Heart of the Matter

The competency of older physicians is being questioned as a result of a recent study that concludes “physicians with more experience may paradoxically be at risk for providing lower-quality care.” An accompanying editorial, which challenges the headline of this column, all but reads us oldies out of the profession until we are reeducated into the new method of care.

I admit to some bias on this topic. The authors indicate that older physicians don't adhere to guidelines like the young ones do and therefore adversely affect the quality of care. However, the authors were unable to provide any convincing data to suggest that noncompliance affected outcome, and admitted that the study was limited and not entirely reliable (Ann. Intern. Med. 2005;142:260-73,302-3).

Prior to the meteoric increase in guidelines in the 1990s, doctors were on their own to make medical decisions, based on the knowledge of pathophysiology, physical diagnosis, and the paucity of drugs available to them. Since the development of guidelines, many young physicians think they have little need for these arcane concepts because they can turn to their PalmPilot for the answers. Laboratory data have become the driving force for decision making: Give me the ejection fraction or the percent stenosis, and I will give you the therapy. Never mind that guidelines are meant to guide and are not written in stone. Forget that fewer than 20% of the patients we treat actually fit into any particular guideline, or that guidelines are constructed largely from clinical trials of patients who only vaguely resemble the general population. And don't forget that guidelines are continually changing, as is science itself.

Deviation from guidelines may in fact represent the vanguard of better medicine. Consider that for years, guidelines for the treatment of ST-segment elevation MI said that every patient should receive intravenous β-blockade unless bradycardia or hypotension is present. Many physicians, young and old, deviated from that dictum, assuming that patients in acute heart failure could do very poorly. Guidelines changed, and recent trials, including COMMIT/CCS-2—see page 18—confirm that such treatment actually may increase mortality.

The young physicians I work with are terrific—well motivated and very smart. They have been schooled in the use of guidelines, but they often lose sight of the patient in their attempt to practice evidence-based medicine. They are using guidelines as a haven in the morass of the uncertainties of decision making and in a false sense of protection from malpractice.

The dissemination of evidence from clinical trials has unquestionably improved the quality of care of cardiac patients worldwide. These trial data have been incorporated into quality standards and care guidelines with great success. Skilled and sensitive physicians, regardless of their age, will take guidelines and apply them to their patients. However, they may appropriately decide to deviate from those guidelines. Adherence to guidelines is an imperfect measure of physician performance. Perhaps older physicians, because of their experience, can function more easily outside the guidelines.

The competency of older physicians is being questioned as a result of a recent study that concludes “physicians with more experience may paradoxically be at risk for providing lower-quality care.” An accompanying editorial, which challenges the headline of this column, all but reads us oldies out of the profession until we are reeducated into the new method of care.

I admit to some bias on this topic. The authors indicate that older physicians don't adhere to guidelines like the young ones do and therefore adversely affect the quality of care. However, the authors were unable to provide any convincing data to suggest that noncompliance affected outcome, and admitted that the study was limited and not entirely reliable (Ann. Intern. Med. 2005;142:260-73,302-3).

Prior to the meteoric increase in guidelines in the 1990s, doctors were on their own to make medical decisions, based on the knowledge of pathophysiology, physical diagnosis, and the paucity of drugs available to them. Since the development of guidelines, many young physicians think they have little need for these arcane concepts because they can turn to their PalmPilot for the answers. Laboratory data have become the driving force for decision making: Give me the ejection fraction or the percent stenosis, and I will give you the therapy. Never mind that guidelines are meant to guide and are not written in stone. Forget that fewer than 20% of the patients we treat actually fit into any particular guideline, or that guidelines are constructed largely from clinical trials of patients who only vaguely resemble the general population. And don't forget that guidelines are continually changing, as is science itself.

Deviation from guidelines may in fact represent the vanguard of better medicine. Consider that for years, guidelines for the treatment of ST-segment elevation MI said that every patient should receive intravenous β-blockade unless bradycardia or hypotension is present. Many physicians, young and old, deviated from that dictum, assuming that patients in acute heart failure could do very poorly. Guidelines changed, and recent trials, including COMMIT/CCS-2—see page 18—confirm that such treatment actually may increase mortality.

The young physicians I work with are terrific—well motivated and very smart. They have been schooled in the use of guidelines, but they often lose sight of the patient in their attempt to practice evidence-based medicine. They are using guidelines as a haven in the morass of the uncertainties of decision making and in a false sense of protection from malpractice.

The dissemination of evidence from clinical trials has unquestionably improved the quality of care of cardiac patients worldwide. These trial data have been incorporated into quality standards and care guidelines with great success. Skilled and sensitive physicians, regardless of their age, will take guidelines and apply them to their patients. However, they may appropriately decide to deviate from those guidelines. Adherence to guidelines is an imperfect measure of physician performance. Perhaps older physicians, because of their experience, can function more easily outside the guidelines.

The competency of older physicians is being questioned as a result of a recent study that concludes “physicians with more experience may paradoxically be at risk for providing lower-quality care.” An accompanying editorial, which challenges the headline of this column, all but reads us oldies out of the profession until we are reeducated into the new method of care.

I admit to some bias on this topic. The authors indicate that older physicians don't adhere to guidelines like the young ones do and therefore adversely affect the quality of care. However, the authors were unable to provide any convincing data to suggest that noncompliance affected outcome, and admitted that the study was limited and not entirely reliable (Ann. Intern. Med. 2005;142:260-73,302-3).

Prior to the meteoric increase in guidelines in the 1990s, doctors were on their own to make medical decisions, based on the knowledge of pathophysiology, physical diagnosis, and the paucity of drugs available to them. Since the development of guidelines, many young physicians think they have little need for these arcane concepts because they can turn to their PalmPilot for the answers. Laboratory data have become the driving force for decision making: Give me the ejection fraction or the percent stenosis, and I will give you the therapy. Never mind that guidelines are meant to guide and are not written in stone. Forget that fewer than 20% of the patients we treat actually fit into any particular guideline, or that guidelines are constructed largely from clinical trials of patients who only vaguely resemble the general population. And don't forget that guidelines are continually changing, as is science itself.

Deviation from guidelines may in fact represent the vanguard of better medicine. Consider that for years, guidelines for the treatment of ST-segment elevation MI said that every patient should receive intravenous β-blockade unless bradycardia or hypotension is present. Many physicians, young and old, deviated from that dictum, assuming that patients in acute heart failure could do very poorly. Guidelines changed, and recent trials, including COMMIT/CCS-2—see page 18—confirm that such treatment actually may increase mortality.

The young physicians I work with are terrific—well motivated and very smart. They have been schooled in the use of guidelines, but they often lose sight of the patient in their attempt to practice evidence-based medicine. They are using guidelines as a haven in the morass of the uncertainties of decision making and in a false sense of protection from malpractice.

The dissemination of evidence from clinical trials has unquestionably improved the quality of care of cardiac patients worldwide. These trial data have been incorporated into quality standards and care guidelines with great success. Skilled and sensitive physicians, regardless of their age, will take guidelines and apply them to their patients. However, they may appropriately decide to deviate from those guidelines. Adherence to guidelines is an imperfect measure of physician performance. Perhaps older physicians, because of their experience, can function more easily outside the guidelines.

The development of the pacemaker in the 1950s led to an entire subspecialty of electrophysiology. The development of ultrasonography and the echocardiogram provided amazing images of the heart, and now it can be viewed in three dimensions. In the not‐too‐distant future the incorporation of magnetic resonance imaging and computed tomography hold the promise that they will change our understanding of cardiovascular disease and its treatment.

The accessibility of these current and future technologies to both the investigator and the clinician is key to the expansion of our knowledge and its application to the patient.

In this issue, a radiologist raises serious issues about the appropriateness of the use of current technology by nonradiologists and, particularly, cardiologists. David C. Levin, M.D., suggests that the ready access of diagnostic technologies in the cardiologist's office is self‐serving and leads to overuse to such an extent that it will “bankrupt the health care system.” These are serious charges that require introspection by cardiologists. He does not speak, however, of the benefit accruing to the patient from the accessibility to diagnostic technology in the physician's office.

We have seen many professional boundaries of diseases become blurred as a result of technological development. The boundaries of cardiac surgery have fallen into the domain of the treating interventional cardiologists with the development of stent technology. Ultrasonography, largely staked out to be the radiologist's domain, lost echocardiography to the cardiologists as they used that technology to understand cardiac physiology.

Now multidetector computed tomography portends to be the next battlefield between the radiologists and the cardiologists. These machines can not only image the degree of cardiac calcification like electron beam CT, which is widely available in a “store front” near you, but also can image with a dye injection the lumen and wall of the coronary artery. Its potential as a screening technique in lieu of angiography has the potential to produce further friction between radiologists and cardiologists. Who owns these new machines and who will interpret the images is of concern to both specialties. Radiologists are already seeking training requirements favorable to their specialty.

Various technologists and scientists can and will add to the development and application of new tools. But the application of these tools to the patients will necessarily reside with the practitioner. This license, however, does not attach to it the right to use it inappropriately. None of us want to put further strains on our health care system, but we do need to have ready access to the diagnostic technologies that we use in the everyday practice of cardiology.

The development of the pacemaker in the 1950s led to an entire subspecialty of electrophysiology. The development of ultrasonography and the echocardiogram provided amazing images of the heart, and now it can be viewed in three dimensions. In the not‐too‐distant future the incorporation of magnetic resonance imaging and computed tomography hold the promise that they will change our understanding of cardiovascular disease and its treatment.

The accessibility of these current and future technologies to both the investigator and the clinician is key to the expansion of our knowledge and its application to the patient.

In this issue, a radiologist raises serious issues about the appropriateness of the use of current technology by nonradiologists and, particularly, cardiologists. David C. Levin, M.D., suggests that the ready access of diagnostic technologies in the cardiologist's office is self‐serving and leads to overuse to such an extent that it will “bankrupt the health care system.” These are serious charges that require introspection by cardiologists. He does not speak, however, of the benefit accruing to the patient from the accessibility to diagnostic technology in the physician's office.

We have seen many professional boundaries of diseases become blurred as a result of technological development. The boundaries of cardiac surgery have fallen into the domain of the treating interventional cardiologists with the development of stent technology. Ultrasonography, largely staked out to be the radiologist's domain, lost echocardiography to the cardiologists as they used that technology to understand cardiac physiology.

Now multidetector computed tomography portends to be the next battlefield between the radiologists and the cardiologists. These machines can not only image the degree of cardiac calcification like electron beam CT, which is widely available in a “store front” near you, but also can image with a dye injection the lumen and wall of the coronary artery. Its potential as a screening technique in lieu of angiography has the potential to produce further friction between radiologists and cardiologists. Who owns these new machines and who will interpret the images is of concern to both specialties. Radiologists are already seeking training requirements favorable to their specialty.

Various technologists and scientists can and will add to the development and application of new tools. But the application of these tools to the patients will necessarily reside with the practitioner. This license, however, does not attach to it the right to use it inappropriately. None of us want to put further strains on our health care system, but we do need to have ready access to the diagnostic technologies that we use in the everyday practice of cardiology.

The development of the pacemaker in the 1950s led to an entire subspecialty of electrophysiology. The development of ultrasonography and the echocardiogram provided amazing images of the heart, and now it can be viewed in three dimensions. In the not‐too‐distant future the incorporation of magnetic resonance imaging and computed tomography hold the promise that they will change our understanding of cardiovascular disease and its treatment.

The accessibility of these current and future technologies to both the investigator and the clinician is key to the expansion of our knowledge and its application to the patient.

In this issue, a radiologist raises serious issues about the appropriateness of the use of current technology by nonradiologists and, particularly, cardiologists. David C. Levin, M.D., suggests that the ready access of diagnostic technologies in the cardiologist's office is self‐serving and leads to overuse to such an extent that it will “bankrupt the health care system.” These are serious charges that require introspection by cardiologists. He does not speak, however, of the benefit accruing to the patient from the accessibility to diagnostic technology in the physician's office.

We have seen many professional boundaries of diseases become blurred as a result of technological development. The boundaries of cardiac surgery have fallen into the domain of the treating interventional cardiologists with the development of stent technology. Ultrasonography, largely staked out to be the radiologist's domain, lost echocardiography to the cardiologists as they used that technology to understand cardiac physiology.

Now multidetector computed tomography portends to be the next battlefield between the radiologists and the cardiologists. These machines can not only image the degree of cardiac calcification like electron beam CT, which is widely available in a “store front” near you, but also can image with a dye injection the lumen and wall of the coronary artery. Its potential as a screening technique in lieu of angiography has the potential to produce further friction between radiologists and cardiologists. Who owns these new machines and who will interpret the images is of concern to both specialties. Radiologists are already seeking training requirements favorable to their specialty.

Various technologists and scientists can and will add to the development and application of new tools. But the application of these tools to the patients will necessarily reside with the practitioner. This license, however, does not attach to it the right to use it inappropriately. None of us want to put further strains on our health care system, but we do need to have ready access to the diagnostic technologies that we use in the everyday practice of cardiology.

In the wake of the Vioxx scandal, the Food and Drug Administration has become the whipping boy of the press, Congress, and even agency.

This column has not been lacking in criticism of the FDA. We have expressed concern about some of its premature decisions and lack of postapproval surveillance of drugs. Nevertheless, let's place some of the blame where it should be placed. The FDA, created in 1906 as part of the Pure Food and Drug Act, has responded to changes in both the industry that it is intended to control and in the human beings it is expected to protect. In its nearly 100 years of life, drugs have become more complex and Americans have grown older. Advances in technology and pharmacology in the last half century have provided physicians and patients a breathtaking array of medical options to prolong and improve the quality of life. But these products have the potential to harm those individuals who are the treatment targets.

It was but a short 12 years ago that Congress pressured the FDA to get in bed with the pharmaceutical industry in order to expedite drug approval and get new drugs to market faster by collecting user fees from applicants. As a result of this and other initiatives, the approval of new molecular entities increased from 30 in 1991 to 53 in 1996. But in order to maintain that pharmaceutical support, other programs had to be cut over time. Now, Congress charges that the FDA has been too hasty and superficial with their drug approval process.

As medical therapy has changed in the last half century, so to has the role of the FDA. Mid-20th-century medical therapy was focused on the treatment of episodic short-term diseases like pneumonia. Safety and efficacy could be measured in days or weeks. Major advances occurred in the 1970s and 1980s that led to the consideration of drugs for the long-term prevention and treatment of chronic diseases that affect an increasingly aging population. Clinical trials suggested that drugs should be taken for a lifetime, and that can be a very long time when therapy was initiated in the midlife or even earlier. These randomized clinical trials, at best, provided information over 1–2 years of therapy and were tested in very unique populations. We have little knowledge of the effects of taking drugs for longer periods and even less information when the drugs are applied to broader and unselected populations. Numerous misadventures emerged. Vioxx (rofecoxib) can be added to a long list of drugs that were not fully investigated prior to their release.

It is therefore critical that we develop methodologies to understand the efficacy and safety of drugs and devices after initial short-term approval.

Some have suggested that we develop a two-track approval process in which drug efficacy and safety are established for a short term, at the same time establishing a surveillance system to monitor the long-term drug safety. The FDA is the proper environment to carry out this mission, but it needs to have Congressional support to make it happen. The Vioxx experience should provide the motivation necessary to achieve this long delayed effort.

In the wake of the Vioxx scandal, the Food and Drug Administration has become the whipping boy of the press, Congress, and even agency.

This column has not been lacking in criticism of the FDA. We have expressed concern about some of its premature decisions and lack of postapproval surveillance of drugs. Nevertheless, let's place some of the blame where it should be placed. The FDA, created in 1906 as part of the Pure Food and Drug Act, has responded to changes in both the industry that it is intended to control and in the human beings it is expected to protect. In its nearly 100 years of life, drugs have become more complex and Americans have grown older. Advances in technology and pharmacology in the last half century have provided physicians and patients a breathtaking array of medical options to prolong and improve the quality of life. But these products have the potential to harm those individuals who are the treatment targets.

It was but a short 12 years ago that Congress pressured the FDA to get in bed with the pharmaceutical industry in order to expedite drug approval and get new drugs to market faster by collecting user fees from applicants. As a result of this and other initiatives, the approval of new molecular entities increased from 30 in 1991 to 53 in 1996. But in order to maintain that pharmaceutical support, other programs had to be cut over time. Now, Congress charges that the FDA has been too hasty and superficial with their drug approval process.

As medical therapy has changed in the last half century, so to has the role of the FDA. Mid-20th-century medical therapy was focused on the treatment of episodic short-term diseases like pneumonia. Safety and efficacy could be measured in days or weeks. Major advances occurred in the 1970s and 1980s that led to the consideration of drugs for the long-term prevention and treatment of chronic diseases that affect an increasingly aging population. Clinical trials suggested that drugs should be taken for a lifetime, and that can be a very long time when therapy was initiated in the midlife or even earlier. These randomized clinical trials, at best, provided information over 1–2 years of therapy and were tested in very unique populations. We have little knowledge of the effects of taking drugs for longer periods and even less information when the drugs are applied to broader and unselected populations. Numerous misadventures emerged. Vioxx (rofecoxib) can be added to a long list of drugs that were not fully investigated prior to their release.

It is therefore critical that we develop methodologies to understand the efficacy and safety of drugs and devices after initial short-term approval.

Some have suggested that we develop a two-track approval process in which drug efficacy and safety are established for a short term, at the same time establishing a surveillance system to monitor the long-term drug safety. The FDA is the proper environment to carry out this mission, but it needs to have Congressional support to make it happen. The Vioxx experience should provide the motivation necessary to achieve this long delayed effort.

In the wake of the Vioxx scandal, the Food and Drug Administration has become the whipping boy of the press, Congress, and even agency.

This column has not been lacking in criticism of the FDA. We have expressed concern about some of its premature decisions and lack of postapproval surveillance of drugs. Nevertheless, let's place some of the blame where it should be placed. The FDA, created in 1906 as part of the Pure Food and Drug Act, has responded to changes in both the industry that it is intended to control and in the human beings it is expected to protect. In its nearly 100 years of life, drugs have become more complex and Americans have grown older. Advances in technology and pharmacology in the last half century have provided physicians and patients a breathtaking array of medical options to prolong and improve the quality of life. But these products have the potential to harm those individuals who are the treatment targets.

It was but a short 12 years ago that Congress pressured the FDA to get in bed with the pharmaceutical industry in order to expedite drug approval and get new drugs to market faster by collecting user fees from applicants. As a result of this and other initiatives, the approval of new molecular entities increased from 30 in 1991 to 53 in 1996. But in order to maintain that pharmaceutical support, other programs had to be cut over time. Now, Congress charges that the FDA has been too hasty and superficial with their drug approval process.

As medical therapy has changed in the last half century, so to has the role of the FDA. Mid-20th-century medical therapy was focused on the treatment of episodic short-term diseases like pneumonia. Safety and efficacy could be measured in days or weeks. Major advances occurred in the 1970s and 1980s that led to the consideration of drugs for the long-term prevention and treatment of chronic diseases that affect an increasingly aging population. Clinical trials suggested that drugs should be taken for a lifetime, and that can be a very long time when therapy was initiated in the midlife or even earlier. These randomized clinical trials, at best, provided information over 1–2 years of therapy and were tested in very unique populations. We have little knowledge of the effects of taking drugs for longer periods and even less information when the drugs are applied to broader and unselected populations. Numerous misadventures emerged. Vioxx (rofecoxib) can be added to a long list of drugs that were not fully investigated prior to their release.

It is therefore critical that we develop methodologies to understand the efficacy and safety of drugs and devices after initial short-term approval.

Some have suggested that we develop a two-track approval process in which drug efficacy and safety are established for a short term, at the same time establishing a surveillance system to monitor the long-term drug safety. The FDA is the proper environment to carry out this mission, but it needs to have Congressional support to make it happen. The Vioxx experience should provide the motivation necessary to achieve this long delayed effort.