On December 2, the House Energy and Commerce Subcommittee on Health held a hearing to review the recently revised breast cancer screening recommendations released by the U.S. Preventive Services Task Force (USPSTF).
“By now, I am sure everyone in this room is familiar with the new guidelines, or at least we are familiar with the controversy surrounding them,” said Chair Frank Pallone (D-NJ). He continued, “From what I have heard from my constituents, friends, family members, and academic institutions in my district, there are a lot of questions, frustration, and confusion around these new guidelines. This is the reason why I am holding this hearing today. It is time for all of our questions to be answered…It is important that all the new medical information is used to empower physicians and their patients when making medical decisions. Scientific studies enable patients and their physicians to make more informed decisions about what is best for them in any given situation. Using scientific-based medical information, physicians, in consultation with their patients, can practice more personalized medicine. At least on reading through the task force guidelines on mammography screenings, this appears to be what the USPSTF is recommending as well. Mammography screening for women in their 40s should be a decision that is left up to the physician and the patient but the decisions to have the test should be made after having an informed conversation about the benefits and risks of the screen.”
Full committee Ranking Member Joe Barton (R-TX) discussed the recent recommendations in the context of current efforts to reform the nation’s health care system, saying, “I have an aunt who passed away in her early 50s as a consequence of breast cancer. I have a sister who was diagnosed with breast cancer in her 30s and, luckily, received proper treatment, had a mastectomy, and so far, in the last 10 years, is cancer-free. I have a wife, a beautiful wife, who is under the age of 50 and she has annual mammograms. I have a good friend who was just diagnosed with breast cancer who is in her mid-40s. Again, she’s undergoing treatment and hopefully she’s going to have a good outcome. To have a task force make the recommendation that has been made, and to have in this bill [H.R. 3962, the Affordable Health Care for America Act] the authority that’s given to various unelected bureaucrats to make health care decisions, including coverage frequency, in my opinion, is wrong. It’s wrong.” Rep. Barton continued, “On a bipartisan basis, this subcommittee and the full committee repeatedly has passed bills increasing and supporting the early detection of breast cancer, the prevention, the research. We do it almost every Congress. We’re starting down a path, in my opinion, of the socialization of medicine in this country with the passage of this bill out of this committee, with its passage on the House floor.”
Dr. Ned Calonge and Dr. Diana Petitti, chair and vice chair, respectively, of the USPSTF, clarified its recommendations for breast cancer screening, saying, “The task force acknowledges that the standard language used to describe its recommendations about breast cancer screening for women age 40-49 did not say what the task force meant to say. The task force communication of the mammography screening recommendation for women 40-49 was poor…The task force appreciates the opportunity to clarify that it recommends the following: ‘Women age 50-74 should have mammography every other year. The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient’s values regarding specific benefits and harms’…What we are saying is that the decision to have a mammogram for women in their 40s should be based on a discussion between a woman and her doctor. Many doctors and many women, perhaps even most women, will decide to have mammography screening starting at age 40. The task force supports those decisions.”
Dr. Petitti discussed the some of the task force’s conclusions: “The task force concluded from the evidence that screening mammography for women [ages] 40-74 has a benefit in reducing death due to breast cancer. The task force focused on reduction in death due to breast cancer because this is the benefit of breast cancer screening that has been the focus of randomized trials. The task force recognizes that there may be other benefits of screening, such as earlier diagnosis that permits less invasive and toxic therapies, for which evidence is lacking.” She also noted, “The benefits of screening mammography have been easy to communicate. These benefits are the identification by mammography of something that turns out to be cancer, the treatment of that cancer, and the effect of the treatment of that cancer in prolonging life by preventing death due to breast cancer. The harms and potential harms of mammography screening have been difficult to communicate. The easily understandable and commonly used definition of harm is a physical injury that is direct and immediate. Some women report a small amount of pain or discomfort when undergoing a screening mammogram. Pain and discomfort are easily understood as harms of screening mammography based on the commonly used definition of harm. These harms are very small. The task force considers as harms not just the physical harms of the screening test and it construes harms more broadly than physical harms. For mammogram screening, false positive tests are viewed as a potential harm of screening. It is not, of course, the false positive test itself that carries the potential for harm. Rather, it is the consequences of the positive test. These include the additional imaging and other tests done to follow-up on a false positive, biopsies done for lesions that turn out not be cancer, and the inconvenience of medical appointments due to false-positive screening tests.”
Dr. Otis Brawley, chief medical officer for the American Cancer Society, explained that the American Cancer Society does not agree with the USPSTF’s recommendations. “Our scientific and medical experts monitor the emerging literature on an ongoing basis to ensure that the Society’s guidelines reflect the most current scientific evidence. As such, the Society’s guidelines are reviewed and updated regularly…The Society’s breast cancer screening guidelines were last systematically reviewed and evaluated in 2003 for average-risk women and in 2007 for high-risk women. Our most current recommendations for breast cancer screening are as follows: Yearly mammograms are recommended starting at age 40 and continuing for as long as a woman is in good health. Clinical breast exam (CBE) should be a part of a periodic health exam, about every three years for women in their 20s and 30s and every year for women 40 and over. Women should know how their breasts normally feel and report any breast change promptly to their health care providers. Breast self-exam (BSE) is an option for women starting in their 20s. Women at high risk (greater than 20 percent lifetime risk) should get an MRI [Magnetic Resonance Imaging] and a mammogram every year. Women at moderately increased risk (15-20 percent lifetime risk) should talk with their doctors about the benefits and limitations of adding MRI screening to their yearly mammograms. Yearly MRI screening is not recommended for those whose lifetime risk of breast cancer is less than 15 percent. The Society is not changing its guidelines for breast cancer as a result of the USPSTF’s new recommendations.”
Dr. Brawley added, “We should be particularly concerned about how these guidelines will influence the perceptions of medically underserved women, such as minority women and those who lack health insurance. Evidence shows that African American and Ashkenazi Jewish women get breast cancer at an earlier age, and may have greater benefit from starting screening sooner. We all have a duty to ensure that progress made in breast cancer does not get reversed as a result of these new recommendations or confusion about what they mean. It is our collective job to strive to do better in providing clear and understandable information about the benefits of evidence-based prevention and early detection, particularly for populations most in need to help decrease disparities in health care and improve health outcomes.”
Jennifer Luray, president of Susan G. Komen for the Cure Advocacy Alliance, discussed the USPSTF’s recommendations within the context of the debate on health care reform, saying, “H.R. 3962 calls for ‘preventive services, including those services recommended with a grade of A or B by the Task Force on Clinical Preventive Services’ to be included in a new minimum benefit package and for those services to be offered with no co-pay or cost sharing requirements. [The task force mammography recommendations for women 40 to 49 received a grade of C.] This will increase access to mammography, Pap smears, and other preventive services for the millions of women who do not currently have access to screening services in the current health care system. Evidence shows that even a relatively small co-payment significantly reduces mammography rates, particularly for women with low incomes. In light of the new recommendations by the USPSTF, we must ensure that women ages 40 to 49 will have access to the same coverage and cost-sharing benefits as women age 50 and older. We understand that the Task Force on Clinical Preventive Services is a new entity, and that the current USPSTF guidelines are not necessarily binding on the new committee. We also understand that the current language does not necessarily exclude from the minimum benefit package services that are not rated A or B. However, I urge you to ensure that mammography services for women ages 40-49 are included in the essential benefits package and that cost sharing is waived for such services. While some women in the 40 to 49 age group may, after consulting with their doctor and weighing the evidence, respond to the task force recommendations by choosing to forego a mammogram, women who choose to have a mammogram should still have access to such screenings on the same terms as women age 50 and older.”
Fran Visco, president of the National Breast Cancer Coalition (NBCC), said, “The NBCC hopes that the task force’s revised evidence-based guidelines on breast cancer screening will help to put screening and its limitation into proper perspective…First, let me say strongly and loudly, mammograms do NOT prevent breast cancer. I have read and heard a number of statements to that effect. Mammograms may find cancer that is already present, but they do nothing to stop tumors from forming. Next, to those that claim these changes represent an example of rationing of care, I would like to point out that the task force did not consider cost when developing their recommendations and, in fact, increased recommended screening to include women up to 74 years old. The task force began its review of the evidence over two years ago. The task force recommendations became tied in with the health care reform debate because of legislative proposals to use their recommendations to decide which screening and preventive services should be covered free of charge, not in deciding what should be covered at all…Some are concerned that screening guidelines that do not recommend mammography under 50 as a matter of routine will prevent underserved women from entering the medical system at all. We would counter that the solution is to enact universal access to medical care for all, not to depend on a faulty test that exposes women to radiation and the risks of false positives, in order to gain them medical care. Disadvantaged women deserve the same access to quality, evidence-based care as advantaged women. Disadvantaged women have the same rights as all women to learn the facts and understand the evidence behind medical procedures. Others have expressed concern about those women who do have breast cancer in their 40s how will it be detected under these new guidelines? The truth is, based on evidence from randomized clinical trials, the highest level of scientific evidence, mammography and self-breast exams do not work in finding life-threatening cancers in this age group or in reducing mortality. The new recommendations give these women control over the decision of whether to undergo screening, after understanding harms and potential benefits.”
Dr. Donna Sweet, past chair of the American College of Physicians’ Board of Regents, said, “ACP believes that the controversy over the breast cancer screening guidelines creates important lessons for policymakers…One lesson is that the public is ill-served when assessments of clinical effectiveness are politicized. For clinicians and patients alike to have confidence in the evidence, we need to know that it has been developed through a process that is independent of political pressure. The U.S. Preventive Services Task Force is a highly regarded, credible, and independent group of experts that conducts its evidence-based assessments, on a purely advisory basis, to the Department of Health and Human Services, as it relates to interventions to prevent or detect diseases. As is often the case with evidence-based reviews, the task force’s recommendations will not always be consistent with the guidelines established by other experts in the field, by professional medical societies, and by patient advocacy groups. Such differences of opinion, expressed in a constructive and transparent manner so that patients and their clinicians can make their own best judgment, are important and welcome…ACP is concerned that such politicization, if left unchallenged, could lead to efforts to eliminate the task force, cut its funding, or result in politically driven changes so that future evaluations are influenced by political or stakeholder interests instead of science. We would be concerned that this would also lead to political interference over other federally funded entities involved in evidence-based research.” She continued, “To support and empower patients in share decision-making, they need to know that the independent clinicians and scientists charged with producing research on clinical effectiveness will be permitted by Congress to make their recommendations based solely on their assessment of the evidence, not the politics of the day or as a result of stakeholder pressure.”
