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Breast cancer technologies need faster progress


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Early detection and intervention

Improving access

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WASHINGTON (CNN) -- Newer technologies in breast cancer detection need more study at a faster pace, according to a new report released Thursday by an Institute of Medicine (IOM) committee.

"We aren't moving fast enough," said Dr. Craig Henderson of the University of California-San Francisco and vice-chair of the committee. "We need to reassess our priorities in this area," he said. "I think we've had a tendency to sit back and say, 'This is an old question ... we've solved. Mammography's enough.' It's not enough."

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The report found that while many technologies appear to offer varying degrees of screening or detection, no "significant" steps forward have been taken in the field of breast imaging, and more research is needed.

"To date, no quantum leap has been made in this area," said Joyce C. Lashof, chair of the committee. "At the same time, many of the newer tools offer certain advantages and deserve to be studied further."

Early detection and intervention

Breast cancer is the second leading cause of death for cancer in women in the United States. More than 180,000 cases of breast cancer are diagnosed and at least 40,000 women die yearly from the disease. Early detection is believed to have reduced breast cancer mortality by allowing early intervention.

Although there are advances on the horizon that show promise in detecting breast cancer, "none have yet proved superior" to traditional X-ray film mammography, the "gold standard" in detection of the disease, according to the study.

The IOM committee looked at 17 breast imaging tools, including the FDA approved digital mammography, ultrasound, computer-aided detection systems and MRI, as well as others not approved by FDA.

Genetics also plays a role, according Henderson. He said most cancers involve changes in the human genome that have occurred over time, and by studying these changes, cancers can be detected before they show up on a mammogram.

The report said there is no one technology that is capable of accurately detecting all breast cancers, and the best method may be a combination of tools. Ultrasound and magnetic resonance imaging have shown "potential" as adjuncts -- additional treatments -- in the diagnosis and screening of breast cancer, especially in getting clearer pictures in dense breast tissue in younger women.

Improving access

In addition to evaluating scientific evidence on the new technologies, the committee also looked at how these technologies work their way through the approval pipeline from testing to clinical usage.

According to the committee, the FDA and the Health Care Financing Administration (HCFA) should base approval and coverage decisions on clinical trial results that prove screening effectiveness.

The committee said greater access to mammography is needed, especially for women who lack health insurance. Currently only about 15 percent of the under-served population has access to mammography. The government is trying to broaden that to 70 percent.

Henderson said in many cases, the cost of a mammogram exceeds reimbursement. "There are many departments of radiology across the country that say, 'Every time we do a mammogram, we lose money and we do it as a service, but we can only do this for so long.' " Another problem is that the under-served often use clinics that don't even have mammography machines, added Henderson.

The committee's recommendations:

  • Government support for the development of new breast cancer technology should continue to emphasize research on the basic biology and etiology of breast cancer and on the classification schemes for breast lesions based on molecular biology.

  • Breast cancer specimen banks should be expanded and researcher access to patient samples should be enhanced.

  • Consistent criteria should be developed and applied by the FDA for the approval of screening and diagnostic devices and tests.

  • For new screening technologies, FDA approval and coverage decisions by HCFA and private insurers should depend on evidence of improved clinical outcome.

  • The National Cancer Institute (NCI) should create a permanent infrastructure for testing the efficacy and clinical effectiveness of new technologies for early cancer detection.

  • HCFA should analyze the current Medicare and Medicaid reimbursement rates for mammography, including a comparison with other radiological techniques, to determine whether they adequately cover the total costs of providing the procedure.

  • The Health Resources and Services Administration should undertake or fund a study that analyzes trends in specialty training for breast cancer screening among radiologists and radiologic technologists. It should examine the factors that affect practitioners' decisions to enter or remain in the field.

  • Until health insurance becomes more universally available, Congress should expand the Centers for Disease Control and Prevention screening program to reach a much larger fraction of eligible women, and state legislatures should participate in the federal Breast and Cervical Treatment Act by providing funds for cancer treatment for eligible women.

  • The NCI should sponsor large randomized trials every 10 to 15 years to reassess the effects of accepted screening modalities on outcome.

  • NCI, in conjunction with the American College of Radiology Imaging Network or the Breast Cancer Surveillance Consortium, should sponsor further studies to define benefits and risks of mammography in women over age 70.



    RELATED STORIES:
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    February 13, 2001
    Hormone replacement may influence mammography accuracy
    January 9, 2001
    Hormone-replacement therapy and breast cancer
    May 26, 1999

    RELATED SITES:
    National Cancer Institute - Breast Cancer
    American Cancer Society - Breast Cancer Resource Center
    Susan G. Komen Breast Cancer Foundation

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