Pink is The New Black

Pink is the new black this October, which marks the 30th anniversary of National Breast Cancer Awareness Month. NFL players are clad in bright pink shoes and wrist bands. American Airlines employees are wearing pink uniform accents and serving complimentary pink lemonade. Police departments across the country are patrolling in pink cruisers. It’s all for a great cause. The money and awareness raised through this campaign helps to fight an insidious disease that will kill more than 40,000 women in the U.S. this year.

But the feel-good spirit is clouded by ongoing debate around the value of breast cancer screening, which is sure to be reignited by the recent announcement of new guidelines by the American Cancer Society. A recent study by JAMA Internal Medicine concluded that more frequent mammography screening results in the “widespread overdiagnosis” of breast cancer, and one its authors opined that, because of the harms caused by false alarms and unnecessary treatment of non-life threatening cancers, we should be doing fewer screenings, not more. This logic is based on data that shows more screening is associated with detection of small cancers but not with serious late-stage cancers or the overall death rate due to breast cancer.

The controversy over too much or too little mammography is completely missing the point. The real problem is our one-size-fits-all approach to breast cancer screening. It doesn’t work—especially not for the nearly 50% of women in the U.S. who have dense breast tissue.

We can argue about when women should start getting mammograms or how often. But totally lost in this discussion is the fact that, while mammography is a proven method for detecting breast cancer in the general population, it has also proven to be a poor tool for detecting early cancers in women with dense breast tissue.

Why is this? Dense breasts have less fatty tissue and more connective, glandular tissue, which appears white on a mammogram. Cancerous lesions also appear white, and this makes looking for cancer in dense breast tissue with mammography very difficult. It’s like looking for a needle not in a haystack, but in a stack of other needles.

The result is that over half of cancers in women with dense breast tissue are initially missed by mammography. Making the situation more concerning is the fact that dense breast tissue has been shown to be an independent risk factor for developing breast cancer. So what we have is roughly 30 million women in the U.S. with a four to five times greater risk of developing cancer being screened by a tool that, for them, is terrible at early detection.

We need to apply the lessons from personalized medicine, where therapeutic approaches are tailored to individuals based on their genetic makeup. We already have different clinical guidelines for women who have an elevated risk of breast cancer due to BRCA gene mutations, but these women account for only around 5-10% of all cases. We also treat women who have a first-degree relative with a history of breast cancer differently, though they account for only around 15% of breast cancers.

Meanwhile, women who have dense breast tissue account for 70% of all breast cancers, and most of them are oblivious to the fact that they have dense breasts and that mammograms cannot be relied upon to detect their cancer at an early stage. This is a very serious, and possibly fatal, disconnect. The relative survival rate for cancers diagnosed at the local stage is 99%, but it drops to 85% for cancer that has spread to the lymph nodes and only 26% for metastatic cancer.

If only we could apply a personalized medicine approach to give the right test for the right patient. If only we had technologies that could better detect cancer in women with dense breast tissue. Guess what? We can and we do.

A new generation of 3D mammography, called digital breast tomosynthesis, has been shown to improve cancer detection in dense breast tissue and is now on its way to replacing the installed base of 2D mammography systems in the U.S. Using ultrasound in combination with mammography also yields better results—a 30-40% increase in cancer detection for women with dense breast tissue. MRI, while prohibitively expensive for widespread secondary screening, increases sensitivity to over 90% and is generally indicated (and reimbursed) for women considered high risk.

The latest technology for dense breast screening involves molecular imaging, which has been shown to detect over four times more invasive cancers in dense breast than mammography alone, while reducing the number of unnecessary biopsies by 50%. Because molecular breast imaging matches the sensitivity of MRI—and improves specificity—at roughly one-third the cost, it has enormous potential as a diagnostic screening tool to resolve dense breast and other ‘complex’ mammograms. One of the companies that offers this technology is Gamma Medica, which markets the LumaGEM Molecular Breast Imaging system. Psilos is an investor in this company.

For me, Breast Cancer Awareness Month is both inspiring and enormously frustrating, because we (rightly) encourage routine screening for breast cancer while ignoring the fact that so many women are being put at risk by today’s standard practices.

Women need to know about their breast density and understand the risks of relying solely on mammograms to find cancer at an early stage. Radiologists and referring physicians need to change the way they practice medicine by engaging their patients on the subject of breast density and adding to their clinical workflow new technologies for improved cancer detection in women with dense breast tissue. Medical societies and other groups need to acknowledge that overdiagnosis is not the problem when it comes to the 50% of women with dense breasts. For these women, underdiagnosis is the problem and the tools that can meaningfully increase early cancer detection for them should be incorporated into clinical guidelines.

Pink is everywhere this month and it’s putting a spotlight on breast cancer. That’s great. What’s not great is that most of us are wearing rose-colored glasses, while others are seeing red, when it comes to routine mammograms. We’re overlooking an opportunity to quickly and effectively improve outcomes for women with dense breast tissue. With improved methods of screening we can better detect early cancer in these women and save a lot of lives.

David Eichler is a managing member of Psilos Group. He focuses on investments in the digital health and medical technology sectors. He is currently chairman of Gamma Medica, a health company focused on overcoming the critical shortcomings of mammography and other screening modalities currently used in the early detection of breast cancer.

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