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The paclitaxel paradox
As medical editor of Vascular Specialist, it has always been my hope to use our excellent reporters and rapid production schedule to keep readers abreast of the latest news in vascular surgery. While my colleagues at the Journal of Vascular Surgery publish studies that will drive treatment, my goal is to drive discussion.
With topics like burnout, workforce shortages, and electronic medical records, I feel we have been successful. The downside of staying current is we sometimes find ourselves publishing contradictory stories. This has been the case with paclitaxel. Let’s take a break from the fray and review where we are, and where we might go from here.
In 2012, the Zilver PTX became the first drug-eluting stent (DES) to gain Food and Drug Administration approval for the treatment of peripheral vascular disease. Two years later, the FDA approved the Lutonix 035 as the first drug-coated balloon (DCB) for use in the femoral-popliteal arteries. The Lutonix would also gain a second indication for failing dialysis fistulas. Medtronic and Spectranetics received authorizations for their DCBs in 2015 and 2017, respectively.
While the safety of paclitaxel-coated devices in the coronary system had previously been called into question, the drug was generally considered safe and effective in the peripheral arterial system. The controversy began in December 2018, when Katsanos et al.1 published a meta-analysis of 28 randomized, controlled trials (RCTs) investigating paclitaxel-coated devices in the femoral-popliteal arteries. While all-cause patient mortality was similar at 1 year between paclitaxel-coated devices and controls (2.3% in each), at 2 years the risk of death was significantly higher in those treated with paclitaxel (7.2% vs. 3.8%). The 5-year data were available for three trials where there was a continued significantly increased risk of mortality with paclitaxel (14.7% vs. 8.1%).
Opposition to these findings was prompt from both physicians and industry. Weaknesses of the analysis, both perceived and real, were hammered. The meta-analysis did not include individual patient data, and the actual cause of death was unknown in most of the included trials. The study was not adequately powered to eliminate the risk of type 1 error when comparing mortality after 2 years. Individuals assigned to the control group may have received paclitaxel treatment at some point in their follow-up. The DCB and DES treatment groups were combined. The methods employed by the authors, however, stood up reasonably well to scrutiny.
On Jan. 17, 2019, the FDA issued their first response stating, “the FDA believes that the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use.”2
Later that month, Peter Schneider, MD, and associates published a patient-level meta-analysis in the Journal of the American College of Cardiology.3 The study included 1,980 patients and found no statistically significant difference in all-cause mortality between DCB (9.3%) and percutaneous transluminal angioplasty (PTA) (11.2%) through 5 years. Shortly after that, however, a correction was issued.
On Feb. 15, 2019, Medtronic reported an error in the 2- and 3-year follow-up periods for the IN.PACT Global postmarket study. The company stated, “Due to a programming error, mortality data were inadvertently omitted from the summary tables included in the statistical analysis.” The mortality in the DCB cohort was corrected from 9.30% to 15.12%. The authors stated that this new mortality rate was still not significantly higher than the PTA group (P = .09).4
Less than 1 week later, another device company issued a correction. And once again, the error had been made in favor of the paclitaxel-treated group. In 2016, the 5-year data from Cook Medical’s Zilver PTX trial were published in Circulation. The study reported a mortality of 10.2% in the DES group and 16.9% in the PTA cohort. Regrettably, these numbers were reversed and significantly higher in the paclitaxel-treated group (16.9% vs. 10.2%, P = .03).5
On Feb. 12, 2019, another response to the Katsanos meta-analysis was published in JAMA Cardiology.6 In this study, Secemsky et al. analyzed patient-level data from a Medicare database. The authors reported finding no evidence of paclitaxel- related deaths in 16,560 patients. Unfortunately, the mean follow-up time was only 389 days, which may have been insufficient to detect the late mortality reported in the Katsanos meta-analysis.
On March 15, 2019, the FDA issued a second statement, this time with a much stronger tone.7 The agency reported an ongoing analysis of the long-term survival data from the pivotal randomized trials. In the three studies with 5-year data available, each showed a significantly higher mortality in the paclitaxel group.
When pooled, there were 975 patients, and the risk of death was 20.1% in the paclitaxel group versus 13.4 % in the controls. The FDA recommended discussing the increased risk of mortality with all patients receiving paclitaxel therapy as part of the informed consent process. They also stated that for most patients alternative options should generally be used until additional analysis of the mortality risk is performed.
Industry bristled at this new, strongly worded statement. Becton Dickinson, makers of the Lutonix balloon, asserted that the FDA recommendation was based on “a limited review of data from less than 1,000 patients.”8 The company noted that its LEVANT 2 trial did not see a signal of increased mortality at 5 years. Although they did acknowledge that, among the randomized patients, there was a significantly higher mortality at 5 years for those treated with paclitaxel.
How do we make sense of this? Pac-litaxel is a cytotoxic drug. Its pharmacokinetics vary significantly based on the preparation and administration. The FDA label for the injectable form (Taxol) warns of anaphylaxis and severe hypersensitivity reactions, but there is no mention of long-term mortality. In the coronary vessels, paclitaxel-coated devices have been associated with myocardial infarction and death. Obviously it is easy to comprehend how local vessel effects in the coronary system can lead to increased mortality. The pathway is less clear with femoral-popliteal interventions. If the association of paclitaxel with death is truly causation there must be some systemic effects. The dose delivered with femoral- popliteal interventions is much higher than that seen with coronary devices.
The mortality may be associated with the platform used or even the formulation (crystalline formularies have a longer half-life). Could it be something more benign? Paclitaxel-treated patients see less recurrence of their femoral-popliteal disease. Are the control group patients with more recurrences seeing their interventionalist more often and therefore receiving more frequent reminders to comply with medical therapy?
At this point, we have few answers. After an all-day town hall at the recent Cardiovascular Research Technologies conference,9 one moderator said, “I came in with uncertainty and now I’m going away with uncertainty, but we made tremendous progress.” His comoderator added, “I know I don’t know.” Well then, glad we cleared that up!
In any event, changes are coming. The BASIL-3 trial has suspended recruitment. Physicians using paclitaxel-coated devices are now advised by the FDA to inform patients of the increased risk of death and to use alternatives in most cases. Therefore, if you employ these devices routinely in the femoral-popliteal vessels you are seemingly doing so in opposition to the recommendations of the FDA. Legal peril may follow.
The time for nitpicking the Katsanos analysis has ended. Our industry partners must be compelled to supply the data and finances needed to settle this issue. The signal seems real and it is time to find answers. Research initiatives are underway through the SVS, the VIVA group, the UK Medicines and Healthcare Products Regulatory Agency, and the FDA.
Going forward, the SVS has formed a Paclitaxel Safety Task Force under the leadership of President-elect Kim Hodgson. Their mission is to facilitate the performance and interpretation of an Individual Patient Data meta-analysis using patient-level RCT data from industry partners. The task force states: “We remain troubled by the recent reports of reanalysis of existing datasets, pooled analyses of RCTs, and other ‘series’, as we believe that the findings of these statistically inferior analyses bring no additional clarity, cannot be relied upon for guidance, and distract us from the analysis that needs to be performed.”
References
1. J Am Heart Assoc. 2018 Dec 18;7(24):e011245.
2. www.fda.gov/medicaldevices/safety/letterstohealthcareproviders/ucm629589.htm.
3. J Am Coll Cardiol. Jan 2019. doi: 10.1016/j.jacc.2019.01.013.
4. Circulation. 2019;139:e42.
5. https://evtoday.com/2019/02/20/zilver-ptx-trial-5-year-mortality-data-corrected-in-circulation.
6. JAMA Cardiol. 2019 Feb 12. doi:10.1001/jamacardio.2019.0325.
7. www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm633614.htm.
8. www.med-technews.com/news/bud-defends-safety-of-drug-coated-device-following-fda-warnin/.
9. www.crtonline.org/news-detail/paclitaxel-device-safety-thoroughly-discussed-at-c.
As medical editor of Vascular Specialist, it has always been my hope to use our excellent reporters and rapid production schedule to keep readers abreast of the latest news in vascular surgery. While my colleagues at the Journal of Vascular Surgery publish studies that will drive treatment, my goal is to drive discussion.
With topics like burnout, workforce shortages, and electronic medical records, I feel we have been successful. The downside of staying current is we sometimes find ourselves publishing contradictory stories. This has been the case with paclitaxel. Let’s take a break from the fray and review where we are, and where we might go from here.
In 2012, the Zilver PTX became the first drug-eluting stent (DES) to gain Food and Drug Administration approval for the treatment of peripheral vascular disease. Two years later, the FDA approved the Lutonix 035 as the first drug-coated balloon (DCB) for use in the femoral-popliteal arteries. The Lutonix would also gain a second indication for failing dialysis fistulas. Medtronic and Spectranetics received authorizations for their DCBs in 2015 and 2017, respectively.
While the safety of paclitaxel-coated devices in the coronary system had previously been called into question, the drug was generally considered safe and effective in the peripheral arterial system. The controversy began in December 2018, when Katsanos et al.1 published a meta-analysis of 28 randomized, controlled trials (RCTs) investigating paclitaxel-coated devices in the femoral-popliteal arteries. While all-cause patient mortality was similar at 1 year between paclitaxel-coated devices and controls (2.3% in each), at 2 years the risk of death was significantly higher in those treated with paclitaxel (7.2% vs. 3.8%). The 5-year data were available for three trials where there was a continued significantly increased risk of mortality with paclitaxel (14.7% vs. 8.1%).
Opposition to these findings was prompt from both physicians and industry. Weaknesses of the analysis, both perceived and real, were hammered. The meta-analysis did not include individual patient data, and the actual cause of death was unknown in most of the included trials. The study was not adequately powered to eliminate the risk of type 1 error when comparing mortality after 2 years. Individuals assigned to the control group may have received paclitaxel treatment at some point in their follow-up. The DCB and DES treatment groups were combined. The methods employed by the authors, however, stood up reasonably well to scrutiny.
On Jan. 17, 2019, the FDA issued their first response stating, “the FDA believes that the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use.”2
Later that month, Peter Schneider, MD, and associates published a patient-level meta-analysis in the Journal of the American College of Cardiology.3 The study included 1,980 patients and found no statistically significant difference in all-cause mortality between DCB (9.3%) and percutaneous transluminal angioplasty (PTA) (11.2%) through 5 years. Shortly after that, however, a correction was issued.
On Feb. 15, 2019, Medtronic reported an error in the 2- and 3-year follow-up periods for the IN.PACT Global postmarket study. The company stated, “Due to a programming error, mortality data were inadvertently omitted from the summary tables included in the statistical analysis.” The mortality in the DCB cohort was corrected from 9.30% to 15.12%. The authors stated that this new mortality rate was still not significantly higher than the PTA group (P = .09).4
Less than 1 week later, another device company issued a correction. And once again, the error had been made in favor of the paclitaxel-treated group. In 2016, the 5-year data from Cook Medical’s Zilver PTX trial were published in Circulation. The study reported a mortality of 10.2% in the DES group and 16.9% in the PTA cohort. Regrettably, these numbers were reversed and significantly higher in the paclitaxel-treated group (16.9% vs. 10.2%, P = .03).5
On Feb. 12, 2019, another response to the Katsanos meta-analysis was published in JAMA Cardiology.6 In this study, Secemsky et al. analyzed patient-level data from a Medicare database. The authors reported finding no evidence of paclitaxel- related deaths in 16,560 patients. Unfortunately, the mean follow-up time was only 389 days, which may have been insufficient to detect the late mortality reported in the Katsanos meta-analysis.
On March 15, 2019, the FDA issued a second statement, this time with a much stronger tone.7 The agency reported an ongoing analysis of the long-term survival data from the pivotal randomized trials. In the three studies with 5-year data available, each showed a significantly higher mortality in the paclitaxel group.
When pooled, there were 975 patients, and the risk of death was 20.1% in the paclitaxel group versus 13.4 % in the controls. The FDA recommended discussing the increased risk of mortality with all patients receiving paclitaxel therapy as part of the informed consent process. They also stated that for most patients alternative options should generally be used until additional analysis of the mortality risk is performed.
Industry bristled at this new, strongly worded statement. Becton Dickinson, makers of the Lutonix balloon, asserted that the FDA recommendation was based on “a limited review of data from less than 1,000 patients.”8 The company noted that its LEVANT 2 trial did not see a signal of increased mortality at 5 years. Although they did acknowledge that, among the randomized patients, there was a significantly higher mortality at 5 years for those treated with paclitaxel.
How do we make sense of this? Pac-litaxel is a cytotoxic drug. Its pharmacokinetics vary significantly based on the preparation and administration. The FDA label for the injectable form (Taxol) warns of anaphylaxis and severe hypersensitivity reactions, but there is no mention of long-term mortality. In the coronary vessels, paclitaxel-coated devices have been associated with myocardial infarction and death. Obviously it is easy to comprehend how local vessel effects in the coronary system can lead to increased mortality. The pathway is less clear with femoral-popliteal interventions. If the association of paclitaxel with death is truly causation there must be some systemic effects. The dose delivered with femoral- popliteal interventions is much higher than that seen with coronary devices.
The mortality may be associated with the platform used or even the formulation (crystalline formularies have a longer half-life). Could it be something more benign? Paclitaxel-treated patients see less recurrence of their femoral-popliteal disease. Are the control group patients with more recurrences seeing their interventionalist more often and therefore receiving more frequent reminders to comply with medical therapy?
At this point, we have few answers. After an all-day town hall at the recent Cardiovascular Research Technologies conference,9 one moderator said, “I came in with uncertainty and now I’m going away with uncertainty, but we made tremendous progress.” His comoderator added, “I know I don’t know.” Well then, glad we cleared that up!
In any event, changes are coming. The BASIL-3 trial has suspended recruitment. Physicians using paclitaxel-coated devices are now advised by the FDA to inform patients of the increased risk of death and to use alternatives in most cases. Therefore, if you employ these devices routinely in the femoral-popliteal vessels you are seemingly doing so in opposition to the recommendations of the FDA. Legal peril may follow.
The time for nitpicking the Katsanos analysis has ended. Our industry partners must be compelled to supply the data and finances needed to settle this issue. The signal seems real and it is time to find answers. Research initiatives are underway through the SVS, the VIVA group, the UK Medicines and Healthcare Products Regulatory Agency, and the FDA.
Going forward, the SVS has formed a Paclitaxel Safety Task Force under the leadership of President-elect Kim Hodgson. Their mission is to facilitate the performance and interpretation of an Individual Patient Data meta-analysis using patient-level RCT data from industry partners. The task force states: “We remain troubled by the recent reports of reanalysis of existing datasets, pooled analyses of RCTs, and other ‘series’, as we believe that the findings of these statistically inferior analyses bring no additional clarity, cannot be relied upon for guidance, and distract us from the analysis that needs to be performed.”
References
1. J Am Heart Assoc. 2018 Dec 18;7(24):e011245.
2. www.fda.gov/medicaldevices/safety/letterstohealthcareproviders/ucm629589.htm.
3. J Am Coll Cardiol. Jan 2019. doi: 10.1016/j.jacc.2019.01.013.
4. Circulation. 2019;139:e42.
5. https://evtoday.com/2019/02/20/zilver-ptx-trial-5-year-mortality-data-corrected-in-circulation.
6. JAMA Cardiol. 2019 Feb 12. doi:10.1001/jamacardio.2019.0325.
7. www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm633614.htm.
8. www.med-technews.com/news/bud-defends-safety-of-drug-coated-device-following-fda-warnin/.
9. www.crtonline.org/news-detail/paclitaxel-device-safety-thoroughly-discussed-at-c.
As medical editor of Vascular Specialist, it has always been my hope to use our excellent reporters and rapid production schedule to keep readers abreast of the latest news in vascular surgery. While my colleagues at the Journal of Vascular Surgery publish studies that will drive treatment, my goal is to drive discussion.
With topics like burnout, workforce shortages, and electronic medical records, I feel we have been successful. The downside of staying current is we sometimes find ourselves publishing contradictory stories. This has been the case with paclitaxel. Let’s take a break from the fray and review where we are, and where we might go from here.
In 2012, the Zilver PTX became the first drug-eluting stent (DES) to gain Food and Drug Administration approval for the treatment of peripheral vascular disease. Two years later, the FDA approved the Lutonix 035 as the first drug-coated balloon (DCB) for use in the femoral-popliteal arteries. The Lutonix would also gain a second indication for failing dialysis fistulas. Medtronic and Spectranetics received authorizations for their DCBs in 2015 and 2017, respectively.
While the safety of paclitaxel-coated devices in the coronary system had previously been called into question, the drug was generally considered safe and effective in the peripheral arterial system. The controversy began in December 2018, when Katsanos et al.1 published a meta-analysis of 28 randomized, controlled trials (RCTs) investigating paclitaxel-coated devices in the femoral-popliteal arteries. While all-cause patient mortality was similar at 1 year between paclitaxel-coated devices and controls (2.3% in each), at 2 years the risk of death was significantly higher in those treated with paclitaxel (7.2% vs. 3.8%). The 5-year data were available for three trials where there was a continued significantly increased risk of mortality with paclitaxel (14.7% vs. 8.1%).
Opposition to these findings was prompt from both physicians and industry. Weaknesses of the analysis, both perceived and real, were hammered. The meta-analysis did not include individual patient data, and the actual cause of death was unknown in most of the included trials. The study was not adequately powered to eliminate the risk of type 1 error when comparing mortality after 2 years. Individuals assigned to the control group may have received paclitaxel treatment at some point in their follow-up. The DCB and DES treatment groups were combined. The methods employed by the authors, however, stood up reasonably well to scrutiny.
On Jan. 17, 2019, the FDA issued their first response stating, “the FDA believes that the benefits continue to outweigh the risks for approved paclitaxel-coated balloons and paclitaxel-eluting stents when used in accordance with their indications for use.”2
Later that month, Peter Schneider, MD, and associates published a patient-level meta-analysis in the Journal of the American College of Cardiology.3 The study included 1,980 patients and found no statistically significant difference in all-cause mortality between DCB (9.3%) and percutaneous transluminal angioplasty (PTA) (11.2%) through 5 years. Shortly after that, however, a correction was issued.
On Feb. 15, 2019, Medtronic reported an error in the 2- and 3-year follow-up periods for the IN.PACT Global postmarket study. The company stated, “Due to a programming error, mortality data were inadvertently omitted from the summary tables included in the statistical analysis.” The mortality in the DCB cohort was corrected from 9.30% to 15.12%. The authors stated that this new mortality rate was still not significantly higher than the PTA group (P = .09).4
Less than 1 week later, another device company issued a correction. And once again, the error had been made in favor of the paclitaxel-treated group. In 2016, the 5-year data from Cook Medical’s Zilver PTX trial were published in Circulation. The study reported a mortality of 10.2% in the DES group and 16.9% in the PTA cohort. Regrettably, these numbers were reversed and significantly higher in the paclitaxel-treated group (16.9% vs. 10.2%, P = .03).5
On Feb. 12, 2019, another response to the Katsanos meta-analysis was published in JAMA Cardiology.6 In this study, Secemsky et al. analyzed patient-level data from a Medicare database. The authors reported finding no evidence of paclitaxel- related deaths in 16,560 patients. Unfortunately, the mean follow-up time was only 389 days, which may have been insufficient to detect the late mortality reported in the Katsanos meta-analysis.
On March 15, 2019, the FDA issued a second statement, this time with a much stronger tone.7 The agency reported an ongoing analysis of the long-term survival data from the pivotal randomized trials. In the three studies with 5-year data available, each showed a significantly higher mortality in the paclitaxel group.
When pooled, there were 975 patients, and the risk of death was 20.1% in the paclitaxel group versus 13.4 % in the controls. The FDA recommended discussing the increased risk of mortality with all patients receiving paclitaxel therapy as part of the informed consent process. They also stated that for most patients alternative options should generally be used until additional analysis of the mortality risk is performed.
Industry bristled at this new, strongly worded statement. Becton Dickinson, makers of the Lutonix balloon, asserted that the FDA recommendation was based on “a limited review of data from less than 1,000 patients.”8 The company noted that its LEVANT 2 trial did not see a signal of increased mortality at 5 years. Although they did acknowledge that, among the randomized patients, there was a significantly higher mortality at 5 years for those treated with paclitaxel.
How do we make sense of this? Pac-litaxel is a cytotoxic drug. Its pharmacokinetics vary significantly based on the preparation and administration. The FDA label for the injectable form (Taxol) warns of anaphylaxis and severe hypersensitivity reactions, but there is no mention of long-term mortality. In the coronary vessels, paclitaxel-coated devices have been associated with myocardial infarction and death. Obviously it is easy to comprehend how local vessel effects in the coronary system can lead to increased mortality. The pathway is less clear with femoral-popliteal interventions. If the association of paclitaxel with death is truly causation there must be some systemic effects. The dose delivered with femoral- popliteal interventions is much higher than that seen with coronary devices.
The mortality may be associated with the platform used or even the formulation (crystalline formularies have a longer half-life). Could it be something more benign? Paclitaxel-treated patients see less recurrence of their femoral-popliteal disease. Are the control group patients with more recurrences seeing their interventionalist more often and therefore receiving more frequent reminders to comply with medical therapy?
At this point, we have few answers. After an all-day town hall at the recent Cardiovascular Research Technologies conference,9 one moderator said, “I came in with uncertainty and now I’m going away with uncertainty, but we made tremendous progress.” His comoderator added, “I know I don’t know.” Well then, glad we cleared that up!
In any event, changes are coming. The BASIL-3 trial has suspended recruitment. Physicians using paclitaxel-coated devices are now advised by the FDA to inform patients of the increased risk of death and to use alternatives in most cases. Therefore, if you employ these devices routinely in the femoral-popliteal vessels you are seemingly doing so in opposition to the recommendations of the FDA. Legal peril may follow.
The time for nitpicking the Katsanos analysis has ended. Our industry partners must be compelled to supply the data and finances needed to settle this issue. The signal seems real and it is time to find answers. Research initiatives are underway through the SVS, the VIVA group, the UK Medicines and Healthcare Products Regulatory Agency, and the FDA.
Going forward, the SVS has formed a Paclitaxel Safety Task Force under the leadership of President-elect Kim Hodgson. Their mission is to facilitate the performance and interpretation of an Individual Patient Data meta-analysis using patient-level RCT data from industry partners. The task force states: “We remain troubled by the recent reports of reanalysis of existing datasets, pooled analyses of RCTs, and other ‘series’, as we believe that the findings of these statistically inferior analyses bring no additional clarity, cannot be relied upon for guidance, and distract us from the analysis that needs to be performed.”
References
1. J Am Heart Assoc. 2018 Dec 18;7(24):e011245.
2. www.fda.gov/medicaldevices/safety/letterstohealthcareproviders/ucm629589.htm.
3. J Am Coll Cardiol. Jan 2019. doi: 10.1016/j.jacc.2019.01.013.
4. Circulation. 2019;139:e42.
5. https://evtoday.com/2019/02/20/zilver-ptx-trial-5-year-mortality-data-corrected-in-circulation.
6. JAMA Cardiol. 2019 Feb 12. doi:10.1001/jamacardio.2019.0325.
7. www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm633614.htm.
8. www.med-technews.com/news/bud-defends-safety-of-drug-coated-device-following-fda-warnin/.
9. www.crtonline.org/news-detail/paclitaxel-device-safety-thoroughly-discussed-at-c.
Death of a sales pitch
The EHR and our troubled health care system, Part 1
In 2000, the Institute of Medicine published “To Err Is Human,” a landmark study that warned that as many as 98,000 people die annually as a result of medical errors. One conclusion of the report stated, “When patients see multiple providers in different settings, none of whom has access to complete information, it becomes easier for things to go wrong.” Government and public reaction to the study resulted in the rushed integration of electronic health records into the U.S. medical system. EHR vendors promised solutions that included a dramatic reduction of preventable errors, a simplified system of physician communication, and the consolidation of a patient’s salient medical information into a single, transferable file. Now, almost 20 years later, these promises remain mostly unfilled. How did we get here?
Systems of medical records have been in place since 1600 B.C. For thousands of years, they consisted mainly of the patient’s diagnosis and the physician’s treatment. In 1968, the New England Journal of Medicine published the special article “Medical Records That Guide and Teach” by Lawrence L. Weed, MD. In the report, Dr. Weed advocated for the organization of medical records by problems rather than by a single diagnosis. This was the birth of our modern system. Medical records would now include lists of symptoms, findings, and problems that would organize the physician’s planning and allow third parties to confirm the initial diagnosis. Nearly concurrent with this publication, the next major innovation was developing in a very unusual location.
In 1999, Fortune magazine labeled Jack Welch “Manager of the Century” for his innovative work as CEO of General Electric. His techniques involved cutting waste and streamlining his workforce. While these methods were somewhat controversial, GE’s market value increased dramatically under his watch. The publishers at Fortune became interested in finding similar innovators in other fields. In this pursuit, they sent journalist Philip Longman to find the “Jack Welch” of health care.
Mr. Longman had recently lost his wife to breast cancer and was becoming obsessed with medical errors and health care quality integration. He set out to discover the best health care system in the United States. After months of research, Mr. Longman reached a startling conclusion. By nearly every metric, the Veterans Affairs system produced the highest quality of care. The key factor in upholding that quality appeared to be the EHR system VistA (Veterans Information Systems and Technology Architecture).
The development of VistA was a grassroots effort begun in the 1970s. Using Tandy computers and Wang processors, the VA “hardhats” sought to develop an electronic system for medical records and communication. This effort was initially opposed and driven underground by the central bureaucracy. Laptops were confiscated, people were fired. Still, development continued, and in 1978, the Decentralized Hospital Computer Program was launched at 20 VA sites. The national rollout occurred in 1994 under the name VistA.
VistA was developed by doctors, for doctors, and routinely enjoys the highest satisfaction rates among all available EHRs. VistA also is an open source model; its code is readily available on the VA website. After seeing the evidence of VistA’s efficacy, Representative Pete Stark (D-CA) introduced HR 6898 on Sept. 15, 2008. The bill would establish a large federal open source health IT system that private hospitals could leverage. The bill also mandated that only open source solutions would receive federal funding. As opposed to proprietary systems, open source models allow for rapid innovation, easy personal configuration, and incorporation of open source apps from unlimited numbers of contributors.
HR 6898 never passed, despite initial bipartisan support. By relying on lobbyists, marketing, and money, the proprietary EHR vendors killed the Stark bill. After a 4-month scramble, the Health Information Technology for Economic and Clinical Health Act (HITECH) passed, with EHR vendor support. HITECH established a certification system for EHRs. While the Stark bill envisioned a single, open source network, there were soon hundreds of certified EHR systems in the United States.
Before the HITECH Act, many EHRs existed, but several barriers blocked full implementation. Early systems were essentially electronic filing cabinets. Their developers had not anticipated the lack of standardization among physicians and hospital systems. The need for custom EHR bases frustrated the vendors. The question of marketing was omnipresent. Who was the actual customer? An economic model developed in which clinicians would bear the time and even financial costs as the benefits would be passed on to insurers, hospitals, and, presumably, the patients.
EHRs needed to become practical, affordable, and interoperable, but who was demanding this? Where was the financial motivation? In the beginning, vendors of EHRs had to convince doctors, the public, and the government of their worth. Now, essentially mandated by the HITECH Act, they only had to sell themselves to hospital administrators, who often had a different motive. Profits.
Many of today’s EHRs are simply modified billing platforms, and doctors are paying the price. The Meaningful Use standards were meant to provide financial incentives for EHR adoption. Stage 2 required EHRs to be able to transport clinical information from one system to another. Looking at our actual practices can provide a master class in the gap between “be able to” and “actually doing.” Again, who does the EHR vendor see as the customer? Certainly not the physician. My patients can list every type of inferior vena cava filter (or at least those with pending legal action), but most of them have never heard of an EHR. Just like “service lines,” EHRs can make it very difficult for patients to seek care outside of their primary system. Who would see this barrier in communication as a perk and not a deficiency? Hospital administrators. The free transfer of medical records is bad for business. Therefore, hospitals don’t prioritize it in their EHRs. The EHR vendors also benefit since an easy transfer of records would simplify a hospital’s transition from one EHR to another. So, as with most deficiencies in the EHR, physicians are left to find ways around these problems. Sometimes, we need to go to comical lengths.
Two months ago, a patient pointed to a large machine behind our check-in desk. “What is that,” he asked incredulously; it was a fax machine. While my competence with this apparatus is marginal (my office staff has taken to yelling “doctor faxing!” to alert one another that I am about to inadvertently copy or scan my documents into oblivion), faxes remain a mainstay of medical care. Abandoned by modern business practices as a relic of the 1980s, why are we constantly faxing medical information? Because we are not the customer.
Disruption is now a favorable term in business. Doctors are busy people. BUSY people. Most of us walk a tightrope, a razor-thin timeline. Will we see the next patient in time, the next surgery? Will we get the medical records done today? Will we get the dictations done before being suspended? Will we make the committee meeting, the conference call, the next clinic across town? Will we have dinner with our spouse or see our kids today? Will we make it to the parent-teacher conference inexplicably scheduled for 10:45 a.m. on a Tuesday??!! When deciding between work commitments and family, we side with work overwhelmingly (and depressingly). Explaining this to a layperson is an impossible feat. I have stopped trying, stopped making excuses. Only we know how catastrophic “disruption” can be. Disruption in a 40-patient clinic. Disruption in the trauma bay. I have seen physicians reduced to tears by this disruption. Some activities need disruption. Typing with your back to the patient. Onerous documentation to facilitate billing. Faxing medical records. Will these be disrupted? Who is the customer?
In 1999, the Institute of Medicine started this process, telling us, “To err is human.” I now respond with another Alexander Pope quote, “The same ambition can destroy or save.” The money and influence of EHR vendors destroyed the chance to nationalize the most successful EHR our country has ever seen. What happens now? EHRs are incontrovertibly associated with burnout. Burnout is incontrovertibly associated with outcomes ranging from early retirement to suicide. EHRs cause physician harm. Major vendors can follow the Big Tobacco play book and deny the obvious, but the burden of proof is shifting to them. With their billions of dollars in profits, what have they done to study this problem? To help?
Who is their customer?
Dr. Sheahan is the Claude C. Craighead Jr. Professor and Chair, division of vascular and endovascular surgery, Louisiana State University Health Sciences Center, New Orleans.
References
Institute of Medicine (US) Committee on Quality of Health Care in America. 2000. To Err Is Human: Building a Safer Health System. Washington: The National Academies Press.
Weed LL. Medical records that guide and teach. N Engl J Med. 1968 Mar 14;278(11):593-600.
Longman P. “Best Care Anywhere: Why VA Health Care Is Better Than Yours.” (Oakland: Berrett-Koehler Publishers).
The EHR and our troubled health care system, Part 1
The EHR and our troubled health care system, Part 1
In 2000, the Institute of Medicine published “To Err Is Human,” a landmark study that warned that as many as 98,000 people die annually as a result of medical errors. One conclusion of the report stated, “When patients see multiple providers in different settings, none of whom has access to complete information, it becomes easier for things to go wrong.” Government and public reaction to the study resulted in the rushed integration of electronic health records into the U.S. medical system. EHR vendors promised solutions that included a dramatic reduction of preventable errors, a simplified system of physician communication, and the consolidation of a patient’s salient medical information into a single, transferable file. Now, almost 20 years later, these promises remain mostly unfilled. How did we get here?
Systems of medical records have been in place since 1600 B.C. For thousands of years, they consisted mainly of the patient’s diagnosis and the physician’s treatment. In 1968, the New England Journal of Medicine published the special article “Medical Records That Guide and Teach” by Lawrence L. Weed, MD. In the report, Dr. Weed advocated for the organization of medical records by problems rather than by a single diagnosis. This was the birth of our modern system. Medical records would now include lists of symptoms, findings, and problems that would organize the physician’s planning and allow third parties to confirm the initial diagnosis. Nearly concurrent with this publication, the next major innovation was developing in a very unusual location.
In 1999, Fortune magazine labeled Jack Welch “Manager of the Century” for his innovative work as CEO of General Electric. His techniques involved cutting waste and streamlining his workforce. While these methods were somewhat controversial, GE’s market value increased dramatically under his watch. The publishers at Fortune became interested in finding similar innovators in other fields. In this pursuit, they sent journalist Philip Longman to find the “Jack Welch” of health care.
Mr. Longman had recently lost his wife to breast cancer and was becoming obsessed with medical errors and health care quality integration. He set out to discover the best health care system in the United States. After months of research, Mr. Longman reached a startling conclusion. By nearly every metric, the Veterans Affairs system produced the highest quality of care. The key factor in upholding that quality appeared to be the EHR system VistA (Veterans Information Systems and Technology Architecture).
The development of VistA was a grassroots effort begun in the 1970s. Using Tandy computers and Wang processors, the VA “hardhats” sought to develop an electronic system for medical records and communication. This effort was initially opposed and driven underground by the central bureaucracy. Laptops were confiscated, people were fired. Still, development continued, and in 1978, the Decentralized Hospital Computer Program was launched at 20 VA sites. The national rollout occurred in 1994 under the name VistA.
VistA was developed by doctors, for doctors, and routinely enjoys the highest satisfaction rates among all available EHRs. VistA also is an open source model; its code is readily available on the VA website. After seeing the evidence of VistA’s efficacy, Representative Pete Stark (D-CA) introduced HR 6898 on Sept. 15, 2008. The bill would establish a large federal open source health IT system that private hospitals could leverage. The bill also mandated that only open source solutions would receive federal funding. As opposed to proprietary systems, open source models allow for rapid innovation, easy personal configuration, and incorporation of open source apps from unlimited numbers of contributors.
HR 6898 never passed, despite initial bipartisan support. By relying on lobbyists, marketing, and money, the proprietary EHR vendors killed the Stark bill. After a 4-month scramble, the Health Information Technology for Economic and Clinical Health Act (HITECH) passed, with EHR vendor support. HITECH established a certification system for EHRs. While the Stark bill envisioned a single, open source network, there were soon hundreds of certified EHR systems in the United States.
Before the HITECH Act, many EHRs existed, but several barriers blocked full implementation. Early systems were essentially electronic filing cabinets. Their developers had not anticipated the lack of standardization among physicians and hospital systems. The need for custom EHR bases frustrated the vendors. The question of marketing was omnipresent. Who was the actual customer? An economic model developed in which clinicians would bear the time and even financial costs as the benefits would be passed on to insurers, hospitals, and, presumably, the patients.
EHRs needed to become practical, affordable, and interoperable, but who was demanding this? Where was the financial motivation? In the beginning, vendors of EHRs had to convince doctors, the public, and the government of their worth. Now, essentially mandated by the HITECH Act, they only had to sell themselves to hospital administrators, who often had a different motive. Profits.
Many of today’s EHRs are simply modified billing platforms, and doctors are paying the price. The Meaningful Use standards were meant to provide financial incentives for EHR adoption. Stage 2 required EHRs to be able to transport clinical information from one system to another. Looking at our actual practices can provide a master class in the gap between “be able to” and “actually doing.” Again, who does the EHR vendor see as the customer? Certainly not the physician. My patients can list every type of inferior vena cava filter (or at least those with pending legal action), but most of them have never heard of an EHR. Just like “service lines,” EHRs can make it very difficult for patients to seek care outside of their primary system. Who would see this barrier in communication as a perk and not a deficiency? Hospital administrators. The free transfer of medical records is bad for business. Therefore, hospitals don’t prioritize it in their EHRs. The EHR vendors also benefit since an easy transfer of records would simplify a hospital’s transition from one EHR to another. So, as with most deficiencies in the EHR, physicians are left to find ways around these problems. Sometimes, we need to go to comical lengths.
Two months ago, a patient pointed to a large machine behind our check-in desk. “What is that,” he asked incredulously; it was a fax machine. While my competence with this apparatus is marginal (my office staff has taken to yelling “doctor faxing!” to alert one another that I am about to inadvertently copy or scan my documents into oblivion), faxes remain a mainstay of medical care. Abandoned by modern business practices as a relic of the 1980s, why are we constantly faxing medical information? Because we are not the customer.
Disruption is now a favorable term in business. Doctors are busy people. BUSY people. Most of us walk a tightrope, a razor-thin timeline. Will we see the next patient in time, the next surgery? Will we get the medical records done today? Will we get the dictations done before being suspended? Will we make the committee meeting, the conference call, the next clinic across town? Will we have dinner with our spouse or see our kids today? Will we make it to the parent-teacher conference inexplicably scheduled for 10:45 a.m. on a Tuesday??!! When deciding between work commitments and family, we side with work overwhelmingly (and depressingly). Explaining this to a layperson is an impossible feat. I have stopped trying, stopped making excuses. Only we know how catastrophic “disruption” can be. Disruption in a 40-patient clinic. Disruption in the trauma bay. I have seen physicians reduced to tears by this disruption. Some activities need disruption. Typing with your back to the patient. Onerous documentation to facilitate billing. Faxing medical records. Will these be disrupted? Who is the customer?
In 1999, the Institute of Medicine started this process, telling us, “To err is human.” I now respond with another Alexander Pope quote, “The same ambition can destroy or save.” The money and influence of EHR vendors destroyed the chance to nationalize the most successful EHR our country has ever seen. What happens now? EHRs are incontrovertibly associated with burnout. Burnout is incontrovertibly associated with outcomes ranging from early retirement to suicide. EHRs cause physician harm. Major vendors can follow the Big Tobacco play book and deny the obvious, but the burden of proof is shifting to them. With their billions of dollars in profits, what have they done to study this problem? To help?
Who is their customer?
Dr. Sheahan is the Claude C. Craighead Jr. Professor and Chair, division of vascular and endovascular surgery, Louisiana State University Health Sciences Center, New Orleans.
References
Institute of Medicine (US) Committee on Quality of Health Care in America. 2000. To Err Is Human: Building a Safer Health System. Washington: The National Academies Press.
Weed LL. Medical records that guide and teach. N Engl J Med. 1968 Mar 14;278(11):593-600.
Longman P. “Best Care Anywhere: Why VA Health Care Is Better Than Yours.” (Oakland: Berrett-Koehler Publishers).
In 2000, the Institute of Medicine published “To Err Is Human,” a landmark study that warned that as many as 98,000 people die annually as a result of medical errors. One conclusion of the report stated, “When patients see multiple providers in different settings, none of whom has access to complete information, it becomes easier for things to go wrong.” Government and public reaction to the study resulted in the rushed integration of electronic health records into the U.S. medical system. EHR vendors promised solutions that included a dramatic reduction of preventable errors, a simplified system of physician communication, and the consolidation of a patient’s salient medical information into a single, transferable file. Now, almost 20 years later, these promises remain mostly unfilled. How did we get here?
Systems of medical records have been in place since 1600 B.C. For thousands of years, they consisted mainly of the patient’s diagnosis and the physician’s treatment. In 1968, the New England Journal of Medicine published the special article “Medical Records That Guide and Teach” by Lawrence L. Weed, MD. In the report, Dr. Weed advocated for the organization of medical records by problems rather than by a single diagnosis. This was the birth of our modern system. Medical records would now include lists of symptoms, findings, and problems that would organize the physician’s planning and allow third parties to confirm the initial diagnosis. Nearly concurrent with this publication, the next major innovation was developing in a very unusual location.
In 1999, Fortune magazine labeled Jack Welch “Manager of the Century” for his innovative work as CEO of General Electric. His techniques involved cutting waste and streamlining his workforce. While these methods were somewhat controversial, GE’s market value increased dramatically under his watch. The publishers at Fortune became interested in finding similar innovators in other fields. In this pursuit, they sent journalist Philip Longman to find the “Jack Welch” of health care.
Mr. Longman had recently lost his wife to breast cancer and was becoming obsessed with medical errors and health care quality integration. He set out to discover the best health care system in the United States. After months of research, Mr. Longman reached a startling conclusion. By nearly every metric, the Veterans Affairs system produced the highest quality of care. The key factor in upholding that quality appeared to be the EHR system VistA (Veterans Information Systems and Technology Architecture).
The development of VistA was a grassroots effort begun in the 1970s. Using Tandy computers and Wang processors, the VA “hardhats” sought to develop an electronic system for medical records and communication. This effort was initially opposed and driven underground by the central bureaucracy. Laptops were confiscated, people were fired. Still, development continued, and in 1978, the Decentralized Hospital Computer Program was launched at 20 VA sites. The national rollout occurred in 1994 under the name VistA.
VistA was developed by doctors, for doctors, and routinely enjoys the highest satisfaction rates among all available EHRs. VistA also is an open source model; its code is readily available on the VA website. After seeing the evidence of VistA’s efficacy, Representative Pete Stark (D-CA) introduced HR 6898 on Sept. 15, 2008. The bill would establish a large federal open source health IT system that private hospitals could leverage. The bill also mandated that only open source solutions would receive federal funding. As opposed to proprietary systems, open source models allow for rapid innovation, easy personal configuration, and incorporation of open source apps from unlimited numbers of contributors.
HR 6898 never passed, despite initial bipartisan support. By relying on lobbyists, marketing, and money, the proprietary EHR vendors killed the Stark bill. After a 4-month scramble, the Health Information Technology for Economic and Clinical Health Act (HITECH) passed, with EHR vendor support. HITECH established a certification system for EHRs. While the Stark bill envisioned a single, open source network, there were soon hundreds of certified EHR systems in the United States.
Before the HITECH Act, many EHRs existed, but several barriers blocked full implementation. Early systems were essentially electronic filing cabinets. Their developers had not anticipated the lack of standardization among physicians and hospital systems. The need for custom EHR bases frustrated the vendors. The question of marketing was omnipresent. Who was the actual customer? An economic model developed in which clinicians would bear the time and even financial costs as the benefits would be passed on to insurers, hospitals, and, presumably, the patients.
EHRs needed to become practical, affordable, and interoperable, but who was demanding this? Where was the financial motivation? In the beginning, vendors of EHRs had to convince doctors, the public, and the government of their worth. Now, essentially mandated by the HITECH Act, they only had to sell themselves to hospital administrators, who often had a different motive. Profits.
Many of today’s EHRs are simply modified billing platforms, and doctors are paying the price. The Meaningful Use standards were meant to provide financial incentives for EHR adoption. Stage 2 required EHRs to be able to transport clinical information from one system to another. Looking at our actual practices can provide a master class in the gap between “be able to” and “actually doing.” Again, who does the EHR vendor see as the customer? Certainly not the physician. My patients can list every type of inferior vena cava filter (or at least those with pending legal action), but most of them have never heard of an EHR. Just like “service lines,” EHRs can make it very difficult for patients to seek care outside of their primary system. Who would see this barrier in communication as a perk and not a deficiency? Hospital administrators. The free transfer of medical records is bad for business. Therefore, hospitals don’t prioritize it in their EHRs. The EHR vendors also benefit since an easy transfer of records would simplify a hospital’s transition from one EHR to another. So, as with most deficiencies in the EHR, physicians are left to find ways around these problems. Sometimes, we need to go to comical lengths.
Two months ago, a patient pointed to a large machine behind our check-in desk. “What is that,” he asked incredulously; it was a fax machine. While my competence with this apparatus is marginal (my office staff has taken to yelling “doctor faxing!” to alert one another that I am about to inadvertently copy or scan my documents into oblivion), faxes remain a mainstay of medical care. Abandoned by modern business practices as a relic of the 1980s, why are we constantly faxing medical information? Because we are not the customer.
Disruption is now a favorable term in business. Doctors are busy people. BUSY people. Most of us walk a tightrope, a razor-thin timeline. Will we see the next patient in time, the next surgery? Will we get the medical records done today? Will we get the dictations done before being suspended? Will we make the committee meeting, the conference call, the next clinic across town? Will we have dinner with our spouse or see our kids today? Will we make it to the parent-teacher conference inexplicably scheduled for 10:45 a.m. on a Tuesday??!! When deciding between work commitments and family, we side with work overwhelmingly (and depressingly). Explaining this to a layperson is an impossible feat. I have stopped trying, stopped making excuses. Only we know how catastrophic “disruption” can be. Disruption in a 40-patient clinic. Disruption in the trauma bay. I have seen physicians reduced to tears by this disruption. Some activities need disruption. Typing with your back to the patient. Onerous documentation to facilitate billing. Faxing medical records. Will these be disrupted? Who is the customer?
In 1999, the Institute of Medicine started this process, telling us, “To err is human.” I now respond with another Alexander Pope quote, “The same ambition can destroy or save.” The money and influence of EHR vendors destroyed the chance to nationalize the most successful EHR our country has ever seen. What happens now? EHRs are incontrovertibly associated with burnout. Burnout is incontrovertibly associated with outcomes ranging from early retirement to suicide. EHRs cause physician harm. Major vendors can follow the Big Tobacco play book and deny the obvious, but the burden of proof is shifting to them. With their billions of dollars in profits, what have they done to study this problem? To help?
Who is their customer?
Dr. Sheahan is the Claude C. Craighead Jr. Professor and Chair, division of vascular and endovascular surgery, Louisiana State University Health Sciences Center, New Orleans.
References
Institute of Medicine (US) Committee on Quality of Health Care in America. 2000. To Err Is Human: Building a Safer Health System. Washington: The National Academies Press.
Weed LL. Medical records that guide and teach. N Engl J Med. 1968 Mar 14;278(11):593-600.
Longman P. “Best Care Anywhere: Why VA Health Care Is Better Than Yours.” (Oakland: Berrett-Koehler Publishers).
From the Editor: An open letter to our hospital consultants
Dear <redacted>,
Just thought I would write and give you a quick update on our situation, not that you asked. As you recall, a few years ago we spent many hours discussing and planning the Heart and Vascular Service Line that you encouraged us to set up in our new hospital. These conversations were filled with the greatest hits of health care administrators. “Institutional silos,” “layers of integration,” and “financial dashboards” were crowd favorites. Personally, I enjoyed the endless timelines, flow charts to nowhere, and of course the countless hours spent crafting a vision statement. It’s a wonder we got any work done! At least one of us was getting paid by the hour.
When I asked you to provide concrete examples of fully integrated, functional Heart and Vascular Service Lines you initially deferred. Finally, you listed three examples. Of course, when I reached out to them, two had disbanded, and the third had no idea what I was talking about. Nevertheless, I pressed on. I tried to figure out how this would all work. What keeps the service line synchronous? My research kept turning up lines like: “alignment across departments and specialists is imperative for addressing the care delivery and business challenges facing cardiovascular providers.” OK sure, but huh?
The purpose of a Heart and Vascular Service Line is purportedly to improve the quality of care of cardiovascular patients. The concept of the service line has been in place for over 20 years, so where is the literature demonstrating the quality benefits? The improved outcomes? As far as I can tell it does not exist. So maybe that was never really the primary goal. Based on the vigor and financial capital hospitals pour into the creation of these lines, there must be a different game afoot. Looking deeper into the health care administration literature it seems the true benefit of a service line is that it keeps patients within the system. Once a patient is brought in by one specialty, the other specialties can converge to offer their services. It soon becomes an assembly line of atherosclerotic delights. The patient enjoys the theoretical advantage of having all of his or her specialists together, and the hospital enjoys the profits.
I would have been comfortable fighting the concept of the service line on the basis of access, practicality, or quality. The truth is, it isn’t about any of these things. If the service line were really about patient convenience, we would have put a vascular lab in the clinic as I requested. But that wouldn’t have been convenient for radiology or cardiology. In your model, which specialty does the work doesn’t matter because the hospital profits regardless. So without a financial map to describe how this all plays out, you just threw us into the same cage Thunderdome-style. Two specialists enter, one specialist leaves. The problem is that CMS is already looking at the volume of diagnostic studies as a factor in total cost. You helped us build a system that enables and encourages more testing. Cue Tina Turner, “We don’t need another ECHO…”
The turning point in our relationship should have come when you sent me the list of CPT codes for the procedures expected to be performed by vascular surgery. You got a few right. Lower extremity bypass, amputations, and even aneurysms were there. You seemed surprised, though, that we would be doing other leg interventions and thought the carotid endarterectomies would be done by neurosurgery. Here the problem was laid out. You were describing in detail the mechanisms for our new service line, but you didn’t really know what a vascular surgeon was. It’s a little late, but let me help you.
When I sent back the CPT list, even I forgot a few. Like 35251 (repair of intra-abdominal blood vessel), 27364 (radical resection of thigh sarcoma), or 35141 (repair of femoral pseudoaneurysm). You see, vascular surgeons are the great facilitators. Our expertise enables other specialties to perform at their highest levels. Comprehensive programs in orthopedics, neurosurgery, cardiology, cardiac surgery, surgical oncology, trauma, and urology would be essentially impossible without vascular surgery. A study conducted at Northwestern showed that 7% of their total volume of vascular surgeries were cases providing intraoperative assistance to other specialties.1 And this excluded trauma. While the hospital greatly benefits from this relationship, the vascular surgeons often do not. Emergently helping other physicians requires canceling our responsibilities, both at work and at home. CPT codes often severely undervalue our time spent assisting with large resections or waiting “on standby.”
The overall financial contributions of vascular surgeons to hospital systems are often overlooked. In a study performed at a tertiary care hospital in New Jersey, vascular surgeons were found to have the leading gross margin per FTE of any specialty, 66% more than cardiology. (And these were academic vascular surgeons, a famously lazy breed!)2 In 2002, Merritt, Hawkins & Associates found that the average vascular surgeon provides over $2 million in revenue to his or her hospital, third highest of any specialty.3 With the widespread adoption of endovascular procedures, this number is likely to be higher today.
So now, an update on our great experiment. Run by cardiology our service line treats heart disease, heart attacks, heart failure, and high blood pressure. At least according to the website. If you want to find vascular surgery, it is listed last, under “other services.” And no, sadly the list is not alphabetical. Around the country, there is a great shortage of vascular surgeons. There are two to three job openings for every graduate annually. Remarkably, our service line boasts ten board-certified vascular surgeons. But people always seem to want what they don’t have. In our service line director’s case, that was a TAVR program. So there was great effort and expense in creating one. When it came time to start our FEVAR program, I simply took my friend Andy Schanzer out to dinner and asked him how he did it at UMass. Then we just started doing cases. No fanfare, no press releases. No expensive hires. The dinner cost about $100 (Andy is a cheap date, but I ordered multiple apps).
Today, our service line is disintegrating. There is no animosity. It just didn’t work out. It never really made sense. Yes, our patients have heart disease. They also have lung cancer, diabetes, prostate disease, and spinal stenosis. They would benefit from wound care, smoking cessation, and certainly a comprehensive vascular lab. None of which were offered in our service line. We didn’t belong in the same silo as cardiology, and I certainly never believed they should be in one that treats PVD. I guess it is quaint to expect that a specialty’s scope of practice matches their ACGME and ABMS training requirements. Maybe I’m old-fashioned.
So <redacted>, looking back on our meetings you often took the tone of an adult explaining a difficult, but necessary thing to a child. Maybe the biggest lie we tell children is that adults know what they’re doing. Vascular surgery is an incredibly valuable asset to a health care system. One threatened by physician scarcity and one deserving of promotion and growth. It seems remarkably shortsighted to bury this asset on a service line under the direction of cardiology.
In the end, I have only one request. The next time you are in a meeting with a vascular surgeon who asks for an example of a successful Heart and Vascular Service Line don’t use us. It didn’t work. I don’t think it ever truly works.
Dr. Sheahan is the Claude C. Craighead Jr. Professor and Chair, division of vascular and endovascular surgery, Louisiana State University Health Sciences Center, New Orleans.
References
1. JAMA Surg. 2016;151(11):1032-8.
2. J. Vasc. Surg. 2012;55(1):281-5.
3. Merritt, Hawkins & Associates, 2002 Physician Inpatient/Outpatient Revenue Survey.
Dear <redacted>,
Just thought I would write and give you a quick update on our situation, not that you asked. As you recall, a few years ago we spent many hours discussing and planning the Heart and Vascular Service Line that you encouraged us to set up in our new hospital. These conversations were filled with the greatest hits of health care administrators. “Institutional silos,” “layers of integration,” and “financial dashboards” were crowd favorites. Personally, I enjoyed the endless timelines, flow charts to nowhere, and of course the countless hours spent crafting a vision statement. It’s a wonder we got any work done! At least one of us was getting paid by the hour.
When I asked you to provide concrete examples of fully integrated, functional Heart and Vascular Service Lines you initially deferred. Finally, you listed three examples. Of course, when I reached out to them, two had disbanded, and the third had no idea what I was talking about. Nevertheless, I pressed on. I tried to figure out how this would all work. What keeps the service line synchronous? My research kept turning up lines like: “alignment across departments and specialists is imperative for addressing the care delivery and business challenges facing cardiovascular providers.” OK sure, but huh?
The purpose of a Heart and Vascular Service Line is purportedly to improve the quality of care of cardiovascular patients. The concept of the service line has been in place for over 20 years, so where is the literature demonstrating the quality benefits? The improved outcomes? As far as I can tell it does not exist. So maybe that was never really the primary goal. Based on the vigor and financial capital hospitals pour into the creation of these lines, there must be a different game afoot. Looking deeper into the health care administration literature it seems the true benefit of a service line is that it keeps patients within the system. Once a patient is brought in by one specialty, the other specialties can converge to offer their services. It soon becomes an assembly line of atherosclerotic delights. The patient enjoys the theoretical advantage of having all of his or her specialists together, and the hospital enjoys the profits.
I would have been comfortable fighting the concept of the service line on the basis of access, practicality, or quality. The truth is, it isn’t about any of these things. If the service line were really about patient convenience, we would have put a vascular lab in the clinic as I requested. But that wouldn’t have been convenient for radiology or cardiology. In your model, which specialty does the work doesn’t matter because the hospital profits regardless. So without a financial map to describe how this all plays out, you just threw us into the same cage Thunderdome-style. Two specialists enter, one specialist leaves. The problem is that CMS is already looking at the volume of diagnostic studies as a factor in total cost. You helped us build a system that enables and encourages more testing. Cue Tina Turner, “We don’t need another ECHO…”
The turning point in our relationship should have come when you sent me the list of CPT codes for the procedures expected to be performed by vascular surgery. You got a few right. Lower extremity bypass, amputations, and even aneurysms were there. You seemed surprised, though, that we would be doing other leg interventions and thought the carotid endarterectomies would be done by neurosurgery. Here the problem was laid out. You were describing in detail the mechanisms for our new service line, but you didn’t really know what a vascular surgeon was. It’s a little late, but let me help you.
When I sent back the CPT list, even I forgot a few. Like 35251 (repair of intra-abdominal blood vessel), 27364 (radical resection of thigh sarcoma), or 35141 (repair of femoral pseudoaneurysm). You see, vascular surgeons are the great facilitators. Our expertise enables other specialties to perform at their highest levels. Comprehensive programs in orthopedics, neurosurgery, cardiology, cardiac surgery, surgical oncology, trauma, and urology would be essentially impossible without vascular surgery. A study conducted at Northwestern showed that 7% of their total volume of vascular surgeries were cases providing intraoperative assistance to other specialties.1 And this excluded trauma. While the hospital greatly benefits from this relationship, the vascular surgeons often do not. Emergently helping other physicians requires canceling our responsibilities, both at work and at home. CPT codes often severely undervalue our time spent assisting with large resections or waiting “on standby.”
The overall financial contributions of vascular surgeons to hospital systems are often overlooked. In a study performed at a tertiary care hospital in New Jersey, vascular surgeons were found to have the leading gross margin per FTE of any specialty, 66% more than cardiology. (And these were academic vascular surgeons, a famously lazy breed!)2 In 2002, Merritt, Hawkins & Associates found that the average vascular surgeon provides over $2 million in revenue to his or her hospital, third highest of any specialty.3 With the widespread adoption of endovascular procedures, this number is likely to be higher today.
So now, an update on our great experiment. Run by cardiology our service line treats heart disease, heart attacks, heart failure, and high blood pressure. At least according to the website. If you want to find vascular surgery, it is listed last, under “other services.” And no, sadly the list is not alphabetical. Around the country, there is a great shortage of vascular surgeons. There are two to three job openings for every graduate annually. Remarkably, our service line boasts ten board-certified vascular surgeons. But people always seem to want what they don’t have. In our service line director’s case, that was a TAVR program. So there was great effort and expense in creating one. When it came time to start our FEVAR program, I simply took my friend Andy Schanzer out to dinner and asked him how he did it at UMass. Then we just started doing cases. No fanfare, no press releases. No expensive hires. The dinner cost about $100 (Andy is a cheap date, but I ordered multiple apps).
Today, our service line is disintegrating. There is no animosity. It just didn’t work out. It never really made sense. Yes, our patients have heart disease. They also have lung cancer, diabetes, prostate disease, and spinal stenosis. They would benefit from wound care, smoking cessation, and certainly a comprehensive vascular lab. None of which were offered in our service line. We didn’t belong in the same silo as cardiology, and I certainly never believed they should be in one that treats PVD. I guess it is quaint to expect that a specialty’s scope of practice matches their ACGME and ABMS training requirements. Maybe I’m old-fashioned.
So <redacted>, looking back on our meetings you often took the tone of an adult explaining a difficult, but necessary thing to a child. Maybe the biggest lie we tell children is that adults know what they’re doing. Vascular surgery is an incredibly valuable asset to a health care system. One threatened by physician scarcity and one deserving of promotion and growth. It seems remarkably shortsighted to bury this asset on a service line under the direction of cardiology.
In the end, I have only one request. The next time you are in a meeting with a vascular surgeon who asks for an example of a successful Heart and Vascular Service Line don’t use us. It didn’t work. I don’t think it ever truly works.
Dr. Sheahan is the Claude C. Craighead Jr. Professor and Chair, division of vascular and endovascular surgery, Louisiana State University Health Sciences Center, New Orleans.
References
1. JAMA Surg. 2016;151(11):1032-8.
2. J. Vasc. Surg. 2012;55(1):281-5.
3. Merritt, Hawkins & Associates, 2002 Physician Inpatient/Outpatient Revenue Survey.
Dear <redacted>,
Just thought I would write and give you a quick update on our situation, not that you asked. As you recall, a few years ago we spent many hours discussing and planning the Heart and Vascular Service Line that you encouraged us to set up in our new hospital. These conversations were filled with the greatest hits of health care administrators. “Institutional silos,” “layers of integration,” and “financial dashboards” were crowd favorites. Personally, I enjoyed the endless timelines, flow charts to nowhere, and of course the countless hours spent crafting a vision statement. It’s a wonder we got any work done! At least one of us was getting paid by the hour.
When I asked you to provide concrete examples of fully integrated, functional Heart and Vascular Service Lines you initially deferred. Finally, you listed three examples. Of course, when I reached out to them, two had disbanded, and the third had no idea what I was talking about. Nevertheless, I pressed on. I tried to figure out how this would all work. What keeps the service line synchronous? My research kept turning up lines like: “alignment across departments and specialists is imperative for addressing the care delivery and business challenges facing cardiovascular providers.” OK sure, but huh?
The purpose of a Heart and Vascular Service Line is purportedly to improve the quality of care of cardiovascular patients. The concept of the service line has been in place for over 20 years, so where is the literature demonstrating the quality benefits? The improved outcomes? As far as I can tell it does not exist. So maybe that was never really the primary goal. Based on the vigor and financial capital hospitals pour into the creation of these lines, there must be a different game afoot. Looking deeper into the health care administration literature it seems the true benefit of a service line is that it keeps patients within the system. Once a patient is brought in by one specialty, the other specialties can converge to offer their services. It soon becomes an assembly line of atherosclerotic delights. The patient enjoys the theoretical advantage of having all of his or her specialists together, and the hospital enjoys the profits.
I would have been comfortable fighting the concept of the service line on the basis of access, practicality, or quality. The truth is, it isn’t about any of these things. If the service line were really about patient convenience, we would have put a vascular lab in the clinic as I requested. But that wouldn’t have been convenient for radiology or cardiology. In your model, which specialty does the work doesn’t matter because the hospital profits regardless. So without a financial map to describe how this all plays out, you just threw us into the same cage Thunderdome-style. Two specialists enter, one specialist leaves. The problem is that CMS is already looking at the volume of diagnostic studies as a factor in total cost. You helped us build a system that enables and encourages more testing. Cue Tina Turner, “We don’t need another ECHO…”
The turning point in our relationship should have come when you sent me the list of CPT codes for the procedures expected to be performed by vascular surgery. You got a few right. Lower extremity bypass, amputations, and even aneurysms were there. You seemed surprised, though, that we would be doing other leg interventions and thought the carotid endarterectomies would be done by neurosurgery. Here the problem was laid out. You were describing in detail the mechanisms for our new service line, but you didn’t really know what a vascular surgeon was. It’s a little late, but let me help you.
When I sent back the CPT list, even I forgot a few. Like 35251 (repair of intra-abdominal blood vessel), 27364 (radical resection of thigh sarcoma), or 35141 (repair of femoral pseudoaneurysm). You see, vascular surgeons are the great facilitators. Our expertise enables other specialties to perform at their highest levels. Comprehensive programs in orthopedics, neurosurgery, cardiology, cardiac surgery, surgical oncology, trauma, and urology would be essentially impossible without vascular surgery. A study conducted at Northwestern showed that 7% of their total volume of vascular surgeries were cases providing intraoperative assistance to other specialties.1 And this excluded trauma. While the hospital greatly benefits from this relationship, the vascular surgeons often do not. Emergently helping other physicians requires canceling our responsibilities, both at work and at home. CPT codes often severely undervalue our time spent assisting with large resections or waiting “on standby.”
The overall financial contributions of vascular surgeons to hospital systems are often overlooked. In a study performed at a tertiary care hospital in New Jersey, vascular surgeons were found to have the leading gross margin per FTE of any specialty, 66% more than cardiology. (And these were academic vascular surgeons, a famously lazy breed!)2 In 2002, Merritt, Hawkins & Associates found that the average vascular surgeon provides over $2 million in revenue to his or her hospital, third highest of any specialty.3 With the widespread adoption of endovascular procedures, this number is likely to be higher today.
So now, an update on our great experiment. Run by cardiology our service line treats heart disease, heart attacks, heart failure, and high blood pressure. At least according to the website. If you want to find vascular surgery, it is listed last, under “other services.” And no, sadly the list is not alphabetical. Around the country, there is a great shortage of vascular surgeons. There are two to three job openings for every graduate annually. Remarkably, our service line boasts ten board-certified vascular surgeons. But people always seem to want what they don’t have. In our service line director’s case, that was a TAVR program. So there was great effort and expense in creating one. When it came time to start our FEVAR program, I simply took my friend Andy Schanzer out to dinner and asked him how he did it at UMass. Then we just started doing cases. No fanfare, no press releases. No expensive hires. The dinner cost about $100 (Andy is a cheap date, but I ordered multiple apps).
Today, our service line is disintegrating. There is no animosity. It just didn’t work out. It never really made sense. Yes, our patients have heart disease. They also have lung cancer, diabetes, prostate disease, and spinal stenosis. They would benefit from wound care, smoking cessation, and certainly a comprehensive vascular lab. None of which were offered in our service line. We didn’t belong in the same silo as cardiology, and I certainly never believed they should be in one that treats PVD. I guess it is quaint to expect that a specialty’s scope of practice matches their ACGME and ABMS training requirements. Maybe I’m old-fashioned.
So <redacted>, looking back on our meetings you often took the tone of an adult explaining a difficult, but necessary thing to a child. Maybe the biggest lie we tell children is that adults know what they’re doing. Vascular surgery is an incredibly valuable asset to a health care system. One threatened by physician scarcity and one deserving of promotion and growth. It seems remarkably shortsighted to bury this asset on a service line under the direction of cardiology.
In the end, I have only one request. The next time you are in a meeting with a vascular surgeon who asks for an example of a successful Heart and Vascular Service Line don’t use us. It didn’t work. I don’t think it ever truly works.
Dr. Sheahan is the Claude C. Craighead Jr. Professor and Chair, division of vascular and endovascular surgery, Louisiana State University Health Sciences Center, New Orleans.
References
1. JAMA Surg. 2016;151(11):1032-8.
2. J. Vasc. Surg. 2012;55(1):281-5.
3. Merritt, Hawkins & Associates, 2002 Physician Inpatient/Outpatient Revenue Survey.
I want you to do my job
It is never easy to replace a legend. The Vascular Specialist that Russell Samson has left behind does not require saving. There are, however, problems ahead for all vascular surgeons, and my hope is to use this forum to unite us. Vascular surgery is a small specialty in an existential crisis. There are just over 3,000 of us in the United States. Think of Vascular Specialist as your hometown newspaper. Instead of high school sports and bake sales we will cover scientific meetings, clinical trials, and relevant legislation. And maybe the occasional swap meet.
Different points of view are going to be an essential part of this process. Russell Samson represented the posh, privileged world of private practice while I come from the rough and tumble streets of academia (just checking to see if he is still reading). My hope is to bring more. More Tips and Tricks, more Point/Counterpoint, more Letters to the Editor, more input from you.
How can you get involved? If you read something and have a response, send it to me. Volunteer to write up a technical tip or provide a medical debate. Have an idea for a guest editorial? Let me know, preferably before you write it. If it is good I will likely publish it. If not, well we can still be friends. Keep in mind, unlike book publishing, we work on strict deadlines. (To the three people I owe book chapters: Soon, I promise!) We will also be starting a vascular news section for brief committee updates, course registration openings, and relevant policy changes.
Vascular Specialist is now open for submissions. Contact us at vascularspecialist@mdedge.com.
It is never easy to replace a legend. The Vascular Specialist that Russell Samson has left behind does not require saving. There are, however, problems ahead for all vascular surgeons, and my hope is to use this forum to unite us. Vascular surgery is a small specialty in an existential crisis. There are just over 3,000 of us in the United States. Think of Vascular Specialist as your hometown newspaper. Instead of high school sports and bake sales we will cover scientific meetings, clinical trials, and relevant legislation. And maybe the occasional swap meet.
Different points of view are going to be an essential part of this process. Russell Samson represented the posh, privileged world of private practice while I come from the rough and tumble streets of academia (just checking to see if he is still reading). My hope is to bring more. More Tips and Tricks, more Point/Counterpoint, more Letters to the Editor, more input from you.
How can you get involved? If you read something and have a response, send it to me. Volunteer to write up a technical tip or provide a medical debate. Have an idea for a guest editorial? Let me know, preferably before you write it. If it is good I will likely publish it. If not, well we can still be friends. Keep in mind, unlike book publishing, we work on strict deadlines. (To the three people I owe book chapters: Soon, I promise!) We will also be starting a vascular news section for brief committee updates, course registration openings, and relevant policy changes.
Vascular Specialist is now open for submissions. Contact us at vascularspecialist@mdedge.com.
It is never easy to replace a legend. The Vascular Specialist that Russell Samson has left behind does not require saving. There are, however, problems ahead for all vascular surgeons, and my hope is to use this forum to unite us. Vascular surgery is a small specialty in an existential crisis. There are just over 3,000 of us in the United States. Think of Vascular Specialist as your hometown newspaper. Instead of high school sports and bake sales we will cover scientific meetings, clinical trials, and relevant legislation. And maybe the occasional swap meet.
Different points of view are going to be an essential part of this process. Russell Samson represented the posh, privileged world of private practice while I come from the rough and tumble streets of academia (just checking to see if he is still reading). My hope is to bring more. More Tips and Tricks, more Point/Counterpoint, more Letters to the Editor, more input from you.
How can you get involved? If you read something and have a response, send it to me. Volunteer to write up a technical tip or provide a medical debate. Have an idea for a guest editorial? Let me know, preferably before you write it. If it is good I will likely publish it. If not, well we can still be friends. Keep in mind, unlike book publishing, we work on strict deadlines. (To the three people I owe book chapters: Soon, I promise!) We will also be starting a vascular news section for brief committee updates, course registration openings, and relevant policy changes.
Vascular Specialist is now open for submissions. Contact us at vascularspecialist@mdedge.com.
It’s time for us to talk about guns
Studies have shown that most of you already have deep-seated beliefs regarding guns. Some of you would frame the issue as Gun Rights, others as Gun Violence. I am not here to change your opinion. I am not in the habit of wasting my time. Logic has been drained from this discussion and emotion infused. As vascular surgeons, it is far past time to overcome these limitations and join the national discussion. Opinions and consensus statements have already been rendered from the American College of Surgeons, the American Medical Association, the American Academy of Pediatrics, the Society of Thoracic Surgeons, and even the American College of Phlebology. Where does the SVS stand?
In January 2013, the Board of Directors of the SVS voted to support the ACS Statement on Firearm Injuries. There is virtually no public record of this endorsement, it does not appear on the SVS website and it was essentially ignored by the public.
Even the diligent National Rifle Association (NRA) left the SVS off their list of “National Organizations with Anti-Gun Policies” (Ed note: for more information, see “The Evolution of the NRA and Our Modern Gun Debate” at www.vascularspecialistonline.com).
We need to do better. If we are truly an independent specialty it is time to behave as such. Vascular surgeons are on the front lines of this battle. We have cared for the injured, revived the dying, and bear witness to the dead. To not have a voice and be counted is a disservice to our patients and ourselves.
What can be done to reduce gun violence? In Australia, between 1979 and 1996, there were 13 mass shootings. After a semiautomatic weapon ban was instituted in 1996 there have been none. The U.S. ban on military style weapons lapsed in 2004. While it is difficult to characterize “mass shootings” in a country our size, there certainly seems to be an increase since then. If defined as “four or more shot and/or killed in a single event, at the same general time and location not including the shooter,” then we have seen 275 mass shootings this year as of Oct. 5, 2017.
The other statistics are familiar and sobering. More Americans have died from guns since 1968 than have died in all the wars since our country’s inception. The United States accounts for 91% of gun deaths of children among developed countries. Our casualty figures more closely mirror Somalia and Honduras, not Britain or Germany.
Contemporary, large-scale research in limiting gun violence is essentially nonexistent since a 1993 Centers for Disease Control and Prevention (CDC) funded study found a link between keeping a gun in the home with an increased risk of homicide. Quick to respond, Congress passed the 1996 Dickey Amendment that prohibits the CDC from funding efforts that “advocate or promote gun control.” This amendment has been renewed every year despite the author of the bill, Representative Jay Dickey, expressing regret for halting all gun research, stating that was not his intention. Rep. Dickey died earlier this year.
In the U.S., gun laws have actually relaxed over time. In 1988, 18 states had laws allowing civilians to carry concealed hand guns in public places, now this practice is legal in 40 states. In a 2008 landmark decision, the Supreme Court struck down a personal handgun ban in the District of Columbia. The Second Amendment rights afforded to a “well-regulated militia” to “keep and bear arms” were now extended to private individuals. Guns are clearly more prevalent and available in the U.S. than ever before.
The congressional ban on firearms research now extends to all Department of Health and Human Services agencies, including the NIH. We need the Dickey Amendment lifted so we can study the relationship of gun ownership and crime. As physicians, we need to deal from an informed, intelligent position and not an emotional one.
Over 50 medical societies, comprising essentially every physician in the U.S., have released statements on gun violence. The AMA has labeled it a “public health crisis.” The ACS stated, in the aftermath of the Las Vegas shooting, “It is important that the American College of Surgeons, whose Fellows care for the victims of these events, be part of the solution.”
Aside from ethical or moral obligations, why should we dive into this quagmire? Most of us are already represented in the discussion through other groups. The answer lies in our identity. If vascular surgery is to become a truly independent specialty, we can’t hide behind the ACS or the AMA when the politics become sticky.
To protect the 30,000 people who die from aneurysm rupture yearly we literally forced an act of Congress. Where do we stand on the more than 33,000 people who die yearly from gun violence? For vascular surgery to have a true public presence, we must be prepared to enter the most public of all discussions.
Luckily, there is already a pathway to consensus. The American College of Surgeons Committee on Trauma (ACS COT) surveyed its members and found that only 15% had no strong opinions on firearms. Just over 50% felt that guns were important for personal safety and defense, while 30% felt the large number of guns in the U.S. was a threat to safety.
Individuals who felt that firearms were important were most likely to associate guns with personal freedom, while those who felt they were a threat were most likely to associate guns with violence.
To further the discussion, the emotional battle between personal freedom and violence needed to be minimized. In doing so, the ACS COT was able to produce a consensus statement despite the seemingly diametrically opposed opinions of its members.
An independent specialty needs an independent voice. If we don’t know our own position, obviously the public doesn’t either.
As a starting point, here is the ACS Statement on Firearms Injuries:
Because violence inflicted by guns continues to be a daily event in the United States and mass casualties involving firearms threaten the health and safety of the public, the American College of Surgeons supports:
1. Legislation banning civilian access to assault weapons, large ammunition clips, and munitions designed for military and law enforcement agencies.
2. Enhancing mandatory background checks for the purchase of firearms to include gun shows and auctions.
3. Assuring that health care professionals can fulfill their role in preventing firearm injuries by health screening, patient counseling, and referral to mental health services for those with behavioral medical conditions. 4. Developing and promoting proactive programs directed at improving safe gun storage and the teaching of nonviolent conflict resolution for a culture that often glorifies guns and violence in media and gaming.
5. Evidence-based research on firearm injury and the creation of a national firearm injury database to inform federal health policy.
Selected References
1) Gun Violence Research: History of Federal Funding Freeze (www.apa.org/science/about/psa/2013/02/gun-violence.aspx)
2) Childhood Firearm Injuries in the United States (www.apa.org/science/about/psa/2013/02/gun-violence.aspx)
3) Gun Violence Letter to the U.S. House of Representatives (2013) (www.acponline.org/acp_policy/letters/gun_violence_letter_house_2013.pdf)
4) Survey of American College of Surgeons Committee on Trauma members on firearm injury: Consensus and opportunities (2016) (www.facs.org).
5) American College of Surgeons Statement on Firearm Injuries (www.facs.org)
Studies have shown that most of you already have deep-seated beliefs regarding guns. Some of you would frame the issue as Gun Rights, others as Gun Violence. I am not here to change your opinion. I am not in the habit of wasting my time. Logic has been drained from this discussion and emotion infused. As vascular surgeons, it is far past time to overcome these limitations and join the national discussion. Opinions and consensus statements have already been rendered from the American College of Surgeons, the American Medical Association, the American Academy of Pediatrics, the Society of Thoracic Surgeons, and even the American College of Phlebology. Where does the SVS stand?
In January 2013, the Board of Directors of the SVS voted to support the ACS Statement on Firearm Injuries. There is virtually no public record of this endorsement, it does not appear on the SVS website and it was essentially ignored by the public.
Even the diligent National Rifle Association (NRA) left the SVS off their list of “National Organizations with Anti-Gun Policies” (Ed note: for more information, see “The Evolution of the NRA and Our Modern Gun Debate” at www.vascularspecialistonline.com).
We need to do better. If we are truly an independent specialty it is time to behave as such. Vascular surgeons are on the front lines of this battle. We have cared for the injured, revived the dying, and bear witness to the dead. To not have a voice and be counted is a disservice to our patients and ourselves.
What can be done to reduce gun violence? In Australia, between 1979 and 1996, there were 13 mass shootings. After a semiautomatic weapon ban was instituted in 1996 there have been none. The U.S. ban on military style weapons lapsed in 2004. While it is difficult to characterize “mass shootings” in a country our size, there certainly seems to be an increase since then. If defined as “four or more shot and/or killed in a single event, at the same general time and location not including the shooter,” then we have seen 275 mass shootings this year as of Oct. 5, 2017.
The other statistics are familiar and sobering. More Americans have died from guns since 1968 than have died in all the wars since our country’s inception. The United States accounts for 91% of gun deaths of children among developed countries. Our casualty figures more closely mirror Somalia and Honduras, not Britain or Germany.
Contemporary, large-scale research in limiting gun violence is essentially nonexistent since a 1993 Centers for Disease Control and Prevention (CDC) funded study found a link between keeping a gun in the home with an increased risk of homicide. Quick to respond, Congress passed the 1996 Dickey Amendment that prohibits the CDC from funding efforts that “advocate or promote gun control.” This amendment has been renewed every year despite the author of the bill, Representative Jay Dickey, expressing regret for halting all gun research, stating that was not his intention. Rep. Dickey died earlier this year.
In the U.S., gun laws have actually relaxed over time. In 1988, 18 states had laws allowing civilians to carry concealed hand guns in public places, now this practice is legal in 40 states. In a 2008 landmark decision, the Supreme Court struck down a personal handgun ban in the District of Columbia. The Second Amendment rights afforded to a “well-regulated militia” to “keep and bear arms” were now extended to private individuals. Guns are clearly more prevalent and available in the U.S. than ever before.
The congressional ban on firearms research now extends to all Department of Health and Human Services agencies, including the NIH. We need the Dickey Amendment lifted so we can study the relationship of gun ownership and crime. As physicians, we need to deal from an informed, intelligent position and not an emotional one.
Over 50 medical societies, comprising essentially every physician in the U.S., have released statements on gun violence. The AMA has labeled it a “public health crisis.” The ACS stated, in the aftermath of the Las Vegas shooting, “It is important that the American College of Surgeons, whose Fellows care for the victims of these events, be part of the solution.”
Aside from ethical or moral obligations, why should we dive into this quagmire? Most of us are already represented in the discussion through other groups. The answer lies in our identity. If vascular surgery is to become a truly independent specialty, we can’t hide behind the ACS or the AMA when the politics become sticky.
To protect the 30,000 people who die from aneurysm rupture yearly we literally forced an act of Congress. Where do we stand on the more than 33,000 people who die yearly from gun violence? For vascular surgery to have a true public presence, we must be prepared to enter the most public of all discussions.
Luckily, there is already a pathway to consensus. The American College of Surgeons Committee on Trauma (ACS COT) surveyed its members and found that only 15% had no strong opinions on firearms. Just over 50% felt that guns were important for personal safety and defense, while 30% felt the large number of guns in the U.S. was a threat to safety.
Individuals who felt that firearms were important were most likely to associate guns with personal freedom, while those who felt they were a threat were most likely to associate guns with violence.
To further the discussion, the emotional battle between personal freedom and violence needed to be minimized. In doing so, the ACS COT was able to produce a consensus statement despite the seemingly diametrically opposed opinions of its members.
An independent specialty needs an independent voice. If we don’t know our own position, obviously the public doesn’t either.
As a starting point, here is the ACS Statement on Firearms Injuries:
Because violence inflicted by guns continues to be a daily event in the United States and mass casualties involving firearms threaten the health and safety of the public, the American College of Surgeons supports:
1. Legislation banning civilian access to assault weapons, large ammunition clips, and munitions designed for military and law enforcement agencies.
2. Enhancing mandatory background checks for the purchase of firearms to include gun shows and auctions.
3. Assuring that health care professionals can fulfill their role in preventing firearm injuries by health screening, patient counseling, and referral to mental health services for those with behavioral medical conditions. 4. Developing and promoting proactive programs directed at improving safe gun storage and the teaching of nonviolent conflict resolution for a culture that often glorifies guns and violence in media and gaming.
5. Evidence-based research on firearm injury and the creation of a national firearm injury database to inform federal health policy.
Selected References
1) Gun Violence Research: History of Federal Funding Freeze (www.apa.org/science/about/psa/2013/02/gun-violence.aspx)
2) Childhood Firearm Injuries in the United States (www.apa.org/science/about/psa/2013/02/gun-violence.aspx)
3) Gun Violence Letter to the U.S. House of Representatives (2013) (www.acponline.org/acp_policy/letters/gun_violence_letter_house_2013.pdf)
4) Survey of American College of Surgeons Committee on Trauma members on firearm injury: Consensus and opportunities (2016) (www.facs.org).
5) American College of Surgeons Statement on Firearm Injuries (www.facs.org)
Studies have shown that most of you already have deep-seated beliefs regarding guns. Some of you would frame the issue as Gun Rights, others as Gun Violence. I am not here to change your opinion. I am not in the habit of wasting my time. Logic has been drained from this discussion and emotion infused. As vascular surgeons, it is far past time to overcome these limitations and join the national discussion. Opinions and consensus statements have already been rendered from the American College of Surgeons, the American Medical Association, the American Academy of Pediatrics, the Society of Thoracic Surgeons, and even the American College of Phlebology. Where does the SVS stand?
In January 2013, the Board of Directors of the SVS voted to support the ACS Statement on Firearm Injuries. There is virtually no public record of this endorsement, it does not appear on the SVS website and it was essentially ignored by the public.
Even the diligent National Rifle Association (NRA) left the SVS off their list of “National Organizations with Anti-Gun Policies” (Ed note: for more information, see “The Evolution of the NRA and Our Modern Gun Debate” at www.vascularspecialistonline.com).
We need to do better. If we are truly an independent specialty it is time to behave as such. Vascular surgeons are on the front lines of this battle. We have cared for the injured, revived the dying, and bear witness to the dead. To not have a voice and be counted is a disservice to our patients and ourselves.
What can be done to reduce gun violence? In Australia, between 1979 and 1996, there were 13 mass shootings. After a semiautomatic weapon ban was instituted in 1996 there have been none. The U.S. ban on military style weapons lapsed in 2004. While it is difficult to characterize “mass shootings” in a country our size, there certainly seems to be an increase since then. If defined as “four or more shot and/or killed in a single event, at the same general time and location not including the shooter,” then we have seen 275 mass shootings this year as of Oct. 5, 2017.
The other statistics are familiar and sobering. More Americans have died from guns since 1968 than have died in all the wars since our country’s inception. The United States accounts for 91% of gun deaths of children among developed countries. Our casualty figures more closely mirror Somalia and Honduras, not Britain or Germany.
Contemporary, large-scale research in limiting gun violence is essentially nonexistent since a 1993 Centers for Disease Control and Prevention (CDC) funded study found a link between keeping a gun in the home with an increased risk of homicide. Quick to respond, Congress passed the 1996 Dickey Amendment that prohibits the CDC from funding efforts that “advocate or promote gun control.” This amendment has been renewed every year despite the author of the bill, Representative Jay Dickey, expressing regret for halting all gun research, stating that was not his intention. Rep. Dickey died earlier this year.
In the U.S., gun laws have actually relaxed over time. In 1988, 18 states had laws allowing civilians to carry concealed hand guns in public places, now this practice is legal in 40 states. In a 2008 landmark decision, the Supreme Court struck down a personal handgun ban in the District of Columbia. The Second Amendment rights afforded to a “well-regulated militia” to “keep and bear arms” were now extended to private individuals. Guns are clearly more prevalent and available in the U.S. than ever before.
The congressional ban on firearms research now extends to all Department of Health and Human Services agencies, including the NIH. We need the Dickey Amendment lifted so we can study the relationship of gun ownership and crime. As physicians, we need to deal from an informed, intelligent position and not an emotional one.
Over 50 medical societies, comprising essentially every physician in the U.S., have released statements on gun violence. The AMA has labeled it a “public health crisis.” The ACS stated, in the aftermath of the Las Vegas shooting, “It is important that the American College of Surgeons, whose Fellows care for the victims of these events, be part of the solution.”
Aside from ethical or moral obligations, why should we dive into this quagmire? Most of us are already represented in the discussion through other groups. The answer lies in our identity. If vascular surgery is to become a truly independent specialty, we can’t hide behind the ACS or the AMA when the politics become sticky.
To protect the 30,000 people who die from aneurysm rupture yearly we literally forced an act of Congress. Where do we stand on the more than 33,000 people who die yearly from gun violence? For vascular surgery to have a true public presence, we must be prepared to enter the most public of all discussions.
Luckily, there is already a pathway to consensus. The American College of Surgeons Committee on Trauma (ACS COT) surveyed its members and found that only 15% had no strong opinions on firearms. Just over 50% felt that guns were important for personal safety and defense, while 30% felt the large number of guns in the U.S. was a threat to safety.
Individuals who felt that firearms were important were most likely to associate guns with personal freedom, while those who felt they were a threat were most likely to associate guns with violence.
To further the discussion, the emotional battle between personal freedom and violence needed to be minimized. In doing so, the ACS COT was able to produce a consensus statement despite the seemingly diametrically opposed opinions of its members.
An independent specialty needs an independent voice. If we don’t know our own position, obviously the public doesn’t either.
As a starting point, here is the ACS Statement on Firearms Injuries:
Because violence inflicted by guns continues to be a daily event in the United States and mass casualties involving firearms threaten the health and safety of the public, the American College of Surgeons supports:
1. Legislation banning civilian access to assault weapons, large ammunition clips, and munitions designed for military and law enforcement agencies.
2. Enhancing mandatory background checks for the purchase of firearms to include gun shows and auctions.
3. Assuring that health care professionals can fulfill their role in preventing firearm injuries by health screening, patient counseling, and referral to mental health services for those with behavioral medical conditions. 4. Developing and promoting proactive programs directed at improving safe gun storage and the teaching of nonviolent conflict resolution for a culture that often glorifies guns and violence in media and gaming.
5. Evidence-based research on firearm injury and the creation of a national firearm injury database to inform federal health policy.
Selected References
1) Gun Violence Research: History of Federal Funding Freeze (www.apa.org/science/about/psa/2013/02/gun-violence.aspx)
2) Childhood Firearm Injuries in the United States (www.apa.org/science/about/psa/2013/02/gun-violence.aspx)
3) Gun Violence Letter to the U.S. House of Representatives (2013) (www.acponline.org/acp_policy/letters/gun_violence_letter_house_2013.pdf)
4) Survey of American College of Surgeons Committee on Trauma members on firearm injury: Consensus and opportunities (2016) (www.facs.org).
5) American College of Surgeons Statement on Firearm Injuries (www.facs.org)