Backlash Continues Against Breast Cancer Screening Guidelines

Radiologists who reacted with shock and outrage to the U.S. Preventive Services Task Force's (USPSTF) revised guidelines recommending that women under age 50 not undergo annual mammography say the controversy shows no signs of waning.

Mary C. Mahoney, M.D. University of Cincinnati Medical Center

“We are still outraged and this issue is not going away,” said Mary C. Mahoney, M.D., director of breast imaging at the University of Cincinnati Medical Center and chair of the RSNA Public Information Committee.

Issued in November, the recommendations advising against routine mammography screening for women 40-49 years of age and for every other year rather than annually for women between 50 and 74, unleashed a firestorm of opposition from organizations such as the American College of Radiology (ACR) and the Society of Breast Imaging (SBI), which said that the recommendations could result in countless unnecessary deaths each year. Both organizations urge adherence to American Cancer Society (ACS) guidelines recommending annual mammography for all healthy women beginning at age 40.

While not legally binding, the new guidelines could already be gaining a legislative foothold, radiologists fear.

For instance, citing budget restrictions, California’s Health and Human Services Agency in mid-December decided to temporarily halt enrollment in a state breast cancer screening program for low-income women and raise the eligibility age from 40 to 50.

That development disturbed Dr. Mahoney and colleagues. “Another radiologist who e-mailed me an article about this development summed it up perfectly in the subject line: ‘It’s starting,’” she said.

In December, more than 20 members of Congress signed a letter to California Gov. Arnold Schwarzenegger urging him to rescind the decision. Regardless of the outcome, radiologists fear this is just the beginning.

“If Medicare stops covering breast screenings for women under 50, most insurance companies will follow immediately,” said Dr. Mahoney.

Guidelines Deemed “Conflicting”

In establishing its guidelines, the USPSTF panel—an independent group of primary care physicians and non-physician scientists funded and staffed by the U.S. Health and Human Services Agency for Healthcare Research and Quality—examined the efficacy of film mammography, clinical breast examination, breast self examination, digital mammography and MR imaging in breast cancer screening.

The panel also analyzed the risks and benefits of screening and used computer modeling to estimate outcomes associated with annual vs. biennial screening that begins and ends at different ages. The analysis is published in the November issue of the Annals of Internal Medicine. (See sidebar)

Although recommending against routine screening mammography in women ages 40 to 49, the panel went on to explain that breast cancer mortality has been decreasing since 1990 by 2.3 percent per year overall and by 3.3 percent for women aged 40 to 50 years. “This decrease is largely attributed to the combination of mammography screening with improved treatment,” the panel stated.

Nevertheless, the panel concluded that “the evidence reviewed by USPSTF indicates that a large proportion of the benefit of screening mammography is maintained by biennial screening, and changing from annual to biennial screening is likely to reduce the harms of mammography screening by half."

The message is ultimately conflicting, according to Carol Lee, M.D., an attending radiologist at Memorial Sloan-Kettering Cancer Center in New York and chair of the ACR Breast Imaging Commission.  Listen In as Dr. Lee discusses her initial reaction to the USPSTF guidelines.

“I don’t understand how the task force reached this conclusion given the numbers they cited,” she said. “To my mind, the risk/benefit ratio came out in favor of annual screening beginning at age 40. Apparently we looked at the same numbers and came up with different conclusions.”  Listen In as Dr. Lee discusses the science behind the guidelines.

On Dec. 1, USPSTF member Bernadette Melnyk, Ph.D., of Arizona State University in Tempe, posted a statement on the university’s Web site reading in part: “The task force recommends that women discuss with their primary care provider the age to start screening after understanding that the benefit of starting to be screened in the 40s compared with starting at 50 is small and that this small benefit needs to be weighed against the possible risks, including false positives, unnecessary biopsies and anxiety.”

RSNA Panel Condemns Guidelines

Along with concurring on the lack of scientific evidence used as a basis for the guidelines, a panel of breast imaging experts at RSNA 2009 criticized USPSTF for its lack of even one breast imaging specialist on its 16-member panel. “There were no radiologists, surgeons, oncologists—no one specializing in breast cancer,” said Dr. Mahoney, who moderated the RSNA panel discussion. “That’s a real problem.”

A panel of breast imaging experts at RSNA 2009, including Stephen A. Feig, M.D., above, criticized the U.S. Preventative Services Task Force’s revised guidelines recommending women under age 50 not undergo annual mammography.

Nor was the USPSTF panel receptive to outside advice from imaging experts, according to Daniel B. Kopans, M.D., who said he e-mailed the task force with research outlining the effectiveness of mammography but received no response.

“It’s hard for me to believe the task force thought about the implications of these guidelines,” said Dr. Kopans, a senior radiologist in the Breast Imaging Division at Massachusetts General Hospital and a professor of radiology at Harvard Medical School, both in Boston. “If they had used the actual available data and not computer modeling, by their own estimates mammography screening would be appropriate for women in their 40s.”

Dr. Kopans pointed out that the age of 50—the threshold used by USPSTF in its analysis—has no basis in science. “It is meaningless with regard to screening since none of the parameters of screening change abruptly at age 50 or any other age,” he said. “It was only by grouping data together that USPSTF made it appear as if there was a sudden change at age 50 when no such change exists; rather the parameters of screening change gradually with increasing age.”

While acknowledging that mammography is not perfect, Stephen A. Feig, M.D., a professor of radiology at the University of California Irving School of Medicine in Irvine and president-elect of the American Society of Breast Disease, called it one of the greatest medical achievements of our time and shared statistics showing a 40-50 percent mortality reduction for women ages 40-75 screened in Sweden and British Columbia.

Although task force members insist that cost was not a factor in their recommendations, Dr. Feig said women who follow them could end up paying the price.

“The net effect of the new guidelines is that screening would begin too late and its effects would be too little,” said Dr. Feig. “We would save money, but lose lives.”

Staying on Message Critical

Despite the backlash, Drs. Lee and Mahoney fear the USPSTF guidelines could influence women reluctant to get breast screenings and deter women already confused about the process. “The natural conclusion is that these guidelines will result in decreased utilization,” said Dr. Lee.  Listen In as Dr. Lee discusses the potential impact of conflicting guidelines.

“We know that about 20 percent of patients diagnosed with breast cancer are in their 40s,” said Dr. Mahoney. “If you have a very official-sounding federally appointed group of doctors saying you don’t need to start screening until 50, some women will believe it.”

Radiologists can only continue to stress the importance of following ACS guidelines and raise awareness about the decades of data supporting the benefits of mammography, said Dr. Mahoney. And new recommendations issued by ACR and SBI stating that breast cancer screening should begin at age 40 and earlier in high-risk patients were published in the January issue of the Journal of the American College of Radiology.

“We definitely need to find better tests, that’s why we’re working in all of these other areas—digital imaging, tomosynthesis, molecular imaging and MR imaging,” she said. “We are constantly working to get better, smarter, improve sensitivity and reduce recall. But right now, mammography is the best test we have.”