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The System Does Work Marcela Bo¨hm-Ve´lez, MD At a time when physicians are often accused of charging high fees, and many malpractice attorneys are all too eager to exploit cases of dubious merit, radiology can ill afford to stand by while unsubstantiated claims are broadcast on the radio, on the Internet, and in newspapers. Fortunately, as I shall review, our specialty societies are on the job, making every effort to protect a largely unsuspecting public. AmeriScan is an Arizona-based company offering whole-body scans and magnetic resonance imaging (MRI) breast screening. Until recently it was open for business in 11 states, including an office in King of Prussia, Pennsylvania. Review of their website (http:// www.ameriscan.org/breastscreen. asp) illustrates AmeriScan’s misleading representation of MRI for breast screening. The following quotations, each of which I proceed to critique, are taken directly, as written, from AmeriScan’s advertising.
do report high MRI sensitivities (in the range of 90% or higher) for identifying cancer, are in women with already palpable masses or suspicious findings on mammograms [2]. It is also noteworthy that the variable specificity of breast MRI, ranging from 21% to 100%, results in a high rate of false positives. Therefore, screening MRI actually has the potential to trigger many more unnecessary biopsies and create added patient anxiety and expense. Preliminary studies comparing MRI and mammography, so far, include relatively small numbers of patients who are actually in the high-risk category for developing breast cancer [3,4]. Although MRI certainly has a growing role in breast imaging, no research study, to date, supports its use in screening either the general population or high-risk patients [5– 8]. The fact that breast MRI is expensive and not easily available further diminishes its role as an adequate screening method.
“The most advanced screening for breast screening available in the world. Without radiation or painful breast compression, the MRI BreastScreen is 3 times more powerful than a mammogram and provides near 100% accuracy in breast cancer detection, which means no more unnecessary biopsies and no more missed diagnosis. You deserve better protection than a mammogram.”
“AmeriScan’s revolutionary MRI BreastScreen is so powerful that no woman should suffer or die from this terrible disease.”
On the contrary, and in fact, there are numerous studies in the literature demonstrating the sensitivity and specificity of mammography, as well as the reduction in mortality to be gained from the use of screening mammography [1]. The studies that 438
Breast MRI screening has not been shown to improve survival. Advertising these inaccurate statements may potentially be psychologically and physically harmful to the public. The implication that mammography is worthless may cause women to forego this well-accepted study in order to pursue the AmeriScan’s MRI screening services. “AmeriScan uses FDA approved MRI technology.” In reality, the MRI devices used by AmeriScan have received clear-
ance through the US Food and Drug Administration’s 510(k) process only to the degree that they meet the general technical efficacy claims of MRI technology to provide imaging and/or spectroscopic information. No MRI device presently on the market can claim specific efficacy in breast cancer detection. Dr. Craig Bittner, the entrepreneur and medical director of AmeriScan, is a radiologist who trained at Stanford University and later with Dr. Werner Kaiser in Germany. In Pennsylvania, AmeriScan charges $1695 for MRI breast screening, and in California, it charges $2200. AmeriScan does not require that patients have had prior mammograms, because, as per its receptionist, MRI shows so much more than mammograms and is 97% accurate. During the past year various radiology trade magazines, society newsletters, and the lay press have focused on this issue [9 –11]. The Pennsylvania Radiological Society (PRS) also became concerned with some of the claims being made by AmeriScan and decided to give priority to the topic of MRI breast screening. The PRS then discussed its options with counsel and the ACR’s attorneys. It was decided to request opinions regarding the efficacy of breast MRI screening from Drs. Mitchell Schnall, Catherine Piccoli, and William Poller. On February 14, 2003, a letter was written by the PRS’s attorney to Dr. Craig Bittner expressing its alarm regarding AmeriScan’s misleading advertisements and website information. It
© 2004 American College of Radiology 0091-2182/04/$30.00 ● DOI 10.1016/j.jacr.2004.01.028
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was requested that AmeriScan immediately cease and desist from making statements about MRI as a breast screen. In their letters, Drs. Schnall, Piccoli, and Poller cited the current scientific literature and their own academic experience with breast MRI. Dr. Bittner’s reply by e-mail (on February 20) was unsatisfactory because he did not present a scientific basis for AmeriScan’s claims. Dr Catherine W. Piccoli, Director of Breast Imaging Services at Thomas Jefferson University (Philadelphia, Pennsylvania) in her analysis of the letter states: “Dr. Bittner quotes a couple of papers that were based on evaluation of patients who were at high risk for developing malignancy. These were relatively small studies performed by highly experienced radiologists. There is no largescale multi-institutional investigation showing efficacy of breast MRI in the general population, yet it is the general population who is targeted by his advertisements. Dr. Bittner also seems to mix-up the meaning of sensitivity and accuracy. Accuracy is a measure of sensitivity and specificity. In the literature, although most sensitivity values for invasive disease are greater than 90%, specificity has differed markedly among investigators, ranging from 28-97%. With specificities as low as 28%, accuracy will not begin to approach 100%.” She goes on to comment that a good screening test is one that is widely available, sensitive, specific and affordable and questions how Dr. Bittner can expect women to pay nearly $2,000 on a yearly basis for ongoing screening. Mitchell Schnall, M.D., Ph.D., Professor of Radiology at the University of Pennsylvania, who has headed multi-institutional clinical trials funded through the National Cancer Institute including several MRI
trials concluded that the small pilot studies which Dr. Bittner cited were biased, since they were in high risk populations and in patients whose cancer had already been detected in a screening mammogram prior to entering the study. In addition, Dr. Bittner’s letter did not address MRI’s limitation in detecting DCIS, which is the earliest and most curable form of breast cancer and presumably the type of cancer a screening test should detect. In fact studies have shown that MRI can miss up to 60% of DCIS cases. On February 21, Dr. Stephen Amis, chair of the ACR, also wrote Dr. Bittner a letter urging that he refrain from using erroneous advertising about MRI breast screening, because it would lead some women to forgo screening mammography and almost certainly result in cases in which diagnoses were missed. He also requested that AmeriScan substantiate its claims with scientific proof. On March 20, the PRS followed with a second letter to Dr. Bittner. At that time, the PRS had also considered contacting the media but deferred in case this action might unintentionally result in free publicity for AmeriScan, because it was believed that even unfavorable attention might benefit them. Further, there was no guarantee that the media would correctly interpret this complex medical issue. Later, a conference call with the ACR was discouraging, because it indicated that at that time, it was not prepared to become more involved. Considering that just approaching our state regulators would require a substantial amount of legal work and might be an isolated action, it was decided that a late resolution should be introduced by the PRS to the ACR Council as a means to open discussion at the national meeting in May of 2003. The resolution, entitled “Claims
Regarding Screening Magnetic Resonance Imaging of the Breast,” requested that the ACR assist its state chapters in taking appropriate action, in conjunction with individual state authorities. Financial assistance was also requested, in an amount determined appropriate by the ACR’s Board of Chancellors. With support from the California and Illinois delegations, as well as the Society of Breast Imaging, the resolution was passed during the ACR meeting. On August 20, 2003, the ACR proceeded to register a complaint with the Federal Trade Commission (FTC) accusing AmeriScan of false advertising in promoting MRI as the superior screening tool. The ACR’s official position is that MRI is not ready for mass screening, and it continues to support mammography as the “most useful and best demonstrated screening modality for the detection of breast cancer available to patients today.” In essence, this reiterated the ACR’s public position of December 2002, when some major newspapers had criticized mammography as a screening technique for breast cancer and the ACR published a strong statement in support of mammography [11]. On September 8, the FTC acknowledged receipt of the ACR’s complaint that claims for the effectiveness of MRI for breast cancer screening raised important health-related issues. Also, the San Francisco District Attorney’s Office and the Medical Board of California have filed suit against Dr. Craig Bittner and AmeriScan. The joint civil lawsuit seeks an injunction to stop the defendants from making claims about MRI breast screening without scientific proof and to impose civil penalties. In the past year, all AmeriScan offices have closed. In a letter to his
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patients, Dr. Bittner accuses the medical establishment of not giving MRI breast screening fair consideration. He portrays himself as a medical crusader for scientific progress, and against the “status quo.” Similarly, the Wall Street Journal reported that other wholebody screening centers were closing throughout the country. It was speculated that these businesses were spending too much on advertising and legal advice. It seems that as long as some find it difficult to reconcile scientific accuracy with their personal commercial interests, the rest of us will have to assume the cost and legal consequences of trying to police medicine [12]. Situations such as this serve to remind us why providing ongoing support to our professional organizations is so relevant. Active participation at all levels by all physicians is therefore essential
in the important effort to apply medical knowledge responsibly. REFERENCES 1. Bird RE, Wallaie TW, Yankaskas BC. Analysis of cancers missed at screening mammography. Radiology 1992;184(3):613-7. 2. Kuhl CK, Schmutzler RK, Leutner CC, et al. Breast MR imaging screening in 192 women proved or suspected to be carriers of a breast cancer susceptibility gene: preliminary results. Radiology 2000;215:267-79. 3. Stoutjesdijk MJ, Boetes C, Jager GJ, et al. Magnetic resonance imaging and mammography in women with a hereditary risk of breast cancer. J Natl Cancer Inst 2001;93: 1095-102. 4. Tilanus-Linthorst MM, Obdeijn IM, Bartels KC, et al. First experiences in screening women at high risk for breast cancer with MR imaging. Breast Cancer Res Treat 2000; 63:53-60. 5. Warner E, Plewes DB, Shumak RS, et al. Comparison of breast magnetic resonance imaging, mammography, and ultrasound for surveillance of women at high risk for hereditary breast cancer. J Clin Oncol 2001; 19:3524-31.
6. Kuhl CK, Schrading S, Leutner CC, et al. Surveillance of “high risk” women with proven or suspected familial (hereditary) breast cancer: first mid-term results of a multi-modality clinical screening trial. Proc Am Soc Clin Oncol 2003;22:2 [abstract]. 7. Rosen M, Lo L, Schnall M, et al. Pilot study of breast MR screening of a high-risk cohort. Radiology 2001;231:430 [abstract]. 8. Morris EA, Liberman L, Ballon DJ, et al. Detection of occult breast carcinoma by MR imaging in a high-risk population. Am J Roentgenol 2003;180(suppl):32 [abstract]. 9. Morris EA, Dershaw DD. MRI screening for breast cancer: is there a rationale? Society of Breast Imaging News. January 2003. 10. Pressing controversy over breast cancer screening. ADVANCE Imaging Radiat Ther Prof. 2003. 11. American College of Radiology letter/complaint to the Federal Trade Commission regarding breast cancer screening and AmeriScan’s advertising claims. August 20, 2003. 12. Mendelson EB, Bittner C. Two views: MRI breast cancer screening. ARRS Memo. August 2003.
Marcela Bo¨ hm-Ve´ lez, MD, Weinstein Imaging Associates, 5850 Centre Avenue, Pittsburgh, PA 15206; e-mail:
[email protected].