Sidney Goldstein, MD

As I listened to Dr. Jackson T. Wright, one of the investigators of the SPRINT Trial, emphasize the importance of treating systolic blood pressure to the target of 120 mm Hg, I thought about the difficulty in treating blood pressure in the elderly.

Successfully lowering blood pressure even to the current target of 140 mm Hg systolic is one of the most difficult therapeutic tasks that I face. But, to my mind, the worldwide success achieved by hypertension therapy has had the most profound effect on cardiovascular medicine in the last half century. I am no epidemiologist, but the striking decrease in cardiovascular mortality in the United States associated with the introduction of the hypertension therapy is undeniable.

The pharmaceutical companies that developed of these drugs, some of which are still around and some that have merged with other entities, never priced these drugs at the potential benefit of decreasing the cost of hypertension to society. If they had, their price would be so exorbitant that their universal benefit to mankind would never have been seen. They were doing their job and returning significant benefit both to humanity and their investors. They priced the drugs so that we could afford to pay for them. All of these drugs – ACE inhibitors, calcium- and beta-blockers, and diuretics – are now available as generics and as a class have had a lasting and continuing impact on the societal cost and benefit.

Yet somehow, the world has changed. I am not the first to notice it. We now have drugs that can cost thousands of dollars a month and none of us can afford to pay for them. Because we now all share in the cost of drug therapy in one way or another, we all pay the cost. The justification for the high price is not based solely on their development cost, which in many instances were developed decades if not centuries ago, but on the presumed net expense of the untreated disease to society or to the achievement of entrepreneurial profits. Hepatitis C was one of the first in which the cost of new drug therapy was based on the net savings associated with the prevention of the chronic liver disease and its subsequent long-term societal expense. Since I am not a hepatologist, it took me a little leap of faith to accept the potential economic benefit of this therapy, but at least the current data suggest that indeed this therapy works. I remain dubious about the calculations of their societal net benefit cost.

Now move forward. We now have two drugs that can lower cholesterol, potentially to levels beyond our imagination, that are now on the high-expense list. According to recent rumors, evolocumab (Repatha, Amgen) and alirocumab (Praluent, Sanofi/Regeneron) will cost someone $12,000-$14,000 a year to lower serum cholesterol almost to immeasurable levels without any evidence of benefit in decreasing cardiovascular disease. (For those of you with short-term memory deficits, we just tried to pump up HDL cholesterol only to find that when successful, it increased mortality.) Now, if these drugs are successful in preventing the development and progression of atherosclerotic disease, as in the example of hepatitis C, I may change my mind and write the script for it.

Meanwhile, drug prices have escalated as a result of speculation in the pharmaceutical market by Wall Street entrepreneurs who buy up the drug patents that have been available for years like isoproterenol and digitalis, for the sole purpose of a creating a monopoly to inflate the price and return large profits to their investors. When questioned about the 20-fold increase in the cost of isoproterenol, a representative of one of the pharmaceutical companies stated, “that the price was based on many factors, including clinical benefits and the value they bring to the patients, physicians, payers, and society” (New York Times 2015 Oct 4 p. BU1, “Side Effects of Hijacking Drug Prices”). The audacity of drug company executives to presume that they are in a position to make that judgment is outrageous. And yet the U.S. Congress makes it illegal for Medicare and Medicaid to bargain for the best drug prices, while European and Asian pay a fraction of what we pay here.

These ruminations only suggest that madness in the pharmaceutical world is not limited to Wall Street but reaches even the higher levels of government. Get your checkbooks out everyone; the best is yet to come.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

As I listened to Dr. Jackson T. Wright, one of the investigators of the SPRINT Trial, emphasize the importance of treating systolic blood pressure to the target of 120 mm Hg, I thought about the difficulty in treating blood pressure in the elderly.

Successfully lowering blood pressure even to the current target of 140 mm Hg systolic is one of the most difficult therapeutic tasks that I face. But, to my mind, the worldwide success achieved by hypertension therapy has had the most profound effect on cardiovascular medicine in the last half century. I am no epidemiologist, but the striking decrease in cardiovascular mortality in the United States associated with the introduction of the hypertension therapy is undeniable.

The pharmaceutical companies that developed of these drugs, some of which are still around and some that have merged with other entities, never priced these drugs at the potential benefit of decreasing the cost of hypertension to society. If they had, their price would be so exorbitant that their universal benefit to mankind would never have been seen. They were doing their job and returning significant benefit both to humanity and their investors. They priced the drugs so that we could afford to pay for them. All of these drugs – ACE inhibitors, calcium- and beta-blockers, and diuretics – are now available as generics and as a class have had a lasting and continuing impact on the societal cost and benefit.

Yet somehow, the world has changed. I am not the first to notice it. We now have drugs that can cost thousands of dollars a month and none of us can afford to pay for them. Because we now all share in the cost of drug therapy in one way or another, we all pay the cost. The justification for the high price is not based solely on their development cost, which in many instances were developed decades if not centuries ago, but on the presumed net expense of the untreated disease to society or to the achievement of entrepreneurial profits. Hepatitis C was one of the first in which the cost of new drug therapy was based on the net savings associated with the prevention of the chronic liver disease and its subsequent long-term societal expense. Since I am not a hepatologist, it took me a little leap of faith to accept the potential economic benefit of this therapy, but at least the current data suggest that indeed this therapy works. I remain dubious about the calculations of their societal net benefit cost.

Now move forward. We now have two drugs that can lower cholesterol, potentially to levels beyond our imagination, that are now on the high-expense list. According to recent rumors, evolocumab (Repatha, Amgen) and alirocumab (Praluent, Sanofi/Regeneron) will cost someone $12,000-$14,000 a year to lower serum cholesterol almost to immeasurable levels without any evidence of benefit in decreasing cardiovascular disease. (For those of you with short-term memory deficits, we just tried to pump up HDL cholesterol only to find that when successful, it increased mortality.) Now, if these drugs are successful in preventing the development and progression of atherosclerotic disease, as in the example of hepatitis C, I may change my mind and write the script for it.

Meanwhile, drug prices have escalated as a result of speculation in the pharmaceutical market by Wall Street entrepreneurs who buy up the drug patents that have been available for years like isoproterenol and digitalis, for the sole purpose of a creating a monopoly to inflate the price and return large profits to their investors. When questioned about the 20-fold increase in the cost of isoproterenol, a representative of one of the pharmaceutical companies stated, “that the price was based on many factors, including clinical benefits and the value they bring to the patients, physicians, payers, and society” (New York Times 2015 Oct 4 p. BU1, “Side Effects of Hijacking Drug Prices”). The audacity of drug company executives to presume that they are in a position to make that judgment is outrageous. And yet the U.S. Congress makes it illegal for Medicare and Medicaid to bargain for the best drug prices, while European and Asian pay a fraction of what we pay here.

These ruminations only suggest that madness in the pharmaceutical world is not limited to Wall Street but reaches even the higher levels of government. Get your checkbooks out everyone; the best is yet to come.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

As I listened to Dr. Jackson T. Wright, one of the investigators of the SPRINT Trial, emphasize the importance of treating systolic blood pressure to the target of 120 mm Hg, I thought about the difficulty in treating blood pressure in the elderly.

Successfully lowering blood pressure even to the current target of 140 mm Hg systolic is one of the most difficult therapeutic tasks that I face. But, to my mind, the worldwide success achieved by hypertension therapy has had the most profound effect on cardiovascular medicine in the last half century. I am no epidemiologist, but the striking decrease in cardiovascular mortality in the United States associated with the introduction of the hypertension therapy is undeniable.

The pharmaceutical companies that developed of these drugs, some of which are still around and some that have merged with other entities, never priced these drugs at the potential benefit of decreasing the cost of hypertension to society. If they had, their price would be so exorbitant that their universal benefit to mankind would never have been seen. They were doing their job and returning significant benefit both to humanity and their investors. They priced the drugs so that we could afford to pay for them. All of these drugs – ACE inhibitors, calcium- and beta-blockers, and diuretics – are now available as generics and as a class have had a lasting and continuing impact on the societal cost and benefit.

Yet somehow, the world has changed. I am not the first to notice it. We now have drugs that can cost thousands of dollars a month and none of us can afford to pay for them. Because we now all share in the cost of drug therapy in one way or another, we all pay the cost. The justification for the high price is not based solely on their development cost, which in many instances were developed decades if not centuries ago, but on the presumed net expense of the untreated disease to society or to the achievement of entrepreneurial profits. Hepatitis C was one of the first in which the cost of new drug therapy was based on the net savings associated with the prevention of the chronic liver disease and its subsequent long-term societal expense. Since I am not a hepatologist, it took me a little leap of faith to accept the potential economic benefit of this therapy, but at least the current data suggest that indeed this therapy works. I remain dubious about the calculations of their societal net benefit cost.

Now move forward. We now have two drugs that can lower cholesterol, potentially to levels beyond our imagination, that are now on the high-expense list. According to recent rumors, evolocumab (Repatha, Amgen) and alirocumab (Praluent, Sanofi/Regeneron) will cost someone $12,000-$14,000 a year to lower serum cholesterol almost to immeasurable levels without any evidence of benefit in decreasing cardiovascular disease. (For those of you with short-term memory deficits, we just tried to pump up HDL cholesterol only to find that when successful, it increased mortality.) Now, if these drugs are successful in preventing the development and progression of atherosclerotic disease, as in the example of hepatitis C, I may change my mind and write the script for it.

Meanwhile, drug prices have escalated as a result of speculation in the pharmaceutical market by Wall Street entrepreneurs who buy up the drug patents that have been available for years like isoproterenol and digitalis, for the sole purpose of a creating a monopoly to inflate the price and return large profits to their investors. When questioned about the 20-fold increase in the cost of isoproterenol, a representative of one of the pharmaceutical companies stated, “that the price was based on many factors, including clinical benefits and the value they bring to the patients, physicians, payers, and society” (New York Times 2015 Oct 4 p. BU1, “Side Effects of Hijacking Drug Prices”). The audacity of drug company executives to presume that they are in a position to make that judgment is outrageous. And yet the U.S. Congress makes it illegal for Medicare and Medicaid to bargain for the best drug prices, while European and Asian pay a fraction of what we pay here.

These ruminations only suggest that madness in the pharmaceutical world is not limited to Wall Street but reaches even the higher levels of government. Get your checkbooks out everyone; the best is yet to come.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

There has been a spate of recent publications dealing with the lack of implantable cardioverter-defibrillator implantations in the elderly. The most recent indicates that only 8% of patients over age 75 years who have experienced a non–ST-segment elevation myocardial infarction (NSTEMI) or STEMI receive an ICD largely due to the restriction of implantation within 40 days of the incident infarction because of the delayed repair of ventricular function after an MI and the uncertainty of ejection fraction measurements during this period. That article indicates that despite this delay, patients who receive an ICD had an improved survival over the subsequent 2 years, compared with those who did not (JAMA. 2015;313[24]:2433-40). Some of my octogenarian friends might question whether improved survival and the prevention of sudden death is a benefit at that age.

An accompanying editorial suggests that a closer follow-up of these patients is warranted in order to improve the rate of implantation in those patients who are discharged so that they do not “fall through the cracks” and are lost to follow-up (JAMA. 2015:313[24]:2429-30).

Although there has been a tapering off of the explosive use of ICDs in the United States, almost a quarter million devices were implanted between 2010 and 2011 (Heart Rhythm. 2013 Apr;10[4]:e59-65). The U.S. number is roughly four times that of Western Europe. Primary prevention was the reason for implantation in 73.8%, and half of the implantations were in patients over 65; 29% were in the 70-79 age group, and 14% were octogenarians. A history of New York Heart Association class II-IV heart failure was present in 82% and a myocardial infarction in 49%.

There are of course other reasons why the elderly may not receive an ICD. The most frequent are the presence of concomitant diseases like stroke, cancer, and chronic renal disease. However, many elderly do not wish to have their survival tied to a device that they have no control over. Some may view sudden death as an acceptable mortality outcome considering other alternatives. Certainly, adverse lifestyle changes at advanced age may be a reason for the reluctance to choose an ICD.

The application of our new technologies like ICDs, catheter-implanted aortic valves, and mini–left ventricular assist devices have been remarkably successful and have brought lifesaving interventions to thousands of patients. Their relative ease of application has led to a casualness in regard to appropriateness in patients with concomitant diseases, and particularly in the elderly.

The definition of who is elderly has changed dramatically in clinical trials from the mid–20th century when those studies excluded patients over 65. In today’s world, the definition of the elderly has become a slippery slope, as there is no age limit and the inclusion of octogenarians is not unusual. The observation that elderly postinfarction patients with decreased ejection fraction can experience improved survival needs to be evaluated in the light of important considerations of current and expected quality of life in individual patients, as well as their own mortality expectations.

Most of the studies examining implantation rates, extensively analyze the effect of comorbidity and cost benefit of implantation. They rarely deal with how quality of life of the patient and their own mortality expectation impacts on the decision for ICD implantation. Once implanted, removal of the device is often impossible and when possible, as with an ICD, raise important and difficult ethical questions for patient, family, and doctor.

For those of us who are octogenarians and treat octogenarians, these issues are first and foremost in the decision process. The decision to use these devices for the relatively short-term benefit may become an onerous burden for the very elderly whose future quality of life can become abruptly abbreviated by the aging process. Easy exodus from life by sudden death may unfortunately be prolonged by an ICD.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

There has been a spate of recent publications dealing with the lack of implantable cardioverter-defibrillator implantations in the elderly. The most recent indicates that only 8% of patients over age 75 years who have experienced a non–ST-segment elevation myocardial infarction (NSTEMI) or STEMI receive an ICD largely due to the restriction of implantation within 40 days of the incident infarction because of the delayed repair of ventricular function after an MI and the uncertainty of ejection fraction measurements during this period. That article indicates that despite this delay, patients who receive an ICD had an improved survival over the subsequent 2 years, compared with those who did not (JAMA. 2015;313[24]:2433-40). Some of my octogenarian friends might question whether improved survival and the prevention of sudden death is a benefit at that age.

An accompanying editorial suggests that a closer follow-up of these patients is warranted in order to improve the rate of implantation in those patients who are discharged so that they do not “fall through the cracks” and are lost to follow-up (JAMA. 2015:313[24]:2429-30).

Although there has been a tapering off of the explosive use of ICDs in the United States, almost a quarter million devices were implanted between 2010 and 2011 (Heart Rhythm. 2013 Apr;10[4]:e59-65). The U.S. number is roughly four times that of Western Europe. Primary prevention was the reason for implantation in 73.8%, and half of the implantations were in patients over 65; 29% were in the 70-79 age group, and 14% were octogenarians. A history of New York Heart Association class II-IV heart failure was present in 82% and a myocardial infarction in 49%.

There are of course other reasons why the elderly may not receive an ICD. The most frequent are the presence of concomitant diseases like stroke, cancer, and chronic renal disease. However, many elderly do not wish to have their survival tied to a device that they have no control over. Some may view sudden death as an acceptable mortality outcome considering other alternatives. Certainly, adverse lifestyle changes at advanced age may be a reason for the reluctance to choose an ICD.

The application of our new technologies like ICDs, catheter-implanted aortic valves, and mini–left ventricular assist devices have been remarkably successful and have brought lifesaving interventions to thousands of patients. Their relative ease of application has led to a casualness in regard to appropriateness in patients with concomitant diseases, and particularly in the elderly.

The definition of who is elderly has changed dramatically in clinical trials from the mid–20th century when those studies excluded patients over 65. In today’s world, the definition of the elderly has become a slippery slope, as there is no age limit and the inclusion of octogenarians is not unusual. The observation that elderly postinfarction patients with decreased ejection fraction can experience improved survival needs to be evaluated in the light of important considerations of current and expected quality of life in individual patients, as well as their own mortality expectations.

Most of the studies examining implantation rates, extensively analyze the effect of comorbidity and cost benefit of implantation. They rarely deal with how quality of life of the patient and their own mortality expectation impacts on the decision for ICD implantation. Once implanted, removal of the device is often impossible and when possible, as with an ICD, raise important and difficult ethical questions for patient, family, and doctor.

For those of us who are octogenarians and treat octogenarians, these issues are first and foremost in the decision process. The decision to use these devices for the relatively short-term benefit may become an onerous burden for the very elderly whose future quality of life can become abruptly abbreviated by the aging process. Easy exodus from life by sudden death may unfortunately be prolonged by an ICD.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

There has been a spate of recent publications dealing with the lack of implantable cardioverter-defibrillator implantations in the elderly. The most recent indicates that only 8% of patients over age 75 years who have experienced a non–ST-segment elevation myocardial infarction (NSTEMI) or STEMI receive an ICD largely due to the restriction of implantation within 40 days of the incident infarction because of the delayed repair of ventricular function after an MI and the uncertainty of ejection fraction measurements during this period. That article indicates that despite this delay, patients who receive an ICD had an improved survival over the subsequent 2 years, compared with those who did not (JAMA. 2015;313[24]:2433-40). Some of my octogenarian friends might question whether improved survival and the prevention of sudden death is a benefit at that age.

An accompanying editorial suggests that a closer follow-up of these patients is warranted in order to improve the rate of implantation in those patients who are discharged so that they do not “fall through the cracks” and are lost to follow-up (JAMA. 2015:313[24]:2429-30).

Although there has been a tapering off of the explosive use of ICDs in the United States, almost a quarter million devices were implanted between 2010 and 2011 (Heart Rhythm. 2013 Apr;10[4]:e59-65). The U.S. number is roughly four times that of Western Europe. Primary prevention was the reason for implantation in 73.8%, and half of the implantations were in patients over 65; 29% were in the 70-79 age group, and 14% were octogenarians. A history of New York Heart Association class II-IV heart failure was present in 82% and a myocardial infarction in 49%.

There are of course other reasons why the elderly may not receive an ICD. The most frequent are the presence of concomitant diseases like stroke, cancer, and chronic renal disease. However, many elderly do not wish to have their survival tied to a device that they have no control over. Some may view sudden death as an acceptable mortality outcome considering other alternatives. Certainly, adverse lifestyle changes at advanced age may be a reason for the reluctance to choose an ICD.

The application of our new technologies like ICDs, catheter-implanted aortic valves, and mini–left ventricular assist devices have been remarkably successful and have brought lifesaving interventions to thousands of patients. Their relative ease of application has led to a casualness in regard to appropriateness in patients with concomitant diseases, and particularly in the elderly.

The definition of who is elderly has changed dramatically in clinical trials from the mid–20th century when those studies excluded patients over 65. In today’s world, the definition of the elderly has become a slippery slope, as there is no age limit and the inclusion of octogenarians is not unusual. The observation that elderly postinfarction patients with decreased ejection fraction can experience improved survival needs to be evaluated in the light of important considerations of current and expected quality of life in individual patients, as well as their own mortality expectations.

Most of the studies examining implantation rates, extensively analyze the effect of comorbidity and cost benefit of implantation. They rarely deal with how quality of life of the patient and their own mortality expectation impacts on the decision for ICD implantation. Once implanted, removal of the device is often impossible and when possible, as with an ICD, raise important and difficult ethical questions for patient, family, and doctor.

For those of us who are octogenarians and treat octogenarians, these issues are first and foremost in the decision process. The decision to use these devices for the relatively short-term benefit may become an onerous burden for the very elderly whose future quality of life can become abruptly abbreviated by the aging process. Easy exodus from life by sudden death may unfortunately be prolonged by an ICD.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

The recent endorsements by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee of the new genetically manufactured, subcutaneously administered cholesterol-lowering agents alirocumab (Sanofi-Regeneron) and evolocumab (Pfizer) have sent a jolt through the world of cholesterol therapy. Proposed for the treatment of patients with high-risk cardiovascular disease and homozygous familial hypercholesterolemia (HoFH), the decisions suggest that the committee has developed a severe case of scientific amnesia.

A case can be made for the approval for the very-high-risk and untreatable patients with HoFH, but the decision to treat millions of Americans based on the paucity of clinical data available would be disturbing, if not irresponsible.

It is clear that these proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors provide a powerful therapy for reducing LDL cholesterol, with a reported decrease of about 60% after only 12 or 52 weeks of treatment. Based on four small studies lasting 10-12 weeks and without any clinical outcome data, the committee recommended approving evolocumab for lifetime therapy without anything to support its clinical effectiveness or safety.

Dr. Robert J. Smith, who chaired the advisory committee meeting, faced with approving the drug or delaying a decision until a randomized clinical trial can be completed said, “I am unwilling to subject patients to the wait.” A publication of the American College of Cardiology suggested that these two monoclonal antibody drugs could replace generic statins in 70 million Americans at an estimated cost of $7,000-$12,000 a year. Talk about breaking the bank.

Only recently, we decided that the appropriate statin therapy for cholesterol control should use the dosing from the original clinical trials rather than chasing LDL levels to the lowest level possible. We now have a class of drugs that clearly can lower the cholesterol to a level never seen before, and we are about to discard that therapeutic advice.

We have experience in chasing blood levels with uncertain outcomes. Reducing blood sugar to a very low hemoglobin A_1c level led to adverse clinical events and increased mortality in type 2 diabetes. Raising HDL with the cholesterol ester transfer protein (CETP) inhibitor torcetrapib in a study of 15,000 patients in an outcome trial carried out over a number of years led to increased blood pressure and mortality by 58%, which was associated with a 25% decrease in LDL cholesterol and a 72% increase in HDL, both effects presumed to be remarkably beneficial (N. Engl. J. Med. 2007;357:2109-22).

It is quite possible that these new agents can further decrease coronary vascular mortality. A healthy controversy has raged for some time in regard to the “LDL hypothesis,” compared with therapy based upon the clinical trial outcome. The recent IMPROVE-IT report (N. Engl. J. Med. 2015;372:2387-97) provides some data to support the LDL hypothesis. In that study, the addition of 10 mg of ezetimibe to 40 mg of simvastatin in 18,144 patients followed for up to 6 years resulted in a 2% decrease in mortality associated with a 15.8-mg decrease in serum LDL.

Would it not be prudent to have similar data with the new drug on the street? If it is as potent as it appears to be, a trial of much shorter duration might demonstrate its potency and safety before it is offered to 70 million Americans. The FDA has been reluctant to use surrogate endpoints for approving drugs, but its position has not always been consistent. For some time the FDA has, on occasion, approved drugs that can lower cholesterol with limited outcome data as it did with ezetimibe. However, the decision in regard to the PCSK9 inhibitors will have a much larger impact on care than an add-on drug like ezetimibe. Let’s hope that the FDA shows better judgment than its advisory committee.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

The recent endorsements by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee of the new genetically manufactured, subcutaneously administered cholesterol-lowering agents alirocumab (Sanofi-Regeneron) and evolocumab (Pfizer) have sent a jolt through the world of cholesterol therapy. Proposed for the treatment of patients with high-risk cardiovascular disease and homozygous familial hypercholesterolemia (HoFH), the decisions suggest that the committee has developed a severe case of scientific amnesia.

A case can be made for the approval for the very-high-risk and untreatable patients with HoFH, but the decision to treat millions of Americans based on the paucity of clinical data available would be disturbing, if not irresponsible.

It is clear that these proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors provide a powerful therapy for reducing LDL cholesterol, with a reported decrease of about 60% after only 12 or 52 weeks of treatment. Based on four small studies lasting 10-12 weeks and without any clinical outcome data, the committee recommended approving evolocumab for lifetime therapy without anything to support its clinical effectiveness or safety.

Dr. Robert J. Smith, who chaired the advisory committee meeting, faced with approving the drug or delaying a decision until a randomized clinical trial can be completed said, “I am unwilling to subject patients to the wait.” A publication of the American College of Cardiology suggested that these two monoclonal antibody drugs could replace generic statins in 70 million Americans at an estimated cost of $7,000-$12,000 a year. Talk about breaking the bank.

Only recently, we decided that the appropriate statin therapy for cholesterol control should use the dosing from the original clinical trials rather than chasing LDL levels to the lowest level possible. We now have a class of drugs that clearly can lower the cholesterol to a level never seen before, and we are about to discard that therapeutic advice.

We have experience in chasing blood levels with uncertain outcomes. Reducing blood sugar to a very low hemoglobin A_1c level led to adverse clinical events and increased mortality in type 2 diabetes. Raising HDL with the cholesterol ester transfer protein (CETP) inhibitor torcetrapib in a study of 15,000 patients in an outcome trial carried out over a number of years led to increased blood pressure and mortality by 58%, which was associated with a 25% decrease in LDL cholesterol and a 72% increase in HDL, both effects presumed to be remarkably beneficial (N. Engl. J. Med. 2007;357:2109-22).

It is quite possible that these new agents can further decrease coronary vascular mortality. A healthy controversy has raged for some time in regard to the “LDL hypothesis,” compared with therapy based upon the clinical trial outcome. The recent IMPROVE-IT report (N. Engl. J. Med. 2015;372:2387-97) provides some data to support the LDL hypothesis. In that study, the addition of 10 mg of ezetimibe to 40 mg of simvastatin in 18,144 patients followed for up to 6 years resulted in a 2% decrease in mortality associated with a 15.8-mg decrease in serum LDL.

Would it not be prudent to have similar data with the new drug on the street? If it is as potent as it appears to be, a trial of much shorter duration might demonstrate its potency and safety before it is offered to 70 million Americans. The FDA has been reluctant to use surrogate endpoints for approving drugs, but its position has not always been consistent. For some time the FDA has, on occasion, approved drugs that can lower cholesterol with limited outcome data as it did with ezetimibe. However, the decision in regard to the PCSK9 inhibitors will have a much larger impact on care than an add-on drug like ezetimibe. Let’s hope that the FDA shows better judgment than its advisory committee.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

The recent endorsements by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee of the new genetically manufactured, subcutaneously administered cholesterol-lowering agents alirocumab (Sanofi-Regeneron) and evolocumab (Pfizer) have sent a jolt through the world of cholesterol therapy. Proposed for the treatment of patients with high-risk cardiovascular disease and homozygous familial hypercholesterolemia (HoFH), the decisions suggest that the committee has developed a severe case of scientific amnesia.

A case can be made for the approval for the very-high-risk and untreatable patients with HoFH, but the decision to treat millions of Americans based on the paucity of clinical data available would be disturbing, if not irresponsible.

It is clear that these proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors provide a powerful therapy for reducing LDL cholesterol, with a reported decrease of about 60% after only 12 or 52 weeks of treatment. Based on four small studies lasting 10-12 weeks and without any clinical outcome data, the committee recommended approving evolocumab for lifetime therapy without anything to support its clinical effectiveness or safety.

Dr. Robert J. Smith, who chaired the advisory committee meeting, faced with approving the drug or delaying a decision until a randomized clinical trial can be completed said, “I am unwilling to subject patients to the wait.” A publication of the American College of Cardiology suggested that these two monoclonal antibody drugs could replace generic statins in 70 million Americans at an estimated cost of $7,000-$12,000 a year. Talk about breaking the bank.

Only recently, we decided that the appropriate statin therapy for cholesterol control should use the dosing from the original clinical trials rather than chasing LDL levels to the lowest level possible. We now have a class of drugs that clearly can lower the cholesterol to a level never seen before, and we are about to discard that therapeutic advice.

We have experience in chasing blood levels with uncertain outcomes. Reducing blood sugar to a very low hemoglobin A_1c level led to adverse clinical events and increased mortality in type 2 diabetes. Raising HDL with the cholesterol ester transfer protein (CETP) inhibitor torcetrapib in a study of 15,000 patients in an outcome trial carried out over a number of years led to increased blood pressure and mortality by 58%, which was associated with a 25% decrease in LDL cholesterol and a 72% increase in HDL, both effects presumed to be remarkably beneficial (N. Engl. J. Med. 2007;357:2109-22).

It is quite possible that these new agents can further decrease coronary vascular mortality. A healthy controversy has raged for some time in regard to the “LDL hypothesis,” compared with therapy based upon the clinical trial outcome. The recent IMPROVE-IT report (N. Engl. J. Med. 2015;372:2387-97) provides some data to support the LDL hypothesis. In that study, the addition of 10 mg of ezetimibe to 40 mg of simvastatin in 18,144 patients followed for up to 6 years resulted in a 2% decrease in mortality associated with a 15.8-mg decrease in serum LDL.

Would it not be prudent to have similar data with the new drug on the street? If it is as potent as it appears to be, a trial of much shorter duration might demonstrate its potency and safety before it is offered to 70 million Americans. The FDA has been reluctant to use surrogate endpoints for approving drugs, but its position has not always been consistent. For some time the FDA has, on occasion, approved drugs that can lower cholesterol with limited outcome data as it did with ezetimibe. However, the decision in regard to the PCSK9 inhibitors will have a much larger impact on care than an add-on drug like ezetimibe. Let’s hope that the FDA shows better judgment than its advisory committee.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Few of my readers were around when Medicare was signed into law in 1965 by President Lyndon Johnson. Mr. Johnson was into his first elected term as president, having first taken the oath of office with the assassination of John F. Kennedy in November 1963.

Hardly a darling of the liberal left, he was maligned as the perpetrator, if not for the expansion, of the Vietnam War. He was elected with the largest presidential plurality in history, receiving 61% of the votes, and he carried with him a solid Democratic Congress bolstered by a large block of solid Southern Democrats, a firmament from which he had emerged. He can be credited for the most far-reaching social legislation of the 20th century, second only to Franklin Delano Roosevelt of the 1930s. Johnson was able to move the Civil Rights Act of 1964 and the Voting Rights Act and Medicare Act through Congress in 1965, the latter of which we celebrate this year.

At the time of passage of Medicare, 35% of Americans over 65 had no health insurance, either because they found insurance unaffordable or because of preexisting illness. Health insurance premiums for the elderly cost roughly three times more than did those for younger individuals. With many of the elderly living on Social Security alone, health insurance was an impossibility. If they needed care, they might find it at the emergency department of their local hospitals.

The battle for the passage of Medicare was formidable. In contrast to the passive role of the American Medical Association in the passage of the Affordable Care Act, Medicare was, to put it mildly, vigorously opposed by most doctors and by the AMA, which viewed it as the harbinger of long-anticipated socialized medicine. It ended up being far from it.

Medicare provided a pathway to an economic bonanza for the practicing physician and to hospitals that they could never have imagined. It immediately expanded the patient population and allowed enterprising and not-so-enterprising doctors and hospitals to run up the costs of health care by strengthening the fee-for-service style of medical care. Doctors, hospitals, and patients had no concern for cost: Medicare paid for everything.

Hospitals found Medicare a ready source of income. Doctor and hospital bills were based on the usual cost to each in their respective communities. Medical educators as well as house staff also saw their income lifted as a result of the federal government’s paying for a large part if not all of the cost of house staff education. Even the small number of physicians who opted out of Medicare, because of the red tape or to preserve their independence from the federal government, benefited. Their fees increased as the payment schedules of Medicare increased in their communities.

One of the by-products of Medicare was the end of hospital segregation. For those of you who were not around then, you can imagine what an impact that had on hospitals and doctors in both the North and the South.

Over time, Medicare expanded its footprint to include treatment of chronic kidney disease at any age, as well as drug coverage. I would guess that most Americans over 65 (this writer included) love Medicare. And doctors? Well, they still grumble about it.

With the recent readjustment of physicians’ Medicare reimbursement rates, the door has been opened to new initiatives based on quality of care. No matter what your political persuasion, it is clear that Americans cannot afford Medicare as we know it. Physicians undoubtedly will find their fee-for-service style of reimbursement curtailed as we learn the definition of “quality care standards.” Quality standards will not only define clinical performance, but will also include cost of rendering that care. So long to the world of fee-for-service reimbursement.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Few of my readers were around when Medicare was signed into law in 1965 by President Lyndon Johnson. Mr. Johnson was into his first elected term as president, having first taken the oath of office with the assassination of John F. Kennedy in November 1963.

Hardly a darling of the liberal left, he was maligned as the perpetrator, if not for the expansion, of the Vietnam War. He was elected with the largest presidential plurality in history, receiving 61% of the votes, and he carried with him a solid Democratic Congress bolstered by a large block of solid Southern Democrats, a firmament from which he had emerged. He can be credited for the most far-reaching social legislation of the 20th century, second only to Franklin Delano Roosevelt of the 1930s. Johnson was able to move the Civil Rights Act of 1964 and the Voting Rights Act and Medicare Act through Congress in 1965, the latter of which we celebrate this year.

At the time of passage of Medicare, 35% of Americans over 65 had no health insurance, either because they found insurance unaffordable or because of preexisting illness. Health insurance premiums for the elderly cost roughly three times more than did those for younger individuals. With many of the elderly living on Social Security alone, health insurance was an impossibility. If they needed care, they might find it at the emergency department of their local hospitals.

The battle for the passage of Medicare was formidable. In contrast to the passive role of the American Medical Association in the passage of the Affordable Care Act, Medicare was, to put it mildly, vigorously opposed by most doctors and by the AMA, which viewed it as the harbinger of long-anticipated socialized medicine. It ended up being far from it.

Medicare provided a pathway to an economic bonanza for the practicing physician and to hospitals that they could never have imagined. It immediately expanded the patient population and allowed enterprising and not-so-enterprising doctors and hospitals to run up the costs of health care by strengthening the fee-for-service style of medical care. Doctors, hospitals, and patients had no concern for cost: Medicare paid for everything.

Hospitals found Medicare a ready source of income. Doctor and hospital bills were based on the usual cost to each in their respective communities. Medical educators as well as house staff also saw their income lifted as a result of the federal government’s paying for a large part if not all of the cost of house staff education. Even the small number of physicians who opted out of Medicare, because of the red tape or to preserve their independence from the federal government, benefited. Their fees increased as the payment schedules of Medicare increased in their communities.

One of the by-products of Medicare was the end of hospital segregation. For those of you who were not around then, you can imagine what an impact that had on hospitals and doctors in both the North and the South.

Over time, Medicare expanded its footprint to include treatment of chronic kidney disease at any age, as well as drug coverage. I would guess that most Americans over 65 (this writer included) love Medicare. And doctors? Well, they still grumble about it.

With the recent readjustment of physicians’ Medicare reimbursement rates, the door has been opened to new initiatives based on quality of care. No matter what your political persuasion, it is clear that Americans cannot afford Medicare as we know it. Physicians undoubtedly will find their fee-for-service style of reimbursement curtailed as we learn the definition of “quality care standards.” Quality standards will not only define clinical performance, but will also include cost of rendering that care. So long to the world of fee-for-service reimbursement.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Few of my readers were around when Medicare was signed into law in 1965 by President Lyndon Johnson. Mr. Johnson was into his first elected term as president, having first taken the oath of office with the assassination of John F. Kennedy in November 1963.

Hardly a darling of the liberal left, he was maligned as the perpetrator, if not for the expansion, of the Vietnam War. He was elected with the largest presidential plurality in history, receiving 61% of the votes, and he carried with him a solid Democratic Congress bolstered by a large block of solid Southern Democrats, a firmament from which he had emerged. He can be credited for the most far-reaching social legislation of the 20th century, second only to Franklin Delano Roosevelt of the 1930s. Johnson was able to move the Civil Rights Act of 1964 and the Voting Rights Act and Medicare Act through Congress in 1965, the latter of which we celebrate this year.

At the time of passage of Medicare, 35% of Americans over 65 had no health insurance, either because they found insurance unaffordable or because of preexisting illness. Health insurance premiums for the elderly cost roughly three times more than did those for younger individuals. With many of the elderly living on Social Security alone, health insurance was an impossibility. If they needed care, they might find it at the emergency department of their local hospitals.

The battle for the passage of Medicare was formidable. In contrast to the passive role of the American Medical Association in the passage of the Affordable Care Act, Medicare was, to put it mildly, vigorously opposed by most doctors and by the AMA, which viewed it as the harbinger of long-anticipated socialized medicine. It ended up being far from it.

Medicare provided a pathway to an economic bonanza for the practicing physician and to hospitals that they could never have imagined. It immediately expanded the patient population and allowed enterprising and not-so-enterprising doctors and hospitals to run up the costs of health care by strengthening the fee-for-service style of medical care. Doctors, hospitals, and patients had no concern for cost: Medicare paid for everything.

Hospitals found Medicare a ready source of income. Doctor and hospital bills were based on the usual cost to each in their respective communities. Medical educators as well as house staff also saw their income lifted as a result of the federal government’s paying for a large part if not all of the cost of house staff education. Even the small number of physicians who opted out of Medicare, because of the red tape or to preserve their independence from the federal government, benefited. Their fees increased as the payment schedules of Medicare increased in their communities.

One of the by-products of Medicare was the end of hospital segregation. For those of you who were not around then, you can imagine what an impact that had on hospitals and doctors in both the North and the South.

Over time, Medicare expanded its footprint to include treatment of chronic kidney disease at any age, as well as drug coverage. I would guess that most Americans over 65 (this writer included) love Medicare. And doctors? Well, they still grumble about it.

With the recent readjustment of physicians’ Medicare reimbursement rates, the door has been opened to new initiatives based on quality of care. No matter what your political persuasion, it is clear that Americans cannot afford Medicare as we know it. Physicians undoubtedly will find their fee-for-service style of reimbursement curtailed as we learn the definition of “quality care standards.” Quality standards will not only define clinical performance, but will also include cost of rendering that care. So long to the world of fee-for-service reimbursement.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

In case you didn’t notice, our clinical practice has been reinforced by a entirely new class of performers who have become essential to our daily activities.

They are Advanced Practice Registered Nurses, whose role has evolved over the last 50 years from the Coronary Care Unit nurse with special training in coronary care to an array of well-trained women and men who have received both Bachelor’s and Master’s degrees in Nursing.

As a further extension of their training, many are now going on to achieve a further doctorate degree in nursing after 90 hours of postgraduate classes at certified academic centers and additional clinical experience in a variety of fields, including cardiology. The nurses completing those programs will be certified and licensed as APRNs. They come to our practice with remarkable experience and expertise in arrhythmia and heart failure management, as well as interventional skills, on top of wide experience in the management of patients in critical care units. Their integration into comprehensive and collaborative cardiac care raises challenges to and opportunities for the cardiologist.

A recent survey of large cardiology clinics initiated by the Summit Medical Group assessed the role of the APRN in the care of patients both in hospitals and in clinics. It reported that in many of cardiology clinics surveyed, APRNs provide an expanding role in patient care leading to variable relationships between the patient and the cardiologist. In some settings, the APRNs often function independent of physician interaction, initiating the patients’ entrance into the clinic and managing their follow-up. In other situations, they may be supervised by a cardiologist and their future laboratory studies and therapy are completely managed by the APRN, who functions as a professional associate of a physician. However, in many situations the cardiologist may have little or no contact with the patient.

While the APRN is seeing the patient, the cardiologists often are seeing their own patients or, more likely, are involved with maintaining the electronic medical record or performing or interpreting tests that are usually reimbursed at a fee that is a multiple of that received for a patient visit alone. Much of this is carried out under the heading of “coordinated care” and is managed in a multidisciplinary matrix in which many specialists and APRNs play a role in the care of the patient. In this setting, the doctor has become manager of a diverse group of support staff, including APRNs, and may be increasingly remote from direct patient care. My medical colleagues find the process as a way to increase the patient “pass through.” Many patients presume that the APRN is a reasonable alternative to a busy cardiologist or are interacting with their cardiologist.

As doctors, we are divesting ourselves from the one thing that sets us apart and makes us unique in the health care system; the ability to interact with patients in a comprehensive way. We seem to be on the slippery slope to medical obsolescence, soon to be replaced by staff who can triage our patients to the next appropriate test. Both the patient and doctor seem to have slipped into a Walmart-like world where expedience dominates over skill and shortcuts are the alternative to thoughtful personal physician-patient interaction.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

In case you didn’t notice, our clinical practice has been reinforced by a entirely new class of performers who have become essential to our daily activities.

They are Advanced Practice Registered Nurses, whose role has evolved over the last 50 years from the Coronary Care Unit nurse with special training in coronary care to an array of well-trained women and men who have received both Bachelor’s and Master’s degrees in Nursing.

As a further extension of their training, many are now going on to achieve a further doctorate degree in nursing after 90 hours of postgraduate classes at certified academic centers and additional clinical experience in a variety of fields, including cardiology. The nurses completing those programs will be certified and licensed as APRNs. They come to our practice with remarkable experience and expertise in arrhythmia and heart failure management, as well as interventional skills, on top of wide experience in the management of patients in critical care units. Their integration into comprehensive and collaborative cardiac care raises challenges to and opportunities for the cardiologist.

A recent survey of large cardiology clinics initiated by the Summit Medical Group assessed the role of the APRN in the care of patients both in hospitals and in clinics. It reported that in many of cardiology clinics surveyed, APRNs provide an expanding role in patient care leading to variable relationships between the patient and the cardiologist. In some settings, the APRNs often function independent of physician interaction, initiating the patients’ entrance into the clinic and managing their follow-up. In other situations, they may be supervised by a cardiologist and their future laboratory studies and therapy are completely managed by the APRN, who functions as a professional associate of a physician. However, in many situations the cardiologist may have little or no contact with the patient.

While the APRN is seeing the patient, the cardiologists often are seeing their own patients or, more likely, are involved with maintaining the electronic medical record or performing or interpreting tests that are usually reimbursed at a fee that is a multiple of that received for a patient visit alone. Much of this is carried out under the heading of “coordinated care” and is managed in a multidisciplinary matrix in which many specialists and APRNs play a role in the care of the patient. In this setting, the doctor has become manager of a diverse group of support staff, including APRNs, and may be increasingly remote from direct patient care. My medical colleagues find the process as a way to increase the patient “pass through.” Many patients presume that the APRN is a reasonable alternative to a busy cardiologist or are interacting with their cardiologist.

As doctors, we are divesting ourselves from the one thing that sets us apart and makes us unique in the health care system; the ability to interact with patients in a comprehensive way. We seem to be on the slippery slope to medical obsolescence, soon to be replaced by staff who can triage our patients to the next appropriate test. Both the patient and doctor seem to have slipped into a Walmart-like world where expedience dominates over skill and shortcuts are the alternative to thoughtful personal physician-patient interaction.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

In case you didn’t notice, our clinical practice has been reinforced by a entirely new class of performers who have become essential to our daily activities.

They are Advanced Practice Registered Nurses, whose role has evolved over the last 50 years from the Coronary Care Unit nurse with special training in coronary care to an array of well-trained women and men who have received both Bachelor’s and Master’s degrees in Nursing.

As a further extension of their training, many are now going on to achieve a further doctorate degree in nursing after 90 hours of postgraduate classes at certified academic centers and additional clinical experience in a variety of fields, including cardiology. The nurses completing those programs will be certified and licensed as APRNs. They come to our practice with remarkable experience and expertise in arrhythmia and heart failure management, as well as interventional skills, on top of wide experience in the management of patients in critical care units. Their integration into comprehensive and collaborative cardiac care raises challenges to and opportunities for the cardiologist.

A recent survey of large cardiology clinics initiated by the Summit Medical Group assessed the role of the APRN in the care of patients both in hospitals and in clinics. It reported that in many of cardiology clinics surveyed, APRNs provide an expanding role in patient care leading to variable relationships between the patient and the cardiologist. In some settings, the APRNs often function independent of physician interaction, initiating the patients’ entrance into the clinic and managing their follow-up. In other situations, they may be supervised by a cardiologist and their future laboratory studies and therapy are completely managed by the APRN, who functions as a professional associate of a physician. However, in many situations the cardiologist may have little or no contact with the patient.

While the APRN is seeing the patient, the cardiologists often are seeing their own patients or, more likely, are involved with maintaining the electronic medical record or performing or interpreting tests that are usually reimbursed at a fee that is a multiple of that received for a patient visit alone. Much of this is carried out under the heading of “coordinated care” and is managed in a multidisciplinary matrix in which many specialists and APRNs play a role in the care of the patient. In this setting, the doctor has become manager of a diverse group of support staff, including APRNs, and may be increasingly remote from direct patient care. My medical colleagues find the process as a way to increase the patient “pass through.” Many patients presume that the APRN is a reasonable alternative to a busy cardiologist or are interacting with their cardiologist.

As doctors, we are divesting ourselves from the one thing that sets us apart and makes us unique in the health care system; the ability to interact with patients in a comprehensive way. We seem to be on the slippery slope to medical obsolescence, soon to be replaced by staff who can triage our patients to the next appropriate test. Both the patient and doctor seem to have slipped into a Walmart-like world where expedience dominates over skill and shortcuts are the alternative to thoughtful personal physician-patient interaction.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Twenty years ago Dr. Joseph Alpert and I published an editorial suggesting that we were training too many cardiologists and that we should begin to decrease the existing training programs. It was written in anticipation of the expansion of health maintenance organizations and the Clinton health care initiatives, neither of which occurred (Am. J. Cardiol. 1994;74:394-5). Our opinions were met with universal disdain among our cardiology colleagues.

However, what did take place over the next 15 years was the creation of a cardiology "boom," inflated by an expansion of cardiology services with coronary stents and multiple imaging techniques, which succeeded in making work for newly trained cardiologists. Most of these procedures, with few exceptions, had little or no impact on the quality of care but did generate a significant increase in cost. From 1995 to 2012, an additional 7,000 cardiologists became members of the American College of Cardiology, swelling its ranks from 21,000 to 28,000 members. Workforce projection in the early 21st century suggested that there would be a continuing need for cardiology specialists well into 2025. These projections were based on the aging of the population and gave little attention to the potential future change in health care financing.

But in fact, changes did occur, and the cardiology boom has been deflated, not like the 2008 deflation of the housing boom, but it is clear that some of the gas has been let out, and the boom will continue to deflate in the future. A recent editorial (J. Am. Coll. Cardiol. 2014,63;1927-8) authored by the ACC leaders suggests that major adjustments in career goals of graduating trainees will have to be made in order to deal with the change in the marketplace. The major change in the reimbursement for outpatient procedures that favored hospital services created a flight of practicing physicians from private to hospital-based practice. The federal government and private insurers can now monitor practice patterns and the utilizations of services more closely, and this has led to a significant decrease in these procedures. At the same time, the conversion of your friendly local hospital to a corporate conglomerate has opened the door for hospital administrators to squeeze cost centers like cardiology in order to improve the bottom line.

The new emphasis on physician participation in cost control, as manifested by the move to medical homes and accountable care organizations, emphasizes quality improvement over quantity billing, where doctors can benefit financially from cost savings. Patients are also becoming more concerned about their own role in medical costs as they begin to face increases in deductible costs. The age of fee-for-service payment is fast coming to an end. We are moving away from high-cost care that led to the boom to efficient care based on value payment models.

As medicine, and particularly cardiology, moves further into the 21st century it is clear that we are victims of our own technology. It is difficult to predict the future when so many countercurrents are in effect in our profession. Joe Alpert and I missed the target by about 20 years, but we could never have anticipated the magnitude of ebb and flow of workforce tides. Many of us presumed that the medical profession would be free of the changes in economy and technology. We are learning now that we are not immune to those changes.

To my readers: After writing this column for almost 18 years, I have decided to take a long summer vacation. I plan to be back in the fall but writing less frequently and sharing this wonderful platform with others. I thank you all for the many comments that I have received through the years, both positive and negative. I also want to thank my editor, Catherine Hackett, who has always encouraged me to speak out without any constraint.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Twenty years ago Dr. Joseph Alpert and I published an editorial suggesting that we were training too many cardiologists and that we should begin to decrease the existing training programs. It was written in anticipation of the expansion of health maintenance organizations and the Clinton health care initiatives, neither of which occurred (Am. J. Cardiol. 1994;74:394-5). Our opinions were met with universal disdain among our cardiology colleagues.

However, what did take place over the next 15 years was the creation of a cardiology "boom," inflated by an expansion of cardiology services with coronary stents and multiple imaging techniques, which succeeded in making work for newly trained cardiologists. Most of these procedures, with few exceptions, had little or no impact on the quality of care but did generate a significant increase in cost. From 1995 to 2012, an additional 7,000 cardiologists became members of the American College of Cardiology, swelling its ranks from 21,000 to 28,000 members. Workforce projection in the early 21st century suggested that there would be a continuing need for cardiology specialists well into 2025. These projections were based on the aging of the population and gave little attention to the potential future change in health care financing.

But in fact, changes did occur, and the cardiology boom has been deflated, not like the 2008 deflation of the housing boom, but it is clear that some of the gas has been let out, and the boom will continue to deflate in the future. A recent editorial (J. Am. Coll. Cardiol. 2014,63;1927-8) authored by the ACC leaders suggests that major adjustments in career goals of graduating trainees will have to be made in order to deal with the change in the marketplace. The major change in the reimbursement for outpatient procedures that favored hospital services created a flight of practicing physicians from private to hospital-based practice. The federal government and private insurers can now monitor practice patterns and the utilizations of services more closely, and this has led to a significant decrease in these procedures. At the same time, the conversion of your friendly local hospital to a corporate conglomerate has opened the door for hospital administrators to squeeze cost centers like cardiology in order to improve the bottom line.

The new emphasis on physician participation in cost control, as manifested by the move to medical homes and accountable care organizations, emphasizes quality improvement over quantity billing, where doctors can benefit financially from cost savings. Patients are also becoming more concerned about their own role in medical costs as they begin to face increases in deductible costs. The age of fee-for-service payment is fast coming to an end. We are moving away from high-cost care that led to the boom to efficient care based on value payment models.

As medicine, and particularly cardiology, moves further into the 21st century it is clear that we are victims of our own technology. It is difficult to predict the future when so many countercurrents are in effect in our profession. Joe Alpert and I missed the target by about 20 years, but we could never have anticipated the magnitude of ebb and flow of workforce tides. Many of us presumed that the medical profession would be free of the changes in economy and technology. We are learning now that we are not immune to those changes.

To my readers: After writing this column for almost 18 years, I have decided to take a long summer vacation. I plan to be back in the fall but writing less frequently and sharing this wonderful platform with others. I thank you all for the many comments that I have received through the years, both positive and negative. I also want to thank my editor, Catherine Hackett, who has always encouraged me to speak out without any constraint.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Twenty years ago Dr. Joseph Alpert and I published an editorial suggesting that we were training too many cardiologists and that we should begin to decrease the existing training programs. It was written in anticipation of the expansion of health maintenance organizations and the Clinton health care initiatives, neither of which occurred (Am. J. Cardiol. 1994;74:394-5). Our opinions were met with universal disdain among our cardiology colleagues.

However, what did take place over the next 15 years was the creation of a cardiology "boom," inflated by an expansion of cardiology services with coronary stents and multiple imaging techniques, which succeeded in making work for newly trained cardiologists. Most of these procedures, with few exceptions, had little or no impact on the quality of care but did generate a significant increase in cost. From 1995 to 2012, an additional 7,000 cardiologists became members of the American College of Cardiology, swelling its ranks from 21,000 to 28,000 members. Workforce projection in the early 21st century suggested that there would be a continuing need for cardiology specialists well into 2025. These projections were based on the aging of the population and gave little attention to the potential future change in health care financing.

But in fact, changes did occur, and the cardiology boom has been deflated, not like the 2008 deflation of the housing boom, but it is clear that some of the gas has been let out, and the boom will continue to deflate in the future. A recent editorial (J. Am. Coll. Cardiol. 2014,63;1927-8) authored by the ACC leaders suggests that major adjustments in career goals of graduating trainees will have to be made in order to deal with the change in the marketplace. The major change in the reimbursement for outpatient procedures that favored hospital services created a flight of practicing physicians from private to hospital-based practice. The federal government and private insurers can now monitor practice patterns and the utilizations of services more closely, and this has led to a significant decrease in these procedures. At the same time, the conversion of your friendly local hospital to a corporate conglomerate has opened the door for hospital administrators to squeeze cost centers like cardiology in order to improve the bottom line.

The new emphasis on physician participation in cost control, as manifested by the move to medical homes and accountable care organizations, emphasizes quality improvement over quantity billing, where doctors can benefit financially from cost savings. Patients are also becoming more concerned about their own role in medical costs as they begin to face increases in deductible costs. The age of fee-for-service payment is fast coming to an end. We are moving away from high-cost care that led to the boom to efficient care based on value payment models.

As medicine, and particularly cardiology, moves further into the 21st century it is clear that we are victims of our own technology. It is difficult to predict the future when so many countercurrents are in effect in our profession. Joe Alpert and I missed the target by about 20 years, but we could never have anticipated the magnitude of ebb and flow of workforce tides. Many of us presumed that the medical profession would be free of the changes in economy and technology. We are learning now that we are not immune to those changes.

To my readers: After writing this column for almost 18 years, I have decided to take a long summer vacation. I plan to be back in the fall but writing less frequently and sharing this wonderful platform with others. I thank you all for the many comments that I have received through the years, both positive and negative. I also want to thank my editor, Catherine Hackett, who has always encouraged me to speak out without any constraint.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Until recently, bariatric surgery was considered a cosmetic operation with little physiologic importance. A series of preliminary randomized clinical trials, however, have suggested that bariatric surgery may have importance in mitigating the adverse pathophysiology associated with obesity, including type 2 diabetes and some cardiovascular risk factors.

The finding of a surgical method of modifying this disease, which has occupied research for the last century, is somewhat unexpected after the many false starts associated with medical interventions. The two most popular surgical procedures, the gastric bypass and the sleeve gastrectomy performed using laparoscopic techniques, are currently being performed in obese patients with BMIs of greater than 35 with very low morbidly and rare mortality events. Several nonrandomized and prospective trials have examined the effect of bariatric surgery and reported beneficial effects on diabetes regression and significant reduction in major cardiovascular disease ( JAMA 2012;307:56-65).

The recent report of the 3-year follow-up of the STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial ( N. Engl. J. Med. 2014;370:2002-13) provides additional physiologic information on the benefits of bariatric surgery in 150 obese diabetic patients aged 20-60 years with BMIs of 27-43, compared with intensive medical therapy. Patients were randomized to three arms: intensive medical therapy, gastric bypass, or sleeve gastrectomy. Most of the patients were white women with a history of diabetes for 8.3 years; the mean hemoglobin A_1c was 9.3%. At baseline, 43% of the patients required insulin therapy. The primary endpoint was the achievement of HbA_1c of 6% or less, which was achieved in 5% of the medically treated patients, compared with 38% in the gastric bypass group and 24% in the sleeve gastrectomy group. Decrease in BMI was the only measure that predicted the achievement of the HbA_1c endpoint. Body weight decreased by 4.5% in the intensive medical group, 24.5% in the gastric bypass group, and 21.1% in the sleeve gastrectomy group. Significant decreases in low-density lipoprotein cholesterol and increases in high-density lipoprotein cholesterol were achieved in both surgical intervention groups, compared with the intensive medical care group. In addition, medical control of diabetes was improved and 69% and 43% of the gastrectomy and sleeve bypass group, respectively, were no longer requiring insulin therapy. There was, however, no significant difference in the change in blood pressure in the three groups. There were no life-threatening complications or deaths in the groups, but there were a number of complications associated with the procedure.

The metabolic changes associated with bariatric surgery reported in STAMPEDE open the door for future randomized studies examining long-term morbidity and mortality benefits that may be attributed to this therapy. Bariatric surgery is being performed widely in the United States with very low mortality and morbidity. Previous short-term studies have reported the benefit of bariatric surgery, compared with intensive medical therapy. The longer duration of follow-up in STAMPEDE emphasizes the need for larger randomized trials of this method of therapy. The study of the surgical patients may also provide new insight into the relationship of body fat to the expression of type 2 diabetes.

The prevention of medical disease using surgical techniques in clinical medicine has not been a particularly fertile road of investigation. Intervention in the treatment of coronary artery disease with bypass surgery although associated with symptomatic benefit and with some exceptions, has not been overwhelmingly successful in affecting the long-term mortality of that disease. Bariatric surgery may be the first surgical intervention that can arrest or even reverse type 2 diabetes and its many sequelae.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Until recently, bariatric surgery was considered a cosmetic operation with little physiologic importance. A series of preliminary randomized clinical trials, however, have suggested that bariatric surgery may have importance in mitigating the adverse pathophysiology associated with obesity, including type 2 diabetes and some cardiovascular risk factors.

The finding of a surgical method of modifying this disease, which has occupied research for the last century, is somewhat unexpected after the many false starts associated with medical interventions. The two most popular surgical procedures, the gastric bypass and the sleeve gastrectomy performed using laparoscopic techniques, are currently being performed in obese patients with BMIs of greater than 35 with very low morbidly and rare mortality events. Several nonrandomized and prospective trials have examined the effect of bariatric surgery and reported beneficial effects on diabetes regression and significant reduction in major cardiovascular disease ( JAMA 2012;307:56-65).

The recent report of the 3-year follow-up of the STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial ( N. Engl. J. Med. 2014;370:2002-13) provides additional physiologic information on the benefits of bariatric surgery in 150 obese diabetic patients aged 20-60 years with BMIs of 27-43, compared with intensive medical therapy. Patients were randomized to three arms: intensive medical therapy, gastric bypass, or sleeve gastrectomy. Most of the patients were white women with a history of diabetes for 8.3 years; the mean hemoglobin A_1c was 9.3%. At baseline, 43% of the patients required insulin therapy. The primary endpoint was the achievement of HbA_1c of 6% or less, which was achieved in 5% of the medically treated patients, compared with 38% in the gastric bypass group and 24% in the sleeve gastrectomy group. Decrease in BMI was the only measure that predicted the achievement of the HbA_1c endpoint. Body weight decreased by 4.5% in the intensive medical group, 24.5% in the gastric bypass group, and 21.1% in the sleeve gastrectomy group. Significant decreases in low-density lipoprotein cholesterol and increases in high-density lipoprotein cholesterol were achieved in both surgical intervention groups, compared with the intensive medical care group. In addition, medical control of diabetes was improved and 69% and 43% of the gastrectomy and sleeve bypass group, respectively, were no longer requiring insulin therapy. There was, however, no significant difference in the change in blood pressure in the three groups. There were no life-threatening complications or deaths in the groups, but there were a number of complications associated with the procedure.

The metabolic changes associated with bariatric surgery reported in STAMPEDE open the door for future randomized studies examining long-term morbidity and mortality benefits that may be attributed to this therapy. Bariatric surgery is being performed widely in the United States with very low mortality and morbidity. Previous short-term studies have reported the benefit of bariatric surgery, compared with intensive medical therapy. The longer duration of follow-up in STAMPEDE emphasizes the need for larger randomized trials of this method of therapy. The study of the surgical patients may also provide new insight into the relationship of body fat to the expression of type 2 diabetes.

The prevention of medical disease using surgical techniques in clinical medicine has not been a particularly fertile road of investigation. Intervention in the treatment of coronary artery disease with bypass surgery although associated with symptomatic benefit and with some exceptions, has not been overwhelmingly successful in affecting the long-term mortality of that disease. Bariatric surgery may be the first surgical intervention that can arrest or even reverse type 2 diabetes and its many sequelae.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Until recently, bariatric surgery was considered a cosmetic operation with little physiologic importance. A series of preliminary randomized clinical trials, however, have suggested that bariatric surgery may have importance in mitigating the adverse pathophysiology associated with obesity, including type 2 diabetes and some cardiovascular risk factors.

The finding of a surgical method of modifying this disease, which has occupied research for the last century, is somewhat unexpected after the many false starts associated with medical interventions. The two most popular surgical procedures, the gastric bypass and the sleeve gastrectomy performed using laparoscopic techniques, are currently being performed in obese patients with BMIs of greater than 35 with very low morbidly and rare mortality events. Several nonrandomized and prospective trials have examined the effect of bariatric surgery and reported beneficial effects on diabetes regression and significant reduction in major cardiovascular disease ( JAMA 2012;307:56-65).

The recent report of the 3-year follow-up of the STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial ( N. Engl. J. Med. 2014;370:2002-13) provides additional physiologic information on the benefits of bariatric surgery in 150 obese diabetic patients aged 20-60 years with BMIs of 27-43, compared with intensive medical therapy. Patients were randomized to three arms: intensive medical therapy, gastric bypass, or sleeve gastrectomy. Most of the patients were white women with a history of diabetes for 8.3 years; the mean hemoglobin A_1c was 9.3%. At baseline, 43% of the patients required insulin therapy. The primary endpoint was the achievement of HbA_1c of 6% or less, which was achieved in 5% of the medically treated patients, compared with 38% in the gastric bypass group and 24% in the sleeve gastrectomy group. Decrease in BMI was the only measure that predicted the achievement of the HbA_1c endpoint. Body weight decreased by 4.5% in the intensive medical group, 24.5% in the gastric bypass group, and 21.1% in the sleeve gastrectomy group. Significant decreases in low-density lipoprotein cholesterol and increases in high-density lipoprotein cholesterol were achieved in both surgical intervention groups, compared with the intensive medical care group. In addition, medical control of diabetes was improved and 69% and 43% of the gastrectomy and sleeve bypass group, respectively, were no longer requiring insulin therapy. There was, however, no significant difference in the change in blood pressure in the three groups. There were no life-threatening complications or deaths in the groups, but there were a number of complications associated with the procedure.

The metabolic changes associated with bariatric surgery reported in STAMPEDE open the door for future randomized studies examining long-term morbidity and mortality benefits that may be attributed to this therapy. Bariatric surgery is being performed widely in the United States with very low mortality and morbidity. Previous short-term studies have reported the benefit of bariatric surgery, compared with intensive medical therapy. The longer duration of follow-up in STAMPEDE emphasizes the need for larger randomized trials of this method of therapy. The study of the surgical patients may also provide new insight into the relationship of body fat to the expression of type 2 diabetes.

The prevention of medical disease using surgical techniques in clinical medicine has not been a particularly fertile road of investigation. Intervention in the treatment of coronary artery disease with bypass surgery although associated with symptomatic benefit and with some exceptions, has not been overwhelmingly successful in affecting the long-term mortality of that disease. Bariatric surgery may be the first surgical intervention that can arrest or even reverse type 2 diabetes and its many sequelae.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

For a problem that has been on the back burner for decades, the treatment of atrial fibrillation has suddenly become a "marquis" diagnosis.

Age and technology have led to an explosion of interest in this arcane cardiac problem. Advertisements for new anticoagulants and thrombin inhibitors for "A Fib" have become almost as common as those for male impotency. The aging of the world population certainly has been a major factor in its increased incidence. New technology and pharmacology has driven the increase in clinical interest and has advanced our knowledge about the disease. Epidemiology data have provided important information about the natural history of paroxysmal atrial fibrillation (AF), and its relationship to chronic AF and its adverse effects on long-term mortality.

The importance of anticoagulant therapy for the prevention of systemic emboli and stroke has been the mainstay of therapy for almost 50 years. Although we have struggled with a variety of antiarrhythmic drugs, their shortcomings have been more than apparent. Most of us now use a rate-control strategy to control the tachycardia inherent in AF. The development of new factor Xa and direct thrombin inhibitor drugs have made the logistics of providing adequate thrombus prevention much simpler, if somewhat more expensive.

The elephant in the room is the increasing use of radiofrequency catheter ablation technology that has had some success in the prevention of AF arising from the tissue in the pulmonary vein–atrial interface. Numerous small studies have reported that this technology surpasses rhythm control with antiarrhythmic agents, a hurdle not too difficult to beat. The best results have been observed in patients with recurrent paroxysmal AF where maintenance of regular sinus rhythm has been the primary outcome measurement (JAMA 2014;311:692-700). Even here, recurrence after ablation has been common. The benefit of ablation therapy in patients with initial paroxysmal AF (N. Engl. J. Med. 2012;367:1587-95) or chronic persistent AF has been uncertain at best. As a result, the AHA/ACC/HRS (American Heart Association/American College of Cardiology/Heart Rhythm Society) guidelines have given a class I (evidence level A) recommendation for ablation therapy for symptomatic paroxysmal AF and class IIa (evidence level A) and IIb (evidence level B) for symptomatic recurrent paroxysmal and longstanding persistent AF when balanced against drug tolerability, respectively (J. Am. Coll. Cardiol. 2014 [doi:10.1016/j.jacc.2014.03.021]).

All of these clinical data are exciting and have led to enthusiasm for ablation technology despite the potential for nonfatal and rare fatal complication, based almost entirely on its ability to improve upon the dismal benefits of antiarrhythmic rhythm control. Even as we consider the benefit of ablation therapy, new techniques are being developed. The lack of mortality and morbidity data is a result of the short follow-up, usually limited to a year or two, and small sample size. This lack of long-term outcome data for ablation therapy should be of some concern to clinicians who have lived through the last few years. Many of my readers had not been born when we embarked on the ineffective and dangerous pharmacologic prevention of sudden death by pharmacologic suppression of ambient ventricular premature beats. Numerous surrogate measures of clinical benefit of a variety of therapeutic interventions have been disproven and disposed of in the subsequent years. The use of surrogate measures like the partial suppression of AF rather than morbidity and mortality outcomes to establish clinical benefit, have been largely discarded as a dead end.

The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA), which is beginning to recruit more than 2,000 patients with new-onset or undertreated paroxysmal, persistent, or longstanding AF to be followed for over 4 years may answer the question of whether radiofrequency ablation therapy, rate control, or rhythm control provides the best clinical treatment of atrial fibrillation. The primary outcome will be the composite endpoint of total mortality, disabling stroke or serious bleeding, or cardiac arrest. An important secondary endpoint will be total mortality. Until its conclusion, we should proceed cautiously with expanding radiofrequency ablation therapy for the treatment of AF.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

For a problem that has been on the back burner for decades, the treatment of atrial fibrillation has suddenly become a "marquis" diagnosis.

Age and technology have led to an explosion of interest in this arcane cardiac problem. Advertisements for new anticoagulants and thrombin inhibitors for "A Fib" have become almost as common as those for male impotency. The aging of the world population certainly has been a major factor in its increased incidence. New technology and pharmacology has driven the increase in clinical interest and has advanced our knowledge about the disease. Epidemiology data have provided important information about the natural history of paroxysmal atrial fibrillation (AF), and its relationship to chronic AF and its adverse effects on long-term mortality.

The importance of anticoagulant therapy for the prevention of systemic emboli and stroke has been the mainstay of therapy for almost 50 years. Although we have struggled with a variety of antiarrhythmic drugs, their shortcomings have been more than apparent. Most of us now use a rate-control strategy to control the tachycardia inherent in AF. The development of new factor Xa and direct thrombin inhibitor drugs have made the logistics of providing adequate thrombus prevention much simpler, if somewhat more expensive.

The elephant in the room is the increasing use of radiofrequency catheter ablation technology that has had some success in the prevention of AF arising from the tissue in the pulmonary vein–atrial interface. Numerous small studies have reported that this technology surpasses rhythm control with antiarrhythmic agents, a hurdle not too difficult to beat. The best results have been observed in patients with recurrent paroxysmal AF where maintenance of regular sinus rhythm has been the primary outcome measurement (JAMA 2014;311:692-700). Even here, recurrence after ablation has been common. The benefit of ablation therapy in patients with initial paroxysmal AF (N. Engl. J. Med. 2012;367:1587-95) or chronic persistent AF has been uncertain at best. As a result, the AHA/ACC/HRS (American Heart Association/American College of Cardiology/Heart Rhythm Society) guidelines have given a class I (evidence level A) recommendation for ablation therapy for symptomatic paroxysmal AF and class IIa (evidence level A) and IIb (evidence level B) for symptomatic recurrent paroxysmal and longstanding persistent AF when balanced against drug tolerability, respectively (J. Am. Coll. Cardiol. 2014 [doi:10.1016/j.jacc.2014.03.021]).

All of these clinical data are exciting and have led to enthusiasm for ablation technology despite the potential for nonfatal and rare fatal complication, based almost entirely on its ability to improve upon the dismal benefits of antiarrhythmic rhythm control. Even as we consider the benefit of ablation therapy, new techniques are being developed. The lack of mortality and morbidity data is a result of the short follow-up, usually limited to a year or two, and small sample size. This lack of long-term outcome data for ablation therapy should be of some concern to clinicians who have lived through the last few years. Many of my readers had not been born when we embarked on the ineffective and dangerous pharmacologic prevention of sudden death by pharmacologic suppression of ambient ventricular premature beats. Numerous surrogate measures of clinical benefit of a variety of therapeutic interventions have been disproven and disposed of in the subsequent years. The use of surrogate measures like the partial suppression of AF rather than morbidity and mortality outcomes to establish clinical benefit, have been largely discarded as a dead end.

The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA), which is beginning to recruit more than 2,000 patients with new-onset or undertreated paroxysmal, persistent, or longstanding AF to be followed for over 4 years may answer the question of whether radiofrequency ablation therapy, rate control, or rhythm control provides the best clinical treatment of atrial fibrillation. The primary outcome will be the composite endpoint of total mortality, disabling stroke or serious bleeding, or cardiac arrest. An important secondary endpoint will be total mortality. Until its conclusion, we should proceed cautiously with expanding radiofrequency ablation therapy for the treatment of AF.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

For a problem that has been on the back burner for decades, the treatment of atrial fibrillation has suddenly become a "marquis" diagnosis.

Age and technology have led to an explosion of interest in this arcane cardiac problem. Advertisements for new anticoagulants and thrombin inhibitors for "A Fib" have become almost as common as those for male impotency. The aging of the world population certainly has been a major factor in its increased incidence. New technology and pharmacology has driven the increase in clinical interest and has advanced our knowledge about the disease. Epidemiology data have provided important information about the natural history of paroxysmal atrial fibrillation (AF), and its relationship to chronic AF and its adverse effects on long-term mortality.

The importance of anticoagulant therapy for the prevention of systemic emboli and stroke has been the mainstay of therapy for almost 50 years. Although we have struggled with a variety of antiarrhythmic drugs, their shortcomings have been more than apparent. Most of us now use a rate-control strategy to control the tachycardia inherent in AF. The development of new factor Xa and direct thrombin inhibitor drugs have made the logistics of providing adequate thrombus prevention much simpler, if somewhat more expensive.

The elephant in the room is the increasing use of radiofrequency catheter ablation technology that has had some success in the prevention of AF arising from the tissue in the pulmonary vein–atrial interface. Numerous small studies have reported that this technology surpasses rhythm control with antiarrhythmic agents, a hurdle not too difficult to beat. The best results have been observed in patients with recurrent paroxysmal AF where maintenance of regular sinus rhythm has been the primary outcome measurement (JAMA 2014;311:692-700). Even here, recurrence after ablation has been common. The benefit of ablation therapy in patients with initial paroxysmal AF (N. Engl. J. Med. 2012;367:1587-95) or chronic persistent AF has been uncertain at best. As a result, the AHA/ACC/HRS (American Heart Association/American College of Cardiology/Heart Rhythm Society) guidelines have given a class I (evidence level A) recommendation for ablation therapy for symptomatic paroxysmal AF and class IIa (evidence level A) and IIb (evidence level B) for symptomatic recurrent paroxysmal and longstanding persistent AF when balanced against drug tolerability, respectively (J. Am. Coll. Cardiol. 2014 [doi:10.1016/j.jacc.2014.03.021]).

All of these clinical data are exciting and have led to enthusiasm for ablation technology despite the potential for nonfatal and rare fatal complication, based almost entirely on its ability to improve upon the dismal benefits of antiarrhythmic rhythm control. Even as we consider the benefit of ablation therapy, new techniques are being developed. The lack of mortality and morbidity data is a result of the short follow-up, usually limited to a year or two, and small sample size. This lack of long-term outcome data for ablation therapy should be of some concern to clinicians who have lived through the last few years. Many of my readers had not been born when we embarked on the ineffective and dangerous pharmacologic prevention of sudden death by pharmacologic suppression of ambient ventricular premature beats. Numerous surrogate measures of clinical benefit of a variety of therapeutic interventions have been disproven and disposed of in the subsequent years. The use of surrogate measures like the partial suppression of AF rather than morbidity and mortality outcomes to establish clinical benefit, have been largely discarded as a dead end.

The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA), which is beginning to recruit more than 2,000 patients with new-onset or undertreated paroxysmal, persistent, or longstanding AF to be followed for over 4 years may answer the question of whether radiofrequency ablation therapy, rate control, or rhythm control provides the best clinical treatment of atrial fibrillation. The primary outcome will be the composite endpoint of total mortality, disabling stroke or serious bleeding, or cardiac arrest. An important secondary endpoint will be total mortality. Until its conclusion, we should proceed cautiously with expanding radiofrequency ablation therapy for the treatment of AF.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

I recently came to the realization that one doesn’t usually end up in an ICU unless the odds of making it out are not in one’s favor.

Now, I want to make it clear from the very first that my wife and I survived life-threatening medical experiences as a result of the superb care provided to both of us. Nevertheless, the experience made me aware of how ICU and hospital care has changed in the last 50 years. I have spent most of my life in ICUs from the "invention" of the Coronary Care Unit in the mid-1960s to its current iteration of an intensely monitored hospital room where emergency surgery could be performed if need be. Much of that change is a result of the variety of medical specialists who are players in the ICU drama. The other major changes have been the time restraints of house staff rotation to meet certification criteria and rotation of the senior staff in order to provide continuing on-site coverage of the ICU. As the acuteness of hospital admissions has increased, the ICU and its management have assumed a larger role in the care and the finances of major hospitals.

Some years ago, we hosted a distinguished European physician who spent 2 months with us as a visiting professor. It was at a time when we felt a need to begin to develop subspecialties in angiography, electrophysiology, and echocardiography in order to provide a research and training atmosphere for our fellowship program. Later, he wrote an editorial in his local medical journal criticizing cardiac care in the United States because of the lack of continuity. He was of the tradition that mandated that he would see the patient in the clinic, perform a cardiac catheterization himself, and follow his patient through surgery and manage their postoperative care, as was standard practice in the mid-20th century. He believed that the concept of delegating diagnostic and care responsibilities to specialty trained colleagues that he observed here was a major disaster. He should see the system now. Nevertheless, his plea for continuity in care resonates in my mind.

That need for continuity came back to me as I experienced the dizzying rotation of house staff and senior staff that takes place in the ICU today. Any semblance of continuity of care was lacking at a time when there was a need to provide information to anxious patients and their families. In the environment of medical uncertainty, when you would like to find a familiar physician to ask "How are we doing," the attending physician or medical resident in charge was either on another rotation or being covered by a colleague. No training or adherence to "sign-off" rounds can replace the need for that professional continuity. As competent and well meaning the covering doctor was, answers to questions seemed shallow. It was difficult even to express gratitude to "a" physician who had tipped the scales in my favor. One had to direct it to an amorphous team of doctors, nurses, and technicians who had participated in care. That is a reality that describes the methodology of ICU and its success. It is a reality that to a similar degree characterizes the current management of inpatient care.

It seemed that in the setting of a life-threatening experience, the link between the treating physicians and the patients or family has almost disappeared in the ICU. The challenge to us as we play our role in the ICU, and the CCU, is to establish and maintain a personal relationship with the patients and their family.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

I recently came to the realization that one doesn’t usually end up in an ICU unless the odds of making it out are not in one’s favor.

Now, I want to make it clear from the very first that my wife and I survived life-threatening medical experiences as a result of the superb care provided to both of us. Nevertheless, the experience made me aware of how ICU and hospital care has changed in the last 50 years. I have spent most of my life in ICUs from the "invention" of the Coronary Care Unit in the mid-1960s to its current iteration of an intensely monitored hospital room where emergency surgery could be performed if need be. Much of that change is a result of the variety of medical specialists who are players in the ICU drama. The other major changes have been the time restraints of house staff rotation to meet certification criteria and rotation of the senior staff in order to provide continuing on-site coverage of the ICU. As the acuteness of hospital admissions has increased, the ICU and its management have assumed a larger role in the care and the finances of major hospitals.

Some years ago, we hosted a distinguished European physician who spent 2 months with us as a visiting professor. It was at a time when we felt a need to begin to develop subspecialties in angiography, electrophysiology, and echocardiography in order to provide a research and training atmosphere for our fellowship program. Later, he wrote an editorial in his local medical journal criticizing cardiac care in the United States because of the lack of continuity. He was of the tradition that mandated that he would see the patient in the clinic, perform a cardiac catheterization himself, and follow his patient through surgery and manage their postoperative care, as was standard practice in the mid-20th century. He believed that the concept of delegating diagnostic and care responsibilities to specialty trained colleagues that he observed here was a major disaster. He should see the system now. Nevertheless, his plea for continuity in care resonates in my mind.

That need for continuity came back to me as I experienced the dizzying rotation of house staff and senior staff that takes place in the ICU today. Any semblance of continuity of care was lacking at a time when there was a need to provide information to anxious patients and their families. In the environment of medical uncertainty, when you would like to find a familiar physician to ask "How are we doing," the attending physician or medical resident in charge was either on another rotation or being covered by a colleague. No training or adherence to "sign-off" rounds can replace the need for that professional continuity. As competent and well meaning the covering doctor was, answers to questions seemed shallow. It was difficult even to express gratitude to "a" physician who had tipped the scales in my favor. One had to direct it to an amorphous team of doctors, nurses, and technicians who had participated in care. That is a reality that describes the methodology of ICU and its success. It is a reality that to a similar degree characterizes the current management of inpatient care.

It seemed that in the setting of a life-threatening experience, the link between the treating physicians and the patients or family has almost disappeared in the ICU. The challenge to us as we play our role in the ICU, and the CCU, is to establish and maintain a personal relationship with the patients and their family.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

I recently came to the realization that one doesn’t usually end up in an ICU unless the odds of making it out are not in one’s favor.

Now, I want to make it clear from the very first that my wife and I survived life-threatening medical experiences as a result of the superb care provided to both of us. Nevertheless, the experience made me aware of how ICU and hospital care has changed in the last 50 years. I have spent most of my life in ICUs from the "invention" of the Coronary Care Unit in the mid-1960s to its current iteration of an intensely monitored hospital room where emergency surgery could be performed if need be. Much of that change is a result of the variety of medical specialists who are players in the ICU drama. The other major changes have been the time restraints of house staff rotation to meet certification criteria and rotation of the senior staff in order to provide continuing on-site coverage of the ICU. As the acuteness of hospital admissions has increased, the ICU and its management have assumed a larger role in the care and the finances of major hospitals.

Some years ago, we hosted a distinguished European physician who spent 2 months with us as a visiting professor. It was at a time when we felt a need to begin to develop subspecialties in angiography, electrophysiology, and echocardiography in order to provide a research and training atmosphere for our fellowship program. Later, he wrote an editorial in his local medical journal criticizing cardiac care in the United States because of the lack of continuity. He was of the tradition that mandated that he would see the patient in the clinic, perform a cardiac catheterization himself, and follow his patient through surgery and manage their postoperative care, as was standard practice in the mid-20th century. He believed that the concept of delegating diagnostic and care responsibilities to specialty trained colleagues that he observed here was a major disaster. He should see the system now. Nevertheless, his plea for continuity in care resonates in my mind.

That need for continuity came back to me as I experienced the dizzying rotation of house staff and senior staff that takes place in the ICU today. Any semblance of continuity of care was lacking at a time when there was a need to provide information to anxious patients and their families. In the environment of medical uncertainty, when you would like to find a familiar physician to ask "How are we doing," the attending physician or medical resident in charge was either on another rotation or being covered by a colleague. No training or adherence to "sign-off" rounds can replace the need for that professional continuity. As competent and well meaning the covering doctor was, answers to questions seemed shallow. It was difficult even to express gratitude to "a" physician who had tipped the scales in my favor. One had to direct it to an amorphous team of doctors, nurses, and technicians who had participated in care. That is a reality that describes the methodology of ICU and its success. It is a reality that to a similar degree characterizes the current management of inpatient care.

It seemed that in the setting of a life-threatening experience, the link between the treating physicians and the patients or family has almost disappeared in the ICU. The challenge to us as we play our role in the ICU, and the CCU, is to establish and maintain a personal relationship with the patients and their family.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Hospital mergers have been accelerating in the last few years, and doctors and other health care workers have been swept up in the process.

The last time merger mania took place in the 1990s, seemingly to provide efficiencies and savings, costs went up. At that time some doctors became interested in joining their local hospitals and became salaried employees. This time around multiple incentives are playing out, and the exodus from private practice has accelerated. Between 2007 and 2012 the number of cardiologists employed by hospitals has increased from 11% to 35% (N. Engl. J. Med. 2014;370;198-9).

The increased need for investment in financial infrastructure has led many private practitioners to seek the umbrella of the local hospital. Cardiology has seen a shift in federal reimbursement rates for imaging favoring hospital-based testing. At the same time, local hospitals have sought out mergers and acquisitions of varying sorts in order to become more competitive in the marketplace and to acquire more development capital. The number of hospital mergers increased almost twofold from 2009 to 2012 (N.Y. Times, Aug. 12, 2013, p. B1). Local hospitals have been anxious to solidify relationships within their local communities by creating referral networks. Others have looked nationally for the "quality branding" for their institution.

Merger mania has also moved from local to national control by both profit and nonprofit corporations. Entrepreneurism has driven financial incentives in order to develop large networks that have the potential to improve quality and efficiency. An unwritten motivation is the potential to generate large profits that have the potential of increasing health care costs in the pre-Medicare population that we saw in the last merger go-around. Several large medical groups, like the Mayo Clinic or the Cleveland Clinic, have expanded their network and instituted franchiselike arrangements with hospitals thousands of miles distant from their headquarters, to create referral networks for highly specialized and high-cost procedures.

Much of this is hardly news to any of us. This trend is a result of multiple forces that include the changes in imaging fees, which provided the potential for expanding sources of revenue to hospitals and hospital networks. Many physicians found that merging their practice with their local hospital, where they had been practicing, was not too wrenching. That is, until they woke up the next morning to learn that their local hospital had just merged with another system. They now found that they had to deal with unfamiliar administrators with different views on health care. The system was no longer sensitive to local health care but to the corporate bottom line. Suddenly, the familiarity with the local hospital administrator, whom they knew, had been replaced by a "corporate vice president for physician relations."

Recent press coverage has recounted tales of corporate initiatives that have driven up expenses in order to improve the bottom line. One recent report recounts the story of emergency department physicians who were financially rewarded or penalized based upon the statistics of their hospital admission rate (N.Y. Times, Jan. 23, 2014, p. A1).

According to the attorney who represented the doctors, "It’s not a doctor in there watching those statistics – it’s the finance people." The economics of cardiology provide many targets for finance people to improve the bottom line. Some examples are biannual or annual stress tests, multiple imaging procedures, and "tack-on" procedures during angiography, to name just a few. The most recent story (Bloomberg News, March 6, 2014) of how one of America’s most prestigious hospitals manipulated admissions for coronary angiography and trolled local communities with stress tests to increase the number of angiograms, raised shudders in this reader. In 2010, seven of the hospital-based cardiologists each averaged 301 referrals to the cath lab, which was "15 times the average by all 546 doctors who sent patients to the lab that year."

These events were not driven by "finance people" alone, but had complicity by doctors. They suggest that the process is endemic in cardiology today. It has been said before; the enemy is US.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Hospital mergers have been accelerating in the last few years, and doctors and other health care workers have been swept up in the process.

The last time merger mania took place in the 1990s, seemingly to provide efficiencies and savings, costs went up. At that time some doctors became interested in joining their local hospitals and became salaried employees. This time around multiple incentives are playing out, and the exodus from private practice has accelerated. Between 2007 and 2012 the number of cardiologists employed by hospitals has increased from 11% to 35% (N. Engl. J. Med. 2014;370;198-9).

The increased need for investment in financial infrastructure has led many private practitioners to seek the umbrella of the local hospital. Cardiology has seen a shift in federal reimbursement rates for imaging favoring hospital-based testing. At the same time, local hospitals have sought out mergers and acquisitions of varying sorts in order to become more competitive in the marketplace and to acquire more development capital. The number of hospital mergers increased almost twofold from 2009 to 2012 (N.Y. Times, Aug. 12, 2013, p. B1). Local hospitals have been anxious to solidify relationships within their local communities by creating referral networks. Others have looked nationally for the "quality branding" for their institution.

Merger mania has also moved from local to national control by both profit and nonprofit corporations. Entrepreneurism has driven financial incentives in order to develop large networks that have the potential to improve quality and efficiency. An unwritten motivation is the potential to generate large profits that have the potential of increasing health care costs in the pre-Medicare population that we saw in the last merger go-around. Several large medical groups, like the Mayo Clinic or the Cleveland Clinic, have expanded their network and instituted franchiselike arrangements with hospitals thousands of miles distant from their headquarters, to create referral networks for highly specialized and high-cost procedures.

Much of this is hardly news to any of us. This trend is a result of multiple forces that include the changes in imaging fees, which provided the potential for expanding sources of revenue to hospitals and hospital networks. Many physicians found that merging their practice with their local hospital, where they had been practicing, was not too wrenching. That is, until they woke up the next morning to learn that their local hospital had just merged with another system. They now found that they had to deal with unfamiliar administrators with different views on health care. The system was no longer sensitive to local health care but to the corporate bottom line. Suddenly, the familiarity with the local hospital administrator, whom they knew, had been replaced by a "corporate vice president for physician relations."

Recent press coverage has recounted tales of corporate initiatives that have driven up expenses in order to improve the bottom line. One recent report recounts the story of emergency department physicians who were financially rewarded or penalized based upon the statistics of their hospital admission rate (N.Y. Times, Jan. 23, 2014, p. A1).

According to the attorney who represented the doctors, "It’s not a doctor in there watching those statistics – it’s the finance people." The economics of cardiology provide many targets for finance people to improve the bottom line. Some examples are biannual or annual stress tests, multiple imaging procedures, and "tack-on" procedures during angiography, to name just a few. The most recent story (Bloomberg News, March 6, 2014) of how one of America’s most prestigious hospitals manipulated admissions for coronary angiography and trolled local communities with stress tests to increase the number of angiograms, raised shudders in this reader. In 2010, seven of the hospital-based cardiologists each averaged 301 referrals to the cath lab, which was "15 times the average by all 546 doctors who sent patients to the lab that year."

These events were not driven by "finance people" alone, but had complicity by doctors. They suggest that the process is endemic in cardiology today. It has been said before; the enemy is US.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

Hospital mergers have been accelerating in the last few years, and doctors and other health care workers have been swept up in the process.

The last time merger mania took place in the 1990s, seemingly to provide efficiencies and savings, costs went up. At that time some doctors became interested in joining their local hospitals and became salaried employees. This time around multiple incentives are playing out, and the exodus from private practice has accelerated. Between 2007 and 2012 the number of cardiologists employed by hospitals has increased from 11% to 35% (N. Engl. J. Med. 2014;370;198-9).

The increased need for investment in financial infrastructure has led many private practitioners to seek the umbrella of the local hospital. Cardiology has seen a shift in federal reimbursement rates for imaging favoring hospital-based testing. At the same time, local hospitals have sought out mergers and acquisitions of varying sorts in order to become more competitive in the marketplace and to acquire more development capital. The number of hospital mergers increased almost twofold from 2009 to 2012 (N.Y. Times, Aug. 12, 2013, p. B1). Local hospitals have been anxious to solidify relationships within their local communities by creating referral networks. Others have looked nationally for the "quality branding" for their institution.

Merger mania has also moved from local to national control by both profit and nonprofit corporations. Entrepreneurism has driven financial incentives in order to develop large networks that have the potential to improve quality and efficiency. An unwritten motivation is the potential to generate large profits that have the potential of increasing health care costs in the pre-Medicare population that we saw in the last merger go-around. Several large medical groups, like the Mayo Clinic or the Cleveland Clinic, have expanded their network and instituted franchiselike arrangements with hospitals thousands of miles distant from their headquarters, to create referral networks for highly specialized and high-cost procedures.

Much of this is hardly news to any of us. This trend is a result of multiple forces that include the changes in imaging fees, which provided the potential for expanding sources of revenue to hospitals and hospital networks. Many physicians found that merging their practice with their local hospital, where they had been practicing, was not too wrenching. That is, until they woke up the next morning to learn that their local hospital had just merged with another system. They now found that they had to deal with unfamiliar administrators with different views on health care. The system was no longer sensitive to local health care but to the corporate bottom line. Suddenly, the familiarity with the local hospital administrator, whom they knew, had been replaced by a "corporate vice president for physician relations."

Recent press coverage has recounted tales of corporate initiatives that have driven up expenses in order to improve the bottom line. One recent report recounts the story of emergency department physicians who were financially rewarded or penalized based upon the statistics of their hospital admission rate (N.Y. Times, Jan. 23, 2014, p. A1).

According to the attorney who represented the doctors, "It’s not a doctor in there watching those statistics – it’s the finance people." The economics of cardiology provide many targets for finance people to improve the bottom line. Some examples are biannual or annual stress tests, multiple imaging procedures, and "tack-on" procedures during angiography, to name just a few. The most recent story (Bloomberg News, March 6, 2014) of how one of America’s most prestigious hospitals manipulated admissions for coronary angiography and trolled local communities with stress tests to increase the number of angiograms, raised shudders in this reader. In 2010, seven of the hospital-based cardiologists each averaged 301 referrals to the cath lab, which was "15 times the average by all 546 doctors who sent patients to the lab that year."

These events were not driven by "finance people" alone, but had complicity by doctors. They suggest that the process is endemic in cardiology today. It has been said before; the enemy is US.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.