107th Congress

Report: Making Sense of the Mammography Controversy: What Women Need to Know—Joint Hearing Before the Senate Health, Education, Labor and Pensions Subcommittee on Public Health and the Senate Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies—February 28, 2002

Members Present

Senator Tom Harkin (D-IA), Chairman, Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies; Senator Arlen Specter (R-PA), Ranking Minority Member, Appropriations Subcommittee on Labor, HHS, Education, and Related Agencies; Senator Barbara Mikulski (D-MD), served as Chair for this hearing; Senator Hillary Rodham Clinton (D-NY); Senator Bill Frist (R-TN); Senator Kay Bailey Hutchison (R-TX); Senator Patty Murray (D-WA); Senator Jack Reed (D-RI)

Witnesses

Panel One:

Andrew von Eschenbach, M.D., Director, National Cancer Institute, National Institutes of Health

Panel Two:

Donald A. Berry, Ph.D., Chairman, Department of Biostatistics and Frank T. McGraw Memorial Chair of Cancer Research, MD Anderson Cancer Center, University of Texas Harmon J. Eyre, M.D., Chief Medical Officer and Executive Vice President for Research and Medical Affairs, American Cancer Society

Panel Three:

Fran Visco, J.D., President, National Breast Cancer Coalition; Carolyn D. Runowicz, M.D., Vice Chair, Department of Obstetrics and Gynecology, St. Luke's Roosevelt Hospital, New York City; Director of Gynecologic Oncology Research for the Women's Health Service Line of Continuum Health Partners, Inc.; Professor of Obstetrics, Gynecology and Women's Health, Albert Einstein College of Medicine; and representative of the American College of Obstetricians and Gynecologists (ACOG) LaSalle D. Leffall, Jr., M.D., Chair-Elect, Susan G. Komen Breast Cancer Foundation

Purpose of Hearing: Studies published in a British medical journal, the Lancet (January 20, 2000, and October 29, 2001), by two Danish researchers, Peter Gotzsche and Ole Olsen, have addressed the question of whether regular screening with mammograms actually reduces breast cancer deaths. The authors concluded that, "screening for breast cancer with mammography is unjustified." Because of the wide news coverage of these findings and the debate in the scientific community, Senators Mikulski and Olympia Snowe (R-ME) called this hearing to clarify what women need to know about the effectiveness of screening mammography.

Opening Statements

Senator Specter recalled initiating a series of hearings in 1997 when a controversy arose as to whether there ought to be mammograms for women between the ages of 40 and 49. Although he concluded at that time that mammograms could be helpful, despite the risk of false positives (an indication that cancer is present when it is not), he was pleased that this hearing was convened to "take a fresh look at the matter." He repeated his personal view that false positives were of lesser consequence than the availability of screening to detect cancer at an early stage when it can be successfully treated.

Senator Mikulski empathized with American women who are confused by the controversy about the effectiveness of screening mammography. She said that the purpose of the hearing was not to debate the issue, but to hear a presentation of views which might "clear the air and clear up what women should do." She sited multiple sources of information that appear to conflict in their recommendations, including: U.S. and international research studies; observations by the Physicians Data Inquiry and Prevention Board; a recent statement by Tommy Thompson, Secretary of Health and Human Services; and differing positions of outside advocacy groups. She also expressed concern that insurance companies will decide not to cover mammograms as a result of this controversy. She stated that, "regardless of the efficacy of mammograms, they are the best tools we have," and suggested that the audience heed an Institute of Medicine's recommendation that additional technologies be developed and that current technology for breast cancer detection be maximized. She also mentioned her efforts in 1992 to establish mammogram quality safety standards that need to be reauthorized soon.

Senator Harkin expressed, from a personal point of view, his concern about clearing the air and gaining an understanding of the risks and benefits of mammograms. He spoke of his two sisters who both died of breast cancer, and the fact that his nieces have asked him for advice about whether or not they should continue to have mammograms. He also stated that the consensus of a recent conversation with his Iowa constituents was that, although mammograms are not a cure-all, they remain a very useful tool. In conclusion, he said, "we all know that early detection and early intervention means that a woman is going to live longer and have a quality of life."

Senator Reed commended Senators Mikulski and Harkin for convening the hearing and stated that he was "here to listen and learn."

Senator Frist welcomed Dr. von Eschenbach and praised him for the sacrifice of setting aside his private practice for public service. He was particularly interested in hearing Dr. Von Eschenbach address the importance of translational research.

Senator Murray congratulated Senator Mikulski for her work on breast cancer and expressed her frustration that, "we've allowed abstract statistical data to confuse and distort the issues." She was concerned that the controversy over mammograms will shift the focus away from prevention and access to health care. She was especially worried about minority women and the fact that the screening rate for Asian and Native American women is so low.

Senator Hutchison recalled the mixed messages she felt women received from the Government in 1994 when the debate centered around whether age 50 or 40 was the appropriate time for a women to begin receiving annual mammograms. She expressed her frustration that women were again receiving mixed messages about the effectiveness and even the possible harm of screening mammograms.

Senator Clinton apologized for not being present to hear Dr. von Eschenbach's testimony and did not provide an opening statement. She did note the high prevalence of breast cancer in New York, which is higher than the national average, and asked several questions of the witnesses.

Statements of Witnesses

Panel One: In his first testimony before a congressional committee as Director of NCI, Dr. Andrew von Eschenbach was clear and to the point regarding the Institute's position on mammography:

• Cancer is a complex disease and, therefore, the solutions are complex.
• The weight of scientific evidence still shows that mammograms save lives through early detection.
• NCI will remain vigilant, evaluating all information on the early detection of breast cancer.
• Overall mortality rates for breast cancer continue to fall.
• Both mammograms and improved therapies are needed to reduce breast cancer mortality.
• Women should continue to get mammograms every 1 to 2 years after the age of 40.
• More research is needed to improve the diagnosis and treatment of breast cancer.

Panel Two: Dr. Berry prefaced his remarks by expressing his respect for Dr. von Eschenbach, with whom he served on the faculty at MD Anderson. Nonetheless, he said he would disagree with him on some things. The main points of his testimony were:

• The Physicians Data Query Screening and Prevention Board (PDQ) has a website that can be accessed by the public as well as physicians. Screening benefits and risks are listed there. The PDQ is independent of the NCI and does not issue guidelines or make official recommendations.
• The PDQ's current statement indicates that the benefits of mammography screening are uncertain based in part on the study of Oleson and Gotzsche. That statement may be modified to add that the existence of a benefit is itself uncertain.
• Women should be informed about the possible benefits and risks along with the associated uncertainties and decide about screening for themselves.
• Dr. Berry agreed with Dr. von Eschenbach that there should not be another randomized trial on mammography in this country.
• Swedish trials should be independently audited.
• An NCI-sponsored program, Cancer Intervention and Surveillance Network (CISNET), could be helpful to women in their decision-making about mammography screening.
• Progress in the biology of breast cancer research holds the most promise towards an understanding of biological markers, early detection and treatment.

Dr. Eyre began his testimony by stating that the scientific evidence supporting mammography in reducing breast cancer death rates is solid. He gave a history of several studies that show the importance of detecting localized breast cancer, and concludes that, while mammography is not a perfect test, it is an effective interim effort to control breast cancer until the answers as to how to prevent and cure it are known. He also lauded the U.S. Preventative Services Task Force affirmation of mammography. As a representative of the American Cancer Society, his advice to women 40 and over is to have an annual mammogram.

Panel Three: Fran Visco emphasized the complexity and medical uncertainty of screening mammography and stated that what women need is to be given the tools and the power to make informed decisions. She felt that a "clear simple message" about mammography meant that women were not hearing the truth. Ms. Visco stated that the truth is, "there is uncertainty about the evidence, or about the existence, if it exists, of the extent of the benefits of screening mammography." She also pointed out that: 1) mammograms do not prevent breast cancer; 2) there are more mastectomies in the groups in the trials that are screened by mammography than in the control groups; 3) as a reviewer for the U.S. Preventive Task Force, she had disagreed with their recommendations; 4) providing health insurance coverage for women is critical; 5) an independent review of the Swedish data is important; 6) the Mammography Quality Standards Act should be reauthorized; 7) priorities for fighting breast cancer must be based on solid scientific evidence, questioning whether the billions that are spent on mammography could be better utilized; and 8) she recommended that Members of Congress and the public read the questions and answers regarding this controversy on the National Breast Cancer Coalition website.

Dr. Runowicz introduced herself as a practicing physician and a 10-year breast cancer survivor who was representing the American College of Obstetricians and Gynecologists (ACOG). Her recommendation to the Subcommittee was that an extensive and objective reassessment of all mammography data may be justified; but until then, women should continue to have screening mammograms. Women in their 40s should have them every 1 to 2 years, and women in their 50s should have them annually. She also stated: 1) a randomized prospective clinical trial in breast cancer screening would be ill-advised for moral and ethical reasons, 2) the controversy over screening mammography should not confuse patients about the fact that early detection that leads to early treatment results in improved health outcomes, 3) she is concerned that the controversy might discourage health insurance plans from covering mammography, and 4) she is concerned about the media hype over this issue.

Dr. Leffall, a surgeon, oncologist, and medical educator, appeared before the Subcommittee representing the Koman Foundation, the Nation's largest source of private funding for breast cancer research and community-based outreach programs. Recognizing that mammography is an imperfect screening tool, Dr. Leffall supported the recommendations of the U.S. Preventive Services Task Force and the National Cancer Institute. He stated that, "regular mammography, as a part of a three-step breast health regimen that includes monthly breast self-exams and annual clinical exams, saves lives." In addition, he noted 1) the improvement over the last 20 years of mammography, radiologists, and technicians; 2) Senator Mikulski's efforts to ensure a high quality of mammography via the Mammography Quality Standards Act; 3) the decline in breast cancer mortality, which he attributed to early detection and timely treatment; 4) women report that the risk of false positives are acceptable when faced with the possibility of a life-threatening disease; and 5) the Koman Foundation remains allied with the NCI and the U.S. Preventive Services Task Force in its support of the current recommendations.

Questions

Senator Mikulski

Senator Mikulski asked Dr. von Eschenbach to repeat his recommendation that women should continue to have screening mammograms and to comment on the scientific and clinical basis of that recommendation. Dr. von Eschenbach explained that even if there is a difference of opinion among statisticians, it does not change the fact that mammograms should still be in the equation along with improved therapies. She also asked if another randomized study should be conducted, and Dr. von Eschenbach explained why that would not be viable or rational.

Senator Harkin

Senator Harkin offered his analysis of the Danish studies and Dr. von Eschenbach concurred. He also followed up on a question that Senator Mikulski had begun to ask regarding the development of future methods of breast cancer screening and new types of technologies. Dr. von Eschenbach discussed digital versus standard mammography, PET scanning, magnetic resonance imaging. When asked about blood testing for the early detection of breast cancer, Dr. von Eschenbach stated that after it is validated for detecting ovarian cancer, there is the hope that it may be more broadly applied. Senator Harkin asked the status of prevention efforts, to which Dr. von Eschenbach replied that NCI's approach is multi-pronged and that tamoxifen and raloxifene are being tested now for their preventative effects.

Senator Frist

Senator Frist asked Dr. von Eschenbach to explain NCI's efforts and philosophy regarding translational research and to use mammography as an example of the importance of translational research. Dr. von Eschenbach explained that translational research will significantly improve the rational application of treatments. He noted the difficulty of determining which breast cancers are actually life-threatening with mammography, and stated that once there is a better understanding of how cancer cells develop and interact with other cells, interventions can be designed to define and treat aggressive cancers, while distinguishing those cancers that may require a lesser response. When asked how that might influence protocols, Dr. von Eschenbach said that the use of molecular and genetic information would allow patients to be separated into low and high risk groups so that the appropriate treatment strategy could be applied.

Senator Reed

Senator Reed asked Dr. von Eschenbach if women should start at a younger age to get mammograms. Dr. von Eschenbach replied that the threshold of 40 years is the recommended age to begin but that in the future, when new research enables women at high risk to be identified, it may be appropriate for those women to receive mammograms at an earlier age. When asked if there were controversies in other areas of cancer research, Dr. von Eschenbach replied that, unfortunately, there were but that clinicians who have direct responsibility for patients must apply the science and, at the same time, use clinical judgment to arrive at the best recommendations for care. Regarding Senator Reed's query about the mortality rate of black women versus white women, Dr. von Eschenbach reported that the gap was beginning to narrow and that, although it may be a coincidence, it may be due to the fact that more black women have reported utilizing mammography.

Senator Murray

Senator Murray was concerned about the current controversy hindering efforts to improve access to screening mammography for minority women. Dr. von Eschenbach assured her that NCI was paying a great deal of attention to ensuring that health and education messages were timely, appropriate and accurate. Senator Murray also asked about what younger women might do to prevent breast cancer. Dr. von Eschenbach replied that encouraging a healthy life style with regard to diet and exercise is preventative but, hopefully, future research will yield biologic interventions, especially for high risk women. Dr. von Eschenbach agreed with Senator Murray's point that early detection meant that therapies could be less mutilating and have less of an impact on the quality of a woman's life.

Senator Hutchison

Senator Hutchison asked about false positives and whether they are a reason why women should not have screening mammograms. Dr. von Eschenbach said that improved technology and the ancillary studies that are used to follow up on mammograms have made false positives less of a concern. Senator Hutchison asked if there was anything harmful about mammography, and Dr. von Eschenbach said there was no harm, except the discomfort that may go along with the examination.

Senator Clinton

Senator Clinton asked for clarification regarding what she should tell her constituents after this hearing. Dr. von Eschenbach stated, "beginning at age 40, you ought to have a mammogram every one to two years." She also asked if Dr. von Eschenbach would be able to advise the Subcommittee regarding modifications to the Mammography Quality Standards Act, and he said he would.

Prepared by Susan Persons/OD/OLPA, March 8, 2002