NEWS

IOM Report Sets Policy Priorities for Improving Breast Cancer Screening

Laura Newman

Last month, an Institute of Medicine committee released a technology assessment on breast cancer screening, identifying key research and policy recommendations to expedite rigorous evaluation of new tools for screening that might outperform mammography.

The report explicitly stated that, so far among imaging tests, only conventional film-screen mammography has demonstrated effectiveness as a screening tool. Despite a flurry of research into promising new tests, no other technique has proven on par with mammography, the panel concluded, saying that it should be the standard to which emerging technologies should be compared.

Yet mammography is far from an ideal screening tool, the panel concluded. "Although mammography reduces breast cancer mortality by 30%, as many as three-quarters of lesions detected on mammography are benign and never life-threatening," said Joyce C. Lashof, M.D., panel chair and professor emerita of the University of California at Berkeley School of Public Health.



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Dr. Joyce C. Lashof

 
All told, the committee set forth an ambitious agenda to enhance new technology research and development and to increase access to state-of-the-art mammography for groups with low screening rates.

The panel ranked gaining a better understanding of the molecular biology of breast cancer a top priority. Government support should continue to back studies on the basic biology of breast cancer, the panel wrote, with the National Cancer Institute helping to expand breast tissue banks and enhance researcher access to the them, a problem that researchers had consistently reported at public workshops held by the panel.

Basic biologic studies of breast cancer account for a "huge part of NCI’s budget," said Peter Greenwald, M.D., director of NCI’s Division of Cancer Prevention, adding that it is an area that NCI will continue to back.

Maryann Napoli, associate director of the Center for Medical Consumers in New York, said that recommending a shift in focus away from imaging toward basic biology, even if it confirms what NCI is already doing, merits reinforcement. "It’s obvious to anyone who has followed the mammography screening trials that mammography is a suboptimal technology," she said.

Another major recommendation of the panel is to try to put promising early detection technologies into screening clinical trials. The panel urged that "the National Cancer Institute sponsor large randomized trials every 10 to 15 years to reassess the effects of accepted screening modalities on clinical outcome."

Craig Henderson, M.D., committee vice chair and adjunct professor of medicine at the University of California San Francisco, noted that since 1966 when the HIP trial was completed, "we have assumed that any technology that allows us to detect a smaller cancer will improve survival," he said. "We have also assumed that a technology that allows us to detect more in situ cancers (which were not present in the cancers detected by the HIP study) will improve survival. It is time to test those two principles."



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Dr. I. Craig Henderson

 
One overlooked population in screening studies done to date is women age 70 and older. The IOM panel recognized that the population is aging. It urged NCI, along with NCI’s Breast Cancer Surveillance Consortium and the American College of Radiology Imaging Network, to back more studies that evaluate the benefits and risks of screening mammography in women over age 70.

Greenwald, however, feared that studies of older women could be costly. Instead, he suggested that "circumstantial evidence," such as life expectancy and other parameters, could be used to evaluate how to screen older women. But Henderson responded: "This is a large group of women and a growing part of the population. This is an important group of people."

Another major concern that the panel grappled with is the trend to use tests and devices approved for diagnosis for screening before they have been proven effective for screening. "It really bothered me that GE advertised its digital mammography machine during the Olympics last year," Lashof remarked.

To help prevent early adoption of diagnostic tests for screening, the committee recommended that breast cancer detection devices and tests approved by the U.S. Food and Drug Administration solely for diagnosis not be permitted to be marketed for screening. Providers should be reimbursed for use of such technologies only in the context of screening clinical trials, the panel concluded, recommending that the Health Care Financing Administration and other payers conditionally cover those tests when women participate in screening clinical trials. Even though payers might feel a pinch initially, such a strategy would prove far less expensive than the costs of premature adoption of new technologies, the panel reasoned.

The panel also suggested that FDA establish a higher bar for a test to pass muster for reimbursement and use in screening. Before new technologies can be used for screening, the panel said the new technologies must show evidence of improved clinical outcomes. An ideal end point would be improved disease-specific mortality, but accepting a surrogate marker, namely reducing the rate of early invasive cancer, would be reasonable for some technologies.

To accomplish this agenda, the panel urged early collaboration between the FDA, HCFA, NCI, private insurers, and advocacy groups.

Yet another aspect of the report was the recommendation NCI set up a permanent infrastructure to permit timely and rigorous evaluation of new breast cancer detection technologies as they emerge. The panel considered NCI’s Breast Cancer Surveillance Consortium and the American College of Radiology Imaging Network "novel platforms" for such an agenda.

Susan Love, M.D., director of the Susan Love MD Breast Cancer Foundation in Santa Barbara, Calif., and adjunct professor of surgery at UCLA, praised the proposal for the infrastructure. "The companies can’t do it alone—so if everyone bought into it, it might help us not get stuck in the morass that we did with bone marrow transplants," she said. "They were being done with no data—but now the vast majority of doctors have stopped them because having the data goes a long way."

Love called the report a "very nice blueprint for how we should approach new technologies for screening." She added: "The worry with digital mammography is that people will jump on the next bandwagon, but the only way to stop it is to have an infrastructure that makes it affordable to test."



             
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