Cost of Care
NC Legislators Wade Into Debate Over Breast Cancer Screening
Legislators are poised this week to require physicians to talk to their mammogram patients about dense breasts. But the policy may not be keeping pace with the science.
By Rose Hoban
Thousands of women die annually from breast cancer in the U.S., and millions have breast cancer screening exams every year.
For decades, medical professionals have been telling women over 40 to have annual mammograms and to perform monthly breast self-exams to check for the presence of cancer.
And this week, North Carolina lawmakers are scheduled to debate a bill in the Senate to require that doctors notify patients with dense breasts that breast density puts women at greater risk for breast cancer and makes it more likely a cancer could be missed in a mammogram.
But some argue that evidence on breast density is inconclusive and that what to do in the case of dense breasts is not decided science.
In fact, a recent large-scale study found that women with dense breasts are not more likely to die of breast cancer than women without dense breasts.
There’s also some question as to what constitutes “dense” breasts.
But none of these issues came up during a Senate committee meeting last week in which the bill was discussed. And it looks as if House Bill 467 is well on its way to becoming law.
“I’m a survivor,” Gina Waters from Summerfield told lawmakers on the Senate Health Committee on June 19. “I was diagnosed with triple-negative ductal invasive breast cancer in June of 2010, and I found the lump myself.
Even though I had been for all of my annual mammograms, my oncologist said this had been in me for two years.”
When Waters found it, the tumor was about three centimeters in diameter, about the size of a walnut.
“By the time I … received my first chemotherapy treatment, it was two weeks, and the tumor had doubled in size to six centimeters,” Waters told the committee.
She endured dozens of intravenous and oral chemotherapy treatments as well as radiation, and eventually had a mastectomy.
“I learned about dense breasts a few months after all my treatments ended,” Waters said. “Come to find out, I had the third level of breast density and my tumor was not visible on a mammogram, even the day I was diagnosed.”
She and another Guilford County woman, Addy Jeffrey, testified that they were unaware they had dense breasts. Both expressed frustration that no one had told them to be more vigilant or had explained the relationship between breast density and a possibility of having a cancer go undetected.
The two took their concern about the lack of breast density awareness to the Commission on the Status of Women in Greensboro. From there, they’ve been advocating to have the state pass a law requiring doctors to talk to women who might have dense breasts about cancer risks and the possible need for additional screening.
“The estimation in the cell division rate [for my tumor] is that the cancer was probably missed by mammograms for several years,” Jeffrey said. “So I think it’s a very important conversation to be involved with.”
Lawmakers reacted strongly to the women’s message. Many recounted stories of family members with breast cancer. One, Sen. Jeff Tarte (R-Cornelius), choked up as he talked about a 34-year-old niece who is now recovering from breast cancer surgery.
“I want the language to be as strong as possible, that a red flag goes up and it’s bright red,” Sen. Floyd McKissick (D-Durham) told Jeffrey after the meeting.
He said he’d be willing to offer amendments on the floor to change the word “may” in the bill to “shall” or “must” in regards to physicians talking about density with their patients.
“Knowledge is power,” said Rep. Jim Fulghum (R-Raleigh), who co-sponsored the bill in the House. “This condition prevents the effective nature of this diagnostic test being effective in all women. All women are not the same. This bill evens out that knowledge gap, and that’s all it does.”
He told the committee that other screening tests are available for women, such as digital mammography and MRI scans.
In most cases, women with highly dense breast tissue are wasting their time getting mammograms, said Fulghum, a semi-retired neurosurgeon.
“They probably should be going through these more highly expensive diagnostic procedures to begin with,” he said.
How dense is dense
Density is an important issue, Laura Esserman, head of the breast center at the University of California, San Francisco Medical Center and a nationally recognized breast cancer researcher, wrote in an email exchange.
However, we do not have a standard way to measure it nor do we know which screening options, if any, should be used,” she continued.
Esserman has been outspoken about over-diagnosis and over-treatment of breast cancers that, in many cases, would not have harmed a woman and would have been harmless if left alone.
In a position statement last year, the American College of Radiology came to the same conclusion, noting: “The assessment of breast density is not reliably reproducible. When the same mammogram is interpreted by a different physician or by the same physician on different occasions, differing density can be reported.” <http://www.acr.org/About-Us/Media-Center/Position-Statements/Position-Statements-Folder/Statement-on-Reporting-Breast-Density-in-Mammography-Reports-and-Patient-Summaries>
“The significance of breast density as a risk factor for breast cancer is highly controversial,” the statement continued. “Moreover, there is no consensus that density per se confers sufficient risk to warrant supplemental screening.”
“Some doctors are very aggressive and say anyone with more than 50 percent density should receive additional screening,” said Russ Harris, a researcher at UNC’s medical and public health schools who is also a member of the American College of Physicians’ clinical guidelines committee.
“But it depends on the definition of density,” Harris said, “and there’s not a clear definition of ‘not dense.'”
Since both dense breast tissue and cancer show up white on a mammogram, for many years the major concern was that density made cancer harder to see.
Greater concerns about breast density came from a 2007 study of about 2,200 women published in the New England Journal of Medicine that found breast density was an independent risk factor for breast cancer for women close to 50 or who are post-menopausal.
However, a more recent study published by the National Cancer Institute that followed more than 9,300 women with breast cancer found no relationship between breast density and dying from breast cancer.
As noted cancer advocate and author Susan Love wrote in an essay, “Maybe dense breast tissue increases the risk of getting cancer, but not dying of it.”
“Legislation can put language in that compels people to do things regardless of the science,” Love continued. “While there is data that suggests a correlation with risk and breast density, the methods for measuring it in a standard way have not been implemented in most places.”
A number of states have now passed laws recommending more breast density awareness and mandating doctors talk to women more about breast density. Sometimes, as in the case of California, those laws have been passed over the objections of multiple physicians’ groups.
“At some point when we have better data, we will be able to recommend appropriate strategies for screening women with extremely dense breasts,” Esserman said. “Until we have some data and some knowledge, legislation only scares women and drives them to use expensive tests that will not likely help them.”
Harris also expressed concern about something he called “guideline creep.”
“People start saying more screening is better, right? We have to screen more, more frequently, with more sensitive instruments,” he said. “And when we start doing that guideline creep, we get more aggressive, and it increases the cost of care” without decreasing the number of women dying from the disease.
Harris said that while doctors say they’re finding more cancers with MRIs, more studies of MRIs and other technologies are needed to determine if those cancers would have caused harm and if people are actually being helped by finding cancers that can’t be seen by a mammogram.
“And the answer is,” he said, “we don’t know.”
“MRI is a very expensive test and it is very sensitive and causes lots of false positives,” Esserman said. “It is not appropriate for most women.”
MRIs cost at least 10 times more than a regular mammogram, while digital mammograms cost about two or three times as much as a regular x-ray mammogram.
“Digital mammograms are more sensitive [than MRI or x-ray mammography], and there is some data that suggests that it picks up more consequential cancers,” Esserman wrote.
Both Esserman and Harris said legislating in the face of incomplete science is a bad idea. And the American College of Radiology wrote that “all stakeholders [should] proceed with caution in considering a statutory or legislative mandate to include breast parenchymal density information in the patient summary or to require that patients receive copies of their imaging reports sent to their ordering physician.”
“If the legislature is saying that we’re going to step into an area of science that we’re still working on, that’s still controversial, and we might have the answer in 10 years,” Harris said, “they’re stepping into an unsettled area.
“They say, ‘We’re going to decide it,’ and it’s not being decided by medical research but by fiat by the General Assembly.
“That’s not the right way to settle science.”
Tagged breast cancer, breast density, Commission on the Status of Women in Greensboro, digital mammogram, Guilford County, mammogram, MRI, National Cancer Institute, New England Journal of Medicine, Rep. Jim Fulghum, Sen Floyd McKissick, Sen Jeff Tarte