Discord over breast screening continues, NIH panel declines to make recommendation

NCI chief Klausner expresses shock at panel's findings

Mammography advocates were poised for good news last month whenthe National Institutes of Health convened a meeting to developa consensus on the institute's position on mammography screeningfor women aged 40 to 49. Those hopes were dashed, however, whenthe NIH declined to recommend that women in their 40s receiveregular mammography screening.

The panel's decision prompted an outpouring of criticism frommammography experts and women's health advocates, and many publichealth groups reiterated their support for screening women inthe younger age group. The outcry even prompted the introductionof two bills in Congress that would require public and privateinsurance reimbursement for annual mammograms for women aged 40and above.

The seeds of last month's imbroglio were planted in 1993, whenthe National Cancer Institute withdrew its recommendation thatwomen aged 40 to 49 receive regular screening (SCAN 12/15/93).The decision was based in large measure on the findings of theCanadian National Breast Screening Study, which questioned theeffectiveness of screening for women in their 40s. Many mammographyexperts, however, believe the Canadian study is flawed.

Since 1993, several other studies have been published indicatingthat screening the younger age group could be beneficial. In particular,studies conducted in Sweden showed that screening mammographycould reduce mortality in women aged 40 to 49 by up to 49%. Thosestudies prompted the NCI to ask the NIH to convene a conferenceto develop a consensus on screening mammography guidelines thattakes into account the new data (SCAN 1/8/97).

The NIH consensus panel, however, found that there was still toomuch uncertainty about the benefits of earlier screening to warrantrecommending the procedure to women aged 40 to 49.

"At the present time, the available data do not warrant asingle recommendation for mammography for all women in their 40s,"said a draft statement summarizing the consensus panel's conclusions."Each woman should decide for herself whether to undergomammography."

Dr. Laurie Fajardo, a professor of radiology and vice chair forresearch in the radiology department at the University of Virginiain Charlottesville, was one of the participants on the consensuspanel. Fajardo said that while the newer data lend more supportto earlier screening, those benefits do not outweigh the risks.

"We felt that there was evidence to show that there is abenefit occurring," Fajardo said. "The magnitude ofthat benefit, weighed with the time the benefit occurs and someof the risks for screening for this age group, was such that arecommendation for broad-scale screening couldn't be made at thistime."

One mammographer who disputed the panel's findings is Dr. DanielKopans, an associate professor of radiology at Harvard MedicalSchool and director of breast imaging at Massachusetts GeneralHospital in Boston. Kopans believes the panel ignored much ofthe latest data on the benefits of screening women in their 40s.

"The panel had been charged with reviewing the latest dataand they essentially ignored all the latest data," Kopanssaid.

The outcome of the conference prompted Rep. Jerrold Nadler (D-NY)to announce his plans to introduce a bill into Congress that wouldprevent any insurance plan from denying coverage of mammogramsfor women over the age of 40. In addition, Sen. Olympia Snow (R-ME)has introduced legislation that would require the NCI to reissuethe guidelines on mammography screening that it supported untilthe change in 1993.

Even NCI director Dr. Richard Klausner disagreed with the panel'sconclusion, stating that he believed the data indicated a statisticallysignificant benefit for earlier screening. The NIH's conclusionprompted Klausner to ask the NCI's National Cancer Advisory Boardto take up the issue at its next meeting, on Feb. 25-26 at theNIH campus in Bethesda, MD. The advisory board in 1993 voted 14to one against withdrawing the recommendation for screening womenin their 40s.

If the board again voices its support for earlier screening, wouldthe position conflict with that of the NIH? No one at the NCIseems to know for sure.

"We don't have any idea what is going on," said an NCIspokesperson.

One evolving development that could change the terms of the debateis full-view digital mammography, which, with its improved imageresolution, may be capable of catching suspicious lesions earlier,according to Hal Kirshner, president and CEO of digital mammographydeveloper Trex Medical.

"As we go through the (Food and Drug Administration) processand as we see the patient outcomes, all indications point to theability to see tumors much earlier with digitally enhanced anddirect digital acquisition mammography," Kirshner said.

Fajardo is working with a beta full-view digital system made byTrex Medical, and is optimistic about the technology. She cautions,however, that it will take years to develop the scientific datathat could be used in a conference such as the one the NIH held.

"There isn't enough scientific data out there to supportthat (digital mammography) does (have a benefit) and that thiscould be a solution," Fajardo said. "That is two tothree years down the road."