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14 | Bulletin | October 2011

Special Section: Breast Imaging

MammographyMammographyMammographyMammographyQualityMammographyQuality

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By Alyssa Martino Two years post-USPSTF guidelines, mammography is still saving lives.

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Advocacy • Economics • Education • Clinical Research • Quality & Safety | 15

In November 2009, the United States Preventive Services Task Force (USPSTF) released new guidelines on screening

mammography that caused an uproar in the breast imaging community. The recommendations (http://bit.ly/aJJ6O7) stated that women ages 50–74 should undergo biennial mammograms, which went against guidelines set by such organizations as the American Cancer Society (ACS), the ACR, and the Society of Breast Imaging (SBI), all of which support annual screening for women beginning at age 40. Furthermore, the guidelines emphasized that the decision to screen women prior to age 50 should be an individual one based on risk.

As W. Phil Evans, M.D., FACR, professor of radiology and director of the Center for Breast Care at University of Texas Southwestern Medical Center in Dallas, president-elect of the ACS, explains, “Typically, an issue like this will receive a lot of media attention for a day … Usually, the interest dies down. But [the USPSTF-related controversy] went on for months.”

Although scrutiny specifically related to the changing guidelines appears to have mostly come and gone, debate about mammography has been ongoing since the imaging method became a staple in women’s health more than 40 years ago. “Mammography is one subject that’s continually in the media,” says Evans. “There are a lot of misconceptions about it.”

How did breast imagers, referring physicians, patients, and the general public react to the USPSTF guidelines? Looking back, what is their overall effect and how can stakeholders continue to promote the importance of screening in women’s health care?

Radiologists RespondWith radiologists as guest stars on

television talk shows, advertisements promoting screening, and articles penned detailing benefits of mammography, the breast imaging community’s reaction to the USPSTF guidelines was immediate. Barbara S. Monsees, M.D., FACR, Ronald and Hanna Evens Professor of Women’s Health and chief of the breast imaging

section at Mallinckrodt Institute of Radiology at Washington University in St. Louis, says the guidelines induced “grave disappointment” among her colleagues.

This disappointment only further compelled Monsees, who also chairs the ACR Commission on Breast Imaging, and many other breast imagers to take a proactive approach to clarify the USPSTF recommendations. “We were concerned that primary care physicians would not have enough time to discuss pros and cons of screening as advised by the task force,” she explains.

“We did a lot of interviews with the local media, mailed letters to our referring physicians, and sent our patients reminder notices, which spelled out the ACS recommendations for screening and why we support them,” Monsees explains. Evans says that professional organizations like the ACR and the SBI also took action to clarify the controversy’s details through public statements, scholarly journal articles, and instituting the Mammography Saves Lives™ campaign. Visit www.mammographysaveslives.org for

1960s1960sScreening Mammography’s Never-ending Story

Mammography screening is one of the most important medical advances in the last 50 years, but it is also one of the most controversial. Since its inception, a continuous debate has raged over the benefits of mammography. The following timeline chronicles 40 years of opposition to mammography — which has frequently been scientifically unsupported — and the subsequent responses grounded in science. The repeated misinformation by the opposition has unfortunately led to confusion and uncertainty among women and their physicians about an exam that has saved tens of thousands of lives.

By Daniel B. Kopans, M.D., FACR

1960s: Opposition said early detection makes no difference.

It was argued that breast cancer was

systemic before it was found, and early

detection would not decrease breast-

cancer deaths. Many remained skeptical

until the Health Insurance Plan of New York

published results of the first randomized,

controlled trial (RCT) of breast screening in

1977 that showed a significant decrease in

deaths due to earlier detection.

1970s: Opposition said radiologists couldn’t possibly screen all women ages 40 and over.

Health planners were concerned that it would be

impossible to screen all U.S. women over age 40.

The Breast Cancer Detection Demonstration Project

by the American Cancer Society and the National

Cancer Institute (NCI) showed that screening could

be effective and efficient even in large populations.

1976: Opposition said radiation from mammography would cause more cancers than would be cured.

An article in the Annals of Internal

Medicine resulted in major concerns that

the radiation from mammography would

cause more cancers than screening would

cure — a theory disproved by studies

showing that women older than 40 have an

immeasurably low radiation risk, and even

the extrapolated risk is so low that it is far

outweighed by the lives saved by screening.

valuable facts, research, survivor stories, and handouts that can help you talk to your patients about breast screening. Check out the campaign’s public service announcements at http://bit.ly/ogFxPJ.

Seeing the Big PictureIn addition to the imaging

community’s proactive response, it was important to rebut the USPSTF recommendations with evidence-based data, some of which the USPSTF did not emphasize when forming its guidelines, according to Mark A. Helvie, M.D., FACR, professor of radiology and director of the breast imaging division at the University of Michigan Medical Center in Ann Arbor, Mich.1

To clarify the finer points of mammography, such as age and screening frequency, the so-called harms of false positives and unnecessary biopsies, and cost-effectiveness, Helvie and other breast imagers continue to seek scientific evidence, including the most recent data from the Swedish Two-County Trial, which followed 130,000 women’s mammogram outcomes for 29 years, and made worldwide news. “The study conclusively shows a 30-percent risk reduction in breast-cancer mortality over a 25-year follow-up period,” says Evans.

Despite the study’s overall results and given mammography’s tenuous history, it would be foolish to expect controversy over the imaging method to end anytime soon. Indeed, then, a

concerted effort among physicians is necessary to keep screening a priority for women. “We tend not to see the big picture,” explains Helvie, “which is the widespread agreement that screening is an effective measure to save lives.”

Follow the timeline to read more about the many misunderstandings mammography has endured over the past 40 years. And yet through it all, says Monsees, “Mammography has survived the test of time and numerous controversies.” //

ENDNOTE1. Hendrick, R.E. et al. “United States Preventive Services Task Force Screening Mammography Recommendations: Science Ignored,” American Journal of Roentgenology 2011;196:W112–W116.


1989 and 1993: Opposition stated that there was no benefit from screening women ages 40–49.

A small group at the NCI disagreed

with the NCI’s own screening guidelines

and used results from a fundamentally

flawed Canadian National Breast Screening

Study (CNBSS1), as well as statistically and

scientifically inappropriate retrospective

subgroup analyses from the other RCT, to

oppose screening for women in their 40s.

1990–present: Opposition argued that breast density compromised screening until the age of 50 when the breasts turn to fat.

Major journals continue to publish papers that use data

grouping to claim that tissue density, which actually changes

gradually with increasing age, appears to change abruptly at

age 50. Not only is there no abrupt change at this age, but

mammography still finds small cancers within dense breasts.

1993–1994: Opposition argued that mammography screening compromised future mammograms for women with lumps.

A women’s health advocacy group was widely quoted that

false-positive mammograms lead to unnecessary biopsies

and permanent scarring of the breast and that when a woman

felt a lump, the mammogram would be useless to evaluate

it. In reality, mammographically guided biopsies do not lead

to permanent scarring. Mammography has little value in

analyzing lumps; its value is in finding cancers before they

become lumps. The false-positive biopsy rate is lower for

mammographically detected lesions than for lesions that the

surgeon palpates, and the cancers found by mammography

are at a smaller size and earlier stage than palpable ones.

1993–1997: Opposition argued that breast cancer was not a major issue for women ages 40–49.

For women in their 40s, the risk of breast cancer is half

that of women in their 50s, but some individuals within the

NCI failed to acknowledge that the difference between

a 1-in-1,000 chance and a 2-in-1,000 chance is of little

consequence and that more than 40 percent of the years

of life lost to breast cancer are from women diagnosed

between ages 40–49.

1993–1997: The NCI would not accept a benefit from screening unless it was statistically significant within five years of the start of an RCT.

Due to “length-bias sampling,” the

decrease in breast-cancer deaths is not

apparent until 5–7 years after the start of

screening. The arbitrary number of five

years was chosen to denigrate screening

for women ages 40–49. The trials did not

include enough women to permit statistical

significance using subgroup analysis. The

NCI set up an arbitrary requirement that

was mathematically impossible to meet.


QUALITY OVER QUANTITYThe questions surrounding mammography are often focused on

the numbers: What age should women begin screening? How often should they receive mammograms? How many patients has mam-mography saved? However, what’s more important to remember is that mammography is focused on quality, and as such, the ACR’s breast accreditation program can demonstrate your practice’s commitment to provide top-notch care.

“The mammography accreditation program started as a voluntary program in the late 1980s,” says W. Phil Evans, M.D., FACR. Then, the Mammography Quality Standards Act was passed in 1992, requiring all mammography facilities to become accredited. “It was the first time anything like that ever happened in medicine in the United States,” explains Evans. “It caused the quality of mammography to be standardized across the country, and it’s been extremely success-ful.” Learn more about accreditation requirements and renewal at www.acr.org/accreditation/mammography.

However, high quality isn’t only dictated by equipment; it’s a standard set through lifelong learning and experienced interpretation skills. The College offers access to a variety of informative and instructional resources designed to assist breast imagers in providing effective, safe, and quality care to patients. Please visit www.acr.org/breast-imaging to view the various educational and CME activities ACR offers for breast imaging.

1994–1997: Opposition suggested that the parameters of screening change abruptly at the age of 40, and screening doesn’t save lives until women reach the age of 50.

Investigators from the NCI and other

organizations argued that factors like recall

rates, biopsy rates, and cancer-detection

rates change abruptly at age 50, when in fact

this was an artifact of data manipulation.

The parameters of screening do not change

abruptly at age 50, or any other age — even

when menopause is reached.

1994–2000: Opposition argued that removing breast cancer early in women younger than age 50 leads to premature death.

Misinterpreting statistical fluctuation during the

early years of follow-up in the RCT, the opposition used

the media to suggest that early detection in younger

women was harmful. After raising concern among

women and their physicians, opponents later admitted

they had been incorrect.

1995: Opposition stated that the benefit of screening that was showing up among women in the Swedish RCTs was due to study participants reaching age 50, when screening suddenly began to work.

This idea (coined “age creep”) was

presented in a paper published in the

Journal of the National Cancer Institute that

used incomplete data to deny women access

to screening in their 40s. The author, with

access to complete data, later recanted his

analysis, but the false concept was perpetu-

ated by others.

1997: At the NCI Consensus Development Conference, the panel claimed there was no reason to encourage women in their 40s to be screened.

The panel co-chair was not persuaded by the new data that

the conference had been convened to review, which showed a

statistically significant decrease in breast-cancer deaths from

screening women ages 40–49 (as high as 44 percent). After the

National Cancer Advisory Board reviewed the data and advised

NCI to support screening at age 40, opponents blamed the NCI

decision on congressional pressure.

2000 and 2001: Gotzsche and Olsen published in the Lancet that there is no benefit from screening women at any age.

Inappropriately basing their analysis only

on the Malmö and CNBSS1 trials, the authors

argued against any benefit for any women

from mammography. They ignored the fact

that CNBSS1 violated the fundamental rules

of RCTs (the CNBSS1 was unblinded and

imbalanced) and that the Malmö trial actually

showed a benefit.

W. Phil Evans, M.D., FACR, says the USPSTF recom-mendations gained more attention than most breast imaging-related controversies.

Barbara S. Mon-sees, M.D., FACR, says the USPSTF 2009 guidelines were a “grave dis-appointment.”

Mark A. Helvie, M.D., FACR, be-lieves people tend to focus on the negative debate surrounding mam-mography rather than its role in early detection.


W ith the FDA’s approval of 3-D tomosynthesis and advances in MR, molecular imaging,

and spectroscopy in 2011, as well as the forthcoming edition of the BI-RADS® Atlas in 2012, numerous topics are up for discussion during the presentations, lectures, and workshops at the 35th National Conference on Breast Cancer™ (NCBC™), April 13–15, 2012, at the Westin Diplomat Resort in Hollywood, Fla. The conference, which is sponsored by the ACR, will seek to answer ques-tions from the breast imaging and other communities, including: • Should I abandon my current digital

imaging systems in favor of the latest 3-D equipment?

• Why do surgeons consider MR not useful in some settings?

• What is the best strategy for imaging when a lesion is probably benign?

• How can I work and interact more effectively with my peers?“Our lectures are designed to provide a

good look at digital mammography and breast imaging from the standpoint of mammography, ultrasound, and MR,” explains Debra L. Monticciolo, M.D., FACR, professor of radiology, vice-chair for research, and section chief of breast imaging at Texas A&M University’s College of Medicine and Scott & White Healthcare System, both in Temple, Texas. Monticciolo cochairs the NCBC Program Committee with Carol H. Lee, M.D., FACR, attending radiologist at

Memorial Sloan-Kettering Cancer Center in New York, professor of radiology at Weill Medical College at Cornell University, and the former chair of the ACR Commission on Breast Imaging.

Finding a Place for MRAmong the most prominent portions

of the program is the Wendell Scott Lecture, which will feature Monica Morrow, M.D., chief of breast service at the Department of Surgery at the Memorial Sloan-Kettering Cancer Center, in New York. During the lecture, “Current Surgical Approach to the Breast Cancer Patient,” Morrow will cite reasons for opposing regular MR use to image patients already diagnosed with breast cancer. “There



2007: Opposition argued that screening women in their 40s should be based on their risk of developing breast cancer.

The American College of Physicians suggested

that screening should be based on risk, despite

the fact that none of the RCTs stratified by risk,

so we did not know if screening only high-risk

women would save any lives. The group also

failed to note that high-risk women account only

for 10–25 percent of breast cancers diagnosed

each year, so that screening only high-risk

women will miss 75–90 percent of women who

are diagnosed with breast cancer each year.

2009: Opposition claimed that cancers detected by mam-mography would “melt away” if not detected by screening.

There are only a handful of breast-cancer cases in the

literature where breast cancer melted away, and these

women still died from their cancers. The thesis, published

by several researchers, is based on flawed methodology.

“Overdiagnosis” is no more than 10 percent and more likely

closer to one percent.

2009: Opposition claimed that since mammography does not find the fastest or most aggressive cancers, it has failed.

Since periodic screening is

not likely to interrupt the fastest

growing cancers, opponents argued

that it is useless. Authors ignored

the fact that, because of length-bias

sampling, screening finds moderate

and slower growing cancers and still

saves many lives.

2009: The United States Preventive Services Task Force (USPSTF) suggested that women ages 40–49 may wish to delay starting screening until age 50.

Using computer modeling and a 15-percent decrease

in deaths (even though the RCT and other major studies

showed a decrease in deaths as high as 30 percent), the

USPSTF caused an uproar with the release of scientifi-

cally unsupportable guidelines. Katherine Sebelius,

secretary of the U.S. Department of Health and Human

Services, subsequently forbid that the guidelines be

used to dictate insurance coverage. Subsequent studies

with the models employed by the USPSTF showed that

tens of thousands of women would die unnecessarily by

following its guidelines.

By Brett Hansen

NCBC™ 2012 addresses new technologies and controversial topics in breast imaging.

2007: Opposition said that the incidence of breast cancer had decreased not because of screening but because of the reduced use of hormones.

Opponents cited a 2002 Women’s Health Initiative study saying

decreased hormone use was the reason that the incidence of breast cancer

had decreased. The authors ignored the fact that the decrease actually

began in 1999 and may well be because of the earlier detection of ductal

carcinoma in situ by mammography, leading to fewer invasive cancers.

Pushing the Envelope

is a feeling among the surgical community that MR is not useful in many settings,” explains Monticciolo.

Immediately following the lecture, Monticciolo will moderate a multidisciplinary case review that will include Morrow, Bruce G. Haffty, M.D., radiation oncologist from The Cancer Institute of New Jersey, in New Brunswick, N.J., Lawrence W. Bassett, M.D., FACR, section chief of the Iris Cantor Center for Breast Imaging at the David Geffen School of Medicine at the University of California, Los Angeles, and Christopher E. Comstock, M.D., FACR, radiologist at the breast imaging service and professor of radiology at Memorial Sloan-Kettering Cancer Center. The panel will discuss the appropriate use of MR and will answer questions about the roles of surgeons, radiologists, and radiation oncologists and how they can interact to provide more effective patient care.

In addition to the controversy between surgeons and radiologists with respect to MR, the MR section of the

current BI-RADS Atlas will be discussed during several sessions. Specific time will be devoted to using current BI-RADS terminology to describe when a lesion is “probably benign.” Elizabeth A. Morris, M.D., FACR, chief of breast imaging service and professor of radiology at Memorial Sloan-Kettering Cancer Center, and NCBC committee member, is serving as chair of the MR section of the upcoming fifth edition of the BI-RADS Atlas, which will feature significant revisions over the fourth edition. She says that the new edition will provide information on updated technology, recommended follow-up visits and other guidelines. Changes to the next edition of the publication, scheduled for release March 2012, will also be discussed.

Other MR-related questions will be fielded by Lee in a session addressing MR-guided biopsy. “While there are many similarities among the various image-guided biopsy procedures, there are some factors that are unique to MR-guided biopsies. I’ll discuss some of

the appropriate follow-up issues as well as some tips, techniques, and technical challenges,” she notes.

Entering Another DimensionIn addition to the evolution of

MR, the conference will also address 3-D tomosynthesis as well as other digital imaging equipment, according to Monticciolo. (In February 2011, Hologic’s Selenia Dimensions 3-D digital mammography tomosynthesis system received FDA approval.) Mammographers are wondering if and when they should begin using 3-D tomosynthesis and if it is worth the cost of replacing their current digital systems. To address these quandaries, Mark A. Helvie, M.D., FACR, director of the breast imaging division at the University of Michigan in Ann Arbor, Mich., will compare tomosynthesis to other digital applications, and Margarita L. Zuley, M.D., medical director of Magee-Womens Hospital of the University of Pittsburgh Medical Center, in Pittsburgh, and an expert on 3-D tomosynthesis, will hold several workshops providing attendees with one-on-one instruction.

Another emerging modality to be discussed is molecular breast imaging (MBI). MBI is three times more effective at finding tumors in dense breast tissue than mammography, according to “Molecular Breast Imaging: Seeing Cancer Tumors,” in the Mayo Clinic’s online magazine Discovery’s Edge from March 2010 (http://bit.ly/d2Nk1w). Michael N. Linver, M.D., FACR, NCBC committee member and director of mammography for X-Ray Associates of New Mexico P.C., in Albuquerque, N.M., will discuss the pros and cons, as well as the latest news, on MBI.

Linver’s discussion, as well as the many other lectures and workshops, will earn attendees up to 20 AMA PRA Category 1 Credits™. For more information or to register, visit the conference website at http://bit.ly/cZ19z8. (Note: all lectures and workshops provide CME.) //Click here for references


201120112011: Opposition claimed that annual mammography is not cost-effective.

This effort to limit screening

is based on modeling that uses a

15-percent decrease in deaths from

screening (instead of 30 percent

found by multiple studies). As-

sumptions used in modeling can be

manipulated to produce any desired

result. Annual screening, beginning

at the age of 40 was shown years ago

to be cost-effective.

Daniel B. Kopans, M.D., FACR

([email protected]), is a radiologist at Massachusetts General Hospital in Boston and professor of radiology at Harvard Medical School in Cambridge, Mass. He has been a leading figure in the debate on screening mammography for more than 30 years.

All references for this timeline can be found in

the digital ACR Bulletin.

2010: Mammography Saves Lives™ is launched.The ACR, Society of Breast Imaging, and American Society of Breast

Disease launched the Mammography Saves Lives™ campaign in late

2010. The coalition was founded to reduce confusion regarding when

and how often women should receive mammograms.

Its website (www.mammographysaveslives.org)

features facts and resources for referring physicians

and patients, including survivor stories, public

service announcements, and scientific articles. Scan

the QR code to visit the site.

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