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A house divided cannot stand
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.
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 [email protected].
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.
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 [email protected].
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.
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 [email protected].
Unvaccinated people 20 times more likely to die from COVID: Texas study
During the month of September, , according to a new study from the Texas Department of State Health Services.
The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.
“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.
“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”
As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.
The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.
In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.
Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.
“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”
About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.
A version of this article first appeared on WebMD.com.
During the month of September, , according to a new study from the Texas Department of State Health Services.
The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.
“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.
“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”
As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.
The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.
In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.
Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.
“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”
About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.
A version of this article first appeared on WebMD.com.
During the month of September, , according to a new study from the Texas Department of State Health Services.
The data also showed that unvaccinated people were 13 times more likely to test positive for COVID-19 than people who were fully vaccinated.
“This analysis quantifies what we’ve known for months,” Jennifer Shuford, MD, the state’s chief epidemiologist, told The Dallas Morning News.
“The COVID-19 vaccines are doing an excellent job of protecting people from getting sick and from dying from COVID-19,” she said. “Vaccination remains the best way to keep yourself and the people close to you safe from this deadly disease.”
As part of the study, researchers analyzed electronic lab reports, death certificates, and state immunization records, with a particular focus on September when the contagious Delta variant surged across Texas. The research marks the state’s first statistical analysis of COVID-19 vaccinations in Texas and the effects, the newspaper reported.
The protective effect of vaccination was most noticeable among younger groups. During September, the risk of COVID-19 death was 23 times higher in unvaccinated people in their 30s and 55 times higher for unvaccinated people in their 40s.
In addition, there were fewer than 10 COVID-19 deaths in September among fully vaccinated people between ages 18-29, as compared with 339 deaths among unvaccinated people in the same age group.
Then, looking at a longer time period -- from Jan. 15 to Oct. 1 -- the researchers found that unvaccinated people were 45 times more likely to contract COVID-19 than fully vaccinated people. The protective effect of vaccination against infection was strong across all adult age groups but greatest among ages 12-17.
“All authorized COVID-19 vaccines in the United States are highly effective at protecting people from getting sick or severely ill with COVID-19, including those infected with Delta and other known variants,” the study authors wrote. “Real world data from Texas clearly shows these benefits.”
About 15.6 million people in Texas have been fully vaccinated against COVID-19 in a state of about 29 million residents, according to state data. About 66% of the population has received at least one dose, while 58% is fully vaccinated.
A version of this article first appeared on WebMD.com.
Practicing telepsychiatry: Include backup plans, ground rules
For psychiatrists embarking on a telemedicine consultation, it might be helpful to review a checklist of steps that will reduce the risk of problems when things go wrong, according to an overview of the dangers at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists, sponsored by Medscape Live.
Ideally, telepsychiatry will function much like an inpatient office visit, but the dynamics differ – as do the things that can go wrong, according to Sanjay Gupta, MD, chief medical officer, BryLin Behavioral Health System, Buffalo, N.Y. “Issues can arise suddenly. You need contingency planning.”
At the outset, psychiatrists should establish the location of the patient. This is necessary at every telemedicine encounter. With a remote device, a patient could be essentially anywhere on Earth. Patients might not even remember to mention that they are vacationing in Australia.
The location of the patient is important in the event of an unexpected crisis. This is not only relevant to an unstable patient at risk of dangerous behavior, such as actively attempting suicide, but to patients who have a seizure or some other emergency that inhibits communication. , and this requires confirming that the patient is where he or she was expected to be.
In addition, there should be a plan for technological failure. As everyone knows, these failures, such as dysfunction of a device, a poor connection, or an Internet outage, can happen at any time. Both the clinician and the patient can derive reassurance from at least one if not two or more plans to reconnect in the event of these failures.
The visit should also begin with questions that will establish the patient has a sense of adequate privacy. This is one of the most common obstacles to an effective telemedicine consultation. Dr. Gupta pointed out that phone or computer cameras do not typically permit the clinician to exclude the presence of another individual sitting even a few feet away from the patient. With spouses and children nearby, there might be a tenuous sense of privacy even if they are unlikely to overhear the telemedicine visit.
One strategy that can be used to assess the patient’s level of comfort is to ask for a description of the patient’s surroundings and any other people at the location. Dr. Gupta also said it is appropriate to establish ground rules about recording of the session, which has its own potential to inhibit the interaction.
Warning that some form of consent to a telemedicine visit is mandatory in most states, Dr. Gupta also cautioned that a formal identification check is appropriate for a first-time visit. The risk of an individual offering a false identification is likely to be low, but it can be eliminated entirely by a protocol that verifies consent and identify before the clinical work begins.
Because of the importance of engaging patients quickly, Dr. Gupta called the first few minutes of a telemedicine visit “crucial.” By initiating the visit with a warm and respectful tone, by relaying a competent and professional appearance, and by establishing an atmosphere that encourages communication, the initial minutes of the call can set a tone that facilitates an effective visit.
Simple and established telehealth etiquette strategies should be employed, according to Dr. Gupta. He suggested paying attention to such issues as lighting, background, and camera position. Descriptions of what constitutes adequate lighting and background are easily obtained on free how-to websites, but the goal is to provide patients with a nondistracting and clear view of the clinician.
During a telemedicine visit, the clinician’s focus should remain on the patient, according to Dr. Gupta. He advised against taking notes or documenting the visit on an electronic health record during the course of the visit. Rather, he advised positioning the camera in a way that the patient feels eye contact is being made.
“It can be helpful to periodically summarize what the patient has said to demonstrate that you are fully engaged,” Dr. Gupta suggested.
Telemedicine is very effective for many but not all patients. Some, such as those with active psychosis, are not suited to this approach, but others are simply uncomfortable with this form of communication. Dr. Gupta suggested that clinicians should be mindful of the advantages and the limitations of telepsychiatry.
Ultimately, Dr. Gupta believes that the substantial expansion of telepsychiatry that took place during the COVID-19 pandemic is likely to persist when the pandemic ends, even if many of the changes that permitted its expansion, such as a relaxation of HIPPA requirements, are withdrawn. However, parity reimbursement for visits offered by telemedicine relative to those that are face-to-face, which greatly facilitated the growth of telepsychiatry, is not guaranteed, so this remains an unanswered question.
“The question is what will happen to the billing codes when we see COVID-19 in the rearview mirror, and the answer is that no one knows,” he said.
Uncertainty about future use
Other experts in this field agreed. James (Jay) H. Shore, MD, MPH, director of telemedicine, Helen and Arthur E. Johnson Depression Center, University of Colorado at Denver, Aurora, has long been an advocate for the value of telepsychiatry for reaching patients with limited psychosocial services. The attention drawn to this practice by the COVID-19 pandemic has been welcome, but he does not know how it will affect the future.
“There is too much uncertainty in the system to make a good prediction of where this may end up,” he said.
It is not just reimbursement that is at risk, according to Peter Yellowlees, MBBS, MD, chief wellness officer at the University of California, Davis. Also a longtime advocate of telepsychiatry, particularly to reach the underserved, Dr. Yellowlees pointed out that the ability to prescribe controlled substances through telemedicine and the ability to consult with patients across state lines might also be in jeopardy if and when rules for telemedicine are revisited after the pandemic.
“Many organizations are lobbying to make the pandemic changes permanent because they greatly support telemedicine delivery,” Dr. Yellowlees said, but agreed about the uncertainty regarding what policy makers will do.
Jayasudha Gude, MD, who is completing her residency in psychiatry at Zucker Hillside Hospital, Northwell Health, New York, recently led a literature review evaluating the needs and viability of telepsychiatry during and after the COVID-19 era (Cureus. 2021 Aug;13:e16974). Based on the benefits she identified in her review, she said, “I would definitely want to advocate for the continued use of telepsychiatry after the pandemic is over.” She hopes that psychiatrists who now have experience in this area will join her.
“I am hopeful that a lot of mental health providers will also be advocating since they have experience, and many will want to continue its use,” she said. Medscape Live and this news organization are owned by the same parent company. Dr. Gupta, Dr. Shore, Dr. Yellowlees, and Dr. Gude reported no potential conflicts of interest.
For psychiatrists embarking on a telemedicine consultation, it might be helpful to review a checklist of steps that will reduce the risk of problems when things go wrong, according to an overview of the dangers at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists, sponsored by Medscape Live.
Ideally, telepsychiatry will function much like an inpatient office visit, but the dynamics differ – as do the things that can go wrong, according to Sanjay Gupta, MD, chief medical officer, BryLin Behavioral Health System, Buffalo, N.Y. “Issues can arise suddenly. You need contingency planning.”
At the outset, psychiatrists should establish the location of the patient. This is necessary at every telemedicine encounter. With a remote device, a patient could be essentially anywhere on Earth. Patients might not even remember to mention that they are vacationing in Australia.
The location of the patient is important in the event of an unexpected crisis. This is not only relevant to an unstable patient at risk of dangerous behavior, such as actively attempting suicide, but to patients who have a seizure or some other emergency that inhibits communication. , and this requires confirming that the patient is where he or she was expected to be.
In addition, there should be a plan for technological failure. As everyone knows, these failures, such as dysfunction of a device, a poor connection, or an Internet outage, can happen at any time. Both the clinician and the patient can derive reassurance from at least one if not two or more plans to reconnect in the event of these failures.
The visit should also begin with questions that will establish the patient has a sense of adequate privacy. This is one of the most common obstacles to an effective telemedicine consultation. Dr. Gupta pointed out that phone or computer cameras do not typically permit the clinician to exclude the presence of another individual sitting even a few feet away from the patient. With spouses and children nearby, there might be a tenuous sense of privacy even if they are unlikely to overhear the telemedicine visit.
One strategy that can be used to assess the patient’s level of comfort is to ask for a description of the patient’s surroundings and any other people at the location. Dr. Gupta also said it is appropriate to establish ground rules about recording of the session, which has its own potential to inhibit the interaction.
Warning that some form of consent to a telemedicine visit is mandatory in most states, Dr. Gupta also cautioned that a formal identification check is appropriate for a first-time visit. The risk of an individual offering a false identification is likely to be low, but it can be eliminated entirely by a protocol that verifies consent and identify before the clinical work begins.
Because of the importance of engaging patients quickly, Dr. Gupta called the first few minutes of a telemedicine visit “crucial.” By initiating the visit with a warm and respectful tone, by relaying a competent and professional appearance, and by establishing an atmosphere that encourages communication, the initial minutes of the call can set a tone that facilitates an effective visit.
Simple and established telehealth etiquette strategies should be employed, according to Dr. Gupta. He suggested paying attention to such issues as lighting, background, and camera position. Descriptions of what constitutes adequate lighting and background are easily obtained on free how-to websites, but the goal is to provide patients with a nondistracting and clear view of the clinician.
During a telemedicine visit, the clinician’s focus should remain on the patient, according to Dr. Gupta. He advised against taking notes or documenting the visit on an electronic health record during the course of the visit. Rather, he advised positioning the camera in a way that the patient feels eye contact is being made.
“It can be helpful to periodically summarize what the patient has said to demonstrate that you are fully engaged,” Dr. Gupta suggested.
Telemedicine is very effective for many but not all patients. Some, such as those with active psychosis, are not suited to this approach, but others are simply uncomfortable with this form of communication. Dr. Gupta suggested that clinicians should be mindful of the advantages and the limitations of telepsychiatry.
Ultimately, Dr. Gupta believes that the substantial expansion of telepsychiatry that took place during the COVID-19 pandemic is likely to persist when the pandemic ends, even if many of the changes that permitted its expansion, such as a relaxation of HIPPA requirements, are withdrawn. However, parity reimbursement for visits offered by telemedicine relative to those that are face-to-face, which greatly facilitated the growth of telepsychiatry, is not guaranteed, so this remains an unanswered question.
“The question is what will happen to the billing codes when we see COVID-19 in the rearview mirror, and the answer is that no one knows,” he said.
Uncertainty about future use
Other experts in this field agreed. James (Jay) H. Shore, MD, MPH, director of telemedicine, Helen and Arthur E. Johnson Depression Center, University of Colorado at Denver, Aurora, has long been an advocate for the value of telepsychiatry for reaching patients with limited psychosocial services. The attention drawn to this practice by the COVID-19 pandemic has been welcome, but he does not know how it will affect the future.
“There is too much uncertainty in the system to make a good prediction of where this may end up,” he said.
It is not just reimbursement that is at risk, according to Peter Yellowlees, MBBS, MD, chief wellness officer at the University of California, Davis. Also a longtime advocate of telepsychiatry, particularly to reach the underserved, Dr. Yellowlees pointed out that the ability to prescribe controlled substances through telemedicine and the ability to consult with patients across state lines might also be in jeopardy if and when rules for telemedicine are revisited after the pandemic.
“Many organizations are lobbying to make the pandemic changes permanent because they greatly support telemedicine delivery,” Dr. Yellowlees said, but agreed about the uncertainty regarding what policy makers will do.
Jayasudha Gude, MD, who is completing her residency in psychiatry at Zucker Hillside Hospital, Northwell Health, New York, recently led a literature review evaluating the needs and viability of telepsychiatry during and after the COVID-19 era (Cureus. 2021 Aug;13:e16974). Based on the benefits she identified in her review, she said, “I would definitely want to advocate for the continued use of telepsychiatry after the pandemic is over.” She hopes that psychiatrists who now have experience in this area will join her.
“I am hopeful that a lot of mental health providers will also be advocating since they have experience, and many will want to continue its use,” she said. Medscape Live and this news organization are owned by the same parent company. Dr. Gupta, Dr. Shore, Dr. Yellowlees, and Dr. Gude reported no potential conflicts of interest.
For psychiatrists embarking on a telemedicine consultation, it might be helpful to review a checklist of steps that will reduce the risk of problems when things go wrong, according to an overview of the dangers at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists, sponsored by Medscape Live.
Ideally, telepsychiatry will function much like an inpatient office visit, but the dynamics differ – as do the things that can go wrong, according to Sanjay Gupta, MD, chief medical officer, BryLin Behavioral Health System, Buffalo, N.Y. “Issues can arise suddenly. You need contingency planning.”
At the outset, psychiatrists should establish the location of the patient. This is necessary at every telemedicine encounter. With a remote device, a patient could be essentially anywhere on Earth. Patients might not even remember to mention that they are vacationing in Australia.
The location of the patient is important in the event of an unexpected crisis. This is not only relevant to an unstable patient at risk of dangerous behavior, such as actively attempting suicide, but to patients who have a seizure or some other emergency that inhibits communication. , and this requires confirming that the patient is where he or she was expected to be.
In addition, there should be a plan for technological failure. As everyone knows, these failures, such as dysfunction of a device, a poor connection, or an Internet outage, can happen at any time. Both the clinician and the patient can derive reassurance from at least one if not two or more plans to reconnect in the event of these failures.
The visit should also begin with questions that will establish the patient has a sense of adequate privacy. This is one of the most common obstacles to an effective telemedicine consultation. Dr. Gupta pointed out that phone or computer cameras do not typically permit the clinician to exclude the presence of another individual sitting even a few feet away from the patient. With spouses and children nearby, there might be a tenuous sense of privacy even if they are unlikely to overhear the telemedicine visit.
One strategy that can be used to assess the patient’s level of comfort is to ask for a description of the patient’s surroundings and any other people at the location. Dr. Gupta also said it is appropriate to establish ground rules about recording of the session, which has its own potential to inhibit the interaction.
Warning that some form of consent to a telemedicine visit is mandatory in most states, Dr. Gupta also cautioned that a formal identification check is appropriate for a first-time visit. The risk of an individual offering a false identification is likely to be low, but it can be eliminated entirely by a protocol that verifies consent and identify before the clinical work begins.
Because of the importance of engaging patients quickly, Dr. Gupta called the first few minutes of a telemedicine visit “crucial.” By initiating the visit with a warm and respectful tone, by relaying a competent and professional appearance, and by establishing an atmosphere that encourages communication, the initial minutes of the call can set a tone that facilitates an effective visit.
Simple and established telehealth etiquette strategies should be employed, according to Dr. Gupta. He suggested paying attention to such issues as lighting, background, and camera position. Descriptions of what constitutes adequate lighting and background are easily obtained on free how-to websites, but the goal is to provide patients with a nondistracting and clear view of the clinician.
During a telemedicine visit, the clinician’s focus should remain on the patient, according to Dr. Gupta. He advised against taking notes or documenting the visit on an electronic health record during the course of the visit. Rather, he advised positioning the camera in a way that the patient feels eye contact is being made.
“It can be helpful to periodically summarize what the patient has said to demonstrate that you are fully engaged,” Dr. Gupta suggested.
Telemedicine is very effective for many but not all patients. Some, such as those with active psychosis, are not suited to this approach, but others are simply uncomfortable with this form of communication. Dr. Gupta suggested that clinicians should be mindful of the advantages and the limitations of telepsychiatry.
Ultimately, Dr. Gupta believes that the substantial expansion of telepsychiatry that took place during the COVID-19 pandemic is likely to persist when the pandemic ends, even if many of the changes that permitted its expansion, such as a relaxation of HIPPA requirements, are withdrawn. However, parity reimbursement for visits offered by telemedicine relative to those that are face-to-face, which greatly facilitated the growth of telepsychiatry, is not guaranteed, so this remains an unanswered question.
“The question is what will happen to the billing codes when we see COVID-19 in the rearview mirror, and the answer is that no one knows,” he said.
Uncertainty about future use
Other experts in this field agreed. James (Jay) H. Shore, MD, MPH, director of telemedicine, Helen and Arthur E. Johnson Depression Center, University of Colorado at Denver, Aurora, has long been an advocate for the value of telepsychiatry for reaching patients with limited psychosocial services. The attention drawn to this practice by the COVID-19 pandemic has been welcome, but he does not know how it will affect the future.
“There is too much uncertainty in the system to make a good prediction of where this may end up,” he said.
It is not just reimbursement that is at risk, according to Peter Yellowlees, MBBS, MD, chief wellness officer at the University of California, Davis. Also a longtime advocate of telepsychiatry, particularly to reach the underserved, Dr. Yellowlees pointed out that the ability to prescribe controlled substances through telemedicine and the ability to consult with patients across state lines might also be in jeopardy if and when rules for telemedicine are revisited after the pandemic.
“Many organizations are lobbying to make the pandemic changes permanent because they greatly support telemedicine delivery,” Dr. Yellowlees said, but agreed about the uncertainty regarding what policy makers will do.
Jayasudha Gude, MD, who is completing her residency in psychiatry at Zucker Hillside Hospital, Northwell Health, New York, recently led a literature review evaluating the needs and viability of telepsychiatry during and after the COVID-19 era (Cureus. 2021 Aug;13:e16974). Based on the benefits she identified in her review, she said, “I would definitely want to advocate for the continued use of telepsychiatry after the pandemic is over.” She hopes that psychiatrists who now have experience in this area will join her.
“I am hopeful that a lot of mental health providers will also be advocating since they have experience, and many will want to continue its use,” she said. Medscape Live and this news organization are owned by the same parent company. Dr. Gupta, Dr. Shore, Dr. Yellowlees, and Dr. Gude reported no potential conflicts of interest.
FROM PSYCHOPHARMACOLOGY UPDATE
Cities, states offer to pay kids to get vaccinated
As millions of children between ages 5-11 became eligible to receive a COVID-19 vaccine recently, .
In New York City, for instance, children can claim $100 if they receive their first dose of the Pfizer vaccine at a city-operated vaccine site. As an alternate choice, they can receive tickets to city attractions such as the Statue of Liberty or the Brooklyn Cyclones baseball team.
“We really want kids to take advantage, families take advantage of that,” Mayor Bill de Blasio said Nov. 4.
“Everyone could use a little more money around the holidays,” he said. “But, most importantly, we want our kids and our families to be safe.”
In Chicago, health officials are offering $100 gift cards to children who get vaccinated at public health events or clinics. The Chicago school district is also closing on Nov. 12 for Vaccination Awareness Day so students can get shots.
“It is rare that we make a late change to the school calendar, but we see this as an important investment in the future of this school year and the health and well-being of our students, staff, and families,” Pedro Martinez, the CEO for Chicago Public Schools, said in a message to parents.
The Centers for Disease Control and Prevention cleared the COVID-19 shot for children as young as age 5 on Nov. 2, making most Americans eligible for the vaccine. Ages 5-11 receive one-third of the dose given to adults and teens.
Other states and cities are offering incentives as well:
- San Antonio: Parents and guardians who take their children to get vaccinated at a Metro Health clinic can receive a $100 gift card for H-E-B grocery stores.
- Louisiana: As part of the “Shot for $100” program, anyone who receives their first shot is eligible for $100. Children between ages 5-11 can receive the cash incentive but require parental consent to get the vaccine.
- Minnesota: As part of the “Kids Deserve a Shot!” program, ages 12-17 can receive a $200 gift card and the opportunity to enter a raffle for a $100,000 college scholarship.
A version of this article first appeared on WebMD.com.
As millions of children between ages 5-11 became eligible to receive a COVID-19 vaccine recently, .
In New York City, for instance, children can claim $100 if they receive their first dose of the Pfizer vaccine at a city-operated vaccine site. As an alternate choice, they can receive tickets to city attractions such as the Statue of Liberty or the Brooklyn Cyclones baseball team.
“We really want kids to take advantage, families take advantage of that,” Mayor Bill de Blasio said Nov. 4.
“Everyone could use a little more money around the holidays,” he said. “But, most importantly, we want our kids and our families to be safe.”
In Chicago, health officials are offering $100 gift cards to children who get vaccinated at public health events or clinics. The Chicago school district is also closing on Nov. 12 for Vaccination Awareness Day so students can get shots.
“It is rare that we make a late change to the school calendar, but we see this as an important investment in the future of this school year and the health and well-being of our students, staff, and families,” Pedro Martinez, the CEO for Chicago Public Schools, said in a message to parents.
The Centers for Disease Control and Prevention cleared the COVID-19 shot for children as young as age 5 on Nov. 2, making most Americans eligible for the vaccine. Ages 5-11 receive one-third of the dose given to adults and teens.
Other states and cities are offering incentives as well:
- San Antonio: Parents and guardians who take their children to get vaccinated at a Metro Health clinic can receive a $100 gift card for H-E-B grocery stores.
- Louisiana: As part of the “Shot for $100” program, anyone who receives their first shot is eligible for $100. Children between ages 5-11 can receive the cash incentive but require parental consent to get the vaccine.
- Minnesota: As part of the “Kids Deserve a Shot!” program, ages 12-17 can receive a $200 gift card and the opportunity to enter a raffle for a $100,000 college scholarship.
A version of this article first appeared on WebMD.com.
As millions of children between ages 5-11 became eligible to receive a COVID-19 vaccine recently, .
In New York City, for instance, children can claim $100 if they receive their first dose of the Pfizer vaccine at a city-operated vaccine site. As an alternate choice, they can receive tickets to city attractions such as the Statue of Liberty or the Brooklyn Cyclones baseball team.
“We really want kids to take advantage, families take advantage of that,” Mayor Bill de Blasio said Nov. 4.
“Everyone could use a little more money around the holidays,” he said. “But, most importantly, we want our kids and our families to be safe.”
In Chicago, health officials are offering $100 gift cards to children who get vaccinated at public health events or clinics. The Chicago school district is also closing on Nov. 12 for Vaccination Awareness Day so students can get shots.
“It is rare that we make a late change to the school calendar, but we see this as an important investment in the future of this school year and the health and well-being of our students, staff, and families,” Pedro Martinez, the CEO for Chicago Public Schools, said in a message to parents.
The Centers for Disease Control and Prevention cleared the COVID-19 shot for children as young as age 5 on Nov. 2, making most Americans eligible for the vaccine. Ages 5-11 receive one-third of the dose given to adults and teens.
Other states and cities are offering incentives as well:
- San Antonio: Parents and guardians who take their children to get vaccinated at a Metro Health clinic can receive a $100 gift card for H-E-B grocery stores.
- Louisiana: As part of the “Shot for $100” program, anyone who receives their first shot is eligible for $100. Children between ages 5-11 can receive the cash incentive but require parental consent to get the vaccine.
- Minnesota: As part of the “Kids Deserve a Shot!” program, ages 12-17 can receive a $200 gift card and the opportunity to enter a raffle for a $100,000 college scholarship.
A version of this article first appeared on WebMD.com.
Children and COVID: New cases up again after dropping for 8 weeks
As children aged 5-11 years began to receive the first officially approved doses of COVID-19 vaccine, new pediatric cases increased after 8 consecutive weeks of declines, according to the American Academy of Pediatrics and the Children’s Hospital Association.
Weekly cases peaked at almost 252,000 in early September and then dropped for 8 straight weeks before this latest rise, the AAP and the CHA said in their weekly COVID report, which is based on data reported by 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The end of that 8-week drop, unfortunately, allowed another streak to continue: New cases have been above 100,000 for 13 consecutive weeks, the AAP and CHA noted.
The cumulative COVID count in children as of Nov. 4 was 6.5 million, the AAP/CHA said, although that figure does not fully cover Alabama, Nebraska, and Texas, which stopped public reporting over the summer. The Centers for Disease Control and Prevention, with input from all states and territories, puts the total through Nov. 8 at almost 5.7 million cases in children under 18 years of age, while most states define a child as someone aged 0-19 years.
As for the newest group of vaccinees, the CDC said that “updated vaccination data for 5-11 year-olds will be added to COVID Data Tracker later this week,” meaning the week of Nov. 7-13. Currently available data, however, show that almost 157,000 children under age 12 initiated vaccination in the 14 days ending Nov. 8, which was more than those aged 12-15 and 16-17 years combined (127,000).
Among those older groups, the CDC reports that 57.1% of 12- to 15-year-olds have received at least one dose and 47.9% are fully vaccinated, while 64.0% of those aged 16-17 have gotten at least one dose and 55.2% are fully vaccinated. Altogether, about 13.9 million children under age 18 have gotten at least one dose and almost 11.6 million are fully vaccinated, according to the CDC.
As children aged 5-11 years began to receive the first officially approved doses of COVID-19 vaccine, new pediatric cases increased after 8 consecutive weeks of declines, according to the American Academy of Pediatrics and the Children’s Hospital Association.
Weekly cases peaked at almost 252,000 in early September and then dropped for 8 straight weeks before this latest rise, the AAP and the CHA said in their weekly COVID report, which is based on data reported by 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The end of that 8-week drop, unfortunately, allowed another streak to continue: New cases have been above 100,000 for 13 consecutive weeks, the AAP and CHA noted.
The cumulative COVID count in children as of Nov. 4 was 6.5 million, the AAP/CHA said, although that figure does not fully cover Alabama, Nebraska, and Texas, which stopped public reporting over the summer. The Centers for Disease Control and Prevention, with input from all states and territories, puts the total through Nov. 8 at almost 5.7 million cases in children under 18 years of age, while most states define a child as someone aged 0-19 years.
As for the newest group of vaccinees, the CDC said that “updated vaccination data for 5-11 year-olds will be added to COVID Data Tracker later this week,” meaning the week of Nov. 7-13. Currently available data, however, show that almost 157,000 children under age 12 initiated vaccination in the 14 days ending Nov. 8, which was more than those aged 12-15 and 16-17 years combined (127,000).
Among those older groups, the CDC reports that 57.1% of 12- to 15-year-olds have received at least one dose and 47.9% are fully vaccinated, while 64.0% of those aged 16-17 have gotten at least one dose and 55.2% are fully vaccinated. Altogether, about 13.9 million children under age 18 have gotten at least one dose and almost 11.6 million are fully vaccinated, according to the CDC.
As children aged 5-11 years began to receive the first officially approved doses of COVID-19 vaccine, new pediatric cases increased after 8 consecutive weeks of declines, according to the American Academy of Pediatrics and the Children’s Hospital Association.
Weekly cases peaked at almost 252,000 in early September and then dropped for 8 straight weeks before this latest rise, the AAP and the CHA said in their weekly COVID report, which is based on data reported by 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The end of that 8-week drop, unfortunately, allowed another streak to continue: New cases have been above 100,000 for 13 consecutive weeks, the AAP and CHA noted.
The cumulative COVID count in children as of Nov. 4 was 6.5 million, the AAP/CHA said, although that figure does not fully cover Alabama, Nebraska, and Texas, which stopped public reporting over the summer. The Centers for Disease Control and Prevention, with input from all states and territories, puts the total through Nov. 8 at almost 5.7 million cases in children under 18 years of age, while most states define a child as someone aged 0-19 years.
As for the newest group of vaccinees, the CDC said that “updated vaccination data for 5-11 year-olds will be added to COVID Data Tracker later this week,” meaning the week of Nov. 7-13. Currently available data, however, show that almost 157,000 children under age 12 initiated vaccination in the 14 days ending Nov. 8, which was more than those aged 12-15 and 16-17 years combined (127,000).
Among those older groups, the CDC reports that 57.1% of 12- to 15-year-olds have received at least one dose and 47.9% are fully vaccinated, while 64.0% of those aged 16-17 have gotten at least one dose and 55.2% are fully vaccinated. Altogether, about 13.9 million children under age 18 have gotten at least one dose and almost 11.6 million are fully vaccinated, according to the CDC.
Early trials underway to test mushrooms as COVID treatment
The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.
The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.
The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA described the trials.
The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.
“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.
For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.
D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.
“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”
Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.
“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.
Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.
“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”
“Not a crazy concept”
Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.
“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”
Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.
“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.
Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.
“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.
As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.
Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.
He gave the example of St. John’s Wort, which has been problematic in HIV treatment.
“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.
Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”
He, too, pointed out that many traditional medicines were discovered from plants.
“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.
He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»
A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.
The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.
The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.
The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA described the trials.
The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.
“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.
For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.
D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.
“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”
Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.
“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.
Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.
“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”
“Not a crazy concept”
Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.
“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”
Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.
“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.
Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.
“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.
As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.
Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.
He gave the example of St. John’s Wort, which has been problematic in HIV treatment.
“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.
Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”
He, too, pointed out that many traditional medicines were discovered from plants.
“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.
He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»
A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.
The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.
The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.
The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA described the trials.
The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.
“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.
For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.
D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.
“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”
Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.
“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.
Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.
“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”
“Not a crazy concept”
Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.
“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”
Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.
“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.
Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.
“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.
As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.
Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.
He gave the example of St. John’s Wort, which has been problematic in HIV treatment.
“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.
Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”
He, too, pointed out that many traditional medicines were discovered from plants.
“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.
He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»
A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.
FROM JAMA
As constituents clamor for ivermectin, Republican politicians embrace the cause
When state senators in South Carolina held two hearings in September about COVID-19 treatments, they got an earful on the benefits of ivermectin — which many of the lawmakers echoed, sharing experiences of their own loved ones.
The demands for access to the drug were loud and insistent, despite federal regulators’ recent warning against using the drug to treat COVID.
Ivermectin is a generic drug that has been used for decades to treat river blindness, scabies, and even head lice. Veterinarians also use it, in different formulations and dosages, to treat animals for parasites like worms.
At one of the South Carolina hearings, Pressley Stutts III reminded the panel that his father, a prominent GOP leader in the state, had died of COVID a month earlier. He believed ivermectin could have helped him. But doctors at the hospital wouldn’t discuss it.
“I went every bit as far as I could without getting myself thrown in jail trying to save my father’s life,” he told the panel, as lawmakers offered condolences.
“What is going on here?” he asked, with the passion in his voice growing. “My dad’s dead!”
After the pandemic began, scientists launched clinical trials to see if ivermectin could help as a treatment for COVID. Some are still ongoing. But providers in mainstream medicine have rejected it as a COVID treatment, citing the poor quality of the studies to date, and two notorious “preprint” studies that were circulated before they were peer-reviewed, and later taken off the internet because of inaccurate and flawed data.
On Aug. 26, the Centers for Disease Control and Prevention advised clinicians not to use ivermectin, citing insufficient evidence of benefit and pointing out that unauthorized use had led to accidental poisonings. Vaccination, the CDC reiterated, is still the best way to avoid serious illness and death from the coronavirus.
But many Americans remain convinced ivermectin could be beneficial, and some politicians appear to be listening to them.
“If we have medications out here that are working — or seem to be working — I think it’s absolutely horrible that we’re not trying them,” said Republican state Sen. Tom Corbin in South Carolina. He questioned doctors who had come to the Statehouse to counter efforts to move ivermectin into mainstream use.
The doctors challenged the implied insult that they weren’t following best practices: “Any implication that any of us would do anything to withhold effective treatments from our patients is really insulting to our profession,” said Dr. Annie Andrews, a professor at the Medical University of South Carolina who has cared for COVID patients throughout the pandemic.
Instead of listening to the medical consensus, some politicians in states like South Carolina seem to be taking cues from doctors on the fringe. During one September hearing, state senators patched in a call from Dr. Pierre Kory.
Last year, Dr. Kory started a nonprofit called the Front Line COVID-19 Critical Care Alliance, which promotes ivermectin. He said he’s not making money by prescribing the drug, though the nonprofit does solicit donations and has not yet filed required financial documents with the IRS.
Dr. Kory acknowledged his medical opinions have landed him on “an island.”
He first testified about ivermectin to a U.S. Senate committee in December. That video went viral. Although it was taken down by YouTube, his Senate testimony prompted patients across the country to ask for ivermectin when they fell ill.
By late August, outpatient prescriptions had jumped 24-fold. Calls to poison control hotlines had tripled, mostly related to people taking ivermectin formulations meant for livestock.
Dr. Kory said he has effectively lost two jobs over his views on ivermectin. At his current hospital in Wisconsin, where he runs the intensive care unit two weeks a month, managers called him to a meeting in September, where he was informed he could no longer prescribe ivermectin. He’d been giving it to “every patient with COVID,” he said.
“After the pharma-geddon that was unleashed, yeah, they shut it down,” he told the South Carolina lawmakers. “And I will tell you that many hospitals across the country had already shut it down months ago.”
Framing the ivermectin fight as a battle against faceless federal agencies and big pharmaceutical corporations appealed to Americans already suspicious of the science behind the pandemic and the approved COVID vaccines.
Dr. Kory suggests success stories with COVID treatments in other parts of the world have been suppressed to instead promote the vaccines.
In an interview with NPR, Dr. Kory said he regrets the flashpoint he helped ignite.
“I feel really bad for the patients, and I feel really bad for the doctors,” he told NPR. “Both of them — both the patients and doctors — are trapped.”
Patients are still demanding the treatment, but doctors sympathetic to their wishes are being told by their health systems not to try it.
Now conservatives in elected office are sensing political payoff if they step in to help patients get the drug. State legislatures, including those in Tennessee and Alaska, are debating various ways to increase access to ivermectin — with proposals such as shielding doctors from repercussions for prescribing it, or forcing pharmacists to fill questionable prescriptions.
The Montana State News Bureau reported that the state’s Republican attorney general dispatched a state trooper to a hospital in Helena where a politically connected patient was dying of COVID. Her family was asking for ivermectin.
In a statement, St. Peter’s Hospital said doctors and nurses were “harassed and threatened by three public officials.”
“These officials have no medical training or experience, yet they were insisting our providers give treatments for COVID-19 that are not authorized, clinically approved, or within the guidelines established by the FDA and the CDC,” the statement added.
On Oct. 14, the Republican attorney general in Nebraska addressed the controversy, issuing a nearly 50-page legal opinion arguing that doctors who consider the “off-label” use of ivermectin and hydroxychloroquine for COVID are acting within the parameters of their state medical licenses, as long as the physician obtains appropriate informed consent from a patient.
Some patients have filed lawsuits to obtain ivermectin, with mixed success. A patient in Illinois was denied. But other hospitals, including one in Ohio, have been forced to administer the drug against the objections of their physicians.
Even as they gain powerful political supporters, some ivermectin fans say they’re now avoiding the health care system — because they’ve lost faith in it.
Lesa Berry, of Richmond, Va., had a friend who died earlier this year of COVID. The doctors refused to use ivermectin, despite requests from Ms. Berry and the patient’s daughter.
They know better now, she said.
“My first attempt would have been to keep her out of the hospital,” Ms. Berry said. “Because right now when you go to the hospital, they only give you what’s on the CDC protocol.”
Ms. Berry and her husband have purchased their own supply of ivermectin, which they keep at home.
This story is from a partnership that includes NPR, Nashville Public Radio and KHN. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
When state senators in South Carolina held two hearings in September about COVID-19 treatments, they got an earful on the benefits of ivermectin — which many of the lawmakers echoed, sharing experiences of their own loved ones.
The demands for access to the drug were loud and insistent, despite federal regulators’ recent warning against using the drug to treat COVID.
Ivermectin is a generic drug that has been used for decades to treat river blindness, scabies, and even head lice. Veterinarians also use it, in different formulations and dosages, to treat animals for parasites like worms.
At one of the South Carolina hearings, Pressley Stutts III reminded the panel that his father, a prominent GOP leader in the state, had died of COVID a month earlier. He believed ivermectin could have helped him. But doctors at the hospital wouldn’t discuss it.
“I went every bit as far as I could without getting myself thrown in jail trying to save my father’s life,” he told the panel, as lawmakers offered condolences.
“What is going on here?” he asked, with the passion in his voice growing. “My dad’s dead!”
After the pandemic began, scientists launched clinical trials to see if ivermectin could help as a treatment for COVID. Some are still ongoing. But providers in mainstream medicine have rejected it as a COVID treatment, citing the poor quality of the studies to date, and two notorious “preprint” studies that were circulated before they were peer-reviewed, and later taken off the internet because of inaccurate and flawed data.
On Aug. 26, the Centers for Disease Control and Prevention advised clinicians not to use ivermectin, citing insufficient evidence of benefit and pointing out that unauthorized use had led to accidental poisonings. Vaccination, the CDC reiterated, is still the best way to avoid serious illness and death from the coronavirus.
But many Americans remain convinced ivermectin could be beneficial, and some politicians appear to be listening to them.
“If we have medications out here that are working — or seem to be working — I think it’s absolutely horrible that we’re not trying them,” said Republican state Sen. Tom Corbin in South Carolina. He questioned doctors who had come to the Statehouse to counter efforts to move ivermectin into mainstream use.
The doctors challenged the implied insult that they weren’t following best practices: “Any implication that any of us would do anything to withhold effective treatments from our patients is really insulting to our profession,” said Dr. Annie Andrews, a professor at the Medical University of South Carolina who has cared for COVID patients throughout the pandemic.
Instead of listening to the medical consensus, some politicians in states like South Carolina seem to be taking cues from doctors on the fringe. During one September hearing, state senators patched in a call from Dr. Pierre Kory.
Last year, Dr. Kory started a nonprofit called the Front Line COVID-19 Critical Care Alliance, which promotes ivermectin. He said he’s not making money by prescribing the drug, though the nonprofit does solicit donations and has not yet filed required financial documents with the IRS.
Dr. Kory acknowledged his medical opinions have landed him on “an island.”
He first testified about ivermectin to a U.S. Senate committee in December. That video went viral. Although it was taken down by YouTube, his Senate testimony prompted patients across the country to ask for ivermectin when they fell ill.
By late August, outpatient prescriptions had jumped 24-fold. Calls to poison control hotlines had tripled, mostly related to people taking ivermectin formulations meant for livestock.
Dr. Kory said he has effectively lost two jobs over his views on ivermectin. At his current hospital in Wisconsin, where he runs the intensive care unit two weeks a month, managers called him to a meeting in September, where he was informed he could no longer prescribe ivermectin. He’d been giving it to “every patient with COVID,” he said.
“After the pharma-geddon that was unleashed, yeah, they shut it down,” he told the South Carolina lawmakers. “And I will tell you that many hospitals across the country had already shut it down months ago.”
Framing the ivermectin fight as a battle against faceless federal agencies and big pharmaceutical corporations appealed to Americans already suspicious of the science behind the pandemic and the approved COVID vaccines.
Dr. Kory suggests success stories with COVID treatments in other parts of the world have been suppressed to instead promote the vaccines.
In an interview with NPR, Dr. Kory said he regrets the flashpoint he helped ignite.
“I feel really bad for the patients, and I feel really bad for the doctors,” he told NPR. “Both of them — both the patients and doctors — are trapped.”
Patients are still demanding the treatment, but doctors sympathetic to their wishes are being told by their health systems not to try it.
Now conservatives in elected office are sensing political payoff if they step in to help patients get the drug. State legislatures, including those in Tennessee and Alaska, are debating various ways to increase access to ivermectin — with proposals such as shielding doctors from repercussions for prescribing it, or forcing pharmacists to fill questionable prescriptions.
The Montana State News Bureau reported that the state’s Republican attorney general dispatched a state trooper to a hospital in Helena where a politically connected patient was dying of COVID. Her family was asking for ivermectin.
In a statement, St. Peter’s Hospital said doctors and nurses were “harassed and threatened by three public officials.”
“These officials have no medical training or experience, yet they were insisting our providers give treatments for COVID-19 that are not authorized, clinically approved, or within the guidelines established by the FDA and the CDC,” the statement added.
On Oct. 14, the Republican attorney general in Nebraska addressed the controversy, issuing a nearly 50-page legal opinion arguing that doctors who consider the “off-label” use of ivermectin and hydroxychloroquine for COVID are acting within the parameters of their state medical licenses, as long as the physician obtains appropriate informed consent from a patient.
Some patients have filed lawsuits to obtain ivermectin, with mixed success. A patient in Illinois was denied. But other hospitals, including one in Ohio, have been forced to administer the drug against the objections of their physicians.
Even as they gain powerful political supporters, some ivermectin fans say they’re now avoiding the health care system — because they’ve lost faith in it.
Lesa Berry, of Richmond, Va., had a friend who died earlier this year of COVID. The doctors refused to use ivermectin, despite requests from Ms. Berry and the patient’s daughter.
They know better now, she said.
“My first attempt would have been to keep her out of the hospital,” Ms. Berry said. “Because right now when you go to the hospital, they only give you what’s on the CDC protocol.”
Ms. Berry and her husband have purchased their own supply of ivermectin, which they keep at home.
This story is from a partnership that includes NPR, Nashville Public Radio and KHN. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
When state senators in South Carolina held two hearings in September about COVID-19 treatments, they got an earful on the benefits of ivermectin — which many of the lawmakers echoed, sharing experiences of their own loved ones.
The demands for access to the drug were loud and insistent, despite federal regulators’ recent warning against using the drug to treat COVID.
Ivermectin is a generic drug that has been used for decades to treat river blindness, scabies, and even head lice. Veterinarians also use it, in different formulations and dosages, to treat animals for parasites like worms.
At one of the South Carolina hearings, Pressley Stutts III reminded the panel that his father, a prominent GOP leader in the state, had died of COVID a month earlier. He believed ivermectin could have helped him. But doctors at the hospital wouldn’t discuss it.
“I went every bit as far as I could without getting myself thrown in jail trying to save my father’s life,” he told the panel, as lawmakers offered condolences.
“What is going on here?” he asked, with the passion in his voice growing. “My dad’s dead!”
After the pandemic began, scientists launched clinical trials to see if ivermectin could help as a treatment for COVID. Some are still ongoing. But providers in mainstream medicine have rejected it as a COVID treatment, citing the poor quality of the studies to date, and two notorious “preprint” studies that were circulated before they were peer-reviewed, and later taken off the internet because of inaccurate and flawed data.
On Aug. 26, the Centers for Disease Control and Prevention advised clinicians not to use ivermectin, citing insufficient evidence of benefit and pointing out that unauthorized use had led to accidental poisonings. Vaccination, the CDC reiterated, is still the best way to avoid serious illness and death from the coronavirus.
But many Americans remain convinced ivermectin could be beneficial, and some politicians appear to be listening to them.
“If we have medications out here that are working — or seem to be working — I think it’s absolutely horrible that we’re not trying them,” said Republican state Sen. Tom Corbin in South Carolina. He questioned doctors who had come to the Statehouse to counter efforts to move ivermectin into mainstream use.
The doctors challenged the implied insult that they weren’t following best practices: “Any implication that any of us would do anything to withhold effective treatments from our patients is really insulting to our profession,” said Dr. Annie Andrews, a professor at the Medical University of South Carolina who has cared for COVID patients throughout the pandemic.
Instead of listening to the medical consensus, some politicians in states like South Carolina seem to be taking cues from doctors on the fringe. During one September hearing, state senators patched in a call from Dr. Pierre Kory.
Last year, Dr. Kory started a nonprofit called the Front Line COVID-19 Critical Care Alliance, which promotes ivermectin. He said he’s not making money by prescribing the drug, though the nonprofit does solicit donations and has not yet filed required financial documents with the IRS.
Dr. Kory acknowledged his medical opinions have landed him on “an island.”
He first testified about ivermectin to a U.S. Senate committee in December. That video went viral. Although it was taken down by YouTube, his Senate testimony prompted patients across the country to ask for ivermectin when they fell ill.
By late August, outpatient prescriptions had jumped 24-fold. Calls to poison control hotlines had tripled, mostly related to people taking ivermectin formulations meant for livestock.
Dr. Kory said he has effectively lost two jobs over his views on ivermectin. At his current hospital in Wisconsin, where he runs the intensive care unit two weeks a month, managers called him to a meeting in September, where he was informed he could no longer prescribe ivermectin. He’d been giving it to “every patient with COVID,” he said.
“After the pharma-geddon that was unleashed, yeah, they shut it down,” he told the South Carolina lawmakers. “And I will tell you that many hospitals across the country had already shut it down months ago.”
Framing the ivermectin fight as a battle against faceless federal agencies and big pharmaceutical corporations appealed to Americans already suspicious of the science behind the pandemic and the approved COVID vaccines.
Dr. Kory suggests success stories with COVID treatments in other parts of the world have been suppressed to instead promote the vaccines.
In an interview with NPR, Dr. Kory said he regrets the flashpoint he helped ignite.
“I feel really bad for the patients, and I feel really bad for the doctors,” he told NPR. “Both of them — both the patients and doctors — are trapped.”
Patients are still demanding the treatment, but doctors sympathetic to their wishes are being told by their health systems not to try it.
Now conservatives in elected office are sensing political payoff if they step in to help patients get the drug. State legislatures, including those in Tennessee and Alaska, are debating various ways to increase access to ivermectin — with proposals such as shielding doctors from repercussions for prescribing it, or forcing pharmacists to fill questionable prescriptions.
The Montana State News Bureau reported that the state’s Republican attorney general dispatched a state trooper to a hospital in Helena where a politically connected patient was dying of COVID. Her family was asking for ivermectin.
In a statement, St. Peter’s Hospital said doctors and nurses were “harassed and threatened by three public officials.”
“These officials have no medical training or experience, yet they were insisting our providers give treatments for COVID-19 that are not authorized, clinically approved, or within the guidelines established by the FDA and the CDC,” the statement added.
On Oct. 14, the Republican attorney general in Nebraska addressed the controversy, issuing a nearly 50-page legal opinion arguing that doctors who consider the “off-label” use of ivermectin and hydroxychloroquine for COVID are acting within the parameters of their state medical licenses, as long as the physician obtains appropriate informed consent from a patient.
Some patients have filed lawsuits to obtain ivermectin, with mixed success. A patient in Illinois was denied. But other hospitals, including one in Ohio, have been forced to administer the drug against the objections of their physicians.
Even as they gain powerful political supporters, some ivermectin fans say they’re now avoiding the health care system — because they’ve lost faith in it.
Lesa Berry, of Richmond, Va., had a friend who died earlier this year of COVID. The doctors refused to use ivermectin, despite requests from Ms. Berry and the patient’s daughter.
They know better now, she said.
“My first attempt would have been to keep her out of the hospital,” Ms. Berry said. “Because right now when you go to the hospital, they only give you what’s on the CDC protocol.”
Ms. Berry and her husband have purchased their own supply of ivermectin, which they keep at home.
This story is from a partnership that includes NPR, Nashville Public Radio and KHN. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Breast milk of COVID-19–infected mothers helps build infant’s immune defenses
It’s rare for mothers with COVID-19 to transfer the infection to their newborns, according to a new small study.
The research, published in JAMA Network Open, found that newborns of mothers infected with the COVID-19 virus were able to develop their own immune defenses via their mother’s breast milk. Researchers detected antibodies in the infants’ saliva.
“It is the first time that this mechanism has been demonstrated,” said study author Rita Carsetti, MD, head of immunology diagnostics for Bambino Gesù Children’s Hospital in Rome. “We now know how breast milk can help babies develop their immune defenses. The system could work the same way for many other pathogens, which are present in the mother during breastfeeding.”
Dr. Carsetti and colleagues examined data from 28 pregnant women who tested positive for COVID-19 and who gave birth at Policlinico Umberto I in Rome between November 2020 and May 2021, and their newborns. They investigated the immune responses of the mothers and their newborns by detecting spike-specific antibodies in serum, and the mucosal immune response was assessed by measuring specific antibodies in maternal breast milk and infant saliva 48 hours after delivery and 2 months later.
Twenty-one mothers and their newborns completed the 2 months of follow-up. Researchers found that the majority of the mothers had mild symptoms of COVID-19, while only three of them were admitted for worsening condition. There was only one reported case of a possible vertical transmission – transmitted in utero – and one case of a horizontal infection through droplets or respiratory secretions, which occurred when the newborn was taken home.
The results of the study showed that antibodies specific to the virus were present in the mothers’ blood at 2 months after delivery, but not at 48 hours. However, in milk, specific antibodies were already present 48 hours after delivery.
Therefore, after 48 hours, the breastfed babies had specific mucosal antibodies against COVID-19 in their saliva that the other newborns did not have. Two months later, these antibodies continued to be present even though the mothers had stopped producing them.
The findings suggest that breast milk offers protection by transferring the antibodies produced by the mother to the baby, but also by helping them to produce their own immune defenses.
“I am not surprised that infants of mothers who had COVID-19 infection in the peripartum period pass anti-spike protein IgA to their infants,” J. Howard Smart, MD, FAAP, who was not involved with the study, said in an interview. “This confirmation is good news for breastfeeding mothers.
“I wonder whether we really know these infants did not become infected, and produce their own antibodies,” said Dr. Smart, chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego.
The American College of Obstetricians and Gynecologists said having COVID-19 should not stop mothers from giving their children breast milk. The organization also said that the chance of COVID-19 passing through the breast milk and causing infection in the newborn infant is slim.
“Breast milk also helps protect babies from infections, including infections of the ears, lungs, and digestive system. For these reasons, having COVID-19 should not stop you from giving your baby breast milk,” according to ACOG’s website.
Similar studies on mothers who received the COVID-19 vaccination rather than being infected would be interesting, Dr. Smart added.
The authors of the current study plan to broaden their research by evaluating the response of pregnant mothers vaccinated against SARS-CoV-2 for the presence of antibodies in the milk and the immunity of their newborns. Dr. Carsetti said her team plans to expand the study to other infections, such as cytomegalovirus and respiratory syncytial virus.
None of the researchers or commentators had financial disclosures.
It’s rare for mothers with COVID-19 to transfer the infection to their newborns, according to a new small study.
The research, published in JAMA Network Open, found that newborns of mothers infected with the COVID-19 virus were able to develop their own immune defenses via their mother’s breast milk. Researchers detected antibodies in the infants’ saliva.
“It is the first time that this mechanism has been demonstrated,” said study author Rita Carsetti, MD, head of immunology diagnostics for Bambino Gesù Children’s Hospital in Rome. “We now know how breast milk can help babies develop their immune defenses. The system could work the same way for many other pathogens, which are present in the mother during breastfeeding.”
Dr. Carsetti and colleagues examined data from 28 pregnant women who tested positive for COVID-19 and who gave birth at Policlinico Umberto I in Rome between November 2020 and May 2021, and their newborns. They investigated the immune responses of the mothers and their newborns by detecting spike-specific antibodies in serum, and the mucosal immune response was assessed by measuring specific antibodies in maternal breast milk and infant saliva 48 hours after delivery and 2 months later.
Twenty-one mothers and their newborns completed the 2 months of follow-up. Researchers found that the majority of the mothers had mild symptoms of COVID-19, while only three of them were admitted for worsening condition. There was only one reported case of a possible vertical transmission – transmitted in utero – and one case of a horizontal infection through droplets or respiratory secretions, which occurred when the newborn was taken home.
The results of the study showed that antibodies specific to the virus were present in the mothers’ blood at 2 months after delivery, but not at 48 hours. However, in milk, specific antibodies were already present 48 hours after delivery.
Therefore, after 48 hours, the breastfed babies had specific mucosal antibodies against COVID-19 in their saliva that the other newborns did not have. Two months later, these antibodies continued to be present even though the mothers had stopped producing them.
The findings suggest that breast milk offers protection by transferring the antibodies produced by the mother to the baby, but also by helping them to produce their own immune defenses.
“I am not surprised that infants of mothers who had COVID-19 infection in the peripartum period pass anti-spike protein IgA to their infants,” J. Howard Smart, MD, FAAP, who was not involved with the study, said in an interview. “This confirmation is good news for breastfeeding mothers.
“I wonder whether we really know these infants did not become infected, and produce their own antibodies,” said Dr. Smart, chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego.
The American College of Obstetricians and Gynecologists said having COVID-19 should not stop mothers from giving their children breast milk. The organization also said that the chance of COVID-19 passing through the breast milk and causing infection in the newborn infant is slim.
“Breast milk also helps protect babies from infections, including infections of the ears, lungs, and digestive system. For these reasons, having COVID-19 should not stop you from giving your baby breast milk,” according to ACOG’s website.
Similar studies on mothers who received the COVID-19 vaccination rather than being infected would be interesting, Dr. Smart added.
The authors of the current study plan to broaden their research by evaluating the response of pregnant mothers vaccinated against SARS-CoV-2 for the presence of antibodies in the milk and the immunity of their newborns. Dr. Carsetti said her team plans to expand the study to other infections, such as cytomegalovirus and respiratory syncytial virus.
None of the researchers or commentators had financial disclosures.
It’s rare for mothers with COVID-19 to transfer the infection to their newborns, according to a new small study.
The research, published in JAMA Network Open, found that newborns of mothers infected with the COVID-19 virus were able to develop their own immune defenses via their mother’s breast milk. Researchers detected antibodies in the infants’ saliva.
“It is the first time that this mechanism has been demonstrated,” said study author Rita Carsetti, MD, head of immunology diagnostics for Bambino Gesù Children’s Hospital in Rome. “We now know how breast milk can help babies develop their immune defenses. The system could work the same way for many other pathogens, which are present in the mother during breastfeeding.”
Dr. Carsetti and colleagues examined data from 28 pregnant women who tested positive for COVID-19 and who gave birth at Policlinico Umberto I in Rome between November 2020 and May 2021, and their newborns. They investigated the immune responses of the mothers and their newborns by detecting spike-specific antibodies in serum, and the mucosal immune response was assessed by measuring specific antibodies in maternal breast milk and infant saliva 48 hours after delivery and 2 months later.
Twenty-one mothers and their newborns completed the 2 months of follow-up. Researchers found that the majority of the mothers had mild symptoms of COVID-19, while only three of them were admitted for worsening condition. There was only one reported case of a possible vertical transmission – transmitted in utero – and one case of a horizontal infection through droplets or respiratory secretions, which occurred when the newborn was taken home.
The results of the study showed that antibodies specific to the virus were present in the mothers’ blood at 2 months after delivery, but not at 48 hours. However, in milk, specific antibodies were already present 48 hours after delivery.
Therefore, after 48 hours, the breastfed babies had specific mucosal antibodies against COVID-19 in their saliva that the other newborns did not have. Two months later, these antibodies continued to be present even though the mothers had stopped producing them.
The findings suggest that breast milk offers protection by transferring the antibodies produced by the mother to the baby, but also by helping them to produce their own immune defenses.
“I am not surprised that infants of mothers who had COVID-19 infection in the peripartum period pass anti-spike protein IgA to their infants,” J. Howard Smart, MD, FAAP, who was not involved with the study, said in an interview. “This confirmation is good news for breastfeeding mothers.
“I wonder whether we really know these infants did not become infected, and produce their own antibodies,” said Dr. Smart, chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego.
The American College of Obstetricians and Gynecologists said having COVID-19 should not stop mothers from giving their children breast milk. The organization also said that the chance of COVID-19 passing through the breast milk and causing infection in the newborn infant is slim.
“Breast milk also helps protect babies from infections, including infections of the ears, lungs, and digestive system. For these reasons, having COVID-19 should not stop you from giving your baby breast milk,” according to ACOG’s website.
Similar studies on mothers who received the COVID-19 vaccination rather than being infected would be interesting, Dr. Smart added.
The authors of the current study plan to broaden their research by evaluating the response of pregnant mothers vaccinated against SARS-CoV-2 for the presence of antibodies in the milk and the immunity of their newborns. Dr. Carsetti said her team plans to expand the study to other infections, such as cytomegalovirus and respiratory syncytial virus.
None of the researchers or commentators had financial disclosures.
FROM JAMA NETWORK OPEN
COVID vaccines’ protection dropped sharply over 6 months: Study
, a study of almost 800,000 veterans found.
The study, published in the journal Science ., says the three vaccines offered about the same protection against the virus in March, when the Delta variant was first detected in the United States, but that changed 6 months later.
The Moderna two-dose vaccine went from being 89% effective in March to 58% effective in September, according to a story about the study in theLos Angeles Times.
Meanwhile, the Pfizer/BioNTech vaccine went from being 87% effective to 45% effective over the same time period.
The Johnson & Johnson vaccine showed the biggest drop -- from 86% effectiveness to 13% over those 6 months.
“In summary, although vaccination remains protective against SARS-CoV-2 infection, protection waned as the Delta variant emerged in the U.S., and this decline did not differ by age,” the study said.
The three vaccines also lost effectiveness in the ability to protect against death in veterans 65 and over after only 3 months, the Los Angeles Times reported.
Compared to unvaccinated veterans in that age group, veterans who got the Moderna vaccine and had a breakthrough case were 76% less likely to die of COVID-19 by July.
The protection was 70% for Pfizer/BioNTech vaccine recipients and 52% for J&J vaccine recipients for the same age group, compared to unvaccinated veterans, according to the newspaper.
For veterans under 65, the protectiveness against a fatal case of COVID was 84% for Pfizer/BioNTech recipients, 82% for Moderna recipients, and 73% for J&J recipients, compared to unvaccinated veterans in that age group.
The study confirms the need for booster vaccines and protective measures such as vaccine passports, vaccine mandates, masking, hand-washing, and social distancing, the researchers said.
Of the veterans studied, about 500,000 were vaccinated and 300,000 were not. Researchers noted that the study population had 6 times as many men as women. About 48% of the study group was 65 or older, 29% was 50-64, while 24% was under 50.
Researchers from the Public Health Institute in Oakland, the Veterans Affairs Medical Center in San Francisco, and the University of Texas Health Science Center conducted the study.
A version of this article first appeared on WebMD.com.
, a study of almost 800,000 veterans found.
The study, published in the journal Science ., says the three vaccines offered about the same protection against the virus in March, when the Delta variant was first detected in the United States, but that changed 6 months later.
The Moderna two-dose vaccine went from being 89% effective in March to 58% effective in September, according to a story about the study in theLos Angeles Times.
Meanwhile, the Pfizer/BioNTech vaccine went from being 87% effective to 45% effective over the same time period.
The Johnson & Johnson vaccine showed the biggest drop -- from 86% effectiveness to 13% over those 6 months.
“In summary, although vaccination remains protective against SARS-CoV-2 infection, protection waned as the Delta variant emerged in the U.S., and this decline did not differ by age,” the study said.
The three vaccines also lost effectiveness in the ability to protect against death in veterans 65 and over after only 3 months, the Los Angeles Times reported.
Compared to unvaccinated veterans in that age group, veterans who got the Moderna vaccine and had a breakthrough case were 76% less likely to die of COVID-19 by July.
The protection was 70% for Pfizer/BioNTech vaccine recipients and 52% for J&J vaccine recipients for the same age group, compared to unvaccinated veterans, according to the newspaper.
For veterans under 65, the protectiveness against a fatal case of COVID was 84% for Pfizer/BioNTech recipients, 82% for Moderna recipients, and 73% for J&J recipients, compared to unvaccinated veterans in that age group.
The study confirms the need for booster vaccines and protective measures such as vaccine passports, vaccine mandates, masking, hand-washing, and social distancing, the researchers said.
Of the veterans studied, about 500,000 were vaccinated and 300,000 were not. Researchers noted that the study population had 6 times as many men as women. About 48% of the study group was 65 or older, 29% was 50-64, while 24% was under 50.
Researchers from the Public Health Institute in Oakland, the Veterans Affairs Medical Center in San Francisco, and the University of Texas Health Science Center conducted the study.
A version of this article first appeared on WebMD.com.
, a study of almost 800,000 veterans found.
The study, published in the journal Science ., says the three vaccines offered about the same protection against the virus in March, when the Delta variant was first detected in the United States, but that changed 6 months later.
The Moderna two-dose vaccine went from being 89% effective in March to 58% effective in September, according to a story about the study in theLos Angeles Times.
Meanwhile, the Pfizer/BioNTech vaccine went from being 87% effective to 45% effective over the same time period.
The Johnson & Johnson vaccine showed the biggest drop -- from 86% effectiveness to 13% over those 6 months.
“In summary, although vaccination remains protective against SARS-CoV-2 infection, protection waned as the Delta variant emerged in the U.S., and this decline did not differ by age,” the study said.
The three vaccines also lost effectiveness in the ability to protect against death in veterans 65 and over after only 3 months, the Los Angeles Times reported.
Compared to unvaccinated veterans in that age group, veterans who got the Moderna vaccine and had a breakthrough case were 76% less likely to die of COVID-19 by July.
The protection was 70% for Pfizer/BioNTech vaccine recipients and 52% for J&J vaccine recipients for the same age group, compared to unvaccinated veterans, according to the newspaper.
For veterans under 65, the protectiveness against a fatal case of COVID was 84% for Pfizer/BioNTech recipients, 82% for Moderna recipients, and 73% for J&J recipients, compared to unvaccinated veterans in that age group.
The study confirms the need for booster vaccines and protective measures such as vaccine passports, vaccine mandates, masking, hand-washing, and social distancing, the researchers said.
Of the veterans studied, about 500,000 were vaccinated and 300,000 were not. Researchers noted that the study population had 6 times as many men as women. About 48% of the study group was 65 or older, 29% was 50-64, while 24% was under 50.
Researchers from the Public Health Institute in Oakland, the Veterans Affairs Medical Center in San Francisco, and the University of Texas Health Science Center conducted the study.
A version of this article first appeared on WebMD.com.
FROM SCIENCE
Severe COVID two times higher for cancer patients
A new systematic review and meta-analysis finds that unvaccinated cancer patients who contracted COVID-19 last year, were more than two times more likely – than people without cancer – to develop a case of COVID-19 so severe it required hospitalization in an intensive care unit.
“Our study provides the most precise measure to date of the effect of COVID-19 in cancer patients,” wrote researchers who were led by Paolo Boffetta, MD, MPH, a specialist in population science with the Stony Brook Cancer Center in New York.
Dr. Boffetta and colleagues also found that patients with hematologic neoplasms had a higher mortality rate from COVID-19 comparable to that of all cancers combined.
Cancer patients have long been considered to be among those patients who are at high risk of developing COVID-19, and if they contract the disease, they are at high risk of having poor outcomes. Other high-risk patients include those with hypertension, diabetes, chronic kidney disease, or COPD, or the elderly. But how high the risk of developing severe COVID-19 disease is for cancer patients hasn’t yet been documented on a wide scale.
The study, which was made available as a preprint on medRxiv on Oct. 23, is based on an analysis of COVID-19 cases that were documented in 35 reviews, meta-analyses, case reports, and studies indexed in PubMed from authors in North America, Europe, and Asia.
In this study, the pooled odds ratio for mortality for all patients with any cancer was 2.32 (95% confidence interval, 1.82-2.94; 24 studies). For ICU admission, the odds ratio was 2.39 (95% CI, 1.90-3.02; I2 0.0%; 5 studies). And, for disease severity or hospitalization, it was 2.08 (95% CI, 1.60-2.72; I2 92.1%; 15 studies). The pooled mortality odds ratio for hematologic neoplasms was 2.14 (95% CI, 1.87-2.44; I2 20.8%; 8 studies).
Their findings, which have not yet been peer reviewed, confirmed the results of a similar analysis from China published as a preprint in May 2020. The analysis included 181,323 patients (23,736 cancer patients) from 26 studies reported an odds ratio of 2.54 (95% CI, 1.47-4.42). “Cancer patients with COVID-19 have an increased likelihood of death compared to non-cancer COVID-19 patients,” Venkatesulu et al. wrote. And a systematic review and meta-analysis of five studies of 2,619 patients published in October 2020 in Medicine also found a significantly higher risk of death from COVID-19 among cancer patients (odds ratio, 2.63; 95% confidence interval, 1.14-6.06; P = .023; I2 = 26.4%).
Fakih et al., writing in the journal Hematology/Oncology and Stem Cell Therapy conducted a meta-analysis early last year finding a threefold increase for admission to the intensive care unit, an almost fourfold increase for a severe SARS-CoV-2 infection, and a fivefold increase for being intubated.
The three studies show that mortality rates were higher early in the pandemic “when diagnosis and treatment for SARS-CoV-2 might have been delayed, resulting in higher death rate,” Boffetta et al. wrote, adding that their analysis showed only a twofold increase most likely because it was a year-long analysis.
“Future studies will be able to better analyze this association for the different subtypes of cancer. Furthermore, they will eventually be able to evaluate whether the difference among vaccinated population is reduced,” Boffetta et al. wrote.
The authors noted several limitations for the study, including the fact that many of the studies included in the analysis did not include sex, age, comorbidities, and therapy. Nor were the authors able to analyze specific cancers other than hematologic neoplasms.
The authors declared no conflicts of interest.
A new systematic review and meta-analysis finds that unvaccinated cancer patients who contracted COVID-19 last year, were more than two times more likely – than people without cancer – to develop a case of COVID-19 so severe it required hospitalization in an intensive care unit.
“Our study provides the most precise measure to date of the effect of COVID-19 in cancer patients,” wrote researchers who were led by Paolo Boffetta, MD, MPH, a specialist in population science with the Stony Brook Cancer Center in New York.
Dr. Boffetta and colleagues also found that patients with hematologic neoplasms had a higher mortality rate from COVID-19 comparable to that of all cancers combined.
Cancer patients have long been considered to be among those patients who are at high risk of developing COVID-19, and if they contract the disease, they are at high risk of having poor outcomes. Other high-risk patients include those with hypertension, diabetes, chronic kidney disease, or COPD, or the elderly. But how high the risk of developing severe COVID-19 disease is for cancer patients hasn’t yet been documented on a wide scale.
The study, which was made available as a preprint on medRxiv on Oct. 23, is based on an analysis of COVID-19 cases that were documented in 35 reviews, meta-analyses, case reports, and studies indexed in PubMed from authors in North America, Europe, and Asia.
In this study, the pooled odds ratio for mortality for all patients with any cancer was 2.32 (95% confidence interval, 1.82-2.94; 24 studies). For ICU admission, the odds ratio was 2.39 (95% CI, 1.90-3.02; I2 0.0%; 5 studies). And, for disease severity or hospitalization, it was 2.08 (95% CI, 1.60-2.72; I2 92.1%; 15 studies). The pooled mortality odds ratio for hematologic neoplasms was 2.14 (95% CI, 1.87-2.44; I2 20.8%; 8 studies).
Their findings, which have not yet been peer reviewed, confirmed the results of a similar analysis from China published as a preprint in May 2020. The analysis included 181,323 patients (23,736 cancer patients) from 26 studies reported an odds ratio of 2.54 (95% CI, 1.47-4.42). “Cancer patients with COVID-19 have an increased likelihood of death compared to non-cancer COVID-19 patients,” Venkatesulu et al. wrote. And a systematic review and meta-analysis of five studies of 2,619 patients published in October 2020 in Medicine also found a significantly higher risk of death from COVID-19 among cancer patients (odds ratio, 2.63; 95% confidence interval, 1.14-6.06; P = .023; I2 = 26.4%).
Fakih et al., writing in the journal Hematology/Oncology and Stem Cell Therapy conducted a meta-analysis early last year finding a threefold increase for admission to the intensive care unit, an almost fourfold increase for a severe SARS-CoV-2 infection, and a fivefold increase for being intubated.
The three studies show that mortality rates were higher early in the pandemic “when diagnosis and treatment for SARS-CoV-2 might have been delayed, resulting in higher death rate,” Boffetta et al. wrote, adding that their analysis showed only a twofold increase most likely because it was a year-long analysis.
“Future studies will be able to better analyze this association for the different subtypes of cancer. Furthermore, they will eventually be able to evaluate whether the difference among vaccinated population is reduced,” Boffetta et al. wrote.
The authors noted several limitations for the study, including the fact that many of the studies included in the analysis did not include sex, age, comorbidities, and therapy. Nor were the authors able to analyze specific cancers other than hematologic neoplasms.
The authors declared no conflicts of interest.
A new systematic review and meta-analysis finds that unvaccinated cancer patients who contracted COVID-19 last year, were more than two times more likely – than people without cancer – to develop a case of COVID-19 so severe it required hospitalization in an intensive care unit.
“Our study provides the most precise measure to date of the effect of COVID-19 in cancer patients,” wrote researchers who were led by Paolo Boffetta, MD, MPH, a specialist in population science with the Stony Brook Cancer Center in New York.
Dr. Boffetta and colleagues also found that patients with hematologic neoplasms had a higher mortality rate from COVID-19 comparable to that of all cancers combined.
Cancer patients have long been considered to be among those patients who are at high risk of developing COVID-19, and if they contract the disease, they are at high risk of having poor outcomes. Other high-risk patients include those with hypertension, diabetes, chronic kidney disease, or COPD, or the elderly. But how high the risk of developing severe COVID-19 disease is for cancer patients hasn’t yet been documented on a wide scale.
The study, which was made available as a preprint on medRxiv on Oct. 23, is based on an analysis of COVID-19 cases that were documented in 35 reviews, meta-analyses, case reports, and studies indexed in PubMed from authors in North America, Europe, and Asia.
In this study, the pooled odds ratio for mortality for all patients with any cancer was 2.32 (95% confidence interval, 1.82-2.94; 24 studies). For ICU admission, the odds ratio was 2.39 (95% CI, 1.90-3.02; I2 0.0%; 5 studies). And, for disease severity or hospitalization, it was 2.08 (95% CI, 1.60-2.72; I2 92.1%; 15 studies). The pooled mortality odds ratio for hematologic neoplasms was 2.14 (95% CI, 1.87-2.44; I2 20.8%; 8 studies).
Their findings, which have not yet been peer reviewed, confirmed the results of a similar analysis from China published as a preprint in May 2020. The analysis included 181,323 patients (23,736 cancer patients) from 26 studies reported an odds ratio of 2.54 (95% CI, 1.47-4.42). “Cancer patients with COVID-19 have an increased likelihood of death compared to non-cancer COVID-19 patients,” Venkatesulu et al. wrote. And a systematic review and meta-analysis of five studies of 2,619 patients published in October 2020 in Medicine also found a significantly higher risk of death from COVID-19 among cancer patients (odds ratio, 2.63; 95% confidence interval, 1.14-6.06; P = .023; I2 = 26.4%).
Fakih et al., writing in the journal Hematology/Oncology and Stem Cell Therapy conducted a meta-analysis early last year finding a threefold increase for admission to the intensive care unit, an almost fourfold increase for a severe SARS-CoV-2 infection, and a fivefold increase for being intubated.
The three studies show that mortality rates were higher early in the pandemic “when diagnosis and treatment for SARS-CoV-2 might have been delayed, resulting in higher death rate,” Boffetta et al. wrote, adding that their analysis showed only a twofold increase most likely because it was a year-long analysis.
“Future studies will be able to better analyze this association for the different subtypes of cancer. Furthermore, they will eventually be able to evaluate whether the difference among vaccinated population is reduced,” Boffetta et al. wrote.
The authors noted several limitations for the study, including the fact that many of the studies included in the analysis did not include sex, age, comorbidities, and therapy. Nor were the authors able to analyze specific cancers other than hematologic neoplasms.
The authors declared no conflicts of interest.
FROM MEDRXIV