Breast density legislation is the issue. Opposing voices battle it out.
It is no secret that dense breast tissue is one of a number of risk factors for cancer. As the American Cancer Society plainly states on its Web site, “Women with denser breast tissue have a higher risk of breast cancer. Dense breast tissue can also make it harder for doctors to spot problems on mammograms.”
However, Nancy Cappello, 58, of Woodbury, Conn, only learned this fact after a doctor diagnosed her with late-stage IIIc breast cancer. Now as the founder of Are You Dense Inc, Cappello is committed not only to raise awareness on this issue but also to ensure that all women receive the information that had been withheld from her.
“My reports all said that I had extremely dense tissue, with no change from my prior exam. I never was told,” said Cappello, who has her PhD in educational administration. “I’m at risk of dying from this disease, and I’m outraged. But I’m taking that outrage and trying to turn it into good for other women.”
Since Cappello first began lobbying her state Legislature in 2004, Connecticut has passed three landmark bills. Two provide expanded coverage for supplemental imaging for women with dense breast tissue; the third catapulted Connecticut into the national—and even international—spotlight. In 2009, the state became the first in the nation to require that physicians include information about an individual’s breast density in their lay letter reports to patients. This year, Texas followed suit, and 11 other states are currently drafting or considering similar legislation. Even representatives from the government of Taiwan have contacted Cappello, telling her of their plans to translate Are You Dense’s Web site into Mandarin.
These efforts are not without some controversy, and several entities in the medical community have emerged to voice their opposition. For example, in California, where—as of print time—a bill to inform patients of their breast density is sitting in the Senate Appropriations Committee, the California Medical Association (CMA) and the American Congress of Obstetricians and Gynecologists?District IX have publicly testified against the proposed law.
“This legislation outlines a course of action that is vague and, in many cases, not necessary,” said Ernie Bondai, MD, director of Breast Surgical Services at Kaiser Permanente in Sacramento and creator of the breast cancer stamp, in a press release. “Many of my colleagues and other major physician organizations have examined the intent, the science, and the cost of this bill and find it to be lacking.”
Nevertheless, practices across the country anticipate possible legislation or recommendations to incorporate additional language in their mammography reports and referring dictations. As a result, radiologists are turning to new technologies to remove the variability in their calculations of breast density and in effect provide patients with more reliable information.
Grassroots Efforts
At the age of 40, Cappello had her first mammogram and, each subsequent year, she had never missed her annual screening exam. “I exercised daily, still do,” she said. “I eat healthy. I did not have any first-degree relatives with breast cancer. I kept myself healthy, and I did all the right things, thinking that if I was ever diagnosed with breast cancer, of course I’d want it diagnosed at the earliest stage when survival is the greatest.”
When she was 51, Cappello received notice that her mammogram was normal—”my happygram,” she says—and a month later went for her yearly gynecological exam. Upon performing a thorough breast examination, her doctor felt a lump in Cappello’s right breast and recommended another mammogram. Again, the results came back normal. However, an ultrasound detected a suspicious mass with a diameter of an inch. A biopsy ultimately showed cancer. After her first of seven surgeries, the pathology report revealed 13 cancerous lymph nodes.
“Thinking that I was a faithful patient, doing what I needed to do, I asked my breast surgeon why the mammogram didn’t find the cancer,” Cappello recalled. “She said, ‘You have dense breast tissue.’ I said, ‘What’s that?’ That was the first time I had ever heard the term.”
With the help of her husband Joe and a few of her friends, Cappello headed up a successful grassroots campaign to pass breast density legislation in her state. In 2008, she founded Are You Dense, which connected her to women in other states who were interested in joining the cause.
“Women started finding me,” Cappello said. “Their stories are my story. The sad thing is my story, while very compelling, is not uncommon. We’re all about giving people access to early detection for women with dense tissue.”
Amy Colton, 49, a registered nurse from Santa Cruz, Calif, reached out to Cappello to share her similar case. Like Cappello, she went every year for her mammogram, received the standard letter, and yet was diagnosed with cancer at an advanced stage.
After requesting all the previous reports that had been sent to her doctor, Colton was shocked to learn that every single one made reference to her dense tissue, of which she had not been aware. Specifically, one read, “Extremely dense mammary tissue with no finding suspicious for malignancy. Owing to the density of the breast, a lesion could easily be hidden and clinical findings in this patient would be extremely important.”
Aligning herself with Cappello’s organization, Colton—a newbie in the political arena—made calls to state senators and assembly members to advocate for a breast density notification bill in California. Her situation eventually caught the eye of state Sen Joe Simitian (D-11), who selected Colton as one of the winners of his annual “There Oughta Be a Law” contest. Specifically, the contest invites the public to submit ideas for new bills. Since 2001, 16 entries have been officially enacted into law.
SB173 would add the following language to notification letters of patients with “heterogeneously dense breasts” or “extremely dense breasts” per the American College of Radiology’s Breast Imaging Reporting and Data System: “Because your mammogram demonstrates that you have dense breast tissue, which could hide small abnormalities, you might benefit from supplementary screening tests, depending on your individual risk factors. A report of your mammography results, which contains information about your breast density, has been sent to your physician’s office and you should contact your physician if you have any questions or concerns about this report.”
“I’m really, really disappointed that there even has to be legislation,” Colton admitted. “I really feel like this is basic information about a person’s own physiology that should be forthcoming. This should not have to be legislated. I’m really regretful that this is the state that we’ve come to and that we have to pursue legislation in this area.”
Controversy
The California Medical Association and the American Congress of Obstetricians and Gynecologists disagree with Colton about the need for a mandate. Acknowledging that the bill intends to empower women and provide them with more control over their own health, the medical societies contend that the legislation is vague and would impose an unnecessary financial burden on patients. “Because high breast density is not currently by itself a risk factor for cancer in medical guidelines, in cases where prior authorization is required for additional screening, the tests may not be covered,” they released in a statement.
Furthermore, they point to the lack of consensus over the meaning of the term “dense breasts” and its appropriate clinical course of action. “CMA doesn’t believe it makes sense to mandate language that suggests women may need additional screening without this medical clarity,” the statement continued.
In hearings, representatives have suggested that the proposed bill would weaken the doctor-patient relationship, place additional burdens on physicians, and open them up for liability.
Two initial opponents of the bill, the California Radiological Society and the Association of Northern California Oncologists, withdrew their opposition and are now neutral.
The American College of Radiology does not have an official position on the matter yet and the topic is under discussion, said Carol Lee, MD, chair of the college’s Breast Imaging Communication Committee and an attending radiologist at Memorial Sloan-Kettering Cancer Center. However, describing her personal belief, Lee said she is concerned about the repercussions of adding the proposed language in patient letters, which she said may raise more unanswered questions.
“In my personal opinion, I don’t think it’s necessarily government’s role to dictate what we do,” Lee said. “I realize that government does get involved. But people’s cholesterol levels are a risk factor for Huntington’s disease, so should we legislate that all people get notified of their cholesterol level, and if it’s high, they should be put on a statin? That is sort of analogous to what some of the legislation is sounding like, and I’m not sure that’s appropriate.”
According to Lee, a major downside to mandated notification is the amount of variability in the assignment of breast density. “There is probably general agreement that when you compare women who have a lot of very dense tissue to women with almost all fat, those with dense tissue do have increased risk,” she said. “But most of us fall in between those two extremes, and where we are in terms of risk is really unclear.
“I think that this is an important topic and that women need to be more aware of it,” Lee continued. “What I personally favor is to encourage all women to have a discussion with their health care provider about their individual risks and whether screening in addition to mammography might be useful in their individual circumstance.”
Yet, the problem is, according to Cappello and Colton, the overwhelming majority of women—even those who faithfully go for their yearly mammograms—have never heard of breast density. Coupled with this lack of knowledge, many doctors do not voluntarily share this information with their patients. Women do not know to ask what they don’t know, and as a result no discussion of dense tissue as a risk factor takes place.
Simitian confessed that he had never heard the phrase “dense breast tissue” before he received Colton’s entry in the contest, and his fellow legislators are no different. “The issue is wholly unfamiliar to most members of the Legislature,” he said. “In a busy legislative session, with literally thousands of bills working their way through the system, the biggest challenge is getting people to sit down and take the time to understand the issue.”
To overcome this hurdle, Simitian met with 20 to 30 individual legislators in their offices, face to face, outside the committee hearings. He said it did not take much time to lay out the basics of the issue. “There is no argument that mammography is a less useful tool for women with dense breast tissue,” he said. “There is no argument that women with dense breast tissue are at higher risk for breast cancer. There is no argument that federal law already requires the assessment of breast density. There is no argument that the information is already provided to the referring physician. There is no argument that federal law requires a layman’s letter to go to the patient. With all of that not being the subject of debate, the only question is whether the patient is entitled to have information that is already being collected, included in a letter that is already being sent to her, about her own body.”
The bill has received widespread bipartisan support, receiving a 7-1 vote in favor in the Senate Health Committee and passed 34-5 in the state Senate. In the Assembly, it received a 9-0 vote in support from the Business, Professions, and Consumer Protection Committee and passed 16-0 in the Health Committee, with three members abstaining. As of press time, the bill is stalled within the Assembly’s Appropriations Committee.
Moving Forward
Addressing the need to remove variability in breast density assignment, several manufacturers have developed products that are designed to quantify density more reliably. For example, both Hologic and Volpara have released breast imaging software tools that generate automatic volumetric breast density values from screening mammograms.
Dennis McDonald, medical director of women’s imaging at Sutter Pacific Medical Foundation’s Women’s Health Center in Santa Rosa, Calif, said his department purchased Volpara’s product in anticipation of future legislation or recommendations. “I even noticed in myself that my quantification of breast density varied from year to year,” he said. “Sometimes that’s a natural phenomenon as the woman post-menopausal loses density. But there are lots of cases that are borderline between the various arbitrary divisions. Also, there were a couple of articles that came out that talked about the variations within the same group. I thought if this is really going to become something that we incorporate into our daily practice, then we needed something more objective than subjective.”
Strong believers in breast ultrasound, the staff at McDonald’s facility perform whole breast exams during supplemental screening, instead of the usual practice of focused-breast exams that target a particular area. McDonald said as a result, radiologists have identified many occult cancers. “Until this time, we never offered screening breast ultrasound,” he said. “It was always diagnostic, driven by a mammography abnormality, and I can just tell you each year I would see a nodular area on the mammography. I would recall the patient to breast ultrasound to evaluate what was shown to be a cyst, but in a completely different quadrant, completely occult on mammography, we’ve found a small cancer. So we’ve known for a long time that ultrasound can find additional lesions.”
Are You Dense Advocacy, the legislative arm of Are You Dense, will continue to work with local political advocates, such as Simitian and New York state Sen John J. Flanagan (R-2), as well as US Rep Steve Israel (D-NY) and US Rep Rosa DeLauro (R-Conn) on a federal bill. Cappello said she has a tentative meeting scheduled in November with the US Food and Drug Administration, which she hopes will revise the Mammography Quality Standards Act to include density language.
According to the California Medical Association, it is voluntarily collecting data through the national American College of Radiology Breast Imaging Reporting and Data System in order to perform further analysis on the appropriate course of action with respect to the presence of high breast density. “Once data is sufficient,” it stated, “professional medical guidelines will change to reflect this new information.”
Elaine Sanchez Wilson is a contributing writer for Axis Imaging News.
