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Half-Truths Produce Whole Failures in Health Policy

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Wed, 04/17/2024 - 15:21

On May 5, 2023, the director of the Centers for Disease Control and Prevention (CDC), Rochelle Walensky, in announcing her resignation after more than 2 years of dedicated service, wrote that she “took on this role … with the goal of leaving behind the dark days of the pandemic and moving the CDC — and public health — forward into a much better and more trusted place.”

Three times in the past 3 years I have written a Beyond the White Coat column emphasizing the importance of trust. Trust in the expertise of scientists. Trust in the integrity of medical research and public health institutions. Trust in the commitment of providers — doctors, nurses, therapists, and first responders — to shepherd us through the pandemic and other medical crises in our lives. This column is take four.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

All human institutions have human imperfections. However, imperfect humans working together in community are more productive and more reliable than nihilism and political polarization. Underlying all of healthcare are compassion and honesty. Honesty means the truth, the whole truth, and nothing but the truth. Honesty is such a simple concept in the moral formation of children, but the concept has evolved aberrantly in the world of woke adults. There appear to be irresistible temptations to shade that truth for political gain. The dominant current mutation is the half-truth. One tells the part of the truth that appears to advance one’s own political aspirations and at the same time one omits or censors other viewpoints.

On April 17, 2023, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Psychiatric Association wrote an open letter to Congressional leaders advocating for transgender female students’ participation in girl’s and women’s sports. The letter was written “On behalf of the more than 165,000” members of those organizations, though public opinion polls show a majority of those members likely oppose the opinion expressed. The letter goes on to extol the benefits that sports might bring to transgender students, but it contains not one word acknowledging the negative impact that participation has on others. That is a half-truth.

The same half-truth methodology distorts dialogue about various therapies for gender dysphoria in children and young adults.

In April 2022, U.S. Assistant Secretary for Health Rachel Levine in an NPR interview declared that, “There is no argument about the value and importance of gender-affirming care.” That might be a half-truth, since I could not locate U.S. specialists who dare to go on record questioning the party line of the World Professional Association for Transgender Health. However, Dr. Levine’s dismissal of any dissent is bizarre since in the prior 2 years multiple countries, including Australia, New Zealand, Sweden, Finland, and the United Kingdom had all issued reports questioning and even rescinding the practices that evolved since the 2012 WPATH guidance. Their main concerns included 1) the marked increase in incidence of gender dysphoria first manifesting in tween and early teenage girls, 2) the inadequate access to mental health screening before considering transitioning, 3) the long-term risks of puberty blockers particularly to bone density, and 4) the low quality of evidence supporting a measurable reduction in suicide rates. There may be reasonable counterarguments to each of those concerns, but a high ranking U.S. government official labeling all those international reports as “no argument” does not produce high quality decision making and does not foster the public’s trust.

Indeed, the public in many cases has decided its elected legislators are more trustworthy on these topics than the medical organizations. As I wrote the first draft of this column, the Missouri state legislators had passed a bill banning gender-affirming health care for transgender minors. They also passed a bill preventing participation of transgender females in women’s sports. Per reckoning by CBS News in the summer of 2023, 16 states had recently enacted laws restricting gender-affirming care and 22 states had restricted transgender participation in sports.

In 2022, I wrote a column claiming that suppressing viewpoints and debate leads to exploding spaceships. I believe the current legislative carnage is just such an explosion. It harms children.

The AAP has experts in advocacy. I am no expert in political advocacy. Perhaps politics has to be played by different rules where half-truths are normalized. Criminal law and advertising use those rules. But this explosion of vitriol and legislative intrusion into medicine should prompt everyone to reassess the use of one-sided advocacy in public and professional circles in healthcare. I want to be associated with a profession that uses evidence-based medicine that is not corrupted with political agendas. I want to be associated with a profession known for telling the whole truth.

In a society that is increasingly polarized, I want to embrace the advice of John Stuart Mill, a 19th century English philosopher best known for utilitarianism, which is often expressed as “the greatest good for the greatest number.” Mr. Mill also wrote on social theory, liberty, and even some early feminist theory. His 1859 work, On Liberty, chapter II, asserts: “He who knows only his own side of the case, knows little of that. His reasons may be good, and no one may have been able to refute them. But if he is equally unable to refute the reasons on the opposite side; if he does not so much as know what they are, he has no ground for preferring either opinion.”

Mr. Mill did not like half-truths.
 

 

 

It’s About Trust

My column is not the instrument to debate the use of hormones as puberty blockers or the fairness of transgender women participating in women’s sports. Those judgments will be rendered by others. I may report on those deliberations, but my column’s emphasis is on how professionals, and their organizations, go about making those determinations

For instance, the National Health Service in the United Kingdom spent 2 years reassessing transgender care for children and in October 2022 released a draft proposal to reduce and limit the aggressive therapies. On June 9, 2023, the NHS fully enacted those changes. Puberty blockers for gender dysphoria would be used only in experimental trials. In April 2024 the NHS began implementing those changes, joining other European countries that have imposed similar restrictions.

Similarly, the debate about transgender participation in women’s sports has continued to rage for years. On April 8, 2024, the National Association of Intercollegiate Athletics passed a resolution that bans almost all transgender participation in NAIA-regulated intercollegiate women’s sports. Dance and cheerleading are exceptions. Participation is still permissible at the intramural level. The NCAA has different rules.

Go to those sources to learn more substance for those debates. This column is about trust.

A major problem currently facing medicine is the public’s trust in expertise. That trust had been seriously weakened before the pandemic and was repeatedly wounded during the pandemic with arguments over masks, vaccines, and shutdowns. It needs repair.

A parent bringing a baby to a pediatrician’s office needs to trust that physician for the relationship to work. This is especially true for pediatric hospitalists that do not have the opportunity that office-based pediatricians have to build rapport with a family over years. At a recent university conference on diversity, equity, and inclusivity, one female rabbi stated, “I cannot be rabbi to everybody.” I agreed, but as a medical professional, sometimes I must be.

Telling half-truths harms the public’s trust in their personal physicians and in the medical establishment. Once people suspect an organization is making decisions based on ideology rather than science, credibility is lost and difficult to recover.

Let us stop telling half-truths. Let us stop suppressing dialogue. Truth can never be completely captured by humans, but if one side of an issue is suppressed by cancel culture, censorship, accusations of homophobia, or threat of cultural war, the search for truth is severely impaired.

Let us, as medical professionals, adopt Stephen Covey’s habit number 5, “Seek first to understand, then to be understood.” Empower voices. Listen to all stakeholders. And when we finally do speak, remember John Stuart Mill and tell the whole truth.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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On May 5, 2023, the director of the Centers for Disease Control and Prevention (CDC), Rochelle Walensky, in announcing her resignation after more than 2 years of dedicated service, wrote that she “took on this role … with the goal of leaving behind the dark days of the pandemic and moving the CDC — and public health — forward into a much better and more trusted place.”

Three times in the past 3 years I have written a Beyond the White Coat column emphasizing the importance of trust. Trust in the expertise of scientists. Trust in the integrity of medical research and public health institutions. Trust in the commitment of providers — doctors, nurses, therapists, and first responders — to shepherd us through the pandemic and other medical crises in our lives. This column is take four.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

All human institutions have human imperfections. However, imperfect humans working together in community are more productive and more reliable than nihilism and political polarization. Underlying all of healthcare are compassion and honesty. Honesty means the truth, the whole truth, and nothing but the truth. Honesty is such a simple concept in the moral formation of children, but the concept has evolved aberrantly in the world of woke adults. There appear to be irresistible temptations to shade that truth for political gain. The dominant current mutation is the half-truth. One tells the part of the truth that appears to advance one’s own political aspirations and at the same time one omits or censors other viewpoints.

On April 17, 2023, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Psychiatric Association wrote an open letter to Congressional leaders advocating for transgender female students’ participation in girl’s and women’s sports. The letter was written “On behalf of the more than 165,000” members of those organizations, though public opinion polls show a majority of those members likely oppose the opinion expressed. The letter goes on to extol the benefits that sports might bring to transgender students, but it contains not one word acknowledging the negative impact that participation has on others. That is a half-truth.

The same half-truth methodology distorts dialogue about various therapies for gender dysphoria in children and young adults.

In April 2022, U.S. Assistant Secretary for Health Rachel Levine in an NPR interview declared that, “There is no argument about the value and importance of gender-affirming care.” That might be a half-truth, since I could not locate U.S. specialists who dare to go on record questioning the party line of the World Professional Association for Transgender Health. However, Dr. Levine’s dismissal of any dissent is bizarre since in the prior 2 years multiple countries, including Australia, New Zealand, Sweden, Finland, and the United Kingdom had all issued reports questioning and even rescinding the practices that evolved since the 2012 WPATH guidance. Their main concerns included 1) the marked increase in incidence of gender dysphoria first manifesting in tween and early teenage girls, 2) the inadequate access to mental health screening before considering transitioning, 3) the long-term risks of puberty blockers particularly to bone density, and 4) the low quality of evidence supporting a measurable reduction in suicide rates. There may be reasonable counterarguments to each of those concerns, but a high ranking U.S. government official labeling all those international reports as “no argument” does not produce high quality decision making and does not foster the public’s trust.

Indeed, the public in many cases has decided its elected legislators are more trustworthy on these topics than the medical organizations. As I wrote the first draft of this column, the Missouri state legislators had passed a bill banning gender-affirming health care for transgender minors. They also passed a bill preventing participation of transgender females in women’s sports. Per reckoning by CBS News in the summer of 2023, 16 states had recently enacted laws restricting gender-affirming care and 22 states had restricted transgender participation in sports.

In 2022, I wrote a column claiming that suppressing viewpoints and debate leads to exploding spaceships. I believe the current legislative carnage is just such an explosion. It harms children.

The AAP has experts in advocacy. I am no expert in political advocacy. Perhaps politics has to be played by different rules where half-truths are normalized. Criminal law and advertising use those rules. But this explosion of vitriol and legislative intrusion into medicine should prompt everyone to reassess the use of one-sided advocacy in public and professional circles in healthcare. I want to be associated with a profession that uses evidence-based medicine that is not corrupted with political agendas. I want to be associated with a profession known for telling the whole truth.

In a society that is increasingly polarized, I want to embrace the advice of John Stuart Mill, a 19th century English philosopher best known for utilitarianism, which is often expressed as “the greatest good for the greatest number.” Mr. Mill also wrote on social theory, liberty, and even some early feminist theory. His 1859 work, On Liberty, chapter II, asserts: “He who knows only his own side of the case, knows little of that. His reasons may be good, and no one may have been able to refute them. But if he is equally unable to refute the reasons on the opposite side; if he does not so much as know what they are, he has no ground for preferring either opinion.”

Mr. Mill did not like half-truths.
 

 

 

It’s About Trust

My column is not the instrument to debate the use of hormones as puberty blockers or the fairness of transgender women participating in women’s sports. Those judgments will be rendered by others. I may report on those deliberations, but my column’s emphasis is on how professionals, and their organizations, go about making those determinations

For instance, the National Health Service in the United Kingdom spent 2 years reassessing transgender care for children and in October 2022 released a draft proposal to reduce and limit the aggressive therapies. On June 9, 2023, the NHS fully enacted those changes. Puberty blockers for gender dysphoria would be used only in experimental trials. In April 2024 the NHS began implementing those changes, joining other European countries that have imposed similar restrictions.

Similarly, the debate about transgender participation in women’s sports has continued to rage for years. On April 8, 2024, the National Association of Intercollegiate Athletics passed a resolution that bans almost all transgender participation in NAIA-regulated intercollegiate women’s sports. Dance and cheerleading are exceptions. Participation is still permissible at the intramural level. The NCAA has different rules.

Go to those sources to learn more substance for those debates. This column is about trust.

A major problem currently facing medicine is the public’s trust in expertise. That trust had been seriously weakened before the pandemic and was repeatedly wounded during the pandemic with arguments over masks, vaccines, and shutdowns. It needs repair.

A parent bringing a baby to a pediatrician’s office needs to trust that physician for the relationship to work. This is especially true for pediatric hospitalists that do not have the opportunity that office-based pediatricians have to build rapport with a family over years. At a recent university conference on diversity, equity, and inclusivity, one female rabbi stated, “I cannot be rabbi to everybody.” I agreed, but as a medical professional, sometimes I must be.

Telling half-truths harms the public’s trust in their personal physicians and in the medical establishment. Once people suspect an organization is making decisions based on ideology rather than science, credibility is lost and difficult to recover.

Let us stop telling half-truths. Let us stop suppressing dialogue. Truth can never be completely captured by humans, but if one side of an issue is suppressed by cancel culture, censorship, accusations of homophobia, or threat of cultural war, the search for truth is severely impaired.

Let us, as medical professionals, adopt Stephen Covey’s habit number 5, “Seek first to understand, then to be understood.” Empower voices. Listen to all stakeholders. And when we finally do speak, remember John Stuart Mill and tell the whole truth.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

On May 5, 2023, the director of the Centers for Disease Control and Prevention (CDC), Rochelle Walensky, in announcing her resignation after more than 2 years of dedicated service, wrote that she “took on this role … with the goal of leaving behind the dark days of the pandemic and moving the CDC — and public health — forward into a much better and more trusted place.”

Three times in the past 3 years I have written a Beyond the White Coat column emphasizing the importance of trust. Trust in the expertise of scientists. Trust in the integrity of medical research and public health institutions. Trust in the commitment of providers — doctors, nurses, therapists, and first responders — to shepherd us through the pandemic and other medical crises in our lives. This column is take four.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

All human institutions have human imperfections. However, imperfect humans working together in community are more productive and more reliable than nihilism and political polarization. Underlying all of healthcare are compassion and honesty. Honesty means the truth, the whole truth, and nothing but the truth. Honesty is such a simple concept in the moral formation of children, but the concept has evolved aberrantly in the world of woke adults. There appear to be irresistible temptations to shade that truth for political gain. The dominant current mutation is the half-truth. One tells the part of the truth that appears to advance one’s own political aspirations and at the same time one omits or censors other viewpoints.

On April 17, 2023, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Psychiatric Association wrote an open letter to Congressional leaders advocating for transgender female students’ participation in girl’s and women’s sports. The letter was written “On behalf of the more than 165,000” members of those organizations, though public opinion polls show a majority of those members likely oppose the opinion expressed. The letter goes on to extol the benefits that sports might bring to transgender students, but it contains not one word acknowledging the negative impact that participation has on others. That is a half-truth.

The same half-truth methodology distorts dialogue about various therapies for gender dysphoria in children and young adults.

In April 2022, U.S. Assistant Secretary for Health Rachel Levine in an NPR interview declared that, “There is no argument about the value and importance of gender-affirming care.” That might be a half-truth, since I could not locate U.S. specialists who dare to go on record questioning the party line of the World Professional Association for Transgender Health. However, Dr. Levine’s dismissal of any dissent is bizarre since in the prior 2 years multiple countries, including Australia, New Zealand, Sweden, Finland, and the United Kingdom had all issued reports questioning and even rescinding the practices that evolved since the 2012 WPATH guidance. Their main concerns included 1) the marked increase in incidence of gender dysphoria first manifesting in tween and early teenage girls, 2) the inadequate access to mental health screening before considering transitioning, 3) the long-term risks of puberty blockers particularly to bone density, and 4) the low quality of evidence supporting a measurable reduction in suicide rates. There may be reasonable counterarguments to each of those concerns, but a high ranking U.S. government official labeling all those international reports as “no argument” does not produce high quality decision making and does not foster the public’s trust.

Indeed, the public in many cases has decided its elected legislators are more trustworthy on these topics than the medical organizations. As I wrote the first draft of this column, the Missouri state legislators had passed a bill banning gender-affirming health care for transgender minors. They also passed a bill preventing participation of transgender females in women’s sports. Per reckoning by CBS News in the summer of 2023, 16 states had recently enacted laws restricting gender-affirming care and 22 states had restricted transgender participation in sports.

In 2022, I wrote a column claiming that suppressing viewpoints and debate leads to exploding spaceships. I believe the current legislative carnage is just such an explosion. It harms children.

The AAP has experts in advocacy. I am no expert in political advocacy. Perhaps politics has to be played by different rules where half-truths are normalized. Criminal law and advertising use those rules. But this explosion of vitriol and legislative intrusion into medicine should prompt everyone to reassess the use of one-sided advocacy in public and professional circles in healthcare. I want to be associated with a profession that uses evidence-based medicine that is not corrupted with political agendas. I want to be associated with a profession known for telling the whole truth.

In a society that is increasingly polarized, I want to embrace the advice of John Stuart Mill, a 19th century English philosopher best known for utilitarianism, which is often expressed as “the greatest good for the greatest number.” Mr. Mill also wrote on social theory, liberty, and even some early feminist theory. His 1859 work, On Liberty, chapter II, asserts: “He who knows only his own side of the case, knows little of that. His reasons may be good, and no one may have been able to refute them. But if he is equally unable to refute the reasons on the opposite side; if he does not so much as know what they are, he has no ground for preferring either opinion.”

Mr. Mill did not like half-truths.
 

 

 

It’s About Trust

My column is not the instrument to debate the use of hormones as puberty blockers or the fairness of transgender women participating in women’s sports. Those judgments will be rendered by others. I may report on those deliberations, but my column’s emphasis is on how professionals, and their organizations, go about making those determinations

For instance, the National Health Service in the United Kingdom spent 2 years reassessing transgender care for children and in October 2022 released a draft proposal to reduce and limit the aggressive therapies. On June 9, 2023, the NHS fully enacted those changes. Puberty blockers for gender dysphoria would be used only in experimental trials. In April 2024 the NHS began implementing those changes, joining other European countries that have imposed similar restrictions.

Similarly, the debate about transgender participation in women’s sports has continued to rage for years. On April 8, 2024, the National Association of Intercollegiate Athletics passed a resolution that bans almost all transgender participation in NAIA-regulated intercollegiate women’s sports. Dance and cheerleading are exceptions. Participation is still permissible at the intramural level. The NCAA has different rules.

Go to those sources to learn more substance for those debates. This column is about trust.

A major problem currently facing medicine is the public’s trust in expertise. That trust had been seriously weakened before the pandemic and was repeatedly wounded during the pandemic with arguments over masks, vaccines, and shutdowns. It needs repair.

A parent bringing a baby to a pediatrician’s office needs to trust that physician for the relationship to work. This is especially true for pediatric hospitalists that do not have the opportunity that office-based pediatricians have to build rapport with a family over years. At a recent university conference on diversity, equity, and inclusivity, one female rabbi stated, “I cannot be rabbi to everybody.” I agreed, but as a medical professional, sometimes I must be.

Telling half-truths harms the public’s trust in their personal physicians and in the medical establishment. Once people suspect an organization is making decisions based on ideology rather than science, credibility is lost and difficult to recover.

Let us stop telling half-truths. Let us stop suppressing dialogue. Truth can never be completely captured by humans, but if one side of an issue is suppressed by cancel culture, censorship, accusations of homophobia, or threat of cultural war, the search for truth is severely impaired.

Let us, as medical professionals, adopt Stephen Covey’s habit number 5, “Seek first to understand, then to be understood.” Empower voices. Listen to all stakeholders. And when we finally do speak, remember John Stuart Mill and tell the whole truth.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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Money can buy health but it may not be affordable

Article Type
Changed
Tue, 02/14/2023 - 15:32

It is said that “Money cannot buy happiness.” But ask anyone who does not have it and you will find that money can buy security and freedom from many fears and aggravations. There are no guarantees, but the odds are better with resources than without them. Nations with higher per capita gross domestic product have longer life expectancies, have more freedom, and offer more opportunities for the favored subsets of their populations. The adage is that a rising tide lifts all boats.

It is also said that “Money cannot buy health.” That is also a half lie. Again, there is no guarantee that money can cure what ails you. But over the past 4 decades, modern medical care has added on average 3 years to the average American’s life expectancy. These gains in life expectancy came at a steep cost. The United States has been paying a luxurious, premium price for health care compared with similarly developed nations. When I started my career studying health economics 40 years ago, U.S. health care had increased from 6% of the gross domestic product, was passing 9%, and per my professors, appeared headed for 12% – at which point the predictions were that the sky would start falling. Costs continued to rise and for the past decade about 17% of the U.S. GDP has been going to health care before the pandemic blip.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

U.S. life expectancy in the past 150 years nearly doubled. This was primarily due to public health measures rather than the small contributions of medical care for individuals. Life expectancy has mostly risen by reducing infant mortality and childhood mortality. The civil engineers who figured out how to get clean running water into cities and sewage out without the two intermingling have saved far more lives than all the doctors graduating from the medical schools. Better nutrition, better sanitation, vaccines, and, to a smaller extent, antibiotics, have all contributed worthy but lesser effects.

When it comes to individual behavior rather than public health measures, the biggest effect comes from advice physicians have been doling out for decades: Stop smoking, exercise, wear your seatbelt, and do not drink and drive. Over the past generation, medical technology added an incremental improvement to the life span (life expectancy once you attain age 60). This has occurred in cardiovascular health by treating high blood pressure, reducing stroke risk, and lowering hemoglobin A1c. Those measures added about 3 years to life span before the obesity epidemic, the opioid epidemic, and the COVID pandemic wiped out the gains. In round numbers, the price for those 3 extra years of life was about the earnings of working an extra 1-2 years in a lifetime. To share those benefits with everyone, the working stiff has to postpone retirement and work an extra 3 years.

Most recently, modern medicine has produced some very expensive therapies that can add months or years to the lives of people with certain diseases. These therapies may involve over $100,000 worth of marginally beneficial medication that statistically adds a few months to the lives of people with certain varieties of prostate, lung, and breast cancers. Similarly, treatments for chronic disease such as AIDS and cystic fibrosis may involve ongoing medication costs of $10,000 or $20,000 or more per year every year for a lifetime. There are even more extreme examples on the horizon. CAR T-cells and Aduhelm [aducanumab] have the potential to break the Medicare bank. Kaftrio [ivacaftor/tezacaftor/elexacaftor], for cystic fibrosis, is being offered only to wealthier countries.

Medical expenses are hard to analyze because the cited “cost” of many of these medications is like a manufacturer’s suggested retail price that few are actually paying. I am a highly educated consumer, and a physician, but various policies at insurance companies and at national chain pharmacies make it impossible for me to comparison shop for lower prices on my personal medicines. It is not just medications. Over the past 15 years, I have noticed that the “cost” charged for routine lab tests I get have also increased to be 300%-900% higher than what the lab ultimately gets paid by my insurance. It is a farce, and I am chagrined to have been a part of the medical system (managed care organizations, pharmacies, hospitals, and government) that concocted this Frankenstein’s monster of health care payments.

Communicating these issues to a polarized public will require leadership. It will also require better speech writing than the distorted story President Biden used to discuss insulin prices during the State of the Union address. The expensive insulin analogues in common use for diabetes are not the same insulin that was discovered a century ago. The newer medications do provide extra benefits. Assigning a fair value to those benefits is the real issue.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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It is said that “Money cannot buy happiness.” But ask anyone who does not have it and you will find that money can buy security and freedom from many fears and aggravations. There are no guarantees, but the odds are better with resources than without them. Nations with higher per capita gross domestic product have longer life expectancies, have more freedom, and offer more opportunities for the favored subsets of their populations. The adage is that a rising tide lifts all boats.

It is also said that “Money cannot buy health.” That is also a half lie. Again, there is no guarantee that money can cure what ails you. But over the past 4 decades, modern medical care has added on average 3 years to the average American’s life expectancy. These gains in life expectancy came at a steep cost. The United States has been paying a luxurious, premium price for health care compared with similarly developed nations. When I started my career studying health economics 40 years ago, U.S. health care had increased from 6% of the gross domestic product, was passing 9%, and per my professors, appeared headed for 12% – at which point the predictions were that the sky would start falling. Costs continued to rise and for the past decade about 17% of the U.S. GDP has been going to health care before the pandemic blip.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

U.S. life expectancy in the past 150 years nearly doubled. This was primarily due to public health measures rather than the small contributions of medical care for individuals. Life expectancy has mostly risen by reducing infant mortality and childhood mortality. The civil engineers who figured out how to get clean running water into cities and sewage out without the two intermingling have saved far more lives than all the doctors graduating from the medical schools. Better nutrition, better sanitation, vaccines, and, to a smaller extent, antibiotics, have all contributed worthy but lesser effects.

When it comes to individual behavior rather than public health measures, the biggest effect comes from advice physicians have been doling out for decades: Stop smoking, exercise, wear your seatbelt, and do not drink and drive. Over the past generation, medical technology added an incremental improvement to the life span (life expectancy once you attain age 60). This has occurred in cardiovascular health by treating high blood pressure, reducing stroke risk, and lowering hemoglobin A1c. Those measures added about 3 years to life span before the obesity epidemic, the opioid epidemic, and the COVID pandemic wiped out the gains. In round numbers, the price for those 3 extra years of life was about the earnings of working an extra 1-2 years in a lifetime. To share those benefits with everyone, the working stiff has to postpone retirement and work an extra 3 years.

Most recently, modern medicine has produced some very expensive therapies that can add months or years to the lives of people with certain diseases. These therapies may involve over $100,000 worth of marginally beneficial medication that statistically adds a few months to the lives of people with certain varieties of prostate, lung, and breast cancers. Similarly, treatments for chronic disease such as AIDS and cystic fibrosis may involve ongoing medication costs of $10,000 or $20,000 or more per year every year for a lifetime. There are even more extreme examples on the horizon. CAR T-cells and Aduhelm [aducanumab] have the potential to break the Medicare bank. Kaftrio [ivacaftor/tezacaftor/elexacaftor], for cystic fibrosis, is being offered only to wealthier countries.

Medical expenses are hard to analyze because the cited “cost” of many of these medications is like a manufacturer’s suggested retail price that few are actually paying. I am a highly educated consumer, and a physician, but various policies at insurance companies and at national chain pharmacies make it impossible for me to comparison shop for lower prices on my personal medicines. It is not just medications. Over the past 15 years, I have noticed that the “cost” charged for routine lab tests I get have also increased to be 300%-900% higher than what the lab ultimately gets paid by my insurance. It is a farce, and I am chagrined to have been a part of the medical system (managed care organizations, pharmacies, hospitals, and government) that concocted this Frankenstein’s monster of health care payments.

Communicating these issues to a polarized public will require leadership. It will also require better speech writing than the distorted story President Biden used to discuss insulin prices during the State of the Union address. The expensive insulin analogues in common use for diabetes are not the same insulin that was discovered a century ago. The newer medications do provide extra benefits. Assigning a fair value to those benefits is the real issue.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

It is said that “Money cannot buy happiness.” But ask anyone who does not have it and you will find that money can buy security and freedom from many fears and aggravations. There are no guarantees, but the odds are better with resources than without them. Nations with higher per capita gross domestic product have longer life expectancies, have more freedom, and offer more opportunities for the favored subsets of their populations. The adage is that a rising tide lifts all boats.

It is also said that “Money cannot buy health.” That is also a half lie. Again, there is no guarantee that money can cure what ails you. But over the past 4 decades, modern medical care has added on average 3 years to the average American’s life expectancy. These gains in life expectancy came at a steep cost. The United States has been paying a luxurious, premium price for health care compared with similarly developed nations. When I started my career studying health economics 40 years ago, U.S. health care had increased from 6% of the gross domestic product, was passing 9%, and per my professors, appeared headed for 12% – at which point the predictions were that the sky would start falling. Costs continued to rise and for the past decade about 17% of the U.S. GDP has been going to health care before the pandemic blip.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

U.S. life expectancy in the past 150 years nearly doubled. This was primarily due to public health measures rather than the small contributions of medical care for individuals. Life expectancy has mostly risen by reducing infant mortality and childhood mortality. The civil engineers who figured out how to get clean running water into cities and sewage out without the two intermingling have saved far more lives than all the doctors graduating from the medical schools. Better nutrition, better sanitation, vaccines, and, to a smaller extent, antibiotics, have all contributed worthy but lesser effects.

When it comes to individual behavior rather than public health measures, the biggest effect comes from advice physicians have been doling out for decades: Stop smoking, exercise, wear your seatbelt, and do not drink and drive. Over the past generation, medical technology added an incremental improvement to the life span (life expectancy once you attain age 60). This has occurred in cardiovascular health by treating high blood pressure, reducing stroke risk, and lowering hemoglobin A1c. Those measures added about 3 years to life span before the obesity epidemic, the opioid epidemic, and the COVID pandemic wiped out the gains. In round numbers, the price for those 3 extra years of life was about the earnings of working an extra 1-2 years in a lifetime. To share those benefits with everyone, the working stiff has to postpone retirement and work an extra 3 years.

Most recently, modern medicine has produced some very expensive therapies that can add months or years to the lives of people with certain diseases. These therapies may involve over $100,000 worth of marginally beneficial medication that statistically adds a few months to the lives of people with certain varieties of prostate, lung, and breast cancers. Similarly, treatments for chronic disease such as AIDS and cystic fibrosis may involve ongoing medication costs of $10,000 or $20,000 or more per year every year for a lifetime. There are even more extreme examples on the horizon. CAR T-cells and Aduhelm [aducanumab] have the potential to break the Medicare bank. Kaftrio [ivacaftor/tezacaftor/elexacaftor], for cystic fibrosis, is being offered only to wealthier countries.

Medical expenses are hard to analyze because the cited “cost” of many of these medications is like a manufacturer’s suggested retail price that few are actually paying. I am a highly educated consumer, and a physician, but various policies at insurance companies and at national chain pharmacies make it impossible for me to comparison shop for lower prices on my personal medicines. It is not just medications. Over the past 15 years, I have noticed that the “cost” charged for routine lab tests I get have also increased to be 300%-900% higher than what the lab ultimately gets paid by my insurance. It is a farce, and I am chagrined to have been a part of the medical system (managed care organizations, pharmacies, hospitals, and government) that concocted this Frankenstein’s monster of health care payments.

Communicating these issues to a polarized public will require leadership. It will also require better speech writing than the distorted story President Biden used to discuss insulin prices during the State of the Union address. The expensive insulin analogues in common use for diabetes are not the same insulin that was discovered a century ago. The newer medications do provide extra benefits. Assigning a fair value to those benefits is the real issue.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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What in medicine is “permissible but not edifying”?

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Changed
Mon, 12/12/2022 - 13:01

Morality is often talked about in binary terms, black and white, right or wrong. That is how children 4-8 years old first conceive of it. Moral development progresses alongside motor, language, and social skills, but pediatricians typically do not screen for it or chart it. In adolescence, the ability for abstract thought develops and, once susceptibility to peer pressure lessens, nuances begin to shade the binary model. Honor codes become possible by the college years; scandals at colleges and military academies demonstrate that some 18- to 22-year-old young adults still lack that maturity. Lawrence Kohlberg, PhD, in the 1950s proposed a six-stage model of moral development and indicated that some people never achieve the upper stages.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

Recently, neuroimaging research has demonstrated that the prefrontal cortex is still developing up to 25 years of age. Those data have ramifications for obtaining truly informed consent for medical procedures. Arbitrarily, driver’s licenses are issued at 16 years of age, the right to vote comes at age 18, and the purchase of alcohol allowed at age 21. Consent for medical care varies by state and by procedure. Treatment for general medical care, pregnancy, sexually transmitted infections, and mental health problems often have different age requirements. In some states, a 14-year-old can give consent for treatment of depression or pregnancy but cannot get a tattoo.

The rules for firearms are also complex and vary by state. Perhaps more important is the determination of medical, psychological, moral, and criminal conditions for which guns should be removed from someone’s access. Some states have created formalized red flag laws to accomplish this. Other states have informal procedures used by police and social workers rather than involving medical personnel. Recent gun-related tragedies at a St. Louis high school near me and at a Colorado Springs bar demonstrate deficiencies in the red flag approach, with multiple fatal consequences.

Some moral issues do not neatly fit the binary approach. There are many concerns that are better described by a paradigm that “all things are permissible but not everything is edifying.” Take as a model of this the consumption of alcohol. The risks of an occasional single drink are very small for most people. For some, one drink leads to binges of alcoholism. Others drink and drive. Over the centuries, various groups in various localities have counseled temperance. Some personally avoid alcohol to avoid leading others astray.

The United States from 1920 to 1933 carried out the national social experiment Prohibition that outlawed intoxicating beverages. Ultimately, the organized crime of black market alcohol production, distribution, and consumption was found to be worse than the disease. Alcohol use was again legalized. That is understandable. Still, I doubt Carrie Nation ever thought that the sponsorship of most major sporting events would rely heavily on beer and liquor companies. Legalization and promotion are two distinct acts.

A federal prohibition of marijuana since the 1950s similarly produced crime from drug dealing. It also induced many otherwise law-abiding citizens to be scofflaws. (I think the 55 mph national speed limit under President Nixon created greater numbers of scofflaws.) In my state recreational marijuana became legal as I write this column. But is that good? Wise? Edifying?

State lotteries were created partly to reduce the negative effects of the numbers games funding organized crime. That rationale is understandable, but why are states promoting the games with commercials and billion dollar payouts?

I find the “permissible but not edifying” paradigm helpful in many areas of medical ethics. The ethical concerns typically then fall into one of four categories: Slippery slope, bright lines, overuse, and conscientiously opting out. All are subspecies of the theme of going too far.

Oregon’s Death with Dignity Act was enacted 25 years ago. Nine other states now allow some form of medically assisted death. Most states prohibit it. As is now the case for abortion, medical care is typically legislated at the state level to reflect local values. Canada goes beyond assisted suicide and in the vast majority of cases employs active euthanasia with a physician pushing lethal drugs intravenously. That action is forbidden in the United States. Currently, euthanasia is involved in 10,000 deaths per year in Canada. A terminal illness is no longer needed; that requirement was ruled unconstitutional. By March 2023, intractable mental health problems will be eligible for the euthanasia cure in Canada. I have long considered myself a navigator of ethical slippery slopes because that is where the suffering people are. Canada has gone too far down this particular slope for my skill set.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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Morality is often talked about in binary terms, black and white, right or wrong. That is how children 4-8 years old first conceive of it. Moral development progresses alongside motor, language, and social skills, but pediatricians typically do not screen for it or chart it. In adolescence, the ability for abstract thought develops and, once susceptibility to peer pressure lessens, nuances begin to shade the binary model. Honor codes become possible by the college years; scandals at colleges and military academies demonstrate that some 18- to 22-year-old young adults still lack that maturity. Lawrence Kohlberg, PhD, in the 1950s proposed a six-stage model of moral development and indicated that some people never achieve the upper stages.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

Recently, neuroimaging research has demonstrated that the prefrontal cortex is still developing up to 25 years of age. Those data have ramifications for obtaining truly informed consent for medical procedures. Arbitrarily, driver’s licenses are issued at 16 years of age, the right to vote comes at age 18, and the purchase of alcohol allowed at age 21. Consent for medical care varies by state and by procedure. Treatment for general medical care, pregnancy, sexually transmitted infections, and mental health problems often have different age requirements. In some states, a 14-year-old can give consent for treatment of depression or pregnancy but cannot get a tattoo.

The rules for firearms are also complex and vary by state. Perhaps more important is the determination of medical, psychological, moral, and criminal conditions for which guns should be removed from someone’s access. Some states have created formalized red flag laws to accomplish this. Other states have informal procedures used by police and social workers rather than involving medical personnel. Recent gun-related tragedies at a St. Louis high school near me and at a Colorado Springs bar demonstrate deficiencies in the red flag approach, with multiple fatal consequences.

Some moral issues do not neatly fit the binary approach. There are many concerns that are better described by a paradigm that “all things are permissible but not everything is edifying.” Take as a model of this the consumption of alcohol. The risks of an occasional single drink are very small for most people. For some, one drink leads to binges of alcoholism. Others drink and drive. Over the centuries, various groups in various localities have counseled temperance. Some personally avoid alcohol to avoid leading others astray.

The United States from 1920 to 1933 carried out the national social experiment Prohibition that outlawed intoxicating beverages. Ultimately, the organized crime of black market alcohol production, distribution, and consumption was found to be worse than the disease. Alcohol use was again legalized. That is understandable. Still, I doubt Carrie Nation ever thought that the sponsorship of most major sporting events would rely heavily on beer and liquor companies. Legalization and promotion are two distinct acts.

A federal prohibition of marijuana since the 1950s similarly produced crime from drug dealing. It also induced many otherwise law-abiding citizens to be scofflaws. (I think the 55 mph national speed limit under President Nixon created greater numbers of scofflaws.) In my state recreational marijuana became legal as I write this column. But is that good? Wise? Edifying?

State lotteries were created partly to reduce the negative effects of the numbers games funding organized crime. That rationale is understandable, but why are states promoting the games with commercials and billion dollar payouts?

I find the “permissible but not edifying” paradigm helpful in many areas of medical ethics. The ethical concerns typically then fall into one of four categories: Slippery slope, bright lines, overuse, and conscientiously opting out. All are subspecies of the theme of going too far.

Oregon’s Death with Dignity Act was enacted 25 years ago. Nine other states now allow some form of medically assisted death. Most states prohibit it. As is now the case for abortion, medical care is typically legislated at the state level to reflect local values. Canada goes beyond assisted suicide and in the vast majority of cases employs active euthanasia with a physician pushing lethal drugs intravenously. That action is forbidden in the United States. Currently, euthanasia is involved in 10,000 deaths per year in Canada. A terminal illness is no longer needed; that requirement was ruled unconstitutional. By March 2023, intractable mental health problems will be eligible for the euthanasia cure in Canada. I have long considered myself a navigator of ethical slippery slopes because that is where the suffering people are. Canada has gone too far down this particular slope for my skill set.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

Morality is often talked about in binary terms, black and white, right or wrong. That is how children 4-8 years old first conceive of it. Moral development progresses alongside motor, language, and social skills, but pediatricians typically do not screen for it or chart it. In adolescence, the ability for abstract thought develops and, once susceptibility to peer pressure lessens, nuances begin to shade the binary model. Honor codes become possible by the college years; scandals at colleges and military academies demonstrate that some 18- to 22-year-old young adults still lack that maturity. Lawrence Kohlberg, PhD, in the 1950s proposed a six-stage model of moral development and indicated that some people never achieve the upper stages.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

Recently, neuroimaging research has demonstrated that the prefrontal cortex is still developing up to 25 years of age. Those data have ramifications for obtaining truly informed consent for medical procedures. Arbitrarily, driver’s licenses are issued at 16 years of age, the right to vote comes at age 18, and the purchase of alcohol allowed at age 21. Consent for medical care varies by state and by procedure. Treatment for general medical care, pregnancy, sexually transmitted infections, and mental health problems often have different age requirements. In some states, a 14-year-old can give consent for treatment of depression or pregnancy but cannot get a tattoo.

The rules for firearms are also complex and vary by state. Perhaps more important is the determination of medical, psychological, moral, and criminal conditions for which guns should be removed from someone’s access. Some states have created formalized red flag laws to accomplish this. Other states have informal procedures used by police and social workers rather than involving medical personnel. Recent gun-related tragedies at a St. Louis high school near me and at a Colorado Springs bar demonstrate deficiencies in the red flag approach, with multiple fatal consequences.

Some moral issues do not neatly fit the binary approach. There are many concerns that are better described by a paradigm that “all things are permissible but not everything is edifying.” Take as a model of this the consumption of alcohol. The risks of an occasional single drink are very small for most people. For some, one drink leads to binges of alcoholism. Others drink and drive. Over the centuries, various groups in various localities have counseled temperance. Some personally avoid alcohol to avoid leading others astray.

The United States from 1920 to 1933 carried out the national social experiment Prohibition that outlawed intoxicating beverages. Ultimately, the organized crime of black market alcohol production, distribution, and consumption was found to be worse than the disease. Alcohol use was again legalized. That is understandable. Still, I doubt Carrie Nation ever thought that the sponsorship of most major sporting events would rely heavily on beer and liquor companies. Legalization and promotion are two distinct acts.

A federal prohibition of marijuana since the 1950s similarly produced crime from drug dealing. It also induced many otherwise law-abiding citizens to be scofflaws. (I think the 55 mph national speed limit under President Nixon created greater numbers of scofflaws.) In my state recreational marijuana became legal as I write this column. But is that good? Wise? Edifying?

State lotteries were created partly to reduce the negative effects of the numbers games funding organized crime. That rationale is understandable, but why are states promoting the games with commercials and billion dollar payouts?

I find the “permissible but not edifying” paradigm helpful in many areas of medical ethics. The ethical concerns typically then fall into one of four categories: Slippery slope, bright lines, overuse, and conscientiously opting out. All are subspecies of the theme of going too far.

Oregon’s Death with Dignity Act was enacted 25 years ago. Nine other states now allow some form of medically assisted death. Most states prohibit it. As is now the case for abortion, medical care is typically legislated at the state level to reflect local values. Canada goes beyond assisted suicide and in the vast majority of cases employs active euthanasia with a physician pushing lethal drugs intravenously. That action is forbidden in the United States. Currently, euthanasia is involved in 10,000 deaths per year in Canada. A terminal illness is no longer needed; that requirement was ruled unconstitutional. By March 2023, intractable mental health problems will be eligible for the euthanasia cure in Canada. I have long considered myself a navigator of ethical slippery slopes because that is where the suffering people are. Canada has gone too far down this particular slope for my skill set.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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Rules for performing research with children

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Changed
Thu, 10/20/2022 - 15:40

 

The road to hell is paved with good intentions – especially true in clinical research. A Food and Drug Administration press release notes, “Historically, children were not included in clinical trials because of a misperception that excluding them from research was in fact protecting them. This resulted in many FDA-approved, licensed, cleared, or authorized drugs, biological products, and medical devices lacking pediatric-specific labeling information.” In an effort to improve on this situation, the FDA published in September 2022 a proposed new draft guidance on performing research with children that is open for public comment for 3 months.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell


There is a long history of government attempts to promote research and development for the benefit of society. Sometimes government succeeds and sometimes not. For instance, when the U.S. federal government funded scientific research in the 1960s, it sought to increase the common good by promulgating those discoveries. The government insisted that all federally funded research be in the public domain. The funding produced a spectacular number of technological advancements that have enriched society. However, a decade later, the government concluded that too many good research ideas were never developed into beneficial products because without the ability to patent the results, the costs and risks of product development were not profitable for industry. By the late 1970s, new laws were enacted to enable universities and their faculty to patent the results of government-funded research and share in any wealth created.

Pharmaceutical research in the 1970s and 1980s was mostly performed on men in order to reduce the risk of giving treatments of unknown safety to pregnant women. The unintended consequence was that the new drugs frequently were less effective for women. This was particularly true for cardiac medications for which lifestyle risk factors differed between the sexes.

Similarly, children were often excluded from research because of the unknown risks of new drugs on growing bodies and brains. Children were also seen as a vulnerable population for whom informed consent was problematic. The result of these well-intentioned restrictions was the creation of new products that did not have pediatric dosing recommendations, pediatric safety assessments, or approval for pediatric indications. To remediate these deficiencies, in 1997 and 2007 the FDA offered a 6-month extension on patent protection as motivation for companies to develop those pediatric recommendations. Alas, those laws were primarily used to extend the profitability of blockbuster products rather than truly benefit children.

Over the past 4 decades, pediatric ethicists proposed and refined rules to govern research on children. The Common Rule used by institutional review boards (IRBs) to protect human research subjects was expanded with guidelines covering children. The new draft guidance is the latest iteration of this effort. Nothing in the 14 pages of draft regulation appears revolutionary to me. The ideas are tweaks, based on theory and experience, of principles agreed upon 30 years ago. Finding the optimal social moral contract involves some empirical assessment of praxis and effectiveness.

I am loathe to summarize this new document, which itself is a summary of a vast body of literature, that supports the Code of Federal Regulations Title 21 Part 50 and 45 CFR Part 46. The draft document is well organized and I recommend it as an excellent primer for the area of pediatric research ethics if the subject is new to you. I also recommend it as required reading for anyone serving on an IRB.

IRBs usually review and approve any research on people. Generally, the selection of people for research should be done equitably. However, children should not be enrolled unless it is necessary to answer an important question relevant to children. For the past 2 decades, there has been an emphasis on obtaining the assent of the child as well as informed consent by the parents.

An important determination is whether the research is likely to help that particular child or whether it is aimed at advancing general knowledge. If there is no prospect of direct benefit, research is still permissible but more restricted for safety and comfort reasons. Next is determining whether the research carries only minimal risk or a minor increase over minimal risk. The draft defines and provides anchor examples of these situations. For instance, oral placebos and single blood draws are typically minimal risk. Multiple injections and blood draws over a year fall into the second category. One MRI is minimal risk but a minor increase in risk if it involves sedation or contrast.

 

 


I strongly support the ideals expressed in these guidelines. They represent the best blend of intentions and practical experience. They will become the law of the land. In ethics, there is merit in striving to do things properly, orderly, and enforceably.

The cynic in me sees two weaknesses in the stated approach. First, the volume of harm to children occurring during organized clinical research is extremely small. The greater harms come from off-label use, nonsystematic research, and the ignorance resulting from a lack of research. Second, my observation in all endeavors of morality is, “Raise the bar high enough and people walk under it.”

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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The road to hell is paved with good intentions – especially true in clinical research. A Food and Drug Administration press release notes, “Historically, children were not included in clinical trials because of a misperception that excluding them from research was in fact protecting them. This resulted in many FDA-approved, licensed, cleared, or authorized drugs, biological products, and medical devices lacking pediatric-specific labeling information.” In an effort to improve on this situation, the FDA published in September 2022 a proposed new draft guidance on performing research with children that is open for public comment for 3 months.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell


There is a long history of government attempts to promote research and development for the benefit of society. Sometimes government succeeds and sometimes not. For instance, when the U.S. federal government funded scientific research in the 1960s, it sought to increase the common good by promulgating those discoveries. The government insisted that all federally funded research be in the public domain. The funding produced a spectacular number of technological advancements that have enriched society. However, a decade later, the government concluded that too many good research ideas were never developed into beneficial products because without the ability to patent the results, the costs and risks of product development were not profitable for industry. By the late 1970s, new laws were enacted to enable universities and their faculty to patent the results of government-funded research and share in any wealth created.

Pharmaceutical research in the 1970s and 1980s was mostly performed on men in order to reduce the risk of giving treatments of unknown safety to pregnant women. The unintended consequence was that the new drugs frequently were less effective for women. This was particularly true for cardiac medications for which lifestyle risk factors differed between the sexes.

Similarly, children were often excluded from research because of the unknown risks of new drugs on growing bodies and brains. Children were also seen as a vulnerable population for whom informed consent was problematic. The result of these well-intentioned restrictions was the creation of new products that did not have pediatric dosing recommendations, pediatric safety assessments, or approval for pediatric indications. To remediate these deficiencies, in 1997 and 2007 the FDA offered a 6-month extension on patent protection as motivation for companies to develop those pediatric recommendations. Alas, those laws were primarily used to extend the profitability of blockbuster products rather than truly benefit children.

Over the past 4 decades, pediatric ethicists proposed and refined rules to govern research on children. The Common Rule used by institutional review boards (IRBs) to protect human research subjects was expanded with guidelines covering children. The new draft guidance is the latest iteration of this effort. Nothing in the 14 pages of draft regulation appears revolutionary to me. The ideas are tweaks, based on theory and experience, of principles agreed upon 30 years ago. Finding the optimal social moral contract involves some empirical assessment of praxis and effectiveness.

I am loathe to summarize this new document, which itself is a summary of a vast body of literature, that supports the Code of Federal Regulations Title 21 Part 50 and 45 CFR Part 46. The draft document is well organized and I recommend it as an excellent primer for the area of pediatric research ethics if the subject is new to you. I also recommend it as required reading for anyone serving on an IRB.

IRBs usually review and approve any research on people. Generally, the selection of people for research should be done equitably. However, children should not be enrolled unless it is necessary to answer an important question relevant to children. For the past 2 decades, there has been an emphasis on obtaining the assent of the child as well as informed consent by the parents.

An important determination is whether the research is likely to help that particular child or whether it is aimed at advancing general knowledge. If there is no prospect of direct benefit, research is still permissible but more restricted for safety and comfort reasons. Next is determining whether the research carries only minimal risk or a minor increase over minimal risk. The draft defines and provides anchor examples of these situations. For instance, oral placebos and single blood draws are typically minimal risk. Multiple injections and blood draws over a year fall into the second category. One MRI is minimal risk but a minor increase in risk if it involves sedation or contrast.

 

 


I strongly support the ideals expressed in these guidelines. They represent the best blend of intentions and practical experience. They will become the law of the land. In ethics, there is merit in striving to do things properly, orderly, and enforceably.

The cynic in me sees two weaknesses in the stated approach. First, the volume of harm to children occurring during organized clinical research is extremely small. The greater harms come from off-label use, nonsystematic research, and the ignorance resulting from a lack of research. Second, my observation in all endeavors of morality is, “Raise the bar high enough and people walk under it.”

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

 

The road to hell is paved with good intentions – especially true in clinical research. A Food and Drug Administration press release notes, “Historically, children were not included in clinical trials because of a misperception that excluding them from research was in fact protecting them. This resulted in many FDA-approved, licensed, cleared, or authorized drugs, biological products, and medical devices lacking pediatric-specific labeling information.” In an effort to improve on this situation, the FDA published in September 2022 a proposed new draft guidance on performing research with children that is open for public comment for 3 months.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell


There is a long history of government attempts to promote research and development for the benefit of society. Sometimes government succeeds and sometimes not. For instance, when the U.S. federal government funded scientific research in the 1960s, it sought to increase the common good by promulgating those discoveries. The government insisted that all federally funded research be in the public domain. The funding produced a spectacular number of technological advancements that have enriched society. However, a decade later, the government concluded that too many good research ideas were never developed into beneficial products because without the ability to patent the results, the costs and risks of product development were not profitable for industry. By the late 1970s, new laws were enacted to enable universities and their faculty to patent the results of government-funded research and share in any wealth created.

Pharmaceutical research in the 1970s and 1980s was mostly performed on men in order to reduce the risk of giving treatments of unknown safety to pregnant women. The unintended consequence was that the new drugs frequently were less effective for women. This was particularly true for cardiac medications for which lifestyle risk factors differed between the sexes.

Similarly, children were often excluded from research because of the unknown risks of new drugs on growing bodies and brains. Children were also seen as a vulnerable population for whom informed consent was problematic. The result of these well-intentioned restrictions was the creation of new products that did not have pediatric dosing recommendations, pediatric safety assessments, or approval for pediatric indications. To remediate these deficiencies, in 1997 and 2007 the FDA offered a 6-month extension on patent protection as motivation for companies to develop those pediatric recommendations. Alas, those laws were primarily used to extend the profitability of blockbuster products rather than truly benefit children.

Over the past 4 decades, pediatric ethicists proposed and refined rules to govern research on children. The Common Rule used by institutional review boards (IRBs) to protect human research subjects was expanded with guidelines covering children. The new draft guidance is the latest iteration of this effort. Nothing in the 14 pages of draft regulation appears revolutionary to me. The ideas are tweaks, based on theory and experience, of principles agreed upon 30 years ago. Finding the optimal social moral contract involves some empirical assessment of praxis and effectiveness.

I am loathe to summarize this new document, which itself is a summary of a vast body of literature, that supports the Code of Federal Regulations Title 21 Part 50 and 45 CFR Part 46. The draft document is well organized and I recommend it as an excellent primer for the area of pediatric research ethics if the subject is new to you. I also recommend it as required reading for anyone serving on an IRB.

IRBs usually review and approve any research on people. Generally, the selection of people for research should be done equitably. However, children should not be enrolled unless it is necessary to answer an important question relevant to children. For the past 2 decades, there has been an emphasis on obtaining the assent of the child as well as informed consent by the parents.

An important determination is whether the research is likely to help that particular child or whether it is aimed at advancing general knowledge. If there is no prospect of direct benefit, research is still permissible but more restricted for safety and comfort reasons. Next is determining whether the research carries only minimal risk or a minor increase over minimal risk. The draft defines and provides anchor examples of these situations. For instance, oral placebos and single blood draws are typically minimal risk. Multiple injections and blood draws over a year fall into the second category. One MRI is minimal risk but a minor increase in risk if it involves sedation or contrast.

 

 


I strongly support the ideals expressed in these guidelines. They represent the best blend of intentions and practical experience. They will become the law of the land. In ethics, there is merit in striving to do things properly, orderly, and enforceably.

The cynic in me sees two weaknesses in the stated approach. First, the volume of harm to children occurring during organized clinical research is extremely small. The greater harms come from off-label use, nonsystematic research, and the ignorance resulting from a lack of research. Second, my observation in all endeavors of morality is, “Raise the bar high enough and people walk under it.”

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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Reliably solving complex problems

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Wed, 08/17/2022 - 16:46

The James Webb Space Telescope (JWST) is an engineering marvel. Costing over $10 billion, it should be. The project cost overrun was 900%. The launch was delayed by more than a decade. The Human Genome Project from 1990 to 2003 was completed slightly ahead of schedule and for less than the $4-$5 billion original estimates. This HGP success story is partly because of private entrepreneurial involvement. The Superconducting Super Collider in Texas spent $2 billion but never got off the ground. Successfully shepherding huge public projects like these involves the art of politics and management as well as science.

Whatever the earlier missteps, the JWST project is now performing above expectations. It has launched, taken up residence a million miles from Earth, deployed its mirrors (a process that had more than 300 possible single points of failure, any one of which would reduce the thing to scrap metal), and been calibrated. The JWST has even been dented by a micrometeoroid – sort of like a parking lot ding on the door of your brand new car. The first images are visually amazing and producing new scientific insights. This is a pinnacle of scientific achievement.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

What characteristics enable such an achievement? How do we foster those same characteristics in the practice of medicine and medical research? Will the success of the JWST increase and restore the public’s trust in science and scientists?

After all the bickering over vaccines and masks for the past 2+ years, medical science could use a boost. The gravitas of scientists, and indeed all experts, has diminished over the 5 decades since humans walked on the moon. It has been harmed by mercenary scientists who sought to sow doubt about whether smoking caused cancer and whether fossil fuels created climate change. No proof was needed, just doubt.

The trust in science has also been harmed by the vast amount of published medical research that is wrong. An effort was made 20 years ago to rid research of the bias of taking money from drug companies. To my observation, that change produced only a small benefit that has been overwhelmed by the unintended harms. The large, well-funded academic labs of full-time researchers have been replaced with unfunded, undertrained, and inadequately supported part-time junior faculty trying to publish enough articles to be promoted. In my opinion, this change is worse than funding from Big Pharma. (Disclosure – I worked in industry prior to graduate school.)

The pressure to publish reduces skepticism, so more incorrect data are published. The small size of these amateur studies produces unconvincing conclusions that feed an industry of meta-analysis that tries to overcome the deficiencies of the individual studies. This fragmented, biased approach is not how you build, launch, deploy, and operate the JWST, which requires very high reliability.

This approach is not working well for pediatrics either. I look at the history of the recommended workup of the febrile young infant from the 1980s until today. I see constant changes to the guidelines but no real progress toward a validated, evidence-based approach. A similar history is behind treatment of neonatal hyperbilirubinemia. In the 1994 publication, there was a movement toward being less aggressive. The 2004 and 2009 editions increased the frequency of screening and phototherapy. Now, the 2022 guidelines have moved in the direction we were headed in the 1990s. The workup of infants and children with possible urinary tract infections has undergone a similar trajectory. So has the screening for neonatal herpes infections. The practice changes are more like Brownian motion than real progress. This inconsistency has led me to be skeptical of the process the American Academy of Pediatrics uses to create guidelines.

Part of solving complex problems is allowing all stakeholders’ voices to be heard. On Jan. 28, 1986, seconds after liftoff, the space shuttle Challenger exploded. In the aftermath, it was determined that some engineers had expressed concern about the very cold weather that morning. The rubber in the O-ring would not be as flexible as designed. Their objection was not listened to. The O-ring failed, the fuel tank exploded, and the ship and crew were lost. It is a lesson many engineers of my generation took to heart. Do not suppress voices.

For example, 1 year ago (September 2021), the Royal Australian and New Zealand College of Psychiatrists published a position statement, “Recognising and addressing the mental health needs of people experiencing gender dysphoria/gender incongruence.” The statement expressed concern about the marked increase in incidence of rapid-onset gender dysphoria and therefore urged more thorough assessment by psychiatry before embarking on puberty-blocking therapies. The RANZCP position is at variance with recent trends in the United States. The topic was censored at the 2021 AAP national conference. Lately, I have heard the words disinformation and homophobic used to describe my RANZCP colleagues. I have been comparing AAP, Britain’s National Institute for Health and Care Excellence, and Royal Children’s Hospital Melbourne guidelines for 20 years. The variation is enlightening. I do not know the correct answer to treating gender dysphoria, but I know suppressing viewpoints and debate leads to exploding spaceships.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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The James Webb Space Telescope (JWST) is an engineering marvel. Costing over $10 billion, it should be. The project cost overrun was 900%. The launch was delayed by more than a decade. The Human Genome Project from 1990 to 2003 was completed slightly ahead of schedule and for less than the $4-$5 billion original estimates. This HGP success story is partly because of private entrepreneurial involvement. The Superconducting Super Collider in Texas spent $2 billion but never got off the ground. Successfully shepherding huge public projects like these involves the art of politics and management as well as science.

Whatever the earlier missteps, the JWST project is now performing above expectations. It has launched, taken up residence a million miles from Earth, deployed its mirrors (a process that had more than 300 possible single points of failure, any one of which would reduce the thing to scrap metal), and been calibrated. The JWST has even been dented by a micrometeoroid – sort of like a parking lot ding on the door of your brand new car. The first images are visually amazing and producing new scientific insights. This is a pinnacle of scientific achievement.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

What characteristics enable such an achievement? How do we foster those same characteristics in the practice of medicine and medical research? Will the success of the JWST increase and restore the public’s trust in science and scientists?

After all the bickering over vaccines and masks for the past 2+ years, medical science could use a boost. The gravitas of scientists, and indeed all experts, has diminished over the 5 decades since humans walked on the moon. It has been harmed by mercenary scientists who sought to sow doubt about whether smoking caused cancer and whether fossil fuels created climate change. No proof was needed, just doubt.

The trust in science has also been harmed by the vast amount of published medical research that is wrong. An effort was made 20 years ago to rid research of the bias of taking money from drug companies. To my observation, that change produced only a small benefit that has been overwhelmed by the unintended harms. The large, well-funded academic labs of full-time researchers have been replaced with unfunded, undertrained, and inadequately supported part-time junior faculty trying to publish enough articles to be promoted. In my opinion, this change is worse than funding from Big Pharma. (Disclosure – I worked in industry prior to graduate school.)

The pressure to publish reduces skepticism, so more incorrect data are published. The small size of these amateur studies produces unconvincing conclusions that feed an industry of meta-analysis that tries to overcome the deficiencies of the individual studies. This fragmented, biased approach is not how you build, launch, deploy, and operate the JWST, which requires very high reliability.

This approach is not working well for pediatrics either. I look at the history of the recommended workup of the febrile young infant from the 1980s until today. I see constant changes to the guidelines but no real progress toward a validated, evidence-based approach. A similar history is behind treatment of neonatal hyperbilirubinemia. In the 1994 publication, there was a movement toward being less aggressive. The 2004 and 2009 editions increased the frequency of screening and phototherapy. Now, the 2022 guidelines have moved in the direction we were headed in the 1990s. The workup of infants and children with possible urinary tract infections has undergone a similar trajectory. So has the screening for neonatal herpes infections. The practice changes are more like Brownian motion than real progress. This inconsistency has led me to be skeptical of the process the American Academy of Pediatrics uses to create guidelines.

Part of solving complex problems is allowing all stakeholders’ voices to be heard. On Jan. 28, 1986, seconds after liftoff, the space shuttle Challenger exploded. In the aftermath, it was determined that some engineers had expressed concern about the very cold weather that morning. The rubber in the O-ring would not be as flexible as designed. Their objection was not listened to. The O-ring failed, the fuel tank exploded, and the ship and crew were lost. It is a lesson many engineers of my generation took to heart. Do not suppress voices.

For example, 1 year ago (September 2021), the Royal Australian and New Zealand College of Psychiatrists published a position statement, “Recognising and addressing the mental health needs of people experiencing gender dysphoria/gender incongruence.” The statement expressed concern about the marked increase in incidence of rapid-onset gender dysphoria and therefore urged more thorough assessment by psychiatry before embarking on puberty-blocking therapies. The RANZCP position is at variance with recent trends in the United States. The topic was censored at the 2021 AAP national conference. Lately, I have heard the words disinformation and homophobic used to describe my RANZCP colleagues. I have been comparing AAP, Britain’s National Institute for Health and Care Excellence, and Royal Children’s Hospital Melbourne guidelines for 20 years. The variation is enlightening. I do not know the correct answer to treating gender dysphoria, but I know suppressing viewpoints and debate leads to exploding spaceships.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

The James Webb Space Telescope (JWST) is an engineering marvel. Costing over $10 billion, it should be. The project cost overrun was 900%. The launch was delayed by more than a decade. The Human Genome Project from 1990 to 2003 was completed slightly ahead of schedule and for less than the $4-$5 billion original estimates. This HGP success story is partly because of private entrepreneurial involvement. The Superconducting Super Collider in Texas spent $2 billion but never got off the ground. Successfully shepherding huge public projects like these involves the art of politics and management as well as science.

Whatever the earlier missteps, the JWST project is now performing above expectations. It has launched, taken up residence a million miles from Earth, deployed its mirrors (a process that had more than 300 possible single points of failure, any one of which would reduce the thing to scrap metal), and been calibrated. The JWST has even been dented by a micrometeoroid – sort of like a parking lot ding on the door of your brand new car. The first images are visually amazing and producing new scientific insights. This is a pinnacle of scientific achievement.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

What characteristics enable such an achievement? How do we foster those same characteristics in the practice of medicine and medical research? Will the success of the JWST increase and restore the public’s trust in science and scientists?

After all the bickering over vaccines and masks for the past 2+ years, medical science could use a boost. The gravitas of scientists, and indeed all experts, has diminished over the 5 decades since humans walked on the moon. It has been harmed by mercenary scientists who sought to sow doubt about whether smoking caused cancer and whether fossil fuels created climate change. No proof was needed, just doubt.

The trust in science has also been harmed by the vast amount of published medical research that is wrong. An effort was made 20 years ago to rid research of the bias of taking money from drug companies. To my observation, that change produced only a small benefit that has been overwhelmed by the unintended harms. The large, well-funded academic labs of full-time researchers have been replaced with unfunded, undertrained, and inadequately supported part-time junior faculty trying to publish enough articles to be promoted. In my opinion, this change is worse than funding from Big Pharma. (Disclosure – I worked in industry prior to graduate school.)

The pressure to publish reduces skepticism, so more incorrect data are published. The small size of these amateur studies produces unconvincing conclusions that feed an industry of meta-analysis that tries to overcome the deficiencies of the individual studies. This fragmented, biased approach is not how you build, launch, deploy, and operate the JWST, which requires very high reliability.

This approach is not working well for pediatrics either. I look at the history of the recommended workup of the febrile young infant from the 1980s until today. I see constant changes to the guidelines but no real progress toward a validated, evidence-based approach. A similar history is behind treatment of neonatal hyperbilirubinemia. In the 1994 publication, there was a movement toward being less aggressive. The 2004 and 2009 editions increased the frequency of screening and phototherapy. Now, the 2022 guidelines have moved in the direction we were headed in the 1990s. The workup of infants and children with possible urinary tract infections has undergone a similar trajectory. So has the screening for neonatal herpes infections. The practice changes are more like Brownian motion than real progress. This inconsistency has led me to be skeptical of the process the American Academy of Pediatrics uses to create guidelines.

Part of solving complex problems is allowing all stakeholders’ voices to be heard. On Jan. 28, 1986, seconds after liftoff, the space shuttle Challenger exploded. In the aftermath, it was determined that some engineers had expressed concern about the very cold weather that morning. The rubber in the O-ring would not be as flexible as designed. Their objection was not listened to. The O-ring failed, the fuel tank exploded, and the ship and crew were lost. It is a lesson many engineers of my generation took to heart. Do not suppress voices.

For example, 1 year ago (September 2021), the Royal Australian and New Zealand College of Psychiatrists published a position statement, “Recognising and addressing the mental health needs of people experiencing gender dysphoria/gender incongruence.” The statement expressed concern about the marked increase in incidence of rapid-onset gender dysphoria and therefore urged more thorough assessment by psychiatry before embarking on puberty-blocking therapies. The RANZCP position is at variance with recent trends in the United States. The topic was censored at the 2021 AAP national conference. Lately, I have heard the words disinformation and homophobic used to describe my RANZCP colleagues. I have been comparing AAP, Britain’s National Institute for Health and Care Excellence, and Royal Children’s Hospital Melbourne guidelines for 20 years. The variation is enlightening. I do not know the correct answer to treating gender dysphoria, but I know suppressing viewpoints and debate leads to exploding spaceships.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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Productively working together

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Thu, 05/19/2022 - 11:54

Recently, some liberal colleagues urged a boycott of a conference in Orlando, Fla., because of various actions by its Republican state governor. At the same time, conservative colleagues advocated the boycott because business actions of Disney have become too leftist. Concerns about spreading COVID-19 at the national gathering have become small, compared with the desire to virtue-signal political viewpoints.

The 1960s in the United States were a time of social upheaval and polarization with many similarities to modern America. One difference is that, after a few years of social revolution, society emphasized bridging the differences. Politicians talked about reaching across the aisle. Religious groups sought ecumenical and interfaith ventures. Business and educational institutions promoted equal opportunity programs. The emphasis was finding common ground.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

A half century later, the polarized work environment of medical organizations in 2022 has led to emphasis on cancel culture, litmus tests, and finding reasons not to work with others and to silence dissent. A professional working in a polarized environment faces frequent challenges that pit ethical and political principles against the pragmatic need to set and accomplish team goals that productively care for patients and support staff. One of the worst things societies can do for children’s health is to perpetuate the paralyzing divisiveness of modern politics.

As Justice Stephen Breyer nears retirement from the Supreme Court, I reflect back to 1994 when, on the day of his nomination to the court by President Clinton, Justice Breyer at a press conference said, “What [the law is] supposed to do seen as a whole is allow all people, all people, to live together in a society where they have so many different views, so many different needs, but to live together in a way that is more harmonious, that is better so that they can work productively together.”

I generally reject secondary boycotts and the hatred they spew. True inclusivity does not divide. True inclusivity is very messy. It rejects tyrants who insist on litmus tests to prove wokeness. Every red state has Democrats and every blue state has Republicans. If you are dedicated to loving your neighbor, I think it is necessary professionally to focus on who you will work with to improve the world. If woke extremism says you can only work with someone who echoes the same end of the blue or red political spectrum as yourself, that is not loving, not inclusive, and not productive.

My advice is to focus on the values, goals, and pathways you share with colleagues rather than using political or social differences to prejudice you against working with someone toward a common goal. The old adage is that politics makes strange bedfellows. People with diverse, divergent, and even opposed life views can work together to build schools and roads that benefit the community, contrary to the polarized examples that have flooded Washington, D.C., for the past 2 decades. (Generation Z: Take this as testimony from a Boomer who saw how politics used to work, especially in small towns.)

My other advice is to believe in free speech, but it requires a long civics lesson to understand what that means. Facebook promulgating unvetted posts as news feeds is not free speech. Facebook creating profiles so the app creates tailored echo chambers of misinformation is not free speech. President Obama ignoring the problem for 8 years as the iPhone became ubiquitous did not help. President Trump’s outreach to the masses via Twitter did not model responsible free speech. Surreptitiously promoting certain political viewpoints in math textbooks is not responsible behavior and has generated mistrust and the replacement of boards of education. Elon Musk wanting to buy Twitter is an unknown.

I won’t attempt to offer any pearls of wisdom on free speech in this column. It is a complex subject. I will suggest that doing a better job with free speech will save far more lives than eliminating crib bumpers.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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Recently, some liberal colleagues urged a boycott of a conference in Orlando, Fla., because of various actions by its Republican state governor. At the same time, conservative colleagues advocated the boycott because business actions of Disney have become too leftist. Concerns about spreading COVID-19 at the national gathering have become small, compared with the desire to virtue-signal political viewpoints.

The 1960s in the United States were a time of social upheaval and polarization with many similarities to modern America. One difference is that, after a few years of social revolution, society emphasized bridging the differences. Politicians talked about reaching across the aisle. Religious groups sought ecumenical and interfaith ventures. Business and educational institutions promoted equal opportunity programs. The emphasis was finding common ground.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

A half century later, the polarized work environment of medical organizations in 2022 has led to emphasis on cancel culture, litmus tests, and finding reasons not to work with others and to silence dissent. A professional working in a polarized environment faces frequent challenges that pit ethical and political principles against the pragmatic need to set and accomplish team goals that productively care for patients and support staff. One of the worst things societies can do for children’s health is to perpetuate the paralyzing divisiveness of modern politics.

As Justice Stephen Breyer nears retirement from the Supreme Court, I reflect back to 1994 when, on the day of his nomination to the court by President Clinton, Justice Breyer at a press conference said, “What [the law is] supposed to do seen as a whole is allow all people, all people, to live together in a society where they have so many different views, so many different needs, but to live together in a way that is more harmonious, that is better so that they can work productively together.”

I generally reject secondary boycotts and the hatred they spew. True inclusivity does not divide. True inclusivity is very messy. It rejects tyrants who insist on litmus tests to prove wokeness. Every red state has Democrats and every blue state has Republicans. If you are dedicated to loving your neighbor, I think it is necessary professionally to focus on who you will work with to improve the world. If woke extremism says you can only work with someone who echoes the same end of the blue or red political spectrum as yourself, that is not loving, not inclusive, and not productive.

My advice is to focus on the values, goals, and pathways you share with colleagues rather than using political or social differences to prejudice you against working with someone toward a common goal. The old adage is that politics makes strange bedfellows. People with diverse, divergent, and even opposed life views can work together to build schools and roads that benefit the community, contrary to the polarized examples that have flooded Washington, D.C., for the past 2 decades. (Generation Z: Take this as testimony from a Boomer who saw how politics used to work, especially in small towns.)

My other advice is to believe in free speech, but it requires a long civics lesson to understand what that means. Facebook promulgating unvetted posts as news feeds is not free speech. Facebook creating profiles so the app creates tailored echo chambers of misinformation is not free speech. President Obama ignoring the problem for 8 years as the iPhone became ubiquitous did not help. President Trump’s outreach to the masses via Twitter did not model responsible free speech. Surreptitiously promoting certain political viewpoints in math textbooks is not responsible behavior and has generated mistrust and the replacement of boards of education. Elon Musk wanting to buy Twitter is an unknown.

I won’t attempt to offer any pearls of wisdom on free speech in this column. It is a complex subject. I will suggest that doing a better job with free speech will save far more lives than eliminating crib bumpers.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

Recently, some liberal colleagues urged a boycott of a conference in Orlando, Fla., because of various actions by its Republican state governor. At the same time, conservative colleagues advocated the boycott because business actions of Disney have become too leftist. Concerns about spreading COVID-19 at the national gathering have become small, compared with the desire to virtue-signal political viewpoints.

The 1960s in the United States were a time of social upheaval and polarization with many similarities to modern America. One difference is that, after a few years of social revolution, society emphasized bridging the differences. Politicians talked about reaching across the aisle. Religious groups sought ecumenical and interfaith ventures. Business and educational institutions promoted equal opportunity programs. The emphasis was finding common ground.

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

A half century later, the polarized work environment of medical organizations in 2022 has led to emphasis on cancel culture, litmus tests, and finding reasons not to work with others and to silence dissent. A professional working in a polarized environment faces frequent challenges that pit ethical and political principles against the pragmatic need to set and accomplish team goals that productively care for patients and support staff. One of the worst things societies can do for children’s health is to perpetuate the paralyzing divisiveness of modern politics.

As Justice Stephen Breyer nears retirement from the Supreme Court, I reflect back to 1994 when, on the day of his nomination to the court by President Clinton, Justice Breyer at a press conference said, “What [the law is] supposed to do seen as a whole is allow all people, all people, to live together in a society where they have so many different views, so many different needs, but to live together in a way that is more harmonious, that is better so that they can work productively together.”

I generally reject secondary boycotts and the hatred they spew. True inclusivity does not divide. True inclusivity is very messy. It rejects tyrants who insist on litmus tests to prove wokeness. Every red state has Democrats and every blue state has Republicans. If you are dedicated to loving your neighbor, I think it is necessary professionally to focus on who you will work with to improve the world. If woke extremism says you can only work with someone who echoes the same end of the blue or red political spectrum as yourself, that is not loving, not inclusive, and not productive.

My advice is to focus on the values, goals, and pathways you share with colleagues rather than using political or social differences to prejudice you against working with someone toward a common goal. The old adage is that politics makes strange bedfellows. People with diverse, divergent, and even opposed life views can work together to build schools and roads that benefit the community, contrary to the polarized examples that have flooded Washington, D.C., for the past 2 decades. (Generation Z: Take this as testimony from a Boomer who saw how politics used to work, especially in small towns.)

My other advice is to believe in free speech, but it requires a long civics lesson to understand what that means. Facebook promulgating unvetted posts as news feeds is not free speech. Facebook creating profiles so the app creates tailored echo chambers of misinformation is not free speech. President Obama ignoring the problem for 8 years as the iPhone became ubiquitous did not help. President Trump’s outreach to the masses via Twitter did not model responsible free speech. Surreptitiously promoting certain political viewpoints in math textbooks is not responsible behavior and has generated mistrust and the replacement of boards of education. Elon Musk wanting to buy Twitter is an unknown.

I won’t attempt to offer any pearls of wisdom on free speech in this column. It is a complex subject. I will suggest that doing a better job with free speech will save far more lives than eliminating crib bumpers.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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Get the science right

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Mon, 03/21/2022 - 14:09

Get the science right. I have spent years researching and reflecting on what makes the best physicians, the best medicine, the optimal organized medical system, and the best medical ethics and law to support all of it. I have traveled to almost innumerable conferences to discuss these topics with colleagues who have similar goals. Time and time again, I come back to the conclusion that, in the modern era, the second-most important thing to do is to get the science right.

The practice of medicine in my Western world can be traced back to Hippocrates and earlier. The practice of nursing has other milestones. The healing arts have different points of origin in other cultures, such as China. In a modern world of mass communication, these various historical paths are converging on scientific evidence. The science to support medicine has always had flaws, but it has fared better than the other options. Sometimes, the science was so sketchy that the key was to believe in whatever the shaman was providing. But for the past 100 years, science, rather than tradition and hierarchy, has been relied upon to guide policy and action. For the past 50 years, evidence-based medicine has ascended. Have we become better than the snake oil salesmen of the late 19th century?

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

Modern health care is far from perfect. The pandemic has been a major stressor to the health care system. The pandemic has revealed flaws and weaknesses, including inequity in access to care, health illiteracy, and a shaky moral compass balancing individual liberty and social good. Overall, despite multiple mistakes dealing with a novel threat, I think the institutions promoting science have performed well during the pandemic, especially when compared with the moral and governmental institutions encouraging ethical behavior and making policies to promote justice.

My highest praise would be for the professionalism of health care workers. Nurses and physicians have staffed the hospitals and clinics caring for people when the hallways were overflowing for days without end. Without the commitment, the teamwork, and the courage to provide that care, the death toll would have been much higher and the suffering unimaginable. My observation is that these people were not motivated by an abstract primum non nocere, first do no harm. It was the commitment to love one’s neighbor and care for the sick. This dedication is the first most important thing in professionalism.

Part of what fuels that commitment is a belief that what they are doing makes a difference. The belief is stronger when there is measurable, scientific evidence that a difference is being made. The scientific decisions have not been perfect, but at this point the evidence is clear that the shutdown flattened the curve. Vaccines saved lives and will continue to do so. Masks saved lives. Nursing care, particularly intensive care, reduced the case fatality rate and assuaged suffering and grief.

What lessons about training new providers can be gleaned from the past 2 years? Those who teach professionalism for physicians, nurses, and other health care workers should strengthen the common value systems that undergird the commitment people have to the patients and the professions. In the face of postmodern nihilism and relativism, virtues need to be clarified and reinforced. In the face of political polarization which seeks to make a political affiliation the locus of loyalty and commitment, emphasize the fellowship of the health care professions.

To me as a scientist, a key lesson is that we need to be better at getting the science right. Two years ago I was wiping some groceries with alcohol and quarantining cans in shopping bags in the corner of the kitchen for 24 hours before shelving them. I still push elevator buttons with my knuckles. The Centers for Disease Control and Prevention needs to revamp their policy making procedures.

Institutions must work to reestablish the public trust in science. That is a challenge because while many amazing scientific advances have occurred (i.e., my MRI last week showed far more going on than my orthopedist and physical therapist detected based on clinical exam). Imaging such as MR and ultrasound have been major advances in diagnostic medicine, but there are also repeated examples demonstrating where medicine has been wrong. In the past 6 months I have read new guidelines for ear tubes, for neonatal jaundice, for newborn sepsis, and for newborn hypoglycemia. All indicate to me that my training 30 years ago was on target and the interval “improvements” in practice have been worthless Brownian motion based on false scientific discoveries. My recommendation would be that pediatrics do one-third as much research but do that research three times better and get it right.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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Get the science right. I have spent years researching and reflecting on what makes the best physicians, the best medicine, the optimal organized medical system, and the best medical ethics and law to support all of it. I have traveled to almost innumerable conferences to discuss these topics with colleagues who have similar goals. Time and time again, I come back to the conclusion that, in the modern era, the second-most important thing to do is to get the science right.

The practice of medicine in my Western world can be traced back to Hippocrates and earlier. The practice of nursing has other milestones. The healing arts have different points of origin in other cultures, such as China. In a modern world of mass communication, these various historical paths are converging on scientific evidence. The science to support medicine has always had flaws, but it has fared better than the other options. Sometimes, the science was so sketchy that the key was to believe in whatever the shaman was providing. But for the past 100 years, science, rather than tradition and hierarchy, has been relied upon to guide policy and action. For the past 50 years, evidence-based medicine has ascended. Have we become better than the snake oil salesmen of the late 19th century?

Dr. Kevin T. Powell, a pediatric hospitalist and clinical ethics consultant in St. Louis.
Dr. Kevin T. Powell

Modern health care is far from perfect. The pandemic has been a major stressor to the health care system. The pandemic has revealed flaws and weaknesses, including inequity in access to care, health illiteracy, and a shaky moral compass balancing individual liberty and social good. Overall, despite multiple mistakes dealing with a novel threat, I think the institutions promoting science have performed well during the pandemic, especially when compared with the moral and governmental institutions encouraging ethical behavior and making policies to promote justice.

My highest praise would be for the professionalism of health care workers. Nurses and physicians have staffed the hospitals and clinics caring for people when the hallways were overflowing for days without end. Without the commitment, the teamwork, and the courage to provide that care, the death toll would have been much higher and the suffering unimaginable. My observation is that these people were not motivated by an abstract primum non nocere, first do no harm. It was the commitment to love one’s neighbor and care for the sick. This dedication is the first most important thing in professionalism.

Part of what fuels that commitment is a belief that what they are doing makes a difference. The belief is stronger when there is measurable, scientific evidence that a difference is being made. The scientific decisions have not been perfect, but at this point the evidence is clear that the shutdown flattened the curve. Vaccines saved lives and will continue to do so. Masks saved lives. Nursing care, particularly intensive care, reduced the case fatality rate and assuaged suffering and grief.

What lessons about training new providers can be gleaned from the past 2 years? Those who teach professionalism for physicians, nurses, and other health care workers should strengthen the common value systems that undergird the commitment people have to the patients and the professions. In the face of postmodern nihilism and relativism, virtues need to be clarified and reinforced. In the face of political polarization which seeks to make a political affiliation the locus of loyalty and commitment, emphasize the fellowship of the health care professions.

To me as a scientist, a key lesson is that we need to be better at getting the science right. Two years ago I was wiping some groceries with alcohol and quarantining cans in shopping bags in the corner of the kitchen for 24 hours before shelving them. I still push elevator buttons with my knuckles. The Centers for Disease Control and Prevention needs to revamp their policy making procedures.

Institutions must work to reestablish the public trust in science. That is a challenge because while many amazing scientific advances have occurred (i.e., my MRI last week showed far more going on than my orthopedist and physical therapist detected based on clinical exam). Imaging such as MR and ultrasound have been major advances in diagnostic medicine, but there are also repeated examples demonstrating where medicine has been wrong. In the past 6 months I have read new guidelines for ear tubes, for neonatal jaundice, for newborn sepsis, and for newborn hypoglycemia. All indicate to me that my training 30 years ago was on target and the interval “improvements” in practice have been worthless Brownian motion based on false scientific discoveries. My recommendation would be that pediatrics do one-third as much research but do that research three times better and get it right.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

Get the science right. I have spent years researching and reflecting on what makes the best physicians, the best medicine, the optimal organized medical system, and the best medical ethics and law to support all of it. I have traveled to almost innumerable conferences to discuss these topics with colleagues who have similar goals. Time and time again, I come back to the conclusion that, in the modern era, the second-most important thing to do is to get the science right.

The practice of medicine in my Western world can be traced back to Hippocrates and earlier. The practice of nursing has other milestones. The healing arts have different points of origin in other cultures, such as China. In a modern world of mass communication, these various historical paths are converging on scientific evidence. The science to support medicine has always had flaws, but it has fared better than the other options. Sometimes, the science was so sketchy that the key was to believe in whatever the shaman was providing. But for the past 100 years, science, rather than tradition and hierarchy, has been relied upon to guide policy and action. For the past 50 years, evidence-based medicine has ascended. Have we become better than the snake oil salesmen of the late 19th century?

Dr. Kevin T. Powell

Modern health care is far from perfect. The pandemic has been a major stressor to the health care system. The pandemic has revealed flaws and weaknesses, including inequity in access to care, health illiteracy, and a shaky moral compass balancing individual liberty and social good. Overall, despite multiple mistakes dealing with a novel threat, I think the institutions promoting science have performed well during the pandemic, especially when compared with the moral and governmental institutions encouraging ethical behavior and making policies to promote justice.

My highest praise would be for the professionalism of health care workers. Nurses and physicians have staffed the hospitals and clinics caring for people when the hallways were overflowing for days without end. Without the commitment, the teamwork, and the courage to provide that care, the death toll would have been much higher and the suffering unimaginable. My observation is that these people were not motivated by an abstract primum non nocere, first do no harm. It was the commitment to love one’s neighbor and care for the sick. This dedication is the first most important thing in professionalism.

Part of what fuels that commitment is a belief that what they are doing makes a difference. The belief is stronger when there is measurable, scientific evidence that a difference is being made. The scientific decisions have not been perfect, but at this point the evidence is clear that the shutdown flattened the curve. Vaccines saved lives and will continue to do so. Masks saved lives. Nursing care, particularly intensive care, reduced the case fatality rate and assuaged suffering and grief.

What lessons about training new providers can be gleaned from the past 2 years? Those who teach professionalism for physicians, nurses, and other health care workers should strengthen the common value systems that undergird the commitment people have to the patients and the professions. In the face of postmodern nihilism and relativism, virtues need to be clarified and reinforced. In the face of political polarization which seeks to make a political affiliation the locus of loyalty and commitment, emphasize the fellowship of the health care professions.

To me as a scientist, a key lesson is that we need to be better at getting the science right. Two years ago I was wiping some groceries with alcohol and quarantining cans in shopping bags in the corner of the kitchen for 24 hours before shelving them. I still push elevator buttons with my knuckles. The Centers for Disease Control and Prevention needs to revamp their policy making procedures.

Institutions must work to reestablish the public trust in science. That is a challenge because while many amazing scientific advances have occurred (i.e., my MRI last week showed far more going on than my orthopedist and physical therapist detected based on clinical exam). Imaging such as MR and ultrasound have been major advances in diagnostic medicine, but there are also repeated examples demonstrating where medicine has been wrong. In the past 6 months I have read new guidelines for ear tubes, for neonatal jaundice, for newborn sepsis, and for newborn hypoglycemia. All indicate to me that my training 30 years ago was on target and the interval “improvements” in practice have been worthless Brownian motion based on false scientific discoveries. My recommendation would be that pediatrics do one-third as much research but do that research three times better and get it right.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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Physician as trusted counselor

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Wed, 01/12/2022 - 09:35

Pediatricians play many roles as they fulfill their duties and responsibilities. Among these is the role of trusted counselor.

A pediatrician is a risk manager. Not the risk manager at a brokerage firm assessing financial risks. Not the hospital lawyer providing legal advice to minimize lawsuits against the hospital. The pediatrician, as risk manager, is a fiduciary, confidant, partner, and guide for parents seeking to protect and maximize the health of their children.

Dr. Kevin T. Powell

The practice of pediatrics deals with many low-probability, high-impact threats. This begins before birth. The obstetrician has already ordered a litany of prenatal screens, blood tests, and ultrasounds. Many of these have a positive predictive value of less than 20%. That means the alarming positive results are wrong more than 80% of the time. Tests done purportedly to reassure the parents are likely to falsely terrify them. This devilish process continues immediately after birth. The newborns are subjected to a wide variety of screening tests that they must pass before being stamped USDA Prime baby. Early in my career, a thorough newborn physical exam was the key means of identifying problems. Modern medicine employs a wide variety of blood tests, a hearing screen, a pulse ox check, and a transcutaneous bilirubin test before discharge. It is a gauntlet that few escape unscathed. Even the totally normal infant is going to flunk a handful of these screens. Then the nursery doctor is ready to erect additional hoops to jump through. Too big or too small? You need glucose checks. Breech presentation? A hip ultrasound. Too long in labor? Blood tests. Too pale or too ruddy? Blood tests. Not acting quite right? Temperature too high? Temperature too low? Too irritable? Too lethargic? Baby, you’ve hit the jackpot for extra blood tests, an app to estimate the risk of early-onset sepsis, and maybe a trip to the NICU.

Many of these protocols have poor positive predictive value results that are not easy to explain to lay people. The ideas are not easily taught to medical students. Those results can be even harder to communicate to new parents with health care careers. A little knowledge goes a long ways toward long, sleepless nights of worrying even though the baby is just fine. Even cute. Snuggly. A good baby! Parents, hug your baby! Feed the baby! Let the professional do most of the worrying.

What does a professional worrier offer? First, a comprehension of the science. The professional understands sensitivity and specificity, false-positive rates, prevalence, and positive predictive value. Second, particular knowledge of the various tests involved, including the confirmatory tests and the risk-benefit of treatment. Third, experienced clinical judgment that knows that lotteries are bad investments even though two people are splitting a $600 million lottery win this week. Most people don’t emotionally cope with small risks. Fourth, the ability to do values clarification. There is not a one-size-fits-all bedside approach in pediatrics. Parents have differing expectations, differing levels of risk aversion, and different methods for handling anxiety. First-time parents may be very risk intolerant with their baby. Some people deal with fear by seeking more information. Others are looking for evidence that the expert physician is committed to compassionately providing whatever is best for their child.

How has medicine evolved recently? I will highlight four items. First, as described earlier, there has been a large increase in the number of these screens that will be failed. Typical office practice continues the methodology with well child exams and developmental screening. Second, many screens have been introduced that have very low positive predictive value. This leads to many anxious parents who will benefit from pediatricians with the bedside manner to guide the parents and their precious baby through this maze of scientific interventions. The science is difficult enough to master during training. It takes more time to learn the art of counseling parents, listening to their concerns, and earning their trust. That art is practiced in face-to-face encounters with the parents. The classic approach to residency training limits the opportunity to observe and mentor the knowledge, skills, and empathy of a good bedside manner.

A third evolution, more recent, has been the widespread pollution of scientific knowledge with misinformation and disinformation through social media. I addressed that issue in my columns in January and March 2019.

Fourth, most recently, I believe the pandemic has emphasized to the public that nothing in life is totally risk free. Extreme efforts to reduce risk produce unwanted consequences. There is a window of opportunity here to work with parents and patients to build relationships that help people to assess risks and make more rational and beneficial choices. For example, when is the risk of meningitis in a febrile young infant low enough to manage at home? The risk will never be zero. But admission to the hospital “just in case” is not risk free either. People are acutely aware of that right now.

Health care professionals can position themselves as the trusted source of health information specific to a particular person’s situation. Health care professionals can be competent, committed, and compassionate listeners to what really worries people. In this way, we manage risk. This role also involves addressing the mental health crisis causing so much suicide and addiction. Severe problems should be referred to specialists, but I anticipate in the near future that most pediatricians will require more skills dealing with risk and anxiety rather than microbes.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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Pediatricians play many roles as they fulfill their duties and responsibilities. Among these is the role of trusted counselor.

A pediatrician is a risk manager. Not the risk manager at a brokerage firm assessing financial risks. Not the hospital lawyer providing legal advice to minimize lawsuits against the hospital. The pediatrician, as risk manager, is a fiduciary, confidant, partner, and guide for parents seeking to protect and maximize the health of their children.

Dr. Kevin T. Powell

The practice of pediatrics deals with many low-probability, high-impact threats. This begins before birth. The obstetrician has already ordered a litany of prenatal screens, blood tests, and ultrasounds. Many of these have a positive predictive value of less than 20%. That means the alarming positive results are wrong more than 80% of the time. Tests done purportedly to reassure the parents are likely to falsely terrify them. This devilish process continues immediately after birth. The newborns are subjected to a wide variety of screening tests that they must pass before being stamped USDA Prime baby. Early in my career, a thorough newborn physical exam was the key means of identifying problems. Modern medicine employs a wide variety of blood tests, a hearing screen, a pulse ox check, and a transcutaneous bilirubin test before discharge. It is a gauntlet that few escape unscathed. Even the totally normal infant is going to flunk a handful of these screens. Then the nursery doctor is ready to erect additional hoops to jump through. Too big or too small? You need glucose checks. Breech presentation? A hip ultrasound. Too long in labor? Blood tests. Too pale or too ruddy? Blood tests. Not acting quite right? Temperature too high? Temperature too low? Too irritable? Too lethargic? Baby, you’ve hit the jackpot for extra blood tests, an app to estimate the risk of early-onset sepsis, and maybe a trip to the NICU.

Many of these protocols have poor positive predictive value results that are not easy to explain to lay people. The ideas are not easily taught to medical students. Those results can be even harder to communicate to new parents with health care careers. A little knowledge goes a long ways toward long, sleepless nights of worrying even though the baby is just fine. Even cute. Snuggly. A good baby! Parents, hug your baby! Feed the baby! Let the professional do most of the worrying.

What does a professional worrier offer? First, a comprehension of the science. The professional understands sensitivity and specificity, false-positive rates, prevalence, and positive predictive value. Second, particular knowledge of the various tests involved, including the confirmatory tests and the risk-benefit of treatment. Third, experienced clinical judgment that knows that lotteries are bad investments even though two people are splitting a $600 million lottery win this week. Most people don’t emotionally cope with small risks. Fourth, the ability to do values clarification. There is not a one-size-fits-all bedside approach in pediatrics. Parents have differing expectations, differing levels of risk aversion, and different methods for handling anxiety. First-time parents may be very risk intolerant with their baby. Some people deal with fear by seeking more information. Others are looking for evidence that the expert physician is committed to compassionately providing whatever is best for their child.

How has medicine evolved recently? I will highlight four items. First, as described earlier, there has been a large increase in the number of these screens that will be failed. Typical office practice continues the methodology with well child exams and developmental screening. Second, many screens have been introduced that have very low positive predictive value. This leads to many anxious parents who will benefit from pediatricians with the bedside manner to guide the parents and their precious baby through this maze of scientific interventions. The science is difficult enough to master during training. It takes more time to learn the art of counseling parents, listening to their concerns, and earning their trust. That art is practiced in face-to-face encounters with the parents. The classic approach to residency training limits the opportunity to observe and mentor the knowledge, skills, and empathy of a good bedside manner.

A third evolution, more recent, has been the widespread pollution of scientific knowledge with misinformation and disinformation through social media. I addressed that issue in my columns in January and March 2019.

Fourth, most recently, I believe the pandemic has emphasized to the public that nothing in life is totally risk free. Extreme efforts to reduce risk produce unwanted consequences. There is a window of opportunity here to work with parents and patients to build relationships that help people to assess risks and make more rational and beneficial choices. For example, when is the risk of meningitis in a febrile young infant low enough to manage at home? The risk will never be zero. But admission to the hospital “just in case” is not risk free either. People are acutely aware of that right now.

Health care professionals can position themselves as the trusted source of health information specific to a particular person’s situation. Health care professionals can be competent, committed, and compassionate listeners to what really worries people. In this way, we manage risk. This role also involves addressing the mental health crisis causing so much suicide and addiction. Severe problems should be referred to specialists, but I anticipate in the near future that most pediatricians will require more skills dealing with risk and anxiety rather than microbes.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

Pediatricians play many roles as they fulfill their duties and responsibilities. Among these is the role of trusted counselor.

A pediatrician is a risk manager. Not the risk manager at a brokerage firm assessing financial risks. Not the hospital lawyer providing legal advice to minimize lawsuits against the hospital. The pediatrician, as risk manager, is a fiduciary, confidant, partner, and guide for parents seeking to protect and maximize the health of their children.

Dr. Kevin T. Powell

The practice of pediatrics deals with many low-probability, high-impact threats. This begins before birth. The obstetrician has already ordered a litany of prenatal screens, blood tests, and ultrasounds. Many of these have a positive predictive value of less than 20%. That means the alarming positive results are wrong more than 80% of the time. Tests done purportedly to reassure the parents are likely to falsely terrify them. This devilish process continues immediately after birth. The newborns are subjected to a wide variety of screening tests that they must pass before being stamped USDA Prime baby. Early in my career, a thorough newborn physical exam was the key means of identifying problems. Modern medicine employs a wide variety of blood tests, a hearing screen, a pulse ox check, and a transcutaneous bilirubin test before discharge. It is a gauntlet that few escape unscathed. Even the totally normal infant is going to flunk a handful of these screens. Then the nursery doctor is ready to erect additional hoops to jump through. Too big or too small? You need glucose checks. Breech presentation? A hip ultrasound. Too long in labor? Blood tests. Too pale or too ruddy? Blood tests. Not acting quite right? Temperature too high? Temperature too low? Too irritable? Too lethargic? Baby, you’ve hit the jackpot for extra blood tests, an app to estimate the risk of early-onset sepsis, and maybe a trip to the NICU.

Many of these protocols have poor positive predictive value results that are not easy to explain to lay people. The ideas are not easily taught to medical students. Those results can be even harder to communicate to new parents with health care careers. A little knowledge goes a long ways toward long, sleepless nights of worrying even though the baby is just fine. Even cute. Snuggly. A good baby! Parents, hug your baby! Feed the baby! Let the professional do most of the worrying.

What does a professional worrier offer? First, a comprehension of the science. The professional understands sensitivity and specificity, false-positive rates, prevalence, and positive predictive value. Second, particular knowledge of the various tests involved, including the confirmatory tests and the risk-benefit of treatment. Third, experienced clinical judgment that knows that lotteries are bad investments even though two people are splitting a $600 million lottery win this week. Most people don’t emotionally cope with small risks. Fourth, the ability to do values clarification. There is not a one-size-fits-all bedside approach in pediatrics. Parents have differing expectations, differing levels of risk aversion, and different methods for handling anxiety. First-time parents may be very risk intolerant with their baby. Some people deal with fear by seeking more information. Others are looking for evidence that the expert physician is committed to compassionately providing whatever is best for their child.

How has medicine evolved recently? I will highlight four items. First, as described earlier, there has been a large increase in the number of these screens that will be failed. Typical office practice continues the methodology with well child exams and developmental screening. Second, many screens have been introduced that have very low positive predictive value. This leads to many anxious parents who will benefit from pediatricians with the bedside manner to guide the parents and their precious baby through this maze of scientific interventions. The science is difficult enough to master during training. It takes more time to learn the art of counseling parents, listening to their concerns, and earning their trust. That art is practiced in face-to-face encounters with the parents. The classic approach to residency training limits the opportunity to observe and mentor the knowledge, skills, and empathy of a good bedside manner.

A third evolution, more recent, has been the widespread pollution of scientific knowledge with misinformation and disinformation through social media. I addressed that issue in my columns in January and March 2019.

Fourth, most recently, I believe the pandemic has emphasized to the public that nothing in life is totally risk free. Extreme efforts to reduce risk produce unwanted consequences. There is a window of opportunity here to work with parents and patients to build relationships that help people to assess risks and make more rational and beneficial choices. For example, when is the risk of meningitis in a febrile young infant low enough to manage at home? The risk will never be zero. But admission to the hospital “just in case” is not risk free either. People are acutely aware of that right now.

Health care professionals can position themselves as the trusted source of health information specific to a particular person’s situation. Health care professionals can be competent, committed, and compassionate listeners to what really worries people. In this way, we manage risk. This role also involves addressing the mental health crisis causing so much suicide and addiction. Severe problems should be referred to specialists, but I anticipate in the near future that most pediatricians will require more skills dealing with risk and anxiety rather than microbes.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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A house divided cannot stand

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Changed
Wed, 11/10/2021 - 13:15

 

The United States of America are not united. Politics have polarized the competing monologues and the policy making around vaccines, masks, children returning to school, what children are taught in school, and whether the federal government (or the National Football League) can or should create universal mandates enforcing one extreme of any of those policy disputes. Public health and health care have become so entangled in polarized politics that the role of science has often been pushed aside.

Dr. Kevin T. Powell

Polarization is not a novel event in the history of governments. The partition of India in 1947 divided most of its Hindu and Muslim inhabitants into separate countries, but that hasn’t stopped the recent resurgence of Hindu nationalism in India. The Thirty Years’ War in Europe sought to decide whether Catholics or Protestants would dominate Western Christianity. Those two sides decided in 1648 that coexistence was wiser than continuing into the abyss of mutual annihilation. Current conflicts between Israelis and Palestinians, between Shia and Sunni Arab states, between China and the Uyghurs, and within Sudan and Ethiopia together demonstrate that polarization to the point of genocide can occur regardless of religion, race, and nationality.

Abraham Lincoln, a lawyer in Illinois with a habit of losing elections, was nominated in 1858 to be the Republican nominee in the U.S. Senate race. His speech accepting the nomination spoke a truth that resonated across the nation and across time. It is known as the House Divided speech. He said: “A house divided against itself cannot stand. I believe this government cannot endure, permanently half slave and half free. I do not expect the Union to be dissolved – I do not expect the house to fall – but I do expect it will cease to be divided. It will become all one thing or all the other.”

The Republican Lincoln, supported by antislavery groups, lost that election to the Democrat Stephen A. Douglas, whose party espoused popular sovereignty and local decision-making about slavery. Lincoln’s acceptance speech propelled him 2 years later to be nominated for and elected President of the United States. Lincoln’s first inaugural address as the President of the United States on March 4, 1861, focused on the issue of division and secession. This time, Lincoln placed much more emphasis on preserving the Union. He specifically renounced any federal efforts to use force to abolish slavery in the states that permitted it. He declared: “I have no purpose, directly or indirectly, to interfere with the institution of slavery in the States where it exists. I believe I have no lawful right to do so, and I have no inclination to do so.”

President Lincoln’s approach might not meet muster in today’s cancel culture. He was facing a precariously divided nation not unlike the current day, so his speech contains insights and wisdom important for today. Lincoln saw government as “a majority held in restraint by constitutional checks and limitations.” I am loath to further quote out of context or paraphrase his masterful words. Go read the original, in its balanced entirety.

I have written previous columns about the importance of taking time to reflect on one’s life and one’s career. Reflection is both a wellness check and a moral compass check. Some call it mindfulness. I lean toward calling it thankfulness and gratitude. Hence, November is a convenient time for pediatricians if flu and respiratory syncytial virus seasons haven’t started.

The Gettysburg Address extols the virtue of dedication. Lincoln’s second inaugural address promotes mercy and forgiveness. His Farewell Address to Springfield in 1861 in a single paragraph captures grief, faith, and hope. Those speeches are my perennial favorites. But this year it is the two aforementioned addresses that must be mined for wisdom.

I advocate vaccine and mask mandates, but I am not enamored with the idea of President Biden using the unchecked power of the executive branch to promulgate a single federal regulation that overreaches into every moderate-size business nationwide. The 1861 inaugural address concurs. Lincoln’s prophecy that division will be solved when one side ultimately wins is not the model I seek. It hasn’t worked for gun control. It hasn’t worked for abortion as we approach the 50th anniversary of Roe v. Wade. The present 50+1 vote majority in the U.S. Senate does not have a mandate to overhaul society, especially when those majorities are transient. One should have the courage to seek change, but beware of creating large divisions with small majorities.

Facebook profits when you meditate in the echo chambers of large, outraged groups. Avoid that. Hebrew tradition has some reflection occurring in groups of two or three, rather than solo. Truth is revealed in community. Voltaire said: “Cherish those who seek the truth but beware of those who find it.” As a scientist, my experience is that humility, skepticism, and a dedication to finding truth have served me well for a lifetime.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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The United States of America are not united. Politics have polarized the competing monologues and the policy making around vaccines, masks, children returning to school, what children are taught in school, and whether the federal government (or the National Football League) can or should create universal mandates enforcing one extreme of any of those policy disputes. Public health and health care have become so entangled in polarized politics that the role of science has often been pushed aside.

Dr. Kevin T. Powell

Polarization is not a novel event in the history of governments. The partition of India in 1947 divided most of its Hindu and Muslim inhabitants into separate countries, but that hasn’t stopped the recent resurgence of Hindu nationalism in India. The Thirty Years’ War in Europe sought to decide whether Catholics or Protestants would dominate Western Christianity. Those two sides decided in 1648 that coexistence was wiser than continuing into the abyss of mutual annihilation. Current conflicts between Israelis and Palestinians, between Shia and Sunni Arab states, between China and the Uyghurs, and within Sudan and Ethiopia together demonstrate that polarization to the point of genocide can occur regardless of religion, race, and nationality.

Abraham Lincoln, a lawyer in Illinois with a habit of losing elections, was nominated in 1858 to be the Republican nominee in the U.S. Senate race. His speech accepting the nomination spoke a truth that resonated across the nation and across time. It is known as the House Divided speech. He said: “A house divided against itself cannot stand. I believe this government cannot endure, permanently half slave and half free. I do not expect the Union to be dissolved – I do not expect the house to fall – but I do expect it will cease to be divided. It will become all one thing or all the other.”

The Republican Lincoln, supported by antislavery groups, lost that election to the Democrat Stephen A. Douglas, whose party espoused popular sovereignty and local decision-making about slavery. Lincoln’s acceptance speech propelled him 2 years later to be nominated for and elected President of the United States. Lincoln’s first inaugural address as the President of the United States on March 4, 1861, focused on the issue of division and secession. This time, Lincoln placed much more emphasis on preserving the Union. He specifically renounced any federal efforts to use force to abolish slavery in the states that permitted it. He declared: “I have no purpose, directly or indirectly, to interfere with the institution of slavery in the States where it exists. I believe I have no lawful right to do so, and I have no inclination to do so.”

President Lincoln’s approach might not meet muster in today’s cancel culture. He was facing a precariously divided nation not unlike the current day, so his speech contains insights and wisdom important for today. Lincoln saw government as “a majority held in restraint by constitutional checks and limitations.” I am loath to further quote out of context or paraphrase his masterful words. Go read the original, in its balanced entirety.

I have written previous columns about the importance of taking time to reflect on one’s life and one’s career. Reflection is both a wellness check and a moral compass check. Some call it mindfulness. I lean toward calling it thankfulness and gratitude. Hence, November is a convenient time for pediatricians if flu and respiratory syncytial virus seasons haven’t started.

The Gettysburg Address extols the virtue of dedication. Lincoln’s second inaugural address promotes mercy and forgiveness. His Farewell Address to Springfield in 1861 in a single paragraph captures grief, faith, and hope. Those speeches are my perennial favorites. But this year it is the two aforementioned addresses that must be mined for wisdom.

I advocate vaccine and mask mandates, but I am not enamored with the idea of President Biden using the unchecked power of the executive branch to promulgate a single federal regulation that overreaches into every moderate-size business nationwide. The 1861 inaugural address concurs. Lincoln’s prophecy that division will be solved when one side ultimately wins is not the model I seek. It hasn’t worked for gun control. It hasn’t worked for abortion as we approach the 50th anniversary of Roe v. Wade. The present 50+1 vote majority in the U.S. Senate does not have a mandate to overhaul society, especially when those majorities are transient. One should have the courage to seek change, but beware of creating large divisions with small majorities.

Facebook profits when you meditate in the echo chambers of large, outraged groups. Avoid that. Hebrew tradition has some reflection occurring in groups of two or three, rather than solo. Truth is revealed in community. Voltaire said: “Cherish those who seek the truth but beware of those who find it.” As a scientist, my experience is that humility, skepticism, and a dedication to finding truth have served me well for a lifetime.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

 

The United States of America are not united. Politics have polarized the competing monologues and the policy making around vaccines, masks, children returning to school, what children are taught in school, and whether the federal government (or the National Football League) can or should create universal mandates enforcing one extreme of any of those policy disputes. Public health and health care have become so entangled in polarized politics that the role of science has often been pushed aside.

Dr. Kevin T. Powell

Polarization is not a novel event in the history of governments. The partition of India in 1947 divided most of its Hindu and Muslim inhabitants into separate countries, but that hasn’t stopped the recent resurgence of Hindu nationalism in India. The Thirty Years’ War in Europe sought to decide whether Catholics or Protestants would dominate Western Christianity. Those two sides decided in 1648 that coexistence was wiser than continuing into the abyss of mutual annihilation. Current conflicts between Israelis and Palestinians, between Shia and Sunni Arab states, between China and the Uyghurs, and within Sudan and Ethiopia together demonstrate that polarization to the point of genocide can occur regardless of religion, race, and nationality.

Abraham Lincoln, a lawyer in Illinois with a habit of losing elections, was nominated in 1858 to be the Republican nominee in the U.S. Senate race. His speech accepting the nomination spoke a truth that resonated across the nation and across time. It is known as the House Divided speech. He said: “A house divided against itself cannot stand. I believe this government cannot endure, permanently half slave and half free. I do not expect the Union to be dissolved – I do not expect the house to fall – but I do expect it will cease to be divided. It will become all one thing or all the other.”

The Republican Lincoln, supported by antislavery groups, lost that election to the Democrat Stephen A. Douglas, whose party espoused popular sovereignty and local decision-making about slavery. Lincoln’s acceptance speech propelled him 2 years later to be nominated for and elected President of the United States. Lincoln’s first inaugural address as the President of the United States on March 4, 1861, focused on the issue of division and secession. This time, Lincoln placed much more emphasis on preserving the Union. He specifically renounced any federal efforts to use force to abolish slavery in the states that permitted it. He declared: “I have no purpose, directly or indirectly, to interfere with the institution of slavery in the States where it exists. I believe I have no lawful right to do so, and I have no inclination to do so.”

President Lincoln’s approach might not meet muster in today’s cancel culture. He was facing a precariously divided nation not unlike the current day, so his speech contains insights and wisdom important for today. Lincoln saw government as “a majority held in restraint by constitutional checks and limitations.” I am loath to further quote out of context or paraphrase his masterful words. Go read the original, in its balanced entirety.

I have written previous columns about the importance of taking time to reflect on one’s life and one’s career. Reflection is both a wellness check and a moral compass check. Some call it mindfulness. I lean toward calling it thankfulness and gratitude. Hence, November is a convenient time for pediatricians if flu and respiratory syncytial virus seasons haven’t started.

The Gettysburg Address extols the virtue of dedication. Lincoln’s second inaugural address promotes mercy and forgiveness. His Farewell Address to Springfield in 1861 in a single paragraph captures grief, faith, and hope. Those speeches are my perennial favorites. But this year it is the two aforementioned addresses that must be mined for wisdom.

I advocate vaccine and mask mandates, but I am not enamored with the idea of President Biden using the unchecked power of the executive branch to promulgate a single federal regulation that overreaches into every moderate-size business nationwide. The 1861 inaugural address concurs. Lincoln’s prophecy that division will be solved when one side ultimately wins is not the model I seek. It hasn’t worked for gun control. It hasn’t worked for abortion as we approach the 50th anniversary of Roe v. Wade. The present 50+1 vote majority in the U.S. Senate does not have a mandate to overhaul society, especially when those majorities are transient. One should have the courage to seek change, but beware of creating large divisions with small majorities.

Facebook profits when you meditate in the echo chambers of large, outraged groups. Avoid that. Hebrew tradition has some reflection occurring in groups of two or three, rather than solo. Truth is revealed in community. Voltaire said: “Cherish those who seek the truth but beware of those who find it.” As a scientist, my experience is that humility, skepticism, and a dedication to finding truth have served me well for a lifetime.
 

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

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How could this happen? Judge forces doctors to give ivermectin

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Tue, 09/28/2021 - 14:38

 

The judge’s order was a major affront to many clinical ethicists. A county judge in Ohio ordered a hospital to give ivermectin to a COVID-19 patient on a ventilator. This order occurred against the advice and judgment of the local physicians. It occurred in spite of the hospital’s lawyers fighting the order. How could such a situation occur?

Dr. Kevin T. Powell

This column is not the appropriate forum to debate the use of ivermectin. The Food and Drug Administration has not approved the drug for treating COVID-19. Indeed, the FDA has specifically recommended against its use.1 So has the Centers for Disease Control and Prevention.2 Poison control centers report a large uptick in exposures this summer because of self-medication, sometimes from veterinary sources.3

Fortunately for this case, the judge who overruled the order, Judge Michael A. Oster, wrote in his decision a summary of facts presented by both sides. The topic here is how a judge could order a medical institution and its staff to provide care against medical judgment. A key tenet of clinical ethics consultation is that the consultant needs to do their own investigation. Most veteran consultants have a litany of anecdotes wherein the initial story changed markedly as new facts were uncovered. The more outrageous the initial story, the more likely a major distortion is found. Therefore, most clinical ethics consultants are reluctant to discuss case studies based solely on publicly available information. Often, it is nearly impossible to obtain further information. One side of the story may be gagged by privacy laws. However, cases must sometimes be discussed based on the limited information available because, without that discussion, egregious violations of medical ethics would not be brought to light.

Fortunately for this case, Judge Osler’s decision contains a summary of facts presented by both sides. In August 2021, a 51-year-old patient with severe COVID-19 is in an Ohio intensive care unit on a ventilator. His wife seeks and obtains a prescription for ivermectin from a physician who has an Ohio state medical license but lives elsewhere, has no clinical privileges at the involved hospital, and has never examined the patient. The wife, as a surrogate decision maker, demands her husband receive the medication. The medical staff involved do not consider it a valid treatment. The wife seeks an injunction. A county judge orders the hospital to administer a specified dose of ivermectin daily for 21 days.4 That judge further grants an emergency preliminary injunction for 14 days that orders administration of the medication while legal appeals are made. Two weeks later, a second county judge hearing the case rules that the wife has not presented convincing evidence that she is likely to ultimately win the case on the merits.5 Therefore, the second judge reverses the preliminary injunction. The hospital need not continue to give the medication while further legal proceedings take place.

Cases like this are uncommon. Judges generally defer the authority for medical decisions to physicians. Various attitudes combine to make such an event happen. The judge may view the hospital as a local monopoly of health care and the patient may be too unstable to transport elsewhere. A judge in that situation, combined with a “the consumer is always right” mentality, and a sympathetic plaintiff, may seek to make miracles happen.

Judges overriding science are more likely to manifest when they see the science as ambiguous. Scientists have lost some of the gravitas they had when men walked on the moon. The spectacular success of the mRNA vaccines has surprisingly not reversed that loss. Science has been tainted by mercenary scientists, biased researchers seeking publications, and the large volume of published medical research that is false.

But there is more going on here. In the United States there has been a significant rebellion against any form of expertise and any form of authority. The echo chambers of misinformation on social media have led to polarization, conspiracy theories, and loyalty to political tribe rather than truth; hence the battle over masks and vaccines. This breakdown in authority is accompanied by losses in virtues such as civic duty and loving one’s neighbor. This is a failure of modern moral institutions. When major medical journals print opinion pieces portraying physicians as interchangeable automatons,6 it should not be surprising to see judges tempted by similar imagery.

One part of the solution is accountability in peer review. With 30,000 county judges scattered in 50 states, there will always be a few rogue and maverick attitudes among judges. The judiciary has a means of reassigning rebels to less impactful tasks. Similarly, if the physician who counseled the wife to use ivermectin had privileges at the admitting hospital, then peer review and credential committees could discipline behaviors that were too far outside accepted norms. Even when a consensus on best practice is hard to establish, damage can be mitigated by creating consequences for promoting aberrant care.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

References

1. “Why you should not use ivermectin to treat or prevent COVID-19,” FDA Consumer Updates, Sept. 3, 2021.

2. “Rapid increase in ivermectin prescriptions and reports of severe illness associated with use of products containing ivermectin to prevent or treat COVID-19,” CDC Health Advisory, Aug. 26, 2021.

3. National Poison Data System Bulletin: COVID-19 (Ivermectin), American Association of Poison Control Centers, 2021.

4. Smith v West Chester Hosptial, LLC, DBA West Chester Hospital, Butler County Clerk of Courts, Aug. 23, 2021.

5. Smith v West Chester Hosptial, LLC, Decision denying plaintiff’s action for a preliminary injunction, Butler County Clerk of Courts, Sept. 6, 2021.

6. “Conscientious objection in medicine,” BMJ 2006 Feb 2. doi: 10.1136/bmj.332.7536.294.

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The judge’s order was a major affront to many clinical ethicists. A county judge in Ohio ordered a hospital to give ivermectin to a COVID-19 patient on a ventilator. This order occurred against the advice and judgment of the local physicians. It occurred in spite of the hospital’s lawyers fighting the order. How could such a situation occur?

Dr. Kevin T. Powell

This column is not the appropriate forum to debate the use of ivermectin. The Food and Drug Administration has not approved the drug for treating COVID-19. Indeed, the FDA has specifically recommended against its use.1 So has the Centers for Disease Control and Prevention.2 Poison control centers report a large uptick in exposures this summer because of self-medication, sometimes from veterinary sources.3

Fortunately for this case, the judge who overruled the order, Judge Michael A. Oster, wrote in his decision a summary of facts presented by both sides. The topic here is how a judge could order a medical institution and its staff to provide care against medical judgment. A key tenet of clinical ethics consultation is that the consultant needs to do their own investigation. Most veteran consultants have a litany of anecdotes wherein the initial story changed markedly as new facts were uncovered. The more outrageous the initial story, the more likely a major distortion is found. Therefore, most clinical ethics consultants are reluctant to discuss case studies based solely on publicly available information. Often, it is nearly impossible to obtain further information. One side of the story may be gagged by privacy laws. However, cases must sometimes be discussed based on the limited information available because, without that discussion, egregious violations of medical ethics would not be brought to light.

Fortunately for this case, Judge Osler’s decision contains a summary of facts presented by both sides. In August 2021, a 51-year-old patient with severe COVID-19 is in an Ohio intensive care unit on a ventilator. His wife seeks and obtains a prescription for ivermectin from a physician who has an Ohio state medical license but lives elsewhere, has no clinical privileges at the involved hospital, and has never examined the patient. The wife, as a surrogate decision maker, demands her husband receive the medication. The medical staff involved do not consider it a valid treatment. The wife seeks an injunction. A county judge orders the hospital to administer a specified dose of ivermectin daily for 21 days.4 That judge further grants an emergency preliminary injunction for 14 days that orders administration of the medication while legal appeals are made. Two weeks later, a second county judge hearing the case rules that the wife has not presented convincing evidence that she is likely to ultimately win the case on the merits.5 Therefore, the second judge reverses the preliminary injunction. The hospital need not continue to give the medication while further legal proceedings take place.

Cases like this are uncommon. Judges generally defer the authority for medical decisions to physicians. Various attitudes combine to make such an event happen. The judge may view the hospital as a local monopoly of health care and the patient may be too unstable to transport elsewhere. A judge in that situation, combined with a “the consumer is always right” mentality, and a sympathetic plaintiff, may seek to make miracles happen.

Judges overriding science are more likely to manifest when they see the science as ambiguous. Scientists have lost some of the gravitas they had when men walked on the moon. The spectacular success of the mRNA vaccines has surprisingly not reversed that loss. Science has been tainted by mercenary scientists, biased researchers seeking publications, and the large volume of published medical research that is false.

But there is more going on here. In the United States there has been a significant rebellion against any form of expertise and any form of authority. The echo chambers of misinformation on social media have led to polarization, conspiracy theories, and loyalty to political tribe rather than truth; hence the battle over masks and vaccines. This breakdown in authority is accompanied by losses in virtues such as civic duty and loving one’s neighbor. This is a failure of modern moral institutions. When major medical journals print opinion pieces portraying physicians as interchangeable automatons,6 it should not be surprising to see judges tempted by similar imagery.

One part of the solution is accountability in peer review. With 30,000 county judges scattered in 50 states, there will always be a few rogue and maverick attitudes among judges. The judiciary has a means of reassigning rebels to less impactful tasks. Similarly, if the physician who counseled the wife to use ivermectin had privileges at the admitting hospital, then peer review and credential committees could discipline behaviors that were too far outside accepted norms. Even when a consensus on best practice is hard to establish, damage can be mitigated by creating consequences for promoting aberrant care.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

References

1. “Why you should not use ivermectin to treat or prevent COVID-19,” FDA Consumer Updates, Sept. 3, 2021.

2. “Rapid increase in ivermectin prescriptions and reports of severe illness associated with use of products containing ivermectin to prevent or treat COVID-19,” CDC Health Advisory, Aug. 26, 2021.

3. National Poison Data System Bulletin: COVID-19 (Ivermectin), American Association of Poison Control Centers, 2021.

4. Smith v West Chester Hosptial, LLC, DBA West Chester Hospital, Butler County Clerk of Courts, Aug. 23, 2021.

5. Smith v West Chester Hosptial, LLC, Decision denying plaintiff’s action for a preliminary injunction, Butler County Clerk of Courts, Sept. 6, 2021.

6. “Conscientious objection in medicine,” BMJ 2006 Feb 2. doi: 10.1136/bmj.332.7536.294.

 

The judge’s order was a major affront to many clinical ethicists. A county judge in Ohio ordered a hospital to give ivermectin to a COVID-19 patient on a ventilator. This order occurred against the advice and judgment of the local physicians. It occurred in spite of the hospital’s lawyers fighting the order. How could such a situation occur?

Dr. Kevin T. Powell

This column is not the appropriate forum to debate the use of ivermectin. The Food and Drug Administration has not approved the drug for treating COVID-19. Indeed, the FDA has specifically recommended against its use.1 So has the Centers for Disease Control and Prevention.2 Poison control centers report a large uptick in exposures this summer because of self-medication, sometimes from veterinary sources.3

Fortunately for this case, the judge who overruled the order, Judge Michael A. Oster, wrote in his decision a summary of facts presented by both sides. The topic here is how a judge could order a medical institution and its staff to provide care against medical judgment. A key tenet of clinical ethics consultation is that the consultant needs to do their own investigation. Most veteran consultants have a litany of anecdotes wherein the initial story changed markedly as new facts were uncovered. The more outrageous the initial story, the more likely a major distortion is found. Therefore, most clinical ethics consultants are reluctant to discuss case studies based solely on publicly available information. Often, it is nearly impossible to obtain further information. One side of the story may be gagged by privacy laws. However, cases must sometimes be discussed based on the limited information available because, without that discussion, egregious violations of medical ethics would not be brought to light.

Fortunately for this case, Judge Osler’s decision contains a summary of facts presented by both sides. In August 2021, a 51-year-old patient with severe COVID-19 is in an Ohio intensive care unit on a ventilator. His wife seeks and obtains a prescription for ivermectin from a physician who has an Ohio state medical license but lives elsewhere, has no clinical privileges at the involved hospital, and has never examined the patient. The wife, as a surrogate decision maker, demands her husband receive the medication. The medical staff involved do not consider it a valid treatment. The wife seeks an injunction. A county judge orders the hospital to administer a specified dose of ivermectin daily for 21 days.4 That judge further grants an emergency preliminary injunction for 14 days that orders administration of the medication while legal appeals are made. Two weeks later, a second county judge hearing the case rules that the wife has not presented convincing evidence that she is likely to ultimately win the case on the merits.5 Therefore, the second judge reverses the preliminary injunction. The hospital need not continue to give the medication while further legal proceedings take place.

Cases like this are uncommon. Judges generally defer the authority for medical decisions to physicians. Various attitudes combine to make such an event happen. The judge may view the hospital as a local monopoly of health care and the patient may be too unstable to transport elsewhere. A judge in that situation, combined with a “the consumer is always right” mentality, and a sympathetic plaintiff, may seek to make miracles happen.

Judges overriding science are more likely to manifest when they see the science as ambiguous. Scientists have lost some of the gravitas they had when men walked on the moon. The spectacular success of the mRNA vaccines has surprisingly not reversed that loss. Science has been tainted by mercenary scientists, biased researchers seeking publications, and the large volume of published medical research that is false.

But there is more going on here. In the United States there has been a significant rebellion against any form of expertise and any form of authority. The echo chambers of misinformation on social media have led to polarization, conspiracy theories, and loyalty to political tribe rather than truth; hence the battle over masks and vaccines. This breakdown in authority is accompanied by losses in virtues such as civic duty and loving one’s neighbor. This is a failure of modern moral institutions. When major medical journals print opinion pieces portraying physicians as interchangeable automatons,6 it should not be surprising to see judges tempted by similar imagery.

One part of the solution is accountability in peer review. With 30,000 county judges scattered in 50 states, there will always be a few rogue and maverick attitudes among judges. The judiciary has a means of reassigning rebels to less impactful tasks. Similarly, if the physician who counseled the wife to use ivermectin had privileges at the admitting hospital, then peer review and credential committees could discipline behaviors that were too far outside accepted norms. Even when a consensus on best practice is hard to establish, damage can be mitigated by creating consequences for promoting aberrant care.

Dr. Powell is a retired pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at pdnews@mdedge.com.

References

1. “Why you should not use ivermectin to treat or prevent COVID-19,” FDA Consumer Updates, Sept. 3, 2021.

2. “Rapid increase in ivermectin prescriptions and reports of severe illness associated with use of products containing ivermectin to prevent or treat COVID-19,” CDC Health Advisory, Aug. 26, 2021.

3. National Poison Data System Bulletin: COVID-19 (Ivermectin), American Association of Poison Control Centers, 2021.

4. Smith v West Chester Hosptial, LLC, DBA West Chester Hospital, Butler County Clerk of Courts, Aug. 23, 2021.

5. Smith v West Chester Hosptial, LLC, Decision denying plaintiff’s action for a preliminary injunction, Butler County Clerk of Courts, Sept. 6, 2021.

6. “Conscientious objection in medicine,” BMJ 2006 Feb 2. doi: 10.1136/bmj.332.7536.294.

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