I was privileged recently to attend a fund-raising event for Are You Dense, Inc., a non-profit organization dedicated to helping women with dense breast tissue get the best early detection services modern medicine can offer. Dense breast tissue both makes cancer more likely, and harder to see on standard mammograms.
I have addressed the topics of medical screening and mammography before. The former works best only when the right people get the right test. Otherwise, screening, which is quite literally looking for trouble, is apt to find just that. A false sense of security from a "normal" mammogram in a woman with dense breast tissue is just the kind of trouble we want to avoid. And while mammograms save lives, they have limitations -- and the best screening programs account for them.
I have also done some homework on the topic of dense breast tissue and learned a bit about how prevalent and important this condition is. But it's always best to get information directly from an expert source. My conversation with the Are You Dense founder, Nancy Cappello, Ph.D., was as informative as her efforts are inspiring. With her permission, I share her answers to some of the questions I posed.
1) What is 'dense breast tissue,' and why does it matter?
There are four categories of breast tissue composition. This scale is known as the BIRADS density scale and has been used by radiologists to standardize density reporting since 1993. The categories are divided in quartiles and range from fatty to scattered to heterogeneously to extremely dense. As a woman's density increases, the sensitivity of the mammogram decreases. While the category of a woman's dense tissue composition is usually shared by the radiologist in a report to her referring doctor, this information is seldom shared with the patient. Dense breast tissue is comprised of less fat and more connective and glandular tissue which appear white on mammographic x-ray. Cancerous tumors also appear white making it nearly impossible to 'see' the tumor. Cancer, hidden by dense tissue, can go undetected for years and once discovered is at a later stage, conveying less treatment options and worse survival outcomes.
2) What is the right approach to early breast cancer detection with dense breast tissue?
A woman needs to know her breast tissue composition and discuss its impact, along with additional risk factors, with her health care providers as she plans her personal screening surveillance. The scientific literature for two decades has concluded that dense tissue is the strongest predictor of the failure of a mammography screening to detect cancer. It is also a well-established predictor of breast cancer risk. The common convention is that women who have greater than 50 percent density are considered to have dense breast tissue, namely heterogeneously and extremely dense. About 40 percent of women of mammographic screening age are 'dense.' Woman must understand that if she has dense tissue her 'normal' mammography report results may be anything but normal, as cancer may be hidden by the dense tissue as in my case. My advanced stage IIIC cancer was discovered within weeks of a normal mammogram. Even though it is known by the medical community of the impact of dense tissue on the accuracy of the mammogram, most doctors do not share this information with women. This fatal flaw in breast cancer screening compelled me to start Are You Dense, Inc., to standardize density reporting across the country and the globe.
3) What is the evidence that modified approaches to early detection make a difference with dense breast tissue?
There are dozens of studies that conclude that screening technologies, such as MRI and ultrasound, added to mammography significantly increase the detection of small, early, invasive cancers. MRI and ultrasound technologies are more sensitive to finding cancers in women with dense breast tissue that are invisible on mammogram -- known as mammographically occult cancers. As with every technology, there are benefits and risks. One of the risks of MRI and ultrasound is that there will be more false positives when the suspicious finding goes directly to biopsy without a diagnostic workup. Two national surveys and one state survey have reported that women want to know their dense tissue composition. Women would rather have a false positive than a missed positive -- a normal mammogram, yet hidden invasive cancer undetected until palpable thus at a later stage. Women with dense breasts need to be informed of the risks and benefits of mammography screening including its impact on delayed diagnoses and advance cancer.
4) What are the obstacles to universal application of optimal methods of early detection?
Opponents to legislative efforts lament that density reporting will cause unnecessary trauma, confuse and frighten women, although we have not been presented with any surveys or studies confirming these assertions. Opponents also report a shortage of radiologists, insufficient screening codes and work-flow issues. All these issues of the profession will not be solved by withholding a woman's dense tissue composition from her. We cannot accept the current standard that a patient should only have the information her doctors choose to tell her, thus denying her the ethical and moral doctrine of informed consent. Since the enactment of CT's density reporting law, published data show a statistically significant increase in the detection of early, invasive, node-negative breast cancer by adding ultrasound screening to women with dense breast tissue and otherwise 'normal' mammograms. While analog mammogram is the only screening tool that has shown, through randomized control trials, a reduction in deaths, we have not been presented with any research that invasive cancers not visible on mammogram and detected by other screening tests are any different and therefore less clinically significant.
5) What is most needed now by Are You Dense, Inc., to advance its mission?
Since our Connecticut density reporting legislation in 2009, hundreds of women have contacted me with the same tragic and compelling story -- delayed diagnoses and advanced cancer with months of a 'normal' mammogram. Some of our patients-turned-advocates have died as they pursued state density-reporting legislation. Reporting the scientific research, we have enlisted champion legislators and physicians in our campaign to ensure that all women are aware of their breast tissue composition and have access to reliable screening tools. As a result of the flurry of interest in legislation, I started Are You Dense Advocacy, Inc., in 2011 and as of this writing, 12 state density-reporting laws have been enacted.
We need supportive medical professionals, health industry personnel, patients-turned-advocates and the public to join our campaign for universal density reporting. The American Society of Breast Disease and the Association for Medical Imaging Management support our density-reporting efforts. We also need financial support to advance our impactful education, outreach and advocacy campaigns. Connecticut Congresswoman Rosa DeLauro is poised to reintroduce a federal density reporting bill and we are working with the FDA for revisions to the MQSA regulations to include density reporting in the patient's mammography results
6) What would it take to be able to say 'mission accomplished'?
Mission is accomplished when uniform density reporting exists across the globe and women have access to reliable screening tools to detect cancer at its earliest stage. We look forward to data confirming that legislative efforts improve breast density knowledge and assist women in discussions with their health care providers about their personal breast-screening protocol. We also expect dense breast tissue to be included in breast cancer risk assessment models. Because of our impactful mission, we anticipate a reduction in the incidence of regional and distant disease and deaths from breast cancer. Isn't that what we all desire for ourselves and our loved ones?
I was left with a rhetorical question I did not ask Nancy. If there is a better protocol and it's the law in 12 states, why isn't it the law in all 50? We don't need legislation to tell doctors what to do, but legislation ensures not only a consistent elevation of clinical practice standards, but also the appropriate coverage/reimbursement so that everyone gets the medical care we all know our loved ones deserve.
We don't know how to make breast tissue less dense, but Are You Dense is showing us how to be a bit less dense about the need to tailor breast cancer screening to suit specific circumstances. Nancy's laudable mission has come a long and impressive way already, but there are still lives at stake, and still miles -- and 38 states -- to go.
Dr. David L. Katz; author of the forthcoming 'Disease Proof'