There's an age-old question that if a tree falls in a forest, and no one is around to witness it, does it make a sound? The question may also apply to the recent Agency for Healthcare Research and Quality (AHRQ) report that stated alternative breast imaging modalities were not a viable alternative to breast biopsy.
The premise of the 130-page report certainly had the potential to stir up serious trouble: imaging modalities such as MRI, PET, and ultrasound have too high of a miss rate to replace biopsy, in the estimation of the AHRQ. But given the controversy that generally permeates breast cancer screening, and mammography in particular, the report's conclusions seemed to have landed with a particular thud.
Except for a brief (less than 200 words) Associated Press article picked up by major media outlets, it didn't cause much of a stir. Compare that to the reaction to a 2002 New York Times article that accused doctors of being the weakest link in breast cancer screening. Or the last time investigators at the Nordic Cochrane Centre in Copenhagen, Denmark, declared that screening mammography did not reduce mortality.
Karen Migdail from the AHRQ public affairs office told AuntMinnie.com that her department was "very pleased with the response to this report." Yet the lackluster response from the public didn't come as a surprise to some imaging experts, who opined that the AHRQ report wasn't all that it was cracked up to be. Still, others dubbed the report a distressing instance in which nonimaging experts have outright failed to understand how the breast cancer care system works.
No new news
"Just to show you the lack of the splash it made in the media, if you look in the (February 14) Wall Street Journal, there's a tiny article buried in the back," pointed out medical malpractice expert Dr. Leonard Berlin, chairman of radiology at Rush North Shore Medical Center in Skokie, IL.
"Frankly, I don't even know the purpose of (the report); to expect that someone is going to come up with a modality to replace biopsy? Nothing is on the horizon to replace biopsy," Berlin added. "I call this a ho hum. It gives you some data on MRI and ultrasound and so forth, but nothing that we don't really know already."
This "preaching to the choir" aspect of the report is one major reason that it didn't pack a punch. Dr. Bruce Porter, medical director of First Hill Diagnostic Imaging in Seattle, told AuntMinnie.com that he didn't necessarily have a problem with the report because it reiterated what breast imagers already know about the value of adjunct imaging: that these modalities cannot necessarily be used to avoid biopsies in women with mammographic abnormalities.
"MR is, by its nature, an adjunctive method to the key screening exam for breast cancer, which is mammography. I do not see any of these exams as adequate or appropriate for screening average-risk patients. The cost, complexity, false positives, and consumption of resources are currently just too great to support that," Porter wrote in an e-mail.
In his practice, Porter stated that he does not use alternative imaging to preclude biopsy if the mammography or ultrasound findings indicate concern for malignancy. Instead, these modalities -- and MR in particular -- are at their best when offering additional information during work-up.
"We contribute significant and important information on occult contralateral tumors, multicentric disease, improved preoperative planning, monitoring neoadjuvant chemotherapy, etc.," he said. "But in the screening arena, (MRI) is appropriately still adjunctive to mammography for the high-risk patients. Of the modalities listed (in the report), MR is the most rapidly improving. Higher resolution and computer-aided detection will further that progress, but I still doubt it will get to the ≤ 2% threshold."
Fundamental misunderstanding
While the report may not have made the top stories on the evening news, it did raise some serious concerns and questions amongst mammographers as to the potential fallout for patients and payors. Specifically, they charge that the AHRQ report committee demonstrated a serious lack of understanding of the stages of breast cancer screening.
Dr. Daniel Kopans, director of breast imaging at Massachusetts General Hospital in Boston and a professor of radiology at Harvard Medical School, deemed the report confusing, misleading, and inappropriate. In his estimation, the authors failed to comprehend even the basics of breast cancer evaluation, let alone the value of more sophisticated imaging techniques.
In the executive summary, "they state 'As a screening test, mammography is used to rule out cancer.' This is exactly what mammography cannot do," Kopans wrote in an e-mail. "It is dangerously misleading to suggest that mammography is used to 'rule out cancer,' and it is dangerously misleading for these authors to suggest that diagnostic imaging should be replaced by biopsy for all 'suspicious' lesions."
Kopans took particular issue with the wording used in the report, most notably the way the terms "suspicious" and "diagnostic" were used in the report. Kopans stated that the AHRQ suggestion that all "suspicious" findings should undergo biopsy was unreasonable.
Twenty-five percent of women who are recalled because of a suspicious screening mammogram turn out to having nothing more than "superimposed normal tissue." "Do (the AHRQ) authors propose that we biopsy something that doesn't exist?" Kopans asked. Click here to read Kopans' complete commentary.
Dr. Wendie Berg, Ph.D., offered a similar criticism. Berg is the lead investigator for the American College of Radiology Imaging Network trial (ACRIN 6666), which is the study of screening breast ultrasound in high-risk women.
"The basic problem with the report is that the process of how breast findings are first determined to be suspicious has been overlooked," Berg told AuntMinnie.com in an e-mail. "It would be inappropriate to proceed straight to biopsy for every possible abnormality seen on screening. Ultrasound plays a critical role in evaluating abnormalities noted on screening mammography and in evaluating palpable masses."
Berg helped author the official ACR response to the report, which can be accessed here. One major complaint is that the report shortchanges the valuable role that ultrasound plays in follow-up breast imaging.
In response to the charges leveled by the ACR, Migdail told AuntMinnie.com:
"This report addressed whether there is a non-invasive imaging test that could reliably preclude biopsy in women with 20% risk (i.e. women who have an average risk of cancer of those going to biopsy currently)," she wrote. "Contextually, this report is focused on the care of the woman once the mammographic work has been completed so that the patient has a BI-RADS score other than 0 (i.e., focusing on the BI-RADS 4-5 population, where the current recommendation is biopsy). This report does not address the use of ultrasound in the BI-RADS 0 case, or use of one of the tests to look for multifocal lesions or localizing lesions for biopsy, etc."
Legal ramifications
Whether the report does bring about a drastic change in the way patients and payors approach breast imaging remains to be seen. But mammographers can take some comfort in the notion that there is one place where the AHRQ report won't be likely to make a huge impact -- the courtroom.
According to Berlin, the outcome of a malpractice case depends on the players involved, with the testimony of a single expert witness carrying more weight than any number of reports or studies.
"The problem with the civil justice that we have today is that in a malpractice case most judges will allow one expert witness on either side. If you look at breast cancer and mammography malpractice lawsuits, that's what it is. It hasn't been changed by this (report). It has neither alleviated nor magnified the (legal situation)," Berlin stated.
By Shalmali Pal
AuntMinnie.com staff writer
February 27, 2006
Related Reading
New report slams breast imaging as flawed compared to biopsy, February 9, 2006
Breast imaging expert accuses major journals of bias against mammo, July 20, 2005
Benefit of breast cancer screening small - study, July 20, 2005
U.K. group accuses breast cancer screening advocates of disinformation, July 11, 2003
ACR blasts PDQ decision, January 28, 2002
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