NIH Consensus Development Statement Sparks Rancor

BETHESDA, Md--The NIH Consensus Development Conference was unanimousin its decision not to recommend routine screening mammography for womenaged 40 to 49, saying that the evidence to date does not show that anypossible benefits outweigh potential risks.

The panel's draft report recommends that women in their 40s evaluatetheir own risk factors and decide for themselves in consultation with theirphysicians whether to be screened.

The draft report was not without support from members of the audience,but its framers faced passionate criticism from many cancer specialists.Debate climaxed with a statement by Richard D. Klausner, MD, director ofthe NCI, who disagreed with the committee report. "My own evaluationis that the data supporting the benefit of initiating screening in the40s is stronger now than it had been," Dr. Klausner said. "Itdoes look significant, and women need to know that." He will presentthe findings to the president's National Cancer Advisory Board for reviewin February.

Concerns and criticisms voiced at the meeting centered around two mainissues: Did the panel appropriately assess new evidence provided by themost recent randomized controlled trials and did it give too much weightto potential and theoretical harm associated with mam-mography? Anotherissue concerned the omission of high-risk groups, especially African-Americans,from the studies upon which the panel based its decision.

Dr. Laszlo Tabar, director of mam-mography, Falun Central Hospital,Sweden, said the panel failed to adequately consider the results of fourrandomized controlled trials conducted in Malmö, Kopperberg/Östergötland,Stockholm, and Gothenburg, Sweden. Results of these trials show an overallreduction in mortality from breast cancer of 23% for women in their 40swho undergo screening mammography, he said.

"It seems clear," Dr. Tabar argued, "that while the sizeand timing of the mortality reduction rate will require further research,the existence of such a reduction is no longer in question."

R. Edward Hendrick, chief of the Department of Radiology, Universityof Colorado Health Sciences Center, charged the panel with ignoring studiesshowing benefits and ignoring "the meta-analyses of those data, whichshow that there is a statistically significant benefit."

Ingvar Andersson, of the University Hospital, Malmö, said thathe was skeptical about the appropriateness of screening for younger women.His own study showed that annual screening of 10,000 women aged 40 to 49would save only 15 breast cancer deaths over a 10-year period, at the costof 1,250 false-positive results requiring further testing. Nevertheless,he agreed with Dr. Tabar that the draft statement does not properly reflectthe state of knowledge today.

The panel was appointed by the NIH's Office of Medical Applicationsof Research. To ensure impartiality, members could not have written onthe subject or have a financial stake in the recommendations. Members readmore than 100 papers and heard from 35 experts at the two-day meeting.

Committee Members: NIH Consensus Development For Breast Cancer Screeningfor Women 40 to 49

Leon Gordis, MD, Chairman, Johns Hopkins University
Donald Berry, PhD, Duke UniversitySusan Chu, PhD, MPH, Group Health Cooperative of Puget Sound,Seattle
Laurie Fajardo, MD, U of VirginiaDavid Hoel, PhD, U of South Carolina
Leslie Laufman, MD, Hematology Oncology Consultants, Columbus,OhioJeanne Petrek, MD, Memorial Sloan-Kettering Cancer Center
Constance Rufenbarger, The Catherine Peachey Fund, Warsaw,Indiana
Julia Scott, RN, National Black Women's Health Project, Washington
Daniel Sullivan, MD, University of Pennsylvania Medical CenterJohn Wasson, MD, Dartmouth Medical School
Carolyn Westhoff, MD, MS, Columbia UniversityRuthan Zern, MD, Greater Baltimore Medical Center, Towson, Maryland

Conference chair Leon Gordis, of Johns Hopkins, insisted that data fromall recent studies were considered and that the evidence presented wasnot sufficient to warrant a change in policy.

The draft report was revised, however, to indicate that although randomizedcontrolled trials show no difference in breast cancer deaths within 7 yearsbetween women assigned to receive or not receive mammography screening,"summary data from these studies have shown an increasing trend infavor of mammog-raphy with longer-term follow-up."

The panel maintains that not all women diagnosed with cancer are helpedby early detection. The report pointed out that ductal carcinoma in situ(DCIS) may not progress to invasive cancer and there is danger of inappropriatetreatment.

Other risks include the false assurance of false-negative readings,anxiety caused by false-positive reports, and discomfort during the procedure.In addition, radiation exposure brings a theoretical risk of one additionalcancer death per 10,000 women tested annually, the report said.

Many radiologists, however, said that the potential risk of radiationwas overstated and that the psychosocial conse-quences of a false-positiveor even a false-negative result were insignificant when compared with thevalue of early detection. Critics also pointed out that therapy for DCISis changing and overtreat-ment is less of a concern than in the past.

The committee recommended that the costs of mammography for women intheir 40s who choose it should be reimbursed by insurers or covered byHMOs. In fact, a bill has been introduced into the House by Rep. JerroldNadler (D-NY) that would prohibit insurers from denying coverage for yearlymammo-grams to women age 40 and above.