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Presidential Operations
796
Letters
with breast cancer. Not that there is anything wrong with that, if you step back to consider that the radiation oncologist will collect $15,000 to 25,000 for their treatment (for whole breast) while the average surgeon is paid under $1,300 by Medicare for a consultation, lumpectomy, and sentinel lymph node biopsy. I think it is imperative that the Journal and its editors demand this type of cost analysis from authors, especially when they are serving as an august panel reviewing a new procedure or treatment, and particularly in this case where some authors have clear conflicts of interest because of their consultant relationships with industry. Costs may not have been important enough to discuss when Fischer and colleagues reported on NSABP-B06 in 1985,2 but they are today.
J Am Coll Surg
for Radiation Oncology (ASTRO). Int J Radiat Oncol Biol Phys 2009;74:987–1001. 2. Suh WW, Pierce LJ, Vicini FA, et al. A cost comparison analysis of partial versus whole-breast irradiation after breast-conserving surgery for early-stage breast cancer. Int J Radiat Oncol Biol Phys 2005;62:790–796. 3. Konski AA. Will partial breast irradiation be a cost-effective alternative to whole breast irradiation in the treatment of early-stage breast cancer? Commun Oncol 2004;1:93–97.
Presidential Operations Kevin R Loughlin, MD, MBA Boston, MA
We agree with Dr Alvarez regarding the importance of cost analyses in the evaluation of new medical technologies including accelerated partial breast irradiation (APBI). However, this consensus statement was intended to address clinical indications for APBI; a cost analysis was beyond its scope as authorized by the American Society for Radiation Oncology (ASTRO).1 To our knowledge, two prior studies have reported cost-comparison analyses of APBI versus whole breast irradiation (WBI).2,3 However, it should be noted that reimbursement has significantly changed since the publication of these studies; reimbursement continues to change; and rates of reimbursement vary substantially between the different APBI and WBI techniques. This combination makes the appropriate presentation of a comprehensive cost analysis challenging and its accuracy short lived.
I read with interest the article by James Wiedeman.1 When one considers that in addition to the seven presidents who underwent surgery, Woodrow Wilson had a significant stroke and several other presidents had serious medical issues, a compelling argument can be made for a review panel to monitor a president’s overall health status. The Presidential Succession Act of 1947 was a response to President Franklin D Roosevelt’s death in 1945 and the 25th Amendment was a reaction to President Dwight D Eisenhower’s heart attack in 1955 and President John F Kennedy’s assassination in 1963.2 However there is currently no provision to monitor the ongoing health of a president. Several recent presidential contenders have had significant health issues including Paul Tsongas’ lymphoma, Bill Bradley’s atrial fibrillation, Joe Biden’s cerebral aneurysm repairs, and John McCain’s melanoma. The election of any one of these candidates as president would have presented a significant risk of a serious health impairment during their presidential term of office. The dilemma has been to balance the individual president’s privacy with the public’s right to know. One option would be to have a non-partisan panel composed of civilians and appropriate medical specialists to periodically monitor the president’s health. They could provide an objectivity that the president’s personal physician might not. A presidential health panel could report to Congress only significant findings that might potentially impact a president’s health. There are certainly lay persons and physicians without any political agendas who could provide such an objective evaluation. Such a panel would eliminate rumor and innuendo about a president’s health and provide the balance between personal privacy and public disclosure.
REFERENCES
REFERENCES
1. Smith BD, Arthur DW, Buchholz TA, et al. Accelerated partial breast irradiation consensus statement from the American Society
1. Wiedeman JE. Presidential operations: medical fact or urban legend? J Am Coll Surg 2009;208:1132–1137.
REFERENCES 1. Smith BD, Arthur DW, Buchholz TA, et al. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). J Am Coll Surg 2009;209: 269–277. 2. Fisher B, Bauer M, Margolese R, et al. Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Eng J Med 1985;312:665–673.
Reply Benjamin D Smith, MD, on behalf of the coauthors of the Consensus Statement Lackland AFB, TX
Vol. 209, No. 6, December 2009
2. Annas GI. The health of the president and presidential candidates-the public’s right to know. N Engl J Med 1995; 333:945–949.
Association of Routine Pretreatment Magnetic Resonance Imaging with Time to Surgery, Mastectomy Rate, and Margin Status Alan B Hollingsworth, MD, FACS Oklahoma City, OK While the title of this paper, “Association of Routine Pretreatment Magnetic Resonance Imaging with Time to Surgery, Mastectomy Rate, and Margin Status,”1 includes the word “routine,” preoperative breast MRI was selective, not routine. Of 577 patients studied, only 130 underwent preoperative MRI, with final surgical procedure unknown in 43 of 130 (33%), possibly introducing selection bias common to similar studies wherein the very reason for ordering MRI is often a risk factor for local recurrence (eg, young age). Thus, equivalent outcomes can mask an MRI benefit. For retrospective studies, “routine” involves consecutive cases wherein the strength is the loss of selection bias, while a weakness emerges through the lack of a synchronous control group. Our series of 603 consecutive preoperative breast MRIs,2 with final surgery status known in 99.3%, was referenced by the authors. Although we did not report a control group to accompany our low re-excision rate after MRI (8.8%), we did present historical controls for our breast conservation rate. In contrast to the present study and that of the Mayo Clinic,3 our conservation rate increased abruptly after the launch of our preoperative MRI program, from 48% to 60%, with an unexpected 70% conservation rate in women with false-positive MRIs. As for prolonging time to treatment, with breast-dedicated MRI housed in our mammography center, the MRI work-up is completed prior to the surgeon’s first open date. While nearly all current preoperative MRI publications are retrospective, we can anticipate inherent biases and controversies in prospective, randomized trials as well. The COMICE trial in the UK has a prospective design wherein biopsy-proven breast cancer patients, “who are scheduled for wide local excision,” are then randomized to preoperative MRI or no MRI.4 Thus, by introducing MRI midalgorithm, there is a predetermined unidirectional path— from conservation to mastectomy—rendering it impossible to identify conversion from mastectomy to lumpectomy, the more powerful vector in our series. While the lure of em-
Letters
797
piricism draws us like moths to the light (or fire) of p values, in practice, we still rely heavily on integrated rationalism based on available data, sharply distinguished from empiricism only in freshman philosophy class. For example, we use pure rationalism when we insist upon preoperative mammography in patients with palpable cancers not yet studied by x-ray. Where is the support for this practice? Preoperative mammograms were not part of the NSABP B-06 protocol or other historical trials, entry being based on physical examination alone. It would be difficult to demonstrate improved clinical outcomes, especially survival, through the use of preoperative mammograms. Yet, our rationalism told us it could be helpful to have a map before we operate on patients, so preoperative mammography became a standard of care without supportive p values. Users of preoperative MRI are simply extending that same rationale by noting that MRI has at least twice the sensitivity of mammography’s 40%,5 while critics charge that cancers discovered by MRI are “subclinical.”6 MRI is a clinical tool, as is all radiologic staging, and if we cannot figure out how to improve outcomes with vastly superior sensitivity, it is probably an indictment of our methodology rather than the technology.
REFERENCES 1. Bleicher RJ, Ciocca RM, Egleston BL, et al. Association of routine pretreatment magnetic resonance imaging with time to surgery, mastectomy rate, and margin status. J Am Coll Surg 2009; 209:180–187. 2. Hollingsworth AB, Stough RG, O’Dell CA, Brekke CE. Breast magnetic resonance imaging for preoperative locoregional staging. Am J Surg 2008;196:389–397. 3. Katipamula R, Hoskin TL, Boughey JC, et al. Trends in mastectomy rates at the Mayo Clinic Rochester: effect of surgical year and preoperative MRI. J Clin Oncol 2008;26:9S. 4. Turnbull LW, Barker S, Liney GP. Comparative effectiveness of magnetic resonance imaging in breast cancer (COMICE trial). Breast Cancer Res 2002;4(Suppl 1):39. 5. Sardanelli F, Podo F. Breast MR imaging in women at high-risk of breast cancer. Is something changing in early breast cancer detection? Eur Radiol 2007;17:873–887. 6. Morrow M. Magnetic resonance imaging in the breast cancer patient: curb your enthusiasm. J Clin Oncol 2008;26:352–353.
Reply Richard J Bleicher, MD, FACS Philadelphia, PA Monica Morrow, MD, FACS New York, NY
Letters
with breast cancer. Not that there is anything wrong with that, if you step back to consider that the radiation oncologist will collect $15,000 to 25,000 for their treatment (for whole breast) while the average surgeon is paid under $1,300 by Medicare for a consultation, lumpectomy, and sentinel lymph node biopsy. I think it is imperative that the Journal and its editors demand this type of cost analysis from authors, especially when they are serving as an august panel reviewing a new procedure or treatment, and particularly in this case where some authors have clear conflicts of interest because of their consultant relationships with industry. Costs may not have been important enough to discuss when Fischer and colleagues reported on NSABP-B06 in 1985,2 but they are today.
J Am Coll Surg
for Radiation Oncology (ASTRO). Int J Radiat Oncol Biol Phys 2009;74:987–1001. 2. Suh WW, Pierce LJ, Vicini FA, et al. A cost comparison analysis of partial versus whole-breast irradiation after breast-conserving surgery for early-stage breast cancer. Int J Radiat Oncol Biol Phys 2005;62:790–796. 3. Konski AA. Will partial breast irradiation be a cost-effective alternative to whole breast irradiation in the treatment of early-stage breast cancer? Commun Oncol 2004;1:93–97.
Presidential Operations Kevin R Loughlin, MD, MBA Boston, MA
We agree with Dr Alvarez regarding the importance of cost analyses in the evaluation of new medical technologies including accelerated partial breast irradiation (APBI). However, this consensus statement was intended to address clinical indications for APBI; a cost analysis was beyond its scope as authorized by the American Society for Radiation Oncology (ASTRO).1 To our knowledge, two prior studies have reported cost-comparison analyses of APBI versus whole breast irradiation (WBI).2,3 However, it should be noted that reimbursement has significantly changed since the publication of these studies; reimbursement continues to change; and rates of reimbursement vary substantially between the different APBI and WBI techniques. This combination makes the appropriate presentation of a comprehensive cost analysis challenging and its accuracy short lived.
I read with interest the article by James Wiedeman.1 When one considers that in addition to the seven presidents who underwent surgery, Woodrow Wilson had a significant stroke and several other presidents had serious medical issues, a compelling argument can be made for a review panel to monitor a president’s overall health status. The Presidential Succession Act of 1947 was a response to President Franklin D Roosevelt’s death in 1945 and the 25th Amendment was a reaction to President Dwight D Eisenhower’s heart attack in 1955 and President John F Kennedy’s assassination in 1963.2 However there is currently no provision to monitor the ongoing health of a president. Several recent presidential contenders have had significant health issues including Paul Tsongas’ lymphoma, Bill Bradley’s atrial fibrillation, Joe Biden’s cerebral aneurysm repairs, and John McCain’s melanoma. The election of any one of these candidates as president would have presented a significant risk of a serious health impairment during their presidential term of office. The dilemma has been to balance the individual president’s privacy with the public’s right to know. One option would be to have a non-partisan panel composed of civilians and appropriate medical specialists to periodically monitor the president’s health. They could provide an objectivity that the president’s personal physician might not. A presidential health panel could report to Congress only significant findings that might potentially impact a president’s health. There are certainly lay persons and physicians without any political agendas who could provide such an objective evaluation. Such a panel would eliminate rumor and innuendo about a president’s health and provide the balance between personal privacy and public disclosure.
REFERENCES
REFERENCES
1. Smith BD, Arthur DW, Buchholz TA, et al. Accelerated partial breast irradiation consensus statement from the American Society
1. Wiedeman JE. Presidential operations: medical fact or urban legend? J Am Coll Surg 2009;208:1132–1137.
REFERENCES 1. Smith BD, Arthur DW, Buchholz TA, et al. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). J Am Coll Surg 2009;209: 269–277. 2. Fisher B, Bauer M, Margolese R, et al. Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Eng J Med 1985;312:665–673.
Reply Benjamin D Smith, MD, on behalf of the coauthors of the Consensus Statement Lackland AFB, TX
Vol. 209, No. 6, December 2009
2. Annas GI. The health of the president and presidential candidates-the public’s right to know. N Engl J Med 1995; 333:945–949.
Association of Routine Pretreatment Magnetic Resonance Imaging with Time to Surgery, Mastectomy Rate, and Margin Status Alan B Hollingsworth, MD, FACS Oklahoma City, OK While the title of this paper, “Association of Routine Pretreatment Magnetic Resonance Imaging with Time to Surgery, Mastectomy Rate, and Margin Status,”1 includes the word “routine,” preoperative breast MRI was selective, not routine. Of 577 patients studied, only 130 underwent preoperative MRI, with final surgical procedure unknown in 43 of 130 (33%), possibly introducing selection bias common to similar studies wherein the very reason for ordering MRI is often a risk factor for local recurrence (eg, young age). Thus, equivalent outcomes can mask an MRI benefit. For retrospective studies, “routine” involves consecutive cases wherein the strength is the loss of selection bias, while a weakness emerges through the lack of a synchronous control group. Our series of 603 consecutive preoperative breast MRIs,2 with final surgery status known in 99.3%, was referenced by the authors. Although we did not report a control group to accompany our low re-excision rate after MRI (8.8%), we did present historical controls for our breast conservation rate. In contrast to the present study and that of the Mayo Clinic,3 our conservation rate increased abruptly after the launch of our preoperative MRI program, from 48% to 60%, with an unexpected 70% conservation rate in women with false-positive MRIs. As for prolonging time to treatment, with breast-dedicated MRI housed in our mammography center, the MRI work-up is completed prior to the surgeon’s first open date. While nearly all current preoperative MRI publications are retrospective, we can anticipate inherent biases and controversies in prospective, randomized trials as well. The COMICE trial in the UK has a prospective design wherein biopsy-proven breast cancer patients, “who are scheduled for wide local excision,” are then randomized to preoperative MRI or no MRI.4 Thus, by introducing MRI midalgorithm, there is a predetermined unidirectional path— from conservation to mastectomy—rendering it impossible to identify conversion from mastectomy to lumpectomy, the more powerful vector in our series. While the lure of em-
Letters
797
piricism draws us like moths to the light (or fire) of p values, in practice, we still rely heavily on integrated rationalism based on available data, sharply distinguished from empiricism only in freshman philosophy class. For example, we use pure rationalism when we insist upon preoperative mammography in patients with palpable cancers not yet studied by x-ray. Where is the support for this practice? Preoperative mammograms were not part of the NSABP B-06 protocol or other historical trials, entry being based on physical examination alone. It would be difficult to demonstrate improved clinical outcomes, especially survival, through the use of preoperative mammograms. Yet, our rationalism told us it could be helpful to have a map before we operate on patients, so preoperative mammography became a standard of care without supportive p values. Users of preoperative MRI are simply extending that same rationale by noting that MRI has at least twice the sensitivity of mammography’s 40%,5 while critics charge that cancers discovered by MRI are “subclinical.”6 MRI is a clinical tool, as is all radiologic staging, and if we cannot figure out how to improve outcomes with vastly superior sensitivity, it is probably an indictment of our methodology rather than the technology.
REFERENCES 1. Bleicher RJ, Ciocca RM, Egleston BL, et al. Association of routine pretreatment magnetic resonance imaging with time to surgery, mastectomy rate, and margin status. J Am Coll Surg 2009; 209:180–187. 2. Hollingsworth AB, Stough RG, O’Dell CA, Brekke CE. Breast magnetic resonance imaging for preoperative locoregional staging. Am J Surg 2008;196:389–397. 3. Katipamula R, Hoskin TL, Boughey JC, et al. Trends in mastectomy rates at the Mayo Clinic Rochester: effect of surgical year and preoperative MRI. J Clin Oncol 2008;26:9S. 4. Turnbull LW, Barker S, Liney GP. Comparative effectiveness of magnetic resonance imaging in breast cancer (COMICE trial). Breast Cancer Res 2002;4(Suppl 1):39. 5. Sardanelli F, Podo F. Breast MR imaging in women at high-risk of breast cancer. Is something changing in early breast cancer detection? Eur Radiol 2007;17:873–887. 6. Morrow M. Magnetic resonance imaging in the breast cancer patient: curb your enthusiasm. J Clin Oncol 2008;26:352–353.
Reply Richard J Bleicher, MD, FACS Philadelphia, PA Monica Morrow, MD, FACS New York, NY