MDedge Emergency Medicine

Prior to George Floyd’s death, Officer Thomas Lane reportedly said, “I am worried about excited delirium or whatever” to his colleague, Officer Derek Chauvin.¹ For those of us who frequently work with law enforcement and in correctional facilities, “excited delirium” is a common refrain. It would be too facile to dismiss the concept as an attempt by police officers to inappropriately use medically sounding jargon to justify violence. “Excited delirium” is a reminder of the complex situations faced by police officers and the need for better medical training, as well as the attention of research on this commonly used label.

Many law enforcement facilities, in particular jails that receive inmates directly from the community, will have large posters educating staff on the “signs of excited delirium.” The concept is not covered in residency training programs, or many of the leading textbooks of psychiatry. Yet, it has become common parlance in law enforcement. Officers in training receive education programs on excited delirium, although those are rarely conducted by clinicians.

In our practice and experience, “excited delirium” has been used by law enforcement officers to describe mood lability from the stress of arrest, acute agitation from stimulant or phencyclidine intoxication, actual delirium from a medical comorbidity, sociopathic aggression for the purpose of violence, and incoherence from psychosis, along with simply describing a person not following direction from a police officer.

Our differential diagnosis when informed that someone was described by a nonclinician as having so-called excited delirium is wider than the Diagnostic and Statistical Manual (DSM). In addition, the term comes at a cost. Its use has been implicated in police-related deaths and brutality.² There is also concern of its disproportionate application to Black people.^3,4

Nonetheless, the term “excited delirium” can sometimes accurately describe critical medical situations. We particularly remember a case of altered mental status from serotonin syndrome, a case of delirium tremens from alcohol withdrawal, and a case of life-threatening dehydration in the context of stimulant intoxication. Each of those cases was appropriately recognized as problematic by perceptive and caring police officers. It is important for police officers to recognize these life-threatening conditions, and they need the language to do so. Having a common label that can be used across professional fields and law enforcement departments to express medical concern in the context of aggressive behavior has value. The question is: can psychiatry help law enforcement describe situations more accurately?

As physicians, it would be overly simple to point out the limited understanding of medical information by police and correctional officers. Naming many behaviors poses significant challenges for psychiatrists and nonclinicians. Examples include the use of the word “agitation” to describe mild restlessness, “delusional” for uncooperative, and “irritable” for opinionated. We must also be cognizant of the infinite demands placed on police officers and that labels must be available to them to express complex situations without being forced to use medical diagnosis and terminology for which they do not have the license or expertise. It is possible that “excited delirium” serves an important role; the problem may not be as much “excited delirium,” the term itself, as the diversion of its use to justify poor policing.

It must be acknowledged that debates, concerns, poor nomenclature, confusing labels, and different interpretations of diagnoses and symptoms are not unusual things in psychiatry, even among professionals. In the 1970s, the famous American and British study of diagnostic criteria,showed that psychiatrists used the diagnosis of schizophrenia to describe vastly different patients.⁵ The findings of the study were a significant cause of the paradigm shift of the DSM in its 3rd edition. More recently, the DSM-5 field trials suggested that the field of psychiatry continues to struggle with this problem.⁶ Nonetheless, each edition of the DSM presents a new opportunity to discuss, refine, and improve our ability to communicate while emphasizing the importance of improving our common language.

Emergency physicians face delirious patients brought to them from the community on a regular basis. As such, it makes sense that they have been at the forefront of this issue and the American College of Emergency Physicians has recognized excited delirium as a condition since 2009.⁷ The emergency physician literature points out that death from excited delirium also happens in hospitals and is not a unique consequence of law enforcement. There is no accepted definition. Reported symptoms include agitation, bizarre behavior, tirelessness, unusual strength, pain tolerance, noncompliance, attraction to reflective surfaces, stupor, fear, panic, hyperthermia, inappropriate clothing, tachycardia, tachypnea, diaphoresis, seizure, and mydriasis. Etiology is suspected to be from catecholaminergic endogenous stress-related catecholamines and exogenous catecholaminergic drugs. In particular is the importance of dopamine through the use of stimulants, specifically cocaine. The literature makes some reference to management, including recommendations aimed at keeping patients on one of their sides, using de-escalation techniques, and performing evaluation in quiet rooms.

We certainly condone and commend efforts to understand and define this condition in the medical literature. The indiscriminate use of “excited delirium” to represent all sorts of behaviors by nonmedical personnel warrants intelligent, relevant, and researched commentary by physicians. There are several potentially appropriate ways forward. First, psychiatry may decide that excited delirium is not a useful diagnosis in the clinical setting and does not belong in the DSM. That distinction in itself would be potentially useful to law enforcement officers, who might welcome the opportunity to create their own nomenclature and classification. Second, psychiatry may decide that excited delirium is not a useful diagnosis in the clinical setting but warrants a definition nonetheless, akin to the ways homelessness and extreme poverty are defined in the DSM; this definition could take into account the wide use of the term by nonclinicians. Third, psychiatry may decide that excited delirium warrants a clinical diagnosis that warrants a distinction and clarification from the current delirium diagnosis with the hyperactive specifier.

At this time, the status quo doesn’t protect or help clinicians in their respective fields of work. “Excited delirium” is routinely used by law enforcement officers without clear meaning. Experts have difficulty pointing out the poor or ill-intended use of the term without a precise or accepted definition to rely on. Some of the proposed criteria, such as “unusual strength,” have unclear scientific legitimacy. Some, such as agitation or bizarre behavior, often have different meanings to nonphysicians. Some, such as poor clothing, may facilitate discrimination. The current state allows some professionals to hide their limited attempts at de-escalation by describing the person of interest as having excited delirium. On the other hand, the current state also prevents well-intended officers from using proper terminology that is understood by others as describing a concerning behavior reliably.

We wonder whether excited delirium is an important facet of the current dilemma of reconsidering the role of law enforcement in society. Frequent use of “excited delirium” by police officers is itself a testament to their desire to have assistance or delegation of certain duties to other social services, such as health care. In some ways, police officers face a difficult position: Admission that a behavior may be attributable to excited delirium should warrant a medical evaluation and, thus, render the person of interest a patient rather than a suspect. As such, this person interacting with police officers should be treated as someone in need of medical care, which makes many interventions – including neck compression – seemingly inappropriate. The frequent use of “excited delirium” suggests that law enforcement is ill-equipped in handling many situations and that an attempt to diversify the composition and funding of emergency response might be warranted. Psychiatry should be at the forefront of this research and effort.

References

1. State of Minnesota v. Derek Michael Chauvin (4th Judicial District, 2020 May 29).

2. J Forensic Leg Med. 2008 May 15(4):227-30.

3. “Excited delirium: Rare and deadly syndrome or a condition to excuse deaths by police?” Florida Today. 2020 Jan 20.

4. J Forensic Sci. 1997 Jan;42(1):25-31.

5. Arch Gen Psychiatry. 1971;25(2):123-30.

6. Am J Psychiatry. 2013 Jan;170(1):59-70.

7. White Paper Report on Excited Delirium Syndrome. ACEP Excited Delirium Task Force. 2009 Sep 10.
 

Dr. Amendolara is a first-year psychiatry resident at University of California, San Diego. He spent years advocating for survivors of rape and domestic violence at the Crime Victims Treatment Center in New York and conducted public health research at Lourdes Center for Public Health in Camden, N.J. Dr. Amendolara has no disclosures. Dr. Malik is a first-year psychiatry resident at the University of California, San Diego. She has a background in policy and grassroots organizing through her time working at the National Coalition for the Homeless and the Women’s Law Project. Dr. Malik has no disclosures. Dr. Abrams is a forensic psychiatrist and attorney in San Diego. He is an expert in addictionology, behavioral toxicology, psychopharmacology, and correctional mental health. He holds teaching positions at the University of California, San Diego. Among his writings are chapters about competency in national textbooks. Dr. Abrams has no disclosures. Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings is chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Cham, Switzerland: Springer, 2019). He has no disclosures.

Prior to George Floyd’s death, Officer Thomas Lane reportedly said, “I am worried about excited delirium or whatever” to his colleague, Officer Derek Chauvin.¹ For those of us who frequently work with law enforcement and in correctional facilities, “excited delirium” is a common refrain. It would be too facile to dismiss the concept as an attempt by police officers to inappropriately use medically sounding jargon to justify violence. “Excited delirium” is a reminder of the complex situations faced by police officers and the need for better medical training, as well as the attention of research on this commonly used label.

Many law enforcement facilities, in particular jails that receive inmates directly from the community, will have large posters educating staff on the “signs of excited delirium.” The concept is not covered in residency training programs, or many of the leading textbooks of psychiatry. Yet, it has become common parlance in law enforcement. Officers in training receive education programs on excited delirium, although those are rarely conducted by clinicians.

In our practice and experience, “excited delirium” has been used by law enforcement officers to describe mood lability from the stress of arrest, acute agitation from stimulant or phencyclidine intoxication, actual delirium from a medical comorbidity, sociopathic aggression for the purpose of violence, and incoherence from psychosis, along with simply describing a person not following direction from a police officer.

Our differential diagnosis when informed that someone was described by a nonclinician as having so-called excited delirium is wider than the Diagnostic and Statistical Manual (DSM). In addition, the term comes at a cost. Its use has been implicated in police-related deaths and brutality.² There is also concern of its disproportionate application to Black people.^3,4

Nonetheless, the term “excited delirium” can sometimes accurately describe critical medical situations. We particularly remember a case of altered mental status from serotonin syndrome, a case of delirium tremens from alcohol withdrawal, and a case of life-threatening dehydration in the context of stimulant intoxication. Each of those cases was appropriately recognized as problematic by perceptive and caring police officers. It is important for police officers to recognize these life-threatening conditions, and they need the language to do so. Having a common label that can be used across professional fields and law enforcement departments to express medical concern in the context of aggressive behavior has value. The question is: can psychiatry help law enforcement describe situations more accurately?

As physicians, it would be overly simple to point out the limited understanding of medical information by police and correctional officers. Naming many behaviors poses significant challenges for psychiatrists and nonclinicians. Examples include the use of the word “agitation” to describe mild restlessness, “delusional” for uncooperative, and “irritable” for opinionated. We must also be cognizant of the infinite demands placed on police officers and that labels must be available to them to express complex situations without being forced to use medical diagnosis and terminology for which they do not have the license or expertise. It is possible that “excited delirium” serves an important role; the problem may not be as much “excited delirium,” the term itself, as the diversion of its use to justify poor policing.

It must be acknowledged that debates, concerns, poor nomenclature, confusing labels, and different interpretations of diagnoses and symptoms are not unusual things in psychiatry, even among professionals. In the 1970s, the famous American and British study of diagnostic criteria,showed that psychiatrists used the diagnosis of schizophrenia to describe vastly different patients.⁵ The findings of the study were a significant cause of the paradigm shift of the DSM in its 3rd edition. More recently, the DSM-5 field trials suggested that the field of psychiatry continues to struggle with this problem.⁶ Nonetheless, each edition of the DSM presents a new opportunity to discuss, refine, and improve our ability to communicate while emphasizing the importance of improving our common language.

Emergency physicians face delirious patients brought to them from the community on a regular basis. As such, it makes sense that they have been at the forefront of this issue and the American College of Emergency Physicians has recognized excited delirium as a condition since 2009.⁷ The emergency physician literature points out that death from excited delirium also happens in hospitals and is not a unique consequence of law enforcement. There is no accepted definition. Reported symptoms include agitation, bizarre behavior, tirelessness, unusual strength, pain tolerance, noncompliance, attraction to reflective surfaces, stupor, fear, panic, hyperthermia, inappropriate clothing, tachycardia, tachypnea, diaphoresis, seizure, and mydriasis. Etiology is suspected to be from catecholaminergic endogenous stress-related catecholamines and exogenous catecholaminergic drugs. In particular is the importance of dopamine through the use of stimulants, specifically cocaine. The literature makes some reference to management, including recommendations aimed at keeping patients on one of their sides, using de-escalation techniques, and performing evaluation in quiet rooms.

We certainly condone and commend efforts to understand and define this condition in the medical literature. The indiscriminate use of “excited delirium” to represent all sorts of behaviors by nonmedical personnel warrants intelligent, relevant, and researched commentary by physicians. There are several potentially appropriate ways forward. First, psychiatry may decide that excited delirium is not a useful diagnosis in the clinical setting and does not belong in the DSM. That distinction in itself would be potentially useful to law enforcement officers, who might welcome the opportunity to create their own nomenclature and classification. Second, psychiatry may decide that excited delirium is not a useful diagnosis in the clinical setting but warrants a definition nonetheless, akin to the ways homelessness and extreme poverty are defined in the DSM; this definition could take into account the wide use of the term by nonclinicians. Third, psychiatry may decide that excited delirium warrants a clinical diagnosis that warrants a distinction and clarification from the current delirium diagnosis with the hyperactive specifier.

At this time, the status quo doesn’t protect or help clinicians in their respective fields of work. “Excited delirium” is routinely used by law enforcement officers without clear meaning. Experts have difficulty pointing out the poor or ill-intended use of the term without a precise or accepted definition to rely on. Some of the proposed criteria, such as “unusual strength,” have unclear scientific legitimacy. Some, such as agitation or bizarre behavior, often have different meanings to nonphysicians. Some, such as poor clothing, may facilitate discrimination. The current state allows some professionals to hide their limited attempts at de-escalation by describing the person of interest as having excited delirium. On the other hand, the current state also prevents well-intended officers from using proper terminology that is understood by others as describing a concerning behavior reliably.

We wonder whether excited delirium is an important facet of the current dilemma of reconsidering the role of law enforcement in society. Frequent use of “excited delirium” by police officers is itself a testament to their desire to have assistance or delegation of certain duties to other social services, such as health care. In some ways, police officers face a difficult position: Admission that a behavior may be attributable to excited delirium should warrant a medical evaluation and, thus, render the person of interest a patient rather than a suspect. As such, this person interacting with police officers should be treated as someone in need of medical care, which makes many interventions – including neck compression – seemingly inappropriate. The frequent use of “excited delirium” suggests that law enforcement is ill-equipped in handling many situations and that an attempt to diversify the composition and funding of emergency response might be warranted. Psychiatry should be at the forefront of this research and effort.

References

1. State of Minnesota v. Derek Michael Chauvin (4th Judicial District, 2020 May 29).

2. J Forensic Leg Med. 2008 May 15(4):227-30.

3. “Excited delirium: Rare and deadly syndrome or a condition to excuse deaths by police?” Florida Today. 2020 Jan 20.

4. J Forensic Sci. 1997 Jan;42(1):25-31.

5. Arch Gen Psychiatry. 1971;25(2):123-30.

6. Am J Psychiatry. 2013 Jan;170(1):59-70.

7. White Paper Report on Excited Delirium Syndrome. ACEP Excited Delirium Task Force. 2009 Sep 10.
 

Dr. Amendolara is a first-year psychiatry resident at University of California, San Diego. He spent years advocating for survivors of rape and domestic violence at the Crime Victims Treatment Center in New York and conducted public health research at Lourdes Center for Public Health in Camden, N.J. Dr. Amendolara has no disclosures. Dr. Malik is a first-year psychiatry resident at the University of California, San Diego. She has a background in policy and grassroots organizing through her time working at the National Coalition for the Homeless and the Women’s Law Project. Dr. Malik has no disclosures. Dr. Abrams is a forensic psychiatrist and attorney in San Diego. He is an expert in addictionology, behavioral toxicology, psychopharmacology, and correctional mental health. He holds teaching positions at the University of California, San Diego. Among his writings are chapters about competency in national textbooks. Dr. Abrams has no disclosures. Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings is chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Cham, Switzerland: Springer, 2019). He has no disclosures.

Prior to George Floyd’s death, Officer Thomas Lane reportedly said, “I am worried about excited delirium or whatever” to his colleague, Officer Derek Chauvin.¹ For those of us who frequently work with law enforcement and in correctional facilities, “excited delirium” is a common refrain. It would be too facile to dismiss the concept as an attempt by police officers to inappropriately use medically sounding jargon to justify violence. “Excited delirium” is a reminder of the complex situations faced by police officers and the need for better medical training, as well as the attention of research on this commonly used label.

Many law enforcement facilities, in particular jails that receive inmates directly from the community, will have large posters educating staff on the “signs of excited delirium.” The concept is not covered in residency training programs, or many of the leading textbooks of psychiatry. Yet, it has become common parlance in law enforcement. Officers in training receive education programs on excited delirium, although those are rarely conducted by clinicians.

In our practice and experience, “excited delirium” has been used by law enforcement officers to describe mood lability from the stress of arrest, acute agitation from stimulant or phencyclidine intoxication, actual delirium from a medical comorbidity, sociopathic aggression for the purpose of violence, and incoherence from psychosis, along with simply describing a person not following direction from a police officer.

Our differential diagnosis when informed that someone was described by a nonclinician as having so-called excited delirium is wider than the Diagnostic and Statistical Manual (DSM). In addition, the term comes at a cost. Its use has been implicated in police-related deaths and brutality.² There is also concern of its disproportionate application to Black people.^3,4

Nonetheless, the term “excited delirium” can sometimes accurately describe critical medical situations. We particularly remember a case of altered mental status from serotonin syndrome, a case of delirium tremens from alcohol withdrawal, and a case of life-threatening dehydration in the context of stimulant intoxication. Each of those cases was appropriately recognized as problematic by perceptive and caring police officers. It is important for police officers to recognize these life-threatening conditions, and they need the language to do so. Having a common label that can be used across professional fields and law enforcement departments to express medical concern in the context of aggressive behavior has value. The question is: can psychiatry help law enforcement describe situations more accurately?

As physicians, it would be overly simple to point out the limited understanding of medical information by police and correctional officers. Naming many behaviors poses significant challenges for psychiatrists and nonclinicians. Examples include the use of the word “agitation” to describe mild restlessness, “delusional” for uncooperative, and “irritable” for opinionated. We must also be cognizant of the infinite demands placed on police officers and that labels must be available to them to express complex situations without being forced to use medical diagnosis and terminology for which they do not have the license or expertise. It is possible that “excited delirium” serves an important role; the problem may not be as much “excited delirium,” the term itself, as the diversion of its use to justify poor policing.

It must be acknowledged that debates, concerns, poor nomenclature, confusing labels, and different interpretations of diagnoses and symptoms are not unusual things in psychiatry, even among professionals. In the 1970s, the famous American and British study of diagnostic criteria,showed that psychiatrists used the diagnosis of schizophrenia to describe vastly different patients.⁵ The findings of the study were a significant cause of the paradigm shift of the DSM in its 3rd edition. More recently, the DSM-5 field trials suggested that the field of psychiatry continues to struggle with this problem.⁶ Nonetheless, each edition of the DSM presents a new opportunity to discuss, refine, and improve our ability to communicate while emphasizing the importance of improving our common language.

Emergency physicians face delirious patients brought to them from the community on a regular basis. As such, it makes sense that they have been at the forefront of this issue and the American College of Emergency Physicians has recognized excited delirium as a condition since 2009.⁷ The emergency physician literature points out that death from excited delirium also happens in hospitals and is not a unique consequence of law enforcement. There is no accepted definition. Reported symptoms include agitation, bizarre behavior, tirelessness, unusual strength, pain tolerance, noncompliance, attraction to reflective surfaces, stupor, fear, panic, hyperthermia, inappropriate clothing, tachycardia, tachypnea, diaphoresis, seizure, and mydriasis. Etiology is suspected to be from catecholaminergic endogenous stress-related catecholamines and exogenous catecholaminergic drugs. In particular is the importance of dopamine through the use of stimulants, specifically cocaine. The literature makes some reference to management, including recommendations aimed at keeping patients on one of their sides, using de-escalation techniques, and performing evaluation in quiet rooms.

We certainly condone and commend efforts to understand and define this condition in the medical literature. The indiscriminate use of “excited delirium” to represent all sorts of behaviors by nonmedical personnel warrants intelligent, relevant, and researched commentary by physicians. There are several potentially appropriate ways forward. First, psychiatry may decide that excited delirium is not a useful diagnosis in the clinical setting and does not belong in the DSM. That distinction in itself would be potentially useful to law enforcement officers, who might welcome the opportunity to create their own nomenclature and classification. Second, psychiatry may decide that excited delirium is not a useful diagnosis in the clinical setting but warrants a definition nonetheless, akin to the ways homelessness and extreme poverty are defined in the DSM; this definition could take into account the wide use of the term by nonclinicians. Third, psychiatry may decide that excited delirium warrants a clinical diagnosis that warrants a distinction and clarification from the current delirium diagnosis with the hyperactive specifier.

At this time, the status quo doesn’t protect or help clinicians in their respective fields of work. “Excited delirium” is routinely used by law enforcement officers without clear meaning. Experts have difficulty pointing out the poor or ill-intended use of the term without a precise or accepted definition to rely on. Some of the proposed criteria, such as “unusual strength,” have unclear scientific legitimacy. Some, such as agitation or bizarre behavior, often have different meanings to nonphysicians. Some, such as poor clothing, may facilitate discrimination. The current state allows some professionals to hide their limited attempts at de-escalation by describing the person of interest as having excited delirium. On the other hand, the current state also prevents well-intended officers from using proper terminology that is understood by others as describing a concerning behavior reliably.

We wonder whether excited delirium is an important facet of the current dilemma of reconsidering the role of law enforcement in society. Frequent use of “excited delirium” by police officers is itself a testament to their desire to have assistance or delegation of certain duties to other social services, such as health care. In some ways, police officers face a difficult position: Admission that a behavior may be attributable to excited delirium should warrant a medical evaluation and, thus, render the person of interest a patient rather than a suspect. As such, this person interacting with police officers should be treated as someone in need of medical care, which makes many interventions – including neck compression – seemingly inappropriate. The frequent use of “excited delirium” suggests that law enforcement is ill-equipped in handling many situations and that an attempt to diversify the composition and funding of emergency response might be warranted. Psychiatry should be at the forefront of this research and effort.

References

1. State of Minnesota v. Derek Michael Chauvin (4th Judicial District, 2020 May 29).

2. J Forensic Leg Med. 2008 May 15(4):227-30.

3. “Excited delirium: Rare and deadly syndrome or a condition to excuse deaths by police?” Florida Today. 2020 Jan 20.

4. J Forensic Sci. 1997 Jan;42(1):25-31.

5. Arch Gen Psychiatry. 1971;25(2):123-30.

6. Am J Psychiatry. 2013 Jan;170(1):59-70.

7. White Paper Report on Excited Delirium Syndrome. ACEP Excited Delirium Task Force. 2009 Sep 10.
 

Dr. Amendolara is a first-year psychiatry resident at University of California, San Diego. He spent years advocating for survivors of rape and domestic violence at the Crime Victims Treatment Center in New York and conducted public health research at Lourdes Center for Public Health in Camden, N.J. Dr. Amendolara has no disclosures. Dr. Malik is a first-year psychiatry resident at the University of California, San Diego. She has a background in policy and grassroots organizing through her time working at the National Coalition for the Homeless and the Women’s Law Project. Dr. Malik has no disclosures. Dr. Abrams is a forensic psychiatrist and attorney in San Diego. He is an expert in addictionology, behavioral toxicology, psychopharmacology, and correctional mental health. He holds teaching positions at the University of California, San Diego. Among his writings are chapters about competency in national textbooks. Dr. Abrams has no disclosures. Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Among his writings is chapter 7 in the book “Critical Psychiatry: Controversies and Clinical Implications” (Cham, Switzerland: Springer, 2019). He has no disclosures.

The American Medical Association House of Delegates has adopted a policy to educate physicians on how to speak with patients about COVID-19 vaccination to counteract widespread misinformation about the vaccine development process.

Other highlights of the AMA’s recent special meeting include a new policy on the ethics of physicians getting immunized against COVID-19 and a far-reaching statement about racism.

Under the organization’s new vaccination education policy, the AMA will provide physicians with “culturally appropriate patient education materials,” according to a news release.

This campaign will be conducted “bearing in mind the historical context of ‘experimentation’ with vaccines and other medication in communities of color,” the AMA said, apparently alluding to the infamous Tuskegee study of syphilis in Black men.

Educating the public about the safety and efficacy of the COVID-19 vaccine programs is an “urgent priority,” the AMA said. This is especially true among populations that have been disproportionately affected by the disease. Black and Latino people are being hospitalized for COVID-19 at far higher rates than White Americans.

“Under the new policy, the AMA will help address patient concerns, dispel misinformation, and build confidence in COVID-19 vaccination,” the release states. The AMA also plans to build a coalition of health care and public health organizations to develop and implement a joint public education program.

Polls have indicated that many people will not get vaccinated when supplies of the new COVID-19 vaccines are available, although public support is rising. A recent Gallup poll found that 58% of surveyed adults were willing to be inoculated, up from 50% in September.

A Kaiser Family Foundation survey in September found that a majority of Americans were skeptical of a rushed vaccine, because they were concerned that the Trump administration was pressuring the Food and Drug Administration to approve a vaccine before the election.

“Given the unprecedented situation with COVID-19 and with vaccine development moving at a rapid pace, many of our patients and the public have questions and concerns,” said AMA President Susan R. Bailey, MD, in the release. “It is essential that we speak together as a strong, unified voice across health care and public health, inclusive of organizations respected in communities of color; to use scientific, fact-based evidence to help allay public concerns; and build confidence in COVID-19 vaccine candidates that are determined to be safe and effective.”
 

Physician, immunize thyself

The AMA also adopted a new ethics policy about physician immunization. On Monday, the AMA House of Delegates stated that physicians who are not immunized from a vaccine-preventable disease have an ethical responsibility to take appropriate actions to protect patients and colleagues.

The AMA code of ethics has long maintained that physicians have a strong ethical duty to accept immunizations when a safe, effective vaccine is available. However, the organization said in a news release, “it is not ethically problematic to exempt individuals when a specific vaccine poses a risk due to underlying medical conditions.”

Ethical concerns arise when physicians are allowed to decline vaccinations for nonmedical reasons, according to a report presented to the House of Delegates by the AMA Council on Ethical and Judicial Affairs.

According to the newly amended AMA ethical guidance, “physicians who are not or cannot be immunized have a responsibility to voluntarily take appropriate actions to protect patients, fellow health care workers and others.” This includes refraining from direct patient contact.

The delegates also approved a guidance asserting that physician practices and health care institutions are responsible for developing policies and procedures for responding to pandemics and epidemics. These policies and procedures should outline appropriate protective equipment allocation, staff immunization programs, and infection control practices.
 

Combating systemic racism

In an effort to reduce racial disparities in healthcare, the AMA House of Delegates adopted new policies recognizing race as a social construct, rather than a biological construct.

“The policies aim to advance data-driven, antiracist concepts challenging the current clinical application of race and its effects on vulnerable patient populations,” an AMA statement said.

The new AMA policies “reflect an understanding of race as a socially constructed category different from ethnicity, genetic ancestry, or biology, and aim to end the misinterpretation of race as a biological category defined by genetic traits or biological differences,” the AMA said.

According to the AMA, the practice of accepting race as a biological construct “exacerbates health disparities and results in detrimental health outcomes for marginalized and minoritized communities.”

Specifically, the AMA said it supports ending the practice of using race as a proxy for biology in medical education, research, and clinical practice. It also encourages medical education programs to recognize the harmful effects of this approach. It recommends that clinicians and researchers focus on genetics and biology, the experience of racism, and social determinants of health when describing risk factors for disease.

“The AMA is dedicated to dismantling racist and discriminatory policies and practices across all of health care, and that includes the way we define race in medicine,” said AMA board member Michael Suk, MD, in its statement. “We believe it is not sufficient for medicine to be nonracist, which is why the AMA is committed to pushing for a shift in thinking from race as a biological risk factor to a deeper understanding of racism as a determinant of health.”

The AMA also plans to partner with physician organizations and other stakeholders “to identify any problematic aspects of medical education that may perpetuate institutional and structural racism.” For example, the AMA will work with other organizations to improve clinical algorithms that incorrectly adjust for race and lead to less-than-optimal care for minority patients.

A version of this article originally appeared on Medscape.com.

The American Medical Association House of Delegates has adopted a policy to educate physicians on how to speak with patients about COVID-19 vaccination to counteract widespread misinformation about the vaccine development process.

Other highlights of the AMA’s recent special meeting include a new policy on the ethics of physicians getting immunized against COVID-19 and a far-reaching statement about racism.

Under the organization’s new vaccination education policy, the AMA will provide physicians with “culturally appropriate patient education materials,” according to a news release.

This campaign will be conducted “bearing in mind the historical context of ‘experimentation’ with vaccines and other medication in communities of color,” the AMA said, apparently alluding to the infamous Tuskegee study of syphilis in Black men.

Educating the public about the safety and efficacy of the COVID-19 vaccine programs is an “urgent priority,” the AMA said. This is especially true among populations that have been disproportionately affected by the disease. Black and Latino people are being hospitalized for COVID-19 at far higher rates than White Americans.

“Under the new policy, the AMA will help address patient concerns, dispel misinformation, and build confidence in COVID-19 vaccination,” the release states. The AMA also plans to build a coalition of health care and public health organizations to develop and implement a joint public education program.

Polls have indicated that many people will not get vaccinated when supplies of the new COVID-19 vaccines are available, although public support is rising. A recent Gallup poll found that 58% of surveyed adults were willing to be inoculated, up from 50% in September.

A Kaiser Family Foundation survey in September found that a majority of Americans were skeptical of a rushed vaccine, because they were concerned that the Trump administration was pressuring the Food and Drug Administration to approve a vaccine before the election.

“Given the unprecedented situation with COVID-19 and with vaccine development moving at a rapid pace, many of our patients and the public have questions and concerns,” said AMA President Susan R. Bailey, MD, in the release. “It is essential that we speak together as a strong, unified voice across health care and public health, inclusive of organizations respected in communities of color; to use scientific, fact-based evidence to help allay public concerns; and build confidence in COVID-19 vaccine candidates that are determined to be safe and effective.”
 

Physician, immunize thyself

The AMA also adopted a new ethics policy about physician immunization. On Monday, the AMA House of Delegates stated that physicians who are not immunized from a vaccine-preventable disease have an ethical responsibility to take appropriate actions to protect patients and colleagues.

The AMA code of ethics has long maintained that physicians have a strong ethical duty to accept immunizations when a safe, effective vaccine is available. However, the organization said in a news release, “it is not ethically problematic to exempt individuals when a specific vaccine poses a risk due to underlying medical conditions.”

Ethical concerns arise when physicians are allowed to decline vaccinations for nonmedical reasons, according to a report presented to the House of Delegates by the AMA Council on Ethical and Judicial Affairs.

According to the newly amended AMA ethical guidance, “physicians who are not or cannot be immunized have a responsibility to voluntarily take appropriate actions to protect patients, fellow health care workers and others.” This includes refraining from direct patient contact.

The delegates also approved a guidance asserting that physician practices and health care institutions are responsible for developing policies and procedures for responding to pandemics and epidemics. These policies and procedures should outline appropriate protective equipment allocation, staff immunization programs, and infection control practices.
 

Combating systemic racism

In an effort to reduce racial disparities in healthcare, the AMA House of Delegates adopted new policies recognizing race as a social construct, rather than a biological construct.

“The policies aim to advance data-driven, antiracist concepts challenging the current clinical application of race and its effects on vulnerable patient populations,” an AMA statement said.

The new AMA policies “reflect an understanding of race as a socially constructed category different from ethnicity, genetic ancestry, or biology, and aim to end the misinterpretation of race as a biological category defined by genetic traits or biological differences,” the AMA said.

According to the AMA, the practice of accepting race as a biological construct “exacerbates health disparities and results in detrimental health outcomes for marginalized and minoritized communities.”

Specifically, the AMA said it supports ending the practice of using race as a proxy for biology in medical education, research, and clinical practice. It also encourages medical education programs to recognize the harmful effects of this approach. It recommends that clinicians and researchers focus on genetics and biology, the experience of racism, and social determinants of health when describing risk factors for disease.

“The AMA is dedicated to dismantling racist and discriminatory policies and practices across all of health care, and that includes the way we define race in medicine,” said AMA board member Michael Suk, MD, in its statement. “We believe it is not sufficient for medicine to be nonracist, which is why the AMA is committed to pushing for a shift in thinking from race as a biological risk factor to a deeper understanding of racism as a determinant of health.”

The AMA also plans to partner with physician organizations and other stakeholders “to identify any problematic aspects of medical education that may perpetuate institutional and structural racism.” For example, the AMA will work with other organizations to improve clinical algorithms that incorrectly adjust for race and lead to less-than-optimal care for minority patients.

A version of this article originally appeared on Medscape.com.

The American Medical Association House of Delegates has adopted a policy to educate physicians on how to speak with patients about COVID-19 vaccination to counteract widespread misinformation about the vaccine development process.

Other highlights of the AMA’s recent special meeting include a new policy on the ethics of physicians getting immunized against COVID-19 and a far-reaching statement about racism.

Under the organization’s new vaccination education policy, the AMA will provide physicians with “culturally appropriate patient education materials,” according to a news release.

This campaign will be conducted “bearing in mind the historical context of ‘experimentation’ with vaccines and other medication in communities of color,” the AMA said, apparently alluding to the infamous Tuskegee study of syphilis in Black men.

Educating the public about the safety and efficacy of the COVID-19 vaccine programs is an “urgent priority,” the AMA said. This is especially true among populations that have been disproportionately affected by the disease. Black and Latino people are being hospitalized for COVID-19 at far higher rates than White Americans.

“Under the new policy, the AMA will help address patient concerns, dispel misinformation, and build confidence in COVID-19 vaccination,” the release states. The AMA also plans to build a coalition of health care and public health organizations to develop and implement a joint public education program.

Polls have indicated that many people will not get vaccinated when supplies of the new COVID-19 vaccines are available, although public support is rising. A recent Gallup poll found that 58% of surveyed adults were willing to be inoculated, up from 50% in September.

A Kaiser Family Foundation survey in September found that a majority of Americans were skeptical of a rushed vaccine, because they were concerned that the Trump administration was pressuring the Food and Drug Administration to approve a vaccine before the election.

“Given the unprecedented situation with COVID-19 and with vaccine development moving at a rapid pace, many of our patients and the public have questions and concerns,” said AMA President Susan R. Bailey, MD, in the release. “It is essential that we speak together as a strong, unified voice across health care and public health, inclusive of organizations respected in communities of color; to use scientific, fact-based evidence to help allay public concerns; and build confidence in COVID-19 vaccine candidates that are determined to be safe and effective.”
 

Physician, immunize thyself

The AMA also adopted a new ethics policy about physician immunization. On Monday, the AMA House of Delegates stated that physicians who are not immunized from a vaccine-preventable disease have an ethical responsibility to take appropriate actions to protect patients and colleagues.

The AMA code of ethics has long maintained that physicians have a strong ethical duty to accept immunizations when a safe, effective vaccine is available. However, the organization said in a news release, “it is not ethically problematic to exempt individuals when a specific vaccine poses a risk due to underlying medical conditions.”

Ethical concerns arise when physicians are allowed to decline vaccinations for nonmedical reasons, according to a report presented to the House of Delegates by the AMA Council on Ethical and Judicial Affairs.

According to the newly amended AMA ethical guidance, “physicians who are not or cannot be immunized have a responsibility to voluntarily take appropriate actions to protect patients, fellow health care workers and others.” This includes refraining from direct patient contact.

The delegates also approved a guidance asserting that physician practices and health care institutions are responsible for developing policies and procedures for responding to pandemics and epidemics. These policies and procedures should outline appropriate protective equipment allocation, staff immunization programs, and infection control practices.
 

Combating systemic racism

In an effort to reduce racial disparities in healthcare, the AMA House of Delegates adopted new policies recognizing race as a social construct, rather than a biological construct.

“The policies aim to advance data-driven, antiracist concepts challenging the current clinical application of race and its effects on vulnerable patient populations,” an AMA statement said.

The new AMA policies “reflect an understanding of race as a socially constructed category different from ethnicity, genetic ancestry, or biology, and aim to end the misinterpretation of race as a biological category defined by genetic traits or biological differences,” the AMA said.

According to the AMA, the practice of accepting race as a biological construct “exacerbates health disparities and results in detrimental health outcomes for marginalized and minoritized communities.”

Specifically, the AMA said it supports ending the practice of using race as a proxy for biology in medical education, research, and clinical practice. It also encourages medical education programs to recognize the harmful effects of this approach. It recommends that clinicians and researchers focus on genetics and biology, the experience of racism, and social determinants of health when describing risk factors for disease.

“The AMA is dedicated to dismantling racist and discriminatory policies and practices across all of health care, and that includes the way we define race in medicine,” said AMA board member Michael Suk, MD, in its statement. “We believe it is not sufficient for medicine to be nonracist, which is why the AMA is committed to pushing for a shift in thinking from race as a biological risk factor to a deeper understanding of racism as a determinant of health.”

The AMA also plans to partner with physician organizations and other stakeholders “to identify any problematic aspects of medical education that may perpetuate institutional and structural racism.” For example, the AMA will work with other organizations to improve clinical algorithms that incorrectly adjust for race and lead to less-than-optimal care for minority patients.

A version of this article originally appeared on Medscape.com.

Cynthia H. Moran, MD, has a medical degree, a passion for treating the elderly, and a desire to work. What she doesn’t have is a job or hopes of getting one anytime soon.

The Houston physician has never been charged with a crime, but she did run afoul of the Texas Medical Board, an experience she said has left her destitute and virtually unemployable in the medical field.

“By the time the board gets through with you, you will be bankrupt and have nothing,” she said.

Dr. Moran has a long, tangled history with the board involving self-prescribing, opioid abuse, depression, and unprofessional conduct. After years of license suspension, drug testing, additional CME, substance abuse treatment, and work restrictions, her supervision by the board ended in 2019, but she has been largely unable to find work as a physician.

“I feel like a felon. I really understand what it’s like to be someone who does their time but then can’t get a job, can’t get an apartment. It’s in your record and there’s nothing you can do about it,” she said.

Although Dr. Moran largely created her own troubles, her experience shows the power state medical licensing boards have when it comes to disciplining physicians.
 

Reprimands to revocations

Many physicians think of their state medical boards as simply the bodies that issue their medical licenses, but the boards have other functions, including investigating complaints against licensed medical professionals and sometimes disciplining them.

According to 2017 statistics from the Federation of State Medical Boards (the most recent available), state boards took 8,813 actions that year. These included 796 suspensions, 764 probations, 570 surrendered licenses, and 264 revoked licenses.

Boards also can order doctors to enter state-run physician health plans to receive treatment for substance abuse, or they can allow physicians to practice only under the supervision of colleagues.

Although they vary by state, the boards are fundamentally similar. Members are appointed by the governor. A majority of them are physicians, and the remainder are nonmedical professionals. Their investigators, often retired law enforcement officials, have broad powers to collect evidence, including medical records. Their authority is backed by the state attorney general.

Although physicians tend to worry more about being sued for malpractice, a medical board investigation can be more worrisome, said William Sullivan, DO, JD, an ED physician and attorney in Illinois who has represented doctors before that state’s board. Board disciplinary actions outnumber malpractice awards by four to one in that state.

“The gravity of this is something that many physicians don’t understand,” he said.
 

You can be the subject of anonymous complaints and investigations

Anyone can file a complaint against a physician with a state board. The grievances can be about anything from a crowded waiting room to physician impairment.

Of course, the most trivial complaints (out-of-date magazines in the waiting room) are dismissed out of hand, but boards have the authority to investigate whatever it chooses. The most common investigations center around complaints of impairment, substance abuse, improper prescribing, faulty medical records, mental and physical health problems, and standard of care. Boards also will act if a physician is found guilty of a crime or misconduct unrelated to his or her medical practice.

“There are a lot of ways doctors get into trouble,” said Edward Dauer, MD, a radiologist who served on the Florida board for 11 years.

Investigations often expand beyond their original scope into all aspects of a practice. “Once you’re on their radar, they can find something,” Dr. Sullivan said.

All punitive actions taken by state boards are reported to the Department of Health & Human Services’ National Practitioner Data Bank, which is accessible to all state boards. Sanctioned physicians who set up practice in another state often find that their new home has adopted the sanctions leveled by the original state, something boards can do without conducting their own investigations.

“For doctors, discipline is forever. It never goes off your record,” Dr. Dauer said.

In addition, Medicare, Medicaid, and private insurers can exclude disciplined physicians, which can cripple a practice’s finances. So what can doctors do to avoid problems with the boards?
 

Don’t do anything wrong

That sounds glib and obvious, but many physicians get into trouble by unwittingly violating state medical regulations regarding such things as CME, insurance requirements, failure to notify the board of address changes, and personal relationships with current or former patients.

“The best advice to avoid these issues is to do a Google search for the Medical Practice Act in the state in which they practice,” said Dr. Sullivan. He noted that doctors should regularly check for changes in regulations.

Keeping on good terms with colleagues and patients also helps, he said, noting that many complaints stem from personal disputes and grievances.

But what if a physician becomes the subject of an investigation? What should they do?
 

Take any complaint seriously

Too many physicians dismiss investigations initially. “Some people have the wrong idea that if they ignore it, it will go away. It won’t go away,” Dr. Sullivan said.

Whether the initial contact comes through a letter or a visit from a board investigator, it should be treated with urgency. Ohio attorney Beth Collis said one client angrily scrawled one-word answers with a Sharpie on the questionnaire he was mailed – answers he was stuck defending throughout the rest of the investigation. Other doctors have ordered investigators out of their offices – another mistake. Failure to cooperate can result in an immediate license suspension.

“They should be speaking to these investigators like they were talking to a highway patrolman on the side of the road. They hold all the cards,” said Ms. Collis, who specializes in representing professionals before licensing boards.

Some physicians mistakenly assume that because their state board is made up mostly of fellow doctors, they will be able to make a complaint go away with some collegial chat.

Not so. “Medical board members see themselves as protecting the public. They’re very punitive,” Ms. Collis said.

At one time, state boards might have been lax in their supervision of physicians, but that changed in the 1980s when the watchdog group Public Citizen began ranking state medical boards by how effective they were in policing doctors.

Public Citizen used FSMB data on serious disciplinary actions per 1,000 doctors in each state to calculate its rankings, a practice that FSMB called incomplete and a misuse of its statistics. Nonetheless, the annual rankings generated a lot of publicity critical of state boards and might have spurred a tougher approach by regulators.

Public Citizen stopped publishing its annual rankings in 2013 after FSMB ceased supplying the data, but the get-tough approach remains, lawyers said.

About 95% of complaints are dismissed with nothing more serious than a letter to the doctor, but boards don’t hesitate to act when the misconduct is serious, said Dr. Dauer. “I felt it was my obligation to protect the public.”
 

Don’t try to fix it yourself

Although many complaints are anonymous, doctors can often figure out what or who it involves. Their impulse might be to contact a patient who complained, correct a medical record, or otherwise try to resolve the matter personally.

It’s better to leave things alone, the experts said. Don’t contact a patient. Give the board access to whatever information it asks for, but don’t alter anything, particularly medical records. “That’s how you’re going to get your license revoked,” Dr. Dauer said. He noted that when doctors add notations to records, they must date them.
 

Hire a lawyer

Many physicians assume they can resolve the complaint easily by explaining themselves to the board or investigators, or they don’t realize their license or practice could be at stake.

They’re better off letting a lawyer speak for them. Attorneys knowledgeable in this realm specialize in representing licensed professionals before regulatory boards and have the greatest knowledge of administrative law and how to negotiate the hearings and procedures.

Typically, a hearing is held before a subcommittee of the board, which can recommend a settlement to the full panel. Cases in which a settlement is not reached can go before the entire board.

Although full hearings can be similar to a trial, there are crucial differences regarding evidentiary rules and other matters, Ms. Collis said. For example, in Ohio, defendant physicians do not get to see the board’s full case against them before the hearing, which can make preparing a defense difficult. And the standard for burden of proof is a preponderance of evidence, as in civil suits, not evidence beyond a reasonable doubt, as in a criminal trial.

Cases that go to full hearings and beyond to appeals in state courts can take years to resolve, and a physician’s license can be suspended for the duration.
 

Get help before it’s too late

Physicians looking for support and advice can turn to organizations such as the Coalition for Physician Rights, an organization formed in 2018 by Kernan Manion, MD, a former psychiatrist who was forced to deactivate his license after an investigation by the North Carolina medical board.

The Coalition for Physician Rights has advised hundreds of physicians, most of whom he said come to him once they realize they’re in over their heads. “Almost everyone comes in too late,” Dr. Manion said. “They’re sitting ducks. They don’t know how to respond.”

In addition to offering advice and support, the Coalition for Physician Rights lobbies for reform in how boards operate. A number of states, including Oklahoma, have made reforms in recent years.

The appointed boards are too reliant on their administration and staff and usually rubber-stamp disciplinary recommendations, Dr. Manion said. He also criticized the boards’ lack of accountability: “A board operates without external or internal oversight. It is an autonomous entity operating on its own.”

As for Dr. Moran, at age 61, she’s interviewing for physician jobs around the country, refusing to give up medicine.

“What else can I do?” she said. “It’s what I’ve done my entire life. It’s what I went to school for. I don’t know how to do anything else.”

A version of this article originally appeared on Medscape.com.

Cynthia H. Moran, MD, has a medical degree, a passion for treating the elderly, and a desire to work. What she doesn’t have is a job or hopes of getting one anytime soon.

The Houston physician has never been charged with a crime, but she did run afoul of the Texas Medical Board, an experience she said has left her destitute and virtually unemployable in the medical field.

“By the time the board gets through with you, you will be bankrupt and have nothing,” she said.

Dr. Moran has a long, tangled history with the board involving self-prescribing, opioid abuse, depression, and unprofessional conduct. After years of license suspension, drug testing, additional CME, substance abuse treatment, and work restrictions, her supervision by the board ended in 2019, but she has been largely unable to find work as a physician.

“I feel like a felon. I really understand what it’s like to be someone who does their time but then can’t get a job, can’t get an apartment. It’s in your record and there’s nothing you can do about it,” she said.

Although Dr. Moran largely created her own troubles, her experience shows the power state medical licensing boards have when it comes to disciplining physicians.
 

Reprimands to revocations

Many physicians think of their state medical boards as simply the bodies that issue their medical licenses, but the boards have other functions, including investigating complaints against licensed medical professionals and sometimes disciplining them.

According to 2017 statistics from the Federation of State Medical Boards (the most recent available), state boards took 8,813 actions that year. These included 796 suspensions, 764 probations, 570 surrendered licenses, and 264 revoked licenses.

Boards also can order doctors to enter state-run physician health plans to receive treatment for substance abuse, or they can allow physicians to practice only under the supervision of colleagues.

Although they vary by state, the boards are fundamentally similar. Members are appointed by the governor. A majority of them are physicians, and the remainder are nonmedical professionals. Their investigators, often retired law enforcement officials, have broad powers to collect evidence, including medical records. Their authority is backed by the state attorney general.

Although physicians tend to worry more about being sued for malpractice, a medical board investigation can be more worrisome, said William Sullivan, DO, JD, an ED physician and attorney in Illinois who has represented doctors before that state’s board. Board disciplinary actions outnumber malpractice awards by four to one in that state.

“The gravity of this is something that many physicians don’t understand,” he said.
 

You can be the subject of anonymous complaints and investigations

Anyone can file a complaint against a physician with a state board. The grievances can be about anything from a crowded waiting room to physician impairment.

Of course, the most trivial complaints (out-of-date magazines in the waiting room) are dismissed out of hand, but boards have the authority to investigate whatever it chooses. The most common investigations center around complaints of impairment, substance abuse, improper prescribing, faulty medical records, mental and physical health problems, and standard of care. Boards also will act if a physician is found guilty of a crime or misconduct unrelated to his or her medical practice.

“There are a lot of ways doctors get into trouble,” said Edward Dauer, MD, a radiologist who served on the Florida board for 11 years.

Investigations often expand beyond their original scope into all aspects of a practice. “Once you’re on their radar, they can find something,” Dr. Sullivan said.

All punitive actions taken by state boards are reported to the Department of Health & Human Services’ National Practitioner Data Bank, which is accessible to all state boards. Sanctioned physicians who set up practice in another state often find that their new home has adopted the sanctions leveled by the original state, something boards can do without conducting their own investigations.

“For doctors, discipline is forever. It never goes off your record,” Dr. Dauer said.

In addition, Medicare, Medicaid, and private insurers can exclude disciplined physicians, which can cripple a practice’s finances. So what can doctors do to avoid problems with the boards?
 

Don’t do anything wrong

That sounds glib and obvious, but many physicians get into trouble by unwittingly violating state medical regulations regarding such things as CME, insurance requirements, failure to notify the board of address changes, and personal relationships with current or former patients.

“The best advice to avoid these issues is to do a Google search for the Medical Practice Act in the state in which they practice,” said Dr. Sullivan. He noted that doctors should regularly check for changes in regulations.

Keeping on good terms with colleagues and patients also helps, he said, noting that many complaints stem from personal disputes and grievances.

But what if a physician becomes the subject of an investigation? What should they do?
 

Take any complaint seriously

Too many physicians dismiss investigations initially. “Some people have the wrong idea that if they ignore it, it will go away. It won’t go away,” Dr. Sullivan said.

Whether the initial contact comes through a letter or a visit from a board investigator, it should be treated with urgency. Ohio attorney Beth Collis said one client angrily scrawled one-word answers with a Sharpie on the questionnaire he was mailed – answers he was stuck defending throughout the rest of the investigation. Other doctors have ordered investigators out of their offices – another mistake. Failure to cooperate can result in an immediate license suspension.

“They should be speaking to these investigators like they were talking to a highway patrolman on the side of the road. They hold all the cards,” said Ms. Collis, who specializes in representing professionals before licensing boards.

Some physicians mistakenly assume that because their state board is made up mostly of fellow doctors, they will be able to make a complaint go away with some collegial chat.

Not so. “Medical board members see themselves as protecting the public. They’re very punitive,” Ms. Collis said.

At one time, state boards might have been lax in their supervision of physicians, but that changed in the 1980s when the watchdog group Public Citizen began ranking state medical boards by how effective they were in policing doctors.

Public Citizen used FSMB data on serious disciplinary actions per 1,000 doctors in each state to calculate its rankings, a practice that FSMB called incomplete and a misuse of its statistics. Nonetheless, the annual rankings generated a lot of publicity critical of state boards and might have spurred a tougher approach by regulators.

Public Citizen stopped publishing its annual rankings in 2013 after FSMB ceased supplying the data, but the get-tough approach remains, lawyers said.

About 95% of complaints are dismissed with nothing more serious than a letter to the doctor, but boards don’t hesitate to act when the misconduct is serious, said Dr. Dauer. “I felt it was my obligation to protect the public.”
 

Don’t try to fix it yourself

Although many complaints are anonymous, doctors can often figure out what or who it involves. Their impulse might be to contact a patient who complained, correct a medical record, or otherwise try to resolve the matter personally.

It’s better to leave things alone, the experts said. Don’t contact a patient. Give the board access to whatever information it asks for, but don’t alter anything, particularly medical records. “That’s how you’re going to get your license revoked,” Dr. Dauer said. He noted that when doctors add notations to records, they must date them.
 

Hire a lawyer

Many physicians assume they can resolve the complaint easily by explaining themselves to the board or investigators, or they don’t realize their license or practice could be at stake.

They’re better off letting a lawyer speak for them. Attorneys knowledgeable in this realm specialize in representing licensed professionals before regulatory boards and have the greatest knowledge of administrative law and how to negotiate the hearings and procedures.

Typically, a hearing is held before a subcommittee of the board, which can recommend a settlement to the full panel. Cases in which a settlement is not reached can go before the entire board.

Although full hearings can be similar to a trial, there are crucial differences regarding evidentiary rules and other matters, Ms. Collis said. For example, in Ohio, defendant physicians do not get to see the board’s full case against them before the hearing, which can make preparing a defense difficult. And the standard for burden of proof is a preponderance of evidence, as in civil suits, not evidence beyond a reasonable doubt, as in a criminal trial.

Cases that go to full hearings and beyond to appeals in state courts can take years to resolve, and a physician’s license can be suspended for the duration.
 

Get help before it’s too late

Physicians looking for support and advice can turn to organizations such as the Coalition for Physician Rights, an organization formed in 2018 by Kernan Manion, MD, a former psychiatrist who was forced to deactivate his license after an investigation by the North Carolina medical board.

The Coalition for Physician Rights has advised hundreds of physicians, most of whom he said come to him once they realize they’re in over their heads. “Almost everyone comes in too late,” Dr. Manion said. “They’re sitting ducks. They don’t know how to respond.”

In addition to offering advice and support, the Coalition for Physician Rights lobbies for reform in how boards operate. A number of states, including Oklahoma, have made reforms in recent years.

The appointed boards are too reliant on their administration and staff and usually rubber-stamp disciplinary recommendations, Dr. Manion said. He also criticized the boards’ lack of accountability: “A board operates without external or internal oversight. It is an autonomous entity operating on its own.”

As for Dr. Moran, at age 61, she’s interviewing for physician jobs around the country, refusing to give up medicine.

“What else can I do?” she said. “It’s what I’ve done my entire life. It’s what I went to school for. I don’t know how to do anything else.”

A version of this article originally appeared on Medscape.com.

Cynthia H. Moran, MD, has a medical degree, a passion for treating the elderly, and a desire to work. What she doesn’t have is a job or hopes of getting one anytime soon.

The Houston physician has never been charged with a crime, but she did run afoul of the Texas Medical Board, an experience she said has left her destitute and virtually unemployable in the medical field.

“By the time the board gets through with you, you will be bankrupt and have nothing,” she said.

Dr. Moran has a long, tangled history with the board involving self-prescribing, opioid abuse, depression, and unprofessional conduct. After years of license suspension, drug testing, additional CME, substance abuse treatment, and work restrictions, her supervision by the board ended in 2019, but she has been largely unable to find work as a physician.

“I feel like a felon. I really understand what it’s like to be someone who does their time but then can’t get a job, can’t get an apartment. It’s in your record and there’s nothing you can do about it,” she said.

Although Dr. Moran largely created her own troubles, her experience shows the power state medical licensing boards have when it comes to disciplining physicians.
 

Reprimands to revocations

Many physicians think of their state medical boards as simply the bodies that issue their medical licenses, but the boards have other functions, including investigating complaints against licensed medical professionals and sometimes disciplining them.

According to 2017 statistics from the Federation of State Medical Boards (the most recent available), state boards took 8,813 actions that year. These included 796 suspensions, 764 probations, 570 surrendered licenses, and 264 revoked licenses.

Boards also can order doctors to enter state-run physician health plans to receive treatment for substance abuse, or they can allow physicians to practice only under the supervision of colleagues.

Although they vary by state, the boards are fundamentally similar. Members are appointed by the governor. A majority of them are physicians, and the remainder are nonmedical professionals. Their investigators, often retired law enforcement officials, have broad powers to collect evidence, including medical records. Their authority is backed by the state attorney general.

Although physicians tend to worry more about being sued for malpractice, a medical board investigation can be more worrisome, said William Sullivan, DO, JD, an ED physician and attorney in Illinois who has represented doctors before that state’s board. Board disciplinary actions outnumber malpractice awards by four to one in that state.

“The gravity of this is something that many physicians don’t understand,” he said.
 

You can be the subject of anonymous complaints and investigations

Anyone can file a complaint against a physician with a state board. The grievances can be about anything from a crowded waiting room to physician impairment.

Of course, the most trivial complaints (out-of-date magazines in the waiting room) are dismissed out of hand, but boards have the authority to investigate whatever it chooses. The most common investigations center around complaints of impairment, substance abuse, improper prescribing, faulty medical records, mental and physical health problems, and standard of care. Boards also will act if a physician is found guilty of a crime or misconduct unrelated to his or her medical practice.

“There are a lot of ways doctors get into trouble,” said Edward Dauer, MD, a radiologist who served on the Florida board for 11 years.

Investigations often expand beyond their original scope into all aspects of a practice. “Once you’re on their radar, they can find something,” Dr. Sullivan said.

All punitive actions taken by state boards are reported to the Department of Health & Human Services’ National Practitioner Data Bank, which is accessible to all state boards. Sanctioned physicians who set up practice in another state often find that their new home has adopted the sanctions leveled by the original state, something boards can do without conducting their own investigations.

“For doctors, discipline is forever. It never goes off your record,” Dr. Dauer said.

In addition, Medicare, Medicaid, and private insurers can exclude disciplined physicians, which can cripple a practice’s finances. So what can doctors do to avoid problems with the boards?
 

Don’t do anything wrong

That sounds glib and obvious, but many physicians get into trouble by unwittingly violating state medical regulations regarding such things as CME, insurance requirements, failure to notify the board of address changes, and personal relationships with current or former patients.

“The best advice to avoid these issues is to do a Google search for the Medical Practice Act in the state in which they practice,” said Dr. Sullivan. He noted that doctors should regularly check for changes in regulations.

Keeping on good terms with colleagues and patients also helps, he said, noting that many complaints stem from personal disputes and grievances.

But what if a physician becomes the subject of an investigation? What should they do?
 

Take any complaint seriously

Too many physicians dismiss investigations initially. “Some people have the wrong idea that if they ignore it, it will go away. It won’t go away,” Dr. Sullivan said.

Whether the initial contact comes through a letter or a visit from a board investigator, it should be treated with urgency. Ohio attorney Beth Collis said one client angrily scrawled one-word answers with a Sharpie on the questionnaire he was mailed – answers he was stuck defending throughout the rest of the investigation. Other doctors have ordered investigators out of their offices – another mistake. Failure to cooperate can result in an immediate license suspension.

“They should be speaking to these investigators like they were talking to a highway patrolman on the side of the road. They hold all the cards,” said Ms. Collis, who specializes in representing professionals before licensing boards.

Some physicians mistakenly assume that because their state board is made up mostly of fellow doctors, they will be able to make a complaint go away with some collegial chat.

Not so. “Medical board members see themselves as protecting the public. They’re very punitive,” Ms. Collis said.

At one time, state boards might have been lax in their supervision of physicians, but that changed in the 1980s when the watchdog group Public Citizen began ranking state medical boards by how effective they were in policing doctors.

Public Citizen used FSMB data on serious disciplinary actions per 1,000 doctors in each state to calculate its rankings, a practice that FSMB called incomplete and a misuse of its statistics. Nonetheless, the annual rankings generated a lot of publicity critical of state boards and might have spurred a tougher approach by regulators.

Public Citizen stopped publishing its annual rankings in 2013 after FSMB ceased supplying the data, but the get-tough approach remains, lawyers said.

About 95% of complaints are dismissed with nothing more serious than a letter to the doctor, but boards don’t hesitate to act when the misconduct is serious, said Dr. Dauer. “I felt it was my obligation to protect the public.”
 

Don’t try to fix it yourself

Although many complaints are anonymous, doctors can often figure out what or who it involves. Their impulse might be to contact a patient who complained, correct a medical record, or otherwise try to resolve the matter personally.

It’s better to leave things alone, the experts said. Don’t contact a patient. Give the board access to whatever information it asks for, but don’t alter anything, particularly medical records. “That’s how you’re going to get your license revoked,” Dr. Dauer said. He noted that when doctors add notations to records, they must date them.
 

Hire a lawyer

Many physicians assume they can resolve the complaint easily by explaining themselves to the board or investigators, or they don’t realize their license or practice could be at stake.

They’re better off letting a lawyer speak for them. Attorneys knowledgeable in this realm specialize in representing licensed professionals before regulatory boards and have the greatest knowledge of administrative law and how to negotiate the hearings and procedures.

Typically, a hearing is held before a subcommittee of the board, which can recommend a settlement to the full panel. Cases in which a settlement is not reached can go before the entire board.

Although full hearings can be similar to a trial, there are crucial differences regarding evidentiary rules and other matters, Ms. Collis said. For example, in Ohio, defendant physicians do not get to see the board’s full case against them before the hearing, which can make preparing a defense difficult. And the standard for burden of proof is a preponderance of evidence, as in civil suits, not evidence beyond a reasonable doubt, as in a criminal trial.

Cases that go to full hearings and beyond to appeals in state courts can take years to resolve, and a physician’s license can be suspended for the duration.
 

Get help before it’s too late

Physicians looking for support and advice can turn to organizations such as the Coalition for Physician Rights, an organization formed in 2018 by Kernan Manion, MD, a former psychiatrist who was forced to deactivate his license after an investigation by the North Carolina medical board.

The Coalition for Physician Rights has advised hundreds of physicians, most of whom he said come to him once they realize they’re in over their heads. “Almost everyone comes in too late,” Dr. Manion said. “They’re sitting ducks. They don’t know how to respond.”

In addition to offering advice and support, the Coalition for Physician Rights lobbies for reform in how boards operate. A number of states, including Oklahoma, have made reforms in recent years.

The appointed boards are too reliant on their administration and staff and usually rubber-stamp disciplinary recommendations, Dr. Manion said. He also criticized the boards’ lack of accountability: “A board operates without external or internal oversight. It is an autonomous entity operating on its own.”

As for Dr. Moran, at age 61, she’s interviewing for physician jobs around the country, refusing to give up medicine.

“What else can I do?” she said. “It’s what I’ve done my entire life. It’s what I went to school for. I don’t know how to do anything else.”

A version of this article originally appeared on Medscape.com.

One month of dual-antiplatelet therapy followed by aspirin monotherapy in patients who’ve received a drug-eluting stent proved noninferior to 6-12 months of DAPT for a composite 1-year endpoint of cardiovascular events or major bleeding in the large, randomized One-Month DAPT trial.

Svisio/Thinkstock

This is the first test of such a strategy. Other trials of short-course DAPT, such as the successful TWILIGHT trial, have dropped the aspirin and continued the P2Y12 inhibitor. But aspirin monotherapy after a single month of DAPT is an attractive alternative in patients undergoing PCI for noncomplex lesions, Myeong-Ki Hong, MD, PhD, said in presenting his results at the American Heart Association scientific sessions.

“In everyday clinical practice, people receiving P2Y12 receptor blockers usually complain of several episodes of minor bleeding. And the cost. Those are strong factors in patient noncompliance,” he said, adding, “I think aspirin monotherapy is more comfortable for the physician and the patient.”

The One-Month DAPT trial included 3,020 patients who underwent percutaneous coronary intervention with drug-eluting stents (DES) at 23 Korean centers. They were split roughly 60/40 between patients with stable angina and those with acute coronary syndrome involving unstable angina. Patients with complex coronary lesions or acute MI were not eligible for enrollment. Participants were randomized to receive either the polymer-free drug-coated BioFreedom stent, in which case they got 1 month of DAPT followed by 11 months of aspirin antiplatelet monotherapy, or they received 6 or 12 months of DAPT in conjunction with a thick-strut BioMatrix or an Ultimaster polymer-based DES. The reason for using different stents in the two study arms is that only the polymer-free stent completes drug release within 1 month; other contemporary DESs release their drug for 3-4 months, and it’s risky to discontinue one of the antiplatelet agents during drug elution, said Dr. Hong, professor of cardiology at Yonsei University in Seoul, South Korea.
 

Patients with stable angina fared best

The primary endpoint in this noninferiority trial was the 1-year composite of cardiac death, MI, target vessel revascularization, stroke, or major bleeding. The incidence was 5.9% in the 1-month DAPT group, statistically noninferior to the 6.5% figure in the 6- or 12-month DAPT group. The major bleeding rate at 1 year was 1.7% with 1 month of DAPT and 2.5% with 6-12 months of DAPT, a nonsignificant difference. Of note, the primary composite endpoint occurred in 5.1% of patients with stable angina who were randomized to 1 month of DAPT, compared with 7.6% with 6 or 12 months of DAPT, a statistically significant difference that translated into a 33% relative risk reduction. In contrast, in patients with unstable angina the primary endpoint occurred in 7.2% of those on 1 month of DAPT and 5.1% with 6 or 12 months of DAPT, a trend that didn’t reach significance.

Roughly 75% of patients in the long-DAPT arm were assigned to 12 months of DAPT. That’s because the trial began in 2015, before clinical practice guidelines declared 6 months of DAPT to be the recommendation in patients with stable coronary artery disease. The choice of 6 versus 12 months of DAPT in the trial was left up to the patient’s physician.

Discussant Roisin Colleran, MBBCh, said the study addresses “an unmet clinical need” for improved antiplatelet regimens following PCI with DES.
 

Trial’s shortcomings temper reaction

“After a period of short DAPT, aspirin monotherapy may be preferable to P2Y12 monotherapy because it’s cheaper, with fewer off-target side effects, less variation in treatment response, and fewer contraindications,” said Dr. Colleran, a cardiologist at Mater Private Hospital, Dublin.

That being said, she shared several reservations about the study. For one, none of the three stents used in the trial is approved by the Food and Drug Administration. The results may not be generalizable to non–East Asian populations. The use of 12 months of DAPT in stable angina patients is out of step with current U.S. and European practice guidelines, which recommend 6 months. And 17% of patients in the 1-month DAPT group were noncompliant with that strategy, meaning they continued on DAPT; had that reverse noncompliance rate been lower, the between-group difference in the primary endpoint might have become statistically significant.

Dr. Hong said he thinks the study findings are applicable elsewhere in the world. The 1-month DAPT followed by aspirin monotherapy strategy is attractive in elderly patients, those on oral anticoagulation for atrial fibrillation, individuals who need to undergo noncardiac surgery, and in the large group of stable patients with noncomplex coronary lesions.

“Let’s provide these patients with some options,” the cardiologist urged.

He is particularly keen on the combination of a polymer-free stent with a drug-elution period of less than 1 month.

“Is polymer perfect? I don’t think so. The polymer is a foreign body. It’s fantastic, but in 5 or 10 years the polymer may cause irritation and chronic inflammation and a new lesion,” Dr. Hong said.

Session moderator Wayne B. Batchelor, MD, commented on the battle for stent market share: “It almost appears that we’re getting to a ceiling point with coronary interventions whereby at a year we’re getting such low ischemic event rates – they’re often in the 5%-7% range – that all of these [head-to-head] studies are noninferiority studies, because it’s just the only way to do these comparisons nowadays. We can’t do 10-, 15-, or 20,000-patient trials. But these noninferiority margins are quite broad.”

“Are we stuck just saying: ‘All stents are equal,’ or are we going to be able to get to the point that we can show that a healing stent is superior?” asked Dr. Batchelor, director of interventional cardiology and interventional cardiology research at the Inova Medical Group in Falls Church, Va.

“I think it’s going to be very hard to beat the current technology,” observed panelist Alexandre Abizaid, MD, PhD, of the Dante Pazzanese Institute of Cardiology in São Paulo. “Even though the polymers are durable, they’re biocompatible, and they’re hard to beat. It’s not going to be easy to show superiority. Maybe in patient subsets.”

Dr. Hong reported having no financial conflicts of interest regarding the One-Month DAPT trial, funded by DIO, Cardinal Health Korea, and Terumo.

[email protected]

One month of dual-antiplatelet therapy followed by aspirin monotherapy in patients who’ve received a drug-eluting stent proved noninferior to 6-12 months of DAPT for a composite 1-year endpoint of cardiovascular events or major bleeding in the large, randomized One-Month DAPT trial.

Svisio/Thinkstock

This is the first test of such a strategy. Other trials of short-course DAPT, such as the successful TWILIGHT trial, have dropped the aspirin and continued the P2Y12 inhibitor. But aspirin monotherapy after a single month of DAPT is an attractive alternative in patients undergoing PCI for noncomplex lesions, Myeong-Ki Hong, MD, PhD, said in presenting his results at the American Heart Association scientific sessions.

“In everyday clinical practice, people receiving P2Y12 receptor blockers usually complain of several episodes of minor bleeding. And the cost. Those are strong factors in patient noncompliance,” he said, adding, “I think aspirin monotherapy is more comfortable for the physician and the patient.”

The One-Month DAPT trial included 3,020 patients who underwent percutaneous coronary intervention with drug-eluting stents (DES) at 23 Korean centers. They were split roughly 60/40 between patients with stable angina and those with acute coronary syndrome involving unstable angina. Patients with complex coronary lesions or acute MI were not eligible for enrollment. Participants were randomized to receive either the polymer-free drug-coated BioFreedom stent, in which case they got 1 month of DAPT followed by 11 months of aspirin antiplatelet monotherapy, or they received 6 or 12 months of DAPT in conjunction with a thick-strut BioMatrix or an Ultimaster polymer-based DES. The reason for using different stents in the two study arms is that only the polymer-free stent completes drug release within 1 month; other contemporary DESs release their drug for 3-4 months, and it’s risky to discontinue one of the antiplatelet agents during drug elution, said Dr. Hong, professor of cardiology at Yonsei University in Seoul, South Korea.
 

Patients with stable angina fared best

The primary endpoint in this noninferiority trial was the 1-year composite of cardiac death, MI, target vessel revascularization, stroke, or major bleeding. The incidence was 5.9% in the 1-month DAPT group, statistically noninferior to the 6.5% figure in the 6- or 12-month DAPT group. The major bleeding rate at 1 year was 1.7% with 1 month of DAPT and 2.5% with 6-12 months of DAPT, a nonsignificant difference. Of note, the primary composite endpoint occurred in 5.1% of patients with stable angina who were randomized to 1 month of DAPT, compared with 7.6% with 6 or 12 months of DAPT, a statistically significant difference that translated into a 33% relative risk reduction. In contrast, in patients with unstable angina the primary endpoint occurred in 7.2% of those on 1 month of DAPT and 5.1% with 6 or 12 months of DAPT, a trend that didn’t reach significance.

Roughly 75% of patients in the long-DAPT arm were assigned to 12 months of DAPT. That’s because the trial began in 2015, before clinical practice guidelines declared 6 months of DAPT to be the recommendation in patients with stable coronary artery disease. The choice of 6 versus 12 months of DAPT in the trial was left up to the patient’s physician.

Discussant Roisin Colleran, MBBCh, said the study addresses “an unmet clinical need” for improved antiplatelet regimens following PCI with DES.
 

Trial’s shortcomings temper reaction

“After a period of short DAPT, aspirin monotherapy may be preferable to P2Y12 monotherapy because it’s cheaper, with fewer off-target side effects, less variation in treatment response, and fewer contraindications,” said Dr. Colleran, a cardiologist at Mater Private Hospital, Dublin.

That being said, she shared several reservations about the study. For one, none of the three stents used in the trial is approved by the Food and Drug Administration. The results may not be generalizable to non–East Asian populations. The use of 12 months of DAPT in stable angina patients is out of step with current U.S. and European practice guidelines, which recommend 6 months. And 17% of patients in the 1-month DAPT group were noncompliant with that strategy, meaning they continued on DAPT; had that reverse noncompliance rate been lower, the between-group difference in the primary endpoint might have become statistically significant.

Dr. Hong said he thinks the study findings are applicable elsewhere in the world. The 1-month DAPT followed by aspirin monotherapy strategy is attractive in elderly patients, those on oral anticoagulation for atrial fibrillation, individuals who need to undergo noncardiac surgery, and in the large group of stable patients with noncomplex coronary lesions.

“Let’s provide these patients with some options,” the cardiologist urged.

He is particularly keen on the combination of a polymer-free stent with a drug-elution period of less than 1 month.

“Is polymer perfect? I don’t think so. The polymer is a foreign body. It’s fantastic, but in 5 or 10 years the polymer may cause irritation and chronic inflammation and a new lesion,” Dr. Hong said.

Session moderator Wayne B. Batchelor, MD, commented on the battle for stent market share: “It almost appears that we’re getting to a ceiling point with coronary interventions whereby at a year we’re getting such low ischemic event rates – they’re often in the 5%-7% range – that all of these [head-to-head] studies are noninferiority studies, because it’s just the only way to do these comparisons nowadays. We can’t do 10-, 15-, or 20,000-patient trials. But these noninferiority margins are quite broad.”

“Are we stuck just saying: ‘All stents are equal,’ or are we going to be able to get to the point that we can show that a healing stent is superior?” asked Dr. Batchelor, director of interventional cardiology and interventional cardiology research at the Inova Medical Group in Falls Church, Va.

“I think it’s going to be very hard to beat the current technology,” observed panelist Alexandre Abizaid, MD, PhD, of the Dante Pazzanese Institute of Cardiology in São Paulo. “Even though the polymers are durable, they’re biocompatible, and they’re hard to beat. It’s not going to be easy to show superiority. Maybe in patient subsets.”

Dr. Hong reported having no financial conflicts of interest regarding the One-Month DAPT trial, funded by DIO, Cardinal Health Korea, and Terumo.

[email protected]

One month of dual-antiplatelet therapy followed by aspirin monotherapy in patients who’ve received a drug-eluting stent proved noninferior to 6-12 months of DAPT for a composite 1-year endpoint of cardiovascular events or major bleeding in the large, randomized One-Month DAPT trial.

Svisio/Thinkstock

This is the first test of such a strategy. Other trials of short-course DAPT, such as the successful TWILIGHT trial, have dropped the aspirin and continued the P2Y12 inhibitor. But aspirin monotherapy after a single month of DAPT is an attractive alternative in patients undergoing PCI for noncomplex lesions, Myeong-Ki Hong, MD, PhD, said in presenting his results at the American Heart Association scientific sessions.

“In everyday clinical practice, people receiving P2Y12 receptor blockers usually complain of several episodes of minor bleeding. And the cost. Those are strong factors in patient noncompliance,” he said, adding, “I think aspirin monotherapy is more comfortable for the physician and the patient.”

The One-Month DAPT trial included 3,020 patients who underwent percutaneous coronary intervention with drug-eluting stents (DES) at 23 Korean centers. They were split roughly 60/40 between patients with stable angina and those with acute coronary syndrome involving unstable angina. Patients with complex coronary lesions or acute MI were not eligible for enrollment. Participants were randomized to receive either the polymer-free drug-coated BioFreedom stent, in which case they got 1 month of DAPT followed by 11 months of aspirin antiplatelet monotherapy, or they received 6 or 12 months of DAPT in conjunction with a thick-strut BioMatrix or an Ultimaster polymer-based DES. The reason for using different stents in the two study arms is that only the polymer-free stent completes drug release within 1 month; other contemporary DESs release their drug for 3-4 months, and it’s risky to discontinue one of the antiplatelet agents during drug elution, said Dr. Hong, professor of cardiology at Yonsei University in Seoul, South Korea.
 

Patients with stable angina fared best

The primary endpoint in this noninferiority trial was the 1-year composite of cardiac death, MI, target vessel revascularization, stroke, or major bleeding. The incidence was 5.9% in the 1-month DAPT group, statistically noninferior to the 6.5% figure in the 6- or 12-month DAPT group. The major bleeding rate at 1 year was 1.7% with 1 month of DAPT and 2.5% with 6-12 months of DAPT, a nonsignificant difference. Of note, the primary composite endpoint occurred in 5.1% of patients with stable angina who were randomized to 1 month of DAPT, compared with 7.6% with 6 or 12 months of DAPT, a statistically significant difference that translated into a 33% relative risk reduction. In contrast, in patients with unstable angina the primary endpoint occurred in 7.2% of those on 1 month of DAPT and 5.1% with 6 or 12 months of DAPT, a trend that didn’t reach significance.

Roughly 75% of patients in the long-DAPT arm were assigned to 12 months of DAPT. That’s because the trial began in 2015, before clinical practice guidelines declared 6 months of DAPT to be the recommendation in patients with stable coronary artery disease. The choice of 6 versus 12 months of DAPT in the trial was left up to the patient’s physician.

Discussant Roisin Colleran, MBBCh, said the study addresses “an unmet clinical need” for improved antiplatelet regimens following PCI with DES.
 

Trial’s shortcomings temper reaction

“After a period of short DAPT, aspirin monotherapy may be preferable to P2Y12 monotherapy because it’s cheaper, with fewer off-target side effects, less variation in treatment response, and fewer contraindications,” said Dr. Colleran, a cardiologist at Mater Private Hospital, Dublin.

That being said, she shared several reservations about the study. For one, none of the three stents used in the trial is approved by the Food and Drug Administration. The results may not be generalizable to non–East Asian populations. The use of 12 months of DAPT in stable angina patients is out of step with current U.S. and European practice guidelines, which recommend 6 months. And 17% of patients in the 1-month DAPT group were noncompliant with that strategy, meaning they continued on DAPT; had that reverse noncompliance rate been lower, the between-group difference in the primary endpoint might have become statistically significant.

Dr. Hong said he thinks the study findings are applicable elsewhere in the world. The 1-month DAPT followed by aspirin monotherapy strategy is attractive in elderly patients, those on oral anticoagulation for atrial fibrillation, individuals who need to undergo noncardiac surgery, and in the large group of stable patients with noncomplex coronary lesions.

“Let’s provide these patients with some options,” the cardiologist urged.

He is particularly keen on the combination of a polymer-free stent with a drug-elution period of less than 1 month.

“Is polymer perfect? I don’t think so. The polymer is a foreign body. It’s fantastic, but in 5 or 10 years the polymer may cause irritation and chronic inflammation and a new lesion,” Dr. Hong said.

Session moderator Wayne B. Batchelor, MD, commented on the battle for stent market share: “It almost appears that we’re getting to a ceiling point with coronary interventions whereby at a year we’re getting such low ischemic event rates – they’re often in the 5%-7% range – that all of these [head-to-head] studies are noninferiority studies, because it’s just the only way to do these comparisons nowadays. We can’t do 10-, 15-, or 20,000-patient trials. But these noninferiority margins are quite broad.”

“Are we stuck just saying: ‘All stents are equal,’ or are we going to be able to get to the point that we can show that a healing stent is superior?” asked Dr. Batchelor, director of interventional cardiology and interventional cardiology research at the Inova Medical Group in Falls Church, Va.

“I think it’s going to be very hard to beat the current technology,” observed panelist Alexandre Abizaid, MD, PhD, of the Dante Pazzanese Institute of Cardiology in São Paulo. “Even though the polymers are durable, they’re biocompatible, and they’re hard to beat. It’s not going to be easy to show superiority. Maybe in patient subsets.”

Dr. Hong reported having no financial conflicts of interest regarding the One-Month DAPT trial, funded by DIO, Cardinal Health Korea, and Terumo.

[email protected]

Marijuana use was associated with a higher prevalence of recurrent MI and a greater risk of bleeding or stroke after percutaneous coronary intervention (PCI) in separate studies.

Rhushik Bhuva, MD, presented the recurrent-MI results from a national U.S. study, and Sang Gune K. Yoo, MD, presented the PCI study, which used data from a Michigan cohort. The studies were presented at the American Heart Association scientific sessions.

Both studies “add to our accumulating knowledge of the cardiovascular risks of marijuana,” Ersilia M. DeFilippis, MD, a cardiology fellow at Columbia University Irvine Medical Center, New York, who was not involved with this research, said in an interview.

Dr. DeFilippis and the two study authors say clinicians and patients need to be more aware of cardiovascular risks from smoking marijuana, and they call for more patient screening, counseling, and research.
 

Need for screening and counseling

Marijuana is a Schedule 1 controlled substance in the United States, which makes it illegal to conduct rigorous controlled trials of marijuana products. Existing knowledge is therefore based on observational studies, Dr. DeFilippis noted.

She was lead author of a review of marijuana use by patients with cardiovascular disease. The review was published in the Journal of the American College of Cardiology. An AHA scientific statement about marijuana and cardiovascular health was published in Circulation.

Both documents drew attention to risks from marijuana use in patients with cardiovascular disease.

Until more data are available, “I think it is absolutely critical” that cardiologists and general providers screen patients for marijuana use, “either at the time of their MI or ideally prior to that, when they are making a cardiovascular risk assessment,” said Dr. DeFilippis.

That is also the time to “counsel patients, especially those who have had an MI, about risks associated with continuing to use marijuana.”

Importantly, providers and patients need to be aware that “cannabinoids, through the cytochrome P450 system, can interact with well-known cardiovascular medications, which we know provide benefit in the post-MI period,” she added. “For example, marijuana can interfere with beta-blockers, statins, antiarrhythmics, and certain anticoagulants.”

Dr. Bhuva, a cardiology fellow with the Wright Center for Community Health, Scranton, Pa., said that it is “concerning” that “recurrent heart attacks and cardiac interventions [were] higher among cannabis users, even though they were younger and had fewer risk factors for heart disease.

“Spreading awareness regarding the potential risk of recurrent heart attacks in middle-aged, African American, and male cannabis users and screening them at an earlier age for potential risk factors of future heart attacks should be encouraged among clinicians,” he urged in a statement from the AHA.

Dr. Yoo, an internal medicine resident at the University of Michigan, Ann Arbor, pointed out that, in their study of patients who underwent PCI after MI or because they had coronary artery disease, those who smoked or vaped marijuana were younger and were more likely to be male. They were less likely to have traditional cardiovascular risk factors except for smoking tobacco, which was highly prevalent.

After propensity matching, patients who used marijuana had a 1.5-fold increased risk of in-hospital bleeding and an 11-fold higher risk for in-hospital stroke following PCI.

However, the absolute number of strokes in PCI was small, and the confidence interval was wide (indicating a large uncertainty), Dr. Yoo said in an interview.

These risks “should not deter patients from undergoing these [lifesaving] procedures,” he said; however, clinicians should be aware of these risks with marijuana use and should screen and counsel patients about this.
 

Hospitalized patients with prior MI

Dr. Bhuva and colleagues identified patients from the National Inpatient Sample who were hospitalized in the United States from 2007 to 2014 and who had experienced a prior MI and had undergone revascularization with PCI or coronary artery bypass grafting (CABG).

There were about 8 million hospital stays per year. The database did not specify the type of marijuana that patients used.

During the 8-year study period, many states legalized or decriminalized medical and/or recreational marijuana, and marijuana use increased steadily, from 0.2% to 0.7%.

Compared with nonusers, those who used marijuana were younger (median age, 53 vs. 72 years), and there were more men (77% vs. 62%) or Black persons (34% vs. 10%) (all P < .001). Fewer marijuana users had hypertension (72% vs. 75%), diabetes (24% vs. 33%), or dyslipidemia (51% vs. 58%) (all P < .001). More marijuana users underwent a repeat MI (67% vs. 41%).

On the other hand, marijuana users, who were younger and healthier than the other patients, were less likely to die during hospitalization for a recurrent MI (0.8% vs. 2.5%), and their hospital costs were lower.

The researchers acknowledged that study limitations include lack of information about marijuana type (smoked, edible, medicinal, or recreational) or dose, as well as the time from marijuana use to cardiac event.
 

In-Hospital outcomes after PCI

Dr. Yoo and colleagues analyzed data from patients who underwent PCI from Jan. 1, 2013, to Oct. 1, 2016, at Michigan’s 48 nonfederal hospitals, which are part of the Blue Cross Blue Shield Michigan Cardiovascular Consortium PCI registry.

In this cohort, 3,970 patients (3.5%) had smoked or vaped marijuana in the month prior to PCI, and 109,507 patients had not done so. The marijuana users were younger (mean age, 54 vs. 66 years) and were more likely to be male (79% vs. 67%) and to smoke cigarettes (73% vs. 27%).

They were less likely to have hypertension, type 2 diabetes, dyslipidemia, cerebrovascular disease, or prior CABG and were equally likely to have had a prior MI (36%).

Compared with nonusers, marijuana users were more likely to present with non–ST-elevation MI (30% vs. 23%) or ST-elevation MI (27% vs. 16%) and were less likely to present with angina.

Using propensity score matching, the researchers matched 3,803 marijuana users with the same number of nonusers.

In the matched cohort, patients who used marijuana had a greater risk of in-hospital bleeding (adjusted odds ratio, 1.54; 95% confidence interval, 1.20-1.97; P < .001) or stroke (aOR, 11.01; 95% CI, 1.32-91.67; P = .026) following PCI.

Marijuana users had a lower risk for acute kidney injury (2.2% vs. 2.9%; P = .007). Transfusion and mortality rates were similar in both groups.

The researchers acknowledged study limitations, including the fact that it did not include marijuana edibles, that the results may not be generalizable, and that marijuana use is now likely more common in Michigan following legalization of recreational marijuana in 2018.

Dr. Bhuva, Dr. Yoo, and Dr. DeFilippis have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Marijuana use was associated with a higher prevalence of recurrent MI and a greater risk of bleeding or stroke after percutaneous coronary intervention (PCI) in separate studies.

Rhushik Bhuva, MD, presented the recurrent-MI results from a national U.S. study, and Sang Gune K. Yoo, MD, presented the PCI study, which used data from a Michigan cohort. The studies were presented at the American Heart Association scientific sessions.

Both studies “add to our accumulating knowledge of the cardiovascular risks of marijuana,” Ersilia M. DeFilippis, MD, a cardiology fellow at Columbia University Irvine Medical Center, New York, who was not involved with this research, said in an interview.

Dr. DeFilippis and the two study authors say clinicians and patients need to be more aware of cardiovascular risks from smoking marijuana, and they call for more patient screening, counseling, and research.
 

Need for screening and counseling

Marijuana is a Schedule 1 controlled substance in the United States, which makes it illegal to conduct rigorous controlled trials of marijuana products. Existing knowledge is therefore based on observational studies, Dr. DeFilippis noted.

She was lead author of a review of marijuana use by patients with cardiovascular disease. The review was published in the Journal of the American College of Cardiology. An AHA scientific statement about marijuana and cardiovascular health was published in Circulation.

Both documents drew attention to risks from marijuana use in patients with cardiovascular disease.

Until more data are available, “I think it is absolutely critical” that cardiologists and general providers screen patients for marijuana use, “either at the time of their MI or ideally prior to that, when they are making a cardiovascular risk assessment,” said Dr. DeFilippis.

That is also the time to “counsel patients, especially those who have had an MI, about risks associated with continuing to use marijuana.”

Importantly, providers and patients need to be aware that “cannabinoids, through the cytochrome P450 system, can interact with well-known cardiovascular medications, which we know provide benefit in the post-MI period,” she added. “For example, marijuana can interfere with beta-blockers, statins, antiarrhythmics, and certain anticoagulants.”

Dr. Bhuva, a cardiology fellow with the Wright Center for Community Health, Scranton, Pa., said that it is “concerning” that “recurrent heart attacks and cardiac interventions [were] higher among cannabis users, even though they were younger and had fewer risk factors for heart disease.

“Spreading awareness regarding the potential risk of recurrent heart attacks in middle-aged, African American, and male cannabis users and screening them at an earlier age for potential risk factors of future heart attacks should be encouraged among clinicians,” he urged in a statement from the AHA.

Dr. Yoo, an internal medicine resident at the University of Michigan, Ann Arbor, pointed out that, in their study of patients who underwent PCI after MI or because they had coronary artery disease, those who smoked or vaped marijuana were younger and were more likely to be male. They were less likely to have traditional cardiovascular risk factors except for smoking tobacco, which was highly prevalent.

After propensity matching, patients who used marijuana had a 1.5-fold increased risk of in-hospital bleeding and an 11-fold higher risk for in-hospital stroke following PCI.

However, the absolute number of strokes in PCI was small, and the confidence interval was wide (indicating a large uncertainty), Dr. Yoo said in an interview.

These risks “should not deter patients from undergoing these [lifesaving] procedures,” he said; however, clinicians should be aware of these risks with marijuana use and should screen and counsel patients about this.
 

Hospitalized patients with prior MI

Dr. Bhuva and colleagues identified patients from the National Inpatient Sample who were hospitalized in the United States from 2007 to 2014 and who had experienced a prior MI and had undergone revascularization with PCI or coronary artery bypass grafting (CABG).

There were about 8 million hospital stays per year. The database did not specify the type of marijuana that patients used.

During the 8-year study period, many states legalized or decriminalized medical and/or recreational marijuana, and marijuana use increased steadily, from 0.2% to 0.7%.

Compared with nonusers, those who used marijuana were younger (median age, 53 vs. 72 years), and there were more men (77% vs. 62%) or Black persons (34% vs. 10%) (all P < .001). Fewer marijuana users had hypertension (72% vs. 75%), diabetes (24% vs. 33%), or dyslipidemia (51% vs. 58%) (all P < .001). More marijuana users underwent a repeat MI (67% vs. 41%).

On the other hand, marijuana users, who were younger and healthier than the other patients, were less likely to die during hospitalization for a recurrent MI (0.8% vs. 2.5%), and their hospital costs were lower.

The researchers acknowledged that study limitations include lack of information about marijuana type (smoked, edible, medicinal, or recreational) or dose, as well as the time from marijuana use to cardiac event.
 

In-Hospital outcomes after PCI

Dr. Yoo and colleagues analyzed data from patients who underwent PCI from Jan. 1, 2013, to Oct. 1, 2016, at Michigan’s 48 nonfederal hospitals, which are part of the Blue Cross Blue Shield Michigan Cardiovascular Consortium PCI registry.

In this cohort, 3,970 patients (3.5%) had smoked or vaped marijuana in the month prior to PCI, and 109,507 patients had not done so. The marijuana users were younger (mean age, 54 vs. 66 years) and were more likely to be male (79% vs. 67%) and to smoke cigarettes (73% vs. 27%).

They were less likely to have hypertension, type 2 diabetes, dyslipidemia, cerebrovascular disease, or prior CABG and were equally likely to have had a prior MI (36%).

Compared with nonusers, marijuana users were more likely to present with non–ST-elevation MI (30% vs. 23%) or ST-elevation MI (27% vs. 16%) and were less likely to present with angina.

Using propensity score matching, the researchers matched 3,803 marijuana users with the same number of nonusers.

In the matched cohort, patients who used marijuana had a greater risk of in-hospital bleeding (adjusted odds ratio, 1.54; 95% confidence interval, 1.20-1.97; P < .001) or stroke (aOR, 11.01; 95% CI, 1.32-91.67; P = .026) following PCI.

Marijuana users had a lower risk for acute kidney injury (2.2% vs. 2.9%; P = .007). Transfusion and mortality rates were similar in both groups.

The researchers acknowledged study limitations, including the fact that it did not include marijuana edibles, that the results may not be generalizable, and that marijuana use is now likely more common in Michigan following legalization of recreational marijuana in 2018.

Dr. Bhuva, Dr. Yoo, and Dr. DeFilippis have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Marijuana use was associated with a higher prevalence of recurrent MI and a greater risk of bleeding or stroke after percutaneous coronary intervention (PCI) in separate studies.

Rhushik Bhuva, MD, presented the recurrent-MI results from a national U.S. study, and Sang Gune K. Yoo, MD, presented the PCI study, which used data from a Michigan cohort. The studies were presented at the American Heart Association scientific sessions.

Both studies “add to our accumulating knowledge of the cardiovascular risks of marijuana,” Ersilia M. DeFilippis, MD, a cardiology fellow at Columbia University Irvine Medical Center, New York, who was not involved with this research, said in an interview.

Dr. DeFilippis and the two study authors say clinicians and patients need to be more aware of cardiovascular risks from smoking marijuana, and they call for more patient screening, counseling, and research.
 

Need for screening and counseling

Marijuana is a Schedule 1 controlled substance in the United States, which makes it illegal to conduct rigorous controlled trials of marijuana products. Existing knowledge is therefore based on observational studies, Dr. DeFilippis noted.

She was lead author of a review of marijuana use by patients with cardiovascular disease. The review was published in the Journal of the American College of Cardiology. An AHA scientific statement about marijuana and cardiovascular health was published in Circulation.

Both documents drew attention to risks from marijuana use in patients with cardiovascular disease.

Until more data are available, “I think it is absolutely critical” that cardiologists and general providers screen patients for marijuana use, “either at the time of their MI or ideally prior to that, when they are making a cardiovascular risk assessment,” said Dr. DeFilippis.

That is also the time to “counsel patients, especially those who have had an MI, about risks associated with continuing to use marijuana.”

Importantly, providers and patients need to be aware that “cannabinoids, through the cytochrome P450 system, can interact with well-known cardiovascular medications, which we know provide benefit in the post-MI period,” she added. “For example, marijuana can interfere with beta-blockers, statins, antiarrhythmics, and certain anticoagulants.”

Dr. Bhuva, a cardiology fellow with the Wright Center for Community Health, Scranton, Pa., said that it is “concerning” that “recurrent heart attacks and cardiac interventions [were] higher among cannabis users, even though they were younger and had fewer risk factors for heart disease.

“Spreading awareness regarding the potential risk of recurrent heart attacks in middle-aged, African American, and male cannabis users and screening them at an earlier age for potential risk factors of future heart attacks should be encouraged among clinicians,” he urged in a statement from the AHA.

Dr. Yoo, an internal medicine resident at the University of Michigan, Ann Arbor, pointed out that, in their study of patients who underwent PCI after MI or because they had coronary artery disease, those who smoked or vaped marijuana were younger and were more likely to be male. They were less likely to have traditional cardiovascular risk factors except for smoking tobacco, which was highly prevalent.

After propensity matching, patients who used marijuana had a 1.5-fold increased risk of in-hospital bleeding and an 11-fold higher risk for in-hospital stroke following PCI.

However, the absolute number of strokes in PCI was small, and the confidence interval was wide (indicating a large uncertainty), Dr. Yoo said in an interview.

These risks “should not deter patients from undergoing these [lifesaving] procedures,” he said; however, clinicians should be aware of these risks with marijuana use and should screen and counsel patients about this.
 

Hospitalized patients with prior MI

Dr. Bhuva and colleagues identified patients from the National Inpatient Sample who were hospitalized in the United States from 2007 to 2014 and who had experienced a prior MI and had undergone revascularization with PCI or coronary artery bypass grafting (CABG).

There were about 8 million hospital stays per year. The database did not specify the type of marijuana that patients used.

During the 8-year study period, many states legalized or decriminalized medical and/or recreational marijuana, and marijuana use increased steadily, from 0.2% to 0.7%.

Compared with nonusers, those who used marijuana were younger (median age, 53 vs. 72 years), and there were more men (77% vs. 62%) or Black persons (34% vs. 10%) (all P < .001). Fewer marijuana users had hypertension (72% vs. 75%), diabetes (24% vs. 33%), or dyslipidemia (51% vs. 58%) (all P < .001). More marijuana users underwent a repeat MI (67% vs. 41%).

On the other hand, marijuana users, who were younger and healthier than the other patients, were less likely to die during hospitalization for a recurrent MI (0.8% vs. 2.5%), and their hospital costs were lower.

The researchers acknowledged that study limitations include lack of information about marijuana type (smoked, edible, medicinal, or recreational) or dose, as well as the time from marijuana use to cardiac event.
 

In-Hospital outcomes after PCI

Dr. Yoo and colleagues analyzed data from patients who underwent PCI from Jan. 1, 2013, to Oct. 1, 2016, at Michigan’s 48 nonfederal hospitals, which are part of the Blue Cross Blue Shield Michigan Cardiovascular Consortium PCI registry.

In this cohort, 3,970 patients (3.5%) had smoked or vaped marijuana in the month prior to PCI, and 109,507 patients had not done so. The marijuana users were younger (mean age, 54 vs. 66 years) and were more likely to be male (79% vs. 67%) and to smoke cigarettes (73% vs. 27%).

They were less likely to have hypertension, type 2 diabetes, dyslipidemia, cerebrovascular disease, or prior CABG and were equally likely to have had a prior MI (36%).

Compared with nonusers, marijuana users were more likely to present with non–ST-elevation MI (30% vs. 23%) or ST-elevation MI (27% vs. 16%) and were less likely to present with angina.

Using propensity score matching, the researchers matched 3,803 marijuana users with the same number of nonusers.

In the matched cohort, patients who used marijuana had a greater risk of in-hospital bleeding (adjusted odds ratio, 1.54; 95% confidence interval, 1.20-1.97; P < .001) or stroke (aOR, 11.01; 95% CI, 1.32-91.67; P = .026) following PCI.

Marijuana users had a lower risk for acute kidney injury (2.2% vs. 2.9%; P = .007). Transfusion and mortality rates were similar in both groups.

The researchers acknowledged study limitations, including the fact that it did not include marijuana edibles, that the results may not be generalizable, and that marijuana use is now likely more common in Michigan following legalization of recreational marijuana in 2018.

Dr. Bhuva, Dr. Yoo, and Dr. DeFilippis have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.

In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.

Antiviral effects?

The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.

Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.

The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.

Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).

Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
 

Hypothesis generating

The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”

However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.

Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.

“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.

“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.

She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”

The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”

However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.

This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.

Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.

A version of this article originally appeared on Medscape.com.

Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.

In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.

Antiviral effects?

The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.

Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.

The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.

Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).

Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
 

Hypothesis generating

The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”

However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.

Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.

“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.

“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.

She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”

The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”

However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.

This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.

Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.

A version of this article originally appeared on Medscape.com.

Early treatment with the antidepressant fluvoxamine (Luvox) may help prevent respiratory deterioration in patients with mild symptomatic COVID-19, results of a preliminary randomized controlled trial suggest.

In the trial, none of the patients who took fluvoxamine within 7 days of first symptoms developed serious breathing difficulties or required hospitalization for respiratory deterioration.

Antiviral effects?

The study included 152 nonhospitalized adults (mean age, 46 years; 72% women) with confirmed SARS-CoV-2 infection and mild COVID-19 symptoms starting within 7 days and oxygen saturation of 92% or greater.

Eighty were randomly assigned to 100 mg of fluvoxamine three times daily for 15 days and 72 to matching placebo.

The primary outcome was clinical deterioration within 15 days of randomization defined by meeting two criteria. These included shortness of breath or hospitalization for shortness of breath or pneumonia and oxygen saturation <92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.

Clinical deterioration occurred in none of the 80 patients taking fluvoxamine compared with 6 of 72 (8.3%) patients taking placebo, an absolute difference of 8.7% (95% confidence interval, 1.8%-16.4%).

Clinical deterioration in the placebo group happened from 1 to 7 days after randomization and from 3 to 12 days after the onset of COVID-19 symptoms. Four of the 6 patients with clinical deterioration were admitted to the hospital for 4-21 days. One patient required mechanical ventilation for 10 days. No patients died.
 

Hypothesis generating

The authors cautioned that the study was small and with short follow-up and that the findings “need to be interpreted as hypothesis generating rather than as a demonstration of efficacy.”

However, they noted, if the drug turns out to be effective for COVID-19, the potential advantages of fluvoxamine for outpatient use include its safety, widespread availability, low cost, and oral administration.

Carolyn Machamer, PhD, member of the COVID-19 Early Treatment Fund (CETF) scientific advisory board, which funded the study, noted that there are several reasons fluvoxamine might be helpful in COVID-19.

“The preliminary data suggest the mechanism involves activation of the sigma-1 receptor, which has a number of documented activities. One strong possibility is that activation dampens cytokine release and thus the inflammatory response,” she said in an interview.

“Other possible mechanisms can include inhibition of platelet activation and modulation of autophagy. Coronaviruses usurp some autophagy machinery to remodel membranes for replicating their genomes, so this last mechanism might actually be antiviral,” said Dr. Machamer.

She added that a much larger trial is “crucial to see if the initial striking results can be reproduced, and the Healthy Mind Lab and CETF are currently coordinating these next steps.”

The editors of JAMA published an “Editor’s Note” with the study. In it, they wrote the pilot study addresses a “critically important question during the pandemic of how to prevent individuals who acquire COVID-19 from deteriorating to serious illness. If an effective treatment is found for this key gap in treatment, it will affect the health of millions of people worldwide.”

However, the study has “important limitations, and the findings should be interpreted as only hypothesis generating; they should not be used as the basis for current treatment decisions,” cautioned authors Christopher Seymour, MD, Howard Bauchner, MD, and Robert Golub, MD.

This study was supported by the Taylor Family Institute for Innovative Psychiatric Treatment at Washington University and the CETF. Additional support was provided by the Center for Brain Research in Mood Disorders at Washington University, the Bantly Foundation, and the National Institutes of Health.

Dr. Lenze has received grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation and has received consulting fees from Janssen and Jazz Pharmaceuticals. Dr. Machamer has disclosed no relevant financial relationships. Dr. Seymour has received grants from the National Institutes of Health and personal fees from Beckman Coulter and Edwards Lifesciences.

A version of this article originally appeared on Medscape.com.

“We must accept finite disappointment, but never lose infinite hope,” Martin Luther King, Jr.

This holiday season will be like no other. We will remember it for the rest of our lives, and we will look back to see how we faced the holidays during a pandemic.

DjelicS/Getty Images

Like the rest of 2020, the holidays will need to be reimagined. Years and even decades of tradition will be broken as we place health above merriment.

Here are a few tips to help all of us and our patients make the most of this holiday season.

• Reprioritize: This holiday season will be about depth not breadth, quality not quantity, and less not more. Trips are canceled and gatherings have shrunk. We are not running from store to store or party to party. Instead, you will find yourself surrounded by fewer friends and family. Some will be alone to optimally protect their health and the health of others. Do your best to focus on the half-full portion.
• Embrace change: Don’t compare or try to make this year like previous years. Be creative and try to find ways to make a new format fun. Meeting during the day and limiting alcohol intake can assist in making sure everyone stays safe. It has been interesting to see how many of my patients have decreased their alcohol use during quarantine. I hope this pattern will continue over the next weeks and months.
• Practice self-care: As health care professionals, we must remember the old adage “physician, heal thyself.” This year has been so difficult for almost all of us. It was filled with unprecedented levels of personal and professional stress. Holidays are often about what we can do for others, but this year we may need to place self-care first. Do what brings you happiness.

With lines between home and work even more eroded as we practice telemedicine, it is important to take time off. Even though you aren’t traveling, you can still disconnect from work. Set up a schedule and stick to it making sure you take plenty of time to rest and enjoy. Many of us have been working extremely long hours and a break is so needed. Take it if you possibly can. Detox from your screen! Limit the news. Creativity and productivity will be enhanced in 2021 if we can come in recharged.

For those remaining on the front lines, be patient; the end is nearing. Take care of yourself when you are not working. We are all so grateful to those in our field who have sacrificed so much to care for others. Eat, drink, and rest well to keep your immune system strong.

• Acknowledge your negative emotions: As we all know, if you try to deny negative emotions, they continue to pop up. If we give them time and space to be felt, we will find they diminish in intensity. Long work hours may have prevented us from feeling our emotions, so don’t be surprised if they surface when we take a break.

Let yourself feel the sadness for what you have experienced this year. Be open about missing those who can’t be with you because of travel or other restrictions. Let yourself feel the disappointment about your holiday travel plans that you can’t embark upon.

You may elect to share these emotions with someone close to you or with a professional. To paraphrase Carl Jung, “what we resist, persists,” so don’t try to hide from your negative emotions. Most of us had lots of them in 2020, so don’t be shy about admitting it.

• Focus on growth: What have we learned from 2020 and how can we be better equipped in 2021 and beyond?

Trauma can bring growth not just disorder. This year has returned well-deserved prestige to our fields. We are being lauded as heroes as we have scarified our health and the health of our loved ones to serve others. Can we choose to celebrate our accomplishments?

We have become more resilient and learned to continue on in the face of great hardship. Many of us have gained confidence as we confronted this historic challenge. As we have been reminded of death daily, we learn to appreciate life more fully and not take any day for granted.

I am proud to be a physician during this pandemic, and I hope you are, too!

• Find joy: Often times, we find real happiness in smaller moments and experiences. For many, this time of year is filled with so much stress that it can be hard to carve out moments of joy. As we may be less busy socially this holiday season, might we find even more joy?

Joy can only be experienced in the present moment. Tap into all your senses. Eat slowly making sure to smell and taste every bite. Cherish those who can still gather at your table. If you find yourself alone, embrace that experience. Safety must continue to come first, and we can’t let down our guard now.

• Reflect: New Year’s Eve is always a time for reflection and hope for the future. Most of us will be glad to see 2020 in the rearview mirror. With multiple and very promising vaccines on the horizon, we can anticipate a brighter future. We must continue to work hard; remain patient; and be creative, resilient, and optimistic. Let’s try to fill our days with hope and purpose and work together to achieve a brighter future for all.
•  

“Learn from yesterday, live for today, hope for tomorrow,” Albert Einstein


Wishing you health and happiness in this holiday season and beyond.

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018). She also is founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world.

“We must accept finite disappointment, but never lose infinite hope,” Martin Luther King, Jr.

This holiday season will be like no other. We will remember it for the rest of our lives, and we will look back to see how we faced the holidays during a pandemic.

DjelicS/Getty Images

Like the rest of 2020, the holidays will need to be reimagined. Years and even decades of tradition will be broken as we place health above merriment.

Here are a few tips to help all of us and our patients make the most of this holiday season.

• Reprioritize: This holiday season will be about depth not breadth, quality not quantity, and less not more. Trips are canceled and gatherings have shrunk. We are not running from store to store or party to party. Instead, you will find yourself surrounded by fewer friends and family. Some will be alone to optimally protect their health and the health of others. Do your best to focus on the half-full portion.
• Embrace change: Don’t compare or try to make this year like previous years. Be creative and try to find ways to make a new format fun. Meeting during the day and limiting alcohol intake can assist in making sure everyone stays safe. It has been interesting to see how many of my patients have decreased their alcohol use during quarantine. I hope this pattern will continue over the next weeks and months.
• Practice self-care: As health care professionals, we must remember the old adage “physician, heal thyself.” This year has been so difficult for almost all of us. It was filled with unprecedented levels of personal and professional stress. Holidays are often about what we can do for others, but this year we may need to place self-care first. Do what brings you happiness.

With lines between home and work even more eroded as we practice telemedicine, it is important to take time off. Even though you aren’t traveling, you can still disconnect from work. Set up a schedule and stick to it making sure you take plenty of time to rest and enjoy. Many of us have been working extremely long hours and a break is so needed. Take it if you possibly can. Detox from your screen! Limit the news. Creativity and productivity will be enhanced in 2021 if we can come in recharged.

For those remaining on the front lines, be patient; the end is nearing. Take care of yourself when you are not working. We are all so grateful to those in our field who have sacrificed so much to care for others. Eat, drink, and rest well to keep your immune system strong.

• Acknowledge your negative emotions: As we all know, if you try to deny negative emotions, they continue to pop up. If we give them time and space to be felt, we will find they diminish in intensity. Long work hours may have prevented us from feeling our emotions, so don’t be surprised if they surface when we take a break.

Let yourself feel the sadness for what you have experienced this year. Be open about missing those who can’t be with you because of travel or other restrictions. Let yourself feel the disappointment about your holiday travel plans that you can’t embark upon.

You may elect to share these emotions with someone close to you or with a professional. To paraphrase Carl Jung, “what we resist, persists,” so don’t try to hide from your negative emotions. Most of us had lots of them in 2020, so don’t be shy about admitting it.

• Focus on growth: What have we learned from 2020 and how can we be better equipped in 2021 and beyond?

Trauma can bring growth not just disorder. This year has returned well-deserved prestige to our fields. We are being lauded as heroes as we have scarified our health and the health of our loved ones to serve others. Can we choose to celebrate our accomplishments?

We have become more resilient and learned to continue on in the face of great hardship. Many of us have gained confidence as we confronted this historic challenge. As we have been reminded of death daily, we learn to appreciate life more fully and not take any day for granted.

I am proud to be a physician during this pandemic, and I hope you are, too!

• Find joy: Often times, we find real happiness in smaller moments and experiences. For many, this time of year is filled with so much stress that it can be hard to carve out moments of joy. As we may be less busy socially this holiday season, might we find even more joy?

Joy can only be experienced in the present moment. Tap into all your senses. Eat slowly making sure to smell and taste every bite. Cherish those who can still gather at your table. If you find yourself alone, embrace that experience. Safety must continue to come first, and we can’t let down our guard now.

• Reflect: New Year’s Eve is always a time for reflection and hope for the future. Most of us will be glad to see 2020 in the rearview mirror. With multiple and very promising vaccines on the horizon, we can anticipate a brighter future. We must continue to work hard; remain patient; and be creative, resilient, and optimistic. Let’s try to fill our days with hope and purpose and work together to achieve a brighter future for all.
•  

“Learn from yesterday, live for today, hope for tomorrow,” Albert Einstein


Wishing you health and happiness in this holiday season and beyond.

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018). She also is founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world.

“We must accept finite disappointment, but never lose infinite hope,” Martin Luther King, Jr.

This holiday season will be like no other. We will remember it for the rest of our lives, and we will look back to see how we faced the holidays during a pandemic.

DjelicS/Getty Images

Like the rest of 2020, the holidays will need to be reimagined. Years and even decades of tradition will be broken as we place health above merriment.

Here are a few tips to help all of us and our patients make the most of this holiday season.

• Reprioritize: This holiday season will be about depth not breadth, quality not quantity, and less not more. Trips are canceled and gatherings have shrunk. We are not running from store to store or party to party. Instead, you will find yourself surrounded by fewer friends and family. Some will be alone to optimally protect their health and the health of others. Do your best to focus on the half-full portion.
• Embrace change: Don’t compare or try to make this year like previous years. Be creative and try to find ways to make a new format fun. Meeting during the day and limiting alcohol intake can assist in making sure everyone stays safe. It has been interesting to see how many of my patients have decreased their alcohol use during quarantine. I hope this pattern will continue over the next weeks and months.
• Practice self-care: As health care professionals, we must remember the old adage “physician, heal thyself.” This year has been so difficult for almost all of us. It was filled with unprecedented levels of personal and professional stress. Holidays are often about what we can do for others, but this year we may need to place self-care first. Do what brings you happiness.

With lines between home and work even more eroded as we practice telemedicine, it is important to take time off. Even though you aren’t traveling, you can still disconnect from work. Set up a schedule and stick to it making sure you take plenty of time to rest and enjoy. Many of us have been working extremely long hours and a break is so needed. Take it if you possibly can. Detox from your screen! Limit the news. Creativity and productivity will be enhanced in 2021 if we can come in recharged.

For those remaining on the front lines, be patient; the end is nearing. Take care of yourself when you are not working. We are all so grateful to those in our field who have sacrificed so much to care for others. Eat, drink, and rest well to keep your immune system strong.

• Acknowledge your negative emotions: As we all know, if you try to deny negative emotions, they continue to pop up. If we give them time and space to be felt, we will find they diminish in intensity. Long work hours may have prevented us from feeling our emotions, so don’t be surprised if they surface when we take a break.

Let yourself feel the sadness for what you have experienced this year. Be open about missing those who can’t be with you because of travel or other restrictions. Let yourself feel the disappointment about your holiday travel plans that you can’t embark upon.

You may elect to share these emotions with someone close to you or with a professional. To paraphrase Carl Jung, “what we resist, persists,” so don’t try to hide from your negative emotions. Most of us had lots of them in 2020, so don’t be shy about admitting it.

• Focus on growth: What have we learned from 2020 and how can we be better equipped in 2021 and beyond?

Trauma can bring growth not just disorder. This year has returned well-deserved prestige to our fields. We are being lauded as heroes as we have scarified our health and the health of our loved ones to serve others. Can we choose to celebrate our accomplishments?

We have become more resilient and learned to continue on in the face of great hardship. Many of us have gained confidence as we confronted this historic challenge. As we have been reminded of death daily, we learn to appreciate life more fully and not take any day for granted.

I am proud to be a physician during this pandemic, and I hope you are, too!

• Find joy: Often times, we find real happiness in smaller moments and experiences. For many, this time of year is filled with so much stress that it can be hard to carve out moments of joy. As we may be less busy socially this holiday season, might we find even more joy?

Joy can only be experienced in the present moment. Tap into all your senses. Eat slowly making sure to smell and taste every bite. Cherish those who can still gather at your table. If you find yourself alone, embrace that experience. Safety must continue to come first, and we can’t let down our guard now.

• Reflect: New Year’s Eve is always a time for reflection and hope for the future. Most of us will be glad to see 2020 in the rearview mirror. With multiple and very promising vaccines on the horizon, we can anticipate a brighter future. We must continue to work hard; remain patient; and be creative, resilient, and optimistic. Let’s try to fill our days with hope and purpose and work together to achieve a brighter future for all.
•  

“Learn from yesterday, live for today, hope for tomorrow,” Albert Einstein


Wishing you health and happiness in this holiday season and beyond.

Dr. Ritvo, a psychiatrist with more than 25 years’ experience, practices in Miami Beach. She is the author of “Bekindr – The Transformative Power of Kindness” (Hellertown, Pa.: Momosa Publishing, 2018). She also is founder of the Bekindr Global Initiative, a movement aimed at cultivating kindness in the world.

The US Food and Drug Administration (FDA) Nov. 19 issued an emergency use authorization (EUA) for the Janus kinase inhibitor baricitinib (Olumiant, Eli Lilly) in combination with remdesivir (Veklury, Gilead) for treating hospitalized adults and children at least 2 years old with suspected or confirmed COVID-19.

The combination treatment is meant for patients who need supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Baricitinib/remdesivir was shown in a clinical trial to reduce time to recovery within 29 days of starting the treatment compared with a control group who received placebo/remdesivir, according to the FDA press release.

The median time to recovery from COVID-19 was 7 days for the combination group vs. 8 days for those in the placebo/remdesivir group. Recovery was defined as either discharge from the hospital or “being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care,” the agency explained in the press release.

The odds of a patient dying or being ventilated at day 29 was lower in the combination group compared with those taking placebo/remdesivir, the press release said without providing specific data. “For all of these endpoints, the effects were statistically significant,” the agency stated.

The safety and efficacy continues to be evaluated. Baricitinib alone is not approved as a treatment for COVID-19.

“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research.

“Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients,” she said.

As a JAK inhibitor, baricitinib interferes with a pathway that leads to inflammation. Baricitinib is already prescribed as an oral medication and is FDA-approved for treating moderate to severe rheumatoid arthritis.

The data supporting the EUA for the combination treatment are based on a randomized, double-blind, placebo-controlled clinical trial (ACTT-2), conducted by the National Institute of Allergy and Infectious Diseases (NIAID).

The trial followed patients for 29 days and included 1,033 patients with moderate to severe COVID-19; 515 patients received baricitinib/remdesivir, and 518 patients received placebo/remdesivir.

The FDA emphasizes that an EUA is not a full FDA approval.

In reviewing the combination, the FDA “determined that it is reasonable to believe that baricitinib, in combination with remdesivir, may be effective in treating COVID-19 for the authorized population” and the known benefits outweigh the known and potential risks. Additionally, there are no adequate, approved, and available alternatives for the treatment population.

“Today’s action demonstrates the FDA’s steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, MD. “As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19.”
 

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) Nov. 19 issued an emergency use authorization (EUA) for the Janus kinase inhibitor baricitinib (Olumiant, Eli Lilly) in combination with remdesivir (Veklury, Gilead) for treating hospitalized adults and children at least 2 years old with suspected or confirmed COVID-19.

The combination treatment is meant for patients who need supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Baricitinib/remdesivir was shown in a clinical trial to reduce time to recovery within 29 days of starting the treatment compared with a control group who received placebo/remdesivir, according to the FDA press release.

The median time to recovery from COVID-19 was 7 days for the combination group vs. 8 days for those in the placebo/remdesivir group. Recovery was defined as either discharge from the hospital or “being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care,” the agency explained in the press release.

The odds of a patient dying or being ventilated at day 29 was lower in the combination group compared with those taking placebo/remdesivir, the press release said without providing specific data. “For all of these endpoints, the effects were statistically significant,” the agency stated.

The safety and efficacy continues to be evaluated. Baricitinib alone is not approved as a treatment for COVID-19.

“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research.

“Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients,” she said.

As a JAK inhibitor, baricitinib interferes with a pathway that leads to inflammation. Baricitinib is already prescribed as an oral medication and is FDA-approved for treating moderate to severe rheumatoid arthritis.

The data supporting the EUA for the combination treatment are based on a randomized, double-blind, placebo-controlled clinical trial (ACTT-2), conducted by the National Institute of Allergy and Infectious Diseases (NIAID).

The trial followed patients for 29 days and included 1,033 patients with moderate to severe COVID-19; 515 patients received baricitinib/remdesivir, and 518 patients received placebo/remdesivir.

The FDA emphasizes that an EUA is not a full FDA approval.

In reviewing the combination, the FDA “determined that it is reasonable to believe that baricitinib, in combination with remdesivir, may be effective in treating COVID-19 for the authorized population” and the known benefits outweigh the known and potential risks. Additionally, there are no adequate, approved, and available alternatives for the treatment population.

“Today’s action demonstrates the FDA’s steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, MD. “As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19.”
 

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) Nov. 19 issued an emergency use authorization (EUA) for the Janus kinase inhibitor baricitinib (Olumiant, Eli Lilly) in combination with remdesivir (Veklury, Gilead) for treating hospitalized adults and children at least 2 years old with suspected or confirmed COVID-19.

The combination treatment is meant for patients who need supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Baricitinib/remdesivir was shown in a clinical trial to reduce time to recovery within 29 days of starting the treatment compared with a control group who received placebo/remdesivir, according to the FDA press release.

The median time to recovery from COVID-19 was 7 days for the combination group vs. 8 days for those in the placebo/remdesivir group. Recovery was defined as either discharge from the hospital or “being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care,” the agency explained in the press release.

The odds of a patient dying or being ventilated at day 29 was lower in the combination group compared with those taking placebo/remdesivir, the press release said without providing specific data. “For all of these endpoints, the effects were statistically significant,” the agency stated.

The safety and efficacy continues to be evaluated. Baricitinib alone is not approved as a treatment for COVID-19.

“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research.

“Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients,” she said.

As a JAK inhibitor, baricitinib interferes with a pathway that leads to inflammation. Baricitinib is already prescribed as an oral medication and is FDA-approved for treating moderate to severe rheumatoid arthritis.

The data supporting the EUA for the combination treatment are based on a randomized, double-blind, placebo-controlled clinical trial (ACTT-2), conducted by the National Institute of Allergy and Infectious Diseases (NIAID).

The trial followed patients for 29 days and included 1,033 patients with moderate to severe COVID-19; 515 patients received baricitinib/remdesivir, and 518 patients received placebo/remdesivir.

The FDA emphasizes that an EUA is not a full FDA approval.

In reviewing the combination, the FDA “determined that it is reasonable to believe that baricitinib, in combination with remdesivir, may be effective in treating COVID-19 for the authorized population” and the known benefits outweigh the known and potential risks. Additionally, there are no adequate, approved, and available alternatives for the treatment population.

“Today’s action demonstrates the FDA’s steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, MD. “As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19.”
 

This article first appeared on Medscape.com.

Greater involvement of the patient and family in decision-making, clarity on the role of genetic testing and parameters for team-oriented care, and use of high-volume specialty centers are cornerstones of the first update in almost a decade of the American Heart Association/American College of Cardiology guideline for patients with hypertrophic cardiomyopathy (HCM).

The update lists 133 recommendations for HCM care in six categories: shared decision-making; role of high-volume HCM centers; diagnosis, initial evaluation, and follow-up; risk assessment and prevention of sudden cardiac death (SCD); management of HCM; and lifestyle considerations for patients.

“The guideline puts the patient front and center in the shared decision-making process and emphasizes the importance of incorporating patient’s lifestyle choices and preferences when making complex, life-altering decisions,” writing committee vice chair Seema Mital, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, said in an interview.

The fully updated guideline, authored by a joint committee of the AHA and ACC with input from other specialty societies, has been published online in the Journal of the American College of Cardiology. It replaces the 2011 guideline.

Another key component of the update is the strong recommendation to utilize multidisciplinary care, said Matthew W. Martinez, MD, a writing committee member and sports cardiologists at Morristown (N.J.) Medical Center. “This is not only as a part of shared decision-making, but really in care for the patients,” he said, “that there’s a level of expertise that is provided by centers of excellence who handle HCM, and we did lay out some recommendations with regards to surgery, imaging, interventionists, and management with electrophysiology, and the care of athletes with potential for HCM and pregnant women.”

The update ranks recommendations by class of recommendation (COR), ranging from strong benefit much greater than risk to harm with risk exceeding benefit, and level of evidence (LOE). The recommendation for shared decision making, for example, carries at COR of 1, the highest rating, and a mid-level LOE of B-NR, meaning from nonrandomized studies. Patients who need septal reduction therapy (SRT) should be referred to a comprehensive or primary HCM center – a recommendation with a COR of 1 but an LOE of C-LD, meaning there are limited data.
 

From diagnosis to follow-up

The most extensive list of recommendations falls under the category covering diagnosis, initial evaluation and follow-up. They include a three-generation family history as part of the initial diagnostic assessment (COR, 1; LOE, B-NR), high-level recommendations for use of transthoracic echocardiogram in the initial work-up, every 1 or 2 years or when the patient’s status changes in confirmed cases, as well as parameters for using other imaging and diagnostic tests. Cardiovascular MRI, for example, is indicated when echocardiography is inconclusive (COR, 1; LOE, B-NR) and in other scenarios. When echocardiography is inconclusive but cardiac MRI isn’t available, cardiac CT is an option, albeit at a lower level of evidence (COR, 2b; LOE, C-LD).

Heart rhythm assessment has a high level of recommendation in multiple scenarios, even in first-degree relatives of HCM patients. Invasive hemodynamic assessment is in order for candidates of SRT whose left ventricular (LV) outflow tract obstruction status is unknown. This category also sets parameters for angiography, and exercise stress testing.

The most extensive recommendations for diagnosis and follow-up cover genetic testing; it consists of nine high-level recommendations.

“The guideline highlights not only the importance of genetic testing of an affected patient and genetic screening of family members, but also emphasizes ongoing reassessment of variant classification as this may evolve with time and change how we recommend ongoing family screening,” Dr. Mital noted.

“The guideline proposes initiating screening of family members at the earliest regardless of age given HCM can manifest at any age in affected families,” she added.

The guideline notes that the usefulness of genetic testing to evaluate the risk of sudden cardiac death (SCD) is uncertain. There’s even guidance for implementing those test results. Further testing is recommended for patients who are genotype positive and phenotype negative for HCM (COR, 1; LOE, B-NR). Those same patients may participate in competitive sports (COR, 2a; LOE, C-LD), but a pacemaker isn’t recommended as a primary prevention (COR, 3 [no benefit]; LOE, B-NR).
 

Risk evaluation and prevention

For SCD risk evaluation and prevention, the guideline spells out five components for the initial and follow-up evaluations (COR, 1; LOE, B-NR). That includes maximal LV wall thickness, ejection fraction, and LV apical aneurysm. The section include multiple recommendations for patient selection for placement of an implantable cardioverter-defibrillator (ICD). For example, it’s recommended for patient’s who’ve had a heart attack or sustained ventricular tachycardia (COR, 1; LOE, B-NR), but not so much for patients without risk factors or for participating in sports (COR, 3 [harm]; LOE, B-NR). The guideline even provides recommendations for selecting an ICD.

Management recommendations address when medical therapy is indicated, including which therapies are indicated for specific scenarios, as well as higher level interventions such as SRT for severely symptomatic patients with obstructive HCM (COR, 2b; LOE, C-LD) and surgical myectomy with ablation in patients with HCM and atrial fibrillation (COR, 2a; LOE, B-NR). This section also provides recommendations for managing patients with HCM and ventricular arrhythmias or advanced heart failure.

The guideline also includes a host of lifestyle considerations. Mild to moderate exercise is beneficial (COR, 1; LOE, B-NR), but athletes with HCM should consult with an “expert provider” (COR, 1; LOE, C, meaning based on expert opinion). Truck drivers, pilots and people who do strenuous physical labor with HCM should meet specific standards.

These recommendations again emphasize the role of shared decision-making, said Dr. Martinez. “It’s not a cookie-cutter discussion. It is taking all of the information, incorporating what the patient’s needs are, and then making sure you appropriately tell them what are the risks of exercising and not exercising. I have as many discussions through the day about what the risks of exercise are as I do the risks of not exercising.”
 

Refining nomenclature, pathophysiology

The writing committee addressed the nomenclature for HCM. The use of HCM to describe increased LV wall thickness linked to systemic diseases or secondary to LV hypertrophy “can lead to confusion,” the committee stated, so other cardiac or systemic causes of LV hypertrophy shouldn’t be labeled HCM. Other etiologies can cause secondary LV hypertrophy that can overlap with HCM; clinical markers and testing can help differentiate these mimickers from HCM. When echocardiography is inconclusive, cardiovascular MRI is indicated (COR, 1; LOE, B-NR).

The guideline update also provides clarity on the pathophysiology of HCM: It consists of dynamic LV outflow tract obstruction, mitral regurgitation, diastolic dysfunction, myocardial ischemia, arrhythmias, or autonomic dysfunction. “For a given patient with HCM, the clinical outcome may be dominated by one of these components or may be the result of a complex interplay,” the guideline states. The clinical evaluation should consider all these conditions.

This update also provides “clear separation” between care of HCM with and without obstruction, Dr. Martinez said. “The role of advanced therapies and referrals with advanced treatment options such as heart transplantation or CRT therapy in this group is different than before, recognizing that people with obstruction have symptoms that may be similar to those without obstruction, and the individual should be [thoroughly] investigated to make sure that you can discern between those two groups to make appropriate recommendations.”

The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, and Society for Cardiovascular Magnetic Resonance. It’s also been endorsed by the Pediatric & Congenital Electrophysiology Society.

Dr. Mital and Dr. Martinez have no relevant financial relationships to disclose.

SOURCE: Mital S et al. J Am Coll Cardiol. 2020 Nov 20. doi: 10.1016/j.jacc.2020.08.044.

Greater involvement of the patient and family in decision-making, clarity on the role of genetic testing and parameters for team-oriented care, and use of high-volume specialty centers are cornerstones of the first update in almost a decade of the American Heart Association/American College of Cardiology guideline for patients with hypertrophic cardiomyopathy (HCM).

The update lists 133 recommendations for HCM care in six categories: shared decision-making; role of high-volume HCM centers; diagnosis, initial evaluation, and follow-up; risk assessment and prevention of sudden cardiac death (SCD); management of HCM; and lifestyle considerations for patients.

“The guideline puts the patient front and center in the shared decision-making process and emphasizes the importance of incorporating patient’s lifestyle choices and preferences when making complex, life-altering decisions,” writing committee vice chair Seema Mital, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, said in an interview.

The fully updated guideline, authored by a joint committee of the AHA and ACC with input from other specialty societies, has been published online in the Journal of the American College of Cardiology. It replaces the 2011 guideline.

Another key component of the update is the strong recommendation to utilize multidisciplinary care, said Matthew W. Martinez, MD, a writing committee member and sports cardiologists at Morristown (N.J.) Medical Center. “This is not only as a part of shared decision-making, but really in care for the patients,” he said, “that there’s a level of expertise that is provided by centers of excellence who handle HCM, and we did lay out some recommendations with regards to surgery, imaging, interventionists, and management with electrophysiology, and the care of athletes with potential for HCM and pregnant women.”

The update ranks recommendations by class of recommendation (COR), ranging from strong benefit much greater than risk to harm with risk exceeding benefit, and level of evidence (LOE). The recommendation for shared decision making, for example, carries at COR of 1, the highest rating, and a mid-level LOE of B-NR, meaning from nonrandomized studies. Patients who need septal reduction therapy (SRT) should be referred to a comprehensive or primary HCM center – a recommendation with a COR of 1 but an LOE of C-LD, meaning there are limited data.
 

From diagnosis to follow-up

The most extensive list of recommendations falls under the category covering diagnosis, initial evaluation and follow-up. They include a three-generation family history as part of the initial diagnostic assessment (COR, 1; LOE, B-NR), high-level recommendations for use of transthoracic echocardiogram in the initial work-up, every 1 or 2 years or when the patient’s status changes in confirmed cases, as well as parameters for using other imaging and diagnostic tests. Cardiovascular MRI, for example, is indicated when echocardiography is inconclusive (COR, 1; LOE, B-NR) and in other scenarios. When echocardiography is inconclusive but cardiac MRI isn’t available, cardiac CT is an option, albeit at a lower level of evidence (COR, 2b; LOE, C-LD).

Heart rhythm assessment has a high level of recommendation in multiple scenarios, even in first-degree relatives of HCM patients. Invasive hemodynamic assessment is in order for candidates of SRT whose left ventricular (LV) outflow tract obstruction status is unknown. This category also sets parameters for angiography, and exercise stress testing.

The most extensive recommendations for diagnosis and follow-up cover genetic testing; it consists of nine high-level recommendations.

“The guideline highlights not only the importance of genetic testing of an affected patient and genetic screening of family members, but also emphasizes ongoing reassessment of variant classification as this may evolve with time and change how we recommend ongoing family screening,” Dr. Mital noted.

“The guideline proposes initiating screening of family members at the earliest regardless of age given HCM can manifest at any age in affected families,” she added.

The guideline notes that the usefulness of genetic testing to evaluate the risk of sudden cardiac death (SCD) is uncertain. There’s even guidance for implementing those test results. Further testing is recommended for patients who are genotype positive and phenotype negative for HCM (COR, 1; LOE, B-NR). Those same patients may participate in competitive sports (COR, 2a; LOE, C-LD), but a pacemaker isn’t recommended as a primary prevention (COR, 3 [no benefit]; LOE, B-NR).
 

Risk evaluation and prevention

For SCD risk evaluation and prevention, the guideline spells out five components for the initial and follow-up evaluations (COR, 1; LOE, B-NR). That includes maximal LV wall thickness, ejection fraction, and LV apical aneurysm. The section include multiple recommendations for patient selection for placement of an implantable cardioverter-defibrillator (ICD). For example, it’s recommended for patient’s who’ve had a heart attack or sustained ventricular tachycardia (COR, 1; LOE, B-NR), but not so much for patients without risk factors or for participating in sports (COR, 3 [harm]; LOE, B-NR). The guideline even provides recommendations for selecting an ICD.

Management recommendations address when medical therapy is indicated, including which therapies are indicated for specific scenarios, as well as higher level interventions such as SRT for severely symptomatic patients with obstructive HCM (COR, 2b; LOE, C-LD) and surgical myectomy with ablation in patients with HCM and atrial fibrillation (COR, 2a; LOE, B-NR). This section also provides recommendations for managing patients with HCM and ventricular arrhythmias or advanced heart failure.

The guideline also includes a host of lifestyle considerations. Mild to moderate exercise is beneficial (COR, 1; LOE, B-NR), but athletes with HCM should consult with an “expert provider” (COR, 1; LOE, C, meaning based on expert opinion). Truck drivers, pilots and people who do strenuous physical labor with HCM should meet specific standards.

These recommendations again emphasize the role of shared decision-making, said Dr. Martinez. “It’s not a cookie-cutter discussion. It is taking all of the information, incorporating what the patient’s needs are, and then making sure you appropriately tell them what are the risks of exercising and not exercising. I have as many discussions through the day about what the risks of exercise are as I do the risks of not exercising.”
 

Refining nomenclature, pathophysiology

The writing committee addressed the nomenclature for HCM. The use of HCM to describe increased LV wall thickness linked to systemic diseases or secondary to LV hypertrophy “can lead to confusion,” the committee stated, so other cardiac or systemic causes of LV hypertrophy shouldn’t be labeled HCM. Other etiologies can cause secondary LV hypertrophy that can overlap with HCM; clinical markers and testing can help differentiate these mimickers from HCM. When echocardiography is inconclusive, cardiovascular MRI is indicated (COR, 1; LOE, B-NR).

The guideline update also provides clarity on the pathophysiology of HCM: It consists of dynamic LV outflow tract obstruction, mitral regurgitation, diastolic dysfunction, myocardial ischemia, arrhythmias, or autonomic dysfunction. “For a given patient with HCM, the clinical outcome may be dominated by one of these components or may be the result of a complex interplay,” the guideline states. The clinical evaluation should consider all these conditions.

This update also provides “clear separation” between care of HCM with and without obstruction, Dr. Martinez said. “The role of advanced therapies and referrals with advanced treatment options such as heart transplantation or CRT therapy in this group is different than before, recognizing that people with obstruction have symptoms that may be similar to those without obstruction, and the individual should be [thoroughly] investigated to make sure that you can discern between those two groups to make appropriate recommendations.”

The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, and Society for Cardiovascular Magnetic Resonance. It’s also been endorsed by the Pediatric & Congenital Electrophysiology Society.

Dr. Mital and Dr. Martinez have no relevant financial relationships to disclose.

SOURCE: Mital S et al. J Am Coll Cardiol. 2020 Nov 20. doi: 10.1016/j.jacc.2020.08.044.

Greater involvement of the patient and family in decision-making, clarity on the role of genetic testing and parameters for team-oriented care, and use of high-volume specialty centers are cornerstones of the first update in almost a decade of the American Heart Association/American College of Cardiology guideline for patients with hypertrophic cardiomyopathy (HCM).

The update lists 133 recommendations for HCM care in six categories: shared decision-making; role of high-volume HCM centers; diagnosis, initial evaluation, and follow-up; risk assessment and prevention of sudden cardiac death (SCD); management of HCM; and lifestyle considerations for patients.

“The guideline puts the patient front and center in the shared decision-making process and emphasizes the importance of incorporating patient’s lifestyle choices and preferences when making complex, life-altering decisions,” writing committee vice chair Seema Mital, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, said in an interview.

The fully updated guideline, authored by a joint committee of the AHA and ACC with input from other specialty societies, has been published online in the Journal of the American College of Cardiology. It replaces the 2011 guideline.

Another key component of the update is the strong recommendation to utilize multidisciplinary care, said Matthew W. Martinez, MD, a writing committee member and sports cardiologists at Morristown (N.J.) Medical Center. “This is not only as a part of shared decision-making, but really in care for the patients,” he said, “that there’s a level of expertise that is provided by centers of excellence who handle HCM, and we did lay out some recommendations with regards to surgery, imaging, interventionists, and management with electrophysiology, and the care of athletes with potential for HCM and pregnant women.”

The update ranks recommendations by class of recommendation (COR), ranging from strong benefit much greater than risk to harm with risk exceeding benefit, and level of evidence (LOE). The recommendation for shared decision making, for example, carries at COR of 1, the highest rating, and a mid-level LOE of B-NR, meaning from nonrandomized studies. Patients who need septal reduction therapy (SRT) should be referred to a comprehensive or primary HCM center – a recommendation with a COR of 1 but an LOE of C-LD, meaning there are limited data.
 

From diagnosis to follow-up

The most extensive list of recommendations falls under the category covering diagnosis, initial evaluation and follow-up. They include a three-generation family history as part of the initial diagnostic assessment (COR, 1; LOE, B-NR), high-level recommendations for use of transthoracic echocardiogram in the initial work-up, every 1 or 2 years or when the patient’s status changes in confirmed cases, as well as parameters for using other imaging and diagnostic tests. Cardiovascular MRI, for example, is indicated when echocardiography is inconclusive (COR, 1; LOE, B-NR) and in other scenarios. When echocardiography is inconclusive but cardiac MRI isn’t available, cardiac CT is an option, albeit at a lower level of evidence (COR, 2b; LOE, C-LD).

Heart rhythm assessment has a high level of recommendation in multiple scenarios, even in first-degree relatives of HCM patients. Invasive hemodynamic assessment is in order for candidates of SRT whose left ventricular (LV) outflow tract obstruction status is unknown. This category also sets parameters for angiography, and exercise stress testing.

The most extensive recommendations for diagnosis and follow-up cover genetic testing; it consists of nine high-level recommendations.

“The guideline highlights not only the importance of genetic testing of an affected patient and genetic screening of family members, but also emphasizes ongoing reassessment of variant classification as this may evolve with time and change how we recommend ongoing family screening,” Dr. Mital noted.

“The guideline proposes initiating screening of family members at the earliest regardless of age given HCM can manifest at any age in affected families,” she added.

The guideline notes that the usefulness of genetic testing to evaluate the risk of sudden cardiac death (SCD) is uncertain. There’s even guidance for implementing those test results. Further testing is recommended for patients who are genotype positive and phenotype negative for HCM (COR, 1; LOE, B-NR). Those same patients may participate in competitive sports (COR, 2a; LOE, C-LD), but a pacemaker isn’t recommended as a primary prevention (COR, 3 [no benefit]; LOE, B-NR).
 

Risk evaluation and prevention

For SCD risk evaluation and prevention, the guideline spells out five components for the initial and follow-up evaluations (COR, 1; LOE, B-NR). That includes maximal LV wall thickness, ejection fraction, and LV apical aneurysm. The section include multiple recommendations for patient selection for placement of an implantable cardioverter-defibrillator (ICD). For example, it’s recommended for patient’s who’ve had a heart attack or sustained ventricular tachycardia (COR, 1; LOE, B-NR), but not so much for patients without risk factors or for participating in sports (COR, 3 [harm]; LOE, B-NR). The guideline even provides recommendations for selecting an ICD.

Management recommendations address when medical therapy is indicated, including which therapies are indicated for specific scenarios, as well as higher level interventions such as SRT for severely symptomatic patients with obstructive HCM (COR, 2b; LOE, C-LD) and surgical myectomy with ablation in patients with HCM and atrial fibrillation (COR, 2a; LOE, B-NR). This section also provides recommendations for managing patients with HCM and ventricular arrhythmias or advanced heart failure.

The guideline also includes a host of lifestyle considerations. Mild to moderate exercise is beneficial (COR, 1; LOE, B-NR), but athletes with HCM should consult with an “expert provider” (COR, 1; LOE, C, meaning based on expert opinion). Truck drivers, pilots and people who do strenuous physical labor with HCM should meet specific standards.

These recommendations again emphasize the role of shared decision-making, said Dr. Martinez. “It’s not a cookie-cutter discussion. It is taking all of the information, incorporating what the patient’s needs are, and then making sure you appropriately tell them what are the risks of exercising and not exercising. I have as many discussions through the day about what the risks of exercise are as I do the risks of not exercising.”
 

Refining nomenclature, pathophysiology

The writing committee addressed the nomenclature for HCM. The use of HCM to describe increased LV wall thickness linked to systemic diseases or secondary to LV hypertrophy “can lead to confusion,” the committee stated, so other cardiac or systemic causes of LV hypertrophy shouldn’t be labeled HCM. Other etiologies can cause secondary LV hypertrophy that can overlap with HCM; clinical markers and testing can help differentiate these mimickers from HCM. When echocardiography is inconclusive, cardiovascular MRI is indicated (COR, 1; LOE, B-NR).

The guideline update also provides clarity on the pathophysiology of HCM: It consists of dynamic LV outflow tract obstruction, mitral regurgitation, diastolic dysfunction, myocardial ischemia, arrhythmias, or autonomic dysfunction. “For a given patient with HCM, the clinical outcome may be dominated by one of these components or may be the result of a complex interplay,” the guideline states. The clinical evaluation should consider all these conditions.

This update also provides “clear separation” between care of HCM with and without obstruction, Dr. Martinez said. “The role of advanced therapies and referrals with advanced treatment options such as heart transplantation or CRT therapy in this group is different than before, recognizing that people with obstruction have symptoms that may be similar to those without obstruction, and the individual should be [thoroughly] investigated to make sure that you can discern between those two groups to make appropriate recommendations.”

The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, American Society of Echocardiography, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, and Society for Cardiovascular Magnetic Resonance. It’s also been endorsed by the Pediatric & Congenital Electrophysiology Society.

Dr. Mital and Dr. Martinez have no relevant financial relationships to disclose.

SOURCE: Mital S et al. J Am Coll Cardiol. 2020 Nov 20. doi: 10.1016/j.jacc.2020.08.044.

Restricting percutaneous interventions (PCI) to only those stenotic lesions that are ischemic by fractional flow reserve (FFR) thresholds is associated with better 5-year outcomes whether or not PCI is deployed, according to a cohort study presented at the American Heart Association scientific sessions.

For those that met the FFR threshold for ischemia, defined as up to 0.80, PCI reduced the risk of a major adverse cardiac event (MACE) at 5 years by 23% (hazard ratio, 0.77) relative to no PCI. Conversely, those not indicated for PCI because of a higher FFR had a 37% higher risk of MACE (HR, 1.37) at 5 years if treated with PCI relative to those who were not.

“The story of overuse of PCI is important,” reported the senior author Dennis Ko, MD, a scientist affiliated with the Schulich Heart Research Program, Sunnybrook Research Institute, University of Toronto, Canada. “We as interventionalists often think that putting in a stent is not harmful, and that turned out not to be the case.”

The FFR threshold for intervening with PCI is evidence based. Several trials, including one published in 2014, have associated PCI with better outcomes relative to medical therapy when FFR is 0.80 or lower. Other evidence suggests no advantage and possible harm for PCI performed if FFR is higher. Multiple guidelines, including those from the AHA, recommend against PCI if FFR is more than 0.80.

“As FRR is gaining in popularity, we were interested in whether physicians follow the thresholds in routine clinical practice and what happens to patient outcomes [if they are or are not followed],” Dr. Ko explained.

In this retrospective study by Dr. Ko’s trainee, Maneesh Sud, MD, and simultaneously published in JAMA, the answer was that there is deviation, and deviation leads to bad outcomes.

The 9,106 coronary artery disease patients included in the study underwent single-vessel FFR assessment within a 5-year period in Canada. The two cohorts evaluated were those with a lesional FFR of 0.80 or less, defined as ischemic, and those with a lesion with higher FFR, defined as nonischemic. The primary MACE outcome comprised death, myocardial infarction, unstable angina, or urgent coronary revascularization.

Of the 2,693 patients who met the FFR threshold of ischemia, 75.3% received PCI, and 24.7% were treated with medical therapy only. Of the 6,413 patients with nonischemic FFR, 87.4% were treated with medical therapy and 12.6% received PCI.

In those with ischemic FFR, event curves for MACE separated rapidly. At 30 days, the risk of MACE was 53% lower (HR, 0.47) in those receiving PCI. By 1 year, the advantage was less (HR, 0.76), but it was steady thereafter and remained about the same at 5 years (HR, 0.77; 95% confidence interval, 0.63-0.94). Relative advantages for each component of MACE went in the same direction. At 5 years, PCI exerted its greatest numerical advantage for the outcome or urgent coronary revascularization (HR, 0.71) and its least numerical advantage for MI (HR, 0.92), but none of these differences reached statistical significance.

In those with nonischemic coronary lesions on FFR, PCI was associated with more than twice the risk for MACE at 30 days (HR, 2.11), but the increase in risk relative to medical management fell at 1 year (HR 1.67) and 5 years (HR, 1.37). All of the individual components of MACE were numerically increased at all time points except for death, which was numerically lower at 30 days (HR, 0.41) and 5 years (HR, 0.94), even though these differences were not significant.

It could not be ascertained from these data why PCI was not performed when there was an indication or why it was performed when there was not. The investigators speculated that some clinicians may decide against PCI for ischemic lesions in the absence of symptoms or when concerned about comorbidities. They might offer PCI in nonischemic lesions because of symptoms, positive tests other than FFR, or FFR values near the threshold.

“I think the main message of our paper is that adherence of the FFR threshold as established by clinical trials is important,” Dr. Ko said in an interview. This not only means performing PCI when it is indicated, but refraining from PCI when it is not.

Basically, this study confirms that the guideline thresholds are valid, according to Jared M. O’Leary, MD, who is experienced with FFR and is Medical Director for Quality at the Vanderbilt Heart and Vascular Institute, Nashville, Tenn.

“It confirms the utility of FFR in the real world,” he said, adding that the results are “totally consistent with our practice.” He called FFR “an important tool in the cardiac cath lab” not only for determining when revascularization will benefit the patient but the opposite.

“The flip side is also true: Stenting should be avoided if a negative FFR is obtained,” he said, calling this technique “particularly useful for lesions that appear borderline by visual estimation alone.”
 

SOURCE: Sud M et al. AHA 2020. JAMA. 2020 Nov 13. doi: 10.1001/jama.2020.22708.

Restricting percutaneous interventions (PCI) to only those stenotic lesions that are ischemic by fractional flow reserve (FFR) thresholds is associated with better 5-year outcomes whether or not PCI is deployed, according to a cohort study presented at the American Heart Association scientific sessions.

For those that met the FFR threshold for ischemia, defined as up to 0.80, PCI reduced the risk of a major adverse cardiac event (MACE) at 5 years by 23% (hazard ratio, 0.77) relative to no PCI. Conversely, those not indicated for PCI because of a higher FFR had a 37% higher risk of MACE (HR, 1.37) at 5 years if treated with PCI relative to those who were not.

“The story of overuse of PCI is important,” reported the senior author Dennis Ko, MD, a scientist affiliated with the Schulich Heart Research Program, Sunnybrook Research Institute, University of Toronto, Canada. “We as interventionalists often think that putting in a stent is not harmful, and that turned out not to be the case.”

The FFR threshold for intervening with PCI is evidence based. Several trials, including one published in 2014, have associated PCI with better outcomes relative to medical therapy when FFR is 0.80 or lower. Other evidence suggests no advantage and possible harm for PCI performed if FFR is higher. Multiple guidelines, including those from the AHA, recommend against PCI if FFR is more than 0.80.

“As FRR is gaining in popularity, we were interested in whether physicians follow the thresholds in routine clinical practice and what happens to patient outcomes [if they are or are not followed],” Dr. Ko explained.

In this retrospective study by Dr. Ko’s trainee, Maneesh Sud, MD, and simultaneously published in JAMA, the answer was that there is deviation, and deviation leads to bad outcomes.

The 9,106 coronary artery disease patients included in the study underwent single-vessel FFR assessment within a 5-year period in Canada. The two cohorts evaluated were those with a lesional FFR of 0.80 or less, defined as ischemic, and those with a lesion with higher FFR, defined as nonischemic. The primary MACE outcome comprised death, myocardial infarction, unstable angina, or urgent coronary revascularization.

Of the 2,693 patients who met the FFR threshold of ischemia, 75.3% received PCI, and 24.7% were treated with medical therapy only. Of the 6,413 patients with nonischemic FFR, 87.4% were treated with medical therapy and 12.6% received PCI.

In those with ischemic FFR, event curves for MACE separated rapidly. At 30 days, the risk of MACE was 53% lower (HR, 0.47) in those receiving PCI. By 1 year, the advantage was less (HR, 0.76), but it was steady thereafter and remained about the same at 5 years (HR, 0.77; 95% confidence interval, 0.63-0.94). Relative advantages for each component of MACE went in the same direction. At 5 years, PCI exerted its greatest numerical advantage for the outcome or urgent coronary revascularization (HR, 0.71) and its least numerical advantage for MI (HR, 0.92), but none of these differences reached statistical significance.

In those with nonischemic coronary lesions on FFR, PCI was associated with more than twice the risk for MACE at 30 days (HR, 2.11), but the increase in risk relative to medical management fell at 1 year (HR 1.67) and 5 years (HR, 1.37). All of the individual components of MACE were numerically increased at all time points except for death, which was numerically lower at 30 days (HR, 0.41) and 5 years (HR, 0.94), even though these differences were not significant.

It could not be ascertained from these data why PCI was not performed when there was an indication or why it was performed when there was not. The investigators speculated that some clinicians may decide against PCI for ischemic lesions in the absence of symptoms or when concerned about comorbidities. They might offer PCI in nonischemic lesions because of symptoms, positive tests other than FFR, or FFR values near the threshold.

“I think the main message of our paper is that adherence of the FFR threshold as established by clinical trials is important,” Dr. Ko said in an interview. This not only means performing PCI when it is indicated, but refraining from PCI when it is not.

Basically, this study confirms that the guideline thresholds are valid, according to Jared M. O’Leary, MD, who is experienced with FFR and is Medical Director for Quality at the Vanderbilt Heart and Vascular Institute, Nashville, Tenn.

“It confirms the utility of FFR in the real world,” he said, adding that the results are “totally consistent with our practice.” He called FFR “an important tool in the cardiac cath lab” not only for determining when revascularization will benefit the patient but the opposite.

“The flip side is also true: Stenting should be avoided if a negative FFR is obtained,” he said, calling this technique “particularly useful for lesions that appear borderline by visual estimation alone.”
 

SOURCE: Sud M et al. AHA 2020. JAMA. 2020 Nov 13. doi: 10.1001/jama.2020.22708.

Restricting percutaneous interventions (PCI) to only those stenotic lesions that are ischemic by fractional flow reserve (FFR) thresholds is associated with better 5-year outcomes whether or not PCI is deployed, according to a cohort study presented at the American Heart Association scientific sessions.

For those that met the FFR threshold for ischemia, defined as up to 0.80, PCI reduced the risk of a major adverse cardiac event (MACE) at 5 years by 23% (hazard ratio, 0.77) relative to no PCI. Conversely, those not indicated for PCI because of a higher FFR had a 37% higher risk of MACE (HR, 1.37) at 5 years if treated with PCI relative to those who were not.

“The story of overuse of PCI is important,” reported the senior author Dennis Ko, MD, a scientist affiliated with the Schulich Heart Research Program, Sunnybrook Research Institute, University of Toronto, Canada. “We as interventionalists often think that putting in a stent is not harmful, and that turned out not to be the case.”

The FFR threshold for intervening with PCI is evidence based. Several trials, including one published in 2014, have associated PCI with better outcomes relative to medical therapy when FFR is 0.80 or lower. Other evidence suggests no advantage and possible harm for PCI performed if FFR is higher. Multiple guidelines, including those from the AHA, recommend against PCI if FFR is more than 0.80.

“As FRR is gaining in popularity, we were interested in whether physicians follow the thresholds in routine clinical practice and what happens to patient outcomes [if they are or are not followed],” Dr. Ko explained.

In this retrospective study by Dr. Ko’s trainee, Maneesh Sud, MD, and simultaneously published in JAMA, the answer was that there is deviation, and deviation leads to bad outcomes.

The 9,106 coronary artery disease patients included in the study underwent single-vessel FFR assessment within a 5-year period in Canada. The two cohorts evaluated were those with a lesional FFR of 0.80 or less, defined as ischemic, and those with a lesion with higher FFR, defined as nonischemic. The primary MACE outcome comprised death, myocardial infarction, unstable angina, or urgent coronary revascularization.

Of the 2,693 patients who met the FFR threshold of ischemia, 75.3% received PCI, and 24.7% were treated with medical therapy only. Of the 6,413 patients with nonischemic FFR, 87.4% were treated with medical therapy and 12.6% received PCI.

In those with ischemic FFR, event curves for MACE separated rapidly. At 30 days, the risk of MACE was 53% lower (HR, 0.47) in those receiving PCI. By 1 year, the advantage was less (HR, 0.76), but it was steady thereafter and remained about the same at 5 years (HR, 0.77; 95% confidence interval, 0.63-0.94). Relative advantages for each component of MACE went in the same direction. At 5 years, PCI exerted its greatest numerical advantage for the outcome or urgent coronary revascularization (HR, 0.71) and its least numerical advantage for MI (HR, 0.92), but none of these differences reached statistical significance.

In those with nonischemic coronary lesions on FFR, PCI was associated with more than twice the risk for MACE at 30 days (HR, 2.11), but the increase in risk relative to medical management fell at 1 year (HR 1.67) and 5 years (HR, 1.37). All of the individual components of MACE were numerically increased at all time points except for death, which was numerically lower at 30 days (HR, 0.41) and 5 years (HR, 0.94), even though these differences were not significant.

It could not be ascertained from these data why PCI was not performed when there was an indication or why it was performed when there was not. The investigators speculated that some clinicians may decide against PCI for ischemic lesions in the absence of symptoms or when concerned about comorbidities. They might offer PCI in nonischemic lesions because of symptoms, positive tests other than FFR, or FFR values near the threshold.

“I think the main message of our paper is that adherence of the FFR threshold as established by clinical trials is important,” Dr. Ko said in an interview. This not only means performing PCI when it is indicated, but refraining from PCI when it is not.

Basically, this study confirms that the guideline thresholds are valid, according to Jared M. O’Leary, MD, who is experienced with FFR and is Medical Director for Quality at the Vanderbilt Heart and Vascular Institute, Nashville, Tenn.

“It confirms the utility of FFR in the real world,” he said, adding that the results are “totally consistent with our practice.” He called FFR “an important tool in the cardiac cath lab” not only for determining when revascularization will benefit the patient but the opposite.

“The flip side is also true: Stenting should be avoided if a negative FFR is obtained,” he said, calling this technique “particularly useful for lesions that appear borderline by visual estimation alone.”
 

SOURCE: Sud M et al. AHA 2020. JAMA. 2020 Nov 13. doi: 10.1001/jama.2020.22708.