One in eight. That’s how many women will be diagnosed with breast cancer in her lifetime, according to the National Cancer Institute (NCI). This grim statistic lands in the spotlight during Breast Cancer Awareness Month, which is currently underway.

But, for all of the awareness raised about breast cancer over the years, there’s a certain term that is largely left out of the lexicon surrounding breast cancer,the most common cancer in women. It’s a term Connecticut resident and cancer survivor Nancy Cappello has spent nearly a decade fighting to retrieve from the shadows and inject into the conversation. This term is “breast density.”

“If you look in the news this October, it’ll be pink, pink, pink for Breast Cancer Awareness month,” says Cappello. “I call it breast density unawareness—many women still do not know of breast density, or if they’ve heard of it, they don’t know what it really means to them.”

Breast density refers to the ratio of tissue to fat in a woman’s breast. A dense breast has more fibroglandular tissue and less fat. Forty percent of women have dense tissue, according to the American College of Radiology Imaging Network (ACRIN), which is significant because these women are five times more likely to develop breast cancer. They’re also less likely to have it detected on a mammogram.

A January 2011 Mayo Clinic study found that mammograms fail to find 75 percent of cancer in women with dense breast tissue. The primary cause of “false-negative results” in mammograms is high breast density, according to the NCI.

However, until recently, it was standard practice nationwide for doctors to keep information about breast density from patients, and as a result many people with dense breasts do not have cancer detected until it is well developed.

While breast density—and the ineffectiveness of mammograms on dense breasts—is not new, in recent years a battle has arisen to bring unprecedented attention to the issue. As a result the standard practice of keeping breast density knowledge a secret from women has begun to change, but not without a surprising amount of opposition. On the frontlines of resistance is the American College of Radiology (ACR), the nation’s principal association of radiology professionals, an organization that benefits financially from mammograms.

The Status Quo

When Cappello was diagnosed with stage-three breast cancer in early 2004, she was baffled. Less than three months earlier, she’d received normal results on her mammogram, just as she always had from her annual screenings, which she was diligent about. Her doctor found a lump during a standard manual exam that turned out to be cancer that had spread to 13 lymph nodes and most likely been developing for years.

“What do you mean I have breast cancer?” she recalls asking her doctor. “What happened? I just got a mammogram that says ‘we are pleased to tell you that your results are normal.’”

The answer she was given perplexed her further. She was told that she had dense breasts, and that dense tissue shows up as white on a mammogram and can “mask,” or obscure, cancer, which also appears as white. (Santa Barbara radiologist Judy Dean has said it has been compared to trying to find a snowball in a blizzard.) Why, Cappello demanded, hadn’t she heard of breast density, or been told that she was affected by it?

Simply put, most doctors do not share this information with women. Ninety-five percent of women don’t know their breast tissue density, and less than one in 10 doctors inform their patients of their density, according to a May 2010 survey conducted by Harris Interactive.

Under current federal law, radiologists must note a patient’s breast density when reporting mammogram results to the referring physician. The law also requires radiologists to send patients a letter (known as a “lay summary”) with their mammogram results—but this letter does not include information regarding breast density, or how the presence of dense tissue could render the mammogram inconclusive.

So, while a woman’s mammogram provider and her physician know whether she has dense tissue, often the patient herself does not.

Radiologist Thomas Kolb explained the problem with this practice at a press conference at the New York Capitol in spring 2012. In 1998 and 2002, Kolb published research that found similar results as the aforementioned Mayo Clinic study about the effectiveness (or lack thereof) of mammograms on dense breasts. While mammograms were able to detect cancer in 98 percent of women with non-dense breasts, he found that 60 percent of cancer in dense breast was “mammographically occult or missed.”

“We as radiologists report to physicians and patients…knowing full well that if a woman has non-dense breasts we are 98% accurate but if she has dense breasts, and were to have a breast cancer, we would only be 40% accurate in our diagnosis,” he said. “Worse, by not detecting her breast cancer we allow it to grow until her next mammogram—or two or three—or until it becomes palpable, which translates to, at a minimum, double the size at which it could have been detected with imaging. However, this information is never directly transmitted to the patient.”

As Cappello was told, patients aren’t notified largely because it is not standard procedure for this information to be included on the lay summary they receive after a mammogram.

As for why the referring doctor hasn’t traditionally told patients (despite the fact that the report they receive from the mammogram provider does include density information), Hospital of Central Connecticut radiologist Jean Weigert says it’s possible that many of doctors have not been educated about density.

“As for referring MDs, they may really not have known about this issue and did not realize that it needed discussing,” Weigert says.

After her diagnosis, Cappello, who holds a doctorate in education administration, was outraged and launched into research on breast density. As she underwent six surgeries, eight chemotherapy treatments, and 24 radiation treatments, she started a 501c3 nonprofit called Are You Dense? out of the spare bedroom in her house. The organization raises awareness about dense breast tissue and promotes early detection. Also during her treatments, she launched a campaign to get a law passed in her home state that would require mammogram providers to tell patients if they have dense breasts.

Taking Legal Action

In 2009, Cappello’s group was successful in making Connecticut the first state to pass breast density notification legislation—a law that adds information about density to mammogram result letters sent to patients. They also helped a breast density insurance bill pass in 2005, which requires that other breast cancer detection screening methods are covered by insurance.

Today, 12 states have notification laws on the books: after Connecticut came Texas, Virginia, New York and California. And in the 2013 legislative session alone, laws were passed in Tennessee, Hawaii, Maryland, Alabama, Nevada, Oregon and North Carolina. Connecticut and Illinois are still the only states with laws that require insurance coverage for additional screening methods, but Illinois does not have a mandatory notification law in place.

Although bills concerning breast density have passed in Utah and Illinois, Capello does not count them among states with notification laws because they do not mandate that patients receive the information.

Cappello says there are “five or six [more state bills] in the hopper,” but points to Pennsylvania, Ohio, Michigan and New Jersey as the states most likely to pass notification laws in 2014. She says 20 states have had such laws introduced, total. While breast density was more or less a secret just a few years ago, major media outlets including CNN, the New York Times and the Wall Street Journal have now covered the issue, and breast cancer literature increasingly includes information about how density affects a woman’s cancer risk.

Cappello may have set the swell of notification laws into motion, but legions of women across the country have picked up the cause in their own states with the help of champion legislators. Many of these advocates have stories very similar to Cappello’s. Some are more tragic than others: A key advocate in the fight for notification legislation in Massachusetts, Ellen Kelliher, passed away from breast cancer in July. Her state has yet to pass such a law, but a strong coalition is continuing to push for one.

While the state-by-state approach continues, advocates are also calling for federal action. A federal bill, H.R. 3102, was introduced in 2011 but never went anywhere. A similar density bill may be reintroduced this fall, according to Cappello.

But breast density awareness bills are not met without a fight: the ACR and its sister organization Society of Breast Imaging (SBI) has opposed attempts to make sure women get density information, be it state laws or changes to the MQSA.

“We’re working with the science, a few champion legislators, and women,” says Cappello. “And then you have lobbyists from organizations working to kill or oppose the bill, or to water it down. It’s so hard to wrap my head around it, even now. I’ve been doing this work for nearly 10 years, and I am still amazed of the relentless work that organizations do to prevent this information from getting to patients.

“What I do know is that it’s unethical at the best, and deadly at the worst,” she adds.

Meanwhile, density activists are also trying another route: working with the FDA to change regulations in its Mammography Quality Standards Act (MQSA) to mandate density notification. Proposed regulation changes may be presented in December, says Cappello.

“We’re hoping that it will be clear in language, consistently applied across the nation, and all women, whether they are in Missouri or Mississippi, will know their breast density and be able to have those conversations with their doctors,” she says.

Unethical Practice

But laws or changes at the FDA shouldn’t be necessary, says Julie Marron, president of the Institute for Health Quality and Ethics (InHQE). The national nonprofit advocates, among other things, for informed consent for patients—something Marron says is violated when this information is kept from women. The organization has spent several years researching the issue.

“Physicians are absolutely required to share material medical information with patients,” says Marron. “There is no justification legal or ethical, [to keep information from patients]. In fact it’s illegal and unethical.”

For the most part, however, she says the fault isn’t with individual doctors.

“I think it’s one of the most egregious examples of denying patients the opportunity to make informed medical decisions, but I don’t necessarily think it’s the fault of individual radiologists or primary care physicians,” she says. “I think by and far most people want to do the best for their patients. What I’ve seen is more at the top—the ACR, that’s the organization that really controls a lot of what happens here—and there are a lot of incentives for them to maintain the status quo in terms of ubiquitous mammogram screenings.”

Marron calls the world of mammography practice and regulation a “closed system,” with the ACR holding the reins. This, she says, makes changing the system difficult.

“The FDA has given the ACR nearly monopoly control over the accreditation of mammogram facilities nationwide,” Marron wrote in a post on the InHQE website. “The ACR also develops the practice guidelines for radiologists and the sample patient notification letter utilized by radiologists and imaging facilities. Leaders of the ACR and its sister organization, the Society for Breast Imaging (SBI) also sit on the National Mammography Quality Assurance Advisory Board at the FDA. This has created a closed system with no checks and balances on the actions of the ACR, which we believe is endangering the lives of thousands of women.”

In May 2012, InHQE filed a complaint with the American Medical Association’s Council on Ethical and Judicial Affairs against the ACR, which is an AMA member.

The complaint reads, “The ACR has repeatedly and systematically violated AMA Ethical Guidelines by supporting the practice of withholding material medical information from women who obtain screening mammograms for the early detection of breast cancer, thereby denying millions of women the right to make informed decisions about their own medical care.”

By the organization’s own estimate, this practice results “in the preventable deaths of 10,000 women each year.”

The AMA responded to the complaint by stating that it can only pursue grievances aimed at individuals, not organizations.

In November 2012, InHQE submitted a citizens’ petition to the FDA asking the administration to uphold and enforce the patient notification amendment in the MQSA, which, Marron says, should already lead to the disclosure of density information.

“The FDA simply isn’t enforcing it,” Marron says, adding that the current surge of laws nationwide will force the FDA to address the issue sooner or later. “The FDA is going to have to take some action.”

Until an FDA regulation change or a federal law exposes the density secret in all corners of the country, it is up to more states to join in the trend and pass breast density inform legislation.

“We will continue to relentlessly pursue early access to an early cancer diagnoses state by state until there is either a federal bill with good language or a regulatory change,” says Cappello. “Until then we can’t give up because cancer doesn’t take a time out.”

Facing the Opposition

In 2013, the NCI estimates that 39,620 women will die of breast cancer and 232,340 will be diagnosed with it. With a fatal problem of this magnitude, why would medical groups oppose the sharing of basic, but potentially life-saving, information with female patients?

Weigert, the aforementioned Hospital of Connecticut radiologist, actually testified in opposition of Connecticut’s notification bill on behalf of the Radiological Society of Connecticut when the law was being considered in 2008.

“We felt that its time hadn’t come yet,” says Weigert. “We’ve been burned on not having data in the past.”

Weigert says the association worried about how many unnecessary ultrasounds or biopsies would result, the extra work the deluge of additional screenings would make, and about women’s ability to handle the information.

“We knew that mammograms could miss breast cancers, but we didn’t know whether bilateral breast ultrasounds would detect enough breast cancers, with the concept that there’d also be a lot of false positives,” she goes on. “And there’d be additional anxiety for patients.

“There are a variety of costs, not just monetarily,” she adds. “There’s time, resources to have the breast technologists being able to perform these, having the equipment and the availability to do them and do them well. It was a big unknown.”

The anxiety argument has been used across the country; Gov. Jerry Brown, in California, sided with radiologists who opposed the state’s bill because it could “cause panic” among women with dense breasts when he vetoed the state’s first bill, in 2011, stating he “struggled over the words. Were they a path to greater knowledge or unnecessary anxiety?” (A 2012 version of the bill did pass.)

At the Nov. 4, 2011 National Mammogram Quality Assurance Advisory Board FDA Hearing, the ACR cautioned against including density information on a patient’s lay summary, echoing the oft-cited anxiety claim: “For women with dense breasts, receipt of breast density information may create undue anxiety about their risk.”

Unsurprisingly, women nationwide have rejected the notion that they can’t handle information about their risk for breast cancer.

Following Brown’s veto in California, the woman behind the state’s bill, registered nurse and cancer patient Amy Colton, wrote an open letter to the governor that read:

“In your veto message, you cite the ‘unnecessary anxiety’ that breast density notification would cause. I ask you for a moment to consider the ‘anxiety’ of a late-stage cancer diagnosis. As if that isn’t devastating enough, imagine learning that your cancer might very well have been detected at an earlier stage had you received notice that you have a condition that masks breast cancer. There is no comparison between the speculated ‘anxiety’ that breast density notification would cause and the ‘anxiety’ of a late-stage cancer diagnosis.”

Lynne Farrow, of Breast Cancer Choices, told her story of having cancer missed by routine mammograms at the November 2011 FDA hearing and condemned the anxiety argument, stating:

“We are grown women. Our lives are at stake. We don’t want any bureaucrats or insurance companies denying us information because we might get anxiety. We’ll be the judge of what causes anxiety.”

Other reasons the ACR has given for opposing density notification align with what Weigert and the Connecticut radiology association asserted. At the FDA hearing, the ACR said notification could cause a “false sense of security” among women with non-dense breasts, lead to an increase in false positives (because MRIs and ultrasounds will detect more malignancies, many of which are benign) and, generally, increase the workload for providers. The more dense-breasted women know about the reduced efficacy of a mammogram for them, the more women will seek additional screening methods.

“Beyond false positives, many radiologists believe that implementing screening ultrasound is simply not viable given the manpower it requires,” the ACR says on its website.

Red Herrings?

The ACR’s given reasons for opposing patient notification are red herrings, says Marron.

“Information patients need to know is being deliberately withheld,” she says. “There is no reasonable justification for doing this, and sometimes the message gets lost in rebutting these absurd reasons.”

The InHQE has suggested that there are ulterior motives behind the organization’s opposition.

In the nonprofit’s complaint to the AMA, it stated, “Even more troubling, however, is the growing suspicion among patients that these organizations are not advocating for this violation of medical ethics due to a misplaced sense of altruism, but due to their reliance on the $7 billion annual revenue stream attributed to mammograms.”

The ubiquity of mammograms—and how that came to be, why, and who profits from it—will be the subject of an upcoming documentary from InHQE called Happygram. Centered on the fact that “happygrams” (patient result letters) can misleadingly give patients “normal” results, the documentary will be completed soon and then submitted to film festivals.

“The industries and organizations that benefit finically have done an effective job of equating mammogram with breast cancer screening,” says Marron, “and at making [mammograms] also equal women’s rights and if you question any part of that then you’re somehow against women. It’s become this absurd mathematical equation.”

Are the ACR and others who benefit from mammograms (such as equipment manufacturers), opposing these changes to notification in order to protect the profits they currently receive from mammograms? Blowing the lid off of the density secret may certainly may put a dent in the reputation of mammograms, which remain the gold standard for breast cancer screening and are still effective for a segment of the female population. Even if dense-breasted women choose to go forward with additional screenings, professionals stress that mammograms should continue to be treated as the first and primary screening method.

As put by Breastdensityinfo.com, a site put together in California by a working group of radiologists and breast cancer risk specialists, “Mammography is the only screening modality that has undergone randomized controlled trials demonstrating a reduction in breast cancer mortality. There is no recommendation that it be replaced with another test in any subset of the population.”

Density notification will lead to more ultrasounds and other screening procedures—but isn’t that just more business for the breast screening industry? Not exactly, says Marron. Mammograms are far less work intensive and can be done in greater quantities.

“Mammograms are a production assembly—you get a woman, prep her, put her in, they’re maximized,” she says. “Except for maybe in rural areas, that’s a very profitable business model. For ultrasounds, at least until recently, it’s more time-consuming. They can’t be sent off and done in batches. It throws a wrench into that workflow. If you have 40 percent of women finding out the mammogram isn’t that effective for them, you’ve got a completely different profit margin, if any, at all.”

However, she adds that new ultrasound technologies being introduced could improve this process.

The Results are In

Connecticut, as the first state to have enacted breast density inform legislation, has demonstrated what the true impacts of notification are.

Weigert and the state radiological association changed their stance on the state’s bill in the spring of 2008, when ACRIN published results from its 6666 Trial, which added bilateral ultrasounds to the screenings of women with a 25 percent higher risk for breast cancer. They found 4.2 additional cancers per 1,000 screenings among women with more than 50 percent breast density and who were in the higher risk category.

“[Radiologists] find between four and six cancers per 1,000 on a screening mammogram—4.2 additional was like doubling that,” explains Weigert. “That’s a lot of cancers. With that data, we felt we couldn’t go against it anymore.”

The Radiological Society of Connecticut, as a result, reversed its position before the bill passed.

Today, breast density notification is a source of contention in the radiological community. As with Connecticut’s radiology society, not all state radiology groups or individual radiologists are aligned with the ACR on the issue. Kolb, from New York, is one example; another is radiologist and founder of the Knoxville Breast Center Kamilia Kozlowski, who rallied for the density law in Tennessee.

“There’s certainly a lot of controversy, still, about it, even among the experts in breast imaging,” says Weigert.

All of the unknowns have had time to play out in Connecticut since the law’s passage. The mandatory notification of density to patients did lead to a spike in ultrasounds, says Weigert. It also led to an increase in detected cancers.

Weigert has conducted research on the outcomes of Connecticut’s law, the findings from which resonate with the earlier ACRIN study.

She gathered data from 12 radiology offices across the state on the first year of ultrasounds following the new law’s passage. Of more than 8,000 bilateral ultrasounds, 3.2 cancers were found per 1,000—all low-stage, or “the kind of cancers we hope to find,” Weigert says. The findings were published in the Breast Journal in November 2012. Another study, by the Chief of Breast Imaging at the Yale University School of Medicine, also produced favorable results about the Connecticut law’s impacts. Both studies are cited nationwide as additional states grapple with the issue.

“I think most of us were surprised with the outcome of finding these cancers,” Weigert says. “They are little and treatable, and it’s wonderful. I don’t know how long it would take for them to manifest on mammograms or as a palpable mass, and at that point you’d worry about the stage and we know that’s harder to treat.”

She now uses her research to try to make the case for density notification among her colleagues.

However, she adds that the law has also resulted in some challenges. The increase in ultrasounds put added strain on radiologists, technicians, their equipment, and their schedules, she says. And while Connecticut is four years “into its routine and comfortable,” other states with new notification laws will need to brace for and try to keep up with the surge in demand.

She also argues that radiologist are not being compensated fairly by insurance companies for whole breast ultrasounds. She says they currently receive the same amount for ultrasounds of the entire breast, which are more time consuming, as they do for appointments where they look at one spot on the breast.

Then there is the issue of affordability for patients, themselves. Weigert’s practice charges $240-$250 for a breast ultrasound. Connecticut’s rare ultrasound insurance law does mean insurance covers this additional screening method, which is not the case in most other states, but women with high deductibles still pick up the tab. In states without an insurance mandate, Weigert worries that women in lower income brackets will not be able to use the information about their breast density as effectively as wealthier women.

“If you can afford it, you can have it, and if you can’t afford it, you can’t have it,” she says. “Which is really a terrible situation.”

Cappello says the density movement won’t stop at mandatory notification—access and coverage are both part of the larger vision.

“We want all women to know their density; women should have that information,” she says. “But, second, we want them to have access to reliable screening methods.”

Awareness about breast density has caught fire in the country, and is spreading slowly and steadily. As a result, Marron, from InHQE, says forces that wish to keep this information from patients are playing a losing game.

“They can’t stop this from happening,” she says.