Are Dense-Breast, Right-to-Know Laws Helpful?

Doctor reviews a digital mammogram of a dense breast and points to a potential cancer. Credit: National Cancer Institute.

In a victory for the dense-breast patient movement, Governor Jerry Brown (D-CA) signed legislation last week requiring that doctors who discover that women have dense breasts on mammography must inform women that:

  • dense breasts are a risk factor for breast cancer;
  • mammography sees cancer less well in dense breasts than in normal breasts; and
  • women may benefit from additional breast cancer screening.

The California law goes into effect on April 1, 2013. It follows four states (Connecticut, Texas, Virginia, and New York) with similar statutes. All have enjoyed solid bipartisan support. Rarely do naysayers or skeptics speak up.

Young women who are leading the charge often bring lawmakers the story of a young constituent, diagnosed with a very aggressive, lethal cancer that was not shown on film-screen mammography. The Are You Dense? patient advocacy group engages patients on Facebook, where women share their experiences with breast cancer, organize events, and lobby for legislation. Individual radiologists work with the advocacy groups, but many radiology groups and breast surgeons do not endorse these laws.

A Closer Look at Breast Cancer Data

Living in an age when information is viewed as an entitlement, knowledge, and power, many physicians find it hard to argue against a patient’s right to know. Can sharing information be a mistake? Some epidemiologists think so. Otis W. Brawley, MD, FACP, Chief Medical & Scientific Officer, American Cancer Society, says: “I really worry when we legislate things that no one understands. People can get harmed.” Numerous issues have to be worked out, according to Brawley. For one, he explains: “There is no standard way to define density.” Additionally, “even though studies suggest that density increases the risk of cancer, these cancers tend to be the less serious kind, but even that is open to question,” Brawley says. “We in medicine do not know what to do for women who have increased density.”

A study of more than 9,000 women in the Journal of the National Cancer Institute revealed that women with very dense breasts were no more likely to die than similar patients whose breasts were not as dense. “When tumors are found later in more dense breasts, they are no more aggressive or difficult to treat,” says Karla Kerlikowske, MD, study coauthor, and professor of medicine and epidemiologist at the University of California San Francisco. In fact, an increased risk of death was only found in women with the least dense breasts.

The trouble is what is known about dense breasts is murky. Asked whether he backs advising women that dense breasts are a risk factor for breast cancer, Anthony B. Miller, MD, Co-Chair of the Cancer Risk Management Initiative and a member of the Action Council, Canadian Partnership Against Cancer, and lead investigator of the Canadian National Breast Cancer Screening Study, says: “I would be very cautious. The trouble is people want certainty and chances are whatever we find, all we can do is explain.”

Women in their forties, who are most likely to have dense breasts (density declines with age) may want to seek out digital mammography. In studies comparing digital mammography to film-screen mammography in the same women, digital mammography has been shown to improve breast cancer detection in women with dense breasts. Findings from the Digital Mammographic Imaging Screening Study, showed better breast cancer detection with digital mammography. But digital mammography is not available in many areas.  Moreover, Miller explains: “We do not know if this will benefit women at all.  It is very probable that removal of the additional small lesions will simply increase anxiety and health costs, including the overdiagnosis of breast cancer, and have no impact upon mortality from breast cancer.”

Additional imaging studies sound attractive to people convinced that there is something clinically significant to find. But as I pointed out in my last post, many radiologists and breast physicians contend that there is no evidence that magnetic resonance imaging or any other imaging study aids breast cancer screening in women with dense breasts. Brawley notes: “These laws will certainly lead to more referral for MRI and ultrasound without clear evidence that women will benefit (lives will be saved.) It’s clear that radiologists will make more money offering more tests.” Miller adds: “A number of doctors are trying to capitalize on this and some of them should know a lot better.”

Many Advocates Question More Tests, Statutes

Even though the “Are You Dense?” campaign has been instrumental in getting legislation on the books across the county, other advocacy groups and patient advocates want research, enhanced patient literacy about risks and benefits of procedures. Many recall mistakes made that led women down the path of aggressive procedures. In that group is the radical Halsted mastectomy, used widely before systematic study, but once studied,  found no better than breast-conserving surgery for many cancers, and bone marrow transplants, also found to be ineffective, wearing, and costly.

Jody Schoger, a breast cancer social media activist at @jodyms who engages women weekly on twitter at #bcsm, had this to say on my blog about the onslaught of additional screening tests:

“What is needed is not another expensive modality… but concentrated focus for a biomarker to indicate the women who WILL benefit from additional screening. Because what’s happening now is an avalanche of screening, and its subsequent emotional and financial costs, that is often far out of proportion to both the relative and absolute risk for invasive cancer. I simply don’t think more “external” technology is the answer but one that evolves from the biology of cancer.”

Eve Harris @harriseve, a proponent of patient navigation and patient literacy, challenged Peter Ubel, MD, professor of business administration and medicine, at Duke University, on his view of the value of patient empowerment on the breast density issue. In a post on Forbes, replicated in Psychology Today, Ubel argued that in cases where the pros and cons of a patient’s alternatives are well known, for example, considering mastectomy or lumpectomy, patient empowerment play an important role. “But we are mistaken to turn to patient empowerment to solve dilemmas about how best to screen for cancer in women with dense breasts,” he writes.

Harris disagrees, making a compelling case for patient engagement:

“I think that we can agree that legislative interference with medical practice is not warranted when it cannot provide true consumer protection. But the context is the biggest culprit in this situation. American women’s fear of breast cancer is out of proportion with its incidence and its mortality rate. Truly empowering people—patients would mean improving health literacy and understanding of risk…”

But evidence and literacy take time, don’t make for snappy reading or headlines, and don’t shore up political points. Can we stop the train towards right-to-inform laws and make real headway in women’s health? Can we reallocate healthcare dollars towards effective treatments that serve patients and engage them in their care? You have to wonder.


MR Imaging, Electronic Test Ordering Creates Waste

Waste is what you get with rampant, uncritical use of MRI and health information technology, according to two papers out this week.  The authors of a companion editorial to one of the papers even go so far as to suggest we should make waste a quality of care measure. I applaud them.

MRI Use Soaring for Stroke Care

James F. Burke, MD, department of neurology, and colleagues from the University of Michigan Medical School, Ann Arbor, MI, take a look at neuroimaging for the evaluation of acute stroke in a paper in the February Annals of Neurology. A companion editorial by S. Claiborne Johnston, MD, PhD, and Stephen L. Hauser, MD, neurologists at the University of California San Francisco, has the provocative title: “Modern Care for Neurological Problems Must Address Waste.”  Tame, yet critical at the same time.

Burke and colleagues acknowledge that imaging is a fundamental part of acute stroke evaluation and that it is more accurate than computed tomography (CT) for stroke diagnosis. However, they also point out that no data has shown that stroke patients undergoing MRI do any better than those who do not. They also note that the most recent American Heart Association Scientific Statement advises the routine use of MRI or CT angiography for stroke (not both). The American Academy of Neurology guideline states that MRI use should be limited to the first 12 hours of stroke onset.

What they found, in a study of neuroimaging for stroke in 11 states between 1999 and 2008, is an astronomical increase in MRI use.  In absolute terms, it is up 38%, relative utilization rose 235% (from use in 28% of strokes to two-thirds in 2008). At first glance, the numbers might seem like a reasonable jump, given the change in clinical practice guidelines.

Delving deeper, they show:

  •     95% of patients getting MRIs also had a CT;
  •    there was striking geographic variation in MRI utilization.
  •    MRI utilization was highest in Arizona (79%), lowest in Oregon (55%).
  •    Diagnostic imaging was the second leading cost center in percentage increase, outpaced only by room and board.
  •    MRI costs rose faster (up 413%), from 1999 to 2007, than overall diagnostic imaging.
  •   In 2008, in this analysis, MRI costs contributed 10% and CT 8% of total hospital costs.
  •    In states with the highest use of MRI, use has leveled off so that just about all eligible patients are getting MRIs.
  •     Head CT use was stable over the same time period.

Doctors order these tests, yet they don’t know yet whether they improve outcomes, according to the paper. Do patients need both tests? Doubtful. Also, all that variation reflects the uncertainty in the standard of care.

“No question, it is very satisfying to see that infarction on the MRI, but does it matter in terms of patient care?,” write Johnston and Hauser, in a companion editorial. “More importantly,” they continue, “would the ca. $700 be better spent focusing on maintaining better secondary prevention, a major problem after stroke that could be addressed with more aggressive disease management.”

When Health Information Technology Jacks Up the Bill

In a separate paper in the March Health Affairs, Danny McCormick, MD, assistant professor of medicine at Harvard Medical School, and director of social and community medicine at Cambridge Health Alliance, and coauthors, challenge the contemporary mantra that health information technology will cure so many ills in our healthcare system.

Here, they demonstrate how the ease of access to electronic test results led to a 40% to 70% jump in ordering imaging studies. when doctors had access to computerized imaging. They argue electronic access to test results alone may offer enticements to additional ordering.

“What we’ve got are computer systems that are essentially built around the bill,” said David Himmelstein, MD, the paper’s senior author, and professor of CUNY School of Public Health at Hunter College, New York, NY, in an interview with Patient POV. “People are buying systems that  jack up the bill. These systems, with rare exception, are not built by clinicians on the ground, and so they tend to overlook clinical information, improving care, and saving dollars.”

I loved this part of the study: even though women received more imaging studies than men, they didn’t get more advanced imaging. Hey girls, I guess these docs just don’t find visualization of us as that interesting or worthwhile. The authors didn’t pursue this, but I wonder whether this reflects that doctors take illness less seriously in women. It’s not as if I want access to the same waste that men get, but don’t you think it’s a finding worth looking at further? It’s got to be hypothesis generating.

Himmelstein was hard on the purchase and dissemination of many off-the-shelf systems. “We keep hearing that we are going to save dollars by computerizing,” he said.“Yet there is not an iota of evidence that this is true.” Importantly, the paper looked at electronic test ordering, not electronic health records. In the paper, they point out that predictions of cost savings as high as $8.3 billion with computerization were based on data from a few stellar systems: the VA, Latter Day Saints, Regenstrief, and Brigham and Women’s Hospital. These systems are not representative of what doctors are buying.

Together, these papers shine a light on how easy it is to order imaging tests and how imaging is the gee-whiz technology of our age. If we really ever get serious about waste and want to work on it equitably, we will have to invite patients to the table from the outset.

Bring the public in early and often in medical technology assessment discussions.

 Don’t say you are committed to “patient-centered care” if you don’t bring patients to the table. Warning: If you leave patients out, the public sees it as  smacking of benefits denied, arbitrariness, and cheapness.

But the other thing is that until we stop rewarding doctors based on volume, and instead, inspire outcomes, we are going to drown in the morass of waste.