IOM Assessing Early Breast Cancer Detection Technologies

WASHINGTON—An Institute of Medicine (IOM) committee has launched an assessment of technologies for the early detection of breast cancer that will include an examination of the policies and economic factors that delay or prevent their adoption. The year-long effort is part of a 5-year project undertaken by the IOM, an arm of the National Academy of Sciences.

Joyce C. Lashof, MD, professor emerita, University of California, Berkeley, School of Public Health, chairs the 15-member panel. At the first of four public meetings it will hold, the committee discussed the scope and goals of its charge. The group also received briefings on the status and potential of imaging devices and biomarkers for breast cancer detection. Two and 4 years after the panel releases its report, the IOM plans to hold workshops to examine the progress made in the field.

In its Statement of Task, the IOM asked the group to begin the 5-year process “by surveying existing technologies and identifying promising new technologies for early detection, assessing the technical and scientific opportunities.” The committee is then to turn “to policies that influence the development, adoption, and use of technologies” and include in this analysis “how breast cancer detection technologies are likely to diffuse into practice, based, in part, on comparison to other medical technologies.”

Almost immediately, committee member Janet K. Baum, MD, associate professor of radiology, Harvard Medical School, and director of breast imaging, Beth Israel Deaconess Hospital, raised the issue of the threat to mammography posed by malpractice lawsuits filed against radiologists. The primary basis for the suits is “delay in detection,” but some women who suffer complications as the result of a biopsy that proves to be negative also file suits, she said.

“The number of malpractice claims in this country on delay in diagnosis in breast cancer is staggering,” Dr. Baum said. “The cost to the medical system in terms of insurance is reflected in the fact that reimbursement from payers doesn’t even cover our malpractice insurance. People in many states are saying, ‘I’m not going to do mammography any more.’ It has already been an issue in the use of MRI in evaluation of breast lesions, and I think it will limit the use of new technologies unless we can find some way of dealing with the issue.”

She added that in Massachusetts, some groups are considering limiting both the number of people doing mammography and the number of examinations done.

In response to one committee member’s query about whether data existed to back up Dr. Baum, Morgan W. Nields, chairman and chief executive officer of Fischer Imaging Corp., Denver, said that indeed it did.

“Physicians’ insurance associations have done studies on this,” said Mr. Nields, who was an invited speaker at the meeting. “In their last report, failure to diagnose breast cancer was the number one lawsuit, not only against radiologists, but against all physicians. It’s not just the radiologist that’s involved. It’s the surgeon, the family practitioner, anybody in the chain is named. The average settlement is approximately $350,000, and the average jury award is about $1.2 million.”

Mr. Nields called this a major societal issue. “Residents are shying away from mammography. It’s poorly reimbursed, and one is frequently sued,” he said.

The multifaceted issues of reimbursement and federal regulation—and their influences on the development and diffusion of new technologies—clearly interested committee members.

“The fact is that the cost of providing mammography services is greater than the reimbursement, and I think that is just about universal,” said panel member Michael W. Vannier, MD, of the University of Iowa School of Medicine.

According to Mr. Nields, Medicare pays $130 to reimburse an osteoporosis screening, but only about half that for a mammogram. And Dr. Vannier pointed out that mammography centers have the extra burden of FDA regulations that require their inspection and certification.

Impact of FDA Regulations

Larry Norton, MD, head of solid tumor oncology, Memorial Sloan-Kettering Cancer Center, alluded to another conflict within today’s medicine. “Companies want to make a product, sell it, and make a profit. They want a product that is useful, but there is a profit motive there,” he said. “Managed care companies want to buy as few machines as possible and do as few tests as possible. Where government weighs in on this situation is extremely important.”

The FDA regulatory process, which is time consuming and expensive, coupled with the money issue, is already affecting imaging technology, Mr. Nields said. “If you get through the regulatory gate, then you have to get through the reimbursement gate. So industry is not pursuing new imaging devices for breast cancer,” he said.

Funding for the committee study is being provided by a group of seven foundations. “Because this isn’t being done at the request of a particular federal agency, this committee has a lot of leeway in defining what its task should be,” said Robert Cook-Deegan, PhD, director of IOM’s National Cancer Policy Board.

Panel members also pondered who their audience might be for the report. Dr. Cook-Deegan cited Congress, the NCI, FDA, Department of Defense, Health Care Financing Administration and private payers, and even the NASA technology transfer program.

Committee vice chair I. Craig Henderson, MD, of the University of California, San Francisco, added two others: industry and investors. “More than drugs, devices have been very dependent on the private sector,” he said. And he added another issue for the panel to consider, one of vital interest to both groups that could seriously influence their decisions on new technologies: “Is there greater risk in investing in early detection than in other areas in health care?”

Dr. Norton reminded the panel that not everyone holds the same view on the need to develop new screening techniques to catch breast cancer at an even earlier stage. “Even if everyone in this room thinks that screening is important, there are people out there who don’t,” he said.