Veith's Views

Today all we hear about is the high cost of U.S. health care, and how for our country to survive economically, it must cut doctors’ payments and spend less for health care, drugs, and medical devices. Certainly there is waste in the system and some physicians perform procedures that are unnecessary. But when one really needs good medical care and a good doctor, they are priceless.

Two recent dramatic examples in my own family made this clear to me. In one, a loved one developed a staphylococcal infection at an epidural injection site. Within 24 hours, she was desperately ill with a temperature of 104º, shaking chills, and excruciating back pain. She was expeditiously admitted to the ICU of an excellent community hospital and started on massive IV antibiotics. She underwent an urgent MRI, which revealed a paravertebral phlegmon. Blood cultures grew Staphyloccus aureus. She was seen repeatedly by her intensive care specialist and her orthopedic surgeon. When she did not improve, her orthopedic surgeon obtained a second MRI 36 hours after the first one. This, unlike the first, revealed an epidural collection, and she promptly underwent a three segment laminectomy to drain the abscess.

Although she required a second drainage procedure and careful adjustment of her IV antibiotics, she survived without any neurologic or cardiac damage. During her complicated and onerous 2½ weeks in the ICU, she was seen 2-3 times a day by both her intensivist and orthopedic surgeon, as well as by a variety of other specialists when they were needed. All made essential contributions to her recovery from this life-threatening illness. The skill and commitment of all these doctors, especially the orthopedic surgeon and the intensivist, made the difference in saving this young life. The care she received was priceless.

The second instance involved the cure of a life-threatening ventricular arrhythmia in a relatively young, productive individual. Although asymptomatic, this individual was having over 40,000 ventricular premature beats with runs of ventricular tachycardia in a 24-hour period. A highly skilled team of super-specialists in cardiac radiofrequency ablation procedures successfully eliminated the focus of these arrhythmias. However, the procedure was difficult and complicated. It took 7 hours and required both left and right heart catheterizations and crossing of the atrial septum and the aortic valve. Despite this, the individual was back at his usual work in 3 days, completely arrhythmia free. He has required no further subsequent treatment.

In both instances, the good care required by these skilled specialists and their colleagues was complicated and demanding but successful. It required enormous expertise and, more importantly, the commitment and dedication of those providing it. Sure, this care was expensive, but it was worth every penny. It was priceless, because the outcomes were life-saving and perfect. These priceless treatments restored two young, productive people to full health.

So in this rush to cut health care costs, let us remember that we in the United States have the best physicians and surgeons, the best hospitals, the best drugs, and medical devices in the world. Let us preserve these assets and not kill the goose that is laying the golden eggs of health care. Let us preserve and reward the priceless individuals and priceless care that can allow many of us in the United States to lead better, more productive lives than we otherwise would.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

Today all we hear about is the high cost of U.S. health care, and how for our country to survive economically, it must cut doctors’ payments and spend less for health care, drugs, and medical devices. Certainly there is waste in the system and some physicians perform procedures that are unnecessary. But when one really needs good medical care and a good doctor, they are priceless.

Two recent dramatic examples in my own family made this clear to me. In one, a loved one developed a staphylococcal infection at an epidural injection site. Within 24 hours, she was desperately ill with a temperature of 104º, shaking chills, and excruciating back pain. She was expeditiously admitted to the ICU of an excellent community hospital and started on massive IV antibiotics. She underwent an urgent MRI, which revealed a paravertebral phlegmon. Blood cultures grew Staphyloccus aureus. She was seen repeatedly by her intensive care specialist and her orthopedic surgeon. When she did not improve, her orthopedic surgeon obtained a second MRI 36 hours after the first one. This, unlike the first, revealed an epidural collection, and she promptly underwent a three segment laminectomy to drain the abscess.

Although she required a second drainage procedure and careful adjustment of her IV antibiotics, she survived without any neurologic or cardiac damage. During her complicated and onerous 2½ weeks in the ICU, she was seen 2-3 times a day by both her intensivist and orthopedic surgeon, as well as by a variety of other specialists when they were needed. All made essential contributions to her recovery from this life-threatening illness. The skill and commitment of all these doctors, especially the orthopedic surgeon and the intensivist, made the difference in saving this young life. The care she received was priceless.

The second instance involved the cure of a life-threatening ventricular arrhythmia in a relatively young, productive individual. Although asymptomatic, this individual was having over 40,000 ventricular premature beats with runs of ventricular tachycardia in a 24-hour period. A highly skilled team of super-specialists in cardiac radiofrequency ablation procedures successfully eliminated the focus of these arrhythmias. However, the procedure was difficult and complicated. It took 7 hours and required both left and right heart catheterizations and crossing of the atrial septum and the aortic valve. Despite this, the individual was back at his usual work in 3 days, completely arrhythmia free. He has required no further subsequent treatment.

In both instances, the good care required by these skilled specialists and their colleagues was complicated and demanding but successful. It required enormous expertise and, more importantly, the commitment and dedication of those providing it. Sure, this care was expensive, but it was worth every penny. It was priceless, because the outcomes were life-saving and perfect. These priceless treatments restored two young, productive people to full health.

So in this rush to cut health care costs, let us remember that we in the United States have the best physicians and surgeons, the best hospitals, the best drugs, and medical devices in the world. Let us preserve these assets and not kill the goose that is laying the golden eggs of health care. Let us preserve and reward the priceless individuals and priceless care that can allow many of us in the United States to lead better, more productive lives than we otherwise would.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

Today all we hear about is the high cost of U.S. health care, and how for our country to survive economically, it must cut doctors’ payments and spend less for health care, drugs, and medical devices. Certainly there is waste in the system and some physicians perform procedures that are unnecessary. But when one really needs good medical care and a good doctor, they are priceless.

Two recent dramatic examples in my own family made this clear to me. In one, a loved one developed a staphylococcal infection at an epidural injection site. Within 24 hours, she was desperately ill with a temperature of 104º, shaking chills, and excruciating back pain. She was expeditiously admitted to the ICU of an excellent community hospital and started on massive IV antibiotics. She underwent an urgent MRI, which revealed a paravertebral phlegmon. Blood cultures grew Staphyloccus aureus. She was seen repeatedly by her intensive care specialist and her orthopedic surgeon. When she did not improve, her orthopedic surgeon obtained a second MRI 36 hours after the first one. This, unlike the first, revealed an epidural collection, and she promptly underwent a three segment laminectomy to drain the abscess.

Although she required a second drainage procedure and careful adjustment of her IV antibiotics, she survived without any neurologic or cardiac damage. During her complicated and onerous 2½ weeks in the ICU, she was seen 2-3 times a day by both her intensivist and orthopedic surgeon, as well as by a variety of other specialists when they were needed. All made essential contributions to her recovery from this life-threatening illness. The skill and commitment of all these doctors, especially the orthopedic surgeon and the intensivist, made the difference in saving this young life. The care she received was priceless.

The second instance involved the cure of a life-threatening ventricular arrhythmia in a relatively young, productive individual. Although asymptomatic, this individual was having over 40,000 ventricular premature beats with runs of ventricular tachycardia in a 24-hour period. A highly skilled team of super-specialists in cardiac radiofrequency ablation procedures successfully eliminated the focus of these arrhythmias. However, the procedure was difficult and complicated. It took 7 hours and required both left and right heart catheterizations and crossing of the atrial septum and the aortic valve. Despite this, the individual was back at his usual work in 3 days, completely arrhythmia free. He has required no further subsequent treatment.

In both instances, the good care required by these skilled specialists and their colleagues was complicated and demanding but successful. It required enormous expertise and, more importantly, the commitment and dedication of those providing it. Sure, this care was expensive, but it was worth every penny. It was priceless, because the outcomes were life-saving and perfect. These priceless treatments restored two young, productive people to full health.

So in this rush to cut health care costs, let us remember that we in the United States have the best physicians and surgeons, the best hospitals, the best drugs, and medical devices in the world. Let us preserve these assets and not kill the goose that is laying the golden eggs of health care. Let us preserve and reward the priceless individuals and priceless care that can allow many of us in the United States to lead better, more productive lives than we otherwise would.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

"For every complex problem, there is an answer that is clear, simple, and wrong."

– H.L. Mencken

Every time I think about trying to solve the complex problems of surgical workforce, I am reminded of that great line from H.L. Mencken.

Some of our troubles began in 1975, when we tried to estimate the need for a surgical workforce. In the Report on the Manpower Subcommittee, written for the Study on Surgical Services for the United States, Dr. F.D. Moore called for moderating (that is, lowering) the output of surgical residents: "Better to have birth control, that is to say, control of the total residency programs, than abortion" (Ann. Surg. 1975;182:526-30). By that, he meant we should control the numbers coming in rather than have more failures by the American Board of Surgery. He was in favor of limiting output.

Similarly, COGME (Council of Graduate Medical Education) in 1992 also recommended fewer specialists and more primary care. In its Summary of the Third Report, Improving Access to Health Care Through Physician Workforce Reform: Directions for the 21st Century, COGME recommended reducing the number of physicians entering residency from 140% to 110% of the number of graduates of medical schools in the United States in 1993 and increasing the percentage of graduates who complete training and enter practice as generalists from the then-current level of 30% to 50%.

COGME was authorized by Congress in 1986 to provide an ongoing assessment of physician workforce trends, training issues, and financing policies, and to recommend appropriate federal and private sector efforts to address identified needs. Its authority was removed and it was disbanded in 2004 in part because its projections were wrong so many times that its recommendations had to be reversed.

Many individuals have criticized the recommendations that there are too many physicians and particularly surgeons in the country. Some of the most vocal critics, and some with the best actual data, are Dr. George Sheldon, Dr. Thomas Ricketts, and Dr. Richard Cooper.

I believe there is little question that we have a maldistribution of the surgical workforce, particularly in the rural setting, and we also have an absolute "undersupply" to address the nation’s surgical needs. What compounds this undersupply is the Balanced Budget Act of 1997, which put a ceiling on the number of residency slots paid for through Medicare.

In the current era of tighter Congressional fiscal control, I am not optimistic that the federal government will make available more money for graduate medical education. In fact, there is a continual threat that the current allocations for GME under Medicare will be reduced. Alternatives must be sought, and the one that comes to mind for most is an "all users fee" (actually a tax) that might include insurance carriers, hospitals, nursing homes, and so on.

Work by Dr. Atul Gawande and his colleagues indicates that the average American undergoes nine invasive procedures in a lifetime: three endoscopies, three outpatient procedures, and three inpatient procedures. I have already used up all of mine, so I am definitely looking for answers.

How can we pay for what we need, encourage young people to join the profession, attract students who are very lifestyle conscious, and keep the high standard and ethos we were brought up with? One of the consistent complaints surgical leaders hear from the men and women actually delivering surgical care is how poorly trained some graduates are when they become practicing surgeons. My friends in private practice say that this as one of our most serious workforce issues.

I recently had the opportunity to learn about a small group of surgical educators who are applying the "Ashley" rule, named after Stan Ashley when he was chairman of the American Board of Surgery. The Ashley rule gives flexibility to surgical trainees to "major" in certain subspecialties of surgery during their residency. Research being spearheaded by Dr. Mary Klingensmith, an ACS Fellow at Washington University in St. Louis, consists of a group of nine training programs across the country that will be used to study application of the Ashley rule. This self-appointed group has taken on the responsibility of trying to fix a least one part of the vast workforce issue we have through a new "innovation."

This is how the group describes innovation: "In this training paradigm, graduates will be able to spend additional months of training in their area of interest, will be able to spend this focused time sooner than traditional fellowship training allows, and will streamline and improve the experiences for all trainees in a single program as each will be afforded a more ‘customized’ training experience [including rural surgery]. As a result, graduates will finish training with additional clinical experience in their area of intended eventual practice; the likely effect of this has two primary outcomes: First, graduates will possess greater comfort with independent practice immediately following training, an issue that has been raised with some graduates of surgical programs since the advent of the duty hour restrictions; second, graduates will be better prepared to provide quality surgical care to their patients, with improved outcomes."

This new research is a refinement of the work many of us did as part of the American Surgical Association Blue Ribbon Committee on Surgical Education, which led to this recommendation: "There needs to be acceptance of the reality that most surgeons will confine the scope of their practices to meet definable goals. This should lead to earlier differentiation into goal-oriented specialty tracks" (Ann. Surg. 2005;241:1-8).

The new work may not solve all of the issues confronting surgical education in the United States, but it’s an important start by serious surgical educators. It will be interesting to watch and see how this work develops.

Dr. Zinner is an ACS Fellow and surgeon in chief at Brigham and Women’s Hospital in Boston.

"For every complex problem, there is an answer that is clear, simple, and wrong."

– H.L. Mencken

Every time I think about trying to solve the complex problems of surgical workforce, I am reminded of that great line from H.L. Mencken.

Some of our troubles began in 1975, when we tried to estimate the need for a surgical workforce. In the Report on the Manpower Subcommittee, written for the Study on Surgical Services for the United States, Dr. F.D. Moore called for moderating (that is, lowering) the output of surgical residents: "Better to have birth control, that is to say, control of the total residency programs, than abortion" (Ann. Surg. 1975;182:526-30). By that, he meant we should control the numbers coming in rather than have more failures by the American Board of Surgery. He was in favor of limiting output.

Similarly, COGME (Council of Graduate Medical Education) in 1992 also recommended fewer specialists and more primary care. In its Summary of the Third Report, Improving Access to Health Care Through Physician Workforce Reform: Directions for the 21st Century, COGME recommended reducing the number of physicians entering residency from 140% to 110% of the number of graduates of medical schools in the United States in 1993 and increasing the percentage of graduates who complete training and enter practice as generalists from the then-current level of 30% to 50%.

COGME was authorized by Congress in 1986 to provide an ongoing assessment of physician workforce trends, training issues, and financing policies, and to recommend appropriate federal and private sector efforts to address identified needs. Its authority was removed and it was disbanded in 2004 in part because its projections were wrong so many times that its recommendations had to be reversed.

Many individuals have criticized the recommendations that there are too many physicians and particularly surgeons in the country. Some of the most vocal critics, and some with the best actual data, are Dr. George Sheldon, Dr. Thomas Ricketts, and Dr. Richard Cooper.

I believe there is little question that we have a maldistribution of the surgical workforce, particularly in the rural setting, and we also have an absolute "undersupply" to address the nation’s surgical needs. What compounds this undersupply is the Balanced Budget Act of 1997, which put a ceiling on the number of residency slots paid for through Medicare.

In the current era of tighter Congressional fiscal control, I am not optimistic that the federal government will make available more money for graduate medical education. In fact, there is a continual threat that the current allocations for GME under Medicare will be reduced. Alternatives must be sought, and the one that comes to mind for most is an "all users fee" (actually a tax) that might include insurance carriers, hospitals, nursing homes, and so on.

Work by Dr. Atul Gawande and his colleagues indicates that the average American undergoes nine invasive procedures in a lifetime: three endoscopies, three outpatient procedures, and three inpatient procedures. I have already used up all of mine, so I am definitely looking for answers.

How can we pay for what we need, encourage young people to join the profession, attract students who are very lifestyle conscious, and keep the high standard and ethos we were brought up with? One of the consistent complaints surgical leaders hear from the men and women actually delivering surgical care is how poorly trained some graduates are when they become practicing surgeons. My friends in private practice say that this as one of our most serious workforce issues.

I recently had the opportunity to learn about a small group of surgical educators who are applying the "Ashley" rule, named after Stan Ashley when he was chairman of the American Board of Surgery. The Ashley rule gives flexibility to surgical trainees to "major" in certain subspecialties of surgery during their residency. Research being spearheaded by Dr. Mary Klingensmith, an ACS Fellow at Washington University in St. Louis, consists of a group of nine training programs across the country that will be used to study application of the Ashley rule. This self-appointed group has taken on the responsibility of trying to fix a least one part of the vast workforce issue we have through a new "innovation."

This is how the group describes innovation: "In this training paradigm, graduates will be able to spend additional months of training in their area of interest, will be able to spend this focused time sooner than traditional fellowship training allows, and will streamline and improve the experiences for all trainees in a single program as each will be afforded a more ‘customized’ training experience [including rural surgery]. As a result, graduates will finish training with additional clinical experience in their area of intended eventual practice; the likely effect of this has two primary outcomes: First, graduates will possess greater comfort with independent practice immediately following training, an issue that has been raised with some graduates of surgical programs since the advent of the duty hour restrictions; second, graduates will be better prepared to provide quality surgical care to their patients, with improved outcomes."

This new research is a refinement of the work many of us did as part of the American Surgical Association Blue Ribbon Committee on Surgical Education, which led to this recommendation: "There needs to be acceptance of the reality that most surgeons will confine the scope of their practices to meet definable goals. This should lead to earlier differentiation into goal-oriented specialty tracks" (Ann. Surg. 2005;241:1-8).

The new work may not solve all of the issues confronting surgical education in the United States, but it’s an important start by serious surgical educators. It will be interesting to watch and see how this work develops.

Dr. Zinner is an ACS Fellow and surgeon in chief at Brigham and Women’s Hospital in Boston.

"For every complex problem, there is an answer that is clear, simple, and wrong."

– H.L. Mencken

Every time I think about trying to solve the complex problems of surgical workforce, I am reminded of that great line from H.L. Mencken.

Some of our troubles began in 1975, when we tried to estimate the need for a surgical workforce. In the Report on the Manpower Subcommittee, written for the Study on Surgical Services for the United States, Dr. F.D. Moore called for moderating (that is, lowering) the output of surgical residents: "Better to have birth control, that is to say, control of the total residency programs, than abortion" (Ann. Surg. 1975;182:526-30). By that, he meant we should control the numbers coming in rather than have more failures by the American Board of Surgery. He was in favor of limiting output.

Similarly, COGME (Council of Graduate Medical Education) in 1992 also recommended fewer specialists and more primary care. In its Summary of the Third Report, Improving Access to Health Care Through Physician Workforce Reform: Directions for the 21st Century, COGME recommended reducing the number of physicians entering residency from 140% to 110% of the number of graduates of medical schools in the United States in 1993 and increasing the percentage of graduates who complete training and enter practice as generalists from the then-current level of 30% to 50%.

COGME was authorized by Congress in 1986 to provide an ongoing assessment of physician workforce trends, training issues, and financing policies, and to recommend appropriate federal and private sector efforts to address identified needs. Its authority was removed and it was disbanded in 2004 in part because its projections were wrong so many times that its recommendations had to be reversed.

Many individuals have criticized the recommendations that there are too many physicians and particularly surgeons in the country. Some of the most vocal critics, and some with the best actual data, are Dr. George Sheldon, Dr. Thomas Ricketts, and Dr. Richard Cooper.

I believe there is little question that we have a maldistribution of the surgical workforce, particularly in the rural setting, and we also have an absolute "undersupply" to address the nation’s surgical needs. What compounds this undersupply is the Balanced Budget Act of 1997, which put a ceiling on the number of residency slots paid for through Medicare.

In the current era of tighter Congressional fiscal control, I am not optimistic that the federal government will make available more money for graduate medical education. In fact, there is a continual threat that the current allocations for GME under Medicare will be reduced. Alternatives must be sought, and the one that comes to mind for most is an "all users fee" (actually a tax) that might include insurance carriers, hospitals, nursing homes, and so on.

Work by Dr. Atul Gawande and his colleagues indicates that the average American undergoes nine invasive procedures in a lifetime: three endoscopies, three outpatient procedures, and three inpatient procedures. I have already used up all of mine, so I am definitely looking for answers.

How can we pay for what we need, encourage young people to join the profession, attract students who are very lifestyle conscious, and keep the high standard and ethos we were brought up with? One of the consistent complaints surgical leaders hear from the men and women actually delivering surgical care is how poorly trained some graduates are when they become practicing surgeons. My friends in private practice say that this as one of our most serious workforce issues.

I recently had the opportunity to learn about a small group of surgical educators who are applying the "Ashley" rule, named after Stan Ashley when he was chairman of the American Board of Surgery. The Ashley rule gives flexibility to surgical trainees to "major" in certain subspecialties of surgery during their residency. Research being spearheaded by Dr. Mary Klingensmith, an ACS Fellow at Washington University in St. Louis, consists of a group of nine training programs across the country that will be used to study application of the Ashley rule. This self-appointed group has taken on the responsibility of trying to fix a least one part of the vast workforce issue we have through a new "innovation."

This is how the group describes innovation: "In this training paradigm, graduates will be able to spend additional months of training in their area of interest, will be able to spend this focused time sooner than traditional fellowship training allows, and will streamline and improve the experiences for all trainees in a single program as each will be afforded a more ‘customized’ training experience [including rural surgery]. As a result, graduates will finish training with additional clinical experience in their area of intended eventual practice; the likely effect of this has two primary outcomes: First, graduates will possess greater comfort with independent practice immediately following training, an issue that has been raised with some graduates of surgical programs since the advent of the duty hour restrictions; second, graduates will be better prepared to provide quality surgical care to their patients, with improved outcomes."

This new research is a refinement of the work many of us did as part of the American Surgical Association Blue Ribbon Committee on Surgical Education, which led to this recommendation: "There needs to be acceptance of the reality that most surgeons will confine the scope of their practices to meet definable goals. This should lead to earlier differentiation into goal-oriented specialty tracks" (Ann. Surg. 2005;241:1-8).

The new work may not solve all of the issues confronting surgical education in the United States, but it’s an important start by serious surgical educators. It will be interesting to watch and see how this work develops.

Dr. Zinner is an ACS Fellow and surgeon in chief at Brigham and Women’s Hospital in Boston.

(Editor's Note: Read Dr. George Andros' introduction to this installment of Veith's Viewpoint.)

The Affordable Care Act (ACA) has the laudable goals of extending health care insurance coverage and reducing overall health care costs. However, hidden in the more than 2400 pages of this bill are a number of provisions, many still unrecognized, which will have detrimental effects on our national economy and the quality of care our health system delivers to society.

One such damaging initiative within the ACA is the thrust to increase the reimbursement for primary care providers and to compensate for this increase by decreasing reimbursement to specialty care providers. Is this a good thing?

Yes, we will need more primary care physicians to do what they do for our increasingly elderly population. The ACA will provide a financial incentive to increase the numbers of such physicians. And yes, health care costs are spiraling upward, and part of this spiral is due to the over-utilization of coronary, carotid and lower extremity stents and other procedures in patients who are not benefited by them or who are actually harmed by them.

Such over-utilization was recently documented in the lead article on the front page of the New York Times (August 7, 2012). This over-utilization of specialty care may be diminished somewhat if the guilty specialists receive less compensation per case.

However, the decreased specialist reimbursement may also have the paradoxical effect of prompting the unethical specialists to do even more unnecessary cases to maintain their incomes. There should be better, more direct ways to stop unnecessary procedures than shifting specialist reimbursement to primary care physicians.

Restoring ethical behavior to physicians and considering how best to modify the reimbursement system to be a disincentive to such bad practices are beyond the scope of this commentary. However, we should examine more carefully the negative effects and unintended consequences of shifting specialist reimbursement to primary care providers.

To do this we have to examine the question: "Who today gets patients who are really sick with an organic problem well?"

It is not primary care physicians. They play valuable roles in preventive medicine, in providing simple care, in comforting and reassuring patients while their self-limited disease runs its course, in recognizing serious illness, and in directing patients to appropriate specialists when needed.

Many of these functions, although very valuable and necessary, could be fulfilled by a trained nurse practitioner or a physician’s assistant and do not require a highly paid primary care physician.

On the other hand, in today’s high tech and complicated medical world, it is the highly trained medical specialist who gets patients well when they have a serious life- or limb-threatening illness. Such skilled specialists can place a coronary stent to prevent or treat an otherwise fatal or disabling myocardial infarction.

Other specialists can ablate a focus of an otherwise fatal cardiac arrhythmia. Still others can exclude an aortic aneurysm before or after it ruptures, or revascularize and save a severely ischemic limb. Other specialists can remove a variety of cancers, reconstruct a destroyed hip or fix other serious problems within the head, chest, abdomen or other parts of the body.

These skilled specialists have to work hard and devote years and long hours to be trained and to maintain their skills. They have to be available 24/7 to provide emergency treatment when minutes and hours make a difference, and they have to take the risks of failure including exposure to medical liability. For these skills, risks and their commitment, they deserve to be highly compensated in keeping with other professions that have similar requirements.

If reimbursement to such specialists is diminished, clearly the level of care that they provide – the care that really makes a difference to patients – will also be diminished. We will be sacrificing the geese that lay the golden eggs of medicine in the U. S. today, and health care will suffer.

This unintended consequence of diminished specialist reimbursement has occurred in other countries where specialists are underpaid.

Thus, as we go about the difficult task of reforming our health care system, decreasing unnecessary procedures and cutting overall costs, we must be sure to preserve what is great about our system and some of the exemplary care it provides. Most of this care is delivered by specialists, and we must be careful to continue to motivate them appropriately.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

(Editor's Note: Read Dr. George Andros' introduction to this installment of Veith's Viewpoint.)

The Affordable Care Act (ACA) has the laudable goals of extending health care insurance coverage and reducing overall health care costs. However, hidden in the more than 2400 pages of this bill are a number of provisions, many still unrecognized, which will have detrimental effects on our national economy and the quality of care our health system delivers to society.

One such damaging initiative within the ACA is the thrust to increase the reimbursement for primary care providers and to compensate for this increase by decreasing reimbursement to specialty care providers. Is this a good thing?

Yes, we will need more primary care physicians to do what they do for our increasingly elderly population. The ACA will provide a financial incentive to increase the numbers of such physicians. And yes, health care costs are spiraling upward, and part of this spiral is due to the over-utilization of coronary, carotid and lower extremity stents and other procedures in patients who are not benefited by them or who are actually harmed by them.

Such over-utilization was recently documented in the lead article on the front page of the New York Times (August 7, 2012). This over-utilization of specialty care may be diminished somewhat if the guilty specialists receive less compensation per case.

However, the decreased specialist reimbursement may also have the paradoxical effect of prompting the unethical specialists to do even more unnecessary cases to maintain their incomes. There should be better, more direct ways to stop unnecessary procedures than shifting specialist reimbursement to primary care physicians.

Restoring ethical behavior to physicians and considering how best to modify the reimbursement system to be a disincentive to such bad practices are beyond the scope of this commentary. However, we should examine more carefully the negative effects and unintended consequences of shifting specialist reimbursement to primary care providers.

To do this we have to examine the question: "Who today gets patients who are really sick with an organic problem well?"

It is not primary care physicians. They play valuable roles in preventive medicine, in providing simple care, in comforting and reassuring patients while their self-limited disease runs its course, in recognizing serious illness, and in directing patients to appropriate specialists when needed.

Many of these functions, although very valuable and necessary, could be fulfilled by a trained nurse practitioner or a physician’s assistant and do not require a highly paid primary care physician.

On the other hand, in today’s high tech and complicated medical world, it is the highly trained medical specialist who gets patients well when they have a serious life- or limb-threatening illness. Such skilled specialists can place a coronary stent to prevent or treat an otherwise fatal or disabling myocardial infarction.

Other specialists can ablate a focus of an otherwise fatal cardiac arrhythmia. Still others can exclude an aortic aneurysm before or after it ruptures, or revascularize and save a severely ischemic limb. Other specialists can remove a variety of cancers, reconstruct a destroyed hip or fix other serious problems within the head, chest, abdomen or other parts of the body.

These skilled specialists have to work hard and devote years and long hours to be trained and to maintain their skills. They have to be available 24/7 to provide emergency treatment when minutes and hours make a difference, and they have to take the risks of failure including exposure to medical liability. For these skills, risks and their commitment, they deserve to be highly compensated in keeping with other professions that have similar requirements.

If reimbursement to such specialists is diminished, clearly the level of care that they provide – the care that really makes a difference to patients – will also be diminished. We will be sacrificing the geese that lay the golden eggs of medicine in the U. S. today, and health care will suffer.

This unintended consequence of diminished specialist reimbursement has occurred in other countries where specialists are underpaid.

Thus, as we go about the difficult task of reforming our health care system, decreasing unnecessary procedures and cutting overall costs, we must be sure to preserve what is great about our system and some of the exemplary care it provides. Most of this care is delivered by specialists, and we must be careful to continue to motivate them appropriately.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

(Editor's Note: Read Dr. George Andros' introduction to this installment of Veith's Viewpoint.)

The Affordable Care Act (ACA) has the laudable goals of extending health care insurance coverage and reducing overall health care costs. However, hidden in the more than 2400 pages of this bill are a number of provisions, many still unrecognized, which will have detrimental effects on our national economy and the quality of care our health system delivers to society.

One such damaging initiative within the ACA is the thrust to increase the reimbursement for primary care providers and to compensate for this increase by decreasing reimbursement to specialty care providers. Is this a good thing?

Yes, we will need more primary care physicians to do what they do for our increasingly elderly population. The ACA will provide a financial incentive to increase the numbers of such physicians. And yes, health care costs are spiraling upward, and part of this spiral is due to the over-utilization of coronary, carotid and lower extremity stents and other procedures in patients who are not benefited by them or who are actually harmed by them.

Such over-utilization was recently documented in the lead article on the front page of the New York Times (August 7, 2012). This over-utilization of specialty care may be diminished somewhat if the guilty specialists receive less compensation per case.

However, the decreased specialist reimbursement may also have the paradoxical effect of prompting the unethical specialists to do even more unnecessary cases to maintain their incomes. There should be better, more direct ways to stop unnecessary procedures than shifting specialist reimbursement to primary care physicians.

Restoring ethical behavior to physicians and considering how best to modify the reimbursement system to be a disincentive to such bad practices are beyond the scope of this commentary. However, we should examine more carefully the negative effects and unintended consequences of shifting specialist reimbursement to primary care providers.

To do this we have to examine the question: "Who today gets patients who are really sick with an organic problem well?"

It is not primary care physicians. They play valuable roles in preventive medicine, in providing simple care, in comforting and reassuring patients while their self-limited disease runs its course, in recognizing serious illness, and in directing patients to appropriate specialists when needed.

Many of these functions, although very valuable and necessary, could be fulfilled by a trained nurse practitioner or a physician’s assistant and do not require a highly paid primary care physician.

On the other hand, in today’s high tech and complicated medical world, it is the highly trained medical specialist who gets patients well when they have a serious life- or limb-threatening illness. Such skilled specialists can place a coronary stent to prevent or treat an otherwise fatal or disabling myocardial infarction.

Other specialists can ablate a focus of an otherwise fatal cardiac arrhythmia. Still others can exclude an aortic aneurysm before or after it ruptures, or revascularize and save a severely ischemic limb. Other specialists can remove a variety of cancers, reconstruct a destroyed hip or fix other serious problems within the head, chest, abdomen or other parts of the body.

These skilled specialists have to work hard and devote years and long hours to be trained and to maintain their skills. They have to be available 24/7 to provide emergency treatment when minutes and hours make a difference, and they have to take the risks of failure including exposure to medical liability. For these skills, risks and their commitment, they deserve to be highly compensated in keeping with other professions that have similar requirements.

If reimbursement to such specialists is diminished, clearly the level of care that they provide – the care that really makes a difference to patients – will also be diminished. We will be sacrificing the geese that lay the golden eggs of medicine in the U. S. today, and health care will suffer.

This unintended consequence of diminished specialist reimbursement has occurred in other countries where specialists are underpaid.

Thus, as we go about the difficult task of reforming our health care system, decreasing unnecessary procedures and cutting overall costs, we must be sure to preserve what is great about our system and some of the exemplary care it provides. Most of this care is delivered by specialists, and we must be careful to continue to motivate them appropriately.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

When the Society for Vascular Surgery (SVS) was approached to become involved in assessing vascular out-patient centers (OEC) the Clinical Practices Committee (CPC) convened to examine this topic that was arousing so much interest and concern among providers and patients.

After reviewing the preliminary CPC assessment, the SVS leadership asked two of the committee to develop an editorial for publication in Vascular Specialist. The intent is to survey the SVS membership on this increasingly relevant issue.

So click on the editorial. Read it. And take the easy online, interactive survey at the bottom.

Your views ARE important. They will help shape how SVS deals with this important issue going forward. Let us know your opinions about OECs. There is room for comment after each survey question, but if you have a lengthier opinion, please take the survey and then e-mail us your in-depth comments at vascularspecialist@elsevier.com.

When the Society for Vascular Surgery (SVS) was approached to become involved in assessing vascular out-patient centers (OEC) the Clinical Practices Committee (CPC) convened to examine this topic that was arousing so much interest and concern among providers and patients.

After reviewing the preliminary CPC assessment, the SVS leadership asked two of the committee to develop an editorial for publication in Vascular Specialist. The intent is to survey the SVS membership on this increasingly relevant issue.

So click on the editorial. Read it. And take the easy online, interactive survey at the bottom.

Your views ARE important. They will help shape how SVS deals with this important issue going forward. Let us know your opinions about OECs. There is room for comment after each survey question, but if you have a lengthier opinion, please take the survey and then e-mail us your in-depth comments at vascularspecialist@elsevier.com.

When the Society for Vascular Surgery (SVS) was approached to become involved in assessing vascular out-patient centers (OEC) the Clinical Practices Committee (CPC) convened to examine this topic that was arousing so much interest and concern among providers and patients.

After reviewing the preliminary CPC assessment, the SVS leadership asked two of the committee to develop an editorial for publication in Vascular Specialist. The intent is to survey the SVS membership on this increasingly relevant issue.

So click on the editorial. Read it. And take the easy online, interactive survey at the bottom.

Your views ARE important. They will help shape how SVS deals with this important issue going forward. Let us know your opinions about OECs. There is room for comment after each survey question, but if you have a lengthier opinion, please take the survey and then e-mail us your in-depth comments at vascularspecialist@elsevier.com.

Vascular surgery is an exciting field. It also faces enormous challenges. These include a difficult economic climate and intense competition from other specialties, both interventional and surgical. Vascular surgery has certain assets, such as its commitment only to the management of vascular disease and its ability to provide medical, open surgical and interventional treatments, depending on which is best for the patient. However, these assets are balanced by liabilities, such as impaired access to interventional suites, the public perception that other specialties can provide better less invasive treatments, and weak influence or power within institutions or departments.

These liabilities are real and impact on both individual vascular surgeons and the specialty as a whole. It is because of these liabilities that vascular surgery has only maintained a degree of stability despite the enormous growth in the number of vascular patients and the introduction of exciting new means of treating these patients less invasively, more safely and more effectively.

How can we overcome these liabilities and make our specialty survive and prosper? The answer is creativity. If we develop new and better ways to manage and treat vascular patients and let the world know we are the innovators, our specialty will grow and prosper. Patients will seek out those that developed the new and better treatments and come to them. Having more patients needing treatment will increase the influence and power of vascular surgeons within institutions and departments.

Let’s look at some examples. I have had experience with three. The first was so-called limb salvage surgery. In the 1960s and 1970s, no one was interested in patients with toe and foot gangrene. However, as techniques were developed to improve the limb circulation in such patients, they flocked to those who could provide these treatments, even though many physicians and surgeons expressed doubts and skepticism about their value.

Later, when less invasive interventional treatments were also developed for improving the circulation, again patients sought out the centers that could provide them. Sure, the open and endovascular treatments for these ischemic problems were difficult to perform. They required skill and commitment. But when they worked, patients found out about them and requested them. The skeptics were eventually proven wrong, and creativity was rewarded.

However, even today skeptics exist with regard to some newer endovascular treatments below the inguinal ligament. I suspect they will again be proven wrong as the treatments improve and indications for use are crystalized.

A second example was endovascular grafts and EVAR. In the beginning, after Juan Parodi’s first demonstration of feasibility, these procedures were regarded with enormous skepticism and even derision. Complications and failures were highlighted by many. But as the techniques and devices were made better, results improved. Innovating vascular surgeons and centers gained in stature, and their patient loads increased. Creativity in developing new and better treatments reaped its rewards for individual surgeons, institutions, and our specialty.

A third example is the newer endovenous treatments to ablate the greater saphenous and other veins less invasively. These treatments work, and because of their less invasive nature, patients seek out those who perform them. This has opened up a new treatment area of opportunity for vascular surgeons. It now comprises a large portion of many vascular surgeons’ practices.

The three examples I have mentioned are now accepted areas of treatment in vascular surgery – all introduced largely by vascular surgeons. All three have also been adopted by other specialists, and there is nothing wrong with that. However, what are we to do about the uncertain future?

We vascular surgeons must continue to be creative. We must devise newer and better techniques for treating vascular disease. We must publicize and document the fact that these innovations have been made by vascular surgeons. This requires not only scientific publication but also an effective public relations campaign on all levels.

For vascular surgeons these new or better techniques can be medical, interventional or open surgical. Examples of medical treatment are those that slow the growth of aneurysms or the development and progression of atherosclerotic lesions.

Patients will seek out these creative improvements and come to the practitioners or centers that provide them. When they do, they will also return when they need a subsequent intervention or open surgical treatment. Our success as vascular surgeons will be enhanced.

The same is true for innovative, safer or better endovascular or open surgical procedures. When properly documented in the scientific peer-reviewed literature and appropriately publicized in the lay media, this creativity will enhance the stature and importance of Vascular Surgery.

Even though we exist in a highly competitive and difficult environment, this creativity more than anything else will help individual vascular surgeons and vascular surgery in general to survive and prosper.n

Dr. Frank J. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or publisher.

Vascular surgery is an exciting field. It also faces enormous challenges. These include a difficult economic climate and intense competition from other specialties, both interventional and surgical. Vascular surgery has certain assets, such as its commitment only to the management of vascular disease and its ability to provide medical, open surgical and interventional treatments, depending on which is best for the patient. However, these assets are balanced by liabilities, such as impaired access to interventional suites, the public perception that other specialties can provide better less invasive treatments, and weak influence or power within institutions or departments.

These liabilities are real and impact on both individual vascular surgeons and the specialty as a whole. It is because of these liabilities that vascular surgery has only maintained a degree of stability despite the enormous growth in the number of vascular patients and the introduction of exciting new means of treating these patients less invasively, more safely and more effectively.

How can we overcome these liabilities and make our specialty survive and prosper? The answer is creativity. If we develop new and better ways to manage and treat vascular patients and let the world know we are the innovators, our specialty will grow and prosper. Patients will seek out those that developed the new and better treatments and come to them. Having more patients needing treatment will increase the influence and power of vascular surgeons within institutions and departments.

Let’s look at some examples. I have had experience with three. The first was so-called limb salvage surgery. In the 1960s and 1970s, no one was interested in patients with toe and foot gangrene. However, as techniques were developed to improve the limb circulation in such patients, they flocked to those who could provide these treatments, even though many physicians and surgeons expressed doubts and skepticism about their value.

Later, when less invasive interventional treatments were also developed for improving the circulation, again patients sought out the centers that could provide them. Sure, the open and endovascular treatments for these ischemic problems were difficult to perform. They required skill and commitment. But when they worked, patients found out about them and requested them. The skeptics were eventually proven wrong, and creativity was rewarded.

However, even today skeptics exist with regard to some newer endovascular treatments below the inguinal ligament. I suspect they will again be proven wrong as the treatments improve and indications for use are crystalized.

A second example was endovascular grafts and EVAR. In the beginning, after Juan Parodi’s first demonstration of feasibility, these procedures were regarded with enormous skepticism and even derision. Complications and failures were highlighted by many. But as the techniques and devices were made better, results improved. Innovating vascular surgeons and centers gained in stature, and their patient loads increased. Creativity in developing new and better treatments reaped its rewards for individual surgeons, institutions, and our specialty.

A third example is the newer endovenous treatments to ablate the greater saphenous and other veins less invasively. These treatments work, and because of their less invasive nature, patients seek out those who perform them. This has opened up a new treatment area of opportunity for vascular surgeons. It now comprises a large portion of many vascular surgeons’ practices.

The three examples I have mentioned are now accepted areas of treatment in vascular surgery – all introduced largely by vascular surgeons. All three have also been adopted by other specialists, and there is nothing wrong with that. However, what are we to do about the uncertain future?

We vascular surgeons must continue to be creative. We must devise newer and better techniques for treating vascular disease. We must publicize and document the fact that these innovations have been made by vascular surgeons. This requires not only scientific publication but also an effective public relations campaign on all levels.

For vascular surgeons these new or better techniques can be medical, interventional or open surgical. Examples of medical treatment are those that slow the growth of aneurysms or the development and progression of atherosclerotic lesions.

Patients will seek out these creative improvements and come to the practitioners or centers that provide them. When they do, they will also return when they need a subsequent intervention or open surgical treatment. Our success as vascular surgeons will be enhanced.

The same is true for innovative, safer or better endovascular or open surgical procedures. When properly documented in the scientific peer-reviewed literature and appropriately publicized in the lay media, this creativity will enhance the stature and importance of Vascular Surgery.

Even though we exist in a highly competitive and difficult environment, this creativity more than anything else will help individual vascular surgeons and vascular surgery in general to survive and prosper.n

Dr. Frank J. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or publisher.

Vascular surgery is an exciting field. It also faces enormous challenges. These include a difficult economic climate and intense competition from other specialties, both interventional and surgical. Vascular surgery has certain assets, such as its commitment only to the management of vascular disease and its ability to provide medical, open surgical and interventional treatments, depending on which is best for the patient. However, these assets are balanced by liabilities, such as impaired access to interventional suites, the public perception that other specialties can provide better less invasive treatments, and weak influence or power within institutions or departments.

These liabilities are real and impact on both individual vascular surgeons and the specialty as a whole. It is because of these liabilities that vascular surgery has only maintained a degree of stability despite the enormous growth in the number of vascular patients and the introduction of exciting new means of treating these patients less invasively, more safely and more effectively.

How can we overcome these liabilities and make our specialty survive and prosper? The answer is creativity. If we develop new and better ways to manage and treat vascular patients and let the world know we are the innovators, our specialty will grow and prosper. Patients will seek out those that developed the new and better treatments and come to them. Having more patients needing treatment will increase the influence and power of vascular surgeons within institutions and departments.

Let’s look at some examples. I have had experience with three. The first was so-called limb salvage surgery. In the 1960s and 1970s, no one was interested in patients with toe and foot gangrene. However, as techniques were developed to improve the limb circulation in such patients, they flocked to those who could provide these treatments, even though many physicians and surgeons expressed doubts and skepticism about their value.

Later, when less invasive interventional treatments were also developed for improving the circulation, again patients sought out the centers that could provide them. Sure, the open and endovascular treatments for these ischemic problems were difficult to perform. They required skill and commitment. But when they worked, patients found out about them and requested them. The skeptics were eventually proven wrong, and creativity was rewarded.

However, even today skeptics exist with regard to some newer endovascular treatments below the inguinal ligament. I suspect they will again be proven wrong as the treatments improve and indications for use are crystalized.

A second example was endovascular grafts and EVAR. In the beginning, after Juan Parodi’s first demonstration of feasibility, these procedures were regarded with enormous skepticism and even derision. Complications and failures were highlighted by many. But as the techniques and devices were made better, results improved. Innovating vascular surgeons and centers gained in stature, and their patient loads increased. Creativity in developing new and better treatments reaped its rewards for individual surgeons, institutions, and our specialty.

A third example is the newer endovenous treatments to ablate the greater saphenous and other veins less invasively. These treatments work, and because of their less invasive nature, patients seek out those who perform them. This has opened up a new treatment area of opportunity for vascular surgeons. It now comprises a large portion of many vascular surgeons’ practices.

The three examples I have mentioned are now accepted areas of treatment in vascular surgery – all introduced largely by vascular surgeons. All three have also been adopted by other specialists, and there is nothing wrong with that. However, what are we to do about the uncertain future?

We vascular surgeons must continue to be creative. We must devise newer and better techniques for treating vascular disease. We must publicize and document the fact that these innovations have been made by vascular surgeons. This requires not only scientific publication but also an effective public relations campaign on all levels.

For vascular surgeons these new or better techniques can be medical, interventional or open surgical. Examples of medical treatment are those that slow the growth of aneurysms or the development and progression of atherosclerotic lesions.

Patients will seek out these creative improvements and come to the practitioners or centers that provide them. When they do, they will also return when they need a subsequent intervention or open surgical treatment. Our success as vascular surgeons will be enhanced.

The same is true for innovative, safer or better endovascular or open surgical procedures. When properly documented in the scientific peer-reviewed literature and appropriately publicized in the lay media, this creativity will enhance the stature and importance of Vascular Surgery.

Even though we exist in a highly competitive and difficult environment, this creativity more than anything else will help individual vascular surgeons and vascular surgery in general to survive and prosper.n

Dr. Frank J. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or publisher.

The Affordable Care Act (ACA) has the laudable goals of extending health care insurance coverage and reducing overall health care costs. However, hidden in the over 2,400 pages of this bill are a number of provisions, many as yet unrecognized, which will have detrimental effects on our national economy, multiple parts of the health care industry, as well as most medical practitioners. 

One of the most onerous aspects of the ACA is the Sunshine Act, which is intended to bring transparency to any and all financial relationships between industry and physicians. This ACA provision mandates that everything a drug company or medical device maker provides to a physician must be disclosed and, after September 30, 2013, it must be published in detail on the Internet.

These disclosures must include pens, thumb drives, shirts and meals, as well as grants for research or travel to present data at meetings and consultant fees for proctoring cases in which new devices are used by physicians unfamiliar with them.

The purpose of this provision is to expose any financial bias or conflict of interest which might increase costs or influence and thereby corrupt research findings, medical education and ultimately medical practice.

On its face governmental involvement in this area might seem justified by the facts that such financial conflicts might lead to care which is unnecessary or harmful to patients (the public), and that government and the taxpayer are largely paying the bills.

Moreover, there have been a few flagrant abuses of the industry-doctor financial relationship in which conflicts of interest have risen to the level of gross commercialism with physicians receiving outlandish sums for providing fraudulent data or promoting drugs or products in a way unjustified by the scientific evidence. So the goal of providing more transparency to the financial relationships between industry and doctors seems a reasonable one.

Don't be fooled. The Sunshine Act's specifics are anything but reasonable. Doctors' judgments and actions are clearly not going to be corrupted by a pen, a thumb drive, or a meal.

It is also reasonable that physicians be compensated fairly for the time spent away from their practice in providing consultant services, participating in educational activities or conducting industry sponsored research, some of which produces valid and important scientific data unobtainable without industry support.

The JUPITER trial is one such example, proving the value of statins in decreasing strokes and myocardial infarctions in high-risk patients with normal lipid profiles. To lump funds received from industry for such meritorious activities together with excessive financial rewards for unjustified promotional activity, as the Sunshine Act's reporting will do, is unfair.

Doctors should not be presumed to be corrupt just because they are paid for legitimate services -- just as are all other professionals.

In addition, the Sunshine Act will require industry to expend many millions of dollars in tedious record keeping and documentation of multiple miniscule details. This plus the implication of taint will discourage relationships between industry and physicians which will have many detrimental effects on medical education and more importantly on U.S. medical innovation.

The latter is already lagging far behind that in other parts of the developed world because of stringent FDA requirements. All these unintended consequences of the Sunshine Act will have a profound negative effect on patient care in our country and thus be harmful to the U.S. public at large.

There are two possible solutions to the problems resulting from the Sunshine Act in its present form. The first is to remove the negativism and unfairness of its reporting requirement by several modifications. The requirement of reporting small and trivial items like pens, thumb drives and meals should be eliminated.

Reporting of only substantial sums in excess of $10,000 or $25,000 should be required. This would decrease markedly the administrative burden of Sunshine reporting.

Moreover, it should be mandated that all funds received from industry by a physician not be listed as a lump sum, but be qualified by the time involved and the type of service rendered.

Just because a physician receives a large payment does not mean it is evil, a bribe, or unjustified. In all other fields, excellence, creativity, knowledge, contribution, and time commitment are rewarded financially, and this should be the case in the industry-doctor relationship arena as well.

A second solution to fix the Sunshine Act and make it fair is to apply all its provisions to Members of Congress and all other elected and non-elected employees of our Federal Government.

After all, just like medical practitioners and those in the health care industry, our federal officials -- and employees -- actions impact on the well-being of our society, and all these individuals in government are paid by the taxpayers.

So let's be fair and apply the same Sunshine Act reporting requirements to those in government to avoid corruption of their actions by unfair and opaque conflicts of interest.

Thus, the Sunshine Act should be fixed. More importantly ,the transparency of its requirements should be allowed to shine on Congress and other federal employees who are paid by the public to support its interests.

If these two corrective actions cannot be taken, the Sunshine Act should be done away with entirely.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist. 

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

The Affordable Care Act (ACA) has the laudable goals of extending health care insurance coverage and reducing overall health care costs. However, hidden in the over 2,400 pages of this bill are a number of provisions, many as yet unrecognized, which will have detrimental effects on our national economy, multiple parts of the health care industry, as well as most medical practitioners. 

One of the most onerous aspects of the ACA is the Sunshine Act, which is intended to bring transparency to any and all financial relationships between industry and physicians. This ACA provision mandates that everything a drug company or medical device maker provides to a physician must be disclosed and, after September 30, 2013, it must be published in detail on the Internet.

These disclosures must include pens, thumb drives, shirts and meals, as well as grants for research or travel to present data at meetings and consultant fees for proctoring cases in which new devices are used by physicians unfamiliar with them.

The purpose of this provision is to expose any financial bias or conflict of interest which might increase costs or influence and thereby corrupt research findings, medical education and ultimately medical practice.

On its face governmental involvement in this area might seem justified by the facts that such financial conflicts might lead to care which is unnecessary or harmful to patients (the public), and that government and the taxpayer are largely paying the bills.

Moreover, there have been a few flagrant abuses of the industry-doctor financial relationship in which conflicts of interest have risen to the level of gross commercialism with physicians receiving outlandish sums for providing fraudulent data or promoting drugs or products in a way unjustified by the scientific evidence. So the goal of providing more transparency to the financial relationships between industry and doctors seems a reasonable one.

Don't be fooled. The Sunshine Act's specifics are anything but reasonable. Doctors' judgments and actions are clearly not going to be corrupted by a pen, a thumb drive, or a meal.

It is also reasonable that physicians be compensated fairly for the time spent away from their practice in providing consultant services, participating in educational activities or conducting industry sponsored research, some of which produces valid and important scientific data unobtainable without industry support.

The JUPITER trial is one such example, proving the value of statins in decreasing strokes and myocardial infarctions in high-risk patients with normal lipid profiles. To lump funds received from industry for such meritorious activities together with excessive financial rewards for unjustified promotional activity, as the Sunshine Act's reporting will do, is unfair.

Doctors should not be presumed to be corrupt just because they are paid for legitimate services -- just as are all other professionals.

In addition, the Sunshine Act will require industry to expend many millions of dollars in tedious record keeping and documentation of multiple miniscule details. This plus the implication of taint will discourage relationships between industry and physicians which will have many detrimental effects on medical education and more importantly on U.S. medical innovation.

The latter is already lagging far behind that in other parts of the developed world because of stringent FDA requirements. All these unintended consequences of the Sunshine Act will have a profound negative effect on patient care in our country and thus be harmful to the U.S. public at large.

There are two possible solutions to the problems resulting from the Sunshine Act in its present form. The first is to remove the negativism and unfairness of its reporting requirement by several modifications. The requirement of reporting small and trivial items like pens, thumb drives and meals should be eliminated.

Reporting of only substantial sums in excess of $10,000 or $25,000 should be required. This would decrease markedly the administrative burden of Sunshine reporting.

Moreover, it should be mandated that all funds received from industry by a physician not be listed as a lump sum, but be qualified by the time involved and the type of service rendered.

Just because a physician receives a large payment does not mean it is evil, a bribe, or unjustified. In all other fields, excellence, creativity, knowledge, contribution, and time commitment are rewarded financially, and this should be the case in the industry-doctor relationship arena as well.

A second solution to fix the Sunshine Act and make it fair is to apply all its provisions to Members of Congress and all other elected and non-elected employees of our Federal Government.

After all, just like medical practitioners and those in the health care industry, our federal officials -- and employees -- actions impact on the well-being of our society, and all these individuals in government are paid by the taxpayers.

So let's be fair and apply the same Sunshine Act reporting requirements to those in government to avoid corruption of their actions by unfair and opaque conflicts of interest.

Thus, the Sunshine Act should be fixed. More importantly ,the transparency of its requirements should be allowed to shine on Congress and other federal employees who are paid by the public to support its interests.

If these two corrective actions cannot be taken, the Sunshine Act should be done away with entirely.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist. 

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

The Affordable Care Act (ACA) has the laudable goals of extending health care insurance coverage and reducing overall health care costs. However, hidden in the over 2,400 pages of this bill are a number of provisions, many as yet unrecognized, which will have detrimental effects on our national economy, multiple parts of the health care industry, as well as most medical practitioners. 

One of the most onerous aspects of the ACA is the Sunshine Act, which is intended to bring transparency to any and all financial relationships between industry and physicians. This ACA provision mandates that everything a drug company or medical device maker provides to a physician must be disclosed and, after September 30, 2013, it must be published in detail on the Internet.

These disclosures must include pens, thumb drives, shirts and meals, as well as grants for research or travel to present data at meetings and consultant fees for proctoring cases in which new devices are used by physicians unfamiliar with them.

The purpose of this provision is to expose any financial bias or conflict of interest which might increase costs or influence and thereby corrupt research findings, medical education and ultimately medical practice.

On its face governmental involvement in this area might seem justified by the facts that such financial conflicts might lead to care which is unnecessary or harmful to patients (the public), and that government and the taxpayer are largely paying the bills.

Moreover, there have been a few flagrant abuses of the industry-doctor financial relationship in which conflicts of interest have risen to the level of gross commercialism with physicians receiving outlandish sums for providing fraudulent data or promoting drugs or products in a way unjustified by the scientific evidence. So the goal of providing more transparency to the financial relationships between industry and doctors seems a reasonable one.

Don't be fooled. The Sunshine Act's specifics are anything but reasonable. Doctors' judgments and actions are clearly not going to be corrupted by a pen, a thumb drive, or a meal.

It is also reasonable that physicians be compensated fairly for the time spent away from their practice in providing consultant services, participating in educational activities or conducting industry sponsored research, some of which produces valid and important scientific data unobtainable without industry support.

The JUPITER trial is one such example, proving the value of statins in decreasing strokes and myocardial infarctions in high-risk patients with normal lipid profiles. To lump funds received from industry for such meritorious activities together with excessive financial rewards for unjustified promotional activity, as the Sunshine Act's reporting will do, is unfair.

Doctors should not be presumed to be corrupt just because they are paid for legitimate services -- just as are all other professionals.

In addition, the Sunshine Act will require industry to expend many millions of dollars in tedious record keeping and documentation of multiple miniscule details. This plus the implication of taint will discourage relationships between industry and physicians which will have many detrimental effects on medical education and more importantly on U.S. medical innovation.

The latter is already lagging far behind that in other parts of the developed world because of stringent FDA requirements. All these unintended consequences of the Sunshine Act will have a profound negative effect on patient care in our country and thus be harmful to the U.S. public at large.

There are two possible solutions to the problems resulting from the Sunshine Act in its present form. The first is to remove the negativism and unfairness of its reporting requirement by several modifications. The requirement of reporting small and trivial items like pens, thumb drives and meals should be eliminated.

Reporting of only substantial sums in excess of $10,000 or $25,000 should be required. This would decrease markedly the administrative burden of Sunshine reporting.

Moreover, it should be mandated that all funds received from industry by a physician not be listed as a lump sum, but be qualified by the time involved and the type of service rendered.

Just because a physician receives a large payment does not mean it is evil, a bribe, or unjustified. In all other fields, excellence, creativity, knowledge, contribution, and time commitment are rewarded financially, and this should be the case in the industry-doctor relationship arena as well.

A second solution to fix the Sunshine Act and make it fair is to apply all its provisions to Members of Congress and all other elected and non-elected employees of our Federal Government.

After all, just like medical practitioners and those in the health care industry, our federal officials -- and employees -- actions impact on the well-being of our society, and all these individuals in government are paid by the taxpayers.

So let's be fair and apply the same Sunshine Act reporting requirements to those in government to avoid corruption of their actions by unfair and opaque conflicts of interest.

Thus, the Sunshine Act should be fixed. More importantly ,the transparency of its requirements should be allowed to shine on Congress and other federal employees who are paid by the public to support its interests.

If these two corrective actions cannot be taken, the Sunshine Act should be done away with entirely.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist. 

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

Vascular patients who most need treatment are often difficult and risky to treat by open operation or an endovascular intervention. In contrast, patients who least need invasive treatment or need it not at all usually have lesions that are easy to treat with good results. Examples are patients with advanced gangrene versus those with intermittent claudication; symptomatic patients with carotid artery stenosis versus those who are asymptomatic; patients with large abdominal aortic aneurysms versus those with small lesions.

This paradoxical situation occurs because most vascular lesions, particularly those associated with atherosclerosis, are in their early phases benign, cause minimal or no symptoms, and are unassociated with widespread vascular disease.

Moreover, many of these lesions, particularly with statins and other good medical therapy, will remain stable for long periods. These early lesions are technically easy to treat invasively, although such treatment may provide little or no benefit to the patient.

In contrast, only when lesions advance, become more complex and are associated with a widely diseased arterial system do they become threatening to life, limb, and the brain. These latter lesions are usually much harder to treat both by transcatheter or open operative techniques. This situation gives rise to several consequences relating to physician judgment, procedural outcomes, physician and institutional incomes, health care costs and ethical considerations.

Everyone in the vascular field should recognize and face these issues.

To help do so, let us examine some of these issues as they relate to the common problem of carotid bifurcation stenosis. High grade stenosis at this site, even when asymptomatic, can cause some strokes. Level 1 evidence from the so-called landmark asymptomatic trials (ACAS, ACST), which randomized patients from 1990-2003, showed significant stroke prevention from carotid endarterectomy (CEA) compared to medical treatment.

However, the benefit was slight (stroke rates were reduced from about 2% per year to about 1% per year), and there have been substantial improvements in medical treatments over the last decade to prevent strokes with statins and other measures. Carotid artery stenting (CAS) has also become a commonly used treatment to prevent strokes in asymptomatic carotid stenosis patients, although there is no convincing evidence that such treatment is more effective than current medical treatment in most if not all of these patients.

In addition, there is no solid evidence that CEA in asymptomatic patients prevents strokes more effectively than current medical treatment. Yet in the United States, 70%-90% of CEAs and 70%-96% of CAS procedures are performed on asymptomatic patients.

Should this be and how does the vascular disease paradox relate to this situation?

Vascular surgeons and interventionalists from all specialties want to continue to intervene on most of these asymptomatic carotid stenosis patients for several reasons. These include gratifyingly good outcomes from treating these usually simple, low-risk asymptomatic lesions and provision of income to physicians and hospitals.

These good outcomes also provide many accessory benefits to the treating physicians and surgeons by improving their overall results, a desirable goal in view of looming audits and pay-for-performance incentives. Also, increasing case numbers help practitioners to meet credentialing requirements.

However, there are negatives to continuing to perform large numbers of invasive treatments on asymptomatic carotid stenosis patients. One is the high cost to our health care system of providing these large numbers of invasive treatments largely to a group of patients who will derive little or no benefit. Another is the possibility that more patients will be harmed than helped.

Clearly what is needed are better ways to detect the asymptomatic patient at high risk for having a stroke so only those patients can be treated invasively. Although no such method is universally accepted, there are glimmers of hope that one or more will be proven effective.

Also needed are trials to establish the effectiveness of current medical therapy for stroke prevention in patients with asymptomatic carotid stenosis. However, such trials will not be simple to design because of the benign nature of most asymptomatic lesions. Thus, such trials will have to be conducted in patients selected to have more risky lesions.

Until such information is available, all practitioners should exercise restraint in treating patients with asymptomatic carotid stenosis invasively. They should not be seduced into treating simply because of the ease of treatment or the good outcomes – the vascular disease paradox. It is risk-benefit ratio that is more important. Physicians and surgeons should recognize that the landmark trials on this subject are now outdated, and should restrict such invasive treatment in some way to fewer patients than in the past – perhaps those with an increasing or very high grade (pinhole) stenosis or a contralateral occlusion.

Finally, it should be noted that a proposal to provide reimbursement for performing CAS on standard and low-risk carotid stenosis patients, including asymptomatic patients, is currently being considered by Medicare.

It is likely that some support for this proposal stems from the facts that lesions in such patients are easy to treat and the results of treatment are excellent. This is the vascular disease paradox which should be recognized and dealt with by all in the field.n

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

Vascular patients who most need treatment are often difficult and risky to treat by open operation or an endovascular intervention. In contrast, patients who least need invasive treatment or need it not at all usually have lesions that are easy to treat with good results. Examples are patients with advanced gangrene versus those with intermittent claudication; symptomatic patients with carotid artery stenosis versus those who are asymptomatic; patients with large abdominal aortic aneurysms versus those with small lesions.

This paradoxical situation occurs because most vascular lesions, particularly those associated with atherosclerosis, are in their early phases benign, cause minimal or no symptoms, and are unassociated with widespread vascular disease.

Moreover, many of these lesions, particularly with statins and other good medical therapy, will remain stable for long periods. These early lesions are technically easy to treat invasively, although such treatment may provide little or no benefit to the patient.

In contrast, only when lesions advance, become more complex and are associated with a widely diseased arterial system do they become threatening to life, limb, and the brain. These latter lesions are usually much harder to treat both by transcatheter or open operative techniques. This situation gives rise to several consequences relating to physician judgment, procedural outcomes, physician and institutional incomes, health care costs and ethical considerations.

Everyone in the vascular field should recognize and face these issues.

To help do so, let us examine some of these issues as they relate to the common problem of carotid bifurcation stenosis. High grade stenosis at this site, even when asymptomatic, can cause some strokes. Level 1 evidence from the so-called landmark asymptomatic trials (ACAS, ACST), which randomized patients from 1990-2003, showed significant stroke prevention from carotid endarterectomy (CEA) compared to medical treatment.

However, the benefit was slight (stroke rates were reduced from about 2% per year to about 1% per year), and there have been substantial improvements in medical treatments over the last decade to prevent strokes with statins and other measures. Carotid artery stenting (CAS) has also become a commonly used treatment to prevent strokes in asymptomatic carotid stenosis patients, although there is no convincing evidence that such treatment is more effective than current medical treatment in most if not all of these patients.

In addition, there is no solid evidence that CEA in asymptomatic patients prevents strokes more effectively than current medical treatment. Yet in the United States, 70%-90% of CEAs and 70%-96% of CAS procedures are performed on asymptomatic patients.

Should this be and how does the vascular disease paradox relate to this situation?

Vascular surgeons and interventionalists from all specialties want to continue to intervene on most of these asymptomatic carotid stenosis patients for several reasons. These include gratifyingly good outcomes from treating these usually simple, low-risk asymptomatic lesions and provision of income to physicians and hospitals.

These good outcomes also provide many accessory benefits to the treating physicians and surgeons by improving their overall results, a desirable goal in view of looming audits and pay-for-performance incentives. Also, increasing case numbers help practitioners to meet credentialing requirements.

However, there are negatives to continuing to perform large numbers of invasive treatments on asymptomatic carotid stenosis patients. One is the high cost to our health care system of providing these large numbers of invasive treatments largely to a group of patients who will derive little or no benefit. Another is the possibility that more patients will be harmed than helped.

Clearly what is needed are better ways to detect the asymptomatic patient at high risk for having a stroke so only those patients can be treated invasively. Although no such method is universally accepted, there are glimmers of hope that one or more will be proven effective.

Also needed are trials to establish the effectiveness of current medical therapy for stroke prevention in patients with asymptomatic carotid stenosis. However, such trials will not be simple to design because of the benign nature of most asymptomatic lesions. Thus, such trials will have to be conducted in patients selected to have more risky lesions.

Until such information is available, all practitioners should exercise restraint in treating patients with asymptomatic carotid stenosis invasively. They should not be seduced into treating simply because of the ease of treatment or the good outcomes – the vascular disease paradox. It is risk-benefit ratio that is more important. Physicians and surgeons should recognize that the landmark trials on this subject are now outdated, and should restrict such invasive treatment in some way to fewer patients than in the past – perhaps those with an increasing or very high grade (pinhole) stenosis or a contralateral occlusion.

Finally, it should be noted that a proposal to provide reimbursement for performing CAS on standard and low-risk carotid stenosis patients, including asymptomatic patients, is currently being considered by Medicare.

It is likely that some support for this proposal stems from the facts that lesions in such patients are easy to treat and the results of treatment are excellent. This is the vascular disease paradox which should be recognized and dealt with by all in the field.n

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

Vascular patients who most need treatment are often difficult and risky to treat by open operation or an endovascular intervention. In contrast, patients who least need invasive treatment or need it not at all usually have lesions that are easy to treat with good results. Examples are patients with advanced gangrene versus those with intermittent claudication; symptomatic patients with carotid artery stenosis versus those who are asymptomatic; patients with large abdominal aortic aneurysms versus those with small lesions.

This paradoxical situation occurs because most vascular lesions, particularly those associated with atherosclerosis, are in their early phases benign, cause minimal or no symptoms, and are unassociated with widespread vascular disease.

Moreover, many of these lesions, particularly with statins and other good medical therapy, will remain stable for long periods. These early lesions are technically easy to treat invasively, although such treatment may provide little or no benefit to the patient.

In contrast, only when lesions advance, become more complex and are associated with a widely diseased arterial system do they become threatening to life, limb, and the brain. These latter lesions are usually much harder to treat both by transcatheter or open operative techniques. This situation gives rise to several consequences relating to physician judgment, procedural outcomes, physician and institutional incomes, health care costs and ethical considerations.

Everyone in the vascular field should recognize and face these issues.

To help do so, let us examine some of these issues as they relate to the common problem of carotid bifurcation stenosis. High grade stenosis at this site, even when asymptomatic, can cause some strokes. Level 1 evidence from the so-called landmark asymptomatic trials (ACAS, ACST), which randomized patients from 1990-2003, showed significant stroke prevention from carotid endarterectomy (CEA) compared to medical treatment.

However, the benefit was slight (stroke rates were reduced from about 2% per year to about 1% per year), and there have been substantial improvements in medical treatments over the last decade to prevent strokes with statins and other measures. Carotid artery stenting (CAS) has also become a commonly used treatment to prevent strokes in asymptomatic carotid stenosis patients, although there is no convincing evidence that such treatment is more effective than current medical treatment in most if not all of these patients.

In addition, there is no solid evidence that CEA in asymptomatic patients prevents strokes more effectively than current medical treatment. Yet in the United States, 70%-90% of CEAs and 70%-96% of CAS procedures are performed on asymptomatic patients.

Should this be and how does the vascular disease paradox relate to this situation?

Vascular surgeons and interventionalists from all specialties want to continue to intervene on most of these asymptomatic carotid stenosis patients for several reasons. These include gratifyingly good outcomes from treating these usually simple, low-risk asymptomatic lesions and provision of income to physicians and hospitals.

These good outcomes also provide many accessory benefits to the treating physicians and surgeons by improving their overall results, a desirable goal in view of looming audits and pay-for-performance incentives. Also, increasing case numbers help practitioners to meet credentialing requirements.

However, there are negatives to continuing to perform large numbers of invasive treatments on asymptomatic carotid stenosis patients. One is the high cost to our health care system of providing these large numbers of invasive treatments largely to a group of patients who will derive little or no benefit. Another is the possibility that more patients will be harmed than helped.

Clearly what is needed are better ways to detect the asymptomatic patient at high risk for having a stroke so only those patients can be treated invasively. Although no such method is universally accepted, there are glimmers of hope that one or more will be proven effective.

Also needed are trials to establish the effectiveness of current medical therapy for stroke prevention in patients with asymptomatic carotid stenosis. However, such trials will not be simple to design because of the benign nature of most asymptomatic lesions. Thus, such trials will have to be conducted in patients selected to have more risky lesions.

Until such information is available, all practitioners should exercise restraint in treating patients with asymptomatic carotid stenosis invasively. They should not be seduced into treating simply because of the ease of treatment or the good outcomes – the vascular disease paradox. It is risk-benefit ratio that is more important. Physicians and surgeons should recognize that the landmark trials on this subject are now outdated, and should restrict such invasive treatment in some way to fewer patients than in the past – perhaps those with an increasing or very high grade (pinhole) stenosis or a contralateral occlusion.

Finally, it should be noted that a proposal to provide reimbursement for performing CAS on standard and low-risk carotid stenosis patients, including asymptomatic patients, is currently being considered by Medicare.

It is likely that some support for this proposal stems from the facts that lesions in such patients are easy to treat and the results of treatment are excellent. This is the vascular disease paradox which should be recognized and dealt with by all in the field.n

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.

The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.

These are hard times for the United States. Our economy is floundering. Unemployment is high. Bankers and financiers seem to be getting away with immoral and even illegal actions. People are disgruntled and dissatisfied. Our government seems to be unable or unwilling to right the obvious wrongs or to get us out of the morass. There is general malaise.

I believe there is a common thread that underlies our present situation. It is the overarching attitude that behavior in our society is primarily determined by the WIIFM principle or ‘What’s in it for me’.

Let us look at some specific examples. Elected politicians in the executive and legislative branches of our federal government should make decisions on the basis of what is best for society and our country. Unfortunately this consideration is a minor motivation.

Uniformly our President and Congress do what is most likely to get themselves re-elected, i.e., what is best for them personally, not what is best for our country. They are constantly campaigning rather than governing. As a result, actions to support entrepreneurship and private job creation are not taken, and class warfare is encouraged because more votes will be gained than lost.

Attorneys who block tort reform are another example of the WIIFM principle. They must know that the present system is imperfect and costing our society billions of dollars, at least some of which are unjustified. Yet they spend millions supporting the re-election campaigns of legislators to block even a wisp of reform. Both the attorneys and the legislators who are influenced by this legal form of bribery are clearly guided by WIIFM. Society pays and suffers.

Similarly, bankers and others in the financial community, known collectively as Wall Street, guided by the WIIFM principle expend great efforts to preserve a system riddled with opaque derivative securities and other practices which benefit a few clever manipulators and harm our financial system and our society. Financial donations to politicians, again legalized bribery, and unfair executive compensation help to sustain a system in which rewards are far in excess of the value contributed to society.

Labor unions and their leaders are also substantially motivated by WIIFM. Otherwise they might compromise on demands to preserve unsustainable pension and benefit systems that are bankrupting our state and federal governments. The promise of votes and again contribution-associated influence over elected leaders are part of the toxic mix. Once again WIIFM triumphs over what is good for our overall economy and our country. The effort to close the job-creating Boeing plant in South Carolina and the pension preserving battles in Wisconsin and Ohio are glaring examples of the evils of WIIFM.

So also are the efforts of some to block any tax increase. If government waste, spending excesses, and unfair tax loopholes can be sharply diminished, reasonable tax increases can be considered part of a shared sacrifice for the common good of deficit reduction. All must acknowledge that our economic problems can only be solved by the compromise of such shared sacrifice. We will be better off in the long run and so will our progeny.

Physicians can also be motivated by the WIIFM principle. There is the temptation to maintain diminishing incomes at all costs – even by performing procedures that may not be fully indicated or justified, or by spending less than adequate time with individual patients. Our health care system is imperfect in many ways, but physicians too must resist the urge to be guided predominantly by WIIFM.

Finally there is the public at large. Are we guided in our voting by short-term WIIFM? Should we vote for the candidate who will lower our personal taxes the most in the next few years? Or should we vote for the individual who we believe will act in the best interests of our country at-large and its future long-term well-being?

We must all recognize the intrinsic dangers of being motivated excessively by WIIFM. Our country cannot survive and prosper if everyone pursues that motivation. We do not have the resources to do so. We must all display some of the courage, restraint, and spirit of compromise of our forefathers who took huge political and physical risks to found our country. They were motivated by a desire to do what was best for the country at large, to work for the greater good, to do what was right for the whole society. It often required self-denial, shared sacrifice, compromise, altruism, and the responsibility to act for the common good. The WIIFM principle had to be suppressed. The result was a United States of unparalleled greatness.

Today we are drifting away from that greatness. Aside from our military and a few other rare exceptions, the WIIFM principle seems to underlie that drift. Although some self-interest is acceptable and part of the human nature, we must all resist the temptation to make that our predominant motivation. Otherwise our country will decline, and we are doomed to failure.

Clearly, this recognition and movement away from WIIFM, this ‘me-first attitude’, this idea of ‘let someone else sacrifice’ should begin with our key political leaders. They must find the courage to do what is right for our country, and give up their WIIFM motivation of acting solely to get re-elected. If they can start the ball rolling in the right direction, surely other segments of society and indeed all of us should be able to follow.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is also an associate medical editor for Vascular Specialist.

The ideas and opinions expresssed in Vascular Specialist do not necessarily reflect those of the Society or the Publisher.

These are hard times for the United States. Our economy is floundering. Unemployment is high. Bankers and financiers seem to be getting away with immoral and even illegal actions. People are disgruntled and dissatisfied. Our government seems to be unable or unwilling to right the obvious wrongs or to get us out of the morass. There is general malaise.

I believe there is a common thread that underlies our present situation. It is the overarching attitude that behavior in our society is primarily determined by the WIIFM principle or ‘What’s in it for me’.

Let us look at some specific examples. Elected politicians in the executive and legislative branches of our federal government should make decisions on the basis of what is best for society and our country. Unfortunately this consideration is a minor motivation.

Uniformly our President and Congress do what is most likely to get themselves re-elected, i.e., what is best for them personally, not what is best for our country. They are constantly campaigning rather than governing. As a result, actions to support entrepreneurship and private job creation are not taken, and class warfare is encouraged because more votes will be gained than lost.

Attorneys who block tort reform are another example of the WIIFM principle. They must know that the present system is imperfect and costing our society billions of dollars, at least some of which are unjustified. Yet they spend millions supporting the re-election campaigns of legislators to block even a wisp of reform. Both the attorneys and the legislators who are influenced by this legal form of bribery are clearly guided by WIIFM. Society pays and suffers.

Similarly, bankers and others in the financial community, known collectively as Wall Street, guided by the WIIFM principle expend great efforts to preserve a system riddled with opaque derivative securities and other practices which benefit a few clever manipulators and harm our financial system and our society. Financial donations to politicians, again legalized bribery, and unfair executive compensation help to sustain a system in which rewards are far in excess of the value contributed to society.

Labor unions and their leaders are also substantially motivated by WIIFM. Otherwise they might compromise on demands to preserve unsustainable pension and benefit systems that are bankrupting our state and federal governments. The promise of votes and again contribution-associated influence over elected leaders are part of the toxic mix. Once again WIIFM triumphs over what is good for our overall economy and our country. The effort to close the job-creating Boeing plant in South Carolina and the pension preserving battles in Wisconsin and Ohio are glaring examples of the evils of WIIFM.

So also are the efforts of some to block any tax increase. If government waste, spending excesses, and unfair tax loopholes can be sharply diminished, reasonable tax increases can be considered part of a shared sacrifice for the common good of deficit reduction. All must acknowledge that our economic problems can only be solved by the compromise of such shared sacrifice. We will be better off in the long run and so will our progeny.

Physicians can also be motivated by the WIIFM principle. There is the temptation to maintain diminishing incomes at all costs – even by performing procedures that may not be fully indicated or justified, or by spending less than adequate time with individual patients. Our health care system is imperfect in many ways, but physicians too must resist the urge to be guided predominantly by WIIFM.

Finally there is the public at large. Are we guided in our voting by short-term WIIFM? Should we vote for the candidate who will lower our personal taxes the most in the next few years? Or should we vote for the individual who we believe will act in the best interests of our country at-large and its future long-term well-being?

We must all recognize the intrinsic dangers of being motivated excessively by WIIFM. Our country cannot survive and prosper if everyone pursues that motivation. We do not have the resources to do so. We must all display some of the courage, restraint, and spirit of compromise of our forefathers who took huge political and physical risks to found our country. They were motivated by a desire to do what was best for the country at large, to work for the greater good, to do what was right for the whole society. It often required self-denial, shared sacrifice, compromise, altruism, and the responsibility to act for the common good. The WIIFM principle had to be suppressed. The result was a United States of unparalleled greatness.

Today we are drifting away from that greatness. Aside from our military and a few other rare exceptions, the WIIFM principle seems to underlie that drift. Although some self-interest is acceptable and part of the human nature, we must all resist the temptation to make that our predominant motivation. Otherwise our country will decline, and we are doomed to failure.

Clearly, this recognition and movement away from WIIFM, this ‘me-first attitude’, this idea of ‘let someone else sacrifice’ should begin with our key political leaders. They must find the courage to do what is right for our country, and give up their WIIFM motivation of acting solely to get re-elected. If they can start the ball rolling in the right direction, surely other segments of society and indeed all of us should be able to follow.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is also an associate medical editor for Vascular Specialist.

The ideas and opinions expresssed in Vascular Specialist do not necessarily reflect those of the Society or the Publisher.

These are hard times for the United States. Our economy is floundering. Unemployment is high. Bankers and financiers seem to be getting away with immoral and even illegal actions. People are disgruntled and dissatisfied. Our government seems to be unable or unwilling to right the obvious wrongs or to get us out of the morass. There is general malaise.

I believe there is a common thread that underlies our present situation. It is the overarching attitude that behavior in our society is primarily determined by the WIIFM principle or ‘What’s in it for me’.

Let us look at some specific examples. Elected politicians in the executive and legislative branches of our federal government should make decisions on the basis of what is best for society and our country. Unfortunately this consideration is a minor motivation.

Uniformly our President and Congress do what is most likely to get themselves re-elected, i.e., what is best for them personally, not what is best for our country. They are constantly campaigning rather than governing. As a result, actions to support entrepreneurship and private job creation are not taken, and class warfare is encouraged because more votes will be gained than lost.

Attorneys who block tort reform are another example of the WIIFM principle. They must know that the present system is imperfect and costing our society billions of dollars, at least some of which are unjustified. Yet they spend millions supporting the re-election campaigns of legislators to block even a wisp of reform. Both the attorneys and the legislators who are influenced by this legal form of bribery are clearly guided by WIIFM. Society pays and suffers.

Similarly, bankers and others in the financial community, known collectively as Wall Street, guided by the WIIFM principle expend great efforts to preserve a system riddled with opaque derivative securities and other practices which benefit a few clever manipulators and harm our financial system and our society. Financial donations to politicians, again legalized bribery, and unfair executive compensation help to sustain a system in which rewards are far in excess of the value contributed to society.

Labor unions and their leaders are also substantially motivated by WIIFM. Otherwise they might compromise on demands to preserve unsustainable pension and benefit systems that are bankrupting our state and federal governments. The promise of votes and again contribution-associated influence over elected leaders are part of the toxic mix. Once again WIIFM triumphs over what is good for our overall economy and our country. The effort to close the job-creating Boeing plant in South Carolina and the pension preserving battles in Wisconsin and Ohio are glaring examples of the evils of WIIFM.

So also are the efforts of some to block any tax increase. If government waste, spending excesses, and unfair tax loopholes can be sharply diminished, reasonable tax increases can be considered part of a shared sacrifice for the common good of deficit reduction. All must acknowledge that our economic problems can only be solved by the compromise of such shared sacrifice. We will be better off in the long run and so will our progeny.

Physicians can also be motivated by the WIIFM principle. There is the temptation to maintain diminishing incomes at all costs – even by performing procedures that may not be fully indicated or justified, or by spending less than adequate time with individual patients. Our health care system is imperfect in many ways, but physicians too must resist the urge to be guided predominantly by WIIFM.

Finally there is the public at large. Are we guided in our voting by short-term WIIFM? Should we vote for the candidate who will lower our personal taxes the most in the next few years? Or should we vote for the individual who we believe will act in the best interests of our country at-large and its future long-term well-being?

We must all recognize the intrinsic dangers of being motivated excessively by WIIFM. Our country cannot survive and prosper if everyone pursues that motivation. We do not have the resources to do so. We must all display some of the courage, restraint, and spirit of compromise of our forefathers who took huge political and physical risks to found our country. They were motivated by a desire to do what was best for the country at large, to work for the greater good, to do what was right for the whole society. It often required self-denial, shared sacrifice, compromise, altruism, and the responsibility to act for the common good. The WIIFM principle had to be suppressed. The result was a United States of unparalleled greatness.

Today we are drifting away from that greatness. Aside from our military and a few other rare exceptions, the WIIFM principle seems to underlie that drift. Although some self-interest is acceptable and part of the human nature, we must all resist the temptation to make that our predominant motivation. Otherwise our country will decline, and we are doomed to failure.

Clearly, this recognition and movement away from WIIFM, this ‘me-first attitude’, this idea of ‘let someone else sacrifice’ should begin with our key political leaders. They must find the courage to do what is right for our country, and give up their WIIFM motivation of acting solely to get re-elected. If they can start the ball rolling in the right direction, surely other segments of society and indeed all of us should be able to follow.

Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is also an associate medical editor for Vascular Specialist.

The ideas and opinions expresssed in Vascular Specialist do not necessarily reflect those of the Society or the Publisher.

If our readers have any doubt, all they need do is casually scan the program for the recent VAM in Chicago or examine the content and Editorial Board of a current copy of the JVS to realize that the Society for Vascular Surgery is unquestionably an international organization. This sort of globalization, in contrast to the variety that, according to Tom Friedman, makes the world flat instead makes our specialty more vibrant and interesting than ever.

Because of this world change we believe that our journals should better represent the people that write and read our journals, and so, too, this newspaper. For this reason, we introduce in this issue our two newest members of the Vascular Specialist Editorial Board: From England, we have Professor Cliff Shearman, and from Australia, Professor Rob Fitridge. Both have a well-deserved preeminence and will broaden the view and the viewpoint of your SVS newspaper.

Professor Shearman is professor of vascular surgery at the University of Southampton and a consultant vascular surgeon at Southampton University Hospitals NHS Trust. He was on the Council and Chairman of the Training and Education Committee of the Vascular Society of Great Britain and Ireland, and President of the Society (2009-2010) He has a long time interest in training and was appointed head of the Wessex Post Graduate School of Surgery in 2007. He is currently president elect of the Society for Academic Research Surgery and Director of Professional Practice for the Association of Surgeons of Great Britain and Ireland. His main clinical interest is in the vascular complications of diabetes and in particular trying to reduce the rate of amputation in this group.

Professor Fitridge is professor of vascular surgery at the University of Adelaide and Head of Vascular Surgery at The Queen Elizabeth Hospital. He became chairman of the Board of Vascular Surgery in 2002 and during his tenure the online curriculum was developed. In collaboration with Matt Thompson he edited "Mechanisms of Vascular Disease: A Textbook for Vascular Surgeons" published by Cambridge University Press. His research interests include the systemic effects of skeletal muscle reperfusion injury and outcome modelling in aortic surgery. He recently was elected president of the ANZSVS and is president of the World Federation of Vascular Societies.

We welcome these new additions to our editorial team.

George Andros, M.D.

Medical Editor

If our readers have any doubt, all they need do is casually scan the program for the recent VAM in Chicago or examine the content and Editorial Board of a current copy of the JVS to realize that the Society for Vascular Surgery is unquestionably an international organization. This sort of globalization, in contrast to the variety that, according to Tom Friedman, makes the world flat instead makes our specialty more vibrant and interesting than ever.

Because of this world change we believe that our journals should better represent the people that write and read our journals, and so, too, this newspaper. For this reason, we introduce in this issue our two newest members of the Vascular Specialist Editorial Board: From England, we have Professor Cliff Shearman, and from Australia, Professor Rob Fitridge. Both have a well-deserved preeminence and will broaden the view and the viewpoint of your SVS newspaper.

Professor Shearman is professor of vascular surgery at the University of Southampton and a consultant vascular surgeon at Southampton University Hospitals NHS Trust. He was on the Council and Chairman of the Training and Education Committee of the Vascular Society of Great Britain and Ireland, and President of the Society (2009-2010) He has a long time interest in training and was appointed head of the Wessex Post Graduate School of Surgery in 2007. He is currently president elect of the Society for Academic Research Surgery and Director of Professional Practice for the Association of Surgeons of Great Britain and Ireland. His main clinical interest is in the vascular complications of diabetes and in particular trying to reduce the rate of amputation in this group.

Professor Fitridge is professor of vascular surgery at the University of Adelaide and Head of Vascular Surgery at The Queen Elizabeth Hospital. He became chairman of the Board of Vascular Surgery in 2002 and during his tenure the online curriculum was developed. In collaboration with Matt Thompson he edited "Mechanisms of Vascular Disease: A Textbook for Vascular Surgeons" published by Cambridge University Press. His research interests include the systemic effects of skeletal muscle reperfusion injury and outcome modelling in aortic surgery. He recently was elected president of the ANZSVS and is president of the World Federation of Vascular Societies.

We welcome these new additions to our editorial team.

George Andros, M.D.

Medical Editor

If our readers have any doubt, all they need do is casually scan the program for the recent VAM in Chicago or examine the content and Editorial Board of a current copy of the JVS to realize that the Society for Vascular Surgery is unquestionably an international organization. This sort of globalization, in contrast to the variety that, according to Tom Friedman, makes the world flat instead makes our specialty more vibrant and interesting than ever.

Because of this world change we believe that our journals should better represent the people that write and read our journals, and so, too, this newspaper. For this reason, we introduce in this issue our two newest members of the Vascular Specialist Editorial Board: From England, we have Professor Cliff Shearman, and from Australia, Professor Rob Fitridge. Both have a well-deserved preeminence and will broaden the view and the viewpoint of your SVS newspaper.

Professor Shearman is professor of vascular surgery at the University of Southampton and a consultant vascular surgeon at Southampton University Hospitals NHS Trust. He was on the Council and Chairman of the Training and Education Committee of the Vascular Society of Great Britain and Ireland, and President of the Society (2009-2010) He has a long time interest in training and was appointed head of the Wessex Post Graduate School of Surgery in 2007. He is currently president elect of the Society for Academic Research Surgery and Director of Professional Practice for the Association of Surgeons of Great Britain and Ireland. His main clinical interest is in the vascular complications of diabetes and in particular trying to reduce the rate of amputation in this group.

Professor Fitridge is professor of vascular surgery at the University of Adelaide and Head of Vascular Surgery at The Queen Elizabeth Hospital. He became chairman of the Board of Vascular Surgery in 2002 and during his tenure the online curriculum was developed. In collaboration with Matt Thompson he edited "Mechanisms of Vascular Disease: A Textbook for Vascular Surgeons" published by Cambridge University Press. His research interests include the systemic effects of skeletal muscle reperfusion injury and outcome modelling in aortic surgery. He recently was elected president of the ANZSVS and is president of the World Federation of Vascular Societies.

We welcome these new additions to our editorial team.

George Andros, M.D.

Medical Editor

Randomized controlled trials (RCTs) constitute level 1 evidence, which is widely considered the best data upon which to base medical practice. This is particularly true when the RCTs are published in leading journals like the New England Journal of Medicine or Lancet. Such trials are viewed by many as the Holy Grail of medicine and thus infallible and inviolate.

However, RCTs can have many flaws that render them obsolete, non-applicable or outright misleading. More importantly RCTs can be misinterpreted or spun by their authors or others so that they exert an effect on practice trends or standards unjustified by their data.

Possible flaws in RCTs are of two types:

1. Timeliness flaws can occur when progress is made in the treatment under evaluation arm or the control arm. Examples would be the early trials of carotid stenting (CAS) vs. carotid endarterectomy (CEA). If progress in CAS technology or patient selection occurs, a trial showing CAS inferiority becomes invalid. In contrast, the landmark trials showing CEA to be superior to medical treatment in preventing strokes have become obsolete because dramatic progress has been made with medical treatment.

2. Many design flaws can impair the validity of RCTs. These include patient selection flaws (e.g. in SAPPHIRE, patients were selected for randomization only if they were high risk for CEA). SAPPHIRE also included 71% asymptomatic patients in whom the high adverse event rates for both CEA and CAS were unjustified. Good medical treatment would have served these patients better. CREST also had patient selection flaws. It was originally designed to compare CAS and CEA only in symptomatic patients. When adequate numbers of patients could not be recruited, asymptomatic patients were added, thereby diluting the power of the study and impairing the statistical significance of some of its results.

Other design flaws include questionable competence of operators in a trial (e.g. the CAS operators in the EVA-3S and ICSS trials); problems with randomization (e.g. SAPPHIRE in which only 10% of eligible patients were randomized); and questionable applicability of RCT results to real world practice (e.g. CAS operators in CREST were highly vetted and more skilled than others performing the procedure).

There are also idiosyncratic flaws, as in the EVAR 2 trial in patients unfit for open repair. Although this trial, published in Lancet, showed EVAR to have similar mortality to no treatment, half the deaths in the group randomized to EVAR occurred from rupture during a lengthy (average 57 days) waiting period before treatment. Had these deaths been prevented by a more timely EVAR, the conclusion of EVAR 2 might have been different.

Inappropriate or questionable primary endpoints in RCTS are another design flaw that can lead to misleading conclusions. An example is the inclusion of minor myocardial infarctions (MIs) with strokes and deaths as a composite endpoint in a CAS vs. CEA trial (e.g. SAPPHIRE and CREST).

The components of the primary endpoint in the CAS and CEA arms of CREST were death, stroke, and myocardial infarction. Total stroke and minor strokes were both significantly different in the two groups in favor of CEA, and death and major strokes, although not significantly different between the two groups were both numerically higher for CAS. (See complete table oline at www. vascularspecialistonline.com)

Although it is arguable, it is hard to understand how minor MIs are the equivalent of strokes and deaths, and only when MIs were included were the adverse event rates in the two groups similar (7.2% for CAS vs 6.8% for CEA, P = .051).

So much for the flaws in RCTs. What about good trials or those with only minor weaknesses? Even these can result in misleading conclusions when the authors reach conclusions unjustified by their own data. SAPPHIRE and CREST are two recent examples.

Despite the flaws in these trials, both of which were reported in the New England Journal of Medicine, the authors concluded that "with high risk patients CAS and CEA are equivalent treatments" (SAPPHIRE) and "among patients with symptomatic and asymptomatic carotid stenosis, the risk of the composite primary end-point ... did not differ significantly in the group undergoing CAS and the group undergoing CEA" (CREST).

Although the CREST authors pointed out the higher incidence of stroke with stenting, others have used the CREST study to claim equivalence of CAS and CEA. Nowhere is this more apparent than in the recent American Heart Association (AHA) Guideline on the management of patients with extracranial carotid and vertebral artery disease.

This important and influential document, which was also approved by 13 other organizations including the SVS, stated that "CAS is indicated as an alternative to CEA for symptomatic patients at average or low risk of complications associated from endovascular interventions...." In Webster’s Dictionary one definition of "alternative" is "a choice between 2 things".

This clearly implies equivalence, and it has been so interpreted by many others, particularly those biased toward catheter based treatment. Of note, the AHA Guideline appears to be based largely on CREST, and did not even consider the findings of the ICSS trial, published in Lancet the same day as the main article reporting CREST.

Although ICSS may also have flaws, it showed, in a large group of only symptomatic patients, that CAS produced significantly more strokes and diffusion weighted MRI defects than did CEA. It is hard to understand why these ICSS results did not have more of an influence on the AHA Guideline.

Although my bias as a CAS enthusiast makes me believe that CAS will ultimately have a major role in the treatment of carotid stenosis patients, that bias is not yet sufficient for me to spin the data and believe we are now there. One has to wonder if bias more intense than mine was involved in the conclusion reached in the AHA Guideline.

Thus, it is apparent that misleading conclusions can be reached in articles reporting RCTs in leading journals. These can be the result of flaws in the RCTs and/or unrecognized author bias. More importantly, the results of even good trials can be further misinterpreted by others to guide practice standards in a way unjustified by the data.

It is important for all to recognize the possible role of bias in these misinterpretations. By recognizing the possible flaws in RCTs and that physicians, like all other people, are influenced by bias, we can exercise the judgment to use RCTs fairly to help us treat individual patients optimally.n

Dr. Frank J. Veith is professor of surgery at New York University Medical Center and professor of surgery and William J. von Liebig Chair in vascular surgery at Case Western Reserve University and The Cleveland Clinic.

Randomized controlled trials (RCTs) constitute level 1 evidence, which is widely considered the best data upon which to base medical practice. This is particularly true when the RCTs are published in leading journals like the New England Journal of Medicine or Lancet. Such trials are viewed by many as the Holy Grail of medicine and thus infallible and inviolate.

However, RCTs can have many flaws that render them obsolete, non-applicable or outright misleading. More importantly RCTs can be misinterpreted or spun by their authors or others so that they exert an effect on practice trends or standards unjustified by their data.

Possible flaws in RCTs are of two types:

1. Timeliness flaws can occur when progress is made in the treatment under evaluation arm or the control arm. Examples would be the early trials of carotid stenting (CAS) vs. carotid endarterectomy (CEA). If progress in CAS technology or patient selection occurs, a trial showing CAS inferiority becomes invalid. In contrast, the landmark trials showing CEA to be superior to medical treatment in preventing strokes have become obsolete because dramatic progress has been made with medical treatment.

2. Many design flaws can impair the validity of RCTs. These include patient selection flaws (e.g. in SAPPHIRE, patients were selected for randomization only if they were high risk for CEA). SAPPHIRE also included 71% asymptomatic patients in whom the high adverse event rates for both CEA and CAS were unjustified. Good medical treatment would have served these patients better. CREST also had patient selection flaws. It was originally designed to compare CAS and CEA only in symptomatic patients. When adequate numbers of patients could not be recruited, asymptomatic patients were added, thereby diluting the power of the study and impairing the statistical significance of some of its results.

Other design flaws include questionable competence of operators in a trial (e.g. the CAS operators in the EVA-3S and ICSS trials); problems with randomization (e.g. SAPPHIRE in which only 10% of eligible patients were randomized); and questionable applicability of RCT results to real world practice (e.g. CAS operators in CREST were highly vetted and more skilled than others performing the procedure).

There are also idiosyncratic flaws, as in the EVAR 2 trial in patients unfit for open repair. Although this trial, published in Lancet, showed EVAR to have similar mortality to no treatment, half the deaths in the group randomized to EVAR occurred from rupture during a lengthy (average 57 days) waiting period before treatment. Had these deaths been prevented by a more timely EVAR, the conclusion of EVAR 2 might have been different.

Inappropriate or questionable primary endpoints in RCTS are another design flaw that can lead to misleading conclusions. An example is the inclusion of minor myocardial infarctions (MIs) with strokes and deaths as a composite endpoint in a CAS vs. CEA trial (e.g. SAPPHIRE and CREST).

The components of the primary endpoint in the CAS and CEA arms of CREST were death, stroke, and myocardial infarction. Total stroke and minor strokes were both significantly different in the two groups in favor of CEA, and death and major strokes, although not significantly different between the two groups were both numerically higher for CAS. (See complete table oline at www. vascularspecialistonline.com)

Although it is arguable, it is hard to understand how minor MIs are the equivalent of strokes and deaths, and only when MIs were included were the adverse event rates in the two groups similar (7.2% for CAS vs 6.8% for CEA, P = .051).

So much for the flaws in RCTs. What about good trials or those with only minor weaknesses? Even these can result in misleading conclusions when the authors reach conclusions unjustified by their own data. SAPPHIRE and CREST are two recent examples.

Despite the flaws in these trials, both of which were reported in the New England Journal of Medicine, the authors concluded that "with high risk patients CAS and CEA are equivalent treatments" (SAPPHIRE) and "among patients with symptomatic and asymptomatic carotid stenosis, the risk of the composite primary end-point ... did not differ significantly in the group undergoing CAS and the group undergoing CEA" (CREST).

Although the CREST authors pointed out the higher incidence of stroke with stenting, others have used the CREST study to claim equivalence of CAS and CEA. Nowhere is this more apparent than in the recent American Heart Association (AHA) Guideline on the management of patients with extracranial carotid and vertebral artery disease.

This important and influential document, which was also approved by 13 other organizations including the SVS, stated that "CAS is indicated as an alternative to CEA for symptomatic patients at average or low risk of complications associated from endovascular interventions...." In Webster’s Dictionary one definition of "alternative" is "a choice between 2 things".

This clearly implies equivalence, and it has been so interpreted by many others, particularly those biased toward catheter based treatment. Of note, the AHA Guideline appears to be based largely on CREST, and did not even consider the findings of the ICSS trial, published in Lancet the same day as the main article reporting CREST.

Although ICSS may also have flaws, it showed, in a large group of only symptomatic patients, that CAS produced significantly more strokes and diffusion weighted MRI defects than did CEA. It is hard to understand why these ICSS results did not have more of an influence on the AHA Guideline.

Although my bias as a CAS enthusiast makes me believe that CAS will ultimately have a major role in the treatment of carotid stenosis patients, that bias is not yet sufficient for me to spin the data and believe we are now there. One has to wonder if bias more intense than mine was involved in the conclusion reached in the AHA Guideline.

Thus, it is apparent that misleading conclusions can be reached in articles reporting RCTs in leading journals. These can be the result of flaws in the RCTs and/or unrecognized author bias. More importantly, the results of even good trials can be further misinterpreted by others to guide practice standards in a way unjustified by the data.

It is important for all to recognize the possible role of bias in these misinterpretations. By recognizing the possible flaws in RCTs and that physicians, like all other people, are influenced by bias, we can exercise the judgment to use RCTs fairly to help us treat individual patients optimally.n

Dr. Frank J. Veith is professor of surgery at New York University Medical Center and professor of surgery and William J. von Liebig Chair in vascular surgery at Case Western Reserve University and The Cleveland Clinic.

Randomized controlled trials (RCTs) constitute level 1 evidence, which is widely considered the best data upon which to base medical practice. This is particularly true when the RCTs are published in leading journals like the New England Journal of Medicine or Lancet. Such trials are viewed by many as the Holy Grail of medicine and thus infallible and inviolate.

However, RCTs can have many flaws that render them obsolete, non-applicable or outright misleading. More importantly RCTs can be misinterpreted or spun by their authors or others so that they exert an effect on practice trends or standards unjustified by their data.

Possible flaws in RCTs are of two types:

1. Timeliness flaws can occur when progress is made in the treatment under evaluation arm or the control arm. Examples would be the early trials of carotid stenting (CAS) vs. carotid endarterectomy (CEA). If progress in CAS technology or patient selection occurs, a trial showing CAS inferiority becomes invalid. In contrast, the landmark trials showing CEA to be superior to medical treatment in preventing strokes have become obsolete because dramatic progress has been made with medical treatment.

2. Many design flaws can impair the validity of RCTs. These include patient selection flaws (e.g. in SAPPHIRE, patients were selected for randomization only if they were high risk for CEA). SAPPHIRE also included 71% asymptomatic patients in whom the high adverse event rates for both CEA and CAS were unjustified. Good medical treatment would have served these patients better. CREST also had patient selection flaws. It was originally designed to compare CAS and CEA only in symptomatic patients. When adequate numbers of patients could not be recruited, asymptomatic patients were added, thereby diluting the power of the study and impairing the statistical significance of some of its results.

Other design flaws include questionable competence of operators in a trial (e.g. the CAS operators in the EVA-3S and ICSS trials); problems with randomization (e.g. SAPPHIRE in which only 10% of eligible patients were randomized); and questionable applicability of RCT results to real world practice (e.g. CAS operators in CREST were highly vetted and more skilled than others performing the procedure).

There are also idiosyncratic flaws, as in the EVAR 2 trial in patients unfit for open repair. Although this trial, published in Lancet, showed EVAR to have similar mortality to no treatment, half the deaths in the group randomized to EVAR occurred from rupture during a lengthy (average 57 days) waiting period before treatment. Had these deaths been prevented by a more timely EVAR, the conclusion of EVAR 2 might have been different.

Inappropriate or questionable primary endpoints in RCTS are another design flaw that can lead to misleading conclusions. An example is the inclusion of minor myocardial infarctions (MIs) with strokes and deaths as a composite endpoint in a CAS vs. CEA trial (e.g. SAPPHIRE and CREST).

The components of the primary endpoint in the CAS and CEA arms of CREST were death, stroke, and myocardial infarction. Total stroke and minor strokes were both significantly different in the two groups in favor of CEA, and death and major strokes, although not significantly different between the two groups were both numerically higher for CAS. (See complete table oline at www. vascularspecialistonline.com)

Although it is arguable, it is hard to understand how minor MIs are the equivalent of strokes and deaths, and only when MIs were included were the adverse event rates in the two groups similar (7.2% for CAS vs 6.8% for CEA, P = .051).

So much for the flaws in RCTs. What about good trials or those with only minor weaknesses? Even these can result in misleading conclusions when the authors reach conclusions unjustified by their own data. SAPPHIRE and CREST are two recent examples.

Despite the flaws in these trials, both of which were reported in the New England Journal of Medicine, the authors concluded that "with high risk patients CAS and CEA are equivalent treatments" (SAPPHIRE) and "among patients with symptomatic and asymptomatic carotid stenosis, the risk of the composite primary end-point ... did not differ significantly in the group undergoing CAS and the group undergoing CEA" (CREST).

Although the CREST authors pointed out the higher incidence of stroke with stenting, others have used the CREST study to claim equivalence of CAS and CEA. Nowhere is this more apparent than in the recent American Heart Association (AHA) Guideline on the management of patients with extracranial carotid and vertebral artery disease.

This important and influential document, which was also approved by 13 other organizations including the SVS, stated that "CAS is indicated as an alternative to CEA for symptomatic patients at average or low risk of complications associated from endovascular interventions...." In Webster’s Dictionary one definition of "alternative" is "a choice between 2 things".

This clearly implies equivalence, and it has been so interpreted by many others, particularly those biased toward catheter based treatment. Of note, the AHA Guideline appears to be based largely on CREST, and did not even consider the findings of the ICSS trial, published in Lancet the same day as the main article reporting CREST.

Although ICSS may also have flaws, it showed, in a large group of only symptomatic patients, that CAS produced significantly more strokes and diffusion weighted MRI defects than did CEA. It is hard to understand why these ICSS results did not have more of an influence on the AHA Guideline.

Although my bias as a CAS enthusiast makes me believe that CAS will ultimately have a major role in the treatment of carotid stenosis patients, that bias is not yet sufficient for me to spin the data and believe we are now there. One has to wonder if bias more intense than mine was involved in the conclusion reached in the AHA Guideline.

Thus, it is apparent that misleading conclusions can be reached in articles reporting RCTs in leading journals. These can be the result of flaws in the RCTs and/or unrecognized author bias. More importantly, the results of even good trials can be further misinterpreted by others to guide practice standards in a way unjustified by the data.

It is important for all to recognize the possible role of bias in these misinterpretations. By recognizing the possible flaws in RCTs and that physicians, like all other people, are influenced by bias, we can exercise the judgment to use RCTs fairly to help us treat individual patients optimally.n

Dr. Frank J. Veith is professor of surgery at New York University Medical Center and professor of surgery and William J. von Liebig Chair in vascular surgery at Case Western Reserve University and The Cleveland Clinic.