We physicians must pull together as a knowledge community

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Changed
Tue, 11/30/2021 - 10:13

The COVID-19 pandemic is a biosocial phenomenon. Patients and doctors alike find themselves assigned to groups designated as responsible and wise, or selfish and irrational, based strictly upon their personal assessments of medical risk. This trend in our culture is represented by threats of disciplinary action issued by medical regulators against physicians who are perceived to be undermining the public health message by spreading “misinformation.”

Dr. Renée S. Kohanski, a psychiatrist in Somerset, N.J.
Dr. Renée S. Kohanski

Our review of the literature reveals many references to “misinformation” but no definition narrow and precise enough to be interpreted consistently in a disciplinary environment. More pressing, this ambiguous word’s use is correlated with negative meaning and innuendo, often discrediting valuable information a priori without actual data points.

Dr. Robert S. Emmons, University of Vermont, Burlington
Dr. Robert S. Emmons

The most basic definition available is Merriam Webster’s: “incorrect or misleading information.” This definition includes no point of reference against which competing scientific claims can be measured.

Claudia E. Haupt, PhD, a political scientist and law professor, articulates a useful framework for understanding the relationship between medicine and state regulators. In the Yale Law Journal, Dr. Haupt wrote: “Knowledge communities have specialized expertise and are closest to those affected; they must have the freedom to work things out for themselves. The professions as knowledge communities have a fundamental interest in not having the state (or anyone else, for that matter) corrupt or distort what amounts to the state of the art in their respective fields.”

Injecting the artificial term “misinformation” into the science information ecosystem obfuscates and impedes the very ability of this vital knowledge community to perform its raison d’être. Use of the term misinformation with no clear scientific parameters ultimately makes it into a word that discredits, restrains, and incites, rather than attending to healing or promoting progress.

Time has certainly shown us that science is anything but settled on all things COVID. If the scientific community accepts disrespect as the response of choice to difference of opinion and practice, we lose the trust in one another as colleagues; we need to keep scientific inquiry and exploration alive. Curiosity, equanimity, and tolerance are key components of the professional attitude as we deftly maneuver against the virus together.

In the face of deadly disease, it is especially imperative that intelligent, thoughtful, highly respected scientists, researchers, and physicians have room to safely share their knowledge and clinical experience. The Association of American Physicians and Surgeons has published a statement on scientific integrity that can be used as a measuring stick for claims about misinformation in medicine. We call on physicians to pull together as a knowledge community. Kindness and respect for patients starts with kindness and respect for one another as colleagues.
 

Dr. Kohanski is in private practice in Somerset, N.J., and is a diplomate of the American Board of Psychiatry & Neurology. She disclosed no relevant financial relationships. Dr. Emmons is part-time clinical associate professor in the department of psychiatry at the University of Vermont, Burlington, and is a past chair of the Ethics Committee for the Vermont District Branch of the American Psychiatric Association. He is in private practice in Moretown, Vt., and disclosed no relevant financial relationships.

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The COVID-19 pandemic is a biosocial phenomenon. Patients and doctors alike find themselves assigned to groups designated as responsible and wise, or selfish and irrational, based strictly upon their personal assessments of medical risk. This trend in our culture is represented by threats of disciplinary action issued by medical regulators against physicians who are perceived to be undermining the public health message by spreading “misinformation.”

Dr. Renée S. Kohanski, a psychiatrist in Somerset, N.J.
Dr. Renée S. Kohanski

Our review of the literature reveals many references to “misinformation” but no definition narrow and precise enough to be interpreted consistently in a disciplinary environment. More pressing, this ambiguous word’s use is correlated with negative meaning and innuendo, often discrediting valuable information a priori without actual data points.

Dr. Robert S. Emmons, University of Vermont, Burlington
Dr. Robert S. Emmons

The most basic definition available is Merriam Webster’s: “incorrect or misleading information.” This definition includes no point of reference against which competing scientific claims can be measured.

Claudia E. Haupt, PhD, a political scientist and law professor, articulates a useful framework for understanding the relationship between medicine and state regulators. In the Yale Law Journal, Dr. Haupt wrote: “Knowledge communities have specialized expertise and are closest to those affected; they must have the freedom to work things out for themselves. The professions as knowledge communities have a fundamental interest in not having the state (or anyone else, for that matter) corrupt or distort what amounts to the state of the art in their respective fields.”

Injecting the artificial term “misinformation” into the science information ecosystem obfuscates and impedes the very ability of this vital knowledge community to perform its raison d’être. Use of the term misinformation with no clear scientific parameters ultimately makes it into a word that discredits, restrains, and incites, rather than attending to healing or promoting progress.

Time has certainly shown us that science is anything but settled on all things COVID. If the scientific community accepts disrespect as the response of choice to difference of opinion and practice, we lose the trust in one another as colleagues; we need to keep scientific inquiry and exploration alive. Curiosity, equanimity, and tolerance are key components of the professional attitude as we deftly maneuver against the virus together.

In the face of deadly disease, it is especially imperative that intelligent, thoughtful, highly respected scientists, researchers, and physicians have room to safely share their knowledge and clinical experience. The Association of American Physicians and Surgeons has published a statement on scientific integrity that can be used as a measuring stick for claims about misinformation in medicine. We call on physicians to pull together as a knowledge community. Kindness and respect for patients starts with kindness and respect for one another as colleagues.
 

Dr. Kohanski is in private practice in Somerset, N.J., and is a diplomate of the American Board of Psychiatry & Neurology. She disclosed no relevant financial relationships. Dr. Emmons is part-time clinical associate professor in the department of psychiatry at the University of Vermont, Burlington, and is a past chair of the Ethics Committee for the Vermont District Branch of the American Psychiatric Association. He is in private practice in Moretown, Vt., and disclosed no relevant financial relationships.

The COVID-19 pandemic is a biosocial phenomenon. Patients and doctors alike find themselves assigned to groups designated as responsible and wise, or selfish and irrational, based strictly upon their personal assessments of medical risk. This trend in our culture is represented by threats of disciplinary action issued by medical regulators against physicians who are perceived to be undermining the public health message by spreading “misinformation.”

Dr. Renée S. Kohanski, a psychiatrist in Somerset, N.J.
Dr. Renée S. Kohanski

Our review of the literature reveals many references to “misinformation” but no definition narrow and precise enough to be interpreted consistently in a disciplinary environment. More pressing, this ambiguous word’s use is correlated with negative meaning and innuendo, often discrediting valuable information a priori without actual data points.

Dr. Robert S. Emmons, University of Vermont, Burlington
Dr. Robert S. Emmons

The most basic definition available is Merriam Webster’s: “incorrect or misleading information.” This definition includes no point of reference against which competing scientific claims can be measured.

Claudia E. Haupt, PhD, a political scientist and law professor, articulates a useful framework for understanding the relationship between medicine and state regulators. In the Yale Law Journal, Dr. Haupt wrote: “Knowledge communities have specialized expertise and are closest to those affected; they must have the freedom to work things out for themselves. The professions as knowledge communities have a fundamental interest in not having the state (or anyone else, for that matter) corrupt or distort what amounts to the state of the art in their respective fields.”

Injecting the artificial term “misinformation” into the science information ecosystem obfuscates and impedes the very ability of this vital knowledge community to perform its raison d’être. Use of the term misinformation with no clear scientific parameters ultimately makes it into a word that discredits, restrains, and incites, rather than attending to healing or promoting progress.

Time has certainly shown us that science is anything but settled on all things COVID. If the scientific community accepts disrespect as the response of choice to difference of opinion and practice, we lose the trust in one another as colleagues; we need to keep scientific inquiry and exploration alive. Curiosity, equanimity, and tolerance are key components of the professional attitude as we deftly maneuver against the virus together.

In the face of deadly disease, it is especially imperative that intelligent, thoughtful, highly respected scientists, researchers, and physicians have room to safely share their knowledge and clinical experience. The Association of American Physicians and Surgeons has published a statement on scientific integrity that can be used as a measuring stick for claims about misinformation in medicine. We call on physicians to pull together as a knowledge community. Kindness and respect for patients starts with kindness and respect for one another as colleagues.
 

Dr. Kohanski is in private practice in Somerset, N.J., and is a diplomate of the American Board of Psychiatry & Neurology. She disclosed no relevant financial relationships. Dr. Emmons is part-time clinical associate professor in the department of psychiatry at the University of Vermont, Burlington, and is a past chair of the Ethics Committee for the Vermont District Branch of the American Psychiatric Association. He is in private practice in Moretown, Vt., and disclosed no relevant financial relationships.

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Let’s not criticize off-label prescribing

Article Type
Changed
Thu, 08/26/2021 - 15:49

The public health crisis sparked by COVID-19 has engendered much debate in the realm where politics, journalism, law, and medicine meet.

Dr. Robert S. Emmons, University of Vermont, Burlington
Dr. Robert S. Emmons

Doctors have used the media to name other doctors as sources of harmful misinformation, in some cases going so far as to invoke medical practice board oversight as a potential intervention when doctors make public statements deemed too far out of bounds scientifically. Over the past year, some physicians have been harshly criticized for speaking about off-label prescribing, a widely accepted part of everyday medical practice.

The science and ethics of off-label prescribing have not changed; what has changed is the quality of dialogue around it. As psychiatrists, it does not fall within our scope of practice to offer definitive public opinions on the treatment of COVID-19, nor is that our purpose here. However, we can speak to a process that damages patients and doctors alike by undermining trust. All of this heat around bad medical information, in our opinion, amounts to using the methods of other fields to evaluate science and clinical practice. A remedy, then, to improve the quality of public medical intelligence would be to clarify the rules of scientific debate and to once again clearly state that off-label prescribing is part and parcel of the good practice of clinical medicine.

Dr. Renée S. Kohanski, a psychiatrist in Somerset, N.J.
Dr. Renée S. Kohanski


Physicians who work in the field of professional discipline have thought about the limits of propriety in making charges of impropriety. We (R.S.E. and R.S.K.) asked the American Psychiatric Association’s Ethics Committee to expand upon its existing commentary on innovative practice and making allegations of professional misconduct. We used the committee’s answers to our questions as the basis for the arguments we are making in this piece.

The APA’s Ethics Committee uses clear-cut benchmarks to define innovative medical care: “The standards of care ... evolve with evidence from research and observations of practice. Among the expected supports for innovative practice are scientific testing, peer-reviewed publication, replication, and broad or widespread acceptance within a relevant scientific or professional community.” When it comes to off-label prescribing for any medical condition, it is easy enough to ascertain whether clinical reports have appeared in peer-reviewed journals.

Two of the biggest blockbusters in psychiatry, chlorpromazine and lithium, began as drugs used for other conditions almost since the inception of our field. In other words, the use of these drugs for mental illness began, in today’s jargon, as off-label. We practitioners of psychiatry live in the land of off-label prescribing and have always comfortably done so. In fact, almost all of medicine does. The key in today’s world of best-practice medicine is obtaining a truly informed consent.

For COVID-19, our incredible psychotropic molecules may once again be doing some trail-blazing off-label work. Late last year, Eric J. Lenze, MD, professor of psychiatry and director of the Healthy Mind Lab at Washington University in St. Louis, reported in a preliminary study of adult outpatients with symptomatic COVID-19 that those treated with fluvoxamine “had a lower likelihood of clinical deterioration over 15 days,” compared with those on placebo (JAMA. 2020;324[22]:2292-300). We were heartened to see Dr. Lenze discuss his work on a recent “60 Minutes” segment. David Seftel, MD, MBA, a clinician who administered fluvoxamine as early treatment for a COVID-19 outbreak that occurred in a community of racetrack employees and their families in the San Francisco Bay Area, also was featured. Rather than waiting for the results of large clinical trials, Dr. Lenze and Dr. Seftel proceeded, based on reports published in peer-reviewed journals, to treat patients whose lives were at risk.

If we find ourselves strongly disagreeing about the science of off-label prescribing, the proper response is to critique methodologies, not the character or competence of colleagues. The APA Ethics Committee discourages use of the media as a forum for making allegations of incompetent or unethical practice: “Judgments regarding violations of established norms of ethical or professional conduct should be made not by individuals but by bodies authorized to take evidence and make informed decisions.”

At least one state legislature is taking action to protect patients’ access to the doctors they trust. In Arizona, SB 1416 passed in the Senate and is now working its way through the House. This bill would prohibit medical boards from disciplining doctors for speaking out about or prescribing off-label drugs when a reasonable basis for use exists.

Physicians in all specialties would do well to studiously observe the conventions of their profession when it comes to critiquing their colleagues. Psychological research on the “backfire effect” suggests that heavy-handed campaigns to enforce medical consensus will only harden minds in ways that neither advance science nor improve the quality of clinical decision-making.

Medical disciplinary boards and the news media were neither designed nor are they equipped to adjudicate scientific debates. Science is never settled: Hypothesis and theory are always open to testing and revision as new evidence emerges. There is a place in medicine for formal disciplinary processes, as well-delineated by professional bodies such as the APA Ethics Committee. Another important part of protecting the public is to support an environment of scientific inquiry in which diversity of opinion is welcomed. As physicians, we translate science into excellent clinical care every day in our practices, and we advance science by sharing what we learn through friendly collegial communication and collaboration.

Dr. Emmons is part-time clinical associate professor in the department of psychiatry at the University of Vermont, Burlington, and is a past chair of the Ethics Committee for the Vermont District Branch of the American Psychiatric Association. He is in private practice in Moretown, Vt., and disclosed no relevant financial relationships. Dr. Kohanski is in private practice in Dayton, N.J., and is a diplomate of the American Board of Psychiatry & Neurology. She also is the host and author of Clinical Correlation, a series of the Psychcast. Dr. Kohanski disclosed no relevant financial relationships.

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Topics
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The public health crisis sparked by COVID-19 has engendered much debate in the realm where politics, journalism, law, and medicine meet.

Dr. Robert S. Emmons, University of Vermont, Burlington
Dr. Robert S. Emmons

Doctors have used the media to name other doctors as sources of harmful misinformation, in some cases going so far as to invoke medical practice board oversight as a potential intervention when doctors make public statements deemed too far out of bounds scientifically. Over the past year, some physicians have been harshly criticized for speaking about off-label prescribing, a widely accepted part of everyday medical practice.

The science and ethics of off-label prescribing have not changed; what has changed is the quality of dialogue around it. As psychiatrists, it does not fall within our scope of practice to offer definitive public opinions on the treatment of COVID-19, nor is that our purpose here. However, we can speak to a process that damages patients and doctors alike by undermining trust. All of this heat around bad medical information, in our opinion, amounts to using the methods of other fields to evaluate science and clinical practice. A remedy, then, to improve the quality of public medical intelligence would be to clarify the rules of scientific debate and to once again clearly state that off-label prescribing is part and parcel of the good practice of clinical medicine.

Dr. Renée S. Kohanski, a psychiatrist in Somerset, N.J.
Dr. Renée S. Kohanski


Physicians who work in the field of professional discipline have thought about the limits of propriety in making charges of impropriety. We (R.S.E. and R.S.K.) asked the American Psychiatric Association’s Ethics Committee to expand upon its existing commentary on innovative practice and making allegations of professional misconduct. We used the committee’s answers to our questions as the basis for the arguments we are making in this piece.

The APA’s Ethics Committee uses clear-cut benchmarks to define innovative medical care: “The standards of care ... evolve with evidence from research and observations of practice. Among the expected supports for innovative practice are scientific testing, peer-reviewed publication, replication, and broad or widespread acceptance within a relevant scientific or professional community.” When it comes to off-label prescribing for any medical condition, it is easy enough to ascertain whether clinical reports have appeared in peer-reviewed journals.

Two of the biggest blockbusters in psychiatry, chlorpromazine and lithium, began as drugs used for other conditions almost since the inception of our field. In other words, the use of these drugs for mental illness began, in today’s jargon, as off-label. We practitioners of psychiatry live in the land of off-label prescribing and have always comfortably done so. In fact, almost all of medicine does. The key in today’s world of best-practice medicine is obtaining a truly informed consent.

For COVID-19, our incredible psychotropic molecules may once again be doing some trail-blazing off-label work. Late last year, Eric J. Lenze, MD, professor of psychiatry and director of the Healthy Mind Lab at Washington University in St. Louis, reported in a preliminary study of adult outpatients with symptomatic COVID-19 that those treated with fluvoxamine “had a lower likelihood of clinical deterioration over 15 days,” compared with those on placebo (JAMA. 2020;324[22]:2292-300). We were heartened to see Dr. Lenze discuss his work on a recent “60 Minutes” segment. David Seftel, MD, MBA, a clinician who administered fluvoxamine as early treatment for a COVID-19 outbreak that occurred in a community of racetrack employees and their families in the San Francisco Bay Area, also was featured. Rather than waiting for the results of large clinical trials, Dr. Lenze and Dr. Seftel proceeded, based on reports published in peer-reviewed journals, to treat patients whose lives were at risk.

If we find ourselves strongly disagreeing about the science of off-label prescribing, the proper response is to critique methodologies, not the character or competence of colleagues. The APA Ethics Committee discourages use of the media as a forum for making allegations of incompetent or unethical practice: “Judgments regarding violations of established norms of ethical or professional conduct should be made not by individuals but by bodies authorized to take evidence and make informed decisions.”

At least one state legislature is taking action to protect patients’ access to the doctors they trust. In Arizona, SB 1416 passed in the Senate and is now working its way through the House. This bill would prohibit medical boards from disciplining doctors for speaking out about or prescribing off-label drugs when a reasonable basis for use exists.

Physicians in all specialties would do well to studiously observe the conventions of their profession when it comes to critiquing their colleagues. Psychological research on the “backfire effect” suggests that heavy-handed campaigns to enforce medical consensus will only harden minds in ways that neither advance science nor improve the quality of clinical decision-making.

Medical disciplinary boards and the news media were neither designed nor are they equipped to adjudicate scientific debates. Science is never settled: Hypothesis and theory are always open to testing and revision as new evidence emerges. There is a place in medicine for formal disciplinary processes, as well-delineated by professional bodies such as the APA Ethics Committee. Another important part of protecting the public is to support an environment of scientific inquiry in which diversity of opinion is welcomed. As physicians, we translate science into excellent clinical care every day in our practices, and we advance science by sharing what we learn through friendly collegial communication and collaboration.

Dr. Emmons is part-time clinical associate professor in the department of psychiatry at the University of Vermont, Burlington, and is a past chair of the Ethics Committee for the Vermont District Branch of the American Psychiatric Association. He is in private practice in Moretown, Vt., and disclosed no relevant financial relationships. Dr. Kohanski is in private practice in Dayton, N.J., and is a diplomate of the American Board of Psychiatry & Neurology. She also is the host and author of Clinical Correlation, a series of the Psychcast. Dr. Kohanski disclosed no relevant financial relationships.

The public health crisis sparked by COVID-19 has engendered much debate in the realm where politics, journalism, law, and medicine meet.

Dr. Robert S. Emmons, University of Vermont, Burlington
Dr. Robert S. Emmons

Doctors have used the media to name other doctors as sources of harmful misinformation, in some cases going so far as to invoke medical practice board oversight as a potential intervention when doctors make public statements deemed too far out of bounds scientifically. Over the past year, some physicians have been harshly criticized for speaking about off-label prescribing, a widely accepted part of everyday medical practice.

The science and ethics of off-label prescribing have not changed; what has changed is the quality of dialogue around it. As psychiatrists, it does not fall within our scope of practice to offer definitive public opinions on the treatment of COVID-19, nor is that our purpose here. However, we can speak to a process that damages patients and doctors alike by undermining trust. All of this heat around bad medical information, in our opinion, amounts to using the methods of other fields to evaluate science and clinical practice. A remedy, then, to improve the quality of public medical intelligence would be to clarify the rules of scientific debate and to once again clearly state that off-label prescribing is part and parcel of the good practice of clinical medicine.

Dr. Renée S. Kohanski, a psychiatrist in Somerset, N.J.
Dr. Renée S. Kohanski


Physicians who work in the field of professional discipline have thought about the limits of propriety in making charges of impropriety. We (R.S.E. and R.S.K.) asked the American Psychiatric Association’s Ethics Committee to expand upon its existing commentary on innovative practice and making allegations of professional misconduct. We used the committee’s answers to our questions as the basis for the arguments we are making in this piece.

The APA’s Ethics Committee uses clear-cut benchmarks to define innovative medical care: “The standards of care ... evolve with evidence from research and observations of practice. Among the expected supports for innovative practice are scientific testing, peer-reviewed publication, replication, and broad or widespread acceptance within a relevant scientific or professional community.” When it comes to off-label prescribing for any medical condition, it is easy enough to ascertain whether clinical reports have appeared in peer-reviewed journals.

Two of the biggest blockbusters in psychiatry, chlorpromazine and lithium, began as drugs used for other conditions almost since the inception of our field. In other words, the use of these drugs for mental illness began, in today’s jargon, as off-label. We practitioners of psychiatry live in the land of off-label prescribing and have always comfortably done so. In fact, almost all of medicine does. The key in today’s world of best-practice medicine is obtaining a truly informed consent.

For COVID-19, our incredible psychotropic molecules may once again be doing some trail-blazing off-label work. Late last year, Eric J. Lenze, MD, professor of psychiatry and director of the Healthy Mind Lab at Washington University in St. Louis, reported in a preliminary study of adult outpatients with symptomatic COVID-19 that those treated with fluvoxamine “had a lower likelihood of clinical deterioration over 15 days,” compared with those on placebo (JAMA. 2020;324[22]:2292-300). We were heartened to see Dr. Lenze discuss his work on a recent “60 Minutes” segment. David Seftel, MD, MBA, a clinician who administered fluvoxamine as early treatment for a COVID-19 outbreak that occurred in a community of racetrack employees and their families in the San Francisco Bay Area, also was featured. Rather than waiting for the results of large clinical trials, Dr. Lenze and Dr. Seftel proceeded, based on reports published in peer-reviewed journals, to treat patients whose lives were at risk.

If we find ourselves strongly disagreeing about the science of off-label prescribing, the proper response is to critique methodologies, not the character or competence of colleagues. The APA Ethics Committee discourages use of the media as a forum for making allegations of incompetent or unethical practice: “Judgments regarding violations of established norms of ethical or professional conduct should be made not by individuals but by bodies authorized to take evidence and make informed decisions.”

At least one state legislature is taking action to protect patients’ access to the doctors they trust. In Arizona, SB 1416 passed in the Senate and is now working its way through the House. This bill would prohibit medical boards from disciplining doctors for speaking out about or prescribing off-label drugs when a reasonable basis for use exists.

Physicians in all specialties would do well to studiously observe the conventions of their profession when it comes to critiquing their colleagues. Psychological research on the “backfire effect” suggests that heavy-handed campaigns to enforce medical consensus will only harden minds in ways that neither advance science nor improve the quality of clinical decision-making.

Medical disciplinary boards and the news media were neither designed nor are they equipped to adjudicate scientific debates. Science is never settled: Hypothesis and theory are always open to testing and revision as new evidence emerges. There is a place in medicine for formal disciplinary processes, as well-delineated by professional bodies such as the APA Ethics Committee. Another important part of protecting the public is to support an environment of scientific inquiry in which diversity of opinion is welcomed. As physicians, we translate science into excellent clinical care every day in our practices, and we advance science by sharing what we learn through friendly collegial communication and collaboration.

Dr. Emmons is part-time clinical associate professor in the department of psychiatry at the University of Vermont, Burlington, and is a past chair of the Ethics Committee for the Vermont District Branch of the American Psychiatric Association. He is in private practice in Moretown, Vt., and disclosed no relevant financial relationships. Dr. Kohanski is in private practice in Dayton, N.J., and is a diplomate of the American Board of Psychiatry & Neurology. She also is the host and author of Clinical Correlation, a series of the Psychcast. Dr. Kohanski disclosed no relevant financial relationships.

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