Breast Density in the News 2019

Thirty-eight states have passed legislation mandating that a woman’s mammogram report include information about her breast density.  The Food and Drug Administration has been mandated to make sure all mammography reports include this information.  However, why this focus on breast density?  The National Breast Cancer Coalition published the following informative response in its recent “Call To Action” newsletter:

 

The National Breast Cancer Coalition (NBCC) is an evidence-based organization. What does that mean? We do NOT want women and men to get advice and information that is based on hope or assumptions. They deserve recommendations that are based on scientific evidence when it exists and to be told when it does not.  To do otherwise risks creating unnecessary harm. This is an important concept not just for the public, but for Congress as well. Legislators must stop enacting laws that fly in the face of scientific evidence.

On February 15, 2019, Congress passed a funding bill[1] that ended the longest ever Federal government shutdown. Unfortunately, this bill did many other things, including issuing a mandate to the U.S. Food and Drug Administration (FDA) about mammography screening and breast density reporting. Specifically….

The Committee recognizes the importance of patients receiving their own personal medical information and directs the Food and Drug Administration to ensure that mammography reports and summaries received by patients and their providers include appropriate information about breast density specified by the Secretary, including, at a minimum, the effect of breast density in masking the presence of breast cancer on a mammogram, the qualitative assessment of the provider who interpreted the mammogram, and a reminder to patients that individuals with dense breast tissue should talk with their providers if they have any questions or concerns about their summary“ (emphasis applied).

Why does Congress want you to know if you have dense breasts?  There really is no good reason. Unfortunately, as of May 2019, a total of 38 states and the District of Columbia have passed varying legislation requiring that women with dense breasts be notified about their breast density. Now the United States Congress wants to make the same mistake and raise it to the national level.

So, what is appropriate information in this instance?

What is Breast Density

Dense breasts are defined by how they appear on a mammogram using the American College of Radiology’s (ACR’s) Breast Imaging Reporting and Data System (BIRADS). This system classifies breasts as “almost entirely fatty,” “scattered fibroglandular densities,” “heterogeneously dense,” or “extremely dense.” With those classifications, approximately 43 percent of all women between the ages of 40 and 74 years have dense breasts (either “heterogeneously dense” or “extremely dense). The problem with this system is that there is considerable variability and subjectivity among radiologists in classifying breast density for patients. Studies have shown that density status is reclassified on subsequent examination for 1 in 5 women (23%) by the same radiologist, and for 1 in 3 women (33%) by a different radiologist.[2] Why should we care?

Breast Density and Mammography

Much of the push for notification is based on the assumption that if you have dense breasts, a mammogram is less likely to “find” a lump.  The thought is, if you have dense breasts and a normal mammogram, you should have additional screening. Of course, that will result in harm to women and significant unnecessary cost to the system, but what benefit would it have? One recent analysis[3] looked at the impact in New Jersey of density reporting requirements on the use of additional screening following normal mammograms in women with high density breasts. It demonstrated a 651 percent increase in the use of ultrasounds for supplemental screening, and a 59 percent increase in the use of breast MRIs. This has huge cost implications for the U.S. health care system when one considers how common dense breast are (43% of all women).[4]

While these additional imaging procedures can detect a small number of cancers missed by mammography, they will also dramatically increase the number of false-positive results which lead to additional procedures, including unnecessary biopsies and their associated risk. And we can’t ignore the potential risks that supplemental screening modalities themselves pose to patients, such as the use of gadolinium contrast required for breast MRI which has been associated with nephrogenic systemic fibrosis in patients with acute kidney injury or chronic kidney disease,[5] and more recent research has shown that IV gadolinium exposure may be associated with neuronal tissue deposition, even with normal renal function.[6] Likewise, harms from digital breast tomosynthesis could come from additional breast radiation exposure.[7]

This proposed national rule change will almost certainly expand the already too high rate of breast cancer testing and overdiagnosis[8] (~20%)—the identification of slow-growing, harmless cancers that won’t kill a person and don’t need to be found and treated in the first place, with resulting over treatment. This is simply not acceptable without solid evidence of benefit in patient-relevant survival outcomes. It may benefit the medical imaging community and oncologists, but not women.

Breast Density and Risk of Dying of Breast Cancer

If a woman has dense breasts is she more likely to die of breast cancer? No. Scientific studies have shown that among women ultimately diagnosed with breast cancer, increased breast density is not related to breast cancer death.[9] [10] [11] [12] [13]

In 2012, investigators10 actually studying this question using data from the Breast Cancer Surveillance Consortium (BCSC) concluded that high mammographic breast density is notassociated with increased risk of death from breast cancer or death from any cause after accounting for other patient and tumor characteristics. Likewise, in 2018 another group of researchers using data from the Population-Based Research Optimizing Screening Through Personalized Regimens (PROSPR) consortium similarly demonstrated that breast density is not associated with breast cancer that has a poorer prognosis.[14] Both of these studies are consistent with the U.S. Preventive Services Task Force (USPSTF) conclusions in the comprehensive synthesis it prepared on this topic in 2016.8 Thus, the requirement to provide notification about the status of breast density lacks any supporting evidence to do so, and in such a limited context is likely to be confusing, anxiety-provoking, and not at all informative for patients.

Breast Density and Risk of Getting Breast Cancer

Does having dense breasts raise your risk of getting breast cancer? Some evidence suggests that it may pose a small risk, but there are many known risk factors, most of which, including density, cannot be changed. Moreover, breast density ranks much lower in terms of absolute risk compared to other risk factors: age, family history, obesity, genetics; notifying patients about their breast density elevates this one risk factor out of context. Moreover, women receiving normal or low breast density assessments may erroneously be given a false sense of security and not consider their other more important individual risks… assuming of course they can do something about them, other than worry.

FDA must involve educated advocates in determining how to respond to this Congressional mandate, including the drafting of ANY information that will be provided to patients. Moreover, information to be included in the lay summary that is ultimately given to patients must explain the limitations of mammography and other screening modalities, the potential for overdiagnosis and overtreatment and the fact that there is no evidence that information about breast density would lower risk of getting or dying of breast cancer. Or have any benefit at all.


[1] Hoeven  J. Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Bill of 2019, S 115-259, 115th Cong, 2nd Sess (2018).https://www.congress.gov/congressional-report/115th-congress/senate-report/259/1?q=%7B%22search%22%3A%5B%22farm%22%5D%7D. Accessed May 23, 2019.

[2] Sprague BL, Gangnon RE, Burt V, Trentham-Dietz A, Hampton JM, Wellman RD, et al. Prevalence of mammographically dense breasts in the United States. J Natl Cancer Inst. 2014;106.

[3] Sanders LM, King AB, Goodman KS. Impact of the New Jersey Breast Density Law on Imaging and Intervention Volumes and Breast Cancer Diagnosis. J Am Coll Radiol. 2016 Oct;13(10):1189-1194.

[4] Sprague BL, Gangnon RE, Burt V, Trentham-Dietz A, Hampton JM, Wellman RD, et al. Prevalence of mammographically dense breasts in the United States. J Natl Cancer Inst. 2014;106.

[5] Fraum TJ, Ludwig DR, Bashir MR, Fowler KJ. Gadolinium-based contrast agents: A comprehensive risk assessment. J Magn Reson Imaging. 2017 Aug;46(2):338-353.

[6] McDonald RJ, McDonald JS, Kallmes DF, et al. Intracranial Gadolinium Deposition after Contrast-enhanced MR Imaging. Radiology. 2015 Jun;275(3):772-82.

[7] Miglioretti DL, Lange J, van Ravesteyn N, et al. Radiation-induced breast cancer and breast cancer death from mammography screening. AHRQ Publication no. 14-05201-EF-5. Rockville, MD: Agency for Healthcare Research and Quality; 2015.

[8] Welch HG, Prorok PC, O’Malley AJ, Kramer BS. Breast-Cancer Tumor Size, Overdiagnosis, and Mammography Screening Effectiveness. N Engl J Med. 2016 Oct 13;375(15):1438-1447.

[9] Siu AL. Screening for breast cancer: US Preventive Services Task Force recommendation statement. Ann

Intern Med. 2016;164(4):279–296.

[10] Weinstein SP, Localio AR, Conant EF, Rosen M, Thomas KM, Schnall MD. Multimodality screening of

high-risk women: a prospective cohort study. JClin Oncol. 2009;27(36):6124–6128.

[11] Kuhl CK, Strobel K, Bieling H, Leutner C, Schild HH, Schrading S. Supplemental breast MR imaging screening

of women with average risk of breast cancer. Radiology. 2017;283(2):361–370.

[12] Berg WA, Zhang Z, Lehrer D, et al. Detection of breast cancer with addition of annual screening ultrasound or

a single screening MRI to mammography in women with elevated breast cancer risk. JAMA. 2012;307(13):1394–1404.

[13] Gierach  GL, Ichikawa  L, Kerlikowske  K,  et al.  Relationship between mammographic density and breast cancer death in the Breast Cancer Surveillance Consortium.  J Natl Cancer Inst. 2012;104(16):1218-1227.

[14] McCarthy  AM, Barlow  WE, Conant  EF,  et al; PROSPR Consortium.  Breast cancer with a poor prognosis diagnosed after screening mammography with negative results.  JAMA Oncol. 2018;4(7):998-1001.

The National Breast Cancer Coalition, founded in 1991, is based on the fact that breast cancer is not only a medical issue, but also a political one.  Every aspect of fighting breast cancer is grounded in politics, from federal funding for breast cancer research to access to quality health care for all to holding elected officials accountable for making breast cancer a priority issue.

With the 2020 Presidential election approaching, the National Breast Cancer Coalition is reaching out to candidates with a Public Policy Platform to endorse and sign.  The Platform states that as candidates (and as a possible President of the United States), the individual would:

•   support adequate and transparent funding for breast cancer research;

•   support access to quality health care for all, including preservation of the Breast and Cervical Cancer Treatment Act;

•   ensure that educated advocates participate where decisions about breast cancer are made.

Candidates are appearing frequently in New Hampshire and Iowa where NBCC Field Coordinators Nancy Ryan and Christine Carpenter, respectively, are attending events and inviting them to sign the Platform.

The list of Democratic hopefuls is long, up to twenty-four.

As of July 12, 2019, nineteen have signed:

 

Beto O’Rourke

Pete Buttigieg

Elizabeth Warren

John Hickenlooper

Julián Castro

Cory Booker

John Delaney

Andrew Yang

Kirsten Gillibrand

Seth Moulton

Marianne Williamson

Bernie Sanders

Bill de Blasio

Amy Klobuchar

Steve Bullock 

Joe Sestak

Tim Ryan

Tulsi Gabbard

Joe Biden

If you would like to help “birddog” candidates in New Hampshire, please contact NHBCC at 603-659-3482.  Thanks!

From April 27 to April 30, 2019, NHBCC Board members Nancy Ryan, Deb Smith, Jackie Staiti and My Breast Cancer Support Executive Direction Jennie Halstead attended the National Breast Cancer Coalition’s Annual Advocacy Training Conference.  The annual meeting was filled to the brim with workshops, plenary sessions, networking and, as usual, culminated in a Lobby Day on Capitol Hill.

This year, the National Breast Cancer Coalition is seeking continued funding for the Department of Defense Peer-Reviewed Breast Cancer Research Program for 2020.  We are seeking $120 million to keep this extraordinary program funded another year.  In addition, NBCC’s other top priority is the Metastatic Breast Cancer Access to Care Act.  This legislation would waive two waiting periods for individuals with metastatic disease who quality for Social Security Disability Benefits:  a five-month waiting period to begin receiving SSI benefits and a 24-month waiting period to enroll in Medicare.  This legislation is overdue, fair and the right thing to do.

Watch for news as the legislation moves along.

Great news!

The New Hampshire Breast Cancer Coalition (NHBCC) has been authorized to sell special decals with our logo that can be placed on a new type of license plate called the “Decal Plate.”  The NHBCC Decals can only be placed on a Decal Plate.

Click Here for what you need to know to obtain your Decal Plate and the NHBCC Logo Decal.

There are two ways to request your NHBCC Logo Decal:

1.)Order your NHBCC Logo Decal and pay using PayPal with the following button:

2.) Click Here to download the Order Form to request your NHBCC Logo Decal. When you complete filling out the Order Form, mail to:

NHBCC, 18 Belle Ln, Lee NH 03861

Here is what the decal looks like!

Our sincere thanks to Hannaford Supermarkets for their awesome support during Breast Cancer Awareness Month!  The combination of a general donation of support and the October state-wide point of sale receipts raised a total of $7,500.00!   This gift will help New Hampshire breast cancer patients who are overwhelmed with their daily financial expenses as they struggle with diagnosis, treatment and recovery.  Thank you, Hannaford!

 

Great news!  During December 2018, there are two ways to can shop Hannaford Supermarkets in New Hampshire and support the New Hampshire Breast Cancer Coalition at the same time!

The New Hampshire Breast Cancer Coalition has been chosen by Hannaford as the latest nonprofit to benefit from the “fresh Cookbook” fundraiser !  Every time a “fresh Cookbook” is purchased at a New Hampshire Hannaford during December 2018, NHBCC receives $5! The newly released fresh Cookbook contains the best fresh Magazine recipes that Hannaford customers have enjoyed for years, and each purchase can generate 20+ nutritious meals for children in families that struggle with food insecurity. Thanks for your support!

In addition, NHBCC has been chosen again by Hannaford Store Leadership to receive a $1.00 donation through the Hannaford Helps Reusable Bag program.  During December 2018, when you visit your Hannaford store in Meredith, NH, at 38 NH Route 25, Unit 5, Meredith, NH, and purchase a Community Reusable Bag, NHBCC will receive a $1.00 donation.

You can find the green Community bag on the reusable bag rack at the store.  Look for the sign that lets you know NHBCC wil benefit!  NHBCC thanks Hannaford for their outstanding support!

 

The wonderful owners, staff, students, clients and friends at Continental Academie in Hudson, New Hampshire, set a goal of $1,000.00 this year to Support A Woman through the New Hampshire Breast Cancer Coalition Support Services Fund.  Here Deb Smith, NHBCC Secretary, (right) accepts this wonderful gift!  Thank you to all.

 

Thanks to our partner Mr. Mac’s Macaroni & Cheese for an outstanding 2018 Breast Cancer Awareness Month fundraiser. What a great team!  The amount raised was $2,000.00!!!  Thanks to owners Valerie Anderson and Patrick Cain, general managers Rob Sideman, Kristofer O’Donnell and Michael Engelhardt, and the staff and customers who supported NHBCC this year!

 

Kudos to our new partner, Bob Mariano Chrysler, Jeep, Dodge and Ram in Concord, New Hampshire for supporting the NHBCC Support Services Fund. Staff and customers rallied to raise over $2,000 during October. Here, owner Brian Duval accepts a token of our appreciation from NHBCC President Nancy Ryan.

 

Thank you to our wonderful partner in the fight against breast cancer, Kaizen Academy, in Raymond, New Hampshire!  Students, families and friends raised $800 this year for the NHBCC Support Services Fund.

Your support means a great deal to us because it will make a critical difference in the lives of New Hampshire women!  Job well done!