January 2010

Stephen N. Bauer, MD

The silver lining on guidelines debate

A physician’s commitment to excellence in the diagnosis and treatment of breast cancer is often as much personal as professional. Most of us have had personal experience related to breast cancer, often the kind of experience that indelibly alters our lives. Only lung cancer is more lethal to American women. American Cancer Society estimates for 2009 predicted that nearly 200,000 women would be newly diagnosed with invasive breast cancer and almost 40,000 would die of the disease.

Given the prevalence and emotional impact of this disease, the extended controversy that ensued when the U.S. Preventive Services Task Force (USPSTF) released updated guidelines for breast cancer screening should have come as no surprise. A recommendation that women delay the onset and decrease the frequency of mammographic screening was going to be news. A suggestion that clinicians need not teach breast self-examination was sure to prompt extensive discussion.

The authors of the USPSTF report made it clear that the new guidelines applied only to average-risk patients. They encouraged women who might be at higher risk to talk to their physicians before making any decision about screening. Yet their release was still highly controversial.

The silver lining on the USPSTF guidelines debate is that it has brought more people to give more thought to how we ensure that all women have access to preventive care. Experiences such as this underscore the potential of personalized health care, which will allow us to move beyond population-based guidelines and give our patients far more specific guidance. The task force noted a need for better understanding of tumor biology and how demographics affect vulnerability to certain cancers, the growth rates of those cancers, and their lethality. Pathologists definitely have a role there and we welcome the opportunity to contribute. For the present, however, I suggest we leave the USPSTF guidelines debate to other breast cancer specialists and patient advocates.

The CAP is just beginning to establish clinical guidelines, and we can learn from the breast screening controversy. Guidelines may be more readily accepted when potential differences are addressed up front. While the USPSTF consists of a prestigious group of primary care physicians and experts in epidemiology, had the guidelines come from a more multidisciplinary panel they might have met greater acceptance. Specialists in oncology, pathology, radiology, and surgery who care for breast cancer patients could have contributed to the conversation. Patient advocacy groups serve a pivotal role providing health information to women; many are highly sophisticated and could have added insights of their own.

The guidelines debate got people thinking about mammography, which is a good thing. My concern about the extended public debate is that the message will get muddled. It’s not so much what the guidelines say as what some women might hear. My fear is that even women who are at increased risk will interpret the USPSTF changes to mean they can safely forego appropriate screening.

Universal access to mammography should be a given, whatever the details on timing might be. Yet, according to Susan G. Komen for the Cure, one in three women does not undergo regular mammography screening. The technology has its limitations, but it’s the best tool we have, and we know it saves lives. I am more concerned that one in three is not being screened than I am about possible overdiagnosis.

The College has taken an activist approach to access through the See, Test, and Treat Program, which has coordinated mammography, Pap testing, and followup for more than 650 women since 2001. This past October, our volunteer pathologists and cytotechnologists joined forces with Susan G. Komen for the Cure, the American Cancer Society, and the NorthPoint Health and Wellness Center to provide preventive care to 149 low-income women in the Minneapolis-St. Paul area. See, Test, and Treat is a valuable, hands-on way to improve access, but we need to better understand the root causes beyond poverty and lack of insurance.

A 2004 Institute of Medicine report showed that while more than 1.2 million American women turn 40 each year, not enough radiologists are specializing in mammography to keep up with the demand, and new screening centers are not opening fast enough to replace those that are closing. We do know that breast cancer leads to more malpractice claims than any other medical condition. Concern about professional liability may be discouraging radiologists from specializing in mammography. It undoubtedly is a factor in other aspects of breast cancer treatment as well. One argument for starting routine mammography later for women at average risk is that low specificity, especially in younger women, results in unnecessary biopsies. I can’t help but wonder how malpractice risk affects the decision to biopsy. Tort reform is a topic for another column, but it is relevant.

Watching all of this unfold, I found myself thinking that the new guidelines for estrogen receptor/progesterone receptor testing that we have developed in collaboration with the American Society of Clinical Oncology might also cause a stir within our professional community. These guidelines were developed with broad input from the medical community, but not from patient groups. Their development required that we negotiate grey areas, which is always the case when science is evolving. These grey areas may be just the ones where we need patient input.

The CAP Center will enable us to take an inclusive approach to guidelines development. Gathering the stakeholders and encouraging open discussion of differences will enable us to produce guidelines that are useful and enlightening to pathologists and those they work with. The prognosis for breast cancer patients will continue to improve as science moves forward. We can catalyze progress by promoting the adoption of carefully vetted guidelines and best practices. The Center will create a new, open space where professional standards and personal commitment will productively intersect.