Commentary

Editor’s note: This commentary relates to the story, “ New classification system for systemic lupus erythematosus moves forward .”

The ACR/EULAR committee that is developing new classification criteria for systemic lupus erythematosus (SLE) has done the field a service by releasing its draft version in a presentation at the recent EULAR meeting. Releasing the draft version facilitates comments before the new classification criteria become finalized.

Many in the derm-rheum field, ourselves included, classify patients with skin-predominant lupus as lupus, but the new draft classification would place a significant percentage of these patients outside of lupus.

The presentation by Dr. Johnson at EULAR stated, “... a patient can’t be classified on skin findings alone. There is concern that skin findings by themselves may not be lupus, but something else, and some people even consider that cutaneous and systemic lupus are two different things.”

Abundant data indicate instead that lupus is a spectrum that includes skin-predominant lupus. For example, the histology is identical between discoid lupus erythematosus whether or not there is SLE. Moreover, we and others have published significant rates of progression of cutaneous lupus erythematosus (CLE) to SLE. By not viewing CLE in the lupus spectrum, we have a false sense that the patients won’t progress to SLE, yet many of them do.

Importantly, patients respond similarly to therapies when they have either CLE or SLE, so removing this subset of lupus hurts their inclusion in trials and access to new treatments.

When criteria are devised by one group without input from experts who see a specific subset of the disease, that is also a problem. We went down that path in dermatomyositis and missed a lot of patients with the disease when criteria were devised that said the patient had to have muscle involvement. Those criteria have now finally been revised as the ACR/EULAR myositis criteria.

We and others from the derm-rheum community would be happy to speak with the ACR/EULAR committee about these concerns.
 

Victoria P. Werth, MD, is professor of medicine and dermatology at the University of Pennsylvania, Philadelphia. Joseph F. Merola, MD, is codirector of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston. Andrew G. Franks, MD, is a clinical professor in the departments of medicine and dermatology at New York University. Benjamin F. Chong, MD, is an assistant professor of dermatology at the University of Texas, Dallas.

Editor’s note: This commentary relates to the story, “ New classification system for systemic lupus erythematosus moves forward .”

The ACR/EULAR committee that is developing new classification criteria for systemic lupus erythematosus (SLE) has done the field a service by releasing its draft version in a presentation at the recent EULAR meeting. Releasing the draft version facilitates comments before the new classification criteria become finalized.

Many in the derm-rheum field, ourselves included, classify patients with skin-predominant lupus as lupus, but the new draft classification would place a significant percentage of these patients outside of lupus.

The presentation by Dr. Johnson at EULAR stated, “... a patient can’t be classified on skin findings alone. There is concern that skin findings by themselves may not be lupus, but something else, and some people even consider that cutaneous and systemic lupus are two different things.”

Abundant data indicate instead that lupus is a spectrum that includes skin-predominant lupus. For example, the histology is identical between discoid lupus erythematosus whether or not there is SLE. Moreover, we and others have published significant rates of progression of cutaneous lupus erythematosus (CLE) to SLE. By not viewing CLE in the lupus spectrum, we have a false sense that the patients won’t progress to SLE, yet many of them do.

Importantly, patients respond similarly to therapies when they have either CLE or SLE, so removing this subset of lupus hurts their inclusion in trials and access to new treatments.

When criteria are devised by one group without input from experts who see a specific subset of the disease, that is also a problem. We went down that path in dermatomyositis and missed a lot of patients with the disease when criteria were devised that said the patient had to have muscle involvement. Those criteria have now finally been revised as the ACR/EULAR myositis criteria.

We and others from the derm-rheum community would be happy to speak with the ACR/EULAR committee about these concerns.
 

Victoria P. Werth, MD, is professor of medicine and dermatology at the University of Pennsylvania, Philadelphia. Joseph F. Merola, MD, is codirector of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston. Andrew G. Franks, MD, is a clinical professor in the departments of medicine and dermatology at New York University. Benjamin F. Chong, MD, is an assistant professor of dermatology at the University of Texas, Dallas.

Editor’s note: This commentary relates to the story, “ New classification system for systemic lupus erythematosus moves forward .”

The ACR/EULAR committee that is developing new classification criteria for systemic lupus erythematosus (SLE) has done the field a service by releasing its draft version in a presentation at the recent EULAR meeting. Releasing the draft version facilitates comments before the new classification criteria become finalized.

Many in the derm-rheum field, ourselves included, classify patients with skin-predominant lupus as lupus, but the new draft classification would place a significant percentage of these patients outside of lupus.

The presentation by Dr. Johnson at EULAR stated, “... a patient can’t be classified on skin findings alone. There is concern that skin findings by themselves may not be lupus, but something else, and some people even consider that cutaneous and systemic lupus are two different things.”

Abundant data indicate instead that lupus is a spectrum that includes skin-predominant lupus. For example, the histology is identical between discoid lupus erythematosus whether or not there is SLE. Moreover, we and others have published significant rates of progression of cutaneous lupus erythematosus (CLE) to SLE. By not viewing CLE in the lupus spectrum, we have a false sense that the patients won’t progress to SLE, yet many of them do.

Importantly, patients respond similarly to therapies when they have either CLE or SLE, so removing this subset of lupus hurts their inclusion in trials and access to new treatments.

When criteria are devised by one group without input from experts who see a specific subset of the disease, that is also a problem. We went down that path in dermatomyositis and missed a lot of patients with the disease when criteria were devised that said the patient had to have muscle involvement. Those criteria have now finally been revised as the ACR/EULAR myositis criteria.

We and others from the derm-rheum community would be happy to speak with the ACR/EULAR committee about these concerns.
 

Victoria P. Werth, MD, is professor of medicine and dermatology at the University of Pennsylvania, Philadelphia. Joseph F. Merola, MD, is codirector of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston. Andrew G. Franks, MD, is a clinical professor in the departments of medicine and dermatology at New York University. Benjamin F. Chong, MD, is an assistant professor of dermatology at the University of Texas, Dallas.

Editor’s note: This commentary relates to the story, “New classification system for systemic lupus erythematosus moves forward.”



While work to develop a new set of lupus classification criteria more suitable for clinical research is important, the Lupus Foundation of America believes the current work is going in the wrong direction.

Increasingly, key opinion leaders understand lupus to be a spectrum of disease, and there is ample justification of this from scientific evidence (Nat Rev Rheumatol. 2015;11[7]:385-6) The criteria being worked on by ACR and EULAR draws upon an archaic concept with the musty name of “systemic lupus erythematosus,” which relies on a 19th century approach to categorizing disease by counting the signs and symptoms instead of by modern concepts of pathophysiology and prognostic severity. This imposes a homogeneity on the population that simply does not exist. Attempts to re-order obsolescent arrays of organs and autoantibodies to classify lupus will be futile, especially if the aim is to improve the rationale for clinical trial recruitment. Recent clinical trials and modern immunologic methods have already demonstrated, beyond a doubt, that subsets of patients, definable by gene expression patterns or state of the art pharmacodynamic responses, do or do not respond to individual targeted treatments. We now know that patients who require different treatments may well share many of their symptoms in many of the same organs, and this fact defies the outmoded, abacus-based approach to disease classification.

We are concerned that redefining SLE by weighting all disease in one organ as more or less impactful than all disease in another organ flies in the face of current scientific knowledge. If this is the direction in which the effort is going, there is the potential for a negative impact on drug development, clinical care, and access to treatment. The term itself, “SLE,” interferes with selecting appropriate lupus patients for participation in trials. Many people have moderate and even severe lupus syndromes who do not meet enough criteria to be labeled “SLE” (for example, immune thrombocytopenia, hemolytic anemia, discoid lupus, or subacute cutaneous lupus, which can cause severe rashes covering wide areas of the body). In this iteration, assigning less weight to cutaneous lupus as currently proposed is not just problematic, it will set the field back.

By not viewing cutaneous lupus as part of the lupus spectrum, we develop a false sense that this subset of people with lupus will not progress to “SLE,” yet many of them do. Even those who do not later develop features in other organs besides the skin may have more severe disease than other patients who do. Minimizing the “score” for cutaneous lupus will lead to individuals who carry a significant burden of disease being barred from trials, and from access to the treatments they need, once approved.

Conversely, people who do meet criteria for “SLE” under any algorithm, past or present, may have a range of severity, from very severe to very mild. The very mild patients (who may have, in their lifetime met the multiorgan criteria) are entering trials in large numbers and contributing to the high placebo responses which have stopped many promising investigational treatments from further development. Additionally, the common misuse of the current classification criteria as diagnostic criteria has become an unacceptable norm in the lupus community. This leads us to believe that new criteria will continue to be misused, further disenfranchising a huge segment of the population who have lupus from access to state-of-the-art research and care.

Advancing the development new classification criteria deserves a wider discussion among the field’s stakeholders, particularly those with expertise in clinical trial outcomes and the clinical care of the full spectrum of lupus patients.
 

Sandra C. Raymond is CEO and President, Leslie M. Hanrahan is VP of Education and Research, and Joan Merrill, MD, is the Chief Adviser for Clinical Development at the Lupus Foundation of America. Dr. Merrill is also the Oklahoma Medical Research Foundation Professor of Medicine at the University of Oklahoma, Oklahoma City.

Editor’s note: This commentary relates to the story, “New classification system for systemic lupus erythematosus moves forward.”



While work to develop a new set of lupus classification criteria more suitable for clinical research is important, the Lupus Foundation of America believes the current work is going in the wrong direction.

Increasingly, key opinion leaders understand lupus to be a spectrum of disease, and there is ample justification of this from scientific evidence (Nat Rev Rheumatol. 2015;11[7]:385-6) The criteria being worked on by ACR and EULAR draws upon an archaic concept with the musty name of “systemic lupus erythematosus,” which relies on a 19th century approach to categorizing disease by counting the signs and symptoms instead of by modern concepts of pathophysiology and prognostic severity. This imposes a homogeneity on the population that simply does not exist. Attempts to re-order obsolescent arrays of organs and autoantibodies to classify lupus will be futile, especially if the aim is to improve the rationale for clinical trial recruitment. Recent clinical trials and modern immunologic methods have already demonstrated, beyond a doubt, that subsets of patients, definable by gene expression patterns or state of the art pharmacodynamic responses, do or do not respond to individual targeted treatments. We now know that patients who require different treatments may well share many of their symptoms in many of the same organs, and this fact defies the outmoded, abacus-based approach to disease classification.

We are concerned that redefining SLE by weighting all disease in one organ as more or less impactful than all disease in another organ flies in the face of current scientific knowledge. If this is the direction in which the effort is going, there is the potential for a negative impact on drug development, clinical care, and access to treatment. The term itself, “SLE,” interferes with selecting appropriate lupus patients for participation in trials. Many people have moderate and even severe lupus syndromes who do not meet enough criteria to be labeled “SLE” (for example, immune thrombocytopenia, hemolytic anemia, discoid lupus, or subacute cutaneous lupus, which can cause severe rashes covering wide areas of the body). In this iteration, assigning less weight to cutaneous lupus as currently proposed is not just problematic, it will set the field back.

By not viewing cutaneous lupus as part of the lupus spectrum, we develop a false sense that this subset of people with lupus will not progress to “SLE,” yet many of them do. Even those who do not later develop features in other organs besides the skin may have more severe disease than other patients who do. Minimizing the “score” for cutaneous lupus will lead to individuals who carry a significant burden of disease being barred from trials, and from access to the treatments they need, once approved.

Conversely, people who do meet criteria for “SLE” under any algorithm, past or present, may have a range of severity, from very severe to very mild. The very mild patients (who may have, in their lifetime met the multiorgan criteria) are entering trials in large numbers and contributing to the high placebo responses which have stopped many promising investigational treatments from further development. Additionally, the common misuse of the current classification criteria as diagnostic criteria has become an unacceptable norm in the lupus community. This leads us to believe that new criteria will continue to be misused, further disenfranchising a huge segment of the population who have lupus from access to state-of-the-art research and care.

Advancing the development new classification criteria deserves a wider discussion among the field’s stakeholders, particularly those with expertise in clinical trial outcomes and the clinical care of the full spectrum of lupus patients.
 

Sandra C. Raymond is CEO and President, Leslie M. Hanrahan is VP of Education and Research, and Joan Merrill, MD, is the Chief Adviser for Clinical Development at the Lupus Foundation of America. Dr. Merrill is also the Oklahoma Medical Research Foundation Professor of Medicine at the University of Oklahoma, Oklahoma City.

Editor’s note: This commentary relates to the story, “New classification system for systemic lupus erythematosus moves forward.”



While work to develop a new set of lupus classification criteria more suitable for clinical research is important, the Lupus Foundation of America believes the current work is going in the wrong direction.

Increasingly, key opinion leaders understand lupus to be a spectrum of disease, and there is ample justification of this from scientific evidence (Nat Rev Rheumatol. 2015;11[7]:385-6) The criteria being worked on by ACR and EULAR draws upon an archaic concept with the musty name of “systemic lupus erythematosus,” which relies on a 19th century approach to categorizing disease by counting the signs and symptoms instead of by modern concepts of pathophysiology and prognostic severity. This imposes a homogeneity on the population that simply does not exist. Attempts to re-order obsolescent arrays of organs and autoantibodies to classify lupus will be futile, especially if the aim is to improve the rationale for clinical trial recruitment. Recent clinical trials and modern immunologic methods have already demonstrated, beyond a doubt, that subsets of patients, definable by gene expression patterns or state of the art pharmacodynamic responses, do or do not respond to individual targeted treatments. We now know that patients who require different treatments may well share many of their symptoms in many of the same organs, and this fact defies the outmoded, abacus-based approach to disease classification.

We are concerned that redefining SLE by weighting all disease in one organ as more or less impactful than all disease in another organ flies in the face of current scientific knowledge. If this is the direction in which the effort is going, there is the potential for a negative impact on drug development, clinical care, and access to treatment. The term itself, “SLE,” interferes with selecting appropriate lupus patients for participation in trials. Many people have moderate and even severe lupus syndromes who do not meet enough criteria to be labeled “SLE” (for example, immune thrombocytopenia, hemolytic anemia, discoid lupus, or subacute cutaneous lupus, which can cause severe rashes covering wide areas of the body). In this iteration, assigning less weight to cutaneous lupus as currently proposed is not just problematic, it will set the field back.

By not viewing cutaneous lupus as part of the lupus spectrum, we develop a false sense that this subset of people with lupus will not progress to “SLE,” yet many of them do. Even those who do not later develop features in other organs besides the skin may have more severe disease than other patients who do. Minimizing the “score” for cutaneous lupus will lead to individuals who carry a significant burden of disease being barred from trials, and from access to the treatments they need, once approved.

Conversely, people who do meet criteria for “SLE” under any algorithm, past or present, may have a range of severity, from very severe to very mild. The very mild patients (who may have, in their lifetime met the multiorgan criteria) are entering trials in large numbers and contributing to the high placebo responses which have stopped many promising investigational treatments from further development. Additionally, the common misuse of the current classification criteria as diagnostic criteria has become an unacceptable norm in the lupus community. This leads us to believe that new criteria will continue to be misused, further disenfranchising a huge segment of the population who have lupus from access to state-of-the-art research and care.

Advancing the development new classification criteria deserves a wider discussion among the field’s stakeholders, particularly those with expertise in clinical trial outcomes and the clinical care of the full spectrum of lupus patients.
 

Sandra C. Raymond is CEO and President, Leslie M. Hanrahan is VP of Education and Research, and Joan Merrill, MD, is the Chief Adviser for Clinical Development at the Lupus Foundation of America. Dr. Merrill is also the Oklahoma Medical Research Foundation Professor of Medicine at the University of Oklahoma, Oklahoma City.

Editor’s note: This commentary relates to the story, “New classification system for systemic lupus erythematosus moves forward.”

While work to develop a new set of lupus classification criteria more suitable for clinical research is important, the Lupus Foundation of America believes the current work is going in the wrong direction.

Increasingly, key opinion leaders understand lupus to be a spectrum of disease, and there is ample justification of this from scientific evidence (Nat Rev Rheumatol. 2015;11[7]:385-6) The criteria being worked on by ACR and EULAR draws upon an archaic concept with the musty name of “systemic lupus erythematosus,” which relies on a 19th century approach to categorizing disease by counting the signs and symptoms instead of by modern concepts of pathophysiology and prognostic severity. This imposes a homogeneity on the population that simply does not exist. Attempts to re-order obsolescent arrays of organs and autoantibodies to classify lupus will be futile, especially if the aim is to improve the rationale for clinical trial recruitment. Recent clinical trials and modern immunologic methods have already demonstrated, beyond a doubt, that subsets of patients, definable by gene expression patterns or state-of-the-art pharmacodynamic responses, do or do not respond to individual targeted treatments. We now know that patients who require different treatments may well share many of their symptoms in many of the same organs, and this fact defies the outmoded, abacus-based approach to disease classification.

We are concerned that redefining SLE by weighting all disease in one organ as more or less impactful than all disease in another organ flies in the face of current scientific knowledge. If this is the direction in which the effort is going, there is the potential for a negative impact on drug development, clinical care, and access to treatment. The term itself, “SLE,” interferes with selecting appropriate lupus patients for participation in trials. Many people have moderate and even severe lupus syndromes who do not meet enough criteria to be labeled “SLE” (for example, immune thrombocytopenia, hemolytic anemia, discoid lupus, or subacute cutaneous lupus, which can cause severe rashes covering wide areas of the body). In this iteration, assigning less weight to cutaneous lupus as currently proposed is not just problematic; it will set the field back.

By not viewing cutaneous lupus as part of the lupus spectrum, we develop a false sense that this subset of people with lupus will not progress to “SLE,” yet many of them do. Even those who do not later develop features in other organs besides the skin may have more severe disease than other patients who do. Minimizing the “score” for cutaneous lupus will lead to individuals who carry a significant burden of disease being barred from trials, and from access to the treatments they need, once approved.

Conversely, people who do meet criteria for “SLE” under any algorithm, past or present, may have a range of severity, from very severe to very mild. The very mild patients (who may have, in their lifetime, met the multiorgan criteria) are entering trials in large numbers and contributing to the high placebo responses which have stopped many promising investigational treatments from further development. Additionally, the common misuse of the current classification criteria as diagnostic criteria has become an unacceptable norm in the lupus community. This leads us to believe that new criteria will continue to be misused, further disenfranchising a huge segment of the population who have lupus from access to state-of-the-art research and care.

Advancing the development of new classification criteria deserves a wider discussion among the field’s stakeholders, particularly those with expertise in clinical trial outcomes and the clinical care of the full spectrum of lupus patients.
 

Sandra C. Raymond is CEO and President, Leslie M. Hanrahan is VP of Education and Research, and Joan Merrill, MD, is the Chief Adviser for Clinical Development at the Lupus Foundation of America. Dr. Merrill is also the Oklahoma Medical Research Foundation Professor of Medicine at the University of Oklahoma, Oklahoma City.

Editor’s note: This commentary relates to the story, “New classification system for systemic lupus erythematosus moves forward.”

While work to develop a new set of lupus classification criteria more suitable for clinical research is important, the Lupus Foundation of America believes the current work is going in the wrong direction.

Increasingly, key opinion leaders understand lupus to be a spectrum of disease, and there is ample justification of this from scientific evidence (Nat Rev Rheumatol. 2015;11[7]:385-6) The criteria being worked on by ACR and EULAR draws upon an archaic concept with the musty name of “systemic lupus erythematosus,” which relies on a 19th century approach to categorizing disease by counting the signs and symptoms instead of by modern concepts of pathophysiology and prognostic severity. This imposes a homogeneity on the population that simply does not exist. Attempts to re-order obsolescent arrays of organs and autoantibodies to classify lupus will be futile, especially if the aim is to improve the rationale for clinical trial recruitment. Recent clinical trials and modern immunologic methods have already demonstrated, beyond a doubt, that subsets of patients, definable by gene expression patterns or state-of-the-art pharmacodynamic responses, do or do not respond to individual targeted treatments. We now know that patients who require different treatments may well share many of their symptoms in many of the same organs, and this fact defies the outmoded, abacus-based approach to disease classification.

We are concerned that redefining SLE by weighting all disease in one organ as more or less impactful than all disease in another organ flies in the face of current scientific knowledge. If this is the direction in which the effort is going, there is the potential for a negative impact on drug development, clinical care, and access to treatment. The term itself, “SLE,” interferes with selecting appropriate lupus patients for participation in trials. Many people have moderate and even severe lupus syndromes who do not meet enough criteria to be labeled “SLE” (for example, immune thrombocytopenia, hemolytic anemia, discoid lupus, or subacute cutaneous lupus, which can cause severe rashes covering wide areas of the body). In this iteration, assigning less weight to cutaneous lupus as currently proposed is not just problematic; it will set the field back.

By not viewing cutaneous lupus as part of the lupus spectrum, we develop a false sense that this subset of people with lupus will not progress to “SLE,” yet many of them do. Even those who do not later develop features in other organs besides the skin may have more severe disease than other patients who do. Minimizing the “score” for cutaneous lupus will lead to individuals who carry a significant burden of disease being barred from trials, and from access to the treatments they need, once approved.

Conversely, people who do meet criteria for “SLE” under any algorithm, past or present, may have a range of severity, from very severe to very mild. The very mild patients (who may have, in their lifetime, met the multiorgan criteria) are entering trials in large numbers and contributing to the high placebo responses which have stopped many promising investigational treatments from further development. Additionally, the common misuse of the current classification criteria as diagnostic criteria has become an unacceptable norm in the lupus community. This leads us to believe that new criteria will continue to be misused, further disenfranchising a huge segment of the population who have lupus from access to state-of-the-art research and care.

Advancing the development of new classification criteria deserves a wider discussion among the field’s stakeholders, particularly those with expertise in clinical trial outcomes and the clinical care of the full spectrum of lupus patients.
 

Sandra C. Raymond is CEO and President, Leslie M. Hanrahan is VP of Education and Research, and Joan Merrill, MD, is the Chief Adviser for Clinical Development at the Lupus Foundation of America. Dr. Merrill is also the Oklahoma Medical Research Foundation Professor of Medicine at the University of Oklahoma, Oklahoma City.

Editor’s note: This commentary relates to the story, “New classification system for systemic lupus erythematosus moves forward.”

While work to develop a new set of lupus classification criteria more suitable for clinical research is important, the Lupus Foundation of America believes the current work is going in the wrong direction.

Increasingly, key opinion leaders understand lupus to be a spectrum of disease, and there is ample justification of this from scientific evidence (Nat Rev Rheumatol. 2015;11[7]:385-6) The criteria being worked on by ACR and EULAR draws upon an archaic concept with the musty name of “systemic lupus erythematosus,” which relies on a 19th century approach to categorizing disease by counting the signs and symptoms instead of by modern concepts of pathophysiology and prognostic severity. This imposes a homogeneity on the population that simply does not exist. Attempts to re-order obsolescent arrays of organs and autoantibodies to classify lupus will be futile, especially if the aim is to improve the rationale for clinical trial recruitment. Recent clinical trials and modern immunologic methods have already demonstrated, beyond a doubt, that subsets of patients, definable by gene expression patterns or state-of-the-art pharmacodynamic responses, do or do not respond to individual targeted treatments. We now know that patients who require different treatments may well share many of their symptoms in many of the same organs, and this fact defies the outmoded, abacus-based approach to disease classification.

We are concerned that redefining SLE by weighting all disease in one organ as more or less impactful than all disease in another organ flies in the face of current scientific knowledge. If this is the direction in which the effort is going, there is the potential for a negative impact on drug development, clinical care, and access to treatment. The term itself, “SLE,” interferes with selecting appropriate lupus patients for participation in trials. Many people have moderate and even severe lupus syndromes who do not meet enough criteria to be labeled “SLE” (for example, immune thrombocytopenia, hemolytic anemia, discoid lupus, or subacute cutaneous lupus, which can cause severe rashes covering wide areas of the body). In this iteration, assigning less weight to cutaneous lupus as currently proposed is not just problematic; it will set the field back.

By not viewing cutaneous lupus as part of the lupus spectrum, we develop a false sense that this subset of people with lupus will not progress to “SLE,” yet many of them do. Even those who do not later develop features in other organs besides the skin may have more severe disease than other patients who do. Minimizing the “score” for cutaneous lupus will lead to individuals who carry a significant burden of disease being barred from trials, and from access to the treatments they need, once approved.

Conversely, people who do meet criteria for “SLE” under any algorithm, past or present, may have a range of severity, from very severe to very mild. The very mild patients (who may have, in their lifetime, met the multiorgan criteria) are entering trials in large numbers and contributing to the high placebo responses which have stopped many promising investigational treatments from further development. Additionally, the common misuse of the current classification criteria as diagnostic criteria has become an unacceptable norm in the lupus community. This leads us to believe that new criteria will continue to be misused, further disenfranchising a huge segment of the population who have lupus from access to state-of-the-art research and care.

Advancing the development of new classification criteria deserves a wider discussion among the field’s stakeholders, particularly those with expertise in clinical trial outcomes and the clinical care of the full spectrum of lupus patients.
 

Sandra C. Raymond is CEO and President, Leslie M. Hanrahan is VP of Education and Research, and Joan Merrill, MD, is the Chief Adviser for Clinical Development at the Lupus Foundation of America. Dr. Merrill is also the Oklahoma Medical Research Foundation Professor of Medicine at the University of Oklahoma, Oklahoma City.

Editor’s note: This commentary relates to the story, “ New classification system for systemic lupus erythematosus moves forward .”

The ACR/EULAR committee that is developing new classification criteria for systemic lupus erythematosus (SLE) has done the field a service by releasing its draft version in a presentation at the recent EULAR meeting. Releasing the draft version facilitates comments before the new classification criteria become finalized.

Many in the derm-rheum field, ourselves included, classify patients with skin-predominant lupus as lupus, but the new draft classification would place a significant percentage of these patients outside of lupus.

The presentation by Dr. Johnson at EULAR stated, “... a patient can’t be classified on skin findings alone. There is concern that skin findings by themselves may not be lupus, but something else, and some people even consider that cutaneous and systemic lupus are two different things.”

Abundant data indicate instead that lupus is a spectrum that includes skin-predominant lupus. For example, the histology is identical between discoid lupus erythematosus whether or not there is SLE. Moreover, we and others have published significant rates of progression of cutaneous lupus erythematosus (CLE) to SLE. By not viewing CLE in the lupus spectrum, we have a false sense that the patients won’t progress to SLE, yet many of them do.

Importantly, patients respond similarly to therapies when they have either CLE or SLE, so removing this subset of lupus hurts their inclusion in trials and access to new treatments.

When criteria are devised by one group without input from experts who see a specific subset of the disease, that is also a problem. We went down that path in dermatomyositis and missed a lot of patients with the disease when criteria were devised that said the patient had to have muscle involvement. Those criteria have now finally been revised as the ACR/EULAR myositis criteria.

We and others from the derm-rheum community would be happy to speak with the ACR/EULAR committee about these concerns.
 

Victoria P. Werth, MD, is professor of medicine and dermatology at the University of Pennsylvania, Philadelphia. Joseph F. Merola, MD, is codirector of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston. Andrew G. Franks, MD, is a clinical professor in the departments of medicine and dermatology at New York University. Benjamin F. Chong, MD, is an assistant professor of dermatology at the University of Texas, Dallas.

Editor’s note: This commentary relates to the story, “ New classification system for systemic lupus erythematosus moves forward .”

The ACR/EULAR committee that is developing new classification criteria for systemic lupus erythematosus (SLE) has done the field a service by releasing its draft version in a presentation at the recent EULAR meeting. Releasing the draft version facilitates comments before the new classification criteria become finalized.

Many in the derm-rheum field, ourselves included, classify patients with skin-predominant lupus as lupus, but the new draft classification would place a significant percentage of these patients outside of lupus.

The presentation by Dr. Johnson at EULAR stated, “... a patient can’t be classified on skin findings alone. There is concern that skin findings by themselves may not be lupus, but something else, and some people even consider that cutaneous and systemic lupus are two different things.”

Abundant data indicate instead that lupus is a spectrum that includes skin-predominant lupus. For example, the histology is identical between discoid lupus erythematosus whether or not there is SLE. Moreover, we and others have published significant rates of progression of cutaneous lupus erythematosus (CLE) to SLE. By not viewing CLE in the lupus spectrum, we have a false sense that the patients won’t progress to SLE, yet many of them do.

Importantly, patients respond similarly to therapies when they have either CLE or SLE, so removing this subset of lupus hurts their inclusion in trials and access to new treatments.

When criteria are devised by one group without input from experts who see a specific subset of the disease, that is also a problem. We went down that path in dermatomyositis and missed a lot of patients with the disease when criteria were devised that said the patient had to have muscle involvement. Those criteria have now finally been revised as the ACR/EULAR myositis criteria.

We and others from the derm-rheum community would be happy to speak with the ACR/EULAR committee about these concerns.
 

Victoria P. Werth, MD, is professor of medicine and dermatology at the University of Pennsylvania, Philadelphia. Joseph F. Merola, MD, is codirector of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston. Andrew G. Franks, MD, is a clinical professor in the departments of medicine and dermatology at New York University. Benjamin F. Chong, MD, is an assistant professor of dermatology at the University of Texas, Dallas.

Editor’s note: This commentary relates to the story, “ New classification system for systemic lupus erythematosus moves forward .”

The ACR/EULAR committee that is developing new classification criteria for systemic lupus erythematosus (SLE) has done the field a service by releasing its draft version in a presentation at the recent EULAR meeting. Releasing the draft version facilitates comments before the new classification criteria become finalized.

Many in the derm-rheum field, ourselves included, classify patients with skin-predominant lupus as lupus, but the new draft classification would place a significant percentage of these patients outside of lupus.

The presentation by Dr. Johnson at EULAR stated, “... a patient can’t be classified on skin findings alone. There is concern that skin findings by themselves may not be lupus, but something else, and some people even consider that cutaneous and systemic lupus are two different things.”

Abundant data indicate instead that lupus is a spectrum that includes skin-predominant lupus. For example, the histology is identical between discoid lupus erythematosus whether or not there is SLE. Moreover, we and others have published significant rates of progression of cutaneous lupus erythematosus (CLE) to SLE. By not viewing CLE in the lupus spectrum, we have a false sense that the patients won’t progress to SLE, yet many of them do.

Importantly, patients respond similarly to therapies when they have either CLE or SLE, so removing this subset of lupus hurts their inclusion in trials and access to new treatments.

When criteria are devised by one group without input from experts who see a specific subset of the disease, that is also a problem. We went down that path in dermatomyositis and missed a lot of patients with the disease when criteria were devised that said the patient had to have muscle involvement. Those criteria have now finally been revised as the ACR/EULAR myositis criteria.

We and others from the derm-rheum community would be happy to speak with the ACR/EULAR committee about these concerns.
 

Victoria P. Werth, MD, is professor of medicine and dermatology at the University of Pennsylvania, Philadelphia. Joseph F. Merola, MD, is codirector of the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston. Andrew G. Franks, MD, is a clinical professor in the departments of medicine and dermatology at New York University. Benjamin F. Chong, MD, is an assistant professor of dermatology at the University of Texas, Dallas.

Antibiotic use and misuse is driving drug resistance. Each year in the United States, at least 2 million people become infected with bacteria that are resistant to antibiotics, and at least 23,000 people die each year as a result of these infections, according to the Centers for Disease Control and Prevention.

Over 70% of U.S. hospitals are small community hospitals with 200 beds or fewer; however, our understanding of antibiotic use in these facilities is extremely limited. Most of the existing data on antibiotic use rates come from larger academic medical centers. Describing antibiotic usage patterns in small facilities is a high priority, given they constitute the majority of acute care hospitals and national antibiotic stewardship is forthcoming.

• Patient care location.

• Facility-wide antibiotic use.

• Use of individual antibiotics.

• Classes of antibiotics.

• Days of therapy.

• Patient-day data.

Antibiotic agents were categorized into five groups based on antibiotic spectrum and ability to treat multidrug-resistant organisms (MDROs). Category one antibiotics are narrower-spectrum agents, and category five antibiotics are the broadest-spectrum antibiotics or associated with treating MDROs. Categories four and five were classified as broad-spectrum antibiotics. Hospital care units were categorized as intensive care, medical/surgical, pediatric, or miscellaneous.

Antibiotic use rates, expressed as days of therapy per 1,000 patient-days (DOT/1000PD), were calculated for each small community hospital and compared with rates in large community hospitals. Negative-binomial regression was used to relate antibiotic use.

The key findings of the study include:

• Total antibiotic use rates varied widely across the 15 small community hospitals and were similar to rates in four large community hospitals.

• The proportion of patient-days spent in the respective care unit types varied substantially within small community hospitals and had a large impact on facility-level antibiotic use rates.

• Broad-spectrum antibiotics accounted for 26% of use in small community hospitals, similar to the proportion in large community hospitals.

• Significant predictors of antibiotic use include case mix index, proportion of patient-days in specific care unit types, and season.

• Small community hospitals need to become a focus of antibiotic stewardship efforts.

All hospitals in 2017 are required to have an antibiotic stewardship program in place according to Joint Commission guidelines. Small community hospitals in the United States face significant challenges meeting the national antibiotic stewardship requirements. These challenges include: limited access to infectious diseases physician and/or pharmacist leadership, limited information technology support, and lack of antibiotic guidance.

In order to holistically address the growing problem of antibiotic-resistant bacteria, the infectious disease community must respond to antibiotic use in ALL hospitals, not just the large academic medical facilities. Small hospitals are least likely to have stewardship programs even though antibiotic usage patterns are similar to larger facilities. We need to bring stewardship support to ALL hospitals, but the challenges come in knowing how to do that.

To address the challenges, researchers at Intermountain Healthcare are currently conducting a study to identify recommendations that will help build antibiotic stewardship programs for these facilities.
 

Eddie Stenehjem, MD, is an infectious disease physician and researcher at Intermountain Medical Center, Salt Lake City, the flagship facility for the Intermountain Healthcare system.

Antibiotic use and misuse is driving drug resistance. Each year in the United States, at least 2 million people become infected with bacteria that are resistant to antibiotics, and at least 23,000 people die each year as a result of these infections, according to the Centers for Disease Control and Prevention.

Over 70% of U.S. hospitals are small community hospitals with 200 beds or fewer; however, our understanding of antibiotic use in these facilities is extremely limited. Most of the existing data on antibiotic use rates come from larger academic medical centers. Describing antibiotic usage patterns in small facilities is a high priority, given they constitute the majority of acute care hospitals and national antibiotic stewardship is forthcoming.

• Patient care location.

• Facility-wide antibiotic use.

• Use of individual antibiotics.

• Classes of antibiotics.

• Days of therapy.

• Patient-day data.

Antibiotic agents were categorized into five groups based on antibiotic spectrum and ability to treat multidrug-resistant organisms (MDROs). Category one antibiotics are narrower-spectrum agents, and category five antibiotics are the broadest-spectrum antibiotics or associated with treating MDROs. Categories four and five were classified as broad-spectrum antibiotics. Hospital care units were categorized as intensive care, medical/surgical, pediatric, or miscellaneous.

Antibiotic use rates, expressed as days of therapy per 1,000 patient-days (DOT/1000PD), were calculated for each small community hospital and compared with rates in large community hospitals. Negative-binomial regression was used to relate antibiotic use.

The key findings of the study include:

• Total antibiotic use rates varied widely across the 15 small community hospitals and were similar to rates in four large community hospitals.

• The proportion of patient-days spent in the respective care unit types varied substantially within small community hospitals and had a large impact on facility-level antibiotic use rates.

• Broad-spectrum antibiotics accounted for 26% of use in small community hospitals, similar to the proportion in large community hospitals.

• Significant predictors of antibiotic use include case mix index, proportion of patient-days in specific care unit types, and season.

• Small community hospitals need to become a focus of antibiotic stewardship efforts.

All hospitals in 2017 are required to have an antibiotic stewardship program in place according to Joint Commission guidelines. Small community hospitals in the United States face significant challenges meeting the national antibiotic stewardship requirements. These challenges include: limited access to infectious diseases physician and/or pharmacist leadership, limited information technology support, and lack of antibiotic guidance.

In order to holistically address the growing problem of antibiotic-resistant bacteria, the infectious disease community must respond to antibiotic use in ALL hospitals, not just the large academic medical facilities. Small hospitals are least likely to have stewardship programs even though antibiotic usage patterns are similar to larger facilities. We need to bring stewardship support to ALL hospitals, but the challenges come in knowing how to do that.

To address the challenges, researchers at Intermountain Healthcare are currently conducting a study to identify recommendations that will help build antibiotic stewardship programs for these facilities.
 

Eddie Stenehjem, MD, is an infectious disease physician and researcher at Intermountain Medical Center, Salt Lake City, the flagship facility for the Intermountain Healthcare system.

Antibiotic use and misuse is driving drug resistance. Each year in the United States, at least 2 million people become infected with bacteria that are resistant to antibiotics, and at least 23,000 people die each year as a result of these infections, according to the Centers for Disease Control and Prevention.

Over 70% of U.S. hospitals are small community hospitals with 200 beds or fewer; however, our understanding of antibiotic use in these facilities is extremely limited. Most of the existing data on antibiotic use rates come from larger academic medical centers. Describing antibiotic usage patterns in small facilities is a high priority, given they constitute the majority of acute care hospitals and national antibiotic stewardship is forthcoming.

• Patient care location.

• Facility-wide antibiotic use.

• Use of individual antibiotics.

• Classes of antibiotics.

• Days of therapy.

• Patient-day data.

Antibiotic agents were categorized into five groups based on antibiotic spectrum and ability to treat multidrug-resistant organisms (MDROs). Category one antibiotics are narrower-spectrum agents, and category five antibiotics are the broadest-spectrum antibiotics or associated with treating MDROs. Categories four and five were classified as broad-spectrum antibiotics. Hospital care units were categorized as intensive care, medical/surgical, pediatric, or miscellaneous.

Antibiotic use rates, expressed as days of therapy per 1,000 patient-days (DOT/1000PD), were calculated for each small community hospital and compared with rates in large community hospitals. Negative-binomial regression was used to relate antibiotic use.

The key findings of the study include:

• Total antibiotic use rates varied widely across the 15 small community hospitals and were similar to rates in four large community hospitals.

• The proportion of patient-days spent in the respective care unit types varied substantially within small community hospitals and had a large impact on facility-level antibiotic use rates.

• Broad-spectrum antibiotics accounted for 26% of use in small community hospitals, similar to the proportion in large community hospitals.

• Significant predictors of antibiotic use include case mix index, proportion of patient-days in specific care unit types, and season.

• Small community hospitals need to become a focus of antibiotic stewardship efforts.

All hospitals in 2017 are required to have an antibiotic stewardship program in place according to Joint Commission guidelines. Small community hospitals in the United States face significant challenges meeting the national antibiotic stewardship requirements. These challenges include: limited access to infectious diseases physician and/or pharmacist leadership, limited information technology support, and lack of antibiotic guidance.

In order to holistically address the growing problem of antibiotic-resistant bacteria, the infectious disease community must respond to antibiotic use in ALL hospitals, not just the large academic medical facilities. Small hospitals are least likely to have stewardship programs even though antibiotic usage patterns are similar to larger facilities. We need to bring stewardship support to ALL hospitals, but the challenges come in knowing how to do that.

To address the challenges, researchers at Intermountain Healthcare are currently conducting a study to identify recommendations that will help build antibiotic stewardship programs for these facilities.
 

Eddie Stenehjem, MD, is an infectious disease physician and researcher at Intermountain Medical Center, Salt Lake City, the flagship facility for the Intermountain Healthcare system.

The long slog toward release of revised U.S. guidelines for treating hypertension may end in September. Or not.

Authoritative U.S. guidelines for managing high blood pressure have traveled a rocky and serpentine path ever since the expert group originally constituted as the Eighth Joint National Committee (JNC 8) released its controversial report in early 2014, when it relaxed the target blood pressure for most adults aged 60-79 years from less than 140 mm Hg to under 150/90 mm Hg (JAMA. 2014 Feb 5;3311[5]:507-20). A few months before those recommendations came out, the National Heart, Lung, and Blood Institute, which since 1977 had organized seven preceding iterations of U.S. blood pressure guidelines, handed off oversight of the project and any future updates to the American Heart Association, the American College of Cardiology, and the American Society of Hypertension. A year later, an expert panel organized by those three groups reset the blood pressure target for most U.S. adults with coronary artery disease back to a pressure of less than 140/90 mm Hg (Hypertension. 2015 Jun;65[6]:1372-1407), and that has been the prevailing U.S. standard in the 2-plus years since.

A few months later, in September 2015, data from the SPRINT trial in more than 9,000 patients with high cardiovascular risk first came out and showed that treating to a target systolic blood pressure of less than 120 mm Hg led to a significant 25% reduction in cardiovascular disease events, compared with controls treated to a systolic pressure of less than 140 mm Hg (N Engl J Med. 2015 Nov 26;373[22]:2103-16). Ever since, the big question surrounding blood pressure targets in U.S. practice has been, when would new official guidelines emerge that took the SPRINT findings into consideration? It now looks like it will finally happen in September 2017.

That’s when the ASH and the AHA’s Hypertension Council will for the first time hold a joint annual meeting, after many years when each organization had its own, individual annual meeting. The ASH’s traditional spring meeting didn’t happen this year; early fall has traditionally been when the AHA’s Hypertension Council meets.

The Council’s posted preliminary program for the September meeting showed, as of late July, an opening session the morning of September 14 called a “Review of AHA Scientific Statement 2017.” On the ASH’s website is a virtual flier for a session the afternoon of September 15 on the “2017 Guidelines for Adult and Pediatric Hypertension.”

[email protected]

On Twitter @mitchelzoler

The long slog toward release of revised U.S. guidelines for treating hypertension may end in September. Or not.

Authoritative U.S. guidelines for managing high blood pressure have traveled a rocky and serpentine path ever since the expert group originally constituted as the Eighth Joint National Committee (JNC 8) released its controversial report in early 2014, when it relaxed the target blood pressure for most adults aged 60-79 years from less than 140 mm Hg to under 150/90 mm Hg (JAMA. 2014 Feb 5;3311[5]:507-20). A few months before those recommendations came out, the National Heart, Lung, and Blood Institute, which since 1977 had organized seven preceding iterations of U.S. blood pressure guidelines, handed off oversight of the project and any future updates to the American Heart Association, the American College of Cardiology, and the American Society of Hypertension. A year later, an expert panel organized by those three groups reset the blood pressure target for most U.S. adults with coronary artery disease back to a pressure of less than 140/90 mm Hg (Hypertension. 2015 Jun;65[6]:1372-1407), and that has been the prevailing U.S. standard in the 2-plus years since.

A few months later, in September 2015, data from the SPRINT trial in more than 9,000 patients with high cardiovascular risk first came out and showed that treating to a target systolic blood pressure of less than 120 mm Hg led to a significant 25% reduction in cardiovascular disease events, compared with controls treated to a systolic pressure of less than 140 mm Hg (N Engl J Med. 2015 Nov 26;373[22]:2103-16). Ever since, the big question surrounding blood pressure targets in U.S. practice has been, when would new official guidelines emerge that took the SPRINT findings into consideration? It now looks like it will finally happen in September 2017.

That’s when the ASH and the AHA’s Hypertension Council will for the first time hold a joint annual meeting, after many years when each organization had its own, individual annual meeting. The ASH’s traditional spring meeting didn’t happen this year; early fall has traditionally been when the AHA’s Hypertension Council meets.

The Council’s posted preliminary program for the September meeting showed, as of late July, an opening session the morning of September 14 called a “Review of AHA Scientific Statement 2017.” On the ASH’s website is a virtual flier for a session the afternoon of September 15 on the “2017 Guidelines for Adult and Pediatric Hypertension.”

[email protected]

On Twitter @mitchelzoler

The long slog toward release of revised U.S. guidelines for treating hypertension may end in September. Or not.

Authoritative U.S. guidelines for managing high blood pressure have traveled a rocky and serpentine path ever since the expert group originally constituted as the Eighth Joint National Committee (JNC 8) released its controversial report in early 2014, when it relaxed the target blood pressure for most adults aged 60-79 years from less than 140 mm Hg to under 150/90 mm Hg (JAMA. 2014 Feb 5;3311[5]:507-20). A few months before those recommendations came out, the National Heart, Lung, and Blood Institute, which since 1977 had organized seven preceding iterations of U.S. blood pressure guidelines, handed off oversight of the project and any future updates to the American Heart Association, the American College of Cardiology, and the American Society of Hypertension. A year later, an expert panel organized by those three groups reset the blood pressure target for most U.S. adults with coronary artery disease back to a pressure of less than 140/90 mm Hg (Hypertension. 2015 Jun;65[6]:1372-1407), and that has been the prevailing U.S. standard in the 2-plus years since.

A few months later, in September 2015, data from the SPRINT trial in more than 9,000 patients with high cardiovascular risk first came out and showed that treating to a target systolic blood pressure of less than 120 mm Hg led to a significant 25% reduction in cardiovascular disease events, compared with controls treated to a systolic pressure of less than 140 mm Hg (N Engl J Med. 2015 Nov 26;373[22]:2103-16). Ever since, the big question surrounding blood pressure targets in U.S. practice has been, when would new official guidelines emerge that took the SPRINT findings into consideration? It now looks like it will finally happen in September 2017.

That’s when the ASH and the AHA’s Hypertension Council will for the first time hold a joint annual meeting, after many years when each organization had its own, individual annual meeting. The ASH’s traditional spring meeting didn’t happen this year; early fall has traditionally been when the AHA’s Hypertension Council meets.

The Council’s posted preliminary program for the September meeting showed, as of late July, an opening session the morning of September 14 called a “Review of AHA Scientific Statement 2017.” On the ASH’s website is a virtual flier for a session the afternoon of September 15 on the “2017 Guidelines for Adult and Pediatric Hypertension.”

[email protected]

On Twitter @mitchelzoler

In his first ever—and perhaps the first ever state of the VA—speech delivered on May 30, 2017, VA Secretary David J. Shulkin, MD, reported to the nation and Congress that “the VA is still in critical condition.” This medical metaphor reflects Dr. Shulkin’s distinction of being the only physician ever to hold this cabinet-level post.

For anyone in health care, such a reference immediately calls forth a variety of associations—most of them serious concerns for the status of the VA and whether it will survive. In this editorial, I will expand on this metaphor and explore its meaning for the future of the VA.

Dr. Shulkin extended the metaphor when he said that the “VA requires intensive care.” For clinicians, this remark tells us that the VA is either seriously ill or injured. Yet there is hope because the chief doctor of the VA reassures us that the patient—the largest health care system in the country—is improving. This improvement from critical care to intensive care status informs us that the VA was very sick, maybe even dying, during the previous administration in which Dr. Shulkin served as VA’s Under Secretary for Health.

Dr. Shulkin, a general internist who still sees primary care patients at the VA, gave us a diagnosis of the VA’s most serious symptoms: a lack of access to timely care, a high rate of veteran suicides, an inability to enforce employee accountability, multiple obstacles to hiring and retaining qualified staff, an unacceptable quality of care at some VAMCs, and a backlog of disability claims due to inefficient processing.

Dr. Shulkin also gave us a broad idea of his goal for care, “We are taking immediate and decisive steps stabilizing the organization.” But the more I thought about this impressive speech, the more I wondered, What is the VA’s actual diagnosis?

Several of the many news commentaries analyzing Shulkin’s State of the VA speech suggested possible etiologies. According to the Public Broadcasting Service (PBS), “In a ‘State of the VA’ report, Shulkin, a physician, issued a blunt diagnosis: ‘There is a lot of work to do.’” Astute clinicians will immediately recognize that PBS is right about the secretary’s honesty regarding the magnitude of the task facing him.

He was not providing a diagnosis as much as offering an indirect assessment of the patient’s condition. “A lot of work,” although not a diagnosis, is a colloquial description of the treatment plan that the secretary further outlined in his report. Like any good treatment plan, there is a direct correlation between the major symptoms of the disorder and the therapies that Dr. Shulkin prescribed.

The Secretary recommended and the President signed the Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017 on June 23, 2017, to make it easier to discipline and terminate VA employees who may be keeping the VA organization ill or at least preventing it from getting better. He also prescribed continued and even higher dose infusions of community care to treat the central access problem. In addition, Dr. Shulkin ordered that the most effective available interventions be used for suicide prevention, enhancement of the overall quality of care, and to improve accountability.

Even with the most efficacious treatments, a high-functioning intensive care unit needs state-of-theart technology and equipment. In a long-awaited announcement, Dr. Shulkin reported on June 5 that of 2 competing modalities to revive the VA’s ailing electronic health record system—the brain of our critical care patient—rather than repair the moribund CPRS, the VA will receive a transplant of the DoD MHS Genesis. Critical care, especially when delivered in a combat zone, requires difficult triage decisions. The secretary has made similar tough resource allocation decisions, determining that some of the VA’s oldest and most debilitated facilities will not be sustained in their present form.

I am near the end of this editorial and still do not have a diagnosis. Pundits, politicians, and policy specialists all have their differential diagnosis as well as veterans groups and VA employees.“Bloated bureaucracy” is the diagnosis from many of these VA critics. Dr. Shulkin proposed a remedy for this disease: He plans to consolidate the VA headquarters.

Even more important, for those who believe the VA should not have a DNR but be allowed to recover, what does the physician who holds the VA’s life in his hands believe is the prognosis for this 86-year-old institution? Dr. Shulkin expressed the hope that the VA can recover its health, saying he is “confident that we will be able turn VA into the organization veterans and their families deserve, and one that America can take pride in.” The most vehement of VA’s opponents would say that pouring additional millions of dollars into such a moribund entity is futile care. Yet the secretary and thousands of VA patients, staff, and supporters believe that the agency that President Lincoln created at the end of the bloodiest war in U.S. history still has value and can be restored to meaningful service for those who have, who are, and who will place their lives on the line for their country.

In his first ever—and perhaps the first ever state of the VA—speech delivered on May 30, 2017, VA Secretary David J. Shulkin, MD, reported to the nation and Congress that “the VA is still in critical condition.” This medical metaphor reflects Dr. Shulkin’s distinction of being the only physician ever to hold this cabinet-level post.

For anyone in health care, such a reference immediately calls forth a variety of associations—most of them serious concerns for the status of the VA and whether it will survive. In this editorial, I will expand on this metaphor and explore its meaning for the future of the VA.

Dr. Shulkin extended the metaphor when he said that the “VA requires intensive care.” For clinicians, this remark tells us that the VA is either seriously ill or injured. Yet there is hope because the chief doctor of the VA reassures us that the patient—the largest health care system in the country—is improving. This improvement from critical care to intensive care status informs us that the VA was very sick, maybe even dying, during the previous administration in which Dr. Shulkin served as VA’s Under Secretary for Health.

Dr. Shulkin, a general internist who still sees primary care patients at the VA, gave us a diagnosis of the VA’s most serious symptoms: a lack of access to timely care, a high rate of veteran suicides, an inability to enforce employee accountability, multiple obstacles to hiring and retaining qualified staff, an unacceptable quality of care at some VAMCs, and a backlog of disability claims due to inefficient processing.

Dr. Shulkin also gave us a broad idea of his goal for care, “We are taking immediate and decisive steps stabilizing the organization.” But the more I thought about this impressive speech, the more I wondered, What is the VA’s actual diagnosis?

Several of the many news commentaries analyzing Shulkin’s State of the VA speech suggested possible etiologies. According to the Public Broadcasting Service (PBS), “In a ‘State of the VA’ report, Shulkin, a physician, issued a blunt diagnosis: ‘There is a lot of work to do.’” Astute clinicians will immediately recognize that PBS is right about the secretary’s honesty regarding the magnitude of the task facing him.

He was not providing a diagnosis as much as offering an indirect assessment of the patient’s condition. “A lot of work,” although not a diagnosis, is a colloquial description of the treatment plan that the secretary further outlined in his report. Like any good treatment plan, there is a direct correlation between the major symptoms of the disorder and the therapies that Dr. Shulkin prescribed.

The Secretary recommended and the President signed the Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017 on June 23, 2017, to make it easier to discipline and terminate VA employees who may be keeping the VA organization ill or at least preventing it from getting better. He also prescribed continued and even higher dose infusions of community care to treat the central access problem. In addition, Dr. Shulkin ordered that the most effective available interventions be used for suicide prevention, enhancement of the overall quality of care, and to improve accountability.

Even with the most efficacious treatments, a high-functioning intensive care unit needs state-of-theart technology and equipment. In a long-awaited announcement, Dr. Shulkin reported on June 5 that of 2 competing modalities to revive the VA’s ailing electronic health record system—the brain of our critical care patient—rather than repair the moribund CPRS, the VA will receive a transplant of the DoD MHS Genesis. Critical care, especially when delivered in a combat zone, requires difficult triage decisions. The secretary has made similar tough resource allocation decisions, determining that some of the VA’s oldest and most debilitated facilities will not be sustained in their present form.

I am near the end of this editorial and still do not have a diagnosis. Pundits, politicians, and policy specialists all have their differential diagnosis as well as veterans groups and VA employees.“Bloated bureaucracy” is the diagnosis from many of these VA critics. Dr. Shulkin proposed a remedy for this disease: He plans to consolidate the VA headquarters.

Even more important, for those who believe the VA should not have a DNR but be allowed to recover, what does the physician who holds the VA’s life in his hands believe is the prognosis for this 86-year-old institution? Dr. Shulkin expressed the hope that the VA can recover its health, saying he is “confident that we will be able turn VA into the organization veterans and their families deserve, and one that America can take pride in.” The most vehement of VA’s opponents would say that pouring additional millions of dollars into such a moribund entity is futile care. Yet the secretary and thousands of VA patients, staff, and supporters believe that the agency that President Lincoln created at the end of the bloodiest war in U.S. history still has value and can be restored to meaningful service for those who have, who are, and who will place their lives on the line for their country.

In his first ever—and perhaps the first ever state of the VA—speech delivered on May 30, 2017, VA Secretary David J. Shulkin, MD, reported to the nation and Congress that “the VA is still in critical condition.” This medical metaphor reflects Dr. Shulkin’s distinction of being the only physician ever to hold this cabinet-level post.

For anyone in health care, such a reference immediately calls forth a variety of associations—most of them serious concerns for the status of the VA and whether it will survive. In this editorial, I will expand on this metaphor and explore its meaning for the future of the VA.

Dr. Shulkin extended the metaphor when he said that the “VA requires intensive care.” For clinicians, this remark tells us that the VA is either seriously ill or injured. Yet there is hope because the chief doctor of the VA reassures us that the patient—the largest health care system in the country—is improving. This improvement from critical care to intensive care status informs us that the VA was very sick, maybe even dying, during the previous administration in which Dr. Shulkin served as VA’s Under Secretary for Health.

Dr. Shulkin, a general internist who still sees primary care patients at the VA, gave us a diagnosis of the VA’s most serious symptoms: a lack of access to timely care, a high rate of veteran suicides, an inability to enforce employee accountability, multiple obstacles to hiring and retaining qualified staff, an unacceptable quality of care at some VAMCs, and a backlog of disability claims due to inefficient processing.

Dr. Shulkin also gave us a broad idea of his goal for care, “We are taking immediate and decisive steps stabilizing the organization.” But the more I thought about this impressive speech, the more I wondered, What is the VA’s actual diagnosis?

Several of the many news commentaries analyzing Shulkin’s State of the VA speech suggested possible etiologies. According to the Public Broadcasting Service (PBS), “In a ‘State of the VA’ report, Shulkin, a physician, issued a blunt diagnosis: ‘There is a lot of work to do.’” Astute clinicians will immediately recognize that PBS is right about the secretary’s honesty regarding the magnitude of the task facing him.

He was not providing a diagnosis as much as offering an indirect assessment of the patient’s condition. “A lot of work,” although not a diagnosis, is a colloquial description of the treatment plan that the secretary further outlined in his report. Like any good treatment plan, there is a direct correlation between the major symptoms of the disorder and the therapies that Dr. Shulkin prescribed.

The Secretary recommended and the President signed the Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017 on June 23, 2017, to make it easier to discipline and terminate VA employees who may be keeping the VA organization ill or at least preventing it from getting better. He also prescribed continued and even higher dose infusions of community care to treat the central access problem. In addition, Dr. Shulkin ordered that the most effective available interventions be used for suicide prevention, enhancement of the overall quality of care, and to improve accountability.

Even with the most efficacious treatments, a high-functioning intensive care unit needs state-of-theart technology and equipment. In a long-awaited announcement, Dr. Shulkin reported on June 5 that of 2 competing modalities to revive the VA’s ailing electronic health record system—the brain of our critical care patient—rather than repair the moribund CPRS, the VA will receive a transplant of the DoD MHS Genesis. Critical care, especially when delivered in a combat zone, requires difficult triage decisions. The secretary has made similar tough resource allocation decisions, determining that some of the VA’s oldest and most debilitated facilities will not be sustained in their present form.

I am near the end of this editorial and still do not have a diagnosis. Pundits, politicians, and policy specialists all have their differential diagnosis as well as veterans groups and VA employees.“Bloated bureaucracy” is the diagnosis from many of these VA critics. Dr. Shulkin proposed a remedy for this disease: He plans to consolidate the VA headquarters.

Even more important, for those who believe the VA should not have a DNR but be allowed to recover, what does the physician who holds the VA’s life in his hands believe is the prognosis for this 86-year-old institution? Dr. Shulkin expressed the hope that the VA can recover its health, saying he is “confident that we will be able turn VA into the organization veterans and their families deserve, and one that America can take pride in.” The most vehement of VA’s opponents would say that pouring additional millions of dollars into such a moribund entity is futile care. Yet the secretary and thousands of VA patients, staff, and supporters believe that the agency that President Lincoln created at the end of the bloodiest war in U.S. history still has value and can be restored to meaningful service for those who have, who are, and who will place their lives on the line for their country.

Unlike Dr. Elsey (“Surgery can be demanding work: Grit needed,” Letter to the Editor, May 2017, p. 6) and many others in various surgical publications, I have NOT enjoyed recent discussions about my generation’s perceived lack of readiness for independent practice following general surgery residency. Having been subjected to another round this month of “Why The Surgical Sky Is Falling,” I would like to take a moment to offer a different viewpoint.

I graduated from Tufts Medical Center’s general surgery residency in June 2014. After taking the written board exams, I started practice in a hospital-based group in Maine that same summer. My partners, both with 20+ years of experience, instituted a probationary period for observation of skill (ostensibly, and with good-natured teasing, to ensure I would not harm their patients, though I suspect such a thing is fairly universal for a new grad to receive institutional privileges), and, after convincing them I was not a reckless maniac, within a few months I was “on my own” in the operating room. I relied heavily on colleagues those first 18 months in practice, and ,if they ever grew weary of my asking advice about hemorrhoids, biliary colic, and diverticular disease, they never displayed perceptible annoyance. They were, and are, the best mentors I could have had.

Dr. Crosslin is a general surgeon practicing in Rockport, Maine, and an FACS Initiate, October 2017.

Unlike Dr. Elsey (“Surgery can be demanding work: Grit needed,” Letter to the Editor, May 2017, p. 6) and many others in various surgical publications, I have NOT enjoyed recent discussions about my generation’s perceived lack of readiness for independent practice following general surgery residency. Having been subjected to another round this month of “Why The Surgical Sky Is Falling,” I would like to take a moment to offer a different viewpoint.

I graduated from Tufts Medical Center’s general surgery residency in June 2014. After taking the written board exams, I started practice in a hospital-based group in Maine that same summer. My partners, both with 20+ years of experience, instituted a probationary period for observation of skill (ostensibly, and with good-natured teasing, to ensure I would not harm their patients, though I suspect such a thing is fairly universal for a new grad to receive institutional privileges), and, after convincing them I was not a reckless maniac, within a few months I was “on my own” in the operating room. I relied heavily on colleagues those first 18 months in practice, and ,if they ever grew weary of my asking advice about hemorrhoids, biliary colic, and diverticular disease, they never displayed perceptible annoyance. They were, and are, the best mentors I could have had.

Dr. Crosslin is a general surgeon practicing in Rockport, Maine, and an FACS Initiate, October 2017.

Unlike Dr. Elsey (“Surgery can be demanding work: Grit needed,” Letter to the Editor, May 2017, p. 6) and many others in various surgical publications, I have NOT enjoyed recent discussions about my generation’s perceived lack of readiness for independent practice following general surgery residency. Having been subjected to another round this month of “Why The Surgical Sky Is Falling,” I would like to take a moment to offer a different viewpoint.

I graduated from Tufts Medical Center’s general surgery residency in June 2014. After taking the written board exams, I started practice in a hospital-based group in Maine that same summer. My partners, both with 20+ years of experience, instituted a probationary period for observation of skill (ostensibly, and with good-natured teasing, to ensure I would not harm their patients, though I suspect such a thing is fairly universal for a new grad to receive institutional privileges), and, after convincing them I was not a reckless maniac, within a few months I was “on my own” in the operating room. I relied heavily on colleagues those first 18 months in practice, and ,if they ever grew weary of my asking advice about hemorrhoids, biliary colic, and diverticular disease, they never displayed perceptible annoyance. They were, and are, the best mentors I could have had.

Dr. Crosslin is a general surgeon practicing in Rockport, Maine, and an FACS Initiate, October 2017.

If you weren’t a young male living in the United States in the 1960s, it may be hard for you to understand my situation. It was a little more than 6 months from my college graduation. Because I couldn’t think of anything else to do, I had applied for and been accepted in a postgraduate fellowship in art history. However, it was clear that this country was becoming entangled in a confusing, unpopular – and from my personal perspective – a dangerous war.

While I was in college I was protected from the draft. But upon graduation, if I were to pursue my studies in something as unrelated to the war effort as art history, I would be ripe for the picking. I’m not sure why, but luckily I had been banking science credits for a rainy day. And in the winter of 1965-1966, it was raining big time.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

If you weren’t a young male living in the United States in the 1960s, it may be hard for you to understand my situation. It was a little more than 6 months from my college graduation. Because I couldn’t think of anything else to do, I had applied for and been accepted in a postgraduate fellowship in art history. However, it was clear that this country was becoming entangled in a confusing, unpopular – and from my personal perspective – a dangerous war.

While I was in college I was protected from the draft. But upon graduation, if I were to pursue my studies in something as unrelated to the war effort as art history, I would be ripe for the picking. I’m not sure why, but luckily I had been banking science credits for a rainy day. And in the winter of 1965-1966, it was raining big time.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

If you weren’t a young male living in the United States in the 1960s, it may be hard for you to understand my situation. It was a little more than 6 months from my college graduation. Because I couldn’t think of anything else to do, I had applied for and been accepted in a postgraduate fellowship in art history. However, it was clear that this country was becoming entangled in a confusing, unpopular – and from my personal perspective – a dangerous war.

While I was in college I was protected from the draft. But upon graduation, if I were to pursue my studies in something as unrelated to the war effort as art history, I would be ripe for the picking. I’m not sure why, but luckily I had been banking science credits for a rainy day. And in the winter of 1965-1966, it was raining big time.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].