S. Institute of
+Medicine report, ``The Unequal Burden of Cancer,'' rates of
+cervical cancer are significantly higher in Hispanic and
+African-American women. We simply must do better. We must
+reinforce our effort to eradicate the terrible disease, but we
+also must continue and expand our efforts to see that this
+information and the knowledge and the education gets to all
+women in America.
+ Research, education, and early detection are the most
+effective weapons that we have in the war on cervical cancer.
+In an effort to help increase awareness and education about
+this disease, today I will introduce a Senate resolution to
+designate the month of January as National Cervical Health
+Month. I am pleased that Senator Diane Feinstein and 31 other
+members of the Senate have agreed to be original co-sponsors of
+this Senate resolution. I know from what has been said already
+here this afternoon that Juanita Millender-McDonald and many of
+you have agreed to co-sponsor similar legislation in the House
+of Representatives.
+ Research is the key to finding a cure for cervical cancer,
+and significant progress is being made in this regard. Just
+last month, for example, the National Cancer Institute took the
+rarely used step of issuing a clinical announcement urging that
+physicians should give strong consideration to adding
+chemotherapy to radiation therapy in the treatment of invasive
+cervical cancer. According to NCI Director Rick Klausner, this
+will likely change the standard of treatment for cervical
+cancer. Dr. Mitchell Morris of the M.D. Anderson Cancer Center
+called this new treatment approach ``the first fundamental
+advance in the treatment of cervical cancer in more than 40
+years.''
+ Mr. Chairman, I am proud to say that in our home State of
+Florida, there are several studies that are underway.
+Scientists at the University of Miami Sylvester Cancer Center
+are studying a new type of cervical cancer immunotherapy. Let
+me just stop there for a moment.
+ I guess it was just fate that 1 day, wandering through a
+bookstore, I saw a book called Transform Cell, and because it
+was about melanoma. it caught my attention. I bought the book
+and read through it, and as you made your way through it, you
+found there were a couple of terms that we really weren't
+hearing. Most of us are familiar with the modalities of
+chemotherapy, radiation therapy, and surgery as the means of
+addressing cancer. But there were a couple of new words that
+were coming into discussion; that was immunotherapy. Dr.
+Rosenberg really believes that we could turn on the immune
+system to fight cancer--and that for some reason, the immune
+system saw cancer cells as just a normal cell in the body. And
+so he began an active pursuit, primarily in the area of
+melanoma in kidney cancers. The concept now is spreading out
+into many other areas.
+ In addition to immunotherapy, we are hearing people talk
+about now gene therapy--again, ideas that just 10 or 12 years
+ago didn't really seem to even be on the horizon. And I think
+that the Congresses in the past have done a tremendous job in
+providing the resources to provide the money for the basic
+research that creates the knowledge that then becomes the
+magnet for investment to develop new drugs and new treatment.
+ Again, at the Sylvester Cancer Center, they are developing
+killer cells specifically designed to target cancer cells which
+express human papillomavirus. By eradicating these cells, the
+hope is to kill the tumor, even if the cancer has spread.
+ At the H. Lee Moffitt Comprehensive Cancer Center in Tampa,
+studies are underway to develop a cervical cancer vaccine using
+some of the same characteristic of the human papillomavirus.
+They are also examining biomarkers to develop cervical cancer
+before malignant changes occur.
+ And just in my last comment, and I do take off my Senate
+hat, I take off my political hat, I take off a Republican hat,
+I put them aside and I just speak to you all for a moment from
+the perspective of a father thinking of my daughter Debbie, of
+a husband thinking of my wife Priscilla. I say that I am
+stunned, frankly, by the President's budget proposal. Last year
+the administration made a major commitment to the fight against
+cancer with a commitment of a 55 percent increase over time. If
+my memory holds right, I think the President's budget calls for
+a 2, maybe 2.6 percent increase in NIH. I would ask all of us,
+again setting aside those labels that I used a minute ago,
+let's rally around. We made a commitment a couple of years ago
+for the effort of doubling the investment that we make at NIH,
+which is obviously more than cancer. It is Parkinson's disease;
+it is sickle cell anemia; you name the disease and we are
+pursuing it. I think this is the greatest investment that we
+can make. So I just would appeal to all of you, let's re-
+commitment ourselves to this commitment we made less than 2
+years ago to double the investment at NIH.
+ And I thank you again, Mr. Chairman, for the opportunity.
+ [The prepared statement of Hon. Connie Mack follows:]
+ Prepared Statement of Hon. Connie Mack, a U.S. Senator from the State
+ of Florida
+ Mr. Chairman, I want to commend you for holding this important
+hearing, and I thank you for inviting me to testify this afternoon.
+ The issue of cervical cancer is one which is deeply personal to my
+wife, Priscilla, and to me. In 1990, our daughter, Debbie, was
+diagnosed with cervical cancer. Because of our family history with
+cancer, Debbie was aware that she had an increased risk of cancer and
+she made sure to take advantage of early detection screening
+procedures. Fortunately, her cervical cancer was detected at an early
+stage, and she was treated successfully with surgery. Not long after
+her treatment, she gave birth to our third grandson. Debbie's
+experience with cervical cancer exemplifies the fact that early
+detection saves lives.
+ According to the American Cancer Society, nearly 1000 women in
+Florida will be diagnosed with cervical cancer in 1999. This year,
+Florida will have the third largest number of new cases of cervical
+cancer. Yet, despite significant progress being made in the war on
+cancer, not all segments of the U.S. population have benefitted to the
+fullest extent from the advances made in the understanding of cancer.
+According to the U.S. Institute of Medicine report, ``The Unequal
+Burden of Cancer,'' rates of cervical cancer are significantly higher
+in Hispanic and African-American women. We simply must reinforce our
+efforts to eradicate this terrible disease.
+ Research, education, and early detection are the most effective
+weapons we have in the war on cervical cancer.
+ In an effort to help increase awareness and education about this
+disease, today I will introduce a Senate Resolution to designate the
+month of January as ``National Cervical Health Month.'' I am pleased
+that Senator Dianne Feinstein and 31 bipartisan colleagues in the
+Senate have agreed to be original co-sponsors of this Senate
+Resolution. I understand that Rep. Juanita Millender-McDonald will be
+introducing similar legislation in the United House of Representatives.
+ Research is the key to finding a cure for cervical cancer, and
+significant progress is being made in this regard. Just last month, for
+example, the National Cancer Institute took the rarely-used step of
+issuing a Clinical Announcement urging physicians to give strong
+consideration to adding chemotherapy to radiation therapy in the
+treatment of invasive cervical cancer. According to NCI Director Rick
+Klausner, this will likely change the standard of treatment for
+cervical cancer. Dr. Mitchell Morris of the M.D. Anderson Cancer Center
+called this new treatment approach, ``the first fundamental advance in
+the treatment of cervical cancer in more than 40 years.''
+ I'm also proud to say that several cutting-edge cervical cancer
+studies are taking place in my home state of Florida. Scientists at the
+University of Miami Sylvester Cancer Center are studying a new type of
+cervical cancer immunotherapy. They are developing ``killer cells''
+specifically designed to target cancer cells which express human
+papilloma (HPV). By eradicating these cells, the hope is to kill the
+tumor, even if the cancer has spread. At the H. Lee Moffitt
+Comprehensive Cancer Center in Tampa, studies are underway to develop a
+cervical cancer vaccine using some of the same characteristics of the
+human papilloma virus. They are also examining biomarkers to detect
+cervical cancer before malignant changes occur.
+ The U.S. Senate and House, working in bipartisan cooperation, have
+embarked upon an historic mission to double funding for the National
+Institutes of Health over the next five years. Last year, the Congress
+overwhelmingly passed, with bipartisan support, a $2 billion increase
+for the National Institutes of Health--the largest increase in NIH
+history.
+ With the tremendous progress being made in cervical cancer and
+other diseases, I was astonished and extremely disappointed the
+President's FY 2000 budget only calls for a meager 2.6% increase for
+medical research at the NIH. This is simply unacceptable. The
+President's proposed budget means a cease-fire in the war against
+cancer, Parkinson's disease, Alzheimer's disease and other illnesses.
+In effect, the President's proposal is a formal act of retreat in the
+heat of battle.
+ I was also shocked that the President's FY 2000 budget calls for
+not one additional penny of funding for the Breast and Cervical Cancer
+Screening program at the U.S. Centers for Disease Control & Prevention.
+For FY 1999, the bipartisan Congress provided a $16 million increase.
+By contrast, the President's request for FY 1999 was for an increase of
+less than $1 million for this life-saving program, and he proposes no
+increase for next year.
+ When it comes to cervical cancer research and screening, the
+President just doesn't get it. It's obvious the leadership on these
+initiatives will have to come from this end of Pennsylvania Avenue. It
+will be through the bipartisan commitment of the Senate and House that
+these important research and detection programs will receive adequate
+funding. I am here to pledge my support, and to work with my colleagues
+in Congress to make sure this happens. Far too many lives depend upon
+it.
+ Again, Mr. Chairman, thank you for holding this important hearing
+and for allowing me the opportunity to appear before this committee.
+
+ Mr. Bilirakis. And I thank you, Connie.
+ Yes, I would wager that most of the members of this
+subcommittee have basically signed on the pledge of doubling
+NIH funding, and that is certainly one of our great big causes,
+working with John Porter and Bill young on the Appropriations
+Committee.
+ Connie, I really have no questions of you and Anna. I just
+want to endorse all of the great things that were said about
+you yesterday in Tallahassee, where we were together for that
+legislative summit. Hopefully, you will continue to use your
+high profile for this important cause.
+ Senator Mack. Well, thank you for the encouragement.
+ Mr. Bilirakis. I commend you both for testifying on this
+important issue.
+ At this point, I would ask unanimous consent that the
+opening statements of all members of this subcommittee and the
+testimony of Congresswoman Juanita Millender-McDonald be made a
+part of the record. Without objection that will be the case.
+ [The prepared statement of Hon. Juanita Millender-McDonald
+follows:]
+Prepared Statement of Hon. Juanita Millender-McDonald, a Representative
+ in Congress from the State of California
+ Mr. Chairman, I would like to thank you, Chairman Bliley, Ranking
+Member Dingell, and Ranking Member Brown for supporting my efforts to
+raise awareness of cervical cancer by serving as original cosponsors of
+the Cervical Cancer Awareness Resolution. I would also like to thank
+all of the Subcommittee members who served as original cosponsors of
+this resolution, and in particular, Congressmen Rick Lazio and Tom
+Coburn, who have been tireless advocates in our effort to introduce and
+pass this resolution to help educate women on this fatal, yet in most
+cases, preventable disease.
+ In 1990, Congress passed the Breast and Cervical Cancer Mortality
+Prevention Act, which enabled the CDC to establish the National Breast
+and Cervical Cancer Early Detection Program. This Program offers
+community-based screening services for women with little access to
+health care, education programs on the benefits of early screenings,
+quality assurance standards for cancer testing, and surveillance system
+on the effectiveness of these programs.
+ I applaud the efforts of our colleagues on the Committee who are
+working to strengthen these programs and create greater access to
+screening and treatment for medically underserved communities. It is
+this lack of access and poor understanding of cervical cancer that
+illuminate the challenge before us today.
+ More than 50 years ago, Dr. George N. Papanicolaou developed what
+is considered the most effective cancer screen in the history of
+medicine, the Papanicolaou test or what we call the Pap smear test.
+Although it is not perfect and we welcome technological advances in the
+field of medicine, it is a remarkable tool in saving lives and
+preventing invasive cervical cancer. The real problem is making sure
+women understand what cervical cancer is, what steps they can take to
+reduce the likelihood of getting cervical cancer, how it can be
+detected early and what all of their treatment options are when facing
+this disease.
+ As you know, tomorrow Committee Members Lazio and Coburn, and I
+will introduce the Cervical Cancer Public Awareness Resolution because
+we want to tackle this problem of misinformation, confusion and
+discomfort that too many women continue to feel on this issue. Our
+resolution is part of a national campaign to raise awareness on
+cervical cancer among women and encourage Americans to become more
+educated on related risk factors, prevention and treatment.
+ An estimated 15,000 women in the United States develop cervical
+cancer each year according to the American Cancer Society. The World
+Health Organization and the National Institutes of Health state that
+the principal cause of cervical cancer is the human papillomavirus or
+HPV infection, which is one of the most common sexually transmitted
+diseases (STDs). Fortunately, when cervical cancer is detected at an
+early stage, the five-year survival rate is 91 percent, according to
+the National Cancer Institute. The Centers for Disease Control and
+Prevention report that the mortality rate among American women with
+cervical cancer declined from 1960 to 1997 in large part due to the
+extensive use of the Pap smear test. However, in 1997 the number began
+to rise I fear because the message on cervical health has not reached
+enough women.
+ In October 1997, a Gallup survey commissioned by the College of
+American Pathologists found that although 87 percent of the women
+surveyed know they should have a Pap test every year, nearly 40 percent
+of these same women failed to do so in the previous year. One in four
+of the women who had not had an annual Pap test said they ``didn't have
+the time.'' The reasons include the belief that they are too old,
+feeling embarrassed or afraid of tie results, or thinking it is too
+expensive. While all of these reasons are valid, they are not
+acceptable when one considers that 80 percent of the women who die of
+cervical cancer have not had a Pap test in five years or more.
+ As with other health issues, there is a tremendous chasm between
+minority, lower-income and/or less educated women as opposed to
+financially stable, employed and/or well educated women. According to
+the Department of Health and Human Services (HHS), one out of every
+three Hispanic women reported that they failed to get a Pap test in the
+preceding three years, compared with about one-quarter of all American
+women. In addition, another survey by HHS on Working Women's Health
+found that 87 percent of employed women had a recent Pap test within
+the past 3 years while 73 percent of women not in the labor force had
+done so. Pap testing for women in managed care plans living in certain
+regions of the country is also lower, according to the 1998 State of
+Managed Care Quality report. For example, 69 percent of women living in
+the mid-western Mountain states had cervical cancer screening while
+76.5 percent of the women in New England states had cervical cancer
+screening.
+ More women of color are dying from this disease as well. For
+instance, the rate of mortality for African American women is nearly
+twice that of Caucasian women according to HHS. Equally disturbing is
+the high rate of STD transmission within this community since HPV is
+the most common STD. In my own district of South-Central Los Angeles,
+the County Health Department reports that the rates of STDs among
+African Americans are up to 20 times higher than among whites and STD
+morbidity (except Chlamydia) is concentrated disproportionately in
+Central and South-Central LA. HPV infection and cervical cancer are
+serious risks for the inner-city communities I represent.
+ That is not to say that HPV infection is the only cause of cervical
+cancer, but rather, an important part of this health problem that is
+far too often misunderstood by women. According to the National Cancer
+Institute, other risk factors include smoking although it is not clear
+exactly how or why. Women whose mothers were given the drug
+diethylstilbestrol (DES) during pregnancy to prevent miscarriage from
+approximately 1940 to 1970 are at increased risk as well. There is also
+evidence indicating that women whose immune systems are weakened as a
+result of an organ transplant where drugs are administered to prevent
+rejection of the new organs are at higher risk.
+ Although the risk factors for cervical cancer can vary, the
+cultural, financial and even geographical barriers that complicate the
+fluid delivery of quality health care linger as a dangerous indication
+of the need for open and honest dialogue on this issue. As Members of
+Congress already in the public eye of our communities, we should do our
+part in raising public awareness on this critical issue.
+ Mr. Chairman, I applaud your work today and appreciate your giving
+me the opportunity to work with you in meeting this goal. Once again, I
+thank you for your support of the Cervical Cancer Public Awareness
+Resolution and I look forward to working with you to advance this
+cause.
+
+ [Additional statements submitted for the record follow:]
+ Prepared Statement of Hon. Rick Lazio, a Representative in Congress
+ from the State of New York
+ Mr. Chairman, one of my priorities as a Congressman is to fight
+cancer by bringing attention to this dreaded disease. We must find
+solutions for the women and men in our country who suffer from all
+forms of cancer.
+ I founded the House Cancer Awareness Working Group, a bipartisan
+working group which provides an educational forum where cancer
+patients, advocates, and scientists can heighten public and
+congressional awareness and offer recommendations to address the most
+pressing issues in the battle against cancer. We have focused on issues
+such as determining the best age for mammography screening, detecting
+prostate and ovarian cancer, preventing the onset of cancer through
+healthy eating, the cancer disparities between races and ethnic groups,
+the progress of genetic research, and the need for anti-discrimination
+legislation. Gaining the recognition of more than 40 Members of
+Congress, as well as the American Cancer Society and the National
+Cancer Institute, the Group will continue to fight cancer here in
+Congress.
+ In addition to the Working Group, I have recently re-introduced my
+legislation, The Breast and Cervical Cancer Treatment Act of 1999. This
+legislation will complete the CDC's National Breast and Cervical Cancer
+Early Detection Program (NBCCEDP) by adding a treatment component to
+the extremely successful screening program for low-income women who
+have little or no health insurance. We encourage early detection and
+screening, but treatment must be coupled with screening if we are ever
+going to save lives.
+ My legislation, introduced with Ms. Eshoo, would create an optional
+state program to allow these women to be covered under Medicaid while
+they are being treated for cancer. The hallmark of fairness is to
+ensure that women stricken with cancer can have the hope of a cure.
+This legislation is the right thing to do and I hope that every member
+of this committee will support it through cosponsorship.
+ Also, I have recently partnered with Rep. Millender-McDonald and
+Rep. Coburn in introducing a cervical cancer resolution recognizing the
+severity of the issue of cervical health and its relation to cancer as
+well as encouraging public awareness, education, and early detection.
+ Mr. Chairman, thank you for having this hearing. I look forward to
+working with you in taking the appropriate steps to combat this dreaded
+disease in every way we know how!
+ ______
+
+ Prepared Statement of Hon. Tom Bliley, Chairman, Committee on Commerce
+ Mr. Chairman, I applaud you for holding this hearing today on the
+issue of cervical cancer. I am proud to say this Committee is the first
+committee to hold such a hearing on this issue. I have worked very hard
+over the years to pass legislation of importance to public health and
+especially those related to the special health concerns of women. For
+example, I recently sent a letter to Dr. Richard Klausner, Director of
+the National Cancer Institute (NCI), on the importance of health
+issues, specifically in regards to women's health. One issue that I
+addressed was cervical cancer.
+ In the response to my letter, NCI stated there are 5,000 women who
+die from cervical cancer each year. In addition, thousands of others
+are diagnosed with the disease and begin treatment. In light of these
+alarming numbers, it is somewhat surprising the lack of attention given
+to cervical cancer in comparison to other diseases. A recent study by
+Wirthlin Worldwide indicated 70% of the women they surveyed did not
+even know what causes cervical cancer. Today, we have the sound medical
+evidence that demonstrates that human papillomavirus or ``H-P-V'',
+while not the only cause of cervical cancer, is the primary cause of
+cervical cancer. It is important that we have this hearing today to
+raise the awareness of cervical cancer and provide much needed
+information on the disease.
+ There are many new advances being made in cervical cancer
+detection, prevention and treatment. Today, we will hear about some of
+the new advances and treatments that are being made in the fight
+against cervical cancer. Until the day that cervical cancer becomes a
+disease of the past, we need to do all we can to make sure women know
+about cervical cancer, its causes and its treatments.
+ I would like to welcome all of our panels here today to testify. I
+would especially like to welcome Sen. Connie Mack for being with us
+today and for all of his efforts in the fight against cancer. In
+addition, I would like to thank Rep. Anna Eshoo, a member of this
+subcommittee, for appearing before it today. Thank you all for coming
+and testifying before us today.
+ ______
+
+ Prepared Statement of Hon. Henry A. Waxman, a Representative in
+ Congress from the State of California
+ Mr. Chairman, it is a pleasure to see this Subcommittee return to
+such an important issue. This is an area of public health where the
+Subcommittee has been aggressive and successful in enacting important
+legislation benefitting women's health.
+ In 1988, Congressman Dingell and I sponsored the Clinical
+Laboratory Improvement Amendments of 1988 (CLIA), which protects women
+from substandard Pap smears. In 1990 and 1993, I sponsored laws
+creating and strengthening the Federal government's programs to screen,
+prevent and treat breast and cervical cancers--the Breast and Cervical
+Cancer Mortality Prevention Act of 1990 and the Breast and Cervical
+Cancer Amendments of 1993.
+ At the time, we believed that these laws would help reduce cervical
+cancer's mortality. We funded comprehensive screening programs for low-
+income women, established quality guidelines for cytological screening,
+and supported health training and public education.
+ There are indications that these efforts, in conjunction with
+improvements in diagnosis and treatment, have borne some fruit. Deaths
+and the incidence of cervical cancer appear to have marginally declined
+in this country.
+ But we must do much more. In 1990, cervical cancer caused 6,000
+deaths. Last year, it caused 4,800 deaths--most of them preventable
+with proper screening and treatment. Despite the availability of such
+services to low-income women, there is evidence that this is not as
+widely known as it should be. That is why I strongly support
+Congresswoman Millender-McDonald and my colleagues on this Subcommittee
+for sponsoring the cervical cancer awareness resolution.
+ To save more lives, the next step for the members of this
+Subcommittee and the Congress will be to determine whether Federal
+funding and reimbursement for preventive screening and follow-up
+treatment is adequate.
+ I join my colleagues in welcoming our witnesses and look forward to
+their testimony.
+ ______
+
+ Prepared Statement of Hon. Gene Green, A Representative in Congress
+ from the State of Texas
+ I want to thank Chairman Bilirakis for scheduling this important
+hearing so that we can learn more about how to prevent and treat
+cervical cancer.
+ Each year in the United States, 15,000 women are diagnosed with and
+5,000 women will die from cervical cancer.
+ In fact, it is the second most common form of cancer effecting
+women today.
+ The good news is that we have learned a great deal about what
+causes cervical cancer.
+ The bad news is that there is no cure when it is not detected early
+on.
+ With this in mind, there are several steps that Congress can and
+should take to help reverse this trend.
+ First, we need better education of the health risks and behaviors
+that can help prevent cervical cancer.
+ Statistics indicate that while 93% of women with cervical cancer
+had the sexually transmitted disease HPV, the overwhelming majority of
+women have never heard of HPV--not to mention how to prevent it.
+ Second, federal health insurance programs should cover not only the
+screening to detect and diagnose cervical cancer--but also financial
+assistance to treat the women who test positive for this disease.
+ The federal government should lead by example when it comes to
+providing the most comprehensive health insurance for women.
+ Finally, we need to continue to increase funding for research by
+doubling the NIH budget.
+ Increasing research at NIH will give the thousands of women who are
+annually diagnosed with cervical cancer the best chance at finding a
+cure.
+ I look forward to hearing from our distinguished witnesses. Before
+Congress can help educate our constituents, we need to be fully aware
+ourselves.
+ ______
+
+ Prepared Statement of Hon. John D. Dingell, a Representative in
+ Congress from the State of Michigan
+ I applaud Mr. Bilirakis for scheduling this hearing on the
+important issue of cervical cancer. I also would like to applaud the
+bipartisan efforts of my colleagues in sponsoring H. Con. Res. 5, a
+resolution to promote public awareness of cervical cancer. This
+resolution points out the serious problems associated with cervical
+cancer and calls on the country as a whole to learn more about this
+disease through public awareness and education.
+ Last year, H.R. 4683, the Women's Health Research and Prevention
+Amendments of 1998, did not address certain important issues that
+affect women's health such as sexually transmitted diseases. Left
+untreated, sexually transmitted diseases can cause infertility, birth
+defects, disease, and can ultimately lead to death.
+ Perhaps now we can begin open, frank discussions of this topic
+since the primary cause of cervical cancer is one of the most common
+sexually transmitted diseases, human papillomavirus (``HPV''). Up to 80
+percent of women develop HPV at some point in their lives. HPV is
+unique in that it is largely asymptomatic, can cause cancer, and is so
+widespread.
+ Each year, an estimated 15,000 cases of cervical cancer are
+diagnosed, and 5,000 women die from this disease. Even though the
+incidents of death are lower when compared to other cancers, the impact
+of cervical cancer is felt worldwide. It is the leading cause of death
+among women in developing countries. The sad part about this is that
+most of these deaths are preventable.
+ The pap smear is the most effective tool for detecting cervical
+cancer; however, in many cases the results are inconclusive. Studies
+indicate that testing for HPV may be a more effective test for cervical
+cancer than pap smears. Regular pap smears combined with HPV testing
+would be a woman's best defense against cervical cancer.
+ I am pleased that my colleagues in the majority on this committee
+have shown interest in this important issue. We must raise awareness
+about cervical cancer if we are to stop women from needlessly dying
+from this curable disease. Let this hearing be a first step in enacting
+legislation that will ensure that the issue of cervical cancer receives
+the attention that it deserves. None of us should be satisfied until
+the cervical cancer death rate drops to zero.
+ Thank you.
+
+ Mr. Bilirakis. Call forward the second panel: Dr. Ronald
+Valdiserri, Deputy Director, Center for Disease Control and
+Prevention; Dr. Nancy Lee, Associate Director for Science, also
+with the Center for Disease Control and Prevention; Dr. Douglas
+Lowey, Deputy Director, National Cancer Institute, and Dr.
+Edward Trimble, Head Surgery Section, National Cancer
+Institute.
+ Welcome to this hearing. I apologize for the late start.
+Often when we're scheduled for a hearing, votes take place on
+the House floor, and that is why we were delayed in getting
+here.
+ Your written statements are a part of the record, and I
+would appreciate it if you could stay as close to the 5-minute
+light as you can in the process of complementing your written
+statement.
+ Dr. Valdiserri, we will start off with you.
+
+STATEMENTS OF RONALD O. VALDISERRI, DEPUTY DIRECTOR, CENTER FOR
+ DISEASE CONTROL AND PREVENTION; NANCY C. LEE, ASSOCIATE
+ DIRECTOR FOR SCIENCE, CENTER FOR DISEASE CONTROL AND
+ PREVENTION; EDWARD L. TRIMBLE, HEAD SURGERY SECTION, NATIONAL
+ CANCER INSTITUTE; AND DOUGLAS R. LOWEY, DEPUTY DIRECTOR,
+ NATIONAL CANCER INSTITUTE
+
+ Mr. Valdiserri. Good afternoon, Mr. Chairman and
+subcommittee members. I am Ron Valdiserri, Deputy Director of
+the National Center for HIV, STD, and TB Prevention at the
+Centers for Disease Control and Prevention. I thank you for the
+opportunity to testify today about what we know about the
+relationship between human papillomavirus infection and cancer
+of the uterine cervix.
+ Human papillomavirus, otherwise known as HPV, is a virus
+that infects the skin and mucus membranes. New laboratory
+techniques to identify HPV became available in the 1980's and
+revolutionized what we know about the epidemiology of HPV
+infection. Over 80 different types have been identified. Some
+viral types infect the hands and feet, causing common warts,
+while others are sexually transmitted and affect the genital
+area. Of the 30 or so types that infect the genital region,
+some cause clinically apparent genital warts and also low-grade
+Pap smear abnormalities, but are not associated with cervical
+cancer; hence, they are termed low-risk types. Approximately 10
+types are considered high risks for cancer, in that they are
+found in approximately 95 percent of all tissue specimens from
+cervical cancer patients.
+ It should be stated, however, the genital HPV infections,
+while they are not curable, that the vast majority are benign.
+Definitive studies on prevention strategies, including male and
+female condoms and newly developed microbicides, are,
+unfortunately, very limited. Most people who are infected with
+HPV are asymptomatic and do not develop warts. Infected men and
+women who develop genital warts are diagnosed by their typical
+appearance, usually without laboratory verification of the
+virus. Most women with HPV are diagnosed indirectly by Pap
+smear or by biopsy findings rather than having the HPV directly
+detected.
+ It is estimated that at least 50 percent of sexually active
+adults will acquire genital HPV infection. As many as 45
+million Americans may already be infected, and an estimated 5
+million new cases develop each year, making HPV the most common
+sexually transmissible disease. Again, more than 90 percent of
+people with HPV infections do not have symptoms, although they
+are potentially infectious.
+ Key risk factors for cervical HPV infection in women
+include a younger age and the number of sex partners. Cigarette
+smoking and oral contraceptive use have also been cited as risk
+factors. Unfortunately, risk factors for HPV in men have not
+been very well studied.
+ In most sexually active women who acquire HPV infection of
+the cervix, the virus becomes undetectable over time without
+specific treatment and causes no problems. However, for women
+whose infections persist, these women are more likely to be
+infected with the cancer-associated HPV types. Approximately 5
+to 10 percent of women with the high-risk types of HPV
+infection will develop cervical cancer without Pap smear
+screening and early treatment. Large studies comparing women
+with cervical cancer to those without it have shown that
+infection with one of these high-risk HPV types increases the
+risk of cervical cancer by at least 30-fold, a level similar to
+or higher than the risk of lung cancer association with
+cigarette smoking.
+ Laboratory and animal experiments also support a causative
+role for HPV and cervical cancer. In summary, there is now
+widespread consensus among cancer researchers that high-risk
+types of genital HPV play a causative role in cervical cancer
+and probably other types of anogenital cancer, including cancer
+of the penis and anus. Having HPV seems to be necessary for
+developing cervical cancer, but just having the infection alone
+is not sufficient to produce cancer. Other co-factors such as
+smoking, an abnormal immune system, and other genital track
+infections may also be important. My CDC colleague, Dr. Nancy
+Lee, will present an overview of cervical cancer screening
+programs later during this panel.
+ The recognition that cervical cancer is caused by a highly
+prevalent STD has important implications for public health.
+Vaccine development is a promising prevention strategy, and my
+NIH colleague will be discussing this issue. But even before
+the development of a vaccine, we can prevent cervical cancer in
+women who are already infected with HPV. For example, it may be
+possible to use HPV DNA tests as an adjunct to the Pap smear to
+improve the latter's accuracy. Studies are now underway to
+determine if these combined modalities would help to identify
+women who might otherwise be missed by Pap smear alone.
+ Several studies have also reported that providing HPV
+testing for these women can help determine who is likely to
+have a more serious problem, and so these tests might be
+combined with Pap smear screening to provide a triage of sorts
+to identify these individuals.
+ CDC is involved in a variety of research and programmatic
+activities related to HPV and cervical cancer. However,
+additional important activities must be undertaken. These
+include determining the clinical usefulness of HPV tests and
+their relative costs and benefits, developing appropriate
+counseling messages for women who learn that they have a
+cancer-associated STD, evaluating the effectiveness of various
+primary prevention strategies, and developing systems to track
+transient HPV.
+ Thank you for the opportunity to bring this important
+public health issue to your attention, and I will be glad to
+answer any questions that you might have.
+ [The prepared statement of Ronald O. Valdiserri follows:]
+ Prepared Statement of Ronald O. Valdiserri, Deputy Director, National
+Center for HIV, STD, and TB Prevention, Centers for Disease Control and
+ Prevention, Department of Health and Human Services
+ human papillomavirus infection and cancer of the cervix: what do we
+ know and what are the implications?
+ I am Dr. Ronald O. Valdiserri, Deputy Director of the National
+Center for HIV, STD, and TB Prevention at the Centers for Disease
+Control and Prevention (CDC). Thank you for the opportunity to present
+what we know about the relationship between human papillomavirus (HPV)
+infection and cancer of the cervix which was one of the most common
+cancers among women in this country prior to the introduction of Pap
+smear screening and remains one of the most common cancers worldwide.
+For more than a century, there have been suspicions that cancer of the
+cervix is caused by an infectious agent and behaves like a sexually
+transmitted disease (STD). For example, epidemiologic studies have
+consistently shown that cervical cancer is rare in virgins but much
+more common in women who are sexually active and at risk for other
+STDs--especially so in women who became sexually active at a young age,
+who have multiple sexual partners, or who have sexual contact with a
+man who has had multiple partners.
+ Over the past 50 years, there have been many studies attempting to
+assess whether a particular infection--such as gonorrhea, syphilis,
+chlamydia, or genital herpes--was the sexually transmitted agent that
+led to cervical cancer. Many of these studies cast suspicion on one or
+more of these infections, but the results remained inconclusive until
+the 1980s when, using newly developed laboratory techniques, evidence
+began to point to another, less well understood, STD: the human
+papillomavirus or HPV. Prior to that time, HPV was known to cause non-
+sexually transmitted warts at body sites such as the hands or feet, as
+well as sexually transmitted warts around the genitals. But because
+warts were rarely found on the cervix, it was thought unlikely that HPV
+could be playing a role in causing cervical cancer. The inability to
+recognize cervical HPV infection was in large part due to the problem
+that, unlike most other STD organisms, there was and still is no way to
+culture HPV in the laboratory.
+ The development of laboratory tests for detection of HPV/DNA, the
+genetic material of the virus, helped to overcome this problem and
+dramatically increased our estimate of just how frequent HPV infection
+of the cervix and other genital sites actually occurs. It is now
+estimated that approximately 5,000,000 new cases of genital HPV
+infection occur in the United States each year, making it the most
+common of all of the STDs. It is further estimated that at least 50
+percent of sexually active men and women will acquire genital HPV
+infection at some point and that as many as 45,000,000 Americans may
+already be infected. As with many STDs, most of these infections are
+asymptomatic, so that the majority of those with genital HPV are
+unaware of their infection--further contributing to its spread. The
+economic burden resulting from these millions of infections has not
+been clearly determined, but is likely quite large. One recent estimate
+by the Institute of Medicine was over $3 billion per year, more than
+that for any other STD apart from HIV infection.
+ The HPV DNA tests have revealed that there are many different
+strains or types of HPV; more than 80 types have been identified.
+Approximately 30 of these are found primarily in the genital area and
+are considered ``genital HPV''. While some of these 30 types are
+considered ``low-risk,'' primarily causing genital warts and low-grade
+Pap smear abnormalities, approximately 10 of these types are considered
+``high-risk'' for cancer in that they are found in approximately 95
+percent of all tissue specimens from cervical cancer. Large
+epidemiologic studies comparing women with cervical cancer to those
+without it have shown that, even when controlling for other factors
+that might make cervical cancer more likely, being infected with one of
+these high-risk HPV types increases the risk of cervical cancer by at
+least 30-fold, a level similar to or higher than the risk of lung
+cancer from smoking. In addition to these human studies, laboratory
+experiments provide additional support that HPV causes cervical cancer,
+by showing that when inoculated into cell culture systems, HPV causes
+the cells to grow in an ``out-of-control'', cancer-like fashion and
+that these out-of-control cells can then cause cancer when injected
+into mice. Thus, while definitively proving that an infectious agent
+causes a disease can be quite difficult, based on a large number of
+studies, there is now widespread consensus among cancer researchers
+that high-risk types of genital HPV clearly play a causative role in
+the development of cervical cancer, and probably other types of
+anogenital cancer, such as cancer of the penis and anus.
+ Having HPV seems to be ``necessary'' for developing cervical
+cancer, although having the infection alone is not ``sufficient'' to
+produce cancer, and other co-factors such as smoking, an abnormal
+immune system, and other infections may be important as well. The role
+of the immune system has been most clearly demonstrated in patients
+with HIV infection in whom very high rates of HPV infection occur and
+in whom both cervical and anal cancer appear to be increased. Although
+a large proportion of sexually active women will become infected with
+genital HPV, the majority of these infections become undetectable over
+time without specific treatment or the development of complications.
+Only those women whose infection persist are at risk for developing
+cancer, and it has been estimated that approximately 5-10 percent of
+women with high-risk types of HPV infection will develop cervical
+cancer. Pap smear screening programs and early treatment reduces this
+percentage even further.
+ The recognition that this important cancer is caused by a highly
+prevalent STD has important implications for public health. The first
+strategy to consider is that of primary prevention, namely, preventing
+cancer by preventing infection. Unfortunately, the traditional STD
+control strategy of preventing transmission by identifying infected
+persons and then treating them and their partners in order to prevent
+transmission to other partners currently has limited value for viral
+STDs such as HPV because existing therapies do not cure infection. The
+therapies available for both genital warts and cervical HPV infection
+will eradicate the tissue abnormality, but probably do not eliminate
+the infection entirely. Abstinence should be effective for preventing
+HPV infections, since the large majority are sexually transmitted.
+However, other approaches to prevent HPV infection are also promising.
+Latex condoms can be expected to be protective if they cover the
+genital skin that is infected and if they are used consistently and
+correctly. Several studies have shown condoms to provide some
+protection against cervical cancer, and the more recently developed
+female condom has promise as a physical barrier in the prevention of
+viral STDs because of its greater surface area.
+ Microbicides, chemicals that inhibit microbial growth and could
+potentially function as ``chemical barriers'' also have potential
+benefit. Some of these agents currently under investigation have been
+shown to inactivate genital HPV in the laboratory. Advantages of
+microbicides include both the possibility of inhibiting multiple STDs--
+such as HPV and HIV--with one agent, and providing a protective
+strategy under the control of the woman, in contrast to male condoms.
+ The most promising primary prevention strategy would be the
+development of an HPV vaccine. There are several animal models in which
+papillomavirus infections specific to the particular animal can be
+effectively prevented by immunization, which has created great optimism
+that vaccines against HPV might be beneficial in humans as well.
+ Several small studies are now underway in humans to determine
+whether the experimental HPV vaccines are sufficiently safe and
+effective at producing an immune response to warrant larger, more
+definitive studies. Because of the relatively large number of high-risk
+HPV-types believed to cause cervical cancer, effective vaccines will
+have to contain multiple types of HPV to achieve high levels of
+benefit, which increases the complexity and length of time it will take
+to develop and test them. Such preventive vaccines would ideally be
+given prior to the onset of sexual activity probably in early
+adolescence since most people who contract genital HPV infection do so
+within the first several years of sexual activity. Because the peak
+incidence of cervical cancer are between 35 to 55 years of age, it
+would likely be at least 20 years after the initiation of vaccine
+programs before we would see reductions in cancer rates. However,
+effective vaccines would also reduce the rate of pre-cancerous Pap
+smear abnormalities, known as dysplasia. Considering that the
+evaluation and treatment of dysplasia is among the most expensive
+aspects of the current cervical cancer prevention efforts, reductions
+would most likely occur much earlier in cost as well as the avoidance
+of anxiety that often accompanies the diagnosis of an incurable STD or
+pre-cancerous changes on a Pap smear.
+ Our current strategy is to prevent cancer in those who already have
+HPV infection. In essence, this is what Pap smear screening is directed
+toward--the early detection of pre-cancerous changes caused by HPV
+infection which can be evaluated and treated to prevent their
+progression. With the knowledge that HPV infection causes cancer, it
+may be possible to use HPV/DNA tests as an adjunct to the Pap smear to
+improve its accuracy. A single Pap smear does not identify all women
+who have serious abnormalities, so serial Pap smear screening is the
+current standard of care. Studies are underway now to find out if using
+HPV/DNA tests, along with the Pap smear, will increase the test
+sensitivity (in other words, the likelihood of identifying women with
+abnormal Pap smears). If these tests work well enough, they might not
+only prevent women with treatable problems from being missed, they
+might also allow Pap smears to be done less frequently than annually in
+most women, thereby reducing costs of screening. Furthermore, because
+samples for HPV testing are easier to collect than Pap smear samples,
+they may permit the development of self-collected swab kits for women,
+which, by avoiding the need for a full gynecologic exam, might be more
+convenient for many women and could encourage many more women to get
+tested for HPV. Such self-collected testing also facilitate development
+of outreach efforts, where field workers go into non-clinic locations
+to do testing, similar to approaches that have been used for community-
+based programs to address high blood pressure, high cholesterol,
+tuberculosis, and even STDs like chlamydia.
+ An even more immediate use of HPV tests for secondary prevention is
+their use to triage women with low-grade Pap smear abnormalities.
+Currently, the large majority of women in the United States with
+abnormal Pap smears have early changes that have a very low risk of
+progression to cancer, and yet, to be sure an important problem isn't
+missed, these women usually need to come back for several follow-up
+examinations, creating tremendous anxiety and expense. Several studies
+have reported that providing HPV testing for these women can help
+determine who is likely to have a more serious problem. If these
+reports can be confirmed by larger studies now underway, they may
+permit a more cost-effective approach to this very common problem.
+ Important work remains to be done before these strategies will be
+ready for widespread implementation. CDC is currently involved in a
+number of applied research and service activities to improve prevention
+of genital HPV infection and cervical cancer. Among these are:
+
+ studies of the epidemiology and natural history of HPV
+ infection and cervical cancer.
+ studies to better define approaches to clinical use of HPV
+ tests.
+ studies to assess HPV-related complications in patients with
+ HIV infection.
+ studies to determine mechanisms by which HPV causes cervical
+ cancer.
+ development and assessment of improved HPV tests.
+ implementation of a pilot national population-based
+ serosurveillance study to more accurately assess the extent of
+ genital HPV infection.
+ support of health care provider training programs regarding
+ both cervical cancer and genital HPV infection.
+ development of clinical practice guidelines for genital HPV
+ infection.
+ education of the general public through the CDC National STD
+ Hotline
+ implementation of the National Breast and Cervical Cancer
+ Early Detection Program that provides access to cancer
+ screening and follow-up for underserved women.
+ development of the National Program of Cancer Registries that
+ will enhance surveillance of cervical and other HPV-related
+ cancers. Currently, serious gaps in our knowledge preclude the
+ formulation of more effective prevention strategies for genital
+ HPV infection and cervical cancer:
+HPV Testing
+ If the ongoing studies to assess use of HPV tests for triage
+ of women with low-grade Pap smear abnormalities find this to be
+ a helpful strategy, we must determine if this approach works
+ equally well in all groups of women. For example, because
+ younger women have much higher background rates of HPV
+ infection than do older women, HPV testing may be too non-
+ specific (i.e. likely to test positive when no serious
+ abnormality really exists) to be helpful in the younger group,
+ and could turn out to be a ``double-edged sword'', creating
+ more anxiety and costs than it saves.
+ Studies to assess the use of HPV tests as an adjunct to Pap
+ smear screening will also need to demonstrate which groups of
+ women (such as younger vs older) get the most benefit from this
+ extra test.
+ As ``self-test'' kits are developed, program evaluations will
+ be necessary to find out how best to distribute them and
+ encourage their use. Any use of such HPV tests will require the
+ development of approaches both to counsel women who suddenly
+ discover that they have a cancer-associated STD, and to
+ evaluate their sexual partners.
+HPV Vaccine Development and Use
+ The development of effective HPV vaccines would be enhanced by
+ collection of additional surveillance data on the prevalence of
+ different types of HPV infection in different groups of men and
+ women, both to determine exactly which types of HPV a final
+ vaccine should contain and to track early benefit of vaccines
+ once they are licensed and widely used.
+ There is virtually no experience in ``marketing'' vaccines for
+ prevention of STDs and cancer to the general public or to
+ health care providers. Yet for HPV vaccines to achieve their
+ promise, their use will need to be as widespread in the
+ population as is the virus. Sexually active persons in all
+ socioeconomic groups are at risk for HPV infection; thus,
+ immunization of all persons who will potentially be sexually
+ active in the future would likely be the most effective
+ prevention approach. Behavioral and social marketing research
+ to explore this issue will be important and such research may
+ also have benefit for other STD vaccines, including those for
+ HIV.
+ To the extent that effective HPV vaccines are developed and
+ utilized and Pap smear abnormalities prevented, approaches used
+ in Pap smear screening programs will also likely evolve, since
+ criteria for what constitutes a suspicious smear may change as
+ certain types of HPV infection are prevented.
+Assessment of Non-Vaccine Strategies for Primary Prevention
+ Pending the availability of effective vaccines, a better
+ understanding of how well other primary prevention strategies
+ may work is important. Understandably, one of the major
+ concerns of patients diagnosed with genital HPV infection is
+ how to prevent it from being transmitted to sexual partners, an
+ issue that will only increase if clinical use of HPV testing
+ becomes more widespread. To this end, better information is
+ needed to determine how long someone with genital HPV is
+ contagious to a sexual partner and which prevention strategies
+ work best to prevent transmission.
+Programs to Assess Burden of Infection
+ Monitoring systems to provide information about rates of
+ various types of Pap smear abnormalities and of type-specific
+ genital HPV infections in targeted populations will be
+ important in planning and evaluating vaccine programs, as well
+ as in tracking the distribution of HPV infection in the
+ population. Such studies may be particularly useful in
+ clarifying rates and types of infections in men about which far
+ less is known than for infections in women.
+ Economic assessments of the costs resulting from HPV infection
+ are limited and not available for all populations. Furthermore,
+ existing analyses address only direct medical costs (the costs
+ of actually providing care), and there is virtually no
+ information on indirect costs (those resulting from lost
+ productivity or premature death of someone with a medical
+ problem) or intangible costs (such as anxiety and distress in
+ personal relationships). Such information is critical in
+ determining the potential public health and societal benefit of
+ various prevention programs.
+Programs to Increase Public and Health Care Provider Awareness
+ While better understanding of the prevalence of HPV and its
+ relationship to cancer will support better prevention efforts,
+ messages to educate the general public about HPV will need to
+ be clearly crafted to avoid undue anxiety, competition with
+ other public health prevention messages, and the possibility
+ because of the stigma associated with STD and undermining Pap
+ smear screening programs.
+ The issues around HPV are complex ones for health care
+ providers who must convey messages that are both accurate and
+ helpful to patients with concerns, often in time-constrained
+ clinical settings. In addition, because genital HPV infection
+ is a minor health problem for the vast majority of infected
+ people, proper education and counseling may be as important as
+ treatment. More cost-effective means to convey this information
+ is an important priority.
+ In April, 1999, CDC and the American Cancer Society will convene a
+pivotal meeting of national and international experts, including our
+NIH colleagues, to review possible prevention strategies and prevention
+research needs for genital HPV infection and its complications. The
+goal of this meeting is to develop priorities for a linked programmatic
+and research agenda for CDC and other public health agencies.
+
+ Mr. Bilirakis. Thank you very much, Dr. Valdiserri.
+ Dr. Lee?
+
+ STATEMENT OF NANCY C. LEE
+
+ Ms. Lee. Good afternoon, Mr. Chairman and the subcommittee
+members. Can you hear me? I am Dr. Nancy Lee, Associate
+Director for Science at the Division of Cancer Prevention and
+Control at the CDC in Atlanta. I am pleased to be here this
+afternoon to discuss how CDC approaches cervical cancer early
+detection through the National Breast and Cervical Cancer Early
+Detection Program.
+ As discussed in the previous presentation, infection with
+certain strains of HPV is one of the strongest risk factors we
+know for cervical cancer. But the most important risk factor
+for developing cervical cancer, at least from the point of view
+of what we can do about it now, is the failure to receive
+regular screening with a Pap smear.
+ Cervical intraepithelial neoplasia or CIN is the pre-
+cancerous condition that can develop into cervical cancer. With
+appropriate treatment, almost all women diagnosed with CIN
+should be cured of their condition. From the time a women
+develops CIN, it usually takes years before cervical cancer
+develops. So we have many opportunities to detect pre-cancerous
+lesions with regular Pap screening, treat them, and actually
+prevent cervical cancer. Furthermore, even if cervical cancer
+has developed, when detected at its earliest stage, the 5-year
+survival is over 90 percent.
+ The accepted screening test for cervical cancer is the Pap
+smear. Since introduction 50 years ago, the Pap smear has been
+credited with the steady decline in cervical cancer deaths in
+the United States. In 1994, well over 90 percent of all women
+had received a Pap test at least once in their lives, and 80
+percent had one within the preceding 3 years.
+ In 1990, as many of you have spoken already, Congress
+passed the Breast and Cervical Cancer Mortality Prevention Act.
+This act authorized CDC to establish a nationwide screening
+program to ensure that low-income women who are uninsured
+receive regular screening for breast and cervical cancer.
+ In fiscal year 1999, with appropriations of $159 million,
+the CDC entered into the ninth year of the National Breast and
+Cervical Cancer Early Detection Program. CDC supports programs
+in all 50 States, 5 U.S. territories, the District of Columbia,
+and 15 American Indian and Alaska Native organizations. The
+national program has provided more than 1.1 million Pap smears
+to over 700,000 women. However, with existing resources, it is
+able to screen only 12 to 15 percent of the eligible population
+annually. Significantly, almost half of the women screened are
+from minority racial and ethnic groups. This is the really good
+news: More than 31,000 cases of these pre-cancerous lesions
+have been detected and only 508 women have been diagnosed with
+cervical cancer.
+ This last set of statistics illustrates a key point that I
+always emphasize when I talk about the program. The main
+purpose of cervical cancer screening is to find pre-cancerous
+lesions, treat them, and cure them so that these women never
+have to be diagnosed with cancer.
+ Our program statistics illustrate the success of Pap
+testing and emphasize the proven strategy that can be used to
+fight this disease. We consider women who do not receive Pap
+tests to be a priority population. The national program
+endeavors to provide cervical cancer screening to women who are
+hard to reach because of cultural, language, or financial
+barriers. Our No. 1 goal must be to reach the largest number of
+unscreened women as our resources allow.
+ For example, many programs are involved with developing low
+literacy, bilingual, or culturally appropriate materials that
+are used in a myriad of training and outreach programs and
+educational campaigns. The various strategies used by different
+programs promote screening and increase knowledge and awareness
+of cervical cancer.
+ The Food and Drug Administration has approved three new
+technologies for Pap smears: ThinPrep, AutoPap and Papnet.
+These technologies all appear to do a somewhat better job of
+detecting cervical disease than conventional Pap tests. They
+are rapidly being adapted by laboratories nationwide and at
+least double the price of the conventional Pap test. However,
+there are concerns that the extra costs associated with these
+technologies will overshadow their benefits. In spite of the
+promise of these new technologies, the American College of
+Obstetricians and Gynecologists stated last year that their
+routine use, ``could not be recommended based on costs and the
+lack of sufficient data demonstrating whether they reduce the
+incidence of or improve the survival rate for an invasive
+cervical cancer.'' The College also concluded that the main
+strategy should be screening women who are not receiving
+regular Pap tests, as they account for the majority of new
+cervical cancer cases each year.
+ CDC is committed to increasing the awareness, availability,
+and use of cervical cancer screening services for women. We
+must also work hard to screen those women who are not receiving
+regular screening, as they are at greatest risk for developing
+cervical cancer. This is the hardest part of our job, but one
+we cannot ignore. The national program will continue to develop
+strategies to find those women most in need of the lifesaving
+benefit of Pap smear screening.
+ Thanks for your interest in cervical cancer detection
+programs at CDC, and I, as well, am pleased to answer any
+questions you may have.
+ [The prepared statement of Nancy C. Lee follows:]
+ Prepared Statement of Nancy C. Lee, Associate Director for Science,
+ National Center for Chronic Disease and Health Promotion, Centers for
+Disease Control and Prevention, Department of Health and Human Services
+ Good Morning, I am Dr. Nancy Lee, Associate Director for Science,
+within the Division of Cancer Prevention and Control of the National
+Centers for Chronic Disease Prevention and Health Promotion, Centers
+for Disease Control and Prevention (CDC) in Atlanta, Georgia. I am
+pleased to be here this morning to discuss how CDC approaches cervical
+cancer early detection through CDC's, National Breast and Cervical
+Cancer Early Detection Program (NBCCEDP).
+Background
+ Cervical cancer is nearly 100 percent preventable, yet according to
+the American Cancer Society, an estimated 12,800 new cases of invasive
+cervical cancer will be diagnosed in 1999 with about 4,800 women dying
+of the disease. The cervical cancer death rate declined 45 percent
+between the periods 1972-74 and 1992-94 and the overall incidence of
+the disease has decreased steadily from 14.2 per 100,000 in 1973 to 7.4
+per 100,000 in 1995. This is largely attributed to the effectiveness of
+Pap smear screening for cervical cytology.
+ Even with this success, there remains significant disparities in
+the incidence and mortality of cervical cancer among some racial and
+ethnic minority women, when compared to the rate in white women. The
+incidence rate for all U.S. women is about 8 per 100,000; however, the
+highest age-adjusted incidence rate of 43 per 100,000 occurs among
+Vietnamese women, probably reflecting lack of appropriate screening.
+Incidence rates of 15 per 100,000 or higher also occur among Alaska
+Native, Korean, and Hispanic women. The death rate of 6.7 per 100,000
+in African American women continues to be more than twice that of
+whites even though their incidence rate is slightly lower.
+Early Detection
+ Cervical cancer occurs at an average age of 54; however, cervical
+intraepithelial neoplasia (or CIN), the precursor lesion to cervical
+cancer, most often occurs in much younger women. For a woman with CIN,
+her likelihood of survival is almost 100 percent with timely and
+appropriate treatment. The fact that CIN occurs at a younger age tells
+us that it usually takes a substantial amount of time for cervical
+cancer to develop. This means that screening younger women is an
+important strategy that actually prevents cervical cancer from ever
+developing. Furthermore, when cervical cancer is detected at its
+earliest stage, the 5-year survival rate is more than 90 percent.
+Risk Factors
+ Studies that have identified risk factors associated with cervical
+cancer have shown that cervical cancer is closely linked to sexual
+behaviors, human papillomavirus (or HPV) infection, immunosuppressive
+disorders such as HIV/AIDS, as well as a failure to receive regular Pap
+smear screening. The sexual behaviors specifically associated with
+greater risk are intercourse at an early age, multiple male sexual
+partners, and sex with a male partner who has had multiple sexual
+partners. Experts agree that infection with certain strains of the HPV
+is one of the strongest risk factors for cervical cancer, but the most
+important risk factor for developing cervical cancer, at least from the
+point of view of what we can do about it, is the failure to receive
+regular screening with a Pap smear.
+Screening Tests
+ The principal screening test for cervical cancer is the Pap smear.
+Since its introduction 50 years ago by Dr. Papanicolaou, the Pap smear
+has been widely used and is credited with the steady decline in
+cervical cancer deaths in the United States. Nationwide estimates from
+1994 indicated that well over 90 percent of all U.S. women had received
+a Pap test at least once in their lives and that 80 percent had
+obtained one within the preceding 3 years.
+ Despite the ability of the Pap test to help reduce cervical cancer
+mortality, the test is far from 100 percent accurate. Approximately
+half of the inaccuracies are due to inadequate collection of the Pap
+smear by the health care provider and the other half are due to errors
+at the laboratory. Detecting a precancerous lesion such as CIN does not
+always mean that a cancer has been prevented because only some of the
+early precancerous lesions progress to cancer. Thus, the search for a
+more efficient means of screening for cervical cancer and precancer is
+ongoing.
+ The Food and Drug Administration has approved three new
+technologies for Pap smears: ThinPrep, AutoPap, and Papnet. The
+technologies all appear to do a somewhat better job of detecting
+cervical disease than conventional Pap tests. They are rapidly being
+adopted by laboratories nationwide and at least double the price of the
+conventional Pap test. However, there are concerns that the extra costs
+associated with these technologies will overshadow their benefits.
+ Two evaluations of cervical cytology were released in January: one
+done for the Agency for Health Care Policy and Research, and the other
+published in the Journal of the American Medical Association. Although
+the analyses were independently done, each determined that new
+screening technologies were cost-effective only if screening was
+infrequent, done every 3-4 years. They also found that the new
+technologies increased life expectancy by a relatively small amount
+compared with conventional Pap testing.
+ In spite of the promise of these new technologies, the American
+College of Obstetricians and Gynecologists stated last year that their
+routine use ``[could] not be recommended based on costs and the lack of
+sufficient data demonstrating whether they reduce the incidence of or
+improve the survival rate from invasive cervical cancer.'' The college
+also concluded that the main focus should remain screening women who
+are not receiving regular screening, as they account for the majority
+of cervical cancer cases.
+Screening Guidelines
+ There are several different recommendations from national,
+professional and governmental organizations on the frequency that women
+should receive a Pap test. The American Cancer Society, National Cancer
+Institute, American College of Obstetricians and Gynecologists,
+American Medical Association, American Academy of Family Physicians,
+and others developed a consensus agreement regarding cervical cancer
+screening. These organizations recommended annual Pap testing for all
+women who have been sexually active, or have reached the age of 18.
+ After three consecutive annual exams with normal findings, the Pap
+test could be performed less frequently at the discretion of the
+physician.
+ The U.S. Preventive Services Task Force recommends regular Pap
+tests for all women who are or have been sexually active, or who are 18
+or older, and who have a cervix. The Pap test should be performed at
+least every 3 years. However, the interval for each patient should be
+determined by the physician, based on the woman's history of risk
+factors.
+National Breast and Cervical Cancer Early Detection Program
+ Recognizing the value of appropriate cancer screening, Congress
+passed the Breast and Cervical Cancer Mortality Prevention Act of 1990
+(Public Law 101-354). This Act authorized the Centers for Disease
+Control and Prevention (CDC) to establish a national screening program
+to ensure that low income women who are uninsured or underinsured
+receive regular screening for breast and cervical cancer and prompt
+followup when necessary. In fiscal year 1999, with Congressional
+appropriations of $159 million, the CDC entered into the ninth year of
+the National Breast and Cervical Cancer Early Detection Program
+(NBCCEDP). This landmark program brings critical breast and cervical
+cancer screening services to underserved women, including older women,
+women with low income, and women of racial and ethnic minorities.
+ CDC supports early detection programs in all 50 states, five U.S.
+territories, the District of Columbia, and 15 American Indian/Alaska
+Native organizations. The goal of the national program is to establish,
+expand, and improve community-based screening services for women at
+risk. The goal is achieved by screening medically underserved women for
+breast and cervical cancer, providing appropriate and timely diagnostic
+evaluations for women with abnormal screening tests and treatment
+services if needed, developing and disseminating public information and
+education related to the detection and control of breast and cervical
+cancer, improving training of health professionals in the detection of
+these cancers, and finally, evaluating program activities through the
+establishment of surveillance systems.
+ The program targets cervical cancer screening services to women who
+are hard to reach and are unlikely to seek a Pap test because of
+cultural, language, monetary or institutional barriers. As a major
+public health program, our overall concern must be to reach the largest
+number of unscreened, eligible women as possible. Thus, we also
+consider all women who do not receive regular Pap tests a priority
+population for the program. Currently, the national program follows
+cervical cancer screening guidelines that are consistent with the
+consensus guidelines developed by the American Cancer Society and
+others.
+ Providing cervical and breast cancer health education and outreach
+services is an essential component to the NBCCEDP. With technical
+guidance, our funded programs have developed projects that are focused
+on specific at-risk populations and cover a wide range of prevention
+and research activities. For example, many programs are involved with
+developing low literacy, bilingual and culturally appropriate
+educational materials that are used in a myriad of unique training and
+outreach programs and educational campaigns. These various strategies
+used by the different programs result in the common goal of increasing
+knowledge and awareness of breast and cervical cancer and promoting
+screening for early detection.
+ CDC partners with many national organizations to address issues
+related to breast and cervical cancer screening in priority
+populations. For instance, CDC funds the American Social Health
+Association to formulate a national model for the prevention of
+cervical cancer, using two counties in North Carolina as pilot sites
+and focusing upon economically disadvantaged Hispanic and African-
+American populations and women living in hard-to-reach urban and rural
+areas. This cervical cancer prevention project consists of developing
+and delivering culturally appropriate media messages, educational
+materials, client support services, and health education workshops in
+the community setting.
+ CDC is committed to increasing the awareness, availability and use
+of cervical cancer screening services for women. The main purpose of
+cervical cancer screening is not to find cancer, but to find
+precancerous lesions. Early detection and treatment of precancerous
+cervical lesions identified by Pap screening can actually prevent
+cervical cancer; thus, the success of any cervical cancer screening
+program depends on the early detection, case management and treatment
+of precancerous cervical lesions.
+ The breast and cervical cancer program has provided more than 1.1
+million Pap test to a total of more than 700,000 women. With existing
+resources, the national program is able to screen 12-15 percent of the
+eligible population annually. Almost half of the women screened are
+from minority racial and ethnic groups. Of Pap tests provided, about 3
+percent were abnormal; more than 31,000 cases of precancerous lesions
+were ultimately diagnosed, and 508 women were diagnosed with invasive
+cervical cancer. These statistics illustrate a key point for this
+essential public health program. The main purpose of cervical cancer
+screening is to find precancerous lesions, treat them, and cure them,
+so that these women do not go on to be diagnosed with cervical cancer.
+Of all the women diagnosed with cervical disease through our program,
+fewer than 2 percent actually had a diagnosis of cancer. The program
+has potentially averted cancer in more than 31,000 women! This
+underscores the success of Pap testing and emphasizes the proven
+strategy that we as public health practitioners can use to fight this
+cancer.
+ As mentioned earlier, the success of any cervical cancer screening
+program depends on the early detection and treatment of precancerous
+cervical lesions. But we must also work hard to screen those women who
+are not regularly screened elsewhere. Research has shown that they are
+at the greatest risk for developing cervical cancer. This is the
+hardest part of our job, but one we cannot ignore. The National Breast
+and Cervical Cancer Early Detection Program will continue to develop
+strategies to find those women and provide the life-saving benefit of
+Pap smear screening.
+ Thank you for your interest in the cervical cancer early detection
+activities at CDC. I would be pleased to answer any questions you may
+have.
+
+ Mr. Bilirakis. Thank you very much, Dr. Lee.
+ Dr. Lowey. Well, all right, Dr. Trimble.
+
+ STATEMENT OF EDWARD L. TRIMBLE
+
+ Mr. Trimble. Good afternoon, Chairman Bilirakis and
+subcommittee members. Thank you for inviting us to speak today.
+I am an obstetrician/gynecologist and gynecologic oncologist.
+My responsibility at NCI is the development of a new treatment
+for women with gynecologic cancer.
+ As we have heard, cervical cancer is the third leading
+cause of cancer deaths for women around the world. In the
+United States the number of cases and deaths have dropped
+dramatically, primarily due to effective screening and
+treatment of pre-invasive disease.
+ As we have heard, more than 90 percent of cases are due to
+infection with the human papillomavirus, but the vast majority
+of men and women who have infection with this virus will face
+no adverse health consequences.
+ The other risk factors that have been identified include
+cigarette smoking, a higher number of pregnancies, lower socio-
+economic status, immunosuppression, multiple sexual partners, a
+high-risk sexual partner, and an early age of onset of sexual
+activity.
+ The treatment for pre-invasive cancer is generally surgery
+for those with disease confined to the cervix, and radiation
+therapy for women found to have cervical cancer grown beyond
+the cervix into the pelvic tissues. The 5-year survival rate
+for those with disease confined to the cervix is 90 percent
+compared to only 50 percent for those whose disease is found to
+extend beyond the cervix.
+ We evaluate new treatment options primarily through the
+NCI's Clinical Trials Cooperative Groups, which bring together
+doctors and nurses and patients around the country. Recently,
+five of these trials--conducted by the Gynecologic Oncology
+Group, the Southwest Oncology Group, and the Radiation Therapy
+Oncology Group--enrolled 1,900 women with cervical cancer. The
+results of these trials showed that chemotherapy given at the
+same time as radiation therapy improved survival and decreased
+the number of recurrences.
+ When the NCI became aware of these results, we convened a
+jury with doctors and a representative from the patient
+advocacy community to review the results. That panel voted
+unanimously that the National Cancer Institute should issue a
+clinical announcement, as Senator Mack mentioned. This
+announcement was sent to 14,000 physicians, was placed on the
+NCI website, and we also worked closely with the New England
+Journal of Medicine, to whom 300 manuscripts were submitted, to
+speed review and publication of these important results.
+ We continue to work through our cancer centers, through our
+cooperative groups, through our grantees, and through
+investigators at the National Institutes of Health on ways to
+improve treatment. We are working to see whether fertility-
+sparing surgery can be useful to see if we can improve our
+chemotherapy and radiation therapy as well as to develop
+vaccines against the human papillomavirus.
+ Dr. Lowey will address the issue of vaccine development in
+greater detail. We are very excited about his research and that
+of other investigators in the field because we have the
+potential that we may able to prevent initial infection with
+human papillomavirus as well as to improve treatment for women
+diagnosed with cervical cancer.
+ Mr. Bilirakis. Thank you, Dr. Trimble.
+ Dr. Lowey.
+
+ STATEMENT OF DOUGLAS R. LOWEY
+
+ Mr. Lowey. Yes, good afternoon, Mr. Chairman and
+subcommittee members. I am Douglas Lowey. I am the Deputy
+Director of the Division of Basic Sciences in the National
+Cancer Institute and also run a research laboratory at the NIH
+that studies papillomaviruses. I would like to thank you for
+the opportunity to talk with you today about the prospects of
+developing a vaccine against HPV infection.
+ As you have already heard, cervical infection with human
+papillomavirus is the most common sexually transmitted
+infection of women. Abnormal Pap smears and pre-malignant
+lesions represent a manifestation of this infection, and
+virtually all cervical cancers arise as a consequence of
+infection by these viruses. In addition, there is also evidence
+that links HPV infection at other sites in the body to several
+other types of cancers.
+ The demonstration that pre-malignant conditions and cancers
+are caused by an infectious agent such as a virus implies that
+a safe and effective vaccine which could prevent the infection,
+would prevent the pre-malignant adnormalities as well as the
+cancers. It is also possible that a vaccine directed against
+the virus might have therapeutic effects. However, the history
+of virus vaccines indicates it is much more difficult to
+develop vaccines that cure established infection than to
+develop ones that prevent infection.
+ The principal message I would like to convey today is that
+we believe real progress is being made toward achieving the
+goal of developing an effective, preventive vaccine against
+HPVs involved in cervical cancer. My reasons for this optimism
+are based on vaccine studies of papillomavirus infection in
+animals, on early phase vaccine trials in normal human
+volunteers, as well as on the composition of the vaccine.
+Efforts to develop papillomavirus vaccines with therapeutic
+potential are also being pursued, as Mr. Mack mentioned in his
+testimony.
+ The preventive papillomavirus vaccine is a subunit vaccine
+that is made by genetic engineering techniques analogous to
+those used to make recombinant Hepatitis B vaccine, which is
+widely used in the United States and elsewhere. The preventive
+vaccine currently in human trials is composed of multiple
+copies of just a single viral protein which self-assembles to
+form the outer shell of the virus particle in a manner that
+faithfully mimics the structure of this shell in an infectious
+virus. However, unlike infectious virus, the virus-like
+particles in the vaccine are not infectious since they don't
+contain any papillomavirus genes. Therefore, the vaccine is
+unlikely to be dangerous for normal individuals.
+ In animal papillomavirus models, vaccination with the
+papillomavirus vaccine has been 90 percent to 100 percent
+effective in preventing infection. Several pharmaceutical
+companies are actively involved in the commercial development
+of such a vaccine.
+ Clinical trials are also being carried out by the National
+Institutes of Health. This represents a trans-NIH effort with
+important support from the NIH Office of Research on Women's
+Health, the NIH Office of Research on Minority Health, the
+National Institute of Allergy and Infectious Diseases, and the
+National Cancer Institute.
+ In humans, although only a little more than 100 individuals
+have thus far received the vaccine, it has been well tolerated
+by those individuals, and almost everyone who has received
+adequate doses of the vaccine has mounted a strong immunologic
+response against the vaccine. Such an immune response often
+correlates with protection against infection, but the early
+phase trials cannot determine whether or not the vaccine is
+effective. These are encouraging results. However, it remains
+possible that the first generation vaccine may not be as
+effective in people as we hope.
+ If additional vaccine studies in normal individuals over
+the next year continue to show promise regarding safety and
+immune response, the National Institutes of Health would plan
+to initiate a large-scale, placebo-controlled efficacy trial in
+Costa Rica, a country with high rates of cervical cancer, where
+the National Cancer Institute already works closely with a
+local research team to study HPV infection in young Costa Rican
+women.
+ An efficacy trial will take a few years to complete since
+the vaccine needs to be evaluated in unaffected women, and its
+effectiveness can only be learned after HPV has developed in a
+reasonable number of those women who receive the placebo.
+Therefore, even if the vaccine proves to be effective in trials
+conducted by the NIH and by pharmaceutical companies, it will
+take several years before the vaccine would become available to
+the general public.
+ I am grateful to you for giving me this opportunity to
+discuss this issue with you, and I applaud your efforts and
+your concerns about cervical cancer and would be happy to
+answer questions. Thank you.
+ [The prepared statement of Edward L. Trimble and Douglas R.
+Lowey follows:]
+ Prepared Statement of Edward L. Trimble, Head, Surgery Section,
+Division of Cancer Treatment and Diagnosis and Douglas R. Lowy, Deputy
+ Director, Division of Basic Sciences, National Cancer Institute,
+ National Institutes of Health, Department of Health and Human Services
+ Good afternoon. We are Edward Trimble, M.D., Head of the Surgery
+Section for Division of Cancer Treatment and Diagnosis and Douglas
+Lowy, M.D., Deputy Director for the Division of Basic Sciences at the
+National Cancer Institute. It is our pleasure to appear today to
+discuss the progress we are making in cancer research, specifically
+cervical cancer research, and to discuss the importance of conveying an
+understanding of these advances to the American public.
+ We are making real progress against cancer. We measure progress
+against cancer in two ways: first, the increase in knowledge about
+cancer, and second, the reduction of the burden of this disease on
+people. We have made progress in both our fundamental understanding of
+this disease and in our efforts to prevent and treat it. This is
+already evident in the declining cancer incidence and death rates.
+Between 1990 and 1995, these rates dropped for all cancers combined and
+for most of the top 10 cancer sites, reversing an almost 60-year trend
+of increasing cancer cases and deaths in the United States.
+ After increasing 1.2 percent per year from 1973 to 1990, the
+incidence rate for all cancers combined declined an average of nearly 1
+percent per year between 1990 and 1995. The incidence rates declined
+for most age groups, for both men and women, and for most racial and
+ethnic groups. The exceptions were black males, where the incidence
+rates continued to increase, and Asian and Pacific Islander females,
+where the incidence rates were level. The overall death rate declined
+an average of 0.5 percent a year from 1990 to 1995, with the declines
+greater for men than for women. The only racial and ethnic group not
+included in the decrease in death rates was Asian and Pacific Islander
+females.
+ From 1950 to 1970, the incidence and mortality rates of invasive
+cervical cancer fell impressively by more than 70 percent. From 1970 to
+1995, these rates decreased by more than 40 percent. Although cervical
+cancer has been steadily decreasing, worldwide it is still the third
+most common cancer among women. About 400,000 new cases are diagnosed
+each year, predominantly among the economically disadvantaged, in both
+developing and industrialized nations. In 1999 an estimated 12,800
+cases of invasive cervical cancer are expected to occur in the United
+States and approximately 4,800 women will die. We must continue our
+research efforts to determine the most effective ways to eliminate
+cervical cancer.
+Recent Advances in Understanding Cancer
+ As we understand the nature of cancer, we understand that it is a
+complex set of diseases, and that the answers to cancer are related to
+the most fundamental mysteries of life itself. We know that cancer is
+not one disease, but at least 100 different diseases that share certain
+features. Because of this it is unlikely that one magic bullet will
+solve the problem.
+ The most remarkable progress in the past 25 years has been in our
+knowledge of cancer biology. We are dramatically extending our
+understanding of what is required to turn a normal cell into a cancer
+cell. Cancer arises when a single cell changes so that it divides
+continuously, released from the controls that constrain the replication
+of normal cells. This transformation results from changes in the
+function and activity of genes. Of the approximately 100,000 genes
+found in the human genome, the altered activities of only a relatively
+small number of genes are responsible for transforming a normal, well-
+behaved cell into a cancer cell. Identifying these cancer genes defines
+the central scientific hunt in cancer biology, and opens an
+unprecedented window into the nature of cancer. Up until now, our
+detection tools have lacked the sensitivity and the specificity that we
+must demand if early detection is to be useful and successful. Our
+interventions, despite their success, have, by and large, been the
+result of guesswork. But now, we are at a point where we can transform
+our approach to cancer.
+ No one genetic alteration is enough to make a normal, healthy cell
+a cancer cell. Rather, an accumulation of changes in a relatively small
+number of genes during the lifetime of a cell is required. We have
+learned that some individuals carry a very high lifetime risk of
+developing cancer. This understanding has allowed us to begin
+describing the evolution of specific cancers from predisposition to
+precancer to cancer. Each cancer is ultimately defined by its
+particular pattern of altered and normal gene activity. This unique
+pattern determines the cancer's rate of growth, tendency to spread,
+responsiveness to hormones and therapies, and also predicts the ability
+of a persons immune system to recognize and respond to the cancer.
+Moreover, cataloging these molecular patterns will ultimately tell us
+how many different cancers exist, and enable us to distinguish the
+differences between a cancer cell and a normal cell.
+ We also are learning to understand the causes of cancer. Research
+on cancer risk--the probability that the disease will occur in a given
+population--is identifying populations with a significant probability
+of developing cancer. Because cancer is a multistage process, analysis
+of risk factors leads to the development of prevention and control
+strategies, as well as early detection methods, and in some cases more
+precise treatments. Epidemiologic research has identified many factors
+that increase cancer risk. Most of these are related to environment and
+lifestyle, while others are part of a person's genetic makeup. With the
+exception of a few genetic conditions, however, it is still not
+possible to predict with any degree of certainty that a person having
+one or more of these factors will develop cancer. This uncertainty is
+related to the very nature of cancer and the need for many specific
+alterations to accumulate in a single cell for that normal cell to be
+transformed into a cancer cell.
+Understanding Cervical Cancer
+ The etiology of cervical cancer is similar throughout the world.
+Cervical cancer results from a series of genetic changes. The National
+Cancer Institute is funding numerous studies to enhance our
+understanding of cervical cancer. Epidemiologic studies have
+demonstrated that infection with human papillomavirus (HPV) is the
+major risk factor for development of preinvasive or invasive carcinoma
+of the cervix. The virus contains oncogenes that can cause genetic
+changes or mutations in the cells, but further changes are necessary
+for cancer to develop. In most women and men with HPV infection, these
+other genetic changes do not occur and therefore, the individuals do
+not develop cancer or experience other adverse health effects besides
+HPV infection. A large study in Costa Rica also aims to understand why
+common HPV infections sometimes persist and progress to cervical
+cancer. Ethnicity-related host factors such as immune status, genetic
+susceptibility markers, parity and nutrition are being studied
+intensively. Findings from this investigation are likely to be relevant
+to minority populations in the United States since the incidence and
+mortality rates for cancer of the cervix are two to three times higher
+in Hispanic and African American women compared to White women. Certain
+Asian American populations, especially Vietnamese women, also have high
+rates of cervical cancer. Ethnic differences exist mainly in women over
+50 and are decreasing over time. Other known cervical cancer risk
+factors include long intervals since last Pap test, multiple sexual
+partners, cigarette smoking and higher number of births.
+Cervical Cancer Screening
+ The majority of cervical cancers develop through a series of
+gradual, well-defined precancerous lesions. During this lengthy
+process, the abnormal tissue is easily detected by the Pap test. In the
+majority of women, the abnormalities will clear up without treatment,
+but in some instances a few of these abnormal cells will develop into
+cervical cancer. Early detection of the disease through the use of a
+Pap test is directly related to survival. The five year relative
+survival rate for cervical cancer is 88 percent for women with an early
+diagnosis of localized disease. For women initially diagnosed with
+later stage cervical cancer, the survival rate is only 13 percent.
+Studies have found that the risk of developing invasive cervical cancer
+is 3-10 times greater in women who have not been screened. Risk also
+increases with longer duration following the last normal Pap test.
+ Women ages 65 and older account for nearly 25 percent of cervical
+cancer cases and 41 percent of cervical cancer deaths in the United
+States. A National Health Interview Survey has shown that more than
+one-half of all women ages 65 and older have not had a Pap test in the
+past three years. The pap test is the most effective screening
+procedure for detecting abnormal changes in the cervix but many older
+women do not know how often to get a Pap test, and are unlikely to be
+tested regularly. Since, many older women do not get regular pap tests,
+the older a woman is when cervical cancer is diagnosed, the more likely
+she is to be diagnosed with later stage disease.
+ NCI is conducting a large national study to find the best way to
+manage the mild abnormalities that often show up on Pap tests. The
+study, called the ASCUS/LSIL Triage Study or ALTS is comparing three
+approaches: 1) immediate colposcopic exam and biopsy (the current
+standard); 2) repeating Pap test every six months (because most
+abnormalities return to normal without treatment); and 3) testing for
+cancer-associated types of HPV as a means to differentiate between
+abnormalities that need immediate colposcopy and those that can be best
+followed with repeat Pap tests. The final results of this study are
+expected in three years and could affect the 2 to 3 million American
+women each year who learn that their Pap test has uncovered a mildly
+abnormal change in cells lining the cervix.
+Advances in Therapy
+ Despite screening, women still get cervical cancer and need
+therapy. Forty years ago, it was not clear that cancer, other than that
+which could be removed surgically, could even theoretically be cured.
+The first proof that cancer can be treated and cured came with
+childhood cancers, where survival was once measured in weeks to months
+and where now the great majority of children with cancer are cured.
+Now, for some cancers, our ability to cure is relatively predictable.
+For others, our ability to cure is remarkably unpredictable.
+ Cancer research is also improving the traditional mainstays of
+treatment--surgery, radiation, and chemotherapy. Clinical trials are
+instrumental in these improvements. Last month in an important advance
+notice, NCI issued a Clinical Announcement to thousands of physicians
+who treat cancer, describing the results of five large studies that
+have shown that women with invasive cervical cancer have better rates
+of survival when they receive chemotherapy that includes the drug
+cisplatin along with radiation therapy. Until last month, surgery or
+radiation alone had been considered standard treatment for this form of
+cancer. The new findings show that the risk of death from cervical
+cancer was decreased by 30 percent to 50 percent by combining
+cisplatin-based chemotherapy with radiation therapy in women who
+require radiation therapy for treatment of cervical cancer. This new
+approach to cancer therapy is the direct result of the Nation's
+clinical trials system.
+Cervical Cancer Prevention
+ NCI is leading the development of a vaccine to prevent cervical
+cancer. This vaccine is based on the concept that almost all cervical
+cancers are caused by papillomavirus infections. (HPV type 16 has been
+found in more than one-half of cervical cancers, and three other types
+of HPV are found in another 30 percent of the tumors.) The vaccine has
+proven highly effective in animal trials. The vaccine is likely to be
+safe since it is not infectious and does not contain the potentially
+cancer causing viral genes. Among prevention vaccines in development,
+three early phase trials are in progress and being tested in people.
+One of these, developed at NCI in collaboration with the National
+Institute of Allergy and Infectious Diseases (NIAID), the NIH Office of
+Research on Minority Health and Johns Hopkins University, has been
+tested in a phase I trial, and the preliminary results have been very
+encouraging, showing that it stimulated production of HPV antibodies
+and was safe. If these results are confirmed after further follow up
+and analysis, a full efficacy trial will test the NCI vaccine in a
+larger group of women in the United States and Costa Rica, leading to a
+full phase III trial in Costa Rica. Determining the long term efficacy
+of this preventative vaccine will take several years. The NCI is also
+working with investigators in universities and industry to develop
+vaccines which might improve cancer treatment.
+ NCI also conducts and supports research into behavioral aspects of
+cancer prevention. Smoking cessation is a major research priority at
+NCI since exposure to cigarette smoke is associated with increased
+rates of many cancers, including cervical. Dietary intervention is
+another research priority for the institute since increased intake of
+certain micronutrients and other dietary factors such as carotenoids
+have been suggested as being associated with a decreased risk for
+developing cervical cancer.
+Public Understanding
+ Communicating with cancer patients, individuals at high risk for
+cancer, the general public, and the health care community is a central
+component of NCI's mission and mandate. Our programs are based upon
+needs identified through epidemiologic studies and market research
+among specific population groups, resulting in programs that are
+relevant and understandable to each group. Our patient education
+program, leadership initiatives for special populations, and minority
+research networks are all actively involved in spreading state-of-the-
+art information about cancer prevention, detection, diagnosis,
+treatment, and care.
+ The primary avenues NCI uses to communicate with the public and the
+health care community are:
+ Clinical Announcements: Important cancer research findings are
+released directly to the public and to the thousands of physicians who
+treat cancer patients through NCI's clinical announcements.
+Announcements of research findings are mailed directly to physicians
+and the national press is provided with the announcements so that they
+can inform the public.
+ World Wide Web (http://www.nci.hih.gov): Currently NCI is
+redesigning its web site to increase its usefulness as a communication
+tool. The new web site will be organized so that clinicians,
+researchers, and the public can quickly and easily locate up-to-the-
+minute information that is relevant to their needs. A new addition to
+NCI's Web site is the Cancer Trials site (http://
+www.cancertrials.ncl.gov). Through this site, patients, health care
+professionals, and the public can learn about ongoing NCI-sponsored
+trials, read about the most recent advances in cancer therapy, and
+explore other information resources related to cancer treatment. This
+web site was used by many patients and others who wanted information
+about treatment advances publicized over the past several months.
+ Cancer Information Service (CIS): The CIS provides accurate, up to
+date cancer information to patients and their families, the public, and
+health care professionals in every state through 19 offices located at
+NCI-funded Cancer Centers and other health care institutions. By
+dialing 1-800-4-CANCER, callers are automatically connected, free of
+charge, to the office serving their region. Information on specific
+cancer types, state-of-the-art care, clinical trials, and resources
+such as support groups or screening and smoking cessation programs is
+provided in English or Spanish by specialists who respond to more than
+600,000 inquiries annually. The CIS regional offices are NCI's focal
+point for state and local cancer education efforts that target
+underserved, high risk, and low literacy populations.
+ The CIS distributes informational resources on cervical cancer free
+of charge. In order to reach the ethnic populations that are at
+increased risk for cervical cancer, NCI is collaborating with the Food
+and Drug Administration in distributing Pap test and cervical cancer
+brochures in Vietnamese, Cambodian, Samoan, Laotian, Thai, Chinese, and
+Korean. The CIS also distributes an intertribal video on early
+detection of cervical cancer for American Indian Women that was
+produced in conjunction with the Nebraska Department of Health.
+ Physician Data Query (PDQ): Patients and health care professionals
+want and need access to accurate, up-to-date, comprehensive information
+about ongoing clinical trials. Through PDQ, NCI provides information
+about NCI-sponsored trials. We are in the process of expanding the
+database, with the cooperation of patient advocates, the Food and Drug
+Administration, and the pharmaceutical industry, to include all cancer
+clinical trials approved by the FDA and to revamp the way information
+is presented. This system has served as a model for other institutes at
+the National Institutes of Health, and we want to ensure that it
+continues to be responsive to the needs of the communities we serve.
+ Medical choices are increasingly made on an individual basis,
+requiring that physicians and their patients have access to the
+resources needed to make an informed decision about their treatment and
+care. Communicating the importance of research findings to physicians
+and patients in a clear and understandable manner is central to making
+critical decisions about a patient's treatment and care. NCI has
+launched a new national media campaign on cervical cancer screening--
+``Pap Tests: A Healthy Habit for Life.'' The first phase of the
+campaign is focused on encouraging women, ages 65 and older, to get
+regular Pap tests since they continue to be at risk for cervical cancer
+although their screening rates decrease with age. The second phase of
+the campaign targets health professionals, encouraging them to continue
+to screen their older female patients because research has shown that
+general and family practitioners are not likely to screen their older
+female patients.
+ NIH Consensus Statement on Cervical Cancer: The objective of this
+NIH Consensus Statement is to inform physicians and the general public
+of the results of the 1996 NIH Consensus Development Conference on
+Cervical Cancer. Following established procedures, the consensus
+statement was prepared by a non-Federal, nonadvocate, 13 member panel
+representing the fields of obstetrics and gynecology, gynecologic
+oncology, radiation oncology and epidemlolgy. The statement provides
+state-of-the-art information regarding preventive approaches and
+appropriate management of cervical cancer and presents the conclusions
+and recommendations of the consensus panel regarding these issues. In
+addition, the statement identifies those areas of study that deserve
+further investigation such as: studies to assess quality-of-life issues
+in patients undergoing therapy for both preinvasive and invasive
+lesions of the cervix; research on the modification of high-risk
+behavior in young people to reduce the rate of HPV; research on ways to
+improve screening in populations that are typically underscreened such
+as the elderly, ethnic minorities, and the poor; and research on the
+development and testing of prophylactic and therapeutic vaccines
+against HPV.
+ We hope this overview provides you and the members of the committee
+a sense of the importance of ongoing research on cervical cancer. Thank
+you for your interest in the cervical cancer research activities of the
+NCI. We would be pleased to answer any questions.
+
+ Mr. Bilirakis. Thank you very much, Dr. Lowey.
+ In the process of trying to prepare for these hearings, we
+always ask that the testimony be submitted as much in advance
+as possible. The testimony came in from CDC, as I understand
+it, this morning. I know that in your particular case, we gave
+you plenty of notice for this hearing.
+ With all due respect, we would appreciate you help by
+submitting testimony promptly in the future.
+ For years, when Florida's late Governor, Lawton Chiles, was
+in the Senate up here, we worked together. I was a co-chairman
+with him on the subject of infant mortality. After discussions
+and research, we determined that there are adequate resources
+available to help reduce the very high incidence of infant
+mortality in this country. But, the problem was being able to
+get the mothers-to-be to the resources. That was a big problem.
+We came up with mobile sources. If we could not get them to
+come to us, we would go to them.
+ If a person qualifies for Medicaid, the program covers the
+Pap smear. Medicare, because of recent legislation I wrote with
+Mr. Brown and others, covers it now. I believe most, if not
+all, private insurance plans do. Now I know that there is a
+group of people who don't fall in those particular categories.
+What is the roadblock to Pap smear screening? We have
+determined that the early detection is so very critical. Can
+you address that, Dr. Valdiserri or Dr. Lee?
+ Ms. Lee. Yes, that is a very good question, and I think
+there are many barriers. There has been a lot of research in
+this area.
+ Our program particularly is targeting those women that
+don't have any insurance, including Medicaid. Those women are
+from that 40 million, and we, of course, only have funds to
+cover about 12 to 15 percent of that population.
+ The research indicates a lot of factors. It is real
+important that physicians and other healthcare providers take
+the lead in encouraging women because many women take their cue
+from their physicians. It is real important for us to encourage
+all healthcare providers to add this to the many things they
+are supposed to be doing.
+ We know that cervical cancer is highest in poor women,
+uninsured women, minority women, and women who are foreign-
+born, and women who don't receive regular healthcare.
+ Mr. Bilirakis. But, you are talking now of women who may
+not be well informed about the nature of this threat.
+ Ms. Lee. Correct. Exactly. So there are many parts of CDC's
+National Breast and Cervical Cancer Early Detection Program
+that we are trying to come in and figure out how to get those
+women--that is what I talked about in my testimony. That is our
+hard job, to get the women who nobody else can seem to get. We
+can pay for it, but we would have to find them.
+ We have given money to many primarily community-based
+organizations throughout the country, to farm worker
+organizations, migrant health, to organizations that provide
+services to Asian immigrants, to Hispanic and Latin American
+immigrants, to organizations targeting Hispanic, elderly and
+the elderly in the Black community. We go through churches. We
+go through community clinics. We have programs that fund lay
+health educators, and actual women who themselves have had
+cancer, but are not otherwise trained in the health profession
+to go out and witness to women about what they need to do. So,
+there are many strategies that we are working on identifying.
+ We actually have a whole set of grants now. I will conclude
+my answer with this: a bunch of grants to these community-based
+organizations take proven strategies that have been proven
+through good evaluation research and disseminate them into the
+community or different communities around the country. These
+are the efforts that we are trying to do to reach these women
+that nobody else can seem to reach.
+ Mr. Bilirakis. College women would not generally fall
+within the category that you described. Yet, I understand that
+last year the New England Journal of Medicine released a study
+that tracked college women at Rutgers University over a 3-year
+period of time and found a high incidence of HPV. So, what is
+the explanation, when they don't fall within that category?
+ Mr. Valdiserri. Two comments on that particular study: I
+think that it reinforces what I said earlier in my testimony
+about probably as many as 50 percent of all sexually active
+adults in America are infected with HPV. I think that, to
+follow up on Dr. Lee's comments, this is an important issue
+that is not, unfortunately, unique to screening for cervical
+cancer. In fact, I remember a very interesting approach to
+this, looking at barriers to prenatal care, where a researcher
+actually went through and characterized a whole set of
+attitudinal barriers, informational barriers, provider
+barriers, system barriers, et cetera. So, to follow up on what
+Dr. Lee was saying, I think that there are a number of reasons
+why; there is no single reason why this is happening. Part of
+the complexity of the program and the need to do operational
+research is to understand what a particular barrier might be
+for a community of women and then to disseminate model
+practices to try to address that.
+ Mr. Coburn. Would the chairman yield for just a second a
+follow-up question?
+ Mr. Bilirakis. The chairman does not have much time, but go
+ahead.
+ Mr. Coburn. Your testimony that 50 percent of sexually
+active adults are carrying this, but, if you exclude monogamous
+relationships, if you include that, what you are really saying
+is that it is a much higher percentage in the population that
+is outside of the married monogamous relationships. So, that's
+the populations that you are studying. So, the real prevalence
+is much higher than 50 percent in terms of the sexually active
+non-monogamous relationships. Is that correct?
+ Mr. Valdiserri. Well, let me, first of all, say that I
+don't believe that I stated that 50 percent were carrying it,
+because I think several of my colleagues indicated that in many
+instances this infection is transient. We don't know a lot
+about the natural history, but I think that there is a belief
+that in some people the infection clears, or at least it is no
+longer detectable.
+ What I did say was there are estimates that at least as
+many as 50 percent may have been infected by HPV. Part of the
+difficulty, Dr. Coburn, is that we do not have a lot of good
+surveillance information nor incidence information about this.
+I think that it is fair to say, as I mentioned, that the number
+of sexual partners is a clear-cut risk factor for becoming
+infected with HPV. So that the greater the number of sex
+partners, the more likely an individual would be exposed to
+HPV.
+ Mr. Coburn. Well, I thank the gentleman.
+ Mr. Bilirakis. Mr. Brown.
+ Mr. Brown. Thank you.
+ Dr. Lee, you talked about the higher rate of cervical
+cancer among foreign-born women, and my understanding is that
+Asian-Indians, in particular, have a higher incidence, and we
+have talked about low-income people having high incidence.
+Explain why that is in all of those groups.
+ Ms. Lee. Maybe can I speculate some? Will you allow me?
+ Actually, the highest rate in recognized racial and
+minority groups in the country is among Vietnamese women.
+Alaskan Natives, Hispanics, Korean women, all have very high
+rates. I think a whole lot of this has to do with being
+recently arrived in this country perhaps from--obviously, not
+from Alaskan Natives, but for the Asian women and for Hispanic
+women from Latin and Central----
+ Mr. Brown. Is it all Asian women or especially--not Indian,
+but especially Korean and Vietnamese?
+ Ms. Lee. It is mainly Southeast Asian and Vietnamese. I
+think Japanese women actually have a very low rate.
+ Mr. Brown. And Indian women?
+ Ms. Lee. I have not seen the rates broken out by Indian.
+ Mr. Brown. Asian-Indians, I am sorry.
+ Mr. Lowey. Native American Indians.
+ Ms. Lee. From the subcontinent.
+ Mr. Lowey. In India there is a very high incidence.
+ Ms. Lee. The statistics we have in this country on Asian
+women don't break out the Asian-Indian women.
+ I think that what we have found in this country is that the
+most profound predictor of getting cervical cancer in this
+country is not having screening. Okay, that does not really
+count in South America, for example.
+ Mr. Brown. Does that account entirely for the high
+incidence among low-income people?
+ Ms. Lee. I would say in this country it is a very important
+thing. I am not talking about the pre-cancerous lesions
+because, if you are screened adequately, you are then diagnosed
+with pre-cancer and that is cured. The pre-cancerous lesions
+are also caused by HPV and the other known risk factors.
+ I think the primary reason that you find high rates, not
+the only but the primary reason, in these foreign-born and
+Hispanic and Asian subgroups is because they have recently
+arrived in this country and came from a place where they were
+not being screened regularly, or they are in a culture in this
+country where they are not getting screened regularly. That is,
+I think, the reason that we see the high rates in those
+subpopulations in this country.
+ Mr. Brown. Talk more about the incidence in low-income
+women, please.
+ Ms. Lee. Now I was talking about the incidence in various
+racial and ethnic minority groups.
+ Mr. Brown. No, I am asking you to discuss why the incidence
+is higher among low-income women.
+ Ms. Lee. I think it is among the same reasons that those
+women of low-income predominantly are overrepresented members
+in the minority community. When we look at screening data from
+national survey data, we are less likely to see women of low-
+income and low-educational status having regular Pap screening.
+ Mr. Coburn. [presiding] Thank you, and I will recognize
+myself, if I may.
+ First thing I would like to do is submit for the record a
+study that was recently published in Pediatrics about the
+incidence of early dysplasia and carcinoma in situ in teenagers
+10 to 19, published March 3, 1999 in New England, and a ratio
+of 4 percent of advanced dysplasia among that group. If I have
+no objection, I would like to enter that into the record.
+ [The information referred to follows:]
+
+ [GRAPHIC] [TIFF OMITTED] T5639.001
+
+ [GRAPHIC] [TIFF OMITTED] T5639.002
+
+ [GRAPHIC] [TIFF OMITTED] T5639.003
+
+ [GRAPHIC] [TIFF OMITTED] T5639.004
+
+ [GRAPHIC] [TIFF OMITTED] T5639.005
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+
+ [GRAPHIC] [TIFF OMITTED] T5639.007
+
+ [GRAPHIC] [TIFF OMITTED] T5639.008
+
+ Mr. Coburn. I want to spend just a few minutes going
+through this. Dr. Valdiserri, you have stated that there are 45
+million people perhaps that have been exposed to this virus or
+this combination of viruses. We know that it accounts for
+somewhere above 90 percent of invasive cervical cancer. We have
+not talked about the tremendous outbreak and tremendous
+epidemic increase in cervical dysplasia in this country that we
+are seeing. Would you care to comment on that?
+ Mr. Valdiserri. I don't know that I am the best person to
+comment on that particular aspect of it. From my focus at CDC,
+in my center we are not doing surveillance on cervical
+dysplasia. In fact, we have a meeting scheduled in early April
+with the American Cancer Society and colleagues from NIH and
+other colleagues at CDC to consider a whole host of issues
+around HPV, and surveillance will be one of the considerations.
+But I think that when we are talking about surveillance in that
+context, we are talking primarily about HPV surveillance.
+ Mr. Coburn. That leads me back to my next question.
+ You said in your verbal statement--and I have read your
+written statement--that we have data that says perhaps this may
+be a short-lived infection. Would you care to submit for this
+committee all the scientific data that you say are the studies,
+the peer-reviewed studies, that are out there that would say
+that this is short-lived, and that we can actually have for us
+to look at the experience model that you are calling on, to
+give us that information?
+ Mr. Valdiserri. Let me state for the record, Dr. Coburn,
+that I am here as a representative of the National Center for
+HIV, STD, and TB Prevention. My particular expertise is not in
+human papillomavirus. I don't know if that was a rhetorical
+question.
+ Mr. Coburn. No, it really was not.
+ Mr. Valdiserri. But, through my reading and through my
+discussions with some of the experts that we have at CDC, let
+me say, first of all, there is much that we don't know about
+the natural history of HPV. There are many, many issues----
+ Mr. Coburn. Right, but let me interrupt you there because
+that is exactly where I am going. My whole point is this is the
+largest sexually transmitted disease that we have in the
+country. It affects more people. It accounts for 90 percent of
+the cervical cancer. My question to you is, why is not a
+reportable disease?
+ Mr. Valdiserri. Let me answer that one. But, let me go back
+to your first question about why I mentioned that some experts
+indicate that this might be short-lived. I think that that is a
+reflection of the fact that there is good evidence to show,
+although there is not incidence data, there are many, many
+studies showing the widespread prevalence of HPV, and this is
+linked with the fact that clinically, as my colleague from NCI
+stated as well, fortunately, for most men and women who are
+infected, this is a benign condition that does not even result
+in any kind of symptomatic presentation.
+ So, I think to go back to your first question, that is why
+some of the experts in the field, they don't know for certain,
+but think that this may be a short-lived condition.
+ Your second question, I am sorry now, I have forgotten it.
+ Mr. Coburn. Why is it not a reportable disease?
+ Mr. Valdiserri. Why is it not reportable? There are two
+ways to answer that. I guess the more direct is that, as you
+well know, reportable diseases are determined by States.
+ Mr. Coburn. As I know, the CDC has a list of 53, I believe,
+that mandate to the States to report them of which some of
+their funding is dependent upon whether or not they report.
+ Mr. Valdiserri. That's not my understanding of the way it
+works out in terms of the Federal and State relations.
+ Mr. Coburn. Then let me rephrase the question. Why is the
+CDC not making a recommendation that this be a reportable
+disease?
+ Mr. Valdiserri. That is what I thought you might be driving
+at. Let me say, first of all, at CDC we would like to go on
+record saying that we would clearly like to have additional
+surveillance information about HPV, for a number of reasons.
+ Mr. Coburn. I am going to interrupt just for a minute. Here
+is the No. 1 cause of cervical cancer in the country. Five
+thousand women, at least, a year are dying from it. It is a
+known etiologic agent. It can be identified. It can be
+prevented with screening. Why would we not want the Center for
+Disease Control to make a recommendation that this is a
+reportable disease? Answer that from a logical conclusion.
+ Mr. Valdiserri. Well, I think there are a number of reasons
+why there would be difficulties, in that if a State determined
+that it wanted to make a law reporting HPV, first of all, what
+test would we use? Would people use abnormal Pap smears as what
+constitutes the reporting condition? Given that most instances
+of HPV infection, as you well know, are asymptomatic and don't
+result in any kind of----
+ Mr. Coburn. Dr. Valdiserri, my point is that every day when
+I am in my practice, I am telling a women she has a cervical
+dysplasia and I am explaining to her how she got that. She got
+it because somebody gave her human papillomavirus. And, if I
+don't follow my obligation as a physician to say you have a
+disease that is transmissible--it is 300 times more
+transmissible than HIV.
+ Now, to tell me that I should not make that a reportable
+disease, that she should not inform her partners--we recently
+had the American College of Pediatricians come out and say we
+should not circumcise young men, but they totally ignored human
+papillomavirus and the disease characteristics that we are
+getting ready to see with cancer of the penis.
+ Mr. Valdiserri. First of all, we don't tell individuals who
+are infected with HPV and have clinical manifestations and know
+that they are infected that they should not inform their
+partners. That is a misperception.
+ Mr. Coburn. No, I did not say that.
+ Mr. Valdiserri. Well, I want to go on record saying that.
+ Mr. Coburn. But, if it is a reportable disease, then it
+becomes an obligation on the part of the physician to do what
+we all know----
+ Mr. Valdiserri. If he or she can report it. What I am
+trying to get in the record is that there are some difficulties
+with the one family of tests that are available. My
+understanding is that they don't identify all the viral
+subtypes.
+ Mr. Coburn. Absolutely not; they don't. You are right.
+ Mr. Valdiserri. That is correct, and we also went on record
+saying that there are a lot of questions about, what does
+antibody mean? Do people have antibody or not?
+ Mr. Coburn. We will spar back and forth here for a minute,
+but we also know that they DNA probes for chlamydia and
+gonorrhea are not 100 percent accurate either, but we still
+report those diseases.
+ Mr. Valdiserri. Not in every State.
+ Mr. Coburn. Well, in most States they are reportable
+diseases.
+ I will yield back my time and then I will ask for
+additional time when we finish. The gentlelady from California.
+ Mrs. Capps. I want to go back a little, although this part
+of what I want to say is not really a question, because I found
+the original discussion, after you made your testimonies and
+throughout your testimonies, to be so much about basic
+healthcare and health education. And, as a school nurse, it
+just resonates with me my bias about cervical cancer, so highly
+treatable, so easily preventable, with all these questions
+about why aren't women who are poor, who are born in other
+countries, and then we are talking about all the barriers to
+access, and it comes right back to people who should be
+talking. We should be talking about this with our well-child
+clinic care providers, pediatricians, and those who work with
+young families, because the next generation starts in utero, as
+was mentioned, in terms of the risk factors, but, also, for the
+education that must go on until we get a climate of being
+comfortable seeking help, particularly, when it comes to
+sexually transmitted diseases. And, we have a lot of discussing
+to do about how we can get to that point in terms of
+healthcare--such preventive healthcare, family oriented, really
+supporting families at a critical time and young people, and
+that is why I am delighted that we are having this hearing.
+ I hope that we can continue that conversation, and that
+whatever we can do here on the Hill to help get some of those
+barriers eliminated in our communities--and I am intrigued by
+the models that you are using. I would like to find ways to
+lift those out, and the ones that work, we should be doing
+everywhere because they are not costly. I know that it is
+mostly working neighborhood to neighborhood using peers and
+survivors, or whatever, the ways that you have found to work.
+ Mr. Valdiserri. May I make just a statement? I think that
+is such an important point, because when we think about an
+infectious disease process or an infectious disease-related
+cancer like we are talking about here, we obviously focus on
+the basic research, which is fundamentally important. But,
+there are a whole host of operational and health services
+research questions like the ones that you have alluded to and
+like to ones that Dr. Lee mentioned that I think are extremely
+important that have to take place, sometimes even after some of
+the basic research questions have been answered. So, I
+appreciate your bringing that point up.
+ Mrs. Capps. Then, just one final note on that: You are
+coming here to the House of Representatives. Each of us has
+local constituencies that we represent of interest to you all,
+and what you do, the health of our communities depends on
+getting this information out. So, that is how I would like to
+see this conversation move forward.
+ What are some of the ways we can help you get the word out,
+try new models, and also, what can we bring to you from our
+communities in terms of either barriers or models for achieving
+success in this area?
+ I think what we have in the situation with cancer of the
+cervix is such an example. It is like a symbol of the good--it
+is treatable. There is a low-cost screening technique that is
+widely available, and yet, why are so few women taking
+advantage of the opportunity? So, that's to be discussed.
+ One quick one for me: A couple of you alluded to smoking
+and the relationship and I am curious. Just a couple of words
+about why.
+ Mr. Trimble. Smoking appears to increase the risk of a
+number of epithelial of skin cancers. So we all are now aware
+of the association between smoking and lung cancer. But, it
+also increases the risk of cancer of the head and neck, cancer
+of the esophagus, cancer of the vulva, cancer of the vagina,
+cancer of the cervix.
+ Mrs. Capps. Is there a particular way that this is easily
+explained to the lay public?
+ Mr. Trimble. No.
+ Mrs. Capps. No. The linkage?
+ Mr. Trimble. Well, we don't fully understand the mechanism
+by which cigarette smoking does increase these risks. We note,
+though, that cotinine, which is one of the byproducts of
+nicotine, is found expressed in the cervical mucus after a
+person smoked a cigarette, but we don't know the specific
+mechanism for each of the cancers.
+ Mrs. Capps. I think we need to disseminate that information
+as well.
+ Mr. Valdiserri. And, I mentioned smoking as an
+epidemiologic factor in HPV infection, but that has not been as
+consistent a finding as smoking in cervical cancer.
+ Mrs. Capps. Thank you very much. Thank you for being here
+today.
+ Yield back the balance of my time.
+ Mr. Coburn. Thank you, and the gentleman from Pennsylvania
+is recognized.
+ Mr. Greenwood. Thank you, Mr. Chairman.
+ I want to do what Senator Mack did and take off all my
+hats, except leave my daddy hat on. My little girls are just
+about to be 12, Katie is, and Laura is 13\1/2\. They are not
+sexually active. They will be someday. I have encouraged them
+to wait until after menopause, but I don't think that I am
+going to succeed there.
+ Mr. Coburn. If the gentleman would yield, there is a study
+that shows the incidence of cervical cancer in nuns is zero.
+ Mr. Greenwood. Nuns. Cervical cancer is zero among nuns.
+That is another option for them that I will encourage.
+ But, realistically, what we just heard about these rates of
+43 percent among college coeds, I can assume that if one of my
+daughters is off at a college campus and becomes sexually
+active, that there is an extraordinarily high likelihood,
+particularly if she had more than one partner, if half the guys
+out there have HPV, and she would have two partners over the
+course of 4 years of college, virtually 100 percent likelihood
+that she gets a disease that is a very strong precursor to a
+very deadly cancer.
+ I would be happy to be corrected if my assumptions there
+need to be corrected. But, I think, whether they do or not, the
+fact is that young people today, being sexually active, as the
+huge percentage are, are enormously at-risk for disease that is
+enormously deadly.
+ I would guess that if you went to any college campus, go to
+the best Ivy League campus in the country and ask male and
+female college students about HPV; I would guess that an
+extraordinarily small percentage of them have ever heard of it,
+know what it means, know how common it is among their fellow
+students and their potential sexual partners--let alone have
+knowledge of the fact that it is essentially incurable, and let
+alone that it is a precursor to cancer which is fatal.
+ I have two questions: One, is there any other disease out
+there that is as widespread, as incurable, and is potentially
+devastating as this one? That is my first question. My second
+question is: Two, what are you doing to inform the American
+public, particularly the young sexually active Americans, that
+every time they get in bed with somebody it is a loaded gun?
+ Mr. Valdiserri. Let me start out, and I suspect that my
+colleagues will want to comment as well.
+ First of all, in answering your first question, I guess I
+would ask you to remember, although we are dealing with an
+extremely serious situation here, that most instances of HPV
+infection are benign and don't result in cervical cancer. I am
+not trying minimize----
+ Mr. Coburn. If the gentleman would yield, I would like for
+you to submit to the committee the scientific peer review data
+that says that, because I can't find a whole lot of it.
+ Mr. Valdiserri. Yes, that is not a problem. There is also a
+very good summary in the new STD text that came out that has
+hundreds of references that tell what we know about natural
+history. So, we can do that.
+ Mr. Greenwood. Just since I am not a physician in this
+triangle here, when you say most cases are benign, tell me what
+you mean by that.
+ Mr. Valdiserri. What I mean is that, based on the evidence
+that we've accumulated, there are specific subtypes, specific
+types of the virus that are associated with cancer and specific
+types of the virus that are not, and maybe my colleagues from
+NIH and NCI can speak to this, but, epidemiologically, the
+estimates that I have seen are that about 5 to 10 percent
+perhaps of women who are infected with the so-called high-risk
+or the cancer-associated viruses will go on to develop cervical
+cancer if there is not the screening that detects the pre-
+cancerous lesions.
+ Again, that is not to minimize that percentage, because it
+is a tragedy each and every time it happens. But, it is
+important to keep that in mind when you think about how
+widespread this viral infection is in the population.
+ I think your second point is perhaps a little easier to
+talk to. You may be aware of the fact that the Institute of
+Medicine published a report on sexually transmissible diseases
+in America, I guess it has been about 2 years ago now, and they
+called it ``The Hidden Epidemic.'' They talked about this whole
+issue of all of the sexually transmissible diseases that
+confront sexually active individuals, and I would just like to
+go on record saying that you are absolutely right; that we do
+have to get this information out there and it is one of the
+reasons it is important to stress to individuals that there are
+a lot of health benefits that derive from delaying sexual
+activity. But we also know that sooner or later people will
+become sexually active, and then we have to also provide, to
+the best of our knowledge, information about prevention in that
+context as well.
+ Mr. Greenwood. The one part of the question that I did not
+get a response to yet was: Is there any other disease that is
+this prevalent? For 50 percent of at least a subset of the
+population that is sexually active, for that population to have
+a particular virus, I can't----
+ Mr. Valdiserri. Off the top of my head, I don't know, and I
+think it reflects the fact that the target organ for HPV is
+skin, an epidermal surface, and that's a pretty big target
+organ; there are a lot of types of them.
+ Ms. Lee. Let me say that once infected is not the same as
+having the disease; Okay? So, like, I had the flu last year,
+and if you went back and you were able to check those
+antibodies, I would have it, but that does not mean I am now
+affected by it. Let me just say that let's look at the positive
+of this. Unlike most cancers, we have a test that works, and we
+have dropped the rate of cervical cancer by 70 percent in the
+last 50 years. And so, most women who are infected with the bad
+kind of HPV virus, and, in fact, go on to develop these
+neoplastic or pre-cancerous changes, can be, and are, detected
+before they ever get cancer, treated in the physician's office
+as an outpatient. Dr. Coburn can do it. They never have to do
+the hospital. They don't have to get a hysterectomy. They can
+still have children, and then they go on. So, we can put a
+good, positive spin on this for this kind of cancer.
+ Mr. Greenwood. We shouldn't put any spin on it at all, but
+my time is out.
+ Mr. Coburn. Next, I'd like to recognize the gentlelady from
+California.
+ Before I do that, I would like unanimous consent to put
+into the record a letter from Dr. Clausner, from NIH Public
+Health Service, dated February 19, to the chairman, in
+relationship to questions that were asked by the committee--I
+believe you all had a copy of this letter--and also a study
+published in the New England Journal of Medicine on the natural
+history of cervical--I will make sure that you have it--
+cervical vaginal papilloma virus infection in young women.
+ [The information referred to follows:]
+ Department of Health & Human Services
+ Public Health Service
+ National Institutes of Health
+ National Cancer Institute
+ Bethesda, Maryland
+ February 19, 1999
+The Honorable Tom Bliley, Jr.
+House of Representatives
+Washington, D.C. 20515
+ Dear Mr. Bliley: I am responding to your letter of January 12,
+1999, in which you pose fifteen questions about the possible
+relationship of induced abortion to breast cancer, the relationship
+between human papillomavirus (HPV) and cervical cancer, and the
+National Cancer Institute's (NCI) dissemination of research findings on
+these topics. I regret that I could not meet your request to provide a
+response by January 29, 1999. My staff have worked closely with Mr.
+Marc Wheat to keep him informed of our progress.
+ As requested, the questions have been restated below. The answer
+follows each numbered question.
+ 1. At the July 20 hearing on ``The State of Cancer Research,'' the
+National Cancer Institute testimony addressed the importance of
+epidemiologic research in identifying the factors that increase cancer
+risk. How much of the NCI budget is allocated to the funding of
+intramural and extramural epidemiologic studies done for that purpose?
+ NCI funds the bulk of this research through the Division of Cancer
+Epidemiology and Genetics (an estimated $60 million for intramural
+epidemiologic studies) and the Division of Cancer Control and
+Population Sciences (an estimated $147 million for extramural
+researchers). Additional funding from other NCI Divisions may be
+relevant, but we included only projects that are directly related to
+studying factors that increase cancer risk.
+ 2. NCI has a long-standing focus on ``preventable causes.'' Are
+there preventable causes for breast cancer that have been identified by
+NCI? What preventable causes have been identified for cervical cancer?
+ After discussion with Mr. Mark Wheat of your staff, ``preventable''
+(for the purpose of this inquiry) exposures are those created by human
+intervention; i.e., herbicides, diet. In contrast, ``unavoidable''
+exposures are those that occur in nature; i.e., genetics.
+Breast Cancer
+ The leading known risk factors for breast cancer are largely
+unavoidable. Age is the leading risk factor, with incidence rates
+increasing dramatically after age 50. Family history is a strong risk
+factor, particularly if a woman's mother or sister has the disease.
+Genetic factors play an important role. About 50 percent of women with
+a mutation in the BRCA-1 gene will develop breast cancer by age 70. It
+is important to keep in mind that only between 5 and 10 percent of all
+breast cancers appear to be attributable to an inherited genetic
+mutation. Some benign breast diseases increase risk, and a previous
+diagnosis of breast, ovarian or endometrial cancer is associated with
+risk.
+ Reproductive events are a strong determinant of subsequent breast
+cancer risk. Early menarche and late menopause increase risk, while
+removal of both ovaries before menopause reduces risk. Having
+additional births after the first is associated with a slightly reduced
+risk. The most consistent reproductive factor is the woman's age at
+first full-term pregnancy. Women without children and women having
+their first child after age 30 have a two- to three-fold increased risk
+of this disease, compared with women who give birth before age 20. A
+woman with an interrupted first pregnancy, either spontaneously or
+through induced abortion, does not reap the protective benefit of a
+full-term pregnancy.
+ Other risk factors may be considered ``preventable.'' Taking oral
+contraceptives may increase risk for breast cancer at an early age
+(before age 45), and estrogen replacement therapy may slightly increase
+risk of breast cancer. Among postmenopausal women, risk increases with
+weight, body mass, and distribution of weight. The association with
+dietary fat consumption is inconclusive, while recent studies have
+shown a fairly consistent though small effect of alcohol consumption on
+breast cancer risk. Exposure to high doses of radiation increases risk,
+although the effects of low-dose radiation are considered minimal.
+ Most of these ``established'' risk factors for breast cancer are
+associated with only a moderately increased risk, suggesting that
+multiple factors may play a role in each woman's disease, and that
+unrecognized factors may exist. Further research is necessary, is
+ongoing, and remains a high priority for the NCI.
+Cervical Cancer
+ Sexual behavior has been identified as the major risk factor for
+cervical cancer. Risk is increased by early age at first intercourse or
+numerous life-time sexual partners. The greater the number of sexual
+partners, the greater the risk of sexually transmitted disease, which
+can be a risk factor. Abundant laboratory and clinical data support a
+role for human papillomavirus (HPV) in cervical cancer. Cigarette
+smoking is associated with increased risk. Barrier methods of
+contraception reduce risk, and the use of oral contraceptives increases
+risk. Giving birth multiple times is an independent risk factor, and
+vitamin C, beta carotene, or folacin (one of the B complex vitamins)
+deficiencies may increase risk.
+ 3. The NIH written testimony for the July 20 hearing states that
+``communicating with . . . individuals at high risk for cancer, the
+general public, and the health care community is a central component of
+NCI's mission and mandate.'' To that end, NCI has identified
+preventable target exposures of cancer-causing agents as a key element
+in the prevention of cancer. What work has NCI done to coordinate a
+Federal response to the prevention of breast and cervical cancer?
+Specifically, what work has NCI done with the Department of Health and
+Human Services Office of Population Affairs and the HHS Health
+Resources and Services Administration to alert women to avoidable
+exposure to carcinogenic agents? Who are the liaisons within NCI, HRSA,
+and the Office of Population Affairs? Has NCI coordinated activity with
+the Title V and Title XX programs within those agencies.?
+ Federal agencies are designated to serve the United States in
+specific ways. The National Institutes of Health (NIH), of which NCI is
+a part, is a research agency. In its mission to protect and improve
+human health, the NIH (and NCI) conducts and supports basic, applied,
+and clinical and health services research to understand the processes
+underlying human health and to acquire new knowledge to help prevent,
+diagnose, and treat human diseases and disabilities. This may include
+developing an information campaign (such as the 5 A Day Program
+described below, which was based on scientific evidence that increasing
+consumption of fruits and vegetables reduces cancer risk) and
+evaluating its effectiveness at achieving its goal (increasing the
+daily intake of fruits and vegetables). NCI also has a mandate to
+disseminate research findings so that when the development and
+evaluation are completed, other Federal and state agencies, and private
+sector organizations, may take this information and apply it
+accordingly. NCI, therefore, plays an integral role in these
+activities. For example, the Steering Committee for the National Action
+Plan on Breast Cancer (NAPBC) includes NCI staff as members and working
+group chairpersons serving this unique public/private trans-Federal
+partnership.
+ The NCI disseminates research findings widely through scientific
+publications, press conferences, press statements, clinical alerts,
+patient education materials, meetings of professional societies,
+television and radio, the World Wide Web, our toll-free Cancer
+Information Service, our PDQ databases, and the Information Associates
+Program. Our staff has many contacts within agencies for a variety of
+programs and issues. Through these personal contacts, and those
+mechanisms mentioned above, Federal agencies and offices have direct
+access to information pertinent to their programs. In addition, we
+maintain and foster close working relationships with other Institutes
+that have formal collaborative relationships with the Office of
+Population Affairs--our projects and programs are thus included in that
+broad knowledge base. NCI has several partnerships with other federal
+agencies and non-federal groups to enhance our information
+dissemination activities.
+ NCI has not formally collaborated specifically on Title V
+(Substance Abuse and Mental Health Services Administration) or Title XX
+(Adolescent Family Life Demonstration Projects) programs. As a research
+agency, NCI's role is to conduct and support research, then disseminate
+widely new knowledge gained. Following are examples of specific
+information campaigns:
+
+ Mammography Screening--Scientific evidence supports NCI's
+ recommendation that lives can be saved if women in their
+ forties or older have regular screening mammograms, every one
+ to two years. Because this constituted a major change in the
+ level of scientific evidence to support screening mammography,
+ it was imperative that NCI disseminate this information widely.
+ Specific information targeting various populations and
+ constituencies was developed and disseminated using a variety
+ of mechanisms, such as patient-oriented publications, education
+ materials, public service announcements, and electronic media.
+ 5 A Day--Because fruit and vegetable intake has been clearly
+ demonstrated to provide a health benefit beyond cancer
+ prevention, increasing American consumption has tremendous
+ potential to improve our Nation's health. Because health
+ messages can be confusing, NCI set aside special funds for
+ grantees to find innovative ways to inform the public. In an
+ unprecedented public/private partnership, grantees and health
+ departments nationwide participated in a study of new methods
+ to reach the public and influence behavior. These grants are
+ completed, and NCI and the Centers for Disease Control and
+ Prevention (CDC) are evaluating their success. If indeed
+ Americans increased their consumption, then other public and
+ private groups will have scientifically proven methods to bring
+ into their communities.
+ ``Risk Disk''--The Breast Cancer Risk Assessment Tool is a
+ computer program that women and their health care providers can
+ use to estimate a woman's risk of developing breast cancer for
+ two time periods--over the next five years and for her
+ lifetime--based on several recognized risk factors (see
+ Question 2 for a discussion of some of those risk factors). The
+ tool compares these risks (given as a percentage) to those of a
+ woman of the same age with no risk factors other than her age,
+ and with the risk of women who were eligible to participate in
+ the breast cancer prevention trial using tamoxifen.
+ 4. The July 20 NCI written testimony states that ``NCI is actively
+pursuing development of a vaccine to prevent cervical cancer . . .
+based on the concept that almost all cervical cancers are caused, at
+least in part, by papilloma virus infections.' What is the status of
+the development of a vaccine for this disease? How long will it be
+before a vaccine enters clinical trials? Have any private sector
+entities partnered with NCI in the development of this vaccine?
+ The vaccine is currently being developed in clinical trials. The
+Phase I study to determine if the vaccine can prevent infection is
+underway at Johns Hopkins University, and preliminary results based on
+laboratory tests are encouraging--with no toxicities yet reported.
+Following completion of the Phase I trial, a Phase II trial to
+determine correct dosage is expected to begin in January 2000. A
+planned Phase III randomized clinical trial involving 10,000 women to
+test the efficacy of preventing HPV (Type 16) infection is expected to
+begin in about 2.5 years. As in many of our drug studies, we have
+partnered with a company to manufacture the virus-like particle
+contained within the vaccine. The manufacturer will have no role in the
+evaluation of its benefit or safety.
+ 5. Earlier this year, the New England Journal of Medicine published
+the results of a study on human papillomavirus (HPV). Among sexually
+active female students at Rutgers University, approximately 60 percent
+tested positive for HPV at some time during the three-year study
+period. Given that HPV is an agent of most cervical cancer cases, which
+kill nearly as many women each year as AIDS, what does a 60 percent
+infection rate suggest to NCI about the long-term consequences of this
+virus? Does this infection rate suggest that condom usage is less
+effective at preventing HPV infection than it is in preventing
+pregnancy? Has NCI sponsored any research as to the effectiveness of
+condoms to prevent the transmission of HPV?
+ Experts estimate that as many as 24 million Americans are infected
+with HPV, and the frequency of infection and disease appears to be
+increasing. For most women, HPV does not remain in the body. After
+initial infection, most women's immune system can clear the virus
+within 18 months. Therefore, a high prevalence at a point in time is
+not indicative of the numbers of women who will suffer health
+consequences. In fact, most women suffer no serious health problems as
+a result of HPV infection, nor do they know they have been infected.
+Although most HPV infections do not progress to cancer, it is important
+for women to have regular Pap smears. Potentially precancerous cervical
+disease is readily treatable. By identifying women with persistent
+infection through screening, and then treating those with precancerous
+conditions (by removing the precancerous cervical tissue affected), we
+relieve most of the burden of cervical cancer from HPV infection in the
+United States.
+ Condoms are ineffective against HPV because the virus is prevalent
+not only in mucosal tissue (genitalia) but also on dry skin of the
+surrounding abdomen and groin, and it can migrate from those areas into
+the vagina and the cervix. Additional research efforts by NCI on the
+effectiveness of condoms in preventing HPV transmission are not
+warranted. However, condom use is extremely important for preventing
+the transmission of other sexually transmitted diseases, and in the
+prevention of pregnancy. We include the use of condoms as an option in
+clinical trials if methods of birth control or disease prevention are
+needed.
+ 6. What is the amount of research dollars expended on HPV as
+compared to the virus that causes AIDS? What is the ratio between the
+two research budgets as compared to the number of women who die of the
+respective viruses?
+ There are over 80 types of HPV, about 15 of which are associated
+with cancer of the cervix. NCI estimates that it will spend about $38
+million on cervical cancer-related HPV research, and about $235 million
+on AIDS-related cancers, in FY 1999.
+ There are about 5,000 deaths in the U.S. from cervical cancer each
+year, and more than 200,000 deaths world wide. Over 90 percent of these
+cancers are HPV-related. There were about 4,600 female deaths in the
+U.S., and 900,000 worldwide, from HIV-related illness in FY 1997.
+ 7. What action does NCI recommend be undertaken by the Federal
+government to address the public health threats of HPV?
+ Human papillomavirus (HPV) is one of the most common causes of
+sexually transmitted disease in the world. The NCI believes that if all
+women had pelvic exams and Pap tests regularly, most precancerous
+conditions would be detected and treated before cancer develops. At
+present, early detection and treatment of precancerous tissue remain
+the most effective ways of preventing cervical cancer. This is
+communicated in our publications and public information. NCI is working
+to develop a vaccine that will prevent the main cancer-causing types of
+HPV, and is investigating the use of HPV testing, via more accurate Pap
+testing programs, to improve cervical cancer screening and prevention.
+ 8. According to an Associated Press report on a Supreme Court
+ruling dated January, 11, 1999, HHS had a hand in the removal of
+controversial posters in the Philadelphia public transit authority that
+linked abortion to breast cancer. According to this report, in ``Early
+February [1996], the authority received a copy of a letter a federal
+health official had sent to the Washington Metropolitan Area Transit
+Authority. Dr. Philip Lee, Assistant Secretary of Health in the
+Department of Health and Human Services, called the anti-abortion ad
+`unfortunately misleading' and `unduly alarming,' and said it `does not
+accurately reflect the weight of the scientific literature.' Based on
+Lee's letter, SEPTA removed the posters on Feb. 16, 1996.'' Please
+provide the Committee with a copy of this letter, and copies of all
+other letters HHS has sent since 1993 raising concerns about ads making
+cancer claims that may be ``unduly alarming.'' On what basis was the ad
+found to be ``unfortunately misleading,'' ``unduly alarming,'' and that
+it ``does not accurately reflect the weight of the scientific
+literature''?
+ In early 1996, NCI staff drafted a response to requests for
+information about the scientific evidence concerning the relationship
+between induced abortion and breast cancer risk. The letter was drafted
+for Dr. Klausner's signature (Attachment 1), but there are no copies of
+other drafts, or of correspondence to SEPTA, signed by either Dr.
+Klausner or Dr. Lee in NCI's central files system or with queried
+staff. There were several meetings with Dr. Lee and/or members of his
+staff to discuss a response. We have suggested to Mr. Wheat that he ask
+the Department of Health and Human Services, too, to search for
+relevant documents. NCI did issue a press statement (Attachment 2) on
+February 14, 1996, regarding the SEPTA campaign's representation of
+information from the scientific literature. A search of NCI's central
+files, and among files of queried NCI staff, revealed no correspondence
+since 1993 concerning other advertisements making other cancer claims.
+ 9. In a line of questioning at the July 20 hearing before the
+Health and Environment Subcommittee, the NCI witness was asked about a
+very substantial body of research linking cancer to what is clearly an
+eminently avoidable exposure which you did not mention in your written
+testimony. Fully 25 out of 31 epidemiologic studies worldwide and 11
+out of 12 studies in the United States (many of which, I am told, were
+conducted or funded by the NCI) show that women who elect to have even
+one induced abortion show an elevated risk of subsequent breast cancer.
+What studies has NCI conducted or funded related to the link between
+abortion and breast cancer?
+ *Note: The written testimony for the July 20 hearing focused on
+recent advances in cancer treatment, as it was our understanding that
+this was the intended topic of the hearing.
+ The body of research conducted before 1997 was, as described in a
+systematic review of the literature by respected epidemiologists,
+``inadequate to infer with confidence the relation between induced or
+spontaneous abortion and breast cancer risk, but it appears that any
+such relation is likely to be small or non-existent.'' Three points
+stood out in 1996. The first point was that the type of study (case-
+control interview study) that dominated the scientific literature at
+that time was subject to a demonstrated bias (``recall bias'') \1\ that
+tended to create an association where such association might not
+actually exist. Also, many of the early studies had no controls for
+other important risk factors. The second point was that the published
+studies showed no consistency in findings--and those that did showed
+what epidemiologists term ``a weak association'' (a relative risk
+between 0.7 and 1.3), or difficult to distinguish from bias or chance.
+The third point was that it seemed unlikely that the type of study that
+was needed--a study design unencumbered by recall bias, such as a
+cohort study--could be performed in the United States.
+---------------------------------------------------------------------------
+ \1\ Women under-report abortions, yet breast cancer patients are
+more willing to acknowledge a previous abortion than other women--a
+difference that produces ``recall bias.''
+---------------------------------------------------------------------------
+ Epidemiologists thus regarded with interest the very large study,
+reported in 1997, which examined medical records--not personal
+interviews--from the entire female population of Denmark. In Denmark,
+routinely maintained population registries of births, deaths, medical
+procedures, and cancer make it possible to compile the data required on
+a large scale without recall bias and with great statistical precision.
+The study found no increased risk of breast cancer in the Danish women
+who had recorded abortions, as compared with women with no record of
+abortion.
+ The NCI conducts and funds many epidemiologic studies of breast
+cancer. Often included in the surveys and/or questionnaires are
+inquiries about a woman's reproductive history which, as stated above
+in the response to Question 2, is a strong determinant for breast
+cancer. These questions typically address her history of spontaneous
+abortion, induced abortion, or full term pregnancy. NCI has funded
+three studies directly related to abortion as a possible risk factor.
+They are listed below:
+
+Breast Cancer in Relation to Prior Induced Abortion (completed 1990)
+ (PI: Daling--Fred Hutchinson Cancer Research Center, Seattle)
+Induced Abortion and Risk of Breast Cancer in Shanghai (completed 1997)
+ (PI: Thomas--Fred Hutchinson Cancer Research Center, Seattle)
+Induced Abortion and Breast Cancer Risk (expected completion 1999) (PI:
+ De-Kun--Kaiser Foundation Research Institute, CA)
+ In summary, the scientific literature does not suggest that women
+who have even one abortion show elevated risk. It remains true that a
+woman whose first pregnancy is interrupted, either by spontaneous or
+induced abortion, does not gain the same degree of protection against
+breast cancer as the woman who is pregnant for the first time at the
+same age and carries her first pregnancy to term; instead, she has
+delayed her age at first birth. The biologic effect of abortion is seen
+by comparing two women who give birth for the first time at the same
+age, one of whom had a prior terminated pregnancy. These two women have
+the same subsequent risk of developing breast cancer, based on the
+epidemiologic data available today.
+ 10. Research presented to the Committee shows that induced abortion
+has been linked with increased risk of breast cancer. What has NCI done
+to alert women that induced abortion has been consistently associated
+with increased breast cancer risk? How has NCI focused its public
+information on at-risk populations?
+ Experts at NCI and elsewhere find that the evidence suggests that
+induced abortion is not associated with an increased risk for breast
+cancer. Our information to women concerned about breast cancer risk
+after abortion addresses the research data to date, and includes
+discussions about data inconsistencies. We also emphasize the
+importance of a woman's discussing her personal risk of breast cancer
+with her physician.
+ In general, NCI reaches out to patients, their families, health
+care providers, researchers, and the public to bring them the most
+accurate, up-to-date cancer information. The NCI provides that
+information by telephone, on the Internet, through the media, in
+partnership with other organizations, and through a wealth of printed
+and audiovisual materials.
+
+ The Cancer Information Service (CIS) answers about 500,000
+ calls a year at 19 regional offices. The toll-free number, 1-
+ 800-4-CANCER, connects English- and Spanish-speaking callers
+ with the office that serves their area. The CIS provides
+ nationwide service to all 50 states and Puerto Rico. It also
+ has an outreach program that develops partnerships with
+ nonprofit, private, and other government agencies at national,
+ regional, and local levels. Two-thirds of CIS partners focus on
+ reaching minority populations.
+ PDQ is NCI's computerized database that gives patients, health
+ professionals, and the public quick and easy access to the
+ latest treatment, supportive care, screening, and prevention
+ information, as well as descriptions of clinical trials that
+ are open for enrollment.
+ NCI's Office of liaison Activities works with national
+ advocacy, voluntary, and professional organizations concerned
+ about cancer to disseminate the latest, most accurate cancer
+ information, and collaborates with these groups in areas of
+ mutual interest. These organizations influence their members,
+ the media, the public, and policymakers.
+ NCI is developing a publication on genetic testing to help
+ people decide if testing is right for them. NCI is also working
+ to increase health care professional awareness and knowledge of
+ human genetics and related ethical, legal, and psycho-social
+ issues.
+ NCI develops media and print materials designed for
+ distribution to a variety of audiences. Some of these are
+ designed specially for minorities and the medically underserved
+ and are often implemented as part of national campaigns. These
+ materials support the main message of a campaign (for example,
+ women over age 40 should have regular mammograms) but are
+ designed to be used by community leaders. For example, some
+ materials for mammography screening include posters in English
+ for African-American, Asian, and Native American women, and in
+ Spanish, Vietnamese, Chinese and Korean. NCI also contributed
+ to a nationally syndicated Spanish radio show promoting breast
+ and cervical cancer prevention and detection.
+ 11. I understand that the body of worldwide epidemiological
+research on the link between abortion and breast cancer reaches back as
+far as 1957. And the first such study conducted in the United States
+occurred as early as 1981. Is it not a fact that a majority of these
+studies show an increased risk (average about 30%) among women who have
+chosen abortion even just once?
+ The only cohort study published before 1996 found a statistically
+significant negative association (that is, abortion was associated with
+reduced risk for breast cancer). Of the 18 case-control studies
+published through 1996, most found no statistically significant
+association, positive or negative. Most of these studies did not
+control for known risk factors, or were limited by inadequate or
+possibly biased reporting of abortions. Because a very weak overall
+association might obscure a stronger one in a subgroup of women
+(perhaps young women), investigators also reported any associations
+noted in subgroups, even though the number of those subjects was very
+small. The subgroups noted to be at risk in one study were not found to
+be at risk in other studies. Thus, even before the large Danish cohort
+study was published the weight of evidence suggested no association, or
+a very weak one. There remains some uncertainty about the relative risk
+for women with very late induced abortions. More data on this finding
+would be valuable.
+ 12. The NCI website on ``Abortion and Breast Cancer'' states that
+``although it has been the subject of extensive research, there is no
+convincing evidence of a direct relationship between breast cancer and
+either induced or spontaneous abortion. Available data are inconsistent
+and inconclusive, with some studies indicating small elevations in
+risk, and others showing no risk associated with either induced or
+spontaneous abortions.''
+ A. Please identify and provide copies of the ``extensive research''
+ to which the website text refers. Was this research peer-
+ reviewed?
+ I have attached copies of a systematic review of the literature
+published in 1996, a Dutch case-control study published later, and the
+large Danish cohort study (Attachments 3, 4, and 5). Each of these
+papers contain an extensive bibliography which, when taken as a whole,
+represent the body of literature used by NCI experts to develop the
+fact sheet to which you refer. All of these papers were published in
+peer-reviewed journals.
+ B. The website states that there is no ``convincing evidence.'' What
+ are NCI's criteria for identifying research that would be
+ considered ``convincing''? Are there statistical benchmarks
+ that NCI uses to distinguish evidence that is convincing and
+ that which is not? How is this evidence measured that would
+ control for bias among researchers or program evaluators?
+ C. Does NCI draw a distinction between ``direct relationship'' and
+ ``indirect relationship'' in determining causality?
+ D. NCI states that ``available data are inconsistent and
+ inconclusive.'' Are the data inconsistent, or are the studies
+ inconsistent? What accounts for data that ``are inconsistent
+ and inconclusive''? Has NCI attempted to replicate studies that
+ may have shown a link between breast cancer and induced
+ abortion?
+ E. The NCI website states that some studies indicate a ``small
+ elevation in risk.'' What does ``small elevation in risk'' mean
+ in this context? By saying there is a ``small elevation in
+ risk,'' is NCI placing the risk on a continuum between no risk
+ and high risk? How does the ``small elevation in risk'' rank on
+ a comparative risk analysis continuum? Based on this continuum,
+ what action has NCI or other Federal agencies taken to warn
+ consumers of cancer risk-factors that are comparable to that of
+ induced abortion? Does ``small elevation in risk'' mean
+ ``acceptable risk''? How does NCI determine that something is
+ an acceptably small risk?
+ Epidemiologists use the terms ``weak associations'' or ``small
+risks'' to express assessment of whether an association is ``real'';
+that is, the probability that a factor causes the development of
+disease. Epidemiologic studies can be subject to errors of several
+types: biases in selection of study participants; biases in the
+observation of comparative data (such as the recall bias so problematic
+in collecting interview data on induced abortion); and statistical
+imprecision as the study size becomes smaller. Thus, ``small'' or
+``weak'' are terms associated with the level of error methodologically
+expected for (1) chance occurrence, (2) a particular feature of the
+disease or the exposure, and (3) study design. The increased risk of
+developing breast cancer associated with each risk factor (see Question
+2, above, for examples) varies from 1.5 to 4 times average risk.
+ An association typically is estimated as the ratio of risks, or the
+``relative risk.'' ``Relative risk'' is the ratio of disease incidence
+in the exposed population to the incidence in the unexposed population.
+A relative risk of ``1.0'' means that women exposed and women unexposed
+to a factor have the same risk of developing disease. It is a
+mathematical computation well-suited for assessing biologic connection.
+It is not intended to address comparison of absolute risk to benefit,
+or to judge what is acceptable risk to each individual. The NCI
+publishes widely the facts known about possible breast cancer risks,
+but decisions about ``acceptable'' risks must be made by a woman and
+her health care provider.
+ For the relationship between abortion and breast cancer, the most
+complete current summary of the uncertainty comes from the Danish
+population record study. The authors estimate that the relative risk
+for breast cancer in women with a recorded abortion is most likely
+between 0.94 and 1.06, with a very narrow interval of uncertainty
+because the study was very large. If a relative risk of ``1.0'' means
+that women exposed and women unexposed to a factor have the same risk,
+then the Danish population record study demonstrates that the women
+exposed to--and those not exposed to--the risk factor (induced
+abortion) have the same risk.
+ In many case control studies, a relative risk of 1.3 (or
+equivalently, a protective effect seen in a relative risk of 0.7) would
+be weak, small, or low. A relative risk of 2.0 is moderate. For
+example, if the initial research suggestion of an overall relative risk
+of 1.3 for developing breast cancer after abortion were supported by
+large and well-controlled epidemiologic studies, and otherwise
+fulfilled criteria for causality (see Question 12F. below), NCI would,
+as with other peer-reviewed information, make that available through
+all our mechanisms of information dissemination (see Question 10,
+above). NCI takes its responsibility for the public trust very
+seriously. All peer-reviewed study data are considered carefully,
+continuously, and comprehensively before we will say with certainty
+that a factor imparts a cancer risk. As discussed previously, the
+scientific literature to date does not suggest that women who have even
+one abortion show elevated risk. Our publications currently reflect
+this.
+ F. NCI also states that some studies indicate ``no risk.'' What level
+ of ``elevation of risk'' is considered to be ``no risk'' by
+ NCI? How is ``no risk'' distinguished from that of ``small
+ risk'' when proving causality is so difficult?
+ Evaluation of causality requires consideration of various types of
+evidence. Whether an exposure causes cancer may be assessed via several
+similar schema, the most common being the Bradford Hill criteria:
+strength of association, consistency, specificity, temporality,
+biologic gradient, plausibility, coherence, experimental evidence, and
+analogy. In many case control studies, a relative risk of 1.3 (or
+equivalently, a protective effect seen in a relative risk of 0.7) would
+be weak, small, or low. The authors of the Danish study estimate that
+the relative risk for breast cancer in women with a recorded abortion
+is most likely between 0.94 and 1.06, with a very narrow interval of
+uncertainty because the study was very large. This falls below the
+level of risk epidemiologists would consider weak, small, or low.
+ 13. Is it true that epidemiologic research has found no overall
+link between spontaneous abortion and breast cancer? Is that not also
+consistent with the fact that most pregnancies which abort
+spontaneously are characterized by subnormal estrogen levels, whereas
+normal pregnancy levels of estrogen are several times higher than non-
+pregnant levels? Is it also true that some form of overexposure to
+estrogen, which stimulates the growth of both normal and precancerous
+breast tissue, is the mechanism by which most of the known breast
+cancer risk factors operate?
+ Yes, it is true that research has found no overall link between
+spontaneous abortion and breast cancer. There are many causes of
+spontaneous abortion, and not all of them are characterized by
+subnormal estrogen levels. Breast cancer is a cancer that is hormonally
+responsive, but it is unclear that estrogen is the only hormone
+involved. Other hormones may also play an important etiologic role.
+ 14. The NCI website's first paragraph concludes with the sentence:
+``The scientific rationale for an association between abortion and
+breast cancer is based on limited experimental data in rats, and is not
+consistent with human data.'' Is this data to which you refer the Russo
+and Russo 1980 study? Is it accurate to summarize that this study,
+where rats were all given a chemical carcinogen, most of those rats
+which were allowed to bear offspring did not get breast cancer, while
+most of those which had their pregnancies surgically aborted did get
+breast cancer?
+ The data referred to in the NCI Fact Sheet on the Web site is the
+Russo & Russo study data. For breast cancer studies, suitable animal
+models have not been found, so extrapolating from animal data to the
+human model may not infer an absolute comparison. Russo & Russo found
+that pregnant rats who carried to term developed fewer mammary tumors
+than did rats who never were pregnant, or whose pregnancies were
+terminated.
+ 15. The NCI website refers to studies finding ``small elevations in
+risk'' in the link between abortion and breast cancer. A 1994 Howard
+University study on African-American women here in the Washington, DC
+area showed a more than three-fold increase in breast cancer risk with
+induced abortion. That same study showed that the risk was almost five-
+fold for African-American women over 50 years old. Is it accurate to
+call that kind of risk elevation ``small''?
+ Abortion was not a risk factor studied in the project referred to
+above. The risk you cite was actually the risk associated with a family
+history of breast cancer among women with two or more abortions. This
+was not the risk associated with abortion.
+ Please do not hesitate to contact me if you have further questions.
+ Sincerely,
+ Richard D. Klausner
+ Director
+Attachments
+
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+
+ Mr. Coburn. I would make one clarifying point. So it is
+important to people that are not medical here. There are non-
+aggressive forms of human papilloma virus; those are of no
+interest to us, because they have no effect. It is only those
+that are aggressive that we are concerned with, and it is only
+those that cause cancer. So that, when we discuss them in
+total, we diminish the importance of the aggressiveness of
+those that do affect humans, and it is important for everybody,
+when we are asking a question about HPV, we are talking about
+those that are carcinogenic or oncogenic, rather than those
+that aren't.
+ The other point that I would make, and I think our panel
+made, that is not the only cancer that they cause. We see
+cancer of the vulva, cancer of the rectum, cancer of the larynx
+associated with these same HPV subtypes.
+ And I would yield to the gentlelady from California.
+ Ms. Eshoo. Thank you for recognizing me, and I want to
+thank each one of the witnesses that are here today because you
+have given us highly informative testimony. I hope there are a
+lot of people that are tuned in or will hear this through a
+repeat program, wherever they are in this country, because I
+think in listening, that at least part the intent of this
+hearing is to educate. Educate, educate, educate.
+ The first request that I have, before I ask my question,
+is, Dr. Lee, Dr. Valdiserri, could you from the CDC provide for
+me--and perhaps the rest of the members of the subcommittee
+would like this as well--I would love to have a list of who you
+contract within my congressional district for the services that
+you provide. I was deeply involved in those issues before I
+came to the House, and the county board of supervisors, and
+established a whole network of clinics in a major county in the
+Bay area. So I would like to know who you are working with.
+Also, we should all be looking into whether we can do public
+service announcements in our congressional districts on this.
+Because to the extent that we get this out, and to the extent
+that we have something in place right now, and to the extent
+that this subcommittee and full committee and the Congress pass
+Mr. Lazio's and Congresswoman Capps' and my original co-
+sponsorship of the legislation, we can really go after this and
+be effective. So if you can do that, we would really appreciate
+it.
+ [The information referred to follows:]
+
+ Question. List of recipients (CBOs, etc) of BCCEDP funds in Ms.
+Eshoo's District (14th District in CA--includes Palo Alto)
+ Answer. CDC funds the California Breast and Cervical Cancer Early
+Detection Program (CBCCEDP) to:
+
+ provide screening to medically underserved women for breast
+ and cervical cancer
+ provide appropriate and timely diagnostic evaluations for
+ women with abnormal screening tests and treatment services if
+ needed
+ develop and disseminate public information and education
+ related to the detection and control of breast and cervical
+ cancer
+ improve training of health professionals in the detection of
+ these cancers
+ and finally, evaluate program activities through the
+ establishment of surveillance systems.
+ The CBCCEDP partners with many organizations throughout the State
+to provide specific services for at risk women. One such partnership in
+the 14th District of California is the Santa Clara Valley Center in San
+Jose, which has breast and cervical cancer screening providers located
+in Palo Alto. Women of the 14th District may also choose to receive
+services from the CBCCEDP sites of Alameda County Medical Center and
+San Francisco Department of Public Health.
+
+Santa Clara Valley Center
+P.O. Box 21949
+San Jose, CA 95151-1940
+Attn: Jennifer Sedbrook, (408) 289-9260
+
+Alameda County Medical Center Fairmont Hospital Administration
+15400 Foothill Boulevard
+San Leandro, CA 94578
+Attn: Carol Oakley, (510) 667-7848
+
+San Francisco Department of Public Health
+101 Grove Street, Room 321
+San Francisco, CA 95151-1940
+Attn: Diane Carr (415) 554-2878
+
+ Question. The National Breast and Cervical Cancer Early Detection
+Program's legislation (Public Law 101-354) provides states with funds
+to offer screening services to women of low-income. What mechanisms are
+in place to provide treatment to women who need it?
+ Answer. Ensuring that all women with abnormal screening results
+receive adequate follow-up and a definitive diagnosis is a crucial
+component of the National Breast and Cervical Cancer Early Detection
+Program (NBCCEDP). Thus, diagnostic services funded through the program
+include diagnostic mammography, breast ultrasound, breast biopsy fine
+needle aspiration, colposcopy, colposcopy-directed biopsy and
+endocervical curettage.
+ The legislation that authorizes the NBCCEDP does not allow
+resources appropriated for the program to be used for treatment.
+However, participating health agencies are required to identify and
+secure resources for diagnostic follow-up services that the program
+does not cover and for cancer treatment services for women in need,
+regardless of their ability to pay. CDC provides careful oversight to
+assure that women who need treatment receive it.
+ Analysis of program data for all abnormal screening mammograms
+reveals a median of 36 days between the initial screening mammogram and
+final diagnosis, and a median of 9 days between diagnosis of breast
+cancer and treatment. Additionally, surveillance data show that 96
+percent of the women diagnosed with invasive or in situ breast cancer
+have initiated treatment. Of the remaining 4 percent, 2 percent
+reportedly refused care, 1 percent had a provider recommendation that
+treatment was not currently indicated, and 1 percent were lost to
+follow-up.
+ In addition, CDC contracted with Battelle Centers for Public Health
+Research and Evaluation and the University of Michigan to document the
+range of systems and strategies used by states to obtain resources for
+treatment and ensure that women diagnosed with cancer or precancerous
+lesions receive timely and appropriate follow-up and treatment
+services. Seven state programs (California, Michigan, Minnesota, New
+Mexico, New York, North Carolina, and Texas) were studied in depth,
+ending in December 1997. Almost 200 people were interviewed; more than
+half of them were screening, diagnostic service, and/or treatment
+providers in local communities.
+ The study results show that innovative and creative approaches have
+been implemented to identify and secure resources for follow-up and
+treatment services. Women diagnosed with cancer through the NBCCEDP are
+receiving treatment. Without exception, study respondents reported that
+of their clients diagnosed with breast cancer or invasive cervical
+cancer, all women who have wanted treatment have indeed initiated
+cancer therapy.
+ Creative partnerships and responses to the lack of NBCCEDP
+resources for some diagnostic services and all treatment services have
+been developed in programs at the state, local, and provider levels.
+Implemented strategies are very similar for breast and cervical cancer,
+although funding from state legislatures and private foundations is
+more prevalent for breast diagnostic services than for cervical
+diagnostic services or for cancer treatment in general. Additionally,
+each of the seven states studied currently has some type of fund,
+centralized at the state level, that supplements the services provided
+by the NBCCEDP. Many financial barriers to diagnostic follow-up and
+some for cancer treatment have been reduced.
+ Findings suggest that state programs and their partners have
+invested significant amounts of time and effort to develop systems of
+care for diagnostic follow-up and treatment, and that these systems
+appear to be working. Tremendous effort is involved in developing,
+implementing, and maintaining strategies and systems for these
+services. Rarely is there a standardized or set way that a state or
+even a facility uses to obtain services women need that are not covered
+by the NBCCEDP. Efforts typically are tailored to an individual
+client's needs and resources.
+ The goal of the NBCCEDP is to reduce mortality from breast and
+cervical cancers, and the success of this effort hinges on the
+identification and treatment of early stage cancers. As they have in
+the past, CDC and its state partners in the NBCCEDP will continue to
+give priority to this critical aspect of the early detection effort.
+ Strategies for Providing Follow-Up and Treatment Services in the
+ National Breast and Cervical Cancer Early Detection Program United
+ States, 1997
+ The Breast and Cervical Cancer Mortality Prevention Act of 1990
+(Public Law 101-354) authorized CDC to establish the National Breast
+and Cervical Cancer Early Detection Program (NBCCEDP) to increase
+screening services for women at low income levels who are uninsured or
+underinsured (1). Although the NBCCEDP covers most diagnostic services
+that women need after receiving an abnormal mammography or Papanicolaou
+(Pap) test result, the program does not reimburse for breast biopsies.
+In addition, the Act prohibits the use of NBCCEDP funds for cancer
+treatment. Participating health agencies must ensure that NBCCEDP
+clients receive timely, appropriate diagnostic and treatment services.
+In 1996, CDC began a case study to determine how early detection
+programs in seven participating states (California, Michigan,
+Minnesota, New Mexico, New York, North Carolina, and Texas) identified
+resources and obtained diagnostic and treatment services. This report
+summarizes the results of the study (2), which indicate that
+respondents in these states reported that treatment had been initiated
+for almost all NBCCEDP clients in whom cancer was diagnosed. However,
+respondents also considered the strategies used to obtain these
+services as short-term solutions that were labor-intensive and diverted
+resources away from screening activities.
+ In the seven states, NBCCEDP sponsored screening services had been
+provided for 3 years, and breast cancer had been diagnosed
+in 60 women. The states were selected to provide a range of
+geographic locations, a combination of urban and rural populations, and
+racial/ethnic diversity among program clients. Researchers conducted
+semistructured interviews with 192 persons affiliated with the seven
+state programs. Of these interviewees, 120 (63%) were providers of
+screening, diagnostic, and/or treatment services; 58 (30%) were state
+program staff; and 14 (7%) were coa-
+
+lition members. Interviews included topics such as guidelines related
+to diagnostic and treatment services, strategies used to obtain and pay
+for services, level of effort required to secure these services, and
+changes in strategies over time. Each interview was tape recorded and
+transcribed. Using a systematic scheme derived from the research
+questions, three researchers coded the same transcripts until an inter-
+rater agreement of 80% was reached. Thereafter, all transcripts were
+coded independently. Coding results were entered into text analysis
+software that sorts text from transcripts into sets of information,
+themes, and evidence relevant to the specific research questions (3).
+The results reflect a synthesis of the interviewees' responses.
+Respondents described several strategies used to ensure necessary
+diagnostic and treatment services for women screened through the
+NBCCEDP. State level strategies in all states included 1) computerized
+tracking and follow-up systems that used program surveillance data to
+identify and manage clients in need of diagnostic and treatment
+services; 2) provisions in contracts requiring screening providers to
+arrange for diagnostic follow-up and treatment before screening women;
+and 3) arrangements with provider groups and state professional
+associations for free or reduced cost services for NBCCEDP clients. All
+states also had access to public or private funds to help support
+services not covered by the program; such revenue sources included
+state appropriations from general or tobacco tax revenues or funds from
+private foundations. These funds were available primarily for breast
+diagnostic services.
+ Local strategies tailored to the needs of individual clients were
+used to obtain diagnostic and treatment services. Common strategies
+reported by respondents included the following: providers billed public
+or private insurance plans; providers or local health departments
+helped clients apply for public assistance programs; providers referred
+clients to public hospitals; county indigent care funds and hospital
+community benefit programs financed services; clients received services
+through individually negotiated payment plans; and clients paid reduced
+or full fees for services.
+ Respondents strongly supported the continued growth of NBCCEDP and
+its goals but expressed several concerns. First, considerable time and
+effort were involved in developing and maintaining systems for
+diagnostic follow-up and treatment. Second, the process of identifying
+available resources within states for diagnostic and treatment services
+was considered labor-intensive. Third, the lack of coverage for
+diagnostic and treatment services negatively affected recruitment of
+providers and restricted the number of women screened. Fourth,
+respondents believed that an increasing number of physicians will not
+have the autonomy, because of changes in the healthcare system, to
+offer free or reduced fee services to NBCCEDP clients.Respondents
+reported that arrangements for treatment were made for almost all
+NBCCEDP clients who received a diagnosis of breast cancer or invasive
+cervical cancer. Respondents stated that some women experienced time
+delays between screening, definitive diagnosis, and initiation of
+treatment. State program officials reported that, according to 1992-
+1996 surveillance data, small numbers of clients in whom cancer was
+diagnosed (i.e., from three to 13 women in each state) subsequently
+refused treatment. Because these clients were not interviewed, it could
+not be determined whether financial barriers contributed to their
+decisions to refuse treatment or their loss to follow-up.
+ Respondents were concerned that the NBCCEDP did not provide funding
+for all diagnostic procedures and treatment for the diseases for which
+clients were being screened; approaches for delivering services were
+fragmented; and the process of obtaining resources required substantial
+effort at the state, local, and provider levels. Respondents reported
+that the continuation of every strategy for diagnostic and treatment
+services beyond the next few years is uncertain. Reported by: PM Lantz,
+PhD, Univ of Michigan School of Public Health, Ann Arbor. LE Sever,
+PhD, Battelle, Centers for Public Health Research and Evaluation,
+Seattle, Washington. Program Svcs Br, Office of the Director, Div of
+Cancer Prevention and Control, National Center for Chronic Disease
+Prevention and Health Promotion, CDC.
+ Editorial Note: During July 1991-March 1997, the NBCCEDP provided
+576,408 mammograms to women aged 40 years, and 3409 cases of
+breast cancer were diagnosed. During this same period, the program
+provided 732,754 Pap tests; 23,782 cases of cervical intraepithelial
+neoplasia and 303 cases of invasive cervical cancer were diagnosed.
+These totals included women referred to the program for diagnostic
+evaluation of an abnormal screening result. The NBCCEDP internal
+estimates suggested that during this period only 12%-15% of uninsured
+women aged 40-64 years in the United States had been screened by the
+program (CDC, unpublished data, 1997).
+ Screening alone does not prevent cancer deaths; it must be coupled
+with timely and appropriate diagnostic and treatment services. The
+Congressional mandate for NBCCEDP requires grantees to take all
+appropriate measures to ensure provision of services required by women
+who have abnormal screening results. CDC provides funds for case
+management to help these women access healthcare services. To increase
+the comprehensive nature of the program, CDC recently approved the use
+of NBCCEDP funds for breast biopsies.
+ The results of this study indicate that state health departments
+and their partners in the seven states had developed a wide range of
+strategies for diagnostic and treatment services in the absence of
+program resources. However, the time and effort required to arrange and
+maintain these services diverted resources away from screening
+activities.
+ This study was subject to at least two limitations. First, the
+results were based solely on the experience and opinions of informed
+professionals affiliated with the program and did not include the
+perspectives of NBCCEDP clients. Second, the results may not reflect
+the program experiences in other states. Case study methods, however,
+are an appropriate and well-accepted approach to gaining in depth
+understanding of complex programs in realife situations (4). The
+validity of the findings was enhanced by developing standard
+instruments to guide the semistructured interviews, protecting the
+confidentiality of respondents' remarks, using interview transcripts
+for data analysis rather than relying on interviewer notes, and
+obtaining feedback concerning state summary reports from respondents.
+ As more women are screened by the NBCCEDP, a greater burden will be
+placed on participating health agencies, providers, and other partners
+to obtain resources for breast and cervical cancer treatment. Case
+management services will continue to be essential in helping
+underserved women overcome financial, logistical, and other barriers to
+receiving these services. Other long term solutions to ensure that
+women in the program receive necessary treatment services are being
+pursued.
+
+ References
+
+ 1. Henson RM, Wyatt SW, Lee NC. The National Breast and Cervical
+Cancer Early Detection Pro-gram: a comprehensive public health response
+to major health issues for women. J Public Health Management and
+Practice 1996;2:36-47.
+ 2. Lantz PM, Macklem DJ, Hare M, Richardson LC, Sever LE, Orians
+CE. Follow-up and treatment issues in the National Breast and Cervical
+Cancer Early Detection Program: results from a multiple-site case
+study--final report. Baltimore: Battelle, Centers for Public Health
+Research and Evaluation, 1997.
+ 3. Miles MB, Huberman MA. Qualitative data analysis: an expanded
+sourcebook. 2nd ed. Thou-sand Oaks, California: Sage, 1994.
+ 4. Yin RK. Case study research: design and methods. Sage: Newbury
+Park, 1989.
+ Strategies for Providing Follow-Up and Treatment Services in the
+National Breast and Cervical Cancer Early Detection Program--United
+States, 1997. Lantz PM, Sever LE, Henson R, Lee NC. MMWR, March
+17,1998; Vol. 47. No. 11. pp 215-218
+
+ Ms. Eshoo. When the CDC does the early detection and the
+screening and something is found, do you have any certain way
+to set women on a path outside of that? Tell me what you do.
+ Ms. Lee. Yes. Yes, I will. Well, as you know, the 1990 act
+specifically forbade the use of Federal Government funds to pay
+for treatment.
+ Ms. Eshoo. Well, we know that. That is why the bill is----
+ Ms. Lee. Yes, right, and that's why you have introduced
+this bill. We are allowed to pay for diagnostic services, and
+so we do provide central diagnostic services.
+ Ms. Eshoo. But once you do what the 1990 legislation set
+up, and I'm not suggesting----
+ Ms. Lee. Okay, so then we diagnose.
+ Ms. Eshoo. [continuing] for giving you permission to go get
+into trouble to go beyond it. Do you have set information for
+women or----
+ Ms. Lee. Yes, we actually have a published paper because we
+have done a study on this. We have a partnership with our
+health agencies, the health agencies, the American Indian
+tribes, et cetera, and as part of that partnership, it is the
+responsibility of the State health agency to assure that all
+women diagnosed with cancer or a pre-cancerous condition
+receive the treatment that they need.
+ Ms. Eshoo. Well, it is not happening, but that is not your
+fault; it is that we haven't taken the next step. But that's
+instructive to me, because I don't think it is happening.
+ Ms. Lee. Well, we actually have a study that was published
+last year----
+ Ms. Eshoo. That says----
+ Ms. Lee. [continuing] that says, by and large, it is
+happening.
+ Ms. Eshoo. That they all got treatment?
+ Ms. Lee. Yes, except for the few, less than 10 percent of
+women----
+ Ms. Eshoo. Well, is it on a timely basis?
+ Ms. Lee. Yes, it is on a timely basis. There are some----
+ Ms. Eshoo. I'd like to see that.
+ Ms. Lee. Yes, I would be happy to provide you that.
+ Ms. Eshoo. I'm not here to question you. I'm here to
+question some of the outcomes and the results.
+ Ms. Lee. Right. We feel very good that we are getting--but
+the problem is, it is a very tenuous system. We really need the
+kind of help that your bill may provide for us. But because
+they have to put it together with a lot of charity, donated
+charity case from this provider----
+ Ms. Eshoo. Well, I think the system, at best, once it comes
+to treatment, is unpredictable Dr. Lee. Yes, absolutely.
+ Ms. Eshoo. It is a patchwork quilt at best--if you even
+want to bring the word ``best'' into this. I think that
+families and women in this country deserve much better. I mean,
+if we can get to the moon, we can do something about this, and
+we got to the moon a long time ago.
+ Let me go to another question, because I think I probably
+don't have that much time left. To Drs. Lowey and Trimble, in
+section 106 of H.R. 358, the Patients' Bill of Rights, it calls
+for the requirement of managed care providers to pay for
+treatment provided in the clinical trial. In your view, would
+enactment of such a provision expand access to clinical trails
+and speed up research aimed at preventing, treating, and curing
+cervical cancer? I mean, we are talking about screening; then
+we are talking about treatment. We know that a lot of the
+treatment isn't there or isn't paid for; there is
+underinsurance for it. But the fact of the matter is that we
+don't have a cure for this.
+ So, can you maybe just comment on that part of the
+legislation? I think it's a very important section, but I would
+like to know what your views are about it.
+ Mr. Trimble. Only 2.5 percent of adults in the United
+States with cancer are enrolled on cancer treatment trials, and
+the National Cancer Institute has been working closely with a
+number of third-party payers to encourage them to pay for the
+patient care costs associated with these clinical trials. The
+NCI has never had the funds to pay for patient care costs. We
+pay for data management or some of the costs of data
+management.
+ We have had reasonable success with some of the third-party
+payers. We have worked out agreements with the Veterans'
+Administration and the Department of Defense, so that the
+patients that they cover can have access to our clinical
+trials. We have not yet been able to reach an agreement with
+the Health Care Financing Administration, and we have continued
+to work with the HMOs, but certainly we are supportive of all
+efforts to gain all Americans access to our trials.
+ Ms. Eshoo. So this would be----
+ Mr. Coburn. Would the gentlelady yield for a minute?
+ Ms. Eshoo. Well, I don't have any time to yield, Mr.
+Chairman.
+ Mr. Coburn. Well, I will be very benevolent with the time
+if we can.
+ We have a cancer patient, a survivor, who is going to
+testify, and I would like to ask you all if you would remain
+there until the rest of our committee can finish their
+questions, and if I can have unanimous consent to have her come
+and give her testimony now, because she has her flight in a
+very short time; otherwise, we will not be able to obtain her
+testimony.
+ Ms. Eshoo. Absolutely. Thank you for the time and thank you
+to the panel for your words and professionalism.
+ Mr. Coburn. Ms. Piker, would you mind coming forward,
+please, and giving us your testimony?
+ Mr. Lazio. Mr. Chairman, could I just ask for unanimous
+consent to make a remark for about 30 seconds?
+ Mr. Coburn. Yes, sir.
+ Mr. Lazio. I am so conflicted. I am supposed to be chairing
+the committee meeting across the hall right now. Just two quick
+remarks and they are: First of all, the need to get more adults
+in clinical trial, I think, is made all the more compelling
+because of the success in childhood cancer. The amount of
+children that are in clinical trials, I think it is up around
+the 90's, either in clinical trials or in NIH protocol
+hospitals, and the success rates, especially in certain
+leukemias, I think really bear out the fact that we need to do
+much better in terms of getting adults into clinical trials.
+ The second point is--this is really in response to Ms.
+Lee's comments about care for those women who receive bad news
+after they have gotten screening through the CDC program--is
+that, actually, the timeliness is much in question by a number
+of advocate groups, about whether they are getting the
+treatment in a timely manner, and whether it is done in a way
+that doesn't accelerate or compound the stress and anxiety that
+women are under.
+ For example, many women that we have talked to have
+incurred substantial debt, and we are talking about women,
+obviously, who are at the lower-income levels, minimum wage
+people, waitresses, people who have no hope of wiping out a
+$20,000 debt. And so I would not want to leave the impression
+that what we have here is a system of care that is reliable and
+that is timely and that does not compound the stress that women
+face when they find out that they have a malignancy.
+ Thank you, Chairman, for your indulgence.
+ Mr. Coburn. Ms. Piker.
+
+ STATEMENT OF LINDA GRACE PIKER, CERVICAL CANCER SURVIVOR
+
+ Ms. Piker. Mr. Chairman, thank you for inviting me to share
+my experience with cervical cancer with this committee. I speak
+today as a cervical cancer survivor, a co-founder of a
+gynecological cancer support group, a cancer advocate, the
+Chair of the Kentucky Breast Cancer Coalition, which addresses
+both breast cancer and other women's cancer in the
+Commonwealth, and most of all, I speak as a friend and a
+confidante to numerous women who have been touched by this
+disease. I have seen the despair and the destruction that
+cervical cancer has caused these women, their families, and
+their friends. There are some stories that I'll never forget.
+ I'll never forget the beautiful young woman who was about
+30 years old, whose physician called me and asked if I could
+talk to her, and when I talked to her, I was totally empty
+handed. She had had a pelvic exenteration at age 32. I also
+talked to another woman who had received the same treatment who
+was 40 years old. I think these are some of the treatments that
+nobody has any idea take place. I mean, the majority of the
+public does not.
+ And I'll never forget another beautiful young woman who
+came to speak to the Cervical Cancer Advisory Committee just
+weeks before her death, and I knew the man that was deeply in
+love with her and I know how much despair he went through after
+this.
+ In addition to the original diagnosis of cervical cancer,
+these women are at increased risk for vaginal, vulva, and anal
+cancers. One woman who was first diagnosed with cervical
+cancer, and then vulva cancer a few years later, stands out in
+my mind. She had the toughest exterior. But when you got to
+know her and you really listened to her, she had despair; she
+was embarrassed, and the fears were all there. She fought long
+and hard, but eventually she died.
+ These are only a few of the women I would like to
+represent. These deaths were needless. If diagnosed early,
+cervical cancer has a 5-year survival rate of approximately 90
+percent. Most importantly, with proper screening and with
+treatment, cervical cancer is a preventable disease. We need to
+educate women on the risk factors for the disease, screening,
+and, if necessary, where to find information, treatment, and
+support.
+ In addition to the shock of being diagnosed with cancer in
+September 1990 when I was 44 years old, I could not understand
+how this could have happened. Since I was 19 years old, I had
+received annual Pap tests. I had had no problems. The more I
+read about the disease, the more confused I became, and the
+more frightening the issue became for me. Did I have an
+aggressive tumor? Would I live to see my 10-year-old son grow
+up? My gynecologic oncologist kept saying, ``You'll be fine,
+Linda. You are going to have a radical hysterectomy with
+regular followup.'' Well, for about the next year, I was very
+frightened because I couldn't figure out why this would happen;
+I did everything you were supposed to do; what was happening?
+ And then to alleviate my fears, I happened to talk to one
+of the fellows who had worked with me from the beginning of my
+cancer, and he said, ``Okay, Linda, what you really need to do
+is get your Pap smear slides, let's look at them, and I can
+tell you if it's aggressive and we will follow you more
+closely, and if not, this should give you some peace of mind.''
+ Well, we had moved to Kentucky the previous year, and so I
+had to call my former physician's office and ask for my slides
+to be sent to Lexington, Kentucky. I was given the address of a
+laboratory in California. When I called, there was no listing
+for the lab, and this was even more confusing. I just could not
+understand, you know, and so I called back to the physician's
+office and I said, ``There's no listing.''
+ Well, to shorten my long story, I found out that my
+physician had been sending the Pap slides to a lab in
+California that was allegedly closed because of poor quality
+assurance. Had I known the name of the lab my Pap slides had
+been sent to, I could have read about it, because they were
+named in The Los Angeles Times and The Wall Street Journal.
+Physicians were not liable for the Pap test; therefore, it is
+my understanding that some physicians decided not to notify
+their patients that the physicians had sent the patient's Pap
+slide to this lab.
+ My cancer was diagnosed when I had a Pap test the following
+year and my Pap slides were read by a different facility in
+Lexington. I spoke to my physician out of State about notifying
+other patients. We had quite a long discussion. It took me
+three phone calls to get to talk to the person, but my
+physician was not receptive to doing this at that time.
+ I suppose this was the crucial experience of my becoming an
+advocate for myself and other women. Not only do women need to
+be educated about the risks associated with cervical cancer,
+but they also need to know what questions to ask about
+screening methods and their laboratories.
+ Since 1993, I have worked in the public health arena, where
+I focus on ways to bring women into local health departments
+for breast and cervical cancer screening. I also work with
+health departments to eliminate missed opportunities for
+screening of current clients. For approximately the last 3
+years, I have worked with community cancer coalitions which
+have unique ways to target women in their communities for
+breast and cervical cancer screening. Cooperative partnerships
+and education are key components in their success for
+increasing the number of breast and cervical cancer screenings
+in the communities.
+ For any education campaign addressing the issue of human
+papilloma virus, or HPV, a clear message will need to be
+presented in a sensitive manner; otherwise, an ill-conceived
+education campaign might well become a barrier for women
+seeking screening.
+ As I leave here today, I thank you for holding a hearing on
+cervical cancer. As a mom of a childhood cancer survivor and
+relative to friends or individuals with the various types of
+cancer, I often call myself the generic cancer survivor.
+Although I am grateful to this committee for addressing the
+issue of cervical cancer, I think that a more comprehensive
+approach to fighting the war on cancer would be more effective.
+I have never been a cancer survivor who wanted to fight the
+body part wars. I look forward to the day when we all unite and
+fight cancer together. Thank you.
+ [The prepared statement of Linda Grace Piker follows:]
+ Prepared Statement of Linda Grace Piker
+ Mr. Chairman, thank you for inviting me to share my experience with
+cervical cancer with this committee. I speak today as a cervical cancer
+survivor, confounder of a gynecological cancer support group, cancer
+advocate, the chair of the Kentucky Breast Cancer Coalition, which
+addresses breast cancer and other women's cancer issues in the
+Commonwealth, and, most of all, I speak as a friend and confidant to
+numerous women who have been touched by this disease. I have seen the
+despair and destruction that cervical cancer has caused to these women,
+their families, and friends. There are some stories I'll never forget:
+the beautiful young woman in her thirties who had a pelvic exenteration
+or the distressing call from a forty-year-old woman who had undergone
+the same treatment. I'll never forget one beautiful young woman who
+spoke to a cervical cancer advisory committee only weeks before her
+death or the young man who was devastated by her death. In addition to
+their original diagnosis of cervical cancer, these women are at
+increased risk for vaginal, vulva or anal cancer. One woman, who was
+first diagnosed with cervical cancer and then vulva cancer, stands out
+in my mind. She was alone, had no medical insurance, and had a low
+paying job prior to her illness. She had a very tough exterior, but
+when you got to know her and listened to her, the despair,
+embarrassment, and fears were all there. She fought long and hard, but
+she eventually died. These are only a few of the women I would like to
+represent. These deaths were needless. If diagnosed early, cervical
+cancer has a five-year survival rate of approximately 90%. Most
+importantly, with proper screening and treatment, cervical cancer is a
+preventable disease. We need to educate women on the risk factors for
+the disease, screening, and, if necessary, where to find information,
+treatment, and support.
+ In addition to the shock of being diagnosed with cancer, in
+September 1990, when I was forty-four years old, I just could not
+understand how this could have happened. Since I was nineteen years
+old, I had received annual Pap tests. I'd had no problems. The more I
+read about the disease, the more confusing and frightening this issue
+became for me. Did I have some aggressive tumor? Would I live to see my
+ten-year-old son grow up? My gynecologic oncologist kept saying I'd be
+fine. I would have a radical hysterectomy and regular follow-up. To
+alleviate my fears of an aggressive cancer, I called my former
+physician's office and asked that my slides be sent to my physician in
+Lexington, KY. I was given the address of a laboratory in California.
+When I called, there was no listing of the lab. I was even more
+confused. To shorten this story, I found out that my physician had been
+sending the Pap test slides to a lab in California that was allegedly
+closed because of poor quality assurance. Had I known the name of the
+lab my Pap test slides had been sent to, I could have read about the
+lab in the Los Angeles Times or the Wall Street Journal. Physicians
+were not liable for the Pap test; therefore, it is my understanding
+that some physicians decided not to notify their patients that they had
+sent their slides to this lab. My cancer was diagnosed when I had my
+Pap test the following year and a lab in Lexington read my slides. I
+spoke to my physician about notifying other patients, I did not feel
+that the physician was receptive to doing this at that time. I suppose
+this was the crucial experience in my becoming an advocate for other
+women and myself. Not only do women need to be educated about the risk
+factors associated with cervical cancer, but also they need to know
+what questions to ask about screening methods and laboratories.
+ Since 1993, I have worked in the public health arena where I focus
+on ways to bring women into local health departments for breast and
+cervical cancer screenings. I also work with health departments to
+eliminate ``missed opportunities'' for screening our current clients.
+For approximately the last three years, I have worked with community
+cancer coalitions, which have found unique ways to target women in
+their communities for breast and cervical cancer screenings.
+Cooperative partnerships and education are key components in their
+success for increasing the number of breast and cervical cancer
+screenings in their communities. For any education campaign addressing
+the issue of human papilloma virus (HPV), a clear message will need to
+be presented in a sensitive manner. Otherwise, an ill-conceived
+education campaign might well become a barrier for women seeking
+screening.
+ As I leave here today, I thank you for holding hearings about
+cervical cancer. As a mom of a childhood cancer survivor and relative
+or friend of individuals with various types of cancer, I often call
+myself the ``generic cancer survivor.'' Although I am grateful this
+committee is addressing the issue of cervical cancer, I think that a
+more comprehensive approach to fighting the war on cancer will be more
+effective. I've never been a cancer survivor who wanted to fight the
+``body part wars.'' I look forward to the day when I can see us all
+united to fight cancer. Thank you.
+
+ Mr. Coburn. Thank you, Ms. Piker. I will defer any
+questions to the ranking member. Do you have any questions of
+the witness? Any other members of the committee have questions
+for this witness?
+ [No response.]
+ Ms. Piker, thank you for being here.
+ The gentleman from Tennessee is recognized.
+ Mr. Bryant. Thank you. Let me add my appreciation, Ms.
+Piker, before you go back to Kentucky, I assume, for your being
+here and also for the very learned panels that we have had
+here.
+ At this time, I have been asked by the chairman if I would
+yield my time to the chairman. I would be happy to do that.
+ Mr. Coburn. I thank the gentleman. I just have a couple
+other questions that I kind of want to follow up on. I
+introduced into the record a few moments ago a letter we
+received on the 19th from Dr. Klausner. The testimony today--we
+have two different testimonies. One testimony is that a condom
+is effective in HPV, and one that says it is not. I wonder if
+any of the panel would help this committee know what this
+answer is to that question. Anybody have an answer for that?
+ Mr. Valdiserri. Let me start. I think it's an extremely
+important question, and I think it is easy to understand why
+there might be some confusion on it.
+ What we know in general--and I'm talking generally now; I'm
+not talking about HPV--but what we know in general about
+condoms and viruses lead us to believe that the condom has at
+least a theoretical possibility of preventing transmission if
+the lesion is confined to the penis that is covered by the
+condom. Now, there are a lot of ``if's.'' Obviously, there are
+a lot of ``if's'' and conditions. Given that HPV infection may
+not result in a visible lesion and that typically that there
+are multiple sites of infection on the genitalia, I think that
+what you will see in most of the articles or textbooks or
+review articles is the statement that there have not been
+definitive studies, prospective studies, that have evaluated
+condom efficacy in terms of preventing HPV. So, I think that's
+why there is that confusion.
+ Mr. Coburn. I would quote Dr.--and you don't have the
+benefit of this letter, but Dr. Klausner states additional
+research efforts by NCI on the effectiveness of condoms in
+preventing HPV transmission are not warranted. And he states in
+his letter why it's not. It's because if you, in fact, are
+infected, the scrotum is infected as well.
+ If I could make one point, you all are behind the curve on
+this. The epidemic is way ahead of you. Is that not really
+true? I mean, the epidemic associated with evasive HPV and
+cervical dysplasia is ahead of where we are. We really don't
+have the knowledge on this sexually transmitted disease that we
+have on many others. Is that a fair statement?
+ Mr. Valdiserri. In some areas, I would agree with certain
+aspects of that statement. Definitely in terms of some of the
+condom efficacy studies and, as we discussed earlier, in terms
+of some of the surveillance information, especially about
+specific types of HPV.
+ Mr. Coburn. I guess if I had my heart of hearts, what I
+would want everybody to know is that we really don't know all
+the answers right now about HPV and that there is an epidemic
+of dysplasia out there. All you have got to do is ask any
+pathologist what they are seeing in their Pap labs. I mean, it
+is growing like crazy right now. We are seeing tons of
+carcinoma in situ, and I know the studies are ongoing in that.
+ The fact is, we don't know. We have an unknown quality
+right now. As we talk about access, there is not one woman that
+I don't want to have access to a high quality Pap smear and
+physical exam every year. I want that for every woman in this
+country, those that have been sexually active and those that
+have not. But I also want them to have the knowledge about what
+the danger is of this disease.
+ I mentioned earlier a Green Journal study in 1987 or 1988,
+where they did culture HPV, one of the aggressive serotypes
+from amniotic fluid, where they do, can culture this same virus
+in the reproductive tract of newborn babies, male and female,
+it is an important consideration that our highest institutions
+have not aggressively researched.
+ And so, my point--and I'm going to submit a list of
+questions, and they will be given to each of you and then I'll
+ask that we divide those up to the appropriate--actually, I'll
+try to get them divided up to the appropriate expert that we
+have here today.
+ You know, we really ought not to worry about where we have
+been, but we really ought to get busy about where we need to go
+on human papilloma virus. I have been in practice 16 years. I
+have never seen anything like it in my office. And if you go
+talk to practicing physicians that are in the middle low-income
+and with teenagers and Medicaid patients, we are seeing an
+explosion of this disease right now. And it is aggressive
+types. I mean, we are seeing a ton of high-grade dysplasia.
+ So, my wish is that, tell us what we need to do so that we
+really know what the science is, because I don't believe it's
+out there right now.
+ Mr. Valdiserri. I don't want to be parochial, but I
+couldn't agree with you more. I do want to say, again, that we
+have been working at CDC and our center and with our colleagues
+on trying to develop a specific plan focused on--we looked
+first at herpes, which is not, obviously, not the focus of this
+meeting, but now we are doing the same thing with HPV. We have
+this big meeting in April with a lot of experts coming in and
+we have actually generated close to 45 specific questions that
+we want these people to grapple with.
+ So, I couldn't agree with you more, Dr. Coburn, that there
+are still some issues that we have to invest in getting answers
+to.
+ Mr. Coburn. Before I would yield to anybody that would like
+additional time--we know that a condom is not preventive. I
+mean, we know that right now. Unless we wrap everybody in saran
+wrap, we are not going to prevent human papilloma virus.
+ Mr. Valdiserri. And we also know that there is more than
+HPV as a sexually transmissible disease. So we have this
+complex issue of--it is not an issue if people are abstinent,
+but we have this complex issue for people who are sexually
+active, where condoms can be helpful in preventing other STDs.
+How do we craft the message so that they know that it might not
+necessarily protect against HPV? And then they will say,
+``Well, gee, why even bother?''
+ Mr. Coburn. Very easy. It is a condom won't protect you
+from human papilloma virus, the No. 1 cause of cervical cancer
+in this country, and it affects 50 percent of those people who
+are sexually active, regardless that it might protect you from
+HIV. If it won't protect you from the No. 1, then it's a false
+safe sex message. It doesn't work. And so we can continue down
+that line of false assumptions, but you are going to find the
+science that will say it doesn't work, and we know it doesn't.
+The practicing physicians out there today know it doesn't work.
+ So, all I'm saying is, we need to look at the data
+completely from a pure scientific--and give us a plan to where
+we can give treatment, whatever we do. I treat kids who are
+going to be sexually active, if they tell me they are; I give
+them very tool I can. But the point is, is we can't send a
+false message about HPV.
+ Mr. Valdiserri. Well, we don't intend to send a false
+message.
+ Mr. Coburn. Thank you. And the ranking member, Mr. Brown.
+ Mr. Brown. Mr. Chairman, I'm a little concerned about the
+sort of exchange and the questions, the letter you have
+submitted, and I'm glad that we finally got a copy of it. I
+understand, from what you just said, you will submit some more
+questions of this panel. I would hope that this subcommittee
+would--and I don't lay the blame at your feet and I appreciate
+your genuineness about this--but would see fit to share with
+the minority some of this information. This letter, it started
+off--you posed 15 questions about the possible relationship of
+induced abortion to breast cancer; these are pretty volatile
+issues that people have very strong feelings about. I know,
+it's more than that; I understand that, but that was the lead
+sentence in it. We just found out about this a month after it
+was received by Mr. Bliley.
+ I would just like to encourage this subcommittee on the
+majority side to make sure the minority, particularly when we
+are talking about issues that people care about and the
+discussion you had with Dr. Valdiserri, just now, that we have
+this information ahead of time.
+ Mr. Coburn. Mr. Brown, the staff tells me that you all
+received a copy of that letter the day it was sent.
+ Mr. Brown. My understanding from our staff is that we
+received the letter that you sent to the doctor, that Chairman
+Bliley sent to HHS, but we have not gotten the response until
+today.
+ Mr. Coburn. If, in fact, you didn't, that is a grave error
+that should be corrected by this committee, and you should have
+the response and any letter that comes to this committee, based
+on a letter from it. As you know, I am not in the position to
+empower that that happens each time.
+ I would just like to ask if any of the other members of
+this panel would like to offer anything for us, tell us where
+we know what we need to do, make recommendations outside of
+what you have made in your testimony.
+ Mr. Valdiserri. May I just again say, please don't forget,
+in addition to the basic research needs, don't forget the whole
+host of operational research questions; and that's fairly
+parochial, because it is what we tend to do at CDC. But our
+last interchange about how do you craft a message for sexually
+active people, about what condoms can and can't do, given that
+in the real world there are many, many STDs, as a perfect
+example of the kind of work that is very important--so, I would
+like to, again, go on record saying that that is a need that we
+have.
+ Mr. Coburn. The gentlemen from New York is here. Would you
+like to ask questions, Mr. Towns? Yes, the gentleman is
+recognized for 5 minutes.
+ Mr. Towns. Thank you very much, Mr. Chairman.
+ What population is considered to be at high risk for
+developing cervical cancer? Anybody?
+ Ms. Lee. There are lots of risk factors. Probably the
+strongest risk factor that is sort of the cause of it is what
+we have been talking about today, which is infection with
+certain subtypes of human papilloma virus. Another very
+important risk factor is failure to be regularly screened with
+Pap smears. Then, you find higher rates of cervical cancer
+developing, and women dying from it, in foreign-born women in
+the United States and women who are Hispanic, who are African-
+American, and who are from certain subpopulations from Asia.
+You also find cervical cancer to occur, and especially cervical
+cancer deaths, to occur more often in older women.
+ Mr. Towns. Decreasing the incidence of cervical cancer 30
+percent, is that dependent on treatment, new treatment methods,
+or----
+ Ms. Lee. Most all of that is probably because of Pap
+screening and you identify the pre-cancerous condition. It is
+easily treated in almost all instances. You cure it and then
+the woman never develops cervical cancer, and therefore, then
+she doesn't get counted as a cancer statistic. And she doesn't
+have it, either.
+ Mr. Towns. Are the new treatment methods for cervical
+cancer considered experimental, or are the likely to be widely
+accepted by the insurance companies as a new standard of
+treatment?
+ Mr. Trimble. There have now been five studies, of which
+three have been published in the medical literature. We think
+that they will be considered as standard of care, and insurance
+companies will reimburse for their use.
+ Mr. Towns. Any other comments on that from anybody else?
+ [No response.]
+ Have we solved the lab certification issue or do we need to
+promote something comparable to the mammography quality
+standards act for Pap smears?
+ Ms. Lee. I am not sure any of us are really up on that. I
+think that the CLIA Act--I can't even come up with what that
+acronym, Clinical Laboratory--oh, yes, you know that; thank
+you. It was designed--and I'm not very much up on this--but it
+was designed, as one of the motivating reasons for its passage
+back, I think last decade, was because of problems with Pap
+screening; and whether is solved it or not, I am not equipped
+to tell.
+ Mr. Towns. Well, let me just say, first of all, Mr.
+Chairman, thank you very much and let me thank all of you for
+your testimony. I am sorry I was not here when you actually
+testified, but I did read almost all the testimonies; I want
+you to know that, and I do plan to read all of them. I was
+involved in another meeting is the reason I was not here;
+because I am very interested in this. You know, I come from a
+family of four and I lost my entire family, except myself, from
+cancer. So, I'm always very interested in terms of learning as
+much about this as I possibly can. I lost my mother, father,
+and a brother from this disease. So I am very interested in
+what you have to say.
+ So I will be reading all the material, and I really
+appreciate the time and the effort you have taken to come here
+to share with us, as well. Thank you so much.
+ Mr. Coburn. The gentleman yields back.
+ I have two things. Dr. Lee, would you note for the record
+when we asked you a question, cancer, under the definition of
+those cases, does that include carcinoma in situ or not? In
+terms of the incidents that you all are quoting, is that
+quoting including carcinoma in situ as well as invasive
+cancers?
+ Ms. Lee. From our program, you mean?
+ Mr. Coburn. Yes.
+ Ms. Lee. No.
+ Mr. Coburn. It is invasive cancer only?
+ Ms. Lee. The 508 are invasive only, and the carcinoma in
+situ's are actually folded in with the CIN-3's.
+ Mr. Coburn. All right. The other question I would ask, if
+you would, in response to Mr. Towns' question, the new
+epidemiological data that I am seeing is saying that the cancer
+now is occurring in earlier and earlier and younger and younger
+women. And, in answer to his question, your response was it is
+actually in older women. Would you mind forwarding any new
+material that you have to this committee, in terms of trends,
+epidemiologically?
+ Ms. Lee. Sure.
+ Mr. Coburn. The friends I have across the country that are
+practicing medicine, what they are seeing and what they are
+saying is that this is a disease that is moving to young women.
+ Ms. Lee. Actually, what I said was the cervical cancer
+deaths are highest in the older women. In fact, the people from
+the NCI collect the good data on this, and we have looked at it
+quite a bit. The rate of cervical cancer among women under 50,
+the new diagnoses are actually going down. I looked at it the
+other day. They are going down, based on seer data.
+ Mr. Coburn. Okay. Thank you very much. We have one
+additional question.
+ Mr. Brown. I'm sorry to keep you here for the rest of the
+evening, but, Dr. Lee, you in your testimony mention
+approximately half the inaccuracies--you said that the Pap test
+is far from 100 percent accurate; approximately half of the
+inadequacies are due to an inadequate collection of the Pap
+smear by the provider, and the other half are due to errors at
+the laboratory. And I know your expertise is not centered
+around this, but does it make sense for us to pursue perhaps
+the MQSA model, where there is inspection once a year, except
+for those who have a record of doing very, very well,
+inspection of facilities once a year? I don't know if
+inspection is the key, or working with, actually re-training of
+the people regularly, the technicians, all of that, re-
+licensing, some of the things that MQSA does. Is that something
+we should consider here?
+ Ms. Lee. That's really something that I am not totally
+expert in. I will tell you this: that the majority--and some
+people might even call the substantial majority--70 to 80
+percent of all new cervical cancer cases occur in women who
+have not been screened in the last 5 years. The issue: There
+are lab errors, and Ms. Piker was one of those unfortunate
+people. There are lab errors, but that is not where the bulk of
+the problem is. And so I will put to you that I think, until we
+have something wonderful like an HPV vaccine, that we can use
+to prevent, or other therapies, that our biggest, the most
+important thing is to continue to go out and try to find women
+who aren't being screened. Because if we spend a lot of time
+trying to improve the collection, we are still going to only
+maybe be affecting up to 20 percent, and not the other 80
+percent.
+ Mr. Valdiserri. To comment on that, there is a part of CDC
+that deals specifically with these issues, our Public Health
+Practice Program Office, and when we go back I will talk to
+their Division of Laboratory Systems--they have been involved
+in the implementation of CLIA--and see if they have any
+specific information, both related to what Mr. Towns asked and
+what you have asked. There may be some data; we just don't have
+it at our fingertips. It does make the point, though, that you
+always need to remember provider education, even when you get
+all these other issues taken care of.
+ Mr. Coburn. Let me thank the panel again for being here and
+persisting with us. I appreciate your input.
+ I would just make one last comment, Dr. Valdiserri: that
+the providers in this country are way behind where they need to
+be in terms of diagnosing STDs. We need to have a good national
+effort to bring them back up. And thank you again.
+ We will bring forward the third and final panel, and I wish
+to apologize for the length of your wait. Dr. John Thomas Cox
+from the University of California in Santa Barbara California,
+and Dr. Sharyn Lenhart, and Rosemarie Gatshca--I like that
+name--that's great--from the American Society of Clinical
+Pathologists.
+ Dr. Cox, if you would care to start and, if you could, be
+as brief as possible with your testimony, so we can spend as
+much time as we can discussing it.
+
+ STATEMENTS OF JOHN THOMAS COX, STUDENT HEALTH SERVICES,
+ UNIVERSITY OF CALIFORNIA AT SANTA BARBARA; SHARYN LENHART,
+IMMEDIATE PAST PRESIDENT, AMERICAN MEDICAL WOMEN'S ASSOCIATION:
+ AND ROSEMARIE GATSCHA, CYTOLOGY MANAGER, AMERICAN SOCIETY OF
+ CLINICAL PATHOLOGISTS
+
+ Mr. Cox. Chairman Bilirakis, Dr. Coburn, members of the
+House Subcommittee on Health and the Environment, my name is
+John Thomas Cox, and I am director of the Women's Clinic,
+University of Southern California in Santa Barbara, Chair of
+the steering committee of the National Cancer Institute-
+sponsored ASCUS LSIL trial, also known as ALTS, and Chair of
+the Practice Guidelines Committee of the American Society of
+Colposcopy and Cervical Pathology.
+ I wanted to express my thanks to you for providing me the
+opportunity to present a clinical perspective on the issues
+related to women and cervical health as I see it in 1999. In
+the interest of time, the following comments are a markedly
+shortened version of my written statement, and I will not be
+discussing the many positives of the Pap smear screening
+program, as has already been mentioned here today. But I do
+want to mention some of the factors that we run into as
+clinicians, and I know, Dr. Coburn, you run into them as well.
+ Despite the positives of the Pap screening program, the
+following problems loom large: that while the majority of
+cervical cancer develops in the segment of the population that
+remains unscreened, approximately 6,000 women develop cervical
+cancer annually, who have had reasonable, if not all perfect,
+Pap smear screening. And, although the incidence of cervical
+cancer and associated mortality has decreased over 40 percent
+since 1973, these numbers have remained constant for over a
+decade. Additionally, since 1986, there has been an annual 3
+percent increase in the incidence of invasive cervical cancer
+in white women under the age of 50. And now, this is the first
+information I have had that that has now ceased to increase.
+ The risk of missing disease in the screened population is
+attributed primarily to false negative cytology. The false
+negative rate of the Pap has been variously estimated to be
+from 2 to 50 percent. However, the Agency for Health Care
+Policy Research just released the evidence report, technology
+assessment entitled, ``Evaluation of Cervical Cytology,'' which
+estimated the true sensitivity of the Pap to be just 0.51.
+Their conclusion was that, ``Despite the demonstrated ability
+of the cervical cytologic screening in reducing cervical cancer
+mortality, the conventional Pap test is less sensitive that it
+is generally believed to be.'' Because of the concern over the
+risk of missing disease, the medical community has responded by
+pursuing the diagnosis and followup of the most minimal
+cellular atypia on the pap. The resulting loss in specificity
+brings exceptional numbers of normal women in for further
+evaluation. The cost in dollars and distress of evaluation of
+approximately 2 million women given the borderline reading of
+ASCUS has been very high. The result is an excessively
+expensive, approximately $6 billion, screening program fraught
+with the risk of over-diagnosis, over-treatment, and increased
+psychological burden.
+ So, I think we need to work on solutions. First, of course,
+we need to start with education, which we have talked a great
+deal about today. Education and outreach, especially to
+populations particularly reluctant to attend screening clinics,
+must be placed at highest priority, since the failure to draw
+the unscreened portion of the population in for routine Pap
+smears remains the most common reason for development of
+cervical cancer. The nature of failure of women to get adequate
+screening is not well understood, and is likely to be the
+result of a complex milieu of cultural, societal, and
+educational factors. Intense efforts will be necessary to
+understand the reasons women do not get Pap smears, or do not
+return, as directed, for followup.
+ Additionally, women receiving cervical screening should be
+educated about the ideology of cervical cancer and the reasons
+for doing Pap smears, including the association with HPV.
+Education must extend to the healthcare providers as well, as
+outreach is doomed to failure without a well-informed and
+empathetic health services sector.
+ Second, we need a more efficient screening system, and
+there will be some controversy over this, but I think we need
+to talk about it. The limitations of cervical cytology in the
+screening system re-
+
+quires a reappraisal, with the following deserving our utmost
+attention. We need to ask whether beginning screening at age
+18, as now recommended, is the best way to spend our cervical
+cancer screen resources, since this is an age in which cervical
+cancer is virtually non-existent, but transient HPV
+manifestations are very common.
+ Additionally, the inability of caregivers to accurately
+predict which women are low risk continues to foster annual
+screening. We will never be able reduce the cost of the
+screening system until we can safely increase the screening
+interval. In order to safely increase the screening interval,
+we will need to reduce the risk of missed disease. New
+technologies have been developed to improve the sensitivity and
+efficiency of detection of cervical disease. These include
+liquid-based thin layer cytology, automated computerized
+analyzers, and tests for the presence of HPV. Despite
+increasing evidence that many of these new technologies are
+already improving the effectiveness of cervical cancer
+screening, or hold great promise in the future, availability of
+the patient has been severely eliminated.
+ In order to improve the efficiency of the system, we must
+find the most efficient and patient acceptable manner of
+evaluating ASCUS paps. The NCI ALTS study is designed to
+provide a clear understanding of the advantages and
+disadvantages of various options for the followup of women
+given the Pap reading of ASCUS or LSIL low-grade squamous
+intraepithial lesion. This study should settle the question
+once and for all, whether women given this Pap reading are best
+referred immediately to colposcopy, best followed by several
+repeat paps at accelerated intervals, or best tested for HPV
+and referred to colposcopy only if the HPV test is positive.
+ Finally, the present intense public interest in healthcare
+quality issues includes questions regarding who should make
+decisions about how effective cervical cancer screening will
+be, and by what measure should effectiveness be evaluated.
+Until now, new cervical screening technology assessments, which
+have influenced public policy, have focused almost entirely on
+the single end-point of cost-effectiveness as measured by
+cancers prevented and lives saved.
+ In contrast, women deserve that cervical cancer screening
+policy be set by a much fairer model, that encompasses quality-
+of-life issues associated with decreasing the ambiguity of
+equivocal paps and with earlier detection of disease. This
+would include reproductive implications and reductions in
+invasive treatments, patient anxiety, and loss of time from
+work and childcare.
+ We must acknowledge the individual patient's interest in
+receiving information about the benefits, risks and costs of
+traditional Pap followup compared with new cytology screening
+enhancements. Women have a right to be routinely informed of
+these issues and to participate in decisionmaking regarding
+their health choices.
+ And, thank you for the opportunity to address these issues,
+and I will be pleased to answer any questions that you may
+have.
+ [The prepared statement of J. Thomas Cox follows:]
+ Prepared Statement of J. Thomas Cox, Director, Women's Clinic,
+ University of California, Santa Barbara
+ Chairman Bilirakis, members of the House Subcommittee on Health and
+the Environment, my name is John Thomas Cox, MD. I am Director of the
+Women's Clinic at the University of California in Santa Barbara, Chair
+of the Steering Committee for the National Cancer Institute sponsored
+ASCUS/LSIL Triage Study (ALTS) and Chair of the Practice Guidelines
+Committee of the American Society of Colposcopy and Cervical Pathology.
+I want to express my thanks for providing me the opportunity to present
+a clinical perspective on the issues related to women and cervical
+health as I see it in 1999.
+The Positives of Cervical Cancer Screening
+ In countries without cervical cancer screening, cervical cancer
+remains first or second amongst all cancers in women in both incidence
+and mortality. The measure of success of the Pap smear screening
+program in countries fortunate enough to have such a program, such as
+the US, is relegation of cervical cancer to the 6th commonest cancer
+amongst women and the 10th leading cause of cancer death. These
+decreases in the US are so dramatic that Pap smear screening is one of
+the few interventions to receive an ``A'' recommendation from the U.S.
+Preventive Services Task Force even though there have been no
+randomized trials demonstrating its effectiveness.
+Problems with the Cervical Cancer Screening Program
+ Approximately 14,000 women develop cervical cancer in the US
+annually and approximately 5000 die of the disease. While the majority
+of cervical cancer develops in the segment of the population that
+remains unscreened, approximately 6000 women develop cervical cancer
+annually who have had reasonable, if not all perfect, Pap smear
+screening. The lifetime likelihood that a women never screened will
+develop cervical cancer is 3,748 women per 100,000 (3.7%), but even
+with annual screening approximately 305 per 100,000 women (0.3%) will
+develop cervical cancer during their life. Although this dramatic drop
+in incidence demonstrates the remarkable effectiveness of the Pap
+screening program, nevertheless this is a toll that is individually
+agonizing for both patient and for care-giver. Even though the
+incidence of cervical cancer and associated mortality have each
+decreased over 40% since 1973, these numbers have remained fairly
+constant for over a decade. Additionally, since 1986 there has been an
+annual 3% increase in the incidence of invasive cervical cancer in
+young white women under the age of 50.
+ These statistics highlight both the success of cervical cytologic
+screening and the fact that, like any other test, achievement will
+never reach a perfect score. The risk of missing disease in the
+screened population is attributed primarily to false-negative cytology.
+The false-negative rate of the Pap has been variously estimated to be
+from 2% to greater than 50%. In January, 1999 the Agency for Health
+Care Policy and Research (AHCPR) released the Evidence Report/
+Technology Assessment, ``Evaluation of Cervical Cytology''. Using a
+stringent meta-analysis of published studies comparing cervical
+cytologic diagnosis with clinical diagnosis based on colposcopy or
+biopsy, the AHCPR provided an estimate of the true sensitivity of the
+Pap to be 0.51. Their conclusion was that ``despite the demonstrated
+ability of cervical cytologic screening in reducing cervical cancer
+mortality, the conventional Pap test is less sensitive than it is
+generally believed to be''.
+ Such statistics are in direct conflict with the public perception
+that the Pap smear is, or should be, an infallible test. The result in
+failed expectations is exceptional medicolegal liability related to the
+development of cervical cancer in any women with a history of previous
+cervical screening. For this reason, failure to diagnose cervical
+cancer is the second leading cause of liability losses for
+gynecologists and the leading liability for laboratories even though
+revenue from cytology accounts for only a small fraction of total
+laboratory income.
+ While false-negative cytology accounts for the majority of failures
+in the screened population, the poor specificity of cytology may be a
+greater problem for both the individual and society. The low rate of
+cervical cancer makes the risk of missing disease statistically small
+for each individual patient and for each Pap. However, the reality of
+the imperfect nature of the test looms large for both the laboratory
+personnel reading the Pap and for the caregiver. When the threshold for
+evaluation of a woman with an abnormal Pap is set very high, i.e. a
+high-grade or HSIL Pap, the specificity of the Pap is very good. That
+means that disease with significant threat to the woman is likely to be
+found on further evaluation. However, in order to protect our patients
+and ourselves from the vicissitudes of missed cervical cancer, the
+medical community has responded by pursuit of even the most minimally
+atypical cells. When the threshold for evaluating women with an
+abnormal Pap is set low, specificity falls dramatically. This means
+that many normal women will be evaluated for minimally abnormal Paps.
+The result is an excessively expensive (6 billion dollar) screening
+program fraught with the risk of overdiagnosis, overtreatment, and
+increased psychological burden. While all who have taken the
+Hippocratic Oath de-
+
+sire to do anything and everything possible to prevent an untimely loss
+of life, we must admit that much of our response to minor cytologic
+abnormalities has developed less out of reason than out of fear of
+liability.
+Solutions
+ How can we penetrate this impasse in the further reduction in
+cervical cancer incidence and mortality? Will attempts to further
+reduce the rate of cervical cancer make the system unaffordable? Should
+we ``tinker'' with the present system or is there reason, or promise,
+to justify a major re-evaluation of how we approach cervical cytologic
+screening and follow-up to abnormal Pap smears? How can we motivate the
+unscreened population to obtain good cervical health care? I believe
+that the answers to these questions can be found by vigorous pursuit of
+the following:
+Education
+ Education and outreach, especially to populations particularly
+reluctant to attend screening clinics must be placed at highest
+priority since the failure to draw the unscreened portion of the
+population in for routine Pap smears remains the most common reason for
+development of cervical cancer. While financial barriers are often
+cited as a major reason in limiting access to cervical screening, most
+studies have concluded that cost plays a minor, almost insignificant
+role. For example, Canadians, for whom all health care coverage is
+provided, have non-compliance patterns nearly identical with those of
+patients in the United States. Additionally, approximately 60% of women
+getting cervical cancer in one of the largest prepaid HMOs in the U.S.
+had not received adequate Pap smear screening even though a large
+percentage of these women had seen their primary care physician in the
+recent past. These statistics highlight the complex nature of failure
+of women to get adequate screening, which is likely to be the result of
+a complex milieu of cultural, societal and educational factors.
+Education must extend not only to women in the unscreened population,
+but women already being screened and to their caregivers. Intense
+efforts will be needed to understand the reasons for failure to attend
+screening and to apply the resources necessary to overcome these
+barriers.
+ Additionally, women receiving cervical screening should be educated
+about the etiology of cervical cancer. In 1995 the Agency for Research
+in Cancer and the World Health Organization (WHO) proclaimed cervical
+cancer to be the virtually exclusive result of the long-term
+persistence of human papillomavirus (HPV). Education must extend to
+health care providers as well, as outreach is doomed to failure without
+a well-informed and empathetic health services sector. Women must be
+made aware of the etiology of cervical cancer and its precursors, and,
+thereby, of the reason for which Pap smear screening is performed.
+Discussion of the sexually transmitted nature of the process cannot be
+avoided. However, it must be done without prejudice and with great
+care, compassion, and reassurance given that although the virus is
+extremely common, the risk for the development of cervical cancer is
+very low, especially with conscientious Pap smear screening. Clinicians
+must be continually reminded of the importance of cervical cancer
+screening so that women attending for medical care for other reasons
+may yet obtain a Pap smear in what may be their only encounter with the
+medical community.
+A More Efficient Screening System
+ Taking a new look at what is generally considered to be a
+successful system is never without controversy. However, the
+limitations of cervical cytology and the screening system requires a
+reappraisal, with the following deserving our utmost attention.
+ 1). Optimal age to begin screening and optimal screening interval:
+The pattern of practice in cervical cancer screening has been largely
+unchanged for 50 years. Annual Paps beginning at age 18 or within one
+year of beginning sexual activity, whichever comes first, remains the
+standard of care even though ACS and ACOG guidelines provide the option
+to extend the screening interval to 3 years in women considered at low
+risk. Concerns regarding false-negative cytology, medicolegal liability
+and the improbability of being able to accurately predict which women
+are really at low risk has served as the major impediment to
+implementation of prolonged screening intervals. Additionally, due to
+the high-prevalence of HPV and its induced cytologic changes in young
+women, a significant portion of the funds available for cervical cancer
+screening are spent on diagnosis and treatment of a commonly transient
+manifestation at little to no immediate risk of cervical cancer, and
+low long-term risk. While it is very important to test for sexually
+transmitted diseases (STDs) in this age group, the peculiar
+characteristics of HPV may not make Pap screening in very young women
+the most prudent approach.
+ In order to provide the safest, yet still cost-efficient coverage,
+we must consider redirecting the greatest concentration of our cervical
+cancer screening resources to those populations at greatest risk and
+least likely to be traumatized unnecessarily by medical intervention.
+This may require beginning screening at a somewhat later age and
+extending the screening interval. However, safely extending the
+screening interval would require greater reassurance than that provided
+by a screening test with just over 0 .50 sensitivity.
+ 2). Reducing the risk of missed disease: New technologies have been
+developed to improve the sensitivity and efficiency of detection of
+cervical disease. These include liquid-based thin-layer cytology,
+automated computerized analyzers, and tests for the presence of HPV.
+False negative Paps are generally very difficult Paps to read, often
+with very few abnormal cells, and often compromised by obscuring
+inflammation, blood or other exudate. Liquid-based cytology eliminates
+much of the potential for obscured Paps and may provide a more
+representative sample. Computer analyzers have been approved for both
+primary review of the Pap and for CLIA mandated rescreening. HPV
+testing as an adjunct to the Pap smear in women over the age of 30, who
+are less likely to be positive for HPV in the absence of cervical
+disease, would appear to increase the negative predictive value of the
+screen to approximately 97% without flooding the system with normal
+women. Yet, despite increasing evidence that many of these new
+technologies are already improving the effectiveness of cervical cancer
+screening, or hold great promise in the near future, availability to
+the patient has been severely limited. The reasons for this are quite
+clear. In the present managed care environment it is not sufficient to
+prove increased efficacy. Increasingly, the interests of third-party
+payers have dictated the interaction between clinician and patient.
+There is now the opportunity to make a significant impact on both the
+loss of life and on the inefficiency of the cervical cytology screening
+program if we have the will and the foresight to integrate the best
+that these technologies provide. If we do not, the present impasse in
+further reduction in cervical cancer will remain, and the commercial
+viability and future availability of these major improvements will be
+lost. Much not only depends upon the willingness of third-party payers
+to cover appropriately effective emerging technologies, but also upon a
+full understanding by clinicians of their potential and the willingness
+to discuss the new methods with their patients.
+ 3). Providing the most objective and efficient triage of women with
+equivocal Paps: The NCI/ALTS Study is designed to provide a clear
+understanding of the advantages and disadvantages of various options
+for the follow-up of women given the equivocal Pap smear reading of
+atypical squamous cells of undetermined significance (ASCUS) and the
+more diagnostic reading (for the probability of association with HPV)
+of low grade squamous intraepithelial lesion (LSIL). The follow-up
+options being evaluated include a). Immediate referral to colposcopy of
+all women with ASCUS or LSIL Paps, b). Repeat Pap until the woman has
+obtained 3 or 4 normal follow-up Paps with referral to colposcopy if
+any repeat is abnormal, or 3). Testing for the presence of HPV and
+referral to colposcopy only if the test is positive for an HPV type
+known to be associated with high-grade cervical precancers and cancer.
+Until this time there has been substantial disagreement amongst the
+medical community regarding which of these options is best. Recently,
+however, the availability in research settings of Hybrid Capture II, a
+new HPV test with improved sensitivity has provided very favorable
+results as a triage option for ASCUS. The comprehensive, randomized
+protocol of the ALTS Trial should once and for all settle the question
+of which follow-up option is most reliable, most cost-efficient, and,
+perhaps of greatest importance, most acceptable to women.
+ 4). Evaluating the cost-effectiveness of cervical screening
+options: The present intense public interest in health care quality
+issues includes questions regarding who should decide how effective
+cervical cancer screening will be, and by what measures should
+effectiveness be evaluated? Two important technology assessment reports
+have recently been released; the report of the Technology Evaluation
+Center of the Blue Cross and Blue Shield Association (April, 1998) and
+the AGOG Committee Opinion: New Pap Screening Techniques (August,
+1998). Both emphasize the group perspective on cost-effectiveness,
+almost to the exclusion of, or even acknowledging the individual
+patient's interest in receiving information about the benefits, risks,
+and costs of traditional Paps compared with new cytology screening
+enhancements. Unfortunately, cost-containment analysis has focused only
+on reduction in death from cervical cancer. Considering the already
+relatively low rate of cervical cancer, this is an endpoint doomed to
+show insignificant changes in increased life expectancy when factored
+over the entire population of women screened. A much fairer model for
+women is one that takes into account all the factors of cervical cancer
+screening that affect their lives. This would encompass quality-of-life
+issues associated with earlier detection of disease, including
+reproductive implications, and reductions in invasive treatments,
+patient anxiety and loss of time from work and childcare. In addition,
+cost-benefit analysis includes an evaluation of the benefits de-
+
+rived for both patient and caregiver of reducing and clarifying the
+nature of borderline Pap readings and obscured or otherwise compromised
+specimens that result in unnecessary repeat visits. Women have a right
+to be routinely informed of these issues and to participate in
+decision-making regarding their health choices.
+ Again, thank you for the opportunity to address these issues. I
+will be pleased to answer any questions that you may have.
+
+ Mr. Coburn. Dr. Lenhart.
+
+ STATEMENT OF SHARYN LENHART
+
+ Mr. Lenhart. Thank you. Good afternoon, Mr. Chairman and
+members of the subcommittee. My name is Dr. Sharyn Lenhart. I
+am the immediate past president of the American Medical Women's
+Association, and I also chair AMWA's Advisory Committee to the
+National Cervical Cancer Public Education Campaign.
+ The American Medical Women's Association or AMWA is a
+national multi-specialty organization comprised of more than
+10,000 women physicians and medical students. As a leading
+advocate for women's health issues since 1915, AMWA members
+have advocated for Federal legislation, influenced local
+policy, developed physician education programs, and spearheaded
+national consumer education campaigns to ensure that women
+patients and women physicians maintain a voice in upholding the
+highest standards of care as they relate to women's health.
+ AMWA believes that there is an important role for the
+Federal Government to play in improving women's health. We
+believe that this role can be fulfilled through Federal
+legislation that recognizes the need for women to understand
+how they can prevent and detect cervical cancer, and through
+legislation which supports adequate coverage of cervical cancer
+screening technologies, treatments, and preventative measures.
+Medicare reimbursement for Pap tests isn't adequate currently
+to cover the costs of providing laboratory services and should
+be increased to ensure the continued availability of this
+primary screening device.
+ Each year in the United States approximately 15,000 women
+are diagnosed with cervical cancer and 5,000 United States
+women die of the disease. Since the introduction of the Pap
+test almost 50 years ago, cervical cancer rates have been
+reduced by 75 percent. The majority of cervical cancers now
+occur in the minority of women who are not adequately screened.
+Two-thirds of cervical cancers occur in women who have not been
+screened and who constitute minority groups, by and large.
+ Despite the enormous success of the Pap smear, however,
+one-third of preventable cervical cancer occurs in women who
+have had a Pap test, at least in the last 5 years. Because
+cervical cancer is a slowly progressing cancer, often taking 10
+to 15 years to develop, regular Pap smear screening, combined
+with new and cutting-edge screening tools, can lead to greater
+success in prevention.
+ The success of cervical screening is that it detects
+abnormal cells which can be treated before an actual cancer
+develops. Recent clinical studies have confirmed that the human
+papillomavirus, HPV, is the primary cause of cervical cancer.
+HPV is a very common virus which can infect any man or woman
+who has ever had sexual intercourse. In most cases HPV is
+harmless and asystematic. It is estimated, however, that up to
+80 percent of women in the United States contract the virus at
+some point during their lives. Only a few of these women, those
+with persistent HPV infection of a high-risk type, will develop
+cervical cancer.
+ Seventy types of HPV have been identified and approximately
+13 of those are high-risk. The ability to identify the
+precedents of the high-risk cancer groups or HPV groups may be
+the key in our efforts to combat this disease. Unfortunately, a
+recent survey confirmed that 70 percent of women are unable to
+name the cause of cervical cancer. While women should receive
+regular Pap smear screening, 2 million of these screenings
+produce borderline results, and another 1.5 million produce
+abnormal results. Recent studies have shown that as a followup
+to borderline Pap smear results, the use of enhanced screening
+technologies, including a new test that detects the presence or
+absence of the HPV, can give a woman's health provider added
+information about the cause of her borderline results. Follow-
+up options can then be tailored appropriately.
+ AMWA believes that cervical cancer can be the first major
+victory in the war against cancer. We believe that, in order to
+achieve this victory, American women and their providers need
+more education about cervical cancer, the importance of regular
+Pap smear screening, appropriate enhanced screening
+technologies, treatment modalities, and current and cutting-
+edge tests for the causes of cervical cancer. As an
+organization of women physicians, AMWA recognizes the crucial
+role we play in leading the fight against this cancer. We are
+more likely to provide Pap smear screening, inform our patients
+about cervical cancer, and encourage routine screening.
+ Essentially, the battle against cervical cancer can only be
+won with a twofold strategy of increasing the number of well-
+educated, pro-active women consumers and enlisting the help of
+physicians who encourage and provide routine screening. AMWA
+views the Pap smear screening as a critical device in detecting
+cervical cancer. We also regard enhanced screening technologies
+and HPV testing, in the event of a borderline Pap smear result,
+to be an effective way to provide healthcare providers with
+important additional information.
+ To this end, we have become a lead partner in the National
+Cervical Cancer Public Education Campaign. The Campaign is a
+collaborative educational effort involving representatives from
+leading women's health and civic organizations designed to
+inform women about the link between HPV and cervical cancer, to
+reinforce the importance of regular Pap smear screening, to
+introduce them to new and existing methods to detect cervical
+cancer, and to empower them to take an active role in
+discussing the disease with their healthcare providers. The
+goal of the Campaign is to reduce the number of preventable
+deaths caused each year by cervical cancer through increased
+education and outreach.
+ Mr. Coburn. Dr. Lenhart, can you summarize?
+ Mr. Lenhart. Yes. AMWA calls on Members of Congress to
+demonstrate their support for public education about cervical
+cancer by signing on as co-sponsors of the Cervical Cancer
+Awareness Resolution and the Breast Cancer Treatment Act.
+ The key to winning the fight against cervical cancer is
+early detection. We can screen for it; we can test for HPV, and
+we can treat it. No woman in this country needs die from
+cervical cancer. If we all do our part, we can make this a
+reality. Thank you.
+ [The prepared statement of Sharyn Lenhart follows:]
+ Prepared Statement of Sharyn Lenhart, Immediate Past President,
+ American Medical Women's Association
+ The American Medical Women's Association (AMWA) is a national
+medical organization comprised of more than 10,000 women physicians and
+medical students. A leading advocate for women's health issues, AMWA is
+dedicated to improving the quality of women's healthcare. Since 1915,
+AMWA members have advocated for federal legislation, influenced local
+policy, developed physician education programs, and spearheaded
+national consumer education campaigns to ensure that women patients and
+women physicians maintain a voice in upholding the highest standards of
+care as they relate to women's health.
+ AMWA believes that there is an important role for the federal
+government to play in improving women's health. We believe this role
+can be fulfilled through federal legislation that recognizes the need
+for women to understand how they can prevent and detect cervical cancer
+and through legislation which supports adequate coverage of cervical
+cancer screening technologies. Currently, Medicare reimbursement for
+Pap tests is inadequate to cover the costs of providing laboratory
+service. Reimbursement should be increased to adequately cover costs,
+ensuring women have access to the most effective technology for
+detecting cervical cancer. The majority of deaths from cervical cancer
+are unnecessary and preventable.
+ the scope of the problem
+ Each year in the United States, approximately 15,000 women are
+diagnosed with cervical cancer and 5,000 women die of the disease.
+Since the introduction of the Pap test over forty-five years ago, U.S.
+incidences of cervical cancer have been reduced by 75%. The majority of
+cervical cancers now occur in the minority of women who are not
+adequately screened. Two-thirds of cervical cancers occur in women who
+have not been screened. Yet despite this enormous success, one third of
+preventable cervical cancer occur in women who have had a Pap smear in
+the last five years. Because cervical cancer is a slowly progressing
+cancer, often taking ten to fifteen years to develop, regular pap smear
+screening combined with new and cutting edge screening tools can lead
+to greater success in prevention. The success of cervical screening is
+that it detects abnormal cells which can be treated before cancer even
+develops.
+ cervical cancer and the human papillomavirus (hpv)
+ Recent clinical studies have confirmed that the human
+papillomavirus (HPV) is the primary cause of cervical cancer. HPV is a
+very common virus which can infect anyone who has ever had sexual
+intercourse. In most cases, HPV is harmless and people never realize
+they have it. It is established that up to 80 percent of women in the
+United States contract the virus at some point during their lives. But,
+only a few of the women with HPV will develop cervical cancer. Although
+infection with certain types of HPV increases the risk of cervical
+cancer, most infected women do not develop cancer. In fact, of the more
+the 70 types of HPV, only 13 are associated with cervical cancer. The
+ability to identify the presence of high risk HPV may be the key in our
+efforts to combat this disease. Unfortunately, a recent survey
+confirmed that 70 percent of women are unable to name the cause of
+cervical cancer. While women should receive regular pap smear
+screening, in many cases, these screenings produce borderline results.
+Of the 50 million Pap smears performed in the United States annually,
+3.5 million produce abnormal results. Recent studies have shown that as
+a follow-up to borderline pap smear results, the use of enhanced
+screening technologies, including a new test that detects the presence
+or absence of HPV, can give a woman's healthcare provider added
+information about the cause of her borderline results. Follow-up
+options can then be tailored appropriately.
+ amwa's perspective on cervical cancer
+ AMWA believes cervical cancer can be the first major victory in the
+war against cancer. We believe that in order to achieve this victory,
+American women and their healthcare providers need more education about
+cervical cancer, the importance of regular pap smear screening,
+enhanced screening technologies, and current and cutting edge tests for
+the causes of cervical cancer. As an organization of women physicians,
+AMWA recognizes the crucial role we play in leading the fight against
+this cancer. We are more likely to provide pap smear screening, inform
+their patients about cervical cancer, and encourage routine screening.
+Essentially, the battle against cervical cancer can only be won with
+the two-fold strategy of increasing the number of well-educated,
+proactive women consumers and enlisting the help of physicians who
+encourage routine screening. AMWA views regular pap smear screening as
+critical in detecting cervical cancer. We also regard HPV testing, in
+the event of a borderline pap smear result, to be an effective way to
+provide healthcare providers with important additional information. To
+this end, we have become the lead partner in the National Cervical
+Cancer Public Education Campaign. The Campaign is a collaborative,
+educational effort involving representatives from leading women's
+health and civic organizations designed to inform women about the link
+between HPV and cervical cancer, reinforce the importance of regular
+pap smear screening, introduce new and existing methods to detect
+cervical cancer, and empower them to take an active role in discussing
+the disease with their healthcare providers. The goal of the Campaign
+is to reduce the number of preventable deaths caused each year by
+cervical cancer through increased education and outreach.
+ conclusion
+ AMWA calls on Members of Congress to demonstrate their support for
+public education about cervical cancer by signing on as cosponsors of
+the Cervical Cancer Awareness Resolution that has been introduced by
+Representatives Millender-McDonald, Lazio and Coburn. The key to
+winning the fight against cervical cancer is early detection. We can
+screen for it, we can test for HPV, and we can treat it. No woman in
+this country need die from cervical cancer. If we all do our part, we
+can make this a reality.
+
+ Mr. Coburn. Thank you, Dr. Lenhart.
+ Ms. Gatscha, please.
+
+ STATEMENT OF ROSEMARIE GATSCHA
+
+ Ms. Gatscha. Mr. Chairman, members of the subcommittee, on
+behalf of the American Society of Clinical Pathologists, I
+would like to thank you for inviting me to speak here today. My
+name is Rosemarie Gatscha, and I am the Cytology Manager at
+Memorial Sloan Kettering Cancer Center in New York City. I am
+here representing the ASCP, which is the largest medical
+laboratory organization in the world. ASCP represents 75,000
+members, including board-certified pathologists, clinical
+scientists, and certified technologists and technicians.
+ I would like to take a moment to explain what I do as a
+cyto-technologist. Cells are collected from a woman's uterine
+cervix, placed on a smear, sent to the laboratory for
+processing and evaluation. Part of my job is processing. Most
+of my job is evaluating these Pap smears.
+ As you can see here, this gives you an example of some
+cells that are present on a smear. These cells, in particular,
+are cancer cells from cervical cancer. It gives you a feeling
+for the numbers of cells that are present on this smear. It
+varies anywhere from 30,000 to 200,000 cells. It is important
+that a well-trained eye be reviewing these cells, and that is
+what a cyto-technologist does, discriminates between normal and
+abnormal cells.
+ While it is difficult to believe more women die of cervical
+cancer because they have never had a Pap smear or because they
+haven't had a Pap smear in the last 5 years than those that die
+of a false negative Pap smear, there are many reasons why some
+women do not have Pap smears and there are reasons why they are
+less available to some women. Let's look at availability first.
+ ASCP's Board of Registry, in conjunction with MORPACE
+International, based in Detroit, conducts the biennial wage and
+vacancy survey of 2,500 medical laboratory supervisors. The
+1998 data was just made available, and the information
+regarding cyto-technologists is of particular concern. The
+current vacancy rate for cyto-technologists working at the
+staff level is 10.5 percent. This is a 3 percent increase over
+the 1996 rate, which was 7 percent. This is the first increase
+in the cyto-technologist staff level vacancy rate in the last 8
+years. What is critical to note is that the vacancy rate in
+rural areas is 17.6 percent. While the overall vacancy rate for
+supervisors, cyto-technology supervisors, has decreased
+slightly over the past 2 years, the vacancy rate in small
+medium-sized cities is increasing. It is 20 percent.
+ These data show some cause for concern, and I realize that
+sometimes numbers of this type may be meaningless, but to put
+it in perspective, you may recall the nursing shortage crisis.
+At the height of their crisis, the shortage was 11.3 percent.
+ Cyto-technologists are highly skilled and trained
+individuals. Laboratories rely on certified cyto-technologists
+to evaluate Pap smears. With high vacancy rates, there is
+concern that some laboratories will not have the appropriate
+personnel available to evaluate those Pap smears. This leads me
+to a related issue.
+ Cyto-pathology smears are currently priced at $7.15 on the
+Medicare laboratory fee schedule. The actual cost of the
+conventional Pap smear is between $13 and $17. This price
+includes cyto-technologists' salaries, overhead costs, CLIA-
+mandated quality control, and laboratory supplies, and also
+supplies that are given to healthcare providers who obtain the
+Pap smear. The Medicare payment rate for Pap smears should
+increase significantly. This, in turn, will help to alleviate
+the personnel shortages that exist which are amongst our most
+serious concerns.
+ Despite increased publicity and a greater emphasis on
+cervical cancer screening, a lack of knowledge continues to be
+a barrier to women in obtaining a Pap smear. A woman is more
+likely to obtain a smear if symptoms are present and if there
+is social pressure on her to do so. Barriers to obtaining a
+smear also include fear and embarrassment, belief that Pap
+smears are unnecessary for older women, economic factors, and
+language and cultural barriers.
+ We look forward to continuing to work with you on the
+prevention of cervical cancer by increasing the availability of
+trained cyto-technologists, increasing Medicare reimbursement
+for Pap smear testing, and minimizing economic and cultural
+factors that stop women from having Pap smears. Thank you very
+much for your attention. If there are any questions, I would be
+pleased to answer them.
+ [The prepared statement of Rosemarie Gatscha follows:]
+Prepared Statement of Rose Marie Gatscha, American Society of Clinical
+ Pathologists
+ Chairman Bilirakis, members of the subcommittee, my name is Rose
+Marie Gatscha, SCT(ASCP). I am Cytology Manager at Memorial Sloan-
+Kettering Cancer Center in New York City. I am here today representing
+the American Society of Clinical Pathologists.
+ The American Society of Clinical Pathologists (ASCP) is a nonprofit
+medical specialty society organized for educational and scientific
+purposes. Its 75,000 members include board certified pathologists,
+other physicians, clinical scientists, and certified technologists and
+technicians. These professionals recognize the Society as the principal
+source of continuing education in pathology and as the leading
+organiza-
+
+tion for the certification of laboratory personnel. ASCP's certifying
+board registers more than 150,000 laboratory professionals annually.
+ the pap smear facts
+ The Pap smear is a proven screening method of detecting and
+preventing cervical cancer. It is the most effective cancer screening
+test in medical history as it is largely responsible for the 70% to 80%
+decline in death due to cervical cancer over the last 50 years in the
+United States.
+ Approximately 4,900 women die from cervical cancer annually in this
+country, making it the tenth leading cause of death from cancer in
+women. Approximately 14,000 new cases of cervical cancer are diagnosed
+each year.
+ The Pap smear is a safe, noninvasive, cost-effective medical
+procedure. Cells collected from a woman's uterine cervix are sent to a
+cytopathology laboratory where the cells are evaluated. The
+cytotechnologist prepares the slide and evaluates the specimen, which
+is composed of thousands of cells--usually between 30,000 to 200,000
+cells in a single specimen. If the specimen is within normal limits, a
+report is sent to the woman's health care provider. If an abnormality
+is detected, then a pathologist examines the slide and issues a final
+diagnosis.
+ barriers to pap smear testing
+ While it is difficult to believe, more women (80%) die of cervical
+cancer because they have never had a Pap smear or they have not had a
+Pap smear in the last five years than those that die of a false
+negative Pap smear. We believe this is unconscionable.
+ There are many reasons why some women do not have Pap smears, or
+why Pap smears may be less available to women. I'd like to devote the
+rest of my comments to exploring those reasons.
+Trained Cytotechnologists Are Needed
+ The American Society of Clinical Pathologists' Board of Registry,
+in conjunction with MORPACE International, Detroit, conducts a biennial
+wage and vacancy survey of 2,500 medical laboratory managers. The
+survey measures the vacancy rates for 10 medical laboratory positions,
+and compares and contrasts these data with that from 1988, 1990, 1992,
+1994, and 1996 studies. The 1998 data has just been made available, and
+the information regarding cytotechnologists, the professionals who
+interpret cellular material such as Pap smears, is of particular
+interest and concern.
+ The current vacancy rate for cytotechnologists (staff level) is
+10.5%, an increase over the 1996 rate, which was 7.1%. This is the
+first increase in the cytotechnologist (staff level) vacancy rate in
+eight years. It is also important to note that for rural areas, the
+cytotechnologist (staff level) vacancy rate is 17.6%, and totals 9.7%
+for small-medium size cities and 12.1% in large cities. Also, while the
+vacancy rate for cytotechnologist (staff level) in large hospitals is
+8.3%, the vacancy rate nearly doubles for hospitals with a 100-299 bed
+size--up to 15.8%. Hospitals with bed size of 300-499 reported vacancy
+rates for these professionals at 14.3%.
+ Laboratory managers were questioned about the difficulty they have
+in filling work shifts. 21% reported problems recruiting
+cytotechnologist (staff level) for day shifts, three times higher than
+the 8% reporting such difficulties in 1996.
+ While the overall vacancy rate for cytotechnologist (supervisor)
+has decreased over the past two years, 10% down from 12.5%, the vacancy
+rate in small-medium size cities for cytotechnologist (supervisor) is
+20.0%. Vacancy rates for cytotechnologist (supervisor), while virtually
+non-existent in the east north central, west south central, and far
+west regions of the country, are explosive in the northeast (16.7%),
+south central atlantic (18.2%), and west north central (12.5%) parts of
+the nation.
+ These data show some cause for concern. Cytotechnologists are
+highly skilled and trained individuals, who must have at least a
+baccalaureate degree followed by a year of specialized training in
+cytology. Cytotechnologists must then take a rigorous national
+certifying examination, administered by the ASCP, in order to become
+certified. Laboratories rely on certified cytotechnologists to evaluate
+all Pap smears. With high vacancy rates, there is concern that some
+laboratories will not have the appropriate personnel available to
+evaluate Pap smears.
+Medicare Reimbursement
+ Cytopathology smears are currently priced at $7.15 on the Medicare
+laboratory fee schedule. The actual cost of the conventional Pap smear
+(excluding new technology and the professional component for
+physicians) is in the range of $13 to $17. The cost of new liquid-based
+Pap testing is $28-$32. This price includes cytotechnologist salaries,
+overhead costs, CLIA-mandated quality control, laboratory supplies, and
+supplies given to healthcare providers who obtain the smear. The
+Medicare payment rate for Pap smears should increase significantly.
+ ASCP and other organizations are working with the Health Care
+Financing Administration to increase the Medicare payment rate for Pap
+smears. In addition, Representative Neil Abercrombie and Representative
+Mary Bono have recently sponsored legislation, HR 976, to increase the
+Medicare payment rate to $14.60. ASCP supports this effort to bring
+attention to the need for the Pap test and a more appropriate payment
+rate.
+Liability
+ With annual screening, the chance of a woman developing cervical
+cancer can be reduced to less than 1%. Pap smears have an irreducible
+false negative rate (10%-40%) due to sampling errors on the part of
+health care providers and screening errors occurring in laboratories.
+ According to a March 1997 report in the Archives of Pathology and
+Laboratory Medicine, the continued availability of Pap cancer screening
+test is threatened by lawsuits because the legal system demands a zero
+error rate which is mathematically unachievable even in the most
+competent professional hands.
+Socioeconomic Barriers
+ According to Healthy People 2000, the National Health Promotion and
+Disease Prevention Objectives, there are several key assumptions that
+may be used to help overcome barriers to cervical cancer screening. The
+objectives state, ``low income, low education and advancing age are all
+associated with a decreased likelihood of receiving Pap tests.'' The
+report continues that ``age influences both cervical cancer incidence
+and survival. While younger women are more frequently diagnosed with
+cervical cancer, older women are more often diagnosed at later stages
+of the disease and are more likely to die from it than younger women.''
+We are also aware that certain populations of women--African American,
+Hispanic, Asian, and low-income rural women--often face cultural and
+economic barriers to Pap screening.
+ For example, it is not uncommon for low-income women of Hispanic
+descent to refuse Pap testing. Even if the Pap smear is free or of
+little cost, these women, whose families may rely on them for income
+and support, refuse the test because they do not want to know if they
+have cancer. A cancer diagnosis, in this instance, would mean
+extensive, and often prohibitive, medical costs to treat the cancer,
+and would tear the women away from their families for extended periods
+of time. Many women in this situation prefer not to know their
+potential cancer status. In addition, a lack of culturally appropriate
+materials or information communicated in Spanish is a barrier to
+Hispanic women being screened.
+ In a study compiled by the Centers for Disease and Prevention, it
+was determined that transportation and its costs were barriers to Pap
+testing for Native American women.
+ In speaking with public health officials, we are also aware of
+examples in certain Asian-American communities where it is considered
+shameful for women to have a Pap smear. In this culture, husbands may
+not want their wives to be examined ``in that way'' by a male
+physician.
+ solutions
+ The Pap smear, named for its creator Dr. George N. Papanicolaou, is
+one of the most effective cancer screening tools available to women
+today. There are ways to lessen the barriers that exist to Pap testing,
+so that cervical cancer becomes a less formidable disease to women.
+ ASCP continues to work with the cytology community to provide
+continuing education and certification for these laboratory
+professionals. ASCP has also established a scholarship program for
+medical technology students, including cytotechnologists. The Society
+awards 100 student scholarships each year to assist with educational
+finances.
+ Last year, your Committee reauthorized Title VII of the Public
+Health Service Act (Health Professions Education Partnerships Act of
+1998, P.L. 105-392), which included a program for Allied Health Project
+Grants. This program has been effective in addressing the training and
+educational needs of allied health personnel, including
+cytotechnologists. However, further strides in funding are still needed
+to increase the number of cytotechnologists to an adequate level.
+ Increasing the Medicare reimbursement for Pap testing to an amount
+more in line with current costs would also help to attract and retain
+professionals in the field.
+ ASCP, along with many other organizations, are working to educate
+the general public and the priority populations mentioned above about
+the importance and effec-
+
+tiveness of the Pap smear. We are particularly proud of the efforts we
+have undertaken to help educate other health care providers about the
+Pap smear.
+ ASCP believes it is important to develop and disseminate
+educational materials to targetted populations and to the health care
+providers that serve them, and develop relationships with community
+organizations, such as schools, retailers, employers, social
+facilities, and churches, to assist in reaching women that are not
+participating in cervical cancer screening programs.
+ We aim to continue these educational efforts, and look forward to
+working with you and others in the prevention of cervical cancer.
+ I would be pleased to answer any questions you may have.
+
+ Mr. Coburn. Thank you, Ms. Gatscha.
+ I am going to take the first round of questions, if I may.
+Dr. Cox, would you tell us a little more about the ALTS study
+and what you hope to come out of that, and the implications for
+us in terms of health policy?
+ Mr. Cox. Yes, I would be very happy to. As you know, the
+1988 Bethesda guidelines created a new category called ASCUS.
+And ASCUS, as an OB-GYN, you know has been probably the hardest
+Pap smear reading for us to deal with. That is why many people
+say, ``Don't ASCUS,'' because it is an equivocal pap. The
+problem with it is that it is the most common Pap smear reading
+that is considered abnormal. It is the least risky in terms of
+the percentage of those with ASCUS that have high-grade
+disease. About 6 to 8 percent will have high grade disease.
+However, the total high-grade disease discovered by Pap smear
+in the United States, about 30 to 40 percent of it comes from
+ASCUS. A great deal of cancer comes from under that Pap smear
+reading as well. So, it is our biggest problem, because most
+people are normal, but there is this hidden sort of group
+underneath that are very, very risky.
+ So the ASCUS LSIL trial was set up to evaluate whether it
+is best to refer women immediately to colposcopy, which is
+looking at the cervix with a microscope on the stand in the
+doctor's office, whether it is better to do that immediately,
+whether it is better to follow ASCUS by repeating the Pap 3 or
+4 times, and if any repeat Pap is abnormal, then colposcopy in
+those women, and if they are not abnormal, sending them back to
+annual exams; or whether it is better to test for the causing
+by bringing the woman back in and doing an HPV test on
+followup; and colposcopy in those women high-risk positive and
+returning the women that are not a high-risk positive either to
+a Pap in 6 months and then annual exams, or maybe immediately
+to Pap smear annually. So the ASCUS LSIL trial was specifically
+set up to determine which triage is most cost-effective, which
+detects the most high-grade disease, which is most patient-
+acceptable, as a very extensive ongoing patient questionnaire
+to see what kinds of issues and anxieties are involved with
+each office visit, et cetera, so that we get some kind of an
+idea what women want to do the most.
+ Mr. Coburn. You mentioned, can you explain for the rest of
+the panel a little bit, about what the new thin-prep is and how
+it works and why it is reported to help us in terms of
+diagnostic criteria?
+ Mr. Cox. In 1996, the FDA approved thin-prep paps, and they
+are, I believe, going to be soon approving a liquid-based Pap
+for Roche as well called CytoRich. These are Pap smears in
+which the sample is taken from the cervix in the same manner as
+for a glass slide pap, which is a conventional pap. But instead
+of putting the swab in, or with a collection device immediately
+on, a slide is put into a liquid media. In terms of the thin-
+prep pap, that liquid media is sent to the cyto-pathology
+laboratory. A cylinder is put in the liquid media and spun to
+disperse the cells. The cells are sucked into a filter, and
+when about 70,000 cells hits that filter enough, a vacuum
+pressure, the vacuum pressure device determines how many cells
+are there. It shuts the vacuum off, and then that little
+filter, 2-centimeter filter of cells is turned upside down on a
+slide, and a positive pressure puts the cells in the slide.
+What it does is it removes potentially obscuring materials,
+especially vaginal discharge. It disperses the cells on a slide
+in what is called a monolayer, so that the cells are not
+overlapping each other. So what it allows is for the slide to
+be looked at by the cyto-tech without having the potential of
+inability to see individual cells.
+ I should actually have, Ms. Gatscha, or a----
+ Ms. Gatscha. Yes.
+ Mr. Cox. There you are. I couldn't see you there for a
+minute. Basically, that would be something for you to comment
+on as well.
+ So that is a thin-prep process, and it has been evaluated
+in the ALTS trial as well as HPV testing.
+ Mr. Coburn. Okay, there's just one followup. Could you let
+the panel know that the difference is in cost in your area for
+a thin-prep versus a conventional pap?
+ Mr. Cox. Right. Well, my wife had one recently and it was
+$60. I don't know; I think the lab charges for--this is private
+paid--the lab charges $32 or $34 for conventional pap. For the
+health center, I can say that the conventional Pap is $10. The
+thin-prep Pap is $20. Basically, the thin-prep Pap has a set
+incremental fee that has to be attached until the prices come
+down, and that is that it is $9.75 for the materials that are
+disposable in the pap, because of the filter, the liquid media,
+and some element of usage of the thin-prep machine which cost
+in itself for the lab to get.
+ Mr. Coburn. The gentleman from Ohio.
+ Mr. Brown. Thank you, Mr. Chairman.
+ I think you heard, I think all three of you were sitting
+there patiently during the last panel, and I had a discussion
+with Dr. Lee about MQSA, what Congress did with that and with
+licensing and inspection of mammography facilities, and how
+that, I think, has been a true success across the country.
+Could you comment, I suppose especially Ms. Gatscha, but really
+all three of you, on any thoughts you would have with--
+obviously, with mammography facilities there is not the
+problem, as Dr. Lee said, as with Pap smears of 50 percent of
+errors due to healthcare provider errors, 50 percent lab
+errors. I mean, it is obviously a different phenomenon with
+MQSA and with mammography facilities.
+ But could you run through what might make the most sense in
+terms of better national licensing or annual inspections or
+licensing and training of personnel or what we might want to
+do?
+ Ms. Gatscha. Yes. What I have found to be the most
+remarkable thing that has happened is CLIA-88. Many
+laboratories that were called into question in all of these
+articles that we read in The Wall Street Journal, et cetera,
+have been forced to institute quality assurance programs. And
+that, in my estimation, has been the strongest avenue to
+pulling the test results into place--getting more accurate
+results, results that correlate with surgical pathology. I
+think that has been the strongest impetus.
+ Mr. Brown. Dr. Lenhart, do you have any thoughts on it?
+ Mr. Lenhart. Well, I think you have to take into
+consideration more that we are just beginning to regulate those
+who read the slides. Because some of the newer techniques
+involve less and less technology from the individual
+pathologists. The auto-prep and papnet involve computerized
+technologies. So that if you were only to look at making sure
+that--it is not really analogous to mammography. That is why we
+are proposing that the public as well as healthcare providers
+start thinking about the best way to use these enhanced
+technologies. Because they might eliminate some of those errors
+through the enhanced technologies without the regulation. They
+also might allow for screening to occur less frequently. They
+also might make it clear to those women who are dealing with
+borderline paps who is really at risk and who isn't, which
+would eliminate a lot of anxiety. So we see it as more
+complicated than just looking at how to make sure that those
+who read Pap smears do it consistently and well.
+ Mr. Coburn. Would the gentlemen yield for just a second?
+ Have there not been a couple of studies that have already
+showed those advanced technologies as improving our diagnostic
+skills at a lower cost?
+ Mr. Lenhart. Yes.
+ Mr. Cox. You know, I think enhancing regulation will not be
+very helpful. I think it is clear CLIA-88 has had a major
+impact on lab quality in almost every area except Pap smear.
+There have been several good studies on the 10 percent
+rescreening, and it has shown that really the amount of disease
+picked up by 10 percent rescreen is very, very little. I think
+that if we are going to really look at how to make the system
+work better, we have to realize that a false negative pap, only
+about 30 percent are screening or interpretive errors. There is
+the other 70 percent that are sampling or preparation errors or
+cells just not on the slide, for whatever reason. And if we are
+going to make a major impact in this problem, we need to try to
+improve the Pap upfront, if that is possible.
+ Now, I think the thin-layer cytology does improve the Pap
+smear upfront, but on a year-to-year, on an annual basis of
+using it annually, it probably is not cost-effective, unless we
+are willing to put that extra money into it and just say it is
+a better test and that we are willing to fund it. But if we
+really look at the ability of a better Pap to potentially allow
+us to increase the screening interval, and realizing that many
+people have an increased screening interval anyway--many people
+only go in every two or 3 years. So if we have a better Pap
+applied to that, then in the end, we don't have to do paps
+every year, that would save substantial money down the road.
+ Part of the reason it would save substantial money is that
+you have to remember that 5 to 10 percent of women that go in
+and get paps every year on an annual basis will get either an
+equivocal Pap or a Pap that is limited in quality; both of
+those require a physician response, bringing the patient back
+for some response. So, those are in many instances false
+positives. If we don't have to do that on a yearly basis and
+bring all of those in, but only have that risk, say, every 3
+years, our system will get much more cost-efficient than it is
+right now, and we can still, I think, pick up as much or more
+cancer than we are picking up under the present system.
+ Mr. Coburn. The gentlelady from California.
+ Mrs. Capps. Thank you. I want to acknowledge--first of all,
+thank you for your testimony, and I would like to address it
+briefly. I know the hour is getting late, but we have sitting
+through this whole discussion this afternoon Dr. Wanda Jones,
+from the Women's Health Office, Department of Health and Human
+Services. I think that is a credit to what they are doing in
+their office and also bears a lot on what we are talking about
+today.
+ It calls to mind for me the United States Public Health
+Service, in combination with the Department of Defense, this
+wonderful mobile unit for a mammogram, the state-of-the-art
+that I was able to, when I was a congressional spouse, had a
+tour of. There are innovations happening in cancer detection
+here, in our Nation's Capital, but also all throughout the
+country. That is what I find intriguing about it.
+ So I want to commend the efforts of the Women's Health
+office for what you do, and also the three of you are touching
+on--and I know that it must be frustrating for you because we
+are barely getting into the topics that you care so deeply
+about. But that is the nature of what we do here. And right
+now, at this late hour, we are getting to part of the
+discussion that we could really sink our teeth into and say,
+you know, what is the next thing to do?
+ Here I feel such an dichotomy. We have a treatable disease,
+and I have had a personal experience now. My daughter was just
+diagnosed with cancer, not this kind, within the last month. So
+I am entered into a world that I didn't think I would have to
+learn about this way.
+ But here we have a preventable disease, according to a
+screening device, which is fairly routine, and I hear from you,
+Ms. Gatscha, the reimbursement rate has something to do with
+how effective this is going to be and we need to be addressing
+that here on the Hill. Also, we have the challenge of getting
+this screening out to more women and having them know more
+about--well, not just women, our society in general. I don't
+want to pin it all onto women--to know what to do about our
+bodies and how to prevent preventable diseases. So we don't
+want to lose that track.
+ Yet, you are saying we should be going the next step. We
+shouldn't be content with the Pap smear that was around 50--I
+know it has been improved, but maybe there is different
+concepts.
+ So, with the little tiny bit of time, can you tell me how
+we should proceed here on the Hill with this topic now? And
+thank you.
+ Mr. Cox. Where I have a hard time answering that is I am
+not sure what laws or power you have in terms of making changes
+in this. My personal feeling is that the agencies that have
+been set up to explore cost-effectiveness and cervical cancer
+screening have taken only a single end-point and used a model
+that was made in 1985 or made in 1990, but used 1985,
+International Agency for Research on Cancer data. The model
+uses a $3 cost for Pap smears. It uses a false negative rate of
+Pap smears of 2 to 3 percent. It uses as the only end-point
+years of life saved, which if you divide the number of lives
+lost in the United States per year by 50 million women
+screened, comes out to very small numbers, especially when you
+talk about enhancements that might improve that.
+ So, what I would really like to see you all encourage is
+that, in those situations in which there are official
+assessments of cost-effectiveness, that really we take into
+account cost-benefit analysis and quality-of-life years.
+Because those are what really matter to women. Women are not at
+huge risk over their lifetime of dying of cervical cancer, but
+they are at huge risk of getting anxiety and distress over
+being diagnosed with something that may have little adverse
+effect on them either now or in the immediate future.
+ I think that we can utilize cost-benefit analysis in a way
+in which we can find that this system can be organized in a
+much better way than it is, and that it can be still as
+effective, and probably more so, with not nearly so much
+trauma, both physical and psychological, to women.
+ So that is where I would like to take it. I would also
+mention maybe not starting the screening interval at 18, and I
+figured I'd get some real hackles out of people for that. I am
+basically in a center where I see 18- to 22-year-olds, and I
+have never seen a cancer in this age group, not an epithelial
+cancer. I've seen rabdomile sarcomas, et cetera, but not
+epithelial cancers. And, indeed, epithelial cancers are
+extremely uncommon in women under the age of 24.
+ So I think that we could consider, if we have to save money
+in the screening system to put elsewhere, to higher-risk
+groups, et cetera--maybe we don't--but if we do, I think we
+could consider looking at what the rest of the world does and
+make that screening start a little bit later, especially in
+terms of the trauma that occurs with young people considering
+the very high positive rate of HPV in that group, the very high
+positive transient nature of the HPV effect in that age group.
+ Mrs. Capps. Thank you. More flexibility then, or----
+ Mr. Lenhart. I would like to add two thoughts that we
+learned through the AMWA campaign that might be utilized on a
+more Federal basis. The first is the importance of involving
+multi-specialty groups in formulating policy. Our advisory
+committee not only included pathologists, cytologists, and some
+experts in virology, but also practicing clinicians, both
+primary care physicians, obstetrician, gynecologists. It was a
+very variable group. And if you want to really tease out cost-
+effectiveness, and the complexity of the issue, you want to
+develop policy based on a consensus group that is more variable
+than is often involved.
+ The second thing that we learned was not to underestimate
+the low cost in high efficiency of women's capacity to be pro-
+active and to communicate. The cost of our campaign is
+relatively low because, essentially, we took our multi-
+specialty advisory committee, said, what are the key things
+that women should know that they don't know about both what's
+new and about what they should be doing more of? Then we gave
+that information free of charge to a number of women's
+organizations, many of them minority organizations, and said to
+them, ``This is what is important. You figure it out.'' We gave
+them suggestions. ``But you figure out the best way to get this
+information across to your groups.'' That is pretty cheap.
+ Mr. Coburn. Dr. Lenhart, let me interrupt and give Mr.
+Towns his time, if we may. We are running way over, and many of
+us have to be in other places about 10 minutes ago. The
+gentleman from New York.
+ Mr. Towns. I will definitely try to respect that, Mr.
+Chairman, and be as brief as possible.
+ You know, I guess I want to ask each panelist this. In your
+opinion, what is the greatest constraint for women to get
+access to quality Pap smears? What is the greatest constraint?
+ Mr. Cox. There is a whole slew of studies and literature on
+this right now. And, unfortunately, they are not going to help
+answer that question very much because most of them have
+indicated the cost is not the primary issue. And, in fact, you
+can look at the Kaiser system, and you can look at the Canadian
+system, where cost is not a factor--women get free access to
+Pap smears--and, yet, this same percentage of women that get
+cervical cancer in that system are those women that don't get
+screened. So, it is not, it doesn't appear to be a cost issue.
+ There really are societal, cultural issues, especially
+cultural, that we have a harder time penetrating, and
+especially in our wonderfully diverse society we have so many
+cultures come in, in which really something that is in that
+part of the human anatomy is really not something that is shown
+even for exam. And, it is those kinds of issues that we have a
+hard time getting beyond. If we can find ways to overcome the
+cultural and societal issues, then I think that we may be able
+to get many, many of these women in. But that is the hardest
+thing to crack, I believe.
+ Mr. Towns. Let me ask you, Doctor, if they come in--I am
+not sure that I am hearing that the medical staff encourages
+them, even when they come in. Then when they come in for
+something else, do they actually encourage them to take a Pap
+smear? Is that going on? I get the feeling that there is
+something missing here.
+ Mr. Cox. I agree. I think that what you are alluding to is
+that there are often visits to the medical practitioner by
+patients, by women, who have never had a Pap or have not had
+one in many, many years, and they are there for some other
+reason and the Pap smear is not done. And I think that is one
+of the things that we have to do. We have to educate physicians
+to always be wary of the fact that when a woman comes in, a Pap
+needs to be done.
+ Kaiser published a good study in the Green Journal this
+year in which they showed that 60 percent of the cancers in
+their population were in women that had not had a Pap smear or
+not had one in the last 5 years, and the majority of those
+women had been in the Kaiser system for some other reason and
+had just not had a Pap when they were there. This is a real
+tragedy and something that has got to be corrected.
+ Mr. Lenhart. We would agree with that. We think that a lot
+of the new information, as well as a lot of vital women's
+health information in general, is often missed in the doctor's
+office. So we have sponsored a number of physician education
+programs that are targeted at getting the information out, as
+well as converting the doctors into advocates and better
+communicators, but also patients into advocates and better
+communicators with their physicians. We think that dialog is a
+very important one to monitor.
+ Mr. Towns. Do you want to add to this?
+ Ms. Gatscha. Yes, well, just one thing really, because
+those are the cruxes of this matter. But I think, also, this
+information has to be disseminated at other levels because
+there are lots of people who don't go to a doctor. They are
+just well. They don't go and no one says, ``Hey, have you had a
+Pap smear?'' I think that at the community level, churches,
+schools, this information has to be part of health programs in
+elementary and high schools. Hopefully, by college, when many
+young women do become sexually active, then they will have
+these tools to use to help them prevent this disease.
+ Mr. Towns. Thank you. Just one other question which is sort
+of really bothering me: Is it realistic to expect that women,
+and particularly low-income women, will have access to new
+cervical cancer treatment? Is it realistic to think that they
+will.?
+ Mr. Cox. Well, I think that resources are available in most
+States. I can only answer for my State--that that there are
+resources for almost all women to get Pap smear screening.
+There is Medical/Medicaid. There is State Office of Family
+Planning, which provides Pap smears to women coming in for
+family planning. I think that it is uncommon in the State of
+California for there to be women totally outside the system,
+unaffordable. Even for women that are caught between the really
+low-income level and the job level where they have insurance
+coverage, there are some women that are not rich and not poor
+and don't have insurance. Those are the ones that often have
+the hardest time, but paps are available through Planned
+Parenthood, for instance, and other agencies on a sliding scale
+that can be very helpful for those women.
+ I think one of the things we forget is that Planned
+Parenthood provides about 2.5 million paps in the United States
+per year. It provides more paps than any other organization in
+the United States, and so that is a very important function for
+it, that women that might otherwise slip through the cracks
+would have access to.
+ Mr. Coburn. Would the gentleman yield?
+ Dr. Lee did testify--she was asked that specific question
+by Ms. Eshoo, and her response was, they are getting the care,
+you know, which surprised me. I will just admit to you I was
+surprised at her answer, and I am going to ask her for that
+data, which leads me to the next question.
+ I would like unanimous consent to add to the record and
+leave the record open until the questions are formulated for
+our panel.
+ Other then that, I want to thank each of you for being here
+and for your contribution and your time.
+ Mr. Cox. Thank you very much.
+ Mr. Coburn. The meeting is adjourned. I guess you do this:
+[using gavel].
+ [Whereupon, at 5:45 p.m., the subcommittee was adjourned.]
+ [Additional material submitted for the record follows:]
+Prepared Statement of Carol Ann Armenti, Director, Center for Cervical
+ Health
+ It is my privilege to contribute to these proceedings on cervical
+issues as a cervical cancer survivor, a patient advocate and a
+healthcare professional. In a recent media interview I was asked with
+how many women did the Center for Cervical Health have direct contact
+over the past year. I was surprised to find that our website, which we
+are proud to say has been reviewed, approved by and linked to such
+pres-
+
+tigious organizations as Yale University, the Women's Cancer Network,
+and the Society of Gynecological Oncology, receives several thousand
+accesses a week, and that I personally counsel and refer for treatment
+as many as a dozen women in a week.
+ It has been my distinct pleasure and honor this past year to be the
+first patient advocate appointed to the American Medical Association
+National Patient Safety Council, to serve as the New Jersey State
+Cervical Chair of the Center for Disease Control Breast and Cervical
+Program, and to be cervical cancer survivor representative to the
+National Cancer Institute Survivorship Research Conference. I served on
+the National Institute of Health cancer survivorship grant funding
+panel which--for the first time--permitted advocates a full vote on
+funding proposals. It was a similar honor to testify before the Food
+and Drug Administration, this past year, on new technologies in the
+detection of cervical disease.
+ I am blessed with the support of the print and broadcasting media,
+advocacy organizations, medical groups and private industry. But I am
+most blessed with this opportunity to represent to you the courage of
+those suffering from cervical disease in this country, it is with
+frustration and anger on their behalf that I advise you of their unmet
+needs, and it is with hope that I ask for the increased support they
+deserve.
+ I call to your attention that fourteen per cent of all cancer
+survivors are those surviving cervical cancer. Other than breast
+cancer, it arguably represents the largest group surviving any form of
+cancer in this country yet relatively little is done to support these
+women who have had what is unique to their being, their reproductive
+organs, mutilated and destroyed. This past week at a National Cancer
+Institute Survivorship Research Conference not one research project
+which focused on cervical cancer was presented in two days of lecture.
+ Of the nearly eighty grant proposals on cancer survivorship
+submitted to the National Institute of Health not one--other than a DES
+follow-up study--focused on cervical cancer. Indeed, I was recently
+contacted by a cancer center in Colorado which was attempting a study
+on cervical cancer survivors. The researchers were disconcerted because
+they could not find more than two dozen cancer survivors eligible and
+willing to participate in a study. I immediately contacted two
+prominent cancer advocates whom I know to be surviving cervical cancer
+and I was told that they did not wish to become ``public.''
+ Our society has branded these women pariahs. They are ashamed to
+discuss their disease, and even worse, they are so embarrassed to
+discuss their symptoms that they frequently do not seek detection of
+early precursor conditions or obtain effective treatment of disease. It
+is incumbent upon us as a nation to provide women with the education
+they need in their earliest, as well as their latest, years to protect
+their lives and their reproductive system. It is further incumbent upon
+us as a nation to provide adequate funding and assurances that women
+who seek detection and treatment will receive it.
+ Strides are currently being made in the areas of detection, new
+technologies which may prove successful in determining the genesis of
+disease. New treatments and vaccines are showing great promise for the
+reduction in morbidity and mortality of cervical disease. Yet I see
+little improvement in the education of young women which may help them
+make better choices. We must see programs which will inform all women
+on the damage to their reproductive systems caused by smoking, and
+inform young women especially of the increased risk to which they
+expose themselves by relations in their teenage years when their immune
+systems may be especially unable to fight disease.
+ Similarly, I see little in this country done to educate physicians
+to the symptoms of cervical disease and even less done to inform them
+on new methods of detection and treatment.
+ Nearly two years ago because of the great silent suffering of these
+women who were willing to share their experiences with me both as a
+sister survivor and psychologist, I began my efforts to increase public
+awareness. Part of those efforts resulted in the declaration of January
+as Cervical Health Month by this administration. Our reward was dozens
+of programs across the country encouraging women to protect themselves
+by having Pap tests, the single most successful cancer screening device
+ever devised, and to have pelvic examinations. Part of our efforts is
+the Resolution, consistent with its predecessor sister resolution for
+breast cancer survivors, currently before the Senate declaring Cervical
+Health Month and conveying the sense of the Senate that these women and
+their families deserve support.
+ I further ask this Committee to support increased funding programs
+for the detection of cervical disease. It is oftentimes said that fully
+half of the women who develop cervical cancer did not receive a Pap
+test. This statement is made as an indictment of those women who
+develop the disease as if they were somehow responsible for their own
+illness. In the State of New Jersey we are both proud and saddened to
+say that we gave a party and everyone came. That is, not only did we
+achieve our goals in the numbers of women who responded to our CDC
+underserved program, more women came than we had funds to test. We must
+ensure that all women who wish to be tested, are tested.
+ I ask that this Committee encourage studies which will ease the
+burden of those surviving cervical cancer. We can learn from these
+women how best to treat future disease with less destruction and less
+mortality. I call to your attention that while the death rate of other
+cancers has declined, the mortality rate of cervical cancer is expected
+to increase this year.
+ Finally, I ask that you encourage the education of both women and
+physicians on causes, symptoms and treatments of this disease, and that
+we do so without the moral judgment which has made women too ashamed in
+the past to seek detection and treatment.
+ I once again thank you for this opportunity to address this
+Committee.
+ ______
+
+ Department of Health & Human Services
+ National Cancer Institute
+ April 8, 1999
+The Honorable Michael Bilirakis
+Chairman, Subcommittee on Health and Environment
+Committee on Commerce
+House of Representatives
+Washington, D.C. 20515
+ Dear Mr. Chairman: I am responding to your letter of March 19,
+1999, in which you pose five questions as a follow-up to my testimony
+before the Subcommittee on Health and Environment on March 16, 1999.
+ As requested, the questions have been restated below. The answer
+follows each numbered question.
+ Question 1. What are some of the side effects of various forms of
+cervical cancer treatment?
+ Response. Three kinds of treatments are used for cervical cancer:
+surgery, radiation therapy and chemotherapy and side effects vary
+depending on the type of treatment chosen. There are also several
+different types of surgery that are used to treat cervical cancer. The
+stage of cervical cancer at the time of diagnosis determines the type
+of treatment and will determine possible side effects.
+ Methods for removing or destroying small cancers on the surface of
+the cervix include: cryosurgery which kills the cancer by freezing;
+cauterization (burning) or laser surgery which destroys the abnormal
+area without harming nearby healthy tissue; a loop electrosurgical
+excision procedure (LEEP) may be preformed in which an electrical
+current is passed through a thin wire loop that acts as a knife to
+remove the abnormal tissue; and conization in which a cone-shaped piece
+of tissue is removed where the abnormality is found. These treatments
+may cause cramping or other pain, bleeding, or a watery discharge.
+ Hysterectomy is another surgical procedure used in the treatment of
+advanced cervical cancer. Women who have a hysterectomy may experience
+pain in the lower abdomen for a few days following surgery. They will
+no longer have their menstrual periods and can no longer have children.
+Sexual dysfunction is another possible side effect. Women who undergo
+hysterectomy also face the risks of major surgery, including bleeding,
+infection, and damage to other organs.
+ Side effects of radiation treatment can include infertility, sexual
+dysfunction, fatigue, hair loss, skin conditions, diarrhea, and
+frequent and uncomfortable urination.
+ Side effects of chemotherapy depend on the drugs and doses the
+patient receives. Side effects can include increased susceptibility to
+infections, bruising, low energy, hair loss, poor appetite, vomiting,
+and mouth sores. Side effects gradually go away during the recovery
+periods between treatments. Women treated with cisplatin can also
+develop chronic neuropathy and renal damage.
+ Question 2. How can screening methods for cervical cancer be
+improved?
+ Response. The Pap test is currently the accepted method used to
+screen for cervical cancer and has been very successful in reducing the
+death rate from cervical cancer. However, as with any medical test, the
+Pap smear has limitations, particularly with respect to false-negative
+screening results. Recently, interest has focused on development of
+technologies to enhance the accuracy of cervical cancer screening. Some
+of these techniques are directed at improving the sampling and specimen
+quality, others are focused on improving the laboratory microscopic
+screening process, and some techniques are visual or molecular rather
+than microscopic.
+ Methods to improve sampling and specimen quality include the use of
+liquid-based collection techniques. Liquid-based collections offer
+improved fixation and presentation of the material in a more uniform
+manner than traditional smears which could make detection of abnormal
+cells easier. This technique also has the ability to test for HPV
+infection if there is a low-grade or equivocal cytology result which
+eliminates additional patient visits for testing.
+ Computer image analysis has been approved to screen cervical
+cytology specimens in an effort to reduce false-negative results. While
+this technology increases the screening sensitivity for atypical
+squamous cells of undetermined significance and low grade squamous
+intraepithelial lesion diagnosis it comes at a significant cost. Used
+in a secondary screening mode, these technologies are cost-effective
+only if incorporated into a less frequent screening strategy.
+ Question 3. What type of education campaign has the National Cancer
+Institute (NCI) sponsored to increase the awareness of cervical cancer?
+Please be specific in describing how NCI has coordinated its activities
+with other Federal agencies and programs.
+ Response. Federal agencies are designated to serve the United
+States in specific ways. The National Institutes of Health (NIH), of
+which NCI is a part, is a research agency. In its mission to protect
+and improve human health, the NIH (and NCI) conducts and supports
+basic, applied, and clinical and health services research to understand
+the processes underlying human health and to acquire new knowledge to
+help prevent, diagnose, and treat human disease and disabilities. This
+may include developing an information campaign such as the Pap Tests: A
+healthy habit for life campaign and evaluating its effectiveness at
+achieving its goal. NCI also has a mandate to disseminate research
+findings so that when the development and evaluation are completed,
+other Federal and state agencies, and private sector organizations, may
+take this information and apply it accordingly. NCI, therefore, plays
+an integral role in these activities.
+ The NCI disseminates research findings widely through scientific
+publication, press conferences, press statements, clinical alerts,
+patient education materials, meetings of professional societies,
+television and radio, the World Wide Web, our toll-free Cancer
+Information Service, our PDQ databases, and the Information Associates
+Program. Our staff has many contacts within agencies for a variety of
+programs and issues. Through these personal contacts, and those
+mechanisms mentioned above, Federal agencies and offices have direct
+access to information pertinent to their programs. In addition, we
+maintain and foster close working relationships with other Institutes
+that have formal collaborative relationships with the Office os
+Population Affairs-our projects and programs are thus included in that
+broad knowledge base. NCI has several partnerships with other federal
+agencies and non-federal groups to enhance our information
+dissemination activities The following are examples of two specific
+information campaigns on cervical cancer:
+
+Pap Tests: A healthy habit for life: In May 1998 the Office of Cancer
+ Communications began a campaign to alert the public of the
+ results of a survey that showed that older women were unaware
+ of their continued risk for cervical cancer. National
+ activities have included the distribution of a media packet
+ that focused on cervical cancer and older women. Additionally,
+ NCI collaborated with the Health Care Financing Administration
+ (HCFA) to reprint an NCI cervical cancer publication with
+ Medicare information for older women. Other activities have
+ included conducting research with physicians to identify their
+ attitudes and perceptions of Pap test screening among women 65
+ and older. Based on this research, a print public service
+ announcement and newsletter article are being developed that
+ encourage physicians to talk to their older patients about Pap
+ test screening. These materials will be promoted through
+ physician publications and newsletters.
+The Pap Test and Cervical Cancer Video: An intertribal video on the
+ early detection of cervical cancer for American Indian women
+ was produced by the NCI in conjunction with the Nebraska
+ Department of Health. The video comes with educational material
+ to help inform American Indian women of the importance of
+ regular Pap tests.
+ Question 4. What is being done to improve the quality of life for
+women who are diagnosed and treated for cervical cancer?
+ Response. Improving the quality of life for cancer patients is a
+very important part of research at NCI. Currently, NCI is working to
+evaluate interventions which can reduce sexual dysfunction caused by
+radiation therapy. In addition, the NCI has ongoing research on ways to
+reduce damage to normal tissue from radiation therapy. The NCI also has
+plans to study fertility-sparing surgery for women with early stage
+cervical cancer.
+ Question 5. In your testimony, you discussed clinical trials that
+NCI is conducting on cervical cancer. What is the percentage of
+cervical cancer patients who participate in these trials?
+ Response. Approximately 2-3% of women diagnosed with cervical
+cancer are enrolled on cancer treatment trials sponsored by the NCI.
+This figure is consistent with other adult cancer sites.
+ Please do not hesitate to contact me if you have further questions.
+ Sincerely,
+ Edward L. Trimble, M.D.
+ Head Surgery Section, Division of Cancer Treatment and Diagnosis
+ ______
+
+ Department of Health & Human Services
+ National Cancer Institute
+ April 8, 1999
+The Honorable Michael Bilirakis
+Chairman, Subcommittee on Health and Environment
+Committee on Commerce
+House of Representatives
+Washington, D.C. 20515
+ Dear Mr. Chairman: I am responding to your letter of March 19,
+1999, in which you pose twelve questions as a follow-up to my testimony
+before the Subcommittee on Health and Environment on March 16, 1999.
+ As requested, the questions have been restated below. The answer
+follows each numbered question.
+ Question 1. The National Cancer Institute (NCI) is in the process
+of conducting a randomized trial to establish the best way to manage
+abnormalities that are discovered during Pap smear tests. This study is
+often referred to as ASCUS/LSIL Triage Study or ALTS. Please explain
+the purpose and significance of this trial?
+ Response. NCI is conducting a large randomized trial to find the
+best way to manage the mild abnormalities that often show up on Pap
+tests and may, in rare instances, progress to cancer if left untreated.
+The ALTS trial is comparing three approaches: 1) immediate colposcopy
+(a procedure in which a physician examines the cervix through a
+magnifying instrument and biopsies any abnormal area; 2) repeating the
+Pap test every six months (because most abnormalities return to normal
+without treatment); and 3) testing for cancer-associated types of HPV
+as a means to differentiate between abnormalities that need immediate
+colposcopy and those that can be best followed with repeat Pap tests.
+Researchers will compare the three different groups to assess the
+effectiveness of each management option in detecting the serious
+abnormalities that can progress to cancer, the acceptability of each
+option to patients, and the cost effectiveness of each option.
+ Question 2. When do you estimate the NCI will develop a vaccine for
+human papillomavirus (HPV)? Can you describe all of the different HPV
+vaccines that are being tested?
+ Response. There are both preventative and therapeutic HPV vaccines
+which have been developed by the NCI that are currently being tested in
+clinical trials. They seek to prevent infection or to induce regression
+of established infection via immune recognition of specific HPV-encoded
+proteins or peptides. Such vaccines can be delivered either directly as
+a protein or by viral vectors derived from organisms of a different but
+related species.
+ Question 3. What effect, if any, does HPV have on men?
+ Response. Scientists have found an association between several
+types of HPV and the development of anal cancer and cancer of the penis
+(a rare cancer). HPV also frequently causes benign warts.
+ Question 4. In addition to cervical cancer, what other effects can
+HPV have on the body?
+ Response. Genital warts (condylomata acuminata or venereal warts)
+are caused by only a few of the many types of HPV. Other common types
+of HPV infections, such as those that cause warts on the hands and
+soles of the feet, only rarely cause genital warts. In women, the warts
+occur on the outside and inside of the vagina, on the cervix, or around
+the anus. In men, genital warts are less common. If present, they are
+seen on the tip of the penis or the urethra; however, they also may be
+found on the shaft of the penis, on the scrotum, or around the anus.
+Rarely, genital warts also can develop in the mouth or throat of a
+person who has had oral sexual contact with an infected person.
+ Question 5. Please provide the number of HPV cases in the U.S. Is
+this number increasing or decreasing? To what can this trend be
+attributed?
+ Response. It is important to remember that estimating the
+prevalence of HPV is difficult. Prevalence depends on many factors
+which include: the population screened, the sexual habits of those
+screened, what is classified as HPV infection at the time of screening,
+etc. Estimates for the number of HPV cases varies. In November of 1996
+the CDC estimated that 24 million Americans were infected with HPV. The
+incidence of HPV infection has increased with changing sexual mores
+starting in the 1960's. It is difficult to know whether variations in
+incidence and prevalence reported during the 1990's represent an actual
+change in the number of cases of HPV.
+ Question 6. What, if any symptoms are associated with HPV? If it is
+asymptomatic, how would one know one is infected?
+ Response. HPV may cause warts with many different characteristics.
+They may appear small or large, flat or raised, single or multiple;
+sometimes the warts may not even be visible to the naked eye. The most
+common places to notice genital warts are outside the vagina, on the
+penis, and around the anus. In women, HPV can lead to the development
+of warts inside the vagina and on the cervix as well. For many people
+who have HPV infection, there are no obvious signs of infection.
+However, if warts are present, a doctor can diagnose HPV infection by
+their characteristic appearance and the history of how they developed.
+In women, to look for warts on the cervix or in the vagina, a doctor
+may use a colposcope, which is like a telescope. In addition, Pap smear
+results may be suggestive of HPV infection. There is currently no blood
+test that has proven reliable in the diagnosis of HPV infection and it
+is not possible to routinely culture HPV. However, there are sensitive
+DNA based assays which can be used to diagnose symptomatic and
+asymptomatic HPV infection.
+ Question 7. How widespread or common is HPV? Of the women who have
+HPV, what is the percentage of those women who will develop cervical
+cancer?
+ Response. More than 80 types of HPV have been identified. However,
+approximately 25 types infect the uterine cervix; of these, only some
+are associated with invasive cervical cancer. They are therefore
+classified into low-risk types, HPV 6 and 11, and high-risk types, most
+commonly 16, 18, 31, and 45, which account for more than 80 percent of
+all invasive cervical cancers. Less than 15 percent of women infected
+with HPV will develop either low-grade squamous intraepithelial lesions
+(LSIL) or high-grade squamous intraepithelial lesions (HSIL). At least
+one-third of all grades of SIL will fade, whereas less than half
+persist and approximately one-quarter progress. Of lesions that
+progress, approximately 10 percent progress to carcinoma in situ and 1
+percent to invasive cancer.
+ Since the virus is transmitted primarily through sexual
+intercourse, there seems to be a peak prevalence of infection in
+sexually active women who are younger than 25 years of age. The
+prevalence of infection decreases with increasing age, suggesting that
+most infections in women and men resolve over time through host immune
+responses.
+ Question 8. The NCI has identified risk factors, such as the human
+papillomavirus, in the development of cervical cancer. What work has
+NCI done to coordinate a Federal response to the prevention of cervical
+cancer? Specifically, what has NCI done to coordinate with the
+Department of Health and Human Services (HHS) Office of Population
+Affairs and the HHS Health Resources and Services Administration (HRSA)
+to alert women concerning the risk factors associated with cervical
+cancer?
+ Response. Federal agencies are designated to serve the United
+States in specific ways. The National Institutes of Health (NIH), of
+which NCI is a part, is a research agency. In its mission to protect
+and improve human health, the NIH (and NCI) conducts and supports
+basic, applied, and clinical and health services research to understand
+the processes underlying human health and to acquire new knowledge to
+help prevent, diagnose, and treat human disease and disabilities. This
+may include developing an information campaign such as the Pap Tests: A
+healthy habit for life campaign and evaluating its effectiveness at
+achieving its goal. NCI also has a mandate to disseminate research
+findings so that when the development and evaluation are completed,
+other Federal and state agencies, and private sector organizations, may
+take this information and apply it accordingly. NCI, therefore, plays
+an integral role in these activities.
+ The NCI disseminates research findings widely through scientific
+publication, press conferences, press statements, clinical alerts,
+patient education materials, meetings of professional societies,
+television and radio, the World Wide Web, our toll-free Cancer
+Information Service, our PDQ databases, and the Information Associates
+Program. Our staff has many contacts within agencies for a variety of
+programs and issues. Through these personal contacts, and those
+mechanisms mentioned above, Federal agencies and offices have direct
+access to information perti-
+
+nent to their programs. In addition, we maintain and foster close
+working relationships with other Institutes that have formal
+collaborative relationships with the Office os Population Affairs-our
+projects and programs are thus included in that broad knowledge base.
+NCI has several partnerships with other federal agencies and non-
+federal groups to enhance our information dissemination activities.
+Following are examples of two specific information campaigns on
+cervical cancer:
+
+Pap Tests: A healthy habit for life: In May 1998 the Office of Cancer
+ Communications began a campaign to alert the public of the
+ results of a survey that showed that older women were unaware
+ of their continued risk for cervical cancer. National
+ activities have included focusing on minority media outreach
+ and the distribution of a media packet that focused on cervical
+ cancer and older women. Additionally, NCI collaborated with the
+ Healthcare Financing Administration (HCFA) to reprint an NCI
+ cervical cancer publication with Medicare information for older
+ women to be distributed through HCFA and NCI networks. Other
+ activities have included conducting research with physicians to
+ identify their attitudes and perceptions of Pap test screening
+ among women 65 and older. Based on this research, a print
+ public service announcement and newsletter article are being
+ developed that encourage physicians to talk to their older
+ patients about Pap test screening. These materials will be
+ promoted through physician publications and newsletters.
+The Pap Test and Cervical Cancer Video: An intertribal video on the
+ early detection of cervical cancer for American Indian Women
+ was produced by the NCI in conjunction with the Nebraska
+ Department of Health. The video comes with educational material
+ to help inform American Indian women of the importance of
+ regular Pap tests.
+ Question 9. Please name the NCI liaisons with CDC, HRSA, and the
+Office of Population Affairs. Has NCI coordinated activity with the
+Title V Abstinence Education Grant Program or the Title XX programs
+within those agencies?
+ Response. As previously stated, NCI staff has many contacts within
+agencies for a variety of programs and issues. Liaisons with CDC, HRSA
+and the Office of Population Affairs vary on the program and issue
+involved.
+ NCI has not formally collaborated specifically on Title V
+Abstinence Education Grant program or the Title XX programs. As a
+research agency, NCI's role is to conduct and support research, then
+disseminate widely, new knowledge gained. This is done through
+information campaigns like the Pap Tests: A healthy habit for life
+campaign.
+ Question 10. What is the amount of research dollars spent by NCI on
+HPV as compared to the virus that causes AIDS? How many women die
+annually in the United States from cervical cancer? How many women die
+annually in the United States from AIDS?
+ Response. There are over 80 types of HPV, about 15 of which are
+associated with cancer of the cervix. NCI estimates that it will spend
+about $38 million on cervical cancer-related HPV research, and about
+$235 million on AIDS related cancers, in FY 1999. There are about 5,000
+deaths in the U.S. from cervical cancer each year, and more than
+200,000 deaths world wide. Over 90 percent of these cancers are HPV-
+related. There were about 4,600 female deaths in the U.S., and 900,000
+worldwide, from HIV-related illness in FY 1997.
+ Question 11. On January 12, 1999, Chairman Bliley sent a letter to
+the NCI on women's health issues, including cervical cancer. In
+response to that letter, NCI estimated the number of Americans with HPV
+to be 24 million. In testimony before this committee by Dr. Ronald
+Valdiserri, of the Centers for Disease Control and Prevention (CDC), on
+March 16, 1999, he indicated that number is 45 million. Can you explain
+the discrepancy in numbers?
+ Response. The NCI estimated number of Americans with HPV came from
+the CDC website. The entry title is ``The Challenge of STD Prevention
+in the U.S.'' and it was written in November 1996. CDC was not
+contacted by NCI for verification of this number and the CDC testified
+using an estimated number that may be more current than the one posted.
+Once again, it is important to remember that estimating the prevalence
+of HPV is difficult. Prevalence depends on many factors which include:
+the population screened, the sexual habits of those screened, what is
+classified as HPV infection at the time of screening, etc.
+ Question 12. In the above referenced letter from NCI to Chairman
+Bliley, NCI stated that, ``Condoms are ineffective against HPV because
+the virus is prevalent not only in mucosal tissue (genitalia) but also
+on dry skin of the surrounding abdomen and groin and it can migrate
+from those areas into the vagina and cervix.'' That letter went on to
+say that ``additional research efforts by NCI on the effectiveness of
+condoms in preventing HPV transmission are not warranted.'' To the
+contrary, Dr. Ronald Valdiserri of CDC testified on March 16, 1999 that
+``Several studies have shown condoms to provide some protection against
+cervical cancer . . .'' Can you explain the difference in conclusions
+made by CDC and NCI?
+ Response. The NCI conclusion that condoms are ineffective against
+HPV infection is based on the results of several long term studies
+which have failed to show that barrier contraceptives prevent cervical
+HPV infection, dysplasia, or cancer (Attachment 1, 2, 3). Dr.
+Valdiserri's testimony might be based on studies that show that while
+condoms are ineffective in preventing transmission of HPV, they are
+quite effective at preventing transmission of HIV and other sexually
+transmitted diseases. CDC would be able to provide insight into the
+basis of Dr. Valdiserri's statement.
+ Please do not hesitate to contact me if you have further questions.
+ Sincerely,
+ Dr. Douglas Lowy
+ Deputy Director, Division of Basic Sciences, NCI
+Enclosures
+
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+ CDC Responses to Questions on HPV and Cervical Cancer from the
+ Subcommittee on Health and Environment
+ Question: 1. How does CDC decide for which sexually transmitted
+diseases it will compile surveillance data? Please provide a list of
+all sexually transmitted diseases for which CDC currently recommends
+that states compile data. Please provide the number of female deaths
+per year associated with the sexually transmitted diseases for which
+the CDC has surveillance data.
+ Answer: Notifiable diseases are determined by individual state
+laws, not by CDC. All reports of notifiable diseases to CDC are
+voluntary on the part of the states. Generally, CDC compiles
+surveillance data for sexually transmitted diseases that are notifiable
+in all 50 states (gonorrhea, syphilis, chancroid; chlamydia is reported
+in 49 states). CDC also monitors non-notifiable diseases such as
+genital herpes by conducting special prevalence studies in the U.S.
+population (e.g., the National Health and Nutrition Examination Survey)
+and in smaller subpopulations. These kinds of special studies define
+the disease burden in the U.S. and often establish the need for
+diseases to become notifiable at the state level.
+ According to a CDC study, there were 2,665 female deaths
+attributable to HIV, 99 to syphilis, and 3 to gonorrhea in 1992, the
+latest year for which comparable data are available (Ebrahim et al.
+Mortality related to STD in US women, 1973 through 1992. American
+Journal of Public Health 1997;87:938-944).
+ Question: 2A. Can the human papillomavirus (``HPV'') be transmitted
+in non-sexual manner? 2B. How can someone prevent its transmission?
+ Answer: A. Of the approximately 80 different types of HPV
+infection, about 50 are considered to be non-genital (i.e., almost
+never occur on genital skin) and are almost always transmitted in a
+non-sexual manner. Of the approximately 30 genital types, sexual
+intercourse appears to be the predominant route of transmission.
+However, it has also been suggested that in rare cases, infection of
+genital skin with HPV can result from vertical transmission (mother-to-
+child during vaginal delivery); ``autoinoculation'' of non-genital
+types of HPV to the genital skin from another body part (such as the
+hand); inoculation through casual contact with genital skin, such as
+bathing; or transmission by inanimate objects (such as towels). (Cason,
+1995).
+ B. The most reliable means of preventing sexual transmission of
+genital HPV infection is likely to be abstinence, although, as noted
+above, non-sexual routes of transmission are possible. Other means of
+protection are more uncertain. The protection provided by condoms has
+been difficult to evaluate because current laboratory tests for HPV
+infection cannot determine whether an infection is new or acquired
+months or even years before. Latex condoms should provide protection if
+they cover the infected genital skin and if used consistently and
+correctly. The greater surface area of the female condom may provide
+even greater protection, although there are no data evaluating its
+effectiveness in this regard. Finally, microbicides under development
+may provide some protective benefit (Howett, 1999). The most promising
+approach for prevention of transmission will be the development of
+preventive vaccines. Carefully designed studies of all of these
+transmission prevention approaches will be important in designing more
+effective prevention strategies.
+ Question: 3A. Can the body eliminate HPV from its system? 3B. What
+can be done for those people who have compromised immune systems?
+ Answer: A. Whether the body can eliminate HPV from its system, that
+is, totally eradicate it (which is what we think happens with
+respiratory viruses such as those which cause influenza or the common
+cold) has been difficult to determine. There is good evidence that in
+most people genital HPV infections become ``undetectable'' by even
+highly sensitive lab tests for detection of HPV DNA (such as PCR) over
+the course of a few months to a few years (Ho, 1998), and it appears
+that such people do not have an increased risk for development of
+dysplasia or cancer. On the other hand, people with persistently
+detectable HPV infection appear to be at higher risk for dysplasia, and
+probably also cancer.
+ Evidence which suggests that undetectable HPV infection might not
+be totally eradicated from the body comes from patients with
+compromised immune systems, such as those taking immunosuppressive
+medication after an organ transplant or those with HIV infection, in
+whom the rate of detectable HPV infection is much higher than it is in
+patients whose immune systems are normal (Sun, 1997; Halpert, 1986).
+While some of this difference could be attributed to a greater risk of
+acquiring a new HPV infection among those with greater sexual risks
+(such as those with sexually acquired HIV), the fact that the rate of
+detectable HPV increases directly with declining immune function, even
+among patients who become less sexually active due to their illness,
+suggests that at least some or most of this excess level of infection
+is due to reactivation of previously undetectable infection which was
+quiescent but not completely eradicated. The similar experience in
+older, and probably less sexually active transplant recipients, is also
+consistent with such a process.
+ B. For those with compromised immune systems, there are two current
+approaches to help them with potential HPV-related problems. The first
+is to be sure that women undergo Pap smear screening at recommended
+intervals (which for those with HIV infection is every 6 months for a
+year and then annually thereafter), as well as follow-up evaluation of
+any abnormalities, in order to prevent what may be an increased risk of
+cervical cancer. The second approach is to attempt to maintain and
+improve immune function if possible, such as with the use of highly
+active antiretroviral therapy in those with HIV infection, which has
+the potential to reduce the risk of HPV-associated dysplasia and
+cancer. Better studies are needed to help develop management approaches
+in people with compromised immune systems.
+ Question: 4. On January 12, 1999, Chairman Bliley sent a letter to
+the National Cancer Institute (NCI) on women's health issues, including
+cervical cancer. In response to that letter, NCI estimated the number
+of Americans with HPV to be 24 million. In testimony before this
+committee on March 16, 1999, you indicated that number is 45 million.
+Can you explain the discrepancy in numbers?
+ Answer: Because HPV infection is not diagnosed in most people who
+are infected and because there are no systems in place for reporting of
+HPV infection, assessment of prevalence can only be based on very
+general estimates. This issue is further complicated, as noted in the
+answer to Question 3, by the problem that it has not yet been
+determined whether infection no longer measurable by sensitive HPV DNA
+detection tests such as PCR have truly resolved or are simply quiescent
+but still present, which is the assumption made for other viral
+sexually transmitted diseases such as genital herpes.
+ With these complexities in mind, there have been several attempts
+to quantify the prevalence of what are considered to be active genital
+HPV infections. Prior to 1999, the most widely quoted estimate of
+active genital HPV infection was 24 million (IOM Report). As of 1999,
+new revised estimates for the prevalence of the various sexually
+transmitted diseases stated that ``a conservative estimate of the
+prevalence of productive HPV (persons with active shedding of HPV DNA)
+is approximately 20 million'' (Cates, 1999).
+ Estimates of viral sexually transmitted disease prevalence based on
+serologic studies (assessments based on the presence of antibody in the
+blood) are much higher. For genital herpes, the estimated prevalence is
+45 million, and the number of cases of genital HPV infection appears to
+be at least as great as the number of cases of genital herpes. However,
+estimates of the number of people who have been infected (and might
+still be at least quiescently infected) with genital HPV based on
+serologic studies are as high as 100 million (Koutsky, 1997).
+ Clearly, a very large number of Americans have genital HPV
+infection, and better studies are needed to further refine these
+estimates.
+ Question: 5. NCI stated that ``additional research efforts by NCI
+on the effectiveness of condoms in preventing HPV transmission are not
+warranted.'' CDC's testimony stated ``Several studies have shown
+condoms to provide some protection against cervical cancer.'' Please
+explain the difference in conclusions and also cite the studies to
+which you refer.
+ Answer: NCI statement refers to genital HPV infection, not cervical
+cancer. Two case-control studies documented a strong protective effect
+of condom use and cervical cancer. In one study in Utah, condom use was
+associated with a lower risk of cervical cancer in women who had more
+than one sex partner; these women had a 47% lower risk of cervical
+cancer compared to women who did not use condoms (Slattery ML, Overall
+JC, Abbott et al: Sexual activity, contraception, genital infections,
+and cervical cancer: support for a sexually transmitted disease
+hypothesis. American Journal of Epidemiology 1989;130:248-258). In
+another study conducted in Los Angeles, women who used condoms for 2-9
+years had a 50% reduction in risk of cervical cancer, and those who
+used condoms for 10 or more years had a 60% reduction in risk, compared
+to women who had 0-2 years of condom use (Peters RK, Thomas D, Hagan
+DG, et al. Risk factors for invasive cervical cancer among Latinas and
+Non-Latinas in Los Angeles County. Journal of the National Cancer
+Institute 1986;77:1063-1077).
+ Other studies have not shown a protective effect (Hildeshim A,
+Brinton LA, Mallin K et al. Barrier and spermicidal contraceptive
+methods and risk of invasive cervical cancer. Epidemiology 1990; 1:226-
+272 and accompanying editorial Daling JR, Weiss NS: Are barrier methods
+protective against cervical cancer? Epidemiology 1990; 1:261-272.)
+ Question: 6. The CDC has identified risk factors, such as the human
+papillomavirus, in the development of cervical cancer. What work has
+CDC done to coordinate a Federal response to the prevention of cervical
+cancer? Specifically, what has CDC done to coordinate with the
+Department of Health and Human Services (HHS) Office of Population
+Affairs and the HHS Health Resources and Services Administration (HRSA)
+to alert women concerning the risk factors associated with cervical
+cancer? Who are the liaisons with CDC, HRSA, and the Office of
+Population Affairs? Has CDC coordinated activity with the Title V and
+Title XX programs within those agencies?
+ Answer: CDC has developed effective partnerships with HRSA and OPA
+on a local level. HRSA directs national health programs which improve
+the health of the nation by assuring quality health care to
+underserved, vulnerable and special-need populations. Under HRSA's
+direction, a nationwide network of 643 community and migrant health
+centers, and 144 primary care programs for the homeless and residents
+of public housing serve 8.1 million Americans each year. CDC's National
+Breast and Cervical Cancer Early Detection Program (NBCCEDP) contracts
+with many local HRSA health centers to provide services. Women eligible
+for CDC's program are referred to HRSA services for screening,
+diagnostic and treatment services as needed. To assist this effort, CDC
+and HRSA partnered on a successful conference, ``Cancer Institute on
+Prevention and Treatment Strategies for Underserved Minority
+Populations,'' to focus effective outreach, prevention, screening,
+diagnosis, and cancer treatment services for underserved minority
+populations.
+ The OPA, within the Office of Public Health and Science of the
+DHHS, provides resources and policy advice on population, family
+planning, reproductive health, and adolescent pregnancy issues. OPA
+also administers two grant programs, the national Family Planning
+Program, authorized under Title X of the Public Health Service Act
+(PHSA) and the Adolescent Family Life Program, authorized under Title
+XX of the PHSA. In Fiscal year 1999, Title X Family Planning Clinics
+expect to serve nearly 5 million persons through a nationwide network
+of 4,600 clinics. Priority is given to persons from low-income
+families; services are provided at no cost to persons at or below the
+poverty level and on a sliding fee scale up to 250 percent of the
+poverty level. Many of CDC's NBCCEDP programs collaborate with Title X
+programs and share information with Title XX demonstration projects on
+a local level. Certain Breast and Cervical Cancer programs contract
+with family planning programs for screening services and some OPA's
+Title X programs refer women to NBCCEDP's contracted facilities for
+additional follow-up and diagnostic care when Pap testing detects
+abnormalities. These special partnerships are arranged on a local,
+State-by-State or program-by-program basis.
+ Finally, CDC's Division of Reproductive Health (DRH) is currently
+examining the effects of parity (the number of children born alive to a
+woman) and age at first birth on risk of invasive cervical cancer. CDC
+is using data from a population-based, case-control study of cervical
+cancer in Costa Rica collected between 1982 and 1984. Preliminary
+results suggest that risk of cervical cancer increased with increasing
+parity and decreased with increasing age at first birth.
+ The liaisons for the respective agencies are Nancy C. Lee, M.D.,
+Division Director, CDC/NCCDPHP/DCPC; Marilyn H. Gaston, M.D., Associate
+Administrator, DHHS/HRSA/BPHC; and Thomas Kring, Deputy Director, DHHS/
+OS/OPHS/OPA.
+ Question: 7A. What is the amount of research dollars spent by CDC
+on HPV as compared to the virus that causes AIDS? 7B. How many women
+die annually in the United States from cervical cancer? 7C. How many
+women die annually in the United States from HIV-related illnesses?
+ Answer: A. During FY98, CDC spent approximately $1.25 million
+dollars for research on HPV and $41.356 million for research on HIV and
+AIDS.
+ B. In 1996, the latest year for which complete data is available,
+4,552 women died of cervical cancer in the United States (CDC, National
+Center for Health Statistics, Deaths: Final Data 1996, National Vital
+Statistics Reports; Volume 47, Number 29).
+ C. In 1996, the latest year for which complete data is available,
+there were 5,853 HIV-related deaths among women in the United States
+(CDC, National Center for Health Statistics, Deaths: Final Data 1996,
+National Vital Statistics Reports; Volume 47, Number 29).
+
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