Breast cancer was not the first thing that came into my mind last November when I noticed a small dimple on my left breast. I had a “clean” mammogram report earlier in the year and no family history of breast cancer. As a woman who spent her career building businesses, I just had my 56th birthday and had gained some weight as I transitioned into deeper menopause territory, my first thought was that aging is tough and cellulite is terrible.
At the urging of my family, I requested a diagnostic mammogram, which showed a sizable tumor on the left side. A subsequent visit with the oncologist did not go well when I asked about whether I could also have breast cancer on the right side and requested additional imaging. “That’s not the standard of care” I was told. After raising what my physician described as a ruckus, I received further imaging that confirmed my original tumor on the left and identified a previously unrecognized tumor on the right side.
I have had mammograms for over a decade and had been told that I had heterogeneously dense breasts. My physicians had noted that since I had no family history of breast cancer that 3D (tomosynthesis) mammography combined with physical exams would be sufficient.
Two months later I had surgery. I have spent my career building life sciences companies for rare diseases in the field of gene therapy, and the technology that I helped advance and out-licensed to third parties created over 10,000 jobs in North Carolina. Because I have heterogeneously dense breasts and experienced inadequate screening, I am now out of the workforce while I recover from surgery and 66 radiation treatments.
I am joined in this story by my friend, who adds his perspective as a practicing physician and health policy expert. Breast cancer affects one out of every 8 women, and the prevalence is rising. Despite the improvements in treatment, the American Cancer Society predicts that 43,700 women in the US will die this year of breast cancer. This is an avoidable statistic: Much of breast cancer is survivable if caught early.
With the Centers for Disease Control and Prevention noting that half of women have heterogeneously dense or dense breasts, mammography is potentially an ineffective screening tool for half of American women. The organized medicine community has left millions of women behind. While the FDA has updated its mammography regulations to require that radiologists, using standardized language, notify women of their breast density, professional society and federal breast cancer screening guidelines have not kept pace with women's needs.
In women with dense breasts, mammograms can miss up to 50% of tumors. Cancer is missed because both cancer and dense breast tissue appears as white on mammograms. Radiologists at times must functionally identify a snowball in a blizzard. Poor visibility is not just an academic exercise: Nearly half of American women have dense breasts.
Other technologies, such as automated ultrasound and breast MRI, are better than mammography in detecting cancer in women with dense breasts. Yet access to ultrasound and breast MRIs are not provided to women who don’t have other risk factors for cancer. Screening modality is driven by professional practice guidelines, which only consider cancer risk—not whether the screening test is the right test for the right patient.
It is said that there is a reluctance on the part of clinicians to expand screening because of the undue stress women experience when they undergo an unnecessary biopsy following a false positive. Such an argument is paternalistic—patients and their physicians should make that choice together.
There have been broad efforts across the country to pass state legislation to mandate insurance coverage for supplemental screening for women with dense breasts. To date, 24 states plus DC have passed such laws. Yet, while state-level actions have been impactful, women with dense breasts are still not receiving potentially life-saving screening. Federal attention to such a critical issue is badly needed. Carefully written, in conjunction with clinical experts and patients, such action should ensure that screening guidelines are the most cost-effective and appropriate for patients.
Because professional and governmental screening guidelines still treat some women as second class citizens, medical professional societies and policymakers must work together to modernize breast cancer screening and ensure that all women have access to the right screening tool.
Sheila Mikhail is a breast cancer patient, serial entrepreneur, and founder of AskBio. Brian J. Miller, MD, MBA, MPH is a Nonresident Fellow at the American Enterprise institute and an Assistant Professor of Medicine at Johns Hopkins University.
