It was hard to miss the loud rumbles in November. In a reversal of its 2002 recommendations, the U.S. Preventive Services Task Force (USPSTF) issued new guidelines last month recommending against routine screening mammography in women aged 40 to 49 years and advocating screening only every two years for women aged 50 to 74 years. The uproar reverberated across the nation and shook up the nation’s Capitol, as well.

“Scientifically unfounded,” “contrary to the evidence” and “incredibly flawed” are just a few of the outcries from the radiology community pertaining to the suggested new guidelines.

“Over the past 17 years, I have routinely diagnosed women in their 40s on a screening or diagnostic mammogram,” says Stamatia Destounis, MD, from the Elizabeth Wende Breast Care Center in Rochester, N.Y.  

After reviewing the center’s data for the last five years, Destounis found a relatively equal number of breast cancers in patients in the age groups 40 to 49, 50 to 59, 60 to 69, and 70 and above. “We found about 25 percent in each category, a considerable number of those detected through screening mammography,” she says. “The recommendation to start screening at age 40 is not empirically derived. The reality is that in the last two decades, we have seen a decrease in mortality from breast cancer, when prior to 1990, the death rate had been flat for many years.”

Despite the USPSTF’s connection to the Department of Health and Human Services (HHS), HHS Secretary Kathleen Sebelius was forced to make several announcements shortly after the release of the new screening recommendations to quell the chaos and confusion felt by women and providers. “The U.S. Preventive Services Task Force is an outside independent panel of doctors and scientists who make recommendations. They do not set federal policy and they don’t determine what services are covered by the federal government,” Sebelius said at a press conference. “Indeed, I would be very surprised if any private insurance company changed its mammography coverage decisions as a result of this action.”

But Tom Harkin, D-IA, chair of the Senate Health, Education, Labor and Pensions Committee, wants to investigate how the recommendations came into being, especially because the task force included representatives from health insurers, but not a single expert in mammography, breast surgery or oncology. Nearly two dozen senators wrote a bipartisan letter in support of Harkin. The American College of Radiology (ACR) has urged Harkin’s committee to allow a member of the ACR to testify at the hearing, which has not yet been scheduled.

Good science or bad policy?
The rallying cry from the breast imaging and radiology communities has been that the recommendations were based on bad science. Some even claim they amount to “healthcare rationing.”

Howard P. Forman, MD, MBA, a professor of diagnostic radiology, economics and public health at Yale University, says the underlying research of the task force is a “thoughtful decision analysis that incorporates the best data that currently exist.” The recommendations “tacitly, but not explicitly, acknowledge some cost issues,” Forman says.

The ACR has not sugar-coated its response. “We feel that the recommendations were cost-cutting measures made by people with no expertise in the subject matter that will cause countless women to die unnecessarily each year from breast cancer,” says Shawn Farley, spokesperson for the ACR. “The fact that insurance company staff were represented on the USPSTF, but not one cancer expert, just does not pass the smell test.”

The ACR issued a statement containing its scientific objections to the new screening recommendations. Among the objectives, the college said there is no scientific justification for choosing the age of 50 as a threshold for screening mammography.

“There are no data that show any of the parameters of screening change abruptly at the age of 50 or any other age,” according to the statement. “The USPSTF grouped women by decades, but it still made it appear as if something biologically important happens at age 50 when the age of 50 is nothing more than an arbitrary selection.”

Daniel B. Kopans, MD, director of breast imaging at Massachusetts General Hospital in Boston, says that the guidelines ignore most of the important scientific evidence and rely on unproven, computer modeling. “You might remember that there were very sophisticated financial computer models that said everything was rosy just before the economic crash,” Kopans says. He adds that the death rate from breast cancer has decreased by 30 percent since screening began, which translates into 15,000-plus saved lives each year. “These new recommendations will set women’s health back more than 20 years.”

Kopans says it’s unclear why the USPSTF decided to drop its support of screening women in their 40s “since the only important new data that have become available since 1997 are national statistics showing that as more women participate in mammography screening, the death rate continues to decrease.”

Kopans notes that the USPSTF incongruously agreed that screening is saving lives, but “the members of the task force felt that the ‘harms’ of screening—anxiety from having the test, breast compression, false positives, biopsies and possible overtreatment—were worse than allowing women to die from breast cancer.”

In the very short run, Forman says there will be an increase in demand for mammography, as some women become concerned that insurance companies will begin to limit such coverage, “and I do believe this is a real concern.” In a few years, Forman expects there will be no change or effect. In the longer term, he says “we should await additional research to better inform evidence-based guidelines.”

Panel pounds guidelines
The new recommendations ignited a flurry of criticism by a panel of breast imaging experts at the recent Radiological Society of North America (RSNA) meeting.

“Screening mammography represents one of the great medical achievements of our time,” said Stephen A. Feig, MD, professor of radiology at the University of California Irvine School of Medicine and president-elect of the American Society of Breast Disease at an RSNA press conference. Annual screening has reduced mortality by 40 to 50 percent for women between the ages of 40 and 75, despite an increase in the disease, Feig noted. 

He cited two randomized, controlled trials: the Swedish two-county trial, which resulted in a 32 percent mortality reduction rate, and the Swedish seven-county service screening study (real-life population), which resulted in a 44 percent mortality reduction—both of which assessed women aged 40 to 74.

The recommendations could have an immediate impact on health insurance coverage, the panel agreed. Under the current healthcare reform bill (HR 3590), private insurers would be required to provide coverage for breast cancer screening for women between the ages of 40 and 49, since the Task Force gave a grade C for this age group. Women older than 74 may not be covered for screening at all as the Task Force assigned a grade I (insufficient evidence) for this age group.

“The Task Force recommendations are taken tremendously seriously, and insurers will follow suit,” said W. Phil Evans, MD, director of the Center for Breast Care at the University of Texas Southwestern Medical Center in Dallas and president of the Society of Breast Imaging. “This is our real concern. However, we’re hoping that most health insurance companies and managed care providers see the benefits of breast cancer, and we’re hoping [common sense] will prevail.”