Federal Practitioner

An experimental cancer drug could be promising for some people hospitalized with COVID-19, a new study shows.

The medication, called sabizabulin and given as a pill, reduced by half the risk of death among participants. It could be more effective than other drugs for those severely sick with COVID-19, The New York Times reports.

The manufacturer, Veru, is seeking emergency use authorization from the Food and Drug Administration. Hospitalized COVID-19 patients currently have only a few pharmaceutical options.

Sabizabulin blocks cells from building molecular cables that carry material from one part of a cell to another. It was created to fight cancer, because tumor cells need those cables (called microtubules) to grow quickly.

Researchers tried it against COVID-19 2 years ago, because viral replication also requires microtubules to bring pieces of new viruses together.

To participate in the small trial, patients had to be receiving oxygen or on a ventilator and at a high risk of dying from COVID-19, “with risk factors such as hypertension, advanced age or obesity,” the Times reported.

A total of 134 patients received the medicine; 70 got a placebo. Among those receiving sabizabulin, 20.2% died within 2 months; 45.1% of those who took the placebo died.

One infectious disease expert told the Times that the high mortality rate of those on the placebo could mean the study was too small to offer conclusive results.

“The 45% mortality rate in the control group jumps out at me as rather high,” said David Boulware, MD, of the University of Minnesota.

A version of this article first appeared on WebMD.com.

An experimental cancer drug could be promising for some people hospitalized with COVID-19, a new study shows.

The medication, called sabizabulin and given as a pill, reduced by half the risk of death among participants. It could be more effective than other drugs for those severely sick with COVID-19, The New York Times reports.

The manufacturer, Veru, is seeking emergency use authorization from the Food and Drug Administration. Hospitalized COVID-19 patients currently have only a few pharmaceutical options.

Sabizabulin blocks cells from building molecular cables that carry material from one part of a cell to another. It was created to fight cancer, because tumor cells need those cables (called microtubules) to grow quickly.

Researchers tried it against COVID-19 2 years ago, because viral replication also requires microtubules to bring pieces of new viruses together.

To participate in the small trial, patients had to be receiving oxygen or on a ventilator and at a high risk of dying from COVID-19, “with risk factors such as hypertension, advanced age or obesity,” the Times reported.

A total of 134 patients received the medicine; 70 got a placebo. Among those receiving sabizabulin, 20.2% died within 2 months; 45.1% of those who took the placebo died.

One infectious disease expert told the Times that the high mortality rate of those on the placebo could mean the study was too small to offer conclusive results.

“The 45% mortality rate in the control group jumps out at me as rather high,” said David Boulware, MD, of the University of Minnesota.

A version of this article first appeared on WebMD.com.

An experimental cancer drug could be promising for some people hospitalized with COVID-19, a new study shows.

The medication, called sabizabulin and given as a pill, reduced by half the risk of death among participants. It could be more effective than other drugs for those severely sick with COVID-19, The New York Times reports.

The manufacturer, Veru, is seeking emergency use authorization from the Food and Drug Administration. Hospitalized COVID-19 patients currently have only a few pharmaceutical options.

Sabizabulin blocks cells from building molecular cables that carry material from one part of a cell to another. It was created to fight cancer, because tumor cells need those cables (called microtubules) to grow quickly.

Researchers tried it against COVID-19 2 years ago, because viral replication also requires microtubules to bring pieces of new viruses together.

To participate in the small trial, patients had to be receiving oxygen or on a ventilator and at a high risk of dying from COVID-19, “with risk factors such as hypertension, advanced age or obesity,” the Times reported.

A total of 134 patients received the medicine; 70 got a placebo. Among those receiving sabizabulin, 20.2% died within 2 months; 45.1% of those who took the placebo died.

One infectious disease expert told the Times that the high mortality rate of those on the placebo could mean the study was too small to offer conclusive results.

“The 45% mortality rate in the control group jumps out at me as rather high,” said David Boulware, MD, of the University of Minnesota.

A version of this article first appeared on WebMD.com.

Physician-musician Cleveland Francis, MD, responded to the recent mass shooting in Buffalo, New York, which left 10 dead, in the only way he knew how. He wrote and recorded a song to honor the victims as “a plea to the other side to recognize us as people,” the Black cardiologist told this news organization.

He couldn’t sleep after the shooting, and “this song was just in my head.” In the 1990s, Dr. Francis took a 3-year sabbatical from medicine to perform and tour as a country singer. He leveraged his Nashville connections to get “Buffalo” produced and recorded.

Acclaimed artist James Threalkill created the accompanying art, titled “The Heavenly Escort of the Buffalo 10,” after listening to a scratch demo.

Dr. Francis doesn’t want people to overlook the massacre as just another gun violence incident because this was “overt hate-crime racism,” he said.

According to the affidavit submitted by FBI agent Christopher J. Dlugokinski, the suspect’s “motive for the mass shooting was to prevent Black people from replacing White people and eliminating the White race, and to inspire others to commit similar attacks.”

Dr. Francis views the Buffalo shooting as distinct from cases like the murder of George Floyd that involved crime or police. It immediately made him think of the Mother Emanuel Church shooting in Charleston, South Carolina. “Having a black skin is now a death warrant,” he said.

The song is also an appeal for White people to fight racism. Dr. Francis is concerned about young men caught up in white supremacy and suggests that we be more alert to children or grandchildren who disconnect from their families, spend time on the dark web, and access guns. The lyrics deliberately don’t mention guns because Dr. Francis wanted to stay out of that debate. “I just sang: ‘What else do I have to do to prove to you that I’m human too?’ ”

Despite his country credentials, Dr. Francis wrote “Buffalo” as a Gospel song because that genre “connects with Black people more and because that civil rights movement was through the church with Dr. Martin Luther King,” he explained. Although he sings all styles of music, the song is performed by Nashville-based singer Michael Lusk so that it’s not a “Cleve Francis thing,” he said, referring to his stage name.

Songwriter Norman Kerner collaborated on the song. The music was produced and recorded by David Thein and mixed by Bob Bullock of Nashville, who Dr. Francis had worked with when he was an artist on Capitol Records.

They sent the video and artwork to the Mayor of Buffalo, Byron Brown, but have yet to hear back. Dr. Francis hopes it could be part of their healing, noting that some people used the song in their Juneteenth celebrations.

The Louisiana native grew up during segregation and was one of two Black students in the Medical College of Virginia class of 1973. After completing his cardiology fellowship, no one would hire him, so Dr. Francis set up his own practice in Northern Virginia. He now works at Inova Heart and Vascular Institute in Alexandria, Va. He remains optimistic about race relations in America and would love a Black pop or Gospel star to record “Buffalo” and bring it to a wider audience.

Dr. Francis is a regular blogger for Medscape. His contribution to country music is recognized in the National Museum of African American History and Culture in Washington, DC. You can find more of his music on YouTube.

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

Physician-musician Cleveland Francis, MD, responded to the recent mass shooting in Buffalo, New York, which left 10 dead, in the only way he knew how. He wrote and recorded a song to honor the victims as “a plea to the other side to recognize us as people,” the Black cardiologist told this news organization.

He couldn’t sleep after the shooting, and “this song was just in my head.” In the 1990s, Dr. Francis took a 3-year sabbatical from medicine to perform and tour as a country singer. He leveraged his Nashville connections to get “Buffalo” produced and recorded.

Acclaimed artist James Threalkill created the accompanying art, titled “The Heavenly Escort of the Buffalo 10,” after listening to a scratch demo.

Dr. Francis doesn’t want people to overlook the massacre as just another gun violence incident because this was “overt hate-crime racism,” he said.

According to the affidavit submitted by FBI agent Christopher J. Dlugokinski, the suspect’s “motive for the mass shooting was to prevent Black people from replacing White people and eliminating the White race, and to inspire others to commit similar attacks.”

Dr. Francis views the Buffalo shooting as distinct from cases like the murder of George Floyd that involved crime or police. It immediately made him think of the Mother Emanuel Church shooting in Charleston, South Carolina. “Having a black skin is now a death warrant,” he said.

The song is also an appeal for White people to fight racism. Dr. Francis is concerned about young men caught up in white supremacy and suggests that we be more alert to children or grandchildren who disconnect from their families, spend time on the dark web, and access guns. The lyrics deliberately don’t mention guns because Dr. Francis wanted to stay out of that debate. “I just sang: ‘What else do I have to do to prove to you that I’m human too?’ ”

Despite his country credentials, Dr. Francis wrote “Buffalo” as a Gospel song because that genre “connects with Black people more and because that civil rights movement was through the church with Dr. Martin Luther King,” he explained. Although he sings all styles of music, the song is performed by Nashville-based singer Michael Lusk so that it’s not a “Cleve Francis thing,” he said, referring to his stage name.

Songwriter Norman Kerner collaborated on the song. The music was produced and recorded by David Thein and mixed by Bob Bullock of Nashville, who Dr. Francis had worked with when he was an artist on Capitol Records.

They sent the video and artwork to the Mayor of Buffalo, Byron Brown, but have yet to hear back. Dr. Francis hopes it could be part of their healing, noting that some people used the song in their Juneteenth celebrations.

The Louisiana native grew up during segregation and was one of two Black students in the Medical College of Virginia class of 1973. After completing his cardiology fellowship, no one would hire him, so Dr. Francis set up his own practice in Northern Virginia. He now works at Inova Heart and Vascular Institute in Alexandria, Va. He remains optimistic about race relations in America and would love a Black pop or Gospel star to record “Buffalo” and bring it to a wider audience.

Dr. Francis is a regular blogger for Medscape. His contribution to country music is recognized in the National Museum of African American History and Culture in Washington, DC. You can find more of his music on YouTube.

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

Physician-musician Cleveland Francis, MD, responded to the recent mass shooting in Buffalo, New York, which left 10 dead, in the only way he knew how. He wrote and recorded a song to honor the victims as “a plea to the other side to recognize us as people,” the Black cardiologist told this news organization.

He couldn’t sleep after the shooting, and “this song was just in my head.” In the 1990s, Dr. Francis took a 3-year sabbatical from medicine to perform and tour as a country singer. He leveraged his Nashville connections to get “Buffalo” produced and recorded.

Acclaimed artist James Threalkill created the accompanying art, titled “The Heavenly Escort of the Buffalo 10,” after listening to a scratch demo.

Dr. Francis doesn’t want people to overlook the massacre as just another gun violence incident because this was “overt hate-crime racism,” he said.

According to the affidavit submitted by FBI agent Christopher J. Dlugokinski, the suspect’s “motive for the mass shooting was to prevent Black people from replacing White people and eliminating the White race, and to inspire others to commit similar attacks.”

Dr. Francis views the Buffalo shooting as distinct from cases like the murder of George Floyd that involved crime or police. It immediately made him think of the Mother Emanuel Church shooting in Charleston, South Carolina. “Having a black skin is now a death warrant,” he said.

The song is also an appeal for White people to fight racism. Dr. Francis is concerned about young men caught up in white supremacy and suggests that we be more alert to children or grandchildren who disconnect from their families, spend time on the dark web, and access guns. The lyrics deliberately don’t mention guns because Dr. Francis wanted to stay out of that debate. “I just sang: ‘What else do I have to do to prove to you that I’m human too?’ ”

Despite his country credentials, Dr. Francis wrote “Buffalo” as a Gospel song because that genre “connects with Black people more and because that civil rights movement was through the church with Dr. Martin Luther King,” he explained. Although he sings all styles of music, the song is performed by Nashville-based singer Michael Lusk so that it’s not a “Cleve Francis thing,” he said, referring to his stage name.

Songwriter Norman Kerner collaborated on the song. The music was produced and recorded by David Thein and mixed by Bob Bullock of Nashville, who Dr. Francis had worked with when he was an artist on Capitol Records.

They sent the video and artwork to the Mayor of Buffalo, Byron Brown, but have yet to hear back. Dr. Francis hopes it could be part of their healing, noting that some people used the song in their Juneteenth celebrations.

The Louisiana native grew up during segregation and was one of two Black students in the Medical College of Virginia class of 1973. After completing his cardiology fellowship, no one would hire him, so Dr. Francis set up his own practice in Northern Virginia. He now works at Inova Heart and Vascular Institute in Alexandria, Va. He remains optimistic about race relations in America and would love a Black pop or Gospel star to record “Buffalo” and bring it to a wider audience.

Dr. Francis is a regular blogger for Medscape. His contribution to country music is recognized in the National Museum of African American History and Culture in Washington, DC. You can find more of his music on YouTube.

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

Skin manifestations of COVID-19 were among the topics presented in several sessions at the 49th Congress of the Spanish Academy of Dermatology and Venereology. Specialists agreed that fewer skin changes associated with this virus have been seen with the latest variants of SARS-CoV-2. They highlighted the results of the most remarkable research on this topic that were presented in this forum.

In the study, which was carried out by Spanish dermatologists with the support of the AEDV, researchers analyzed skin reactions associated with the COVID-19 vaccine.

Study author Cristina Galván, MD, a dermatologist at the University Hospital of Móstoles, Madrid, said, “This is the first study that analyzes a significant number of cases assessed by dermatologists and illustrated with clinical images of the dermatological manifestations caused as a reaction to these vaccines.”

The study was carried out during the first months of COVID-19 vaccination, Dr. Galván told this news organization. It was proposed as a continuation of a COVID skin study that was published in the British Journal of Dermatology. That study documented the first classification of skin lesions associated with COVID-19. Dr. Galván is the lead author of the latter study.

“The objectives of this study were to characterize and classify skin reactions after vaccination, identify their chronology, and analyze the associations with a series of antecedents: dermatological and allergic diseases, previous SARS-CoV-2 infection, and skin reactions associated with COVID-19,” said Dr. Galván. The study was a team effort, she added.

“It was conducted between Feb. 15 and May 12, 2021, and information was gathered on 405 reactions that appeared during the 21 days after any dose of the COVID-19 vaccines approved at that time in Spain: the Pfizer/BioNTech, Moderna, and University of Oxford/AstraZeneca vaccines,” she added.

Dr. Galván explained that the study shows very clear patterns and investigators reached conclusions that match those of other groups that have investigated this topic. “Six reaction patterns were described according to their frequency. The first is the ‘COVID-19 arm,’ which consists of a local reaction at the injection site and occurs almost exclusively in women and in 70% of cases after inoculation with the Moderna serum. It is a manifestation that resolves well and does not always recur in subsequent doses. More than half are of delayed onset: biopsied patients show signs of a delayed hypersensitivity reaction. In line with all the publications in this regard, it was found that this reaction is not a reason to skip or delay a dose.”
 

Herpes zoster reactivation

The second pattern is urticarial, which, according to the specialist, occurs with equal frequency after the administration of all vaccines and is well controlled with antihistamines. “This is a very nonspecific pattern, which does not prevent it from still being frequent. It was not associated with drug intake.

“The morbilliform pattern is more frequent after the Pfizer/BioNTech and AstraZeneca vaccines. It affects the trunk and extremities, and up to a quarter of the cases required systemic corticosteroids. The papulovesicular and pityriasis rosea–like patterns are equally frequent in all vaccines. The latter is found in a younger age group. Finally, there is the purpuric pattern, more localized in the extremities and more frequent after the Pfizer/BioNTech and AstraZeneca vaccines. On biopsy, this pattern showed small-vessel vasculitis.”

Less frequently, reactivations or de novo onset of different dermatologic diseases were found. “Varicella-zoster virus reactivations were observed with a frequency of 13.8%, being more common after the Pfizer/BioNTech vaccine,” said Dr. Galván. “Other studies have corroborated this increase in herpes zoster, although it has been seen that the absolute number is low, so the benefits of the vaccine outweigh this eventual complication. At the same time and along the same lines, vaccination against herpes zoster is recommended for those over 50 years of age.”

Another fact revealed by the study is that these reactions were not significantly more severe in people with dermatologic diseases, those with previous infection, or those with skin manifestation associated with COVID-19.

Dr. Galván highlighted that, except for the COVID-19 arm, these patterns were among those associated with the disease, “which supports [the idea] that it does not demonstrate that the host’s immune reaction to the infection was playing a role.”
 

Women and young people

“As for pseudoperniosis, it is poorly represented in our series: 0.7% compared to 2% in the American registry. Although neither the SARS-CoV-2–pseudoperniosis association nor its pathophysiology is clear, the idea is that if this manifestation is related to the host’s immune response during infection, pseudoperniosis after vaccination could also be linked to the immune response to the vaccine,” said Dr. Galván.

Many of these reactions are more intense in women. “Before starting to use these vaccines, we already knew that messenger RNA vaccines (a powerful activator of innate immunity) induce frequent reactions, that adjuvants and excipients (polyethylene glycol and polysorbate) also generate them, and that other factors influence reactogenicity, among those of us of the same age and sex, reactions being more frequent in younger people and in women,” said Dr. Galván. “This may be one of the reasons why the COVID-19 arm is so much more prevalent in the female population and that 80% of all reactions that were collected were in women.”

In relation to the fact that manifestations differed, depending on the type of inoculated serum, Dr. Galván said, “Some reactions are just as common after any of the vaccines. However, others are not, as is the case with the COVID-19 arm for the Moderna vaccine or reactivations of the herpes virus, more frequent after the Pfizer/BioNTech vaccine.

“Undoubtedly, behind these differences are particularities in the immune reaction caused by each of the vaccines and their composition, including the excipients,” she said.

Regarding the fact that these reactions were the same throughout the vaccine regimen or that they varied in intensity, depending on the dose, Dr. Galván said, “In our study, as in those carried out by other groups, there were no significant differences in terms of frequency after the first and second doses. One thing to keep in mind is that, due to the temporary design of our study and the time at which it was conducted, it was not possible to collect reactions after second doses of AstraZeneca.

“Manifestations have generally been mild and well controlled. Many of them did not recur after the second dose, and the vast majority did not prevent completion of the vaccination scheme, but we must not lose sight of the fact that 20% of these manifestations were assessed by the dermatologist as serious or very serious,” Dr. Galván added.

Regarding the next steps planned for this line of research, Dr. Galván commented, “We are awaiting the evolution of the reported cases and the reactions that may arise, although for now, our group does not have any open studies. The most important thing now is to be alert and report the data observed in the pharmacovigilance systems, in open registries, and in scientific literature to generate evidence.”

Dr. Galván has disclosed no relevant financial relationships.

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

Skin manifestations of COVID-19 were among the topics presented in several sessions at the 49th Congress of the Spanish Academy of Dermatology and Venereology. Specialists agreed that fewer skin changes associated with this virus have been seen with the latest variants of SARS-CoV-2. They highlighted the results of the most remarkable research on this topic that were presented in this forum.

In the study, which was carried out by Spanish dermatologists with the support of the AEDV, researchers analyzed skin reactions associated with the COVID-19 vaccine.

Study author Cristina Galván, MD, a dermatologist at the University Hospital of Móstoles, Madrid, said, “This is the first study that analyzes a significant number of cases assessed by dermatologists and illustrated with clinical images of the dermatological manifestations caused as a reaction to these vaccines.”

The study was carried out during the first months of COVID-19 vaccination, Dr. Galván told this news organization. It was proposed as a continuation of a COVID skin study that was published in the British Journal of Dermatology. That study documented the first classification of skin lesions associated with COVID-19. Dr. Galván is the lead author of the latter study.

“The objectives of this study were to characterize and classify skin reactions after vaccination, identify their chronology, and analyze the associations with a series of antecedents: dermatological and allergic diseases, previous SARS-CoV-2 infection, and skin reactions associated with COVID-19,” said Dr. Galván. The study was a team effort, she added.

“It was conducted between Feb. 15 and May 12, 2021, and information was gathered on 405 reactions that appeared during the 21 days after any dose of the COVID-19 vaccines approved at that time in Spain: the Pfizer/BioNTech, Moderna, and University of Oxford/AstraZeneca vaccines,” she added.

Dr. Galván explained that the study shows very clear patterns and investigators reached conclusions that match those of other groups that have investigated this topic. “Six reaction patterns were described according to their frequency. The first is the ‘COVID-19 arm,’ which consists of a local reaction at the injection site and occurs almost exclusively in women and in 70% of cases after inoculation with the Moderna serum. It is a manifestation that resolves well and does not always recur in subsequent doses. More than half are of delayed onset: biopsied patients show signs of a delayed hypersensitivity reaction. In line with all the publications in this regard, it was found that this reaction is not a reason to skip or delay a dose.”
 

Herpes zoster reactivation

The second pattern is urticarial, which, according to the specialist, occurs with equal frequency after the administration of all vaccines and is well controlled with antihistamines. “This is a very nonspecific pattern, which does not prevent it from still being frequent. It was not associated with drug intake.

“The morbilliform pattern is more frequent after the Pfizer/BioNTech and AstraZeneca vaccines. It affects the trunk and extremities, and up to a quarter of the cases required systemic corticosteroids. The papulovesicular and pityriasis rosea–like patterns are equally frequent in all vaccines. The latter is found in a younger age group. Finally, there is the purpuric pattern, more localized in the extremities and more frequent after the Pfizer/BioNTech and AstraZeneca vaccines. On biopsy, this pattern showed small-vessel vasculitis.”

Less frequently, reactivations or de novo onset of different dermatologic diseases were found. “Varicella-zoster virus reactivations were observed with a frequency of 13.8%, being more common after the Pfizer/BioNTech vaccine,” said Dr. Galván. “Other studies have corroborated this increase in herpes zoster, although it has been seen that the absolute number is low, so the benefits of the vaccine outweigh this eventual complication. At the same time and along the same lines, vaccination against herpes zoster is recommended for those over 50 years of age.”

Another fact revealed by the study is that these reactions were not significantly more severe in people with dermatologic diseases, those with previous infection, or those with skin manifestation associated with COVID-19.

Dr. Galván highlighted that, except for the COVID-19 arm, these patterns were among those associated with the disease, “which supports [the idea] that it does not demonstrate that the host’s immune reaction to the infection was playing a role.”
 

Women and young people

“As for pseudoperniosis, it is poorly represented in our series: 0.7% compared to 2% in the American registry. Although neither the SARS-CoV-2–pseudoperniosis association nor its pathophysiology is clear, the idea is that if this manifestation is related to the host’s immune response during infection, pseudoperniosis after vaccination could also be linked to the immune response to the vaccine,” said Dr. Galván.

Many of these reactions are more intense in women. “Before starting to use these vaccines, we already knew that messenger RNA vaccines (a powerful activator of innate immunity) induce frequent reactions, that adjuvants and excipients (polyethylene glycol and polysorbate) also generate them, and that other factors influence reactogenicity, among those of us of the same age and sex, reactions being more frequent in younger people and in women,” said Dr. Galván. “This may be one of the reasons why the COVID-19 arm is so much more prevalent in the female population and that 80% of all reactions that were collected were in women.”

In relation to the fact that manifestations differed, depending on the type of inoculated serum, Dr. Galván said, “Some reactions are just as common after any of the vaccines. However, others are not, as is the case with the COVID-19 arm for the Moderna vaccine or reactivations of the herpes virus, more frequent after the Pfizer/BioNTech vaccine.

“Undoubtedly, behind these differences are particularities in the immune reaction caused by each of the vaccines and their composition, including the excipients,” she said.

Regarding the fact that these reactions were the same throughout the vaccine regimen or that they varied in intensity, depending on the dose, Dr. Galván said, “In our study, as in those carried out by other groups, there were no significant differences in terms of frequency after the first and second doses. One thing to keep in mind is that, due to the temporary design of our study and the time at which it was conducted, it was not possible to collect reactions after second doses of AstraZeneca.

“Manifestations have generally been mild and well controlled. Many of them did not recur after the second dose, and the vast majority did not prevent completion of the vaccination scheme, but we must not lose sight of the fact that 20% of these manifestations were assessed by the dermatologist as serious or very serious,” Dr. Galván added.

Regarding the next steps planned for this line of research, Dr. Galván commented, “We are awaiting the evolution of the reported cases and the reactions that may arise, although for now, our group does not have any open studies. The most important thing now is to be alert and report the data observed in the pharmacovigilance systems, in open registries, and in scientific literature to generate evidence.”

Dr. Galván has disclosed no relevant financial relationships.

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

Skin manifestations of COVID-19 were among the topics presented in several sessions at the 49th Congress of the Spanish Academy of Dermatology and Venereology. Specialists agreed that fewer skin changes associated with this virus have been seen with the latest variants of SARS-CoV-2. They highlighted the results of the most remarkable research on this topic that were presented in this forum.

In the study, which was carried out by Spanish dermatologists with the support of the AEDV, researchers analyzed skin reactions associated with the COVID-19 vaccine.

Study author Cristina Galván, MD, a dermatologist at the University Hospital of Móstoles, Madrid, said, “This is the first study that analyzes a significant number of cases assessed by dermatologists and illustrated with clinical images of the dermatological manifestations caused as a reaction to these vaccines.”

The study was carried out during the first months of COVID-19 vaccination, Dr. Galván told this news organization. It was proposed as a continuation of a COVID skin study that was published in the British Journal of Dermatology. That study documented the first classification of skin lesions associated with COVID-19. Dr. Galván is the lead author of the latter study.

“The objectives of this study were to characterize and classify skin reactions after vaccination, identify their chronology, and analyze the associations with a series of antecedents: dermatological and allergic diseases, previous SARS-CoV-2 infection, and skin reactions associated with COVID-19,” said Dr. Galván. The study was a team effort, she added.

“It was conducted between Feb. 15 and May 12, 2021, and information was gathered on 405 reactions that appeared during the 21 days after any dose of the COVID-19 vaccines approved at that time in Spain: the Pfizer/BioNTech, Moderna, and University of Oxford/AstraZeneca vaccines,” she added.

Dr. Galván explained that the study shows very clear patterns and investigators reached conclusions that match those of other groups that have investigated this topic. “Six reaction patterns were described according to their frequency. The first is the ‘COVID-19 arm,’ which consists of a local reaction at the injection site and occurs almost exclusively in women and in 70% of cases after inoculation with the Moderna serum. It is a manifestation that resolves well and does not always recur in subsequent doses. More than half are of delayed onset: biopsied patients show signs of a delayed hypersensitivity reaction. In line with all the publications in this regard, it was found that this reaction is not a reason to skip or delay a dose.”
 

Herpes zoster reactivation

The second pattern is urticarial, which, according to the specialist, occurs with equal frequency after the administration of all vaccines and is well controlled with antihistamines. “This is a very nonspecific pattern, which does not prevent it from still being frequent. It was not associated with drug intake.

“The morbilliform pattern is more frequent after the Pfizer/BioNTech and AstraZeneca vaccines. It affects the trunk and extremities, and up to a quarter of the cases required systemic corticosteroids. The papulovesicular and pityriasis rosea–like patterns are equally frequent in all vaccines. The latter is found in a younger age group. Finally, there is the purpuric pattern, more localized in the extremities and more frequent after the Pfizer/BioNTech and AstraZeneca vaccines. On biopsy, this pattern showed small-vessel vasculitis.”

Less frequently, reactivations or de novo onset of different dermatologic diseases were found. “Varicella-zoster virus reactivations were observed with a frequency of 13.8%, being more common after the Pfizer/BioNTech vaccine,” said Dr. Galván. “Other studies have corroborated this increase in herpes zoster, although it has been seen that the absolute number is low, so the benefits of the vaccine outweigh this eventual complication. At the same time and along the same lines, vaccination against herpes zoster is recommended for those over 50 years of age.”

Another fact revealed by the study is that these reactions were not significantly more severe in people with dermatologic diseases, those with previous infection, or those with skin manifestation associated with COVID-19.

Dr. Galván highlighted that, except for the COVID-19 arm, these patterns were among those associated with the disease, “which supports [the idea] that it does not demonstrate that the host’s immune reaction to the infection was playing a role.”
 

Women and young people

“As for pseudoperniosis, it is poorly represented in our series: 0.7% compared to 2% in the American registry. Although neither the SARS-CoV-2–pseudoperniosis association nor its pathophysiology is clear, the idea is that if this manifestation is related to the host’s immune response during infection, pseudoperniosis after vaccination could also be linked to the immune response to the vaccine,” said Dr. Galván.

Many of these reactions are more intense in women. “Before starting to use these vaccines, we already knew that messenger RNA vaccines (a powerful activator of innate immunity) induce frequent reactions, that adjuvants and excipients (polyethylene glycol and polysorbate) also generate them, and that other factors influence reactogenicity, among those of us of the same age and sex, reactions being more frequent in younger people and in women,” said Dr. Galván. “This may be one of the reasons why the COVID-19 arm is so much more prevalent in the female population and that 80% of all reactions that were collected were in women.”

In relation to the fact that manifestations differed, depending on the type of inoculated serum, Dr. Galván said, “Some reactions are just as common after any of the vaccines. However, others are not, as is the case with the COVID-19 arm for the Moderna vaccine or reactivations of the herpes virus, more frequent after the Pfizer/BioNTech vaccine.

“Undoubtedly, behind these differences are particularities in the immune reaction caused by each of the vaccines and their composition, including the excipients,” she said.

Regarding the fact that these reactions were the same throughout the vaccine regimen or that they varied in intensity, depending on the dose, Dr. Galván said, “In our study, as in those carried out by other groups, there were no significant differences in terms of frequency after the first and second doses. One thing to keep in mind is that, due to the temporary design of our study and the time at which it was conducted, it was not possible to collect reactions after second doses of AstraZeneca.

“Manifestations have generally been mild and well controlled. Many of them did not recur after the second dose, and the vast majority did not prevent completion of the vaccination scheme, but we must not lose sight of the fact that 20% of these manifestations were assessed by the dermatologist as serious or very serious,” Dr. Galván added.

Regarding the next steps planned for this line of research, Dr. Galván commented, “We are awaiting the evolution of the reported cases and the reactions that may arise, although for now, our group does not have any open studies. The most important thing now is to be alert and report the data observed in the pharmacovigilance systems, in open registries, and in scientific literature to generate evidence.”

Dr. Galván has disclosed no relevant financial relationships.

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

Almost half of adult patients with eosinophilic esophagitis (EoE) reported poor adherence to long-term medical and dietary therapy, with age younger than 40 years and low necessity beliefs being the strongest predictors, a new study finds.

Clinicians need to spend more time discussing the need for EoE therapy with their patients, especially if they are younger, according to lead author Maria L. Haasnoot, MD, of Amsterdam University Medical Center (UMC), the Netherlands, and colleagues.

“Chronic treatment is necessary to maintain suppression of the inflammation and prevent negative outcomes in the long-term,” they write.

Until the recent approval of dupilumab (Dupixent) by the U.S. Food and Drug Administration, patients with EoE relied upon off-label options, including proton pump inhibitors and swallowed topical steroids, as well as dietary interventions for ongoing suppression of inflammation. But only about 1 in 6 patients achieve complete remission at 5 years, according to Dr. Haasnoot and colleagues.

“It is uncertain to what degree limited adherence to treatment [plays] a role in the limited long-term effects of treatment,” they write.

The findings were published online in American Journal of Gastroenterology.
 

Addressing a knowledge gap

The cross-sectional study involved 177 adult patients with EoE treated at Amsterdam UMC, who were prescribed dietary or medical maintenance therapy. Of note, some patients were treated with budesonide, which is approved for EoE in Europe but not in the United States.

Median participant age was 43 years, with a male-skewed distribution (71% men). Patients had been on EoE treatment for 2-6 years. Most (76%) were on medical treatments. Nearly half were on diets that avoided one to five food groups, with some on both medical treatments and elimination diets.

Using a link sent by mail, participants completed the online Medication Adherence Rating Scale, along with several other questionnaires, such as the Beliefs about Medicine Questionnaire, to measure secondary outcomes, including a patient’s view of how necessary or disruptive maintenance therapy is in their life.

The overall prevalence of poor adherence to therapy was high (41.8%), including a nonsignificant difference in adherence between medical and dietary therapies.

“It might come as a surprise that dietary-treated patients are certainly not less adherent to treatment than medically treated patients,” the authors write, noting that the opposite is usually true.

Multivariate logistic regression showed that patients younger than 40 years were more than twice as likely to be poorly adherent (odds ratio, 2.571; 95% confidence interval, 1.195-5.532). Those with low necessity beliefs were more than four times as likely to be poorly adherent (OR, 4.423; 95% CI, 2.169-9.016). Other factors linked to poor adherence were patients with longer disease duration and more severe symptoms.

“Clinicians should pay more attention to treatment adherence, particularly in younger patients,” the authors conclude. “The necessity of treatment should be actively discussed, and efforts should be done to take doubts away, as this may improve treatment adherence and subsequently may improve treatment effects and long-term outcomes.”
 

More patient education needed

According to Jennifer L. Horsley-Silva, MD, of Mayo Clinic, Scottsdale, Ariz., “This study is important, as it is one of the first studies to investigate the rate of treatment adherence in EoE patients and attempts to identify factors associated with adherence both in medically and dietary treated patients.”

Dr. Horsley-Silva commented that the findings align with recent research she and her colleagues conducted at the Mayo Clinic, where few patients successfully completed a six-food elimination diet, even when paired with a dietitian. As with the present study, success trended lower among younger adults. “These findings highlight the need for physicians treating EoE to motivate all patients, but especially younger patients, by discussing disease pathophysiology and explaining the reason for maintenance treatment early on,” Dr. Horsley-Silva said.

Conversations should also address the discordance between symptoms and histologic disease, patient doubts and concerns, and other barriers to adherence, she noted.

“Shared decisionmaking is of utmost importance when deciding upon a maintenance treatment strategy and should be readdressed continually,” she added.

Gary W. Falk, MD, of Penn Medicine, Philadelphia, said that patients with EoE may be poorly adherent because therapies tend to be complicated and people often forget to take their medications, especially when their symptoms improve, even though this is a poor indicator of underlying disease. The discordance between symptoms and histology is “not commonly appreciated by the EoE GI community,” he noted.

Patients may benefit from knowing that untreated or undertreated EoE increases the risk for strictures and stenoses, need for dilation, and frequency of food bolus impactions, Dr. Falk said.

“The other thing we know is that once someone is induced into remission, and they stay on therapy ... long-term remission can be maintained,” he added.
 

The impact of Dupilumab

John Leung, MD, of Boston Food Allergy Center, also cited the complexities of EoE therapies as reason for poor adherence, though he believes this paradigm will shift now that dupilumab has been approved. Dupilumab injections are “just once a week, so it’s much easier in terms of frequency,” Dr. Leung said. “I would expect that the compliance [for dupilumab] will be better” than for older therapies.

Dr. Leung, who helped conduct the dupilumab clinical trials contributing to its approval for EoE and receives speaking honoraria from manufacturer Regeneron/Sanofi, said that dupilumab also overcomes the challenges with elimination diets while offering relief for concomitant conditions, such as “asthma, eczema, food allergies, and seasonal allergies.”

But Dr. Falk, who also worked on the dupilumab clinical trials, said the situation is “not straightforward,” even with FDA approval.

“There are going to be significant costs with [prescribing dupilumab], because it’s a biologic,” Dr. Falk said.

Dr. Falk also pointed out that prior authorization will be required, and until more studies can be conducted, the true impact of once-weekly dosing versus daily dosing remains unknown.

“I would say [dupilumab] has the potential to improve adherence, but we need to see if that’s going to be the case or not,” Dr. Falk said.

The authors disclosed relationships with Dr. Falk Pharma, AstraZeneca, and Sanofi/Regeneron (the manufacturers of Dupixent [dupilumab]), among others. Dr. Horsley-Silva, Dr. Falk, and Dr. Leung conducted clinical trials for dupilumab on behalf of Sanofi/Regeneron, with Dr. Leung also disclosing speaking honoraria from Sanofi/Regeneron. Dr. Horsley-Silva has acted as a clinical trial site principal investigator for Allakos and Celgene/Bristol-Myers Squibb.

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

Almost half of adult patients with eosinophilic esophagitis (EoE) reported poor adherence to long-term medical and dietary therapy, with age younger than 40 years and low necessity beliefs being the strongest predictors, a new study finds.

Clinicians need to spend more time discussing the need for EoE therapy with their patients, especially if they are younger, according to lead author Maria L. Haasnoot, MD, of Amsterdam University Medical Center (UMC), the Netherlands, and colleagues.

“Chronic treatment is necessary to maintain suppression of the inflammation and prevent negative outcomes in the long-term,” they write.

Until the recent approval of dupilumab (Dupixent) by the U.S. Food and Drug Administration, patients with EoE relied upon off-label options, including proton pump inhibitors and swallowed topical steroids, as well as dietary interventions for ongoing suppression of inflammation. But only about 1 in 6 patients achieve complete remission at 5 years, according to Dr. Haasnoot and colleagues.

“It is uncertain to what degree limited adherence to treatment [plays] a role in the limited long-term effects of treatment,” they write.

The findings were published online in American Journal of Gastroenterology.
 

Addressing a knowledge gap

The cross-sectional study involved 177 adult patients with EoE treated at Amsterdam UMC, who were prescribed dietary or medical maintenance therapy. Of note, some patients were treated with budesonide, which is approved for EoE in Europe but not in the United States.

Median participant age was 43 years, with a male-skewed distribution (71% men). Patients had been on EoE treatment for 2-6 years. Most (76%) were on medical treatments. Nearly half were on diets that avoided one to five food groups, with some on both medical treatments and elimination diets.

Using a link sent by mail, participants completed the online Medication Adherence Rating Scale, along with several other questionnaires, such as the Beliefs about Medicine Questionnaire, to measure secondary outcomes, including a patient’s view of how necessary or disruptive maintenance therapy is in their life.

The overall prevalence of poor adherence to therapy was high (41.8%), including a nonsignificant difference in adherence between medical and dietary therapies.

“It might come as a surprise that dietary-treated patients are certainly not less adherent to treatment than medically treated patients,” the authors write, noting that the opposite is usually true.

Multivariate logistic regression showed that patients younger than 40 years were more than twice as likely to be poorly adherent (odds ratio, 2.571; 95% confidence interval, 1.195-5.532). Those with low necessity beliefs were more than four times as likely to be poorly adherent (OR, 4.423; 95% CI, 2.169-9.016). Other factors linked to poor adherence were patients with longer disease duration and more severe symptoms.

“Clinicians should pay more attention to treatment adherence, particularly in younger patients,” the authors conclude. “The necessity of treatment should be actively discussed, and efforts should be done to take doubts away, as this may improve treatment adherence and subsequently may improve treatment effects and long-term outcomes.”
 

More patient education needed

According to Jennifer L. Horsley-Silva, MD, of Mayo Clinic, Scottsdale, Ariz., “This study is important, as it is one of the first studies to investigate the rate of treatment adherence in EoE patients and attempts to identify factors associated with adherence both in medically and dietary treated patients.”

Dr. Horsley-Silva commented that the findings align with recent research she and her colleagues conducted at the Mayo Clinic, where few patients successfully completed a six-food elimination diet, even when paired with a dietitian. As with the present study, success trended lower among younger adults. “These findings highlight the need for physicians treating EoE to motivate all patients, but especially younger patients, by discussing disease pathophysiology and explaining the reason for maintenance treatment early on,” Dr. Horsley-Silva said.

Conversations should also address the discordance between symptoms and histologic disease, patient doubts and concerns, and other barriers to adherence, she noted.

“Shared decisionmaking is of utmost importance when deciding upon a maintenance treatment strategy and should be readdressed continually,” she added.

Gary W. Falk, MD, of Penn Medicine, Philadelphia, said that patients with EoE may be poorly adherent because therapies tend to be complicated and people often forget to take their medications, especially when their symptoms improve, even though this is a poor indicator of underlying disease. The discordance between symptoms and histology is “not commonly appreciated by the EoE GI community,” he noted.

Patients may benefit from knowing that untreated or undertreated EoE increases the risk for strictures and stenoses, need for dilation, and frequency of food bolus impactions, Dr. Falk said.

“The other thing we know is that once someone is induced into remission, and they stay on therapy ... long-term remission can be maintained,” he added.
 

The impact of Dupilumab

John Leung, MD, of Boston Food Allergy Center, also cited the complexities of EoE therapies as reason for poor adherence, though he believes this paradigm will shift now that dupilumab has been approved. Dupilumab injections are “just once a week, so it’s much easier in terms of frequency,” Dr. Leung said. “I would expect that the compliance [for dupilumab] will be better” than for older therapies.

Dr. Leung, who helped conduct the dupilumab clinical trials contributing to its approval for EoE and receives speaking honoraria from manufacturer Regeneron/Sanofi, said that dupilumab also overcomes the challenges with elimination diets while offering relief for concomitant conditions, such as “asthma, eczema, food allergies, and seasonal allergies.”

But Dr. Falk, who also worked on the dupilumab clinical trials, said the situation is “not straightforward,” even with FDA approval.

“There are going to be significant costs with [prescribing dupilumab], because it’s a biologic,” Dr. Falk said.

Dr. Falk also pointed out that prior authorization will be required, and until more studies can be conducted, the true impact of once-weekly dosing versus daily dosing remains unknown.

“I would say [dupilumab] has the potential to improve adherence, but we need to see if that’s going to be the case or not,” Dr. Falk said.

The authors disclosed relationships with Dr. Falk Pharma, AstraZeneca, and Sanofi/Regeneron (the manufacturers of Dupixent [dupilumab]), among others. Dr. Horsley-Silva, Dr. Falk, and Dr. Leung conducted clinical trials for dupilumab on behalf of Sanofi/Regeneron, with Dr. Leung also disclosing speaking honoraria from Sanofi/Regeneron. Dr. Horsley-Silva has acted as a clinical trial site principal investigator for Allakos and Celgene/Bristol-Myers Squibb.

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

Almost half of adult patients with eosinophilic esophagitis (EoE) reported poor adherence to long-term medical and dietary therapy, with age younger than 40 years and low necessity beliefs being the strongest predictors, a new study finds.

Clinicians need to spend more time discussing the need for EoE therapy with their patients, especially if they are younger, according to lead author Maria L. Haasnoot, MD, of Amsterdam University Medical Center (UMC), the Netherlands, and colleagues.

“Chronic treatment is necessary to maintain suppression of the inflammation and prevent negative outcomes in the long-term,” they write.

Until the recent approval of dupilumab (Dupixent) by the U.S. Food and Drug Administration, patients with EoE relied upon off-label options, including proton pump inhibitors and swallowed topical steroids, as well as dietary interventions for ongoing suppression of inflammation. But only about 1 in 6 patients achieve complete remission at 5 years, according to Dr. Haasnoot and colleagues.

“It is uncertain to what degree limited adherence to treatment [plays] a role in the limited long-term effects of treatment,” they write.

The findings were published online in American Journal of Gastroenterology.
 

Addressing a knowledge gap

The cross-sectional study involved 177 adult patients with EoE treated at Amsterdam UMC, who were prescribed dietary or medical maintenance therapy. Of note, some patients were treated with budesonide, which is approved for EoE in Europe but not in the United States.

Median participant age was 43 years, with a male-skewed distribution (71% men). Patients had been on EoE treatment for 2-6 years. Most (76%) were on medical treatments. Nearly half were on diets that avoided one to five food groups, with some on both medical treatments and elimination diets.

Using a link sent by mail, participants completed the online Medication Adherence Rating Scale, along with several other questionnaires, such as the Beliefs about Medicine Questionnaire, to measure secondary outcomes, including a patient’s view of how necessary or disruptive maintenance therapy is in their life.

The overall prevalence of poor adherence to therapy was high (41.8%), including a nonsignificant difference in adherence between medical and dietary therapies.

“It might come as a surprise that dietary-treated patients are certainly not less adherent to treatment than medically treated patients,” the authors write, noting that the opposite is usually true.

Multivariate logistic regression showed that patients younger than 40 years were more than twice as likely to be poorly adherent (odds ratio, 2.571; 95% confidence interval, 1.195-5.532). Those with low necessity beliefs were more than four times as likely to be poorly adherent (OR, 4.423; 95% CI, 2.169-9.016). Other factors linked to poor adherence were patients with longer disease duration and more severe symptoms.

“Clinicians should pay more attention to treatment adherence, particularly in younger patients,” the authors conclude. “The necessity of treatment should be actively discussed, and efforts should be done to take doubts away, as this may improve treatment adherence and subsequently may improve treatment effects and long-term outcomes.”
 

More patient education needed

According to Jennifer L. Horsley-Silva, MD, of Mayo Clinic, Scottsdale, Ariz., “This study is important, as it is one of the first studies to investigate the rate of treatment adherence in EoE patients and attempts to identify factors associated with adherence both in medically and dietary treated patients.”

Dr. Horsley-Silva commented that the findings align with recent research she and her colleagues conducted at the Mayo Clinic, where few patients successfully completed a six-food elimination diet, even when paired with a dietitian. As with the present study, success trended lower among younger adults. “These findings highlight the need for physicians treating EoE to motivate all patients, but especially younger patients, by discussing disease pathophysiology and explaining the reason for maintenance treatment early on,” Dr. Horsley-Silva said.

Conversations should also address the discordance between symptoms and histologic disease, patient doubts and concerns, and other barriers to adherence, she noted.

“Shared decisionmaking is of utmost importance when deciding upon a maintenance treatment strategy and should be readdressed continually,” she added.

Gary W. Falk, MD, of Penn Medicine, Philadelphia, said that patients with EoE may be poorly adherent because therapies tend to be complicated and people often forget to take their medications, especially when their symptoms improve, even though this is a poor indicator of underlying disease. The discordance between symptoms and histology is “not commonly appreciated by the EoE GI community,” he noted.

Patients may benefit from knowing that untreated or undertreated EoE increases the risk for strictures and stenoses, need for dilation, and frequency of food bolus impactions, Dr. Falk said.

“The other thing we know is that once someone is induced into remission, and they stay on therapy ... long-term remission can be maintained,” he added.
 

The impact of Dupilumab

John Leung, MD, of Boston Food Allergy Center, also cited the complexities of EoE therapies as reason for poor adherence, though he believes this paradigm will shift now that dupilumab has been approved. Dupilumab injections are “just once a week, so it’s much easier in terms of frequency,” Dr. Leung said. “I would expect that the compliance [for dupilumab] will be better” than for older therapies.

Dr. Leung, who helped conduct the dupilumab clinical trials contributing to its approval for EoE and receives speaking honoraria from manufacturer Regeneron/Sanofi, said that dupilumab also overcomes the challenges with elimination diets while offering relief for concomitant conditions, such as “asthma, eczema, food allergies, and seasonal allergies.”

But Dr. Falk, who also worked on the dupilumab clinical trials, said the situation is “not straightforward,” even with FDA approval.

“There are going to be significant costs with [prescribing dupilumab], because it’s a biologic,” Dr. Falk said.

Dr. Falk also pointed out that prior authorization will be required, and until more studies can be conducted, the true impact of once-weekly dosing versus daily dosing remains unknown.

“I would say [dupilumab] has the potential to improve adherence, but we need to see if that’s going to be the case or not,” Dr. Falk said.

The authors disclosed relationships with Dr. Falk Pharma, AstraZeneca, and Sanofi/Regeneron (the manufacturers of Dupixent [dupilumab]), among others. Dr. Horsley-Silva, Dr. Falk, and Dr. Leung conducted clinical trials for dupilumab on behalf of Sanofi/Regeneron, with Dr. Leung also disclosing speaking honoraria from Sanofi/Regeneron. Dr. Horsley-Silva has acted as a clinical trial site principal investigator for Allakos and Celgene/Bristol-Myers Squibb.

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

Posttraumatic stress disorder (PTSD) is associated with accelerated cognitive decline over time, new research suggests.

In an analysis of more than 12,000 middle-aged women who had experienced at least one trauma in their lives, those with PTSD symptoms showed an approximately twofold faster decline in cognition during follow-up compared with those who did not have PTSD symptoms.

These associations were not fully explained by other known cognition-related factors such as depression, the researchers noted.

“PTSD may increase the risk of dementia by accelerating cognitive decline at midlife,” coinvestigator Jiaxuan Liu, a doctoral candidate at Harvard TH Chan School of Public Health, Boston, said in an interview.

“Our findings may suggest the value of earlier cognitive screening among individuals with PTSD and the importance of PTSD prevention and treatment across the lifespan,” she added.

The results were published online in JAMA Network Open.

Vital public health issue

“Cognitive decline at midlife and older is of vital public health interest,” Ms. Liu said. “It is a risk factor for a variety of poor health outcomes and strongly predicts Alzheimer’s disease and other dementias.

Although PTSD has been linked to lower cognitive function and dementia incidence, it has not been known whether it is associated with decline in cognitive function, she added.

“In addition, both PTSD and dementia are more common in women than men, so it’s important to understand a possible link,” Ms. Liu said.

Because no large-scale study had examined whether PTSD is associated with cognitive decline in women, the current researchers examined PTSD symptoms and their association with repeated measures of cognitive function among a large civilian trauma-exposed cohort of women aged 50-70 years at study baseline.

Participants were drawn from the Nurses’ Health Study II, a longitudinal study of a cohort of 116,429 U.S. female nurses who were between 25 and 42 years old at enrollment in 1989. Participants completed biennial questionnaires, with follow-up on an ongoing basis.

The current analysis included 12,270 trauma-exposed women (mean age at baseline, 61.1 years) who completed assessments every 1 or 12 months for up to 24 months after baseline. The mean follow-up time was 0.9 years.

In the study population, 95.9% were non-Hispanic White, 1.3% were Hispanic, 1% were Asian, 0.6% were Black, and 1.2% were classified as “other.”
 

Higher depression scores

Lifetime trauma exposure and PTSD symptoms were assessed from March 1, 2008, to Feb. 28, 2010, using the Short Screening Scale for DSM-IV PTSD.

In total, 67% of the participants reported experiencing PTSD symptoms. The women were divided into four groups, on the basis of symptom number: no PTSD symptoms (n = 4,052), one to three PTSD symptoms (n = 5,058), four to five PTSD symptoms (n = 2,018), and six to seven PTSD symptoms (n = 1,052).

The Cogstate Brief Battery, a validated and self-administered online cognitive assessment, was completed by participants between Oct. 3, 2014, and July 30, 2019. The researchers measured cognitive function with two composite scores: psychomotor speed and attention, and learning and working memory.

Covariates potentially associated with cognitive decline included demographic, educational, and behavior-related health factors such as body mass index, physical activity, cigarette smoking, diet quality, and alcohol consumption.

The researchers conducted secondary analyses that adjusted for symptoms and history of depression as well as the consequences of potential practice effects of taking the test multiple times.

Behavior-related health factors “did not substantially differ by PTSD symptom level,” the investigators noted. However, compared with women who did not have PTSD symptoms, those who had such symptoms had higher depressive symptom scores and higher rates of clinician-diagnosed depression.

Both cognitive composite scores improved through the follow-up period, “likely because of practice effects,” the researchers wrote. But after adjusting for practice effects, they found a decline over time in both composite scores.
 

Dose-related trajectories

Results showed that having more PTSD symptoms was associated with dose-related poorer cognitive trajectories.

After adjustment for demographic characteristics, women with the highest symptom level (six to seven symptoms) had a significantly worse rate of change in both composite domains of learning and working memory (beta = −0.08 SD/y; 95% confidence interval [CI], −0.11 to −0.04 SD/y; P < .001) and of psychomotor speed and attention (beta = −0.05 SD/y; 95% CI, −0.09 to −0.01 SD/y; P  = .02) compared with women with no PTSD symptoms.

Women with four to five PTSD symptoms showed a worse rate of change in learning and working memory compared with those who had no symptoms, but not in psychomotor speed and attention. Women with one to three PTSD symptoms had cognitive scores similar to those of women without PTSD symptoms.

Notably, the associations of PTSD with cognitive change remained evident after additional adjustment for behavioral factors and health conditions – and were only “partially attenuated but still evident” after further adjustment for practice effects and comorbid depression, the investigators wrote.

“We thought PTSD might be associated with worse cognitive decline through health behaviors like smoking and alcohol drinking and higher risk of other health conditions like hypertension and depression,” Ms. Liu said.

However, those factors did not account for the current study’s findings, she noted.

“We could not determine why women with PTSD had faster cognitive decline than those without PTSD,” she said.

Ms. Liu suggested that PTSD “may have effects on the brain, such as altering brain structures and affecting brain immune function.” However, more research is needed “to investigate these mechanisms that might underlie the association we found between PTSD and cognitive decline,” she said.
 

Neurotoxic effect

In a comment, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said, “It is well known that stress is neurotoxic, and PTSD is a particularly serious form of stress.”

Dr. Fillit, clinical professor of geriatric medicine and palliative care, medicine, and neuroscience at Mount Sinai Hospital, New York, was not involved with the study.

“We tend to think of PTSD in postacute settings, such as soldiers returning from war,” he said. “This study contributes to our understanding of the long-term effects of PTSD on cognitive decline, measured objectively over time”

Dr. Fillit noted that an important implication is that, by increasing the risk for cognitive decline, PTSD also increases risk for Alzheimer’s disease. This leads to the “main take-home, which is that PTSD is a risk factor not only for cognitive decline but also for Alzheimer’s and related dementias,” he said.

However, this opens a potential therapeutic approach, Dr. Fillit added.

Because cortisol and other stress hormones drive the stress response, finding ways to block the neurotoxic effects of these hormones “might be a target to prevent cognitive decline and decrease Alzheimer’s disease risk,” he said.

The study was supported by grants from the National Institute of Mental Health and the National Institutes of Health. Ms. Liu and Dr. Fillit report no relevant financial relationships.

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

Posttraumatic stress disorder (PTSD) is associated with accelerated cognitive decline over time, new research suggests.

In an analysis of more than 12,000 middle-aged women who had experienced at least one trauma in their lives, those with PTSD symptoms showed an approximately twofold faster decline in cognition during follow-up compared with those who did not have PTSD symptoms.

These associations were not fully explained by other known cognition-related factors such as depression, the researchers noted.

“PTSD may increase the risk of dementia by accelerating cognitive decline at midlife,” coinvestigator Jiaxuan Liu, a doctoral candidate at Harvard TH Chan School of Public Health, Boston, said in an interview.

“Our findings may suggest the value of earlier cognitive screening among individuals with PTSD and the importance of PTSD prevention and treatment across the lifespan,” she added.

The results were published online in JAMA Network Open.

Vital public health issue

“Cognitive decline at midlife and older is of vital public health interest,” Ms. Liu said. “It is a risk factor for a variety of poor health outcomes and strongly predicts Alzheimer’s disease and other dementias.

Although PTSD has been linked to lower cognitive function and dementia incidence, it has not been known whether it is associated with decline in cognitive function, she added.

“In addition, both PTSD and dementia are more common in women than men, so it’s important to understand a possible link,” Ms. Liu said.

Because no large-scale study had examined whether PTSD is associated with cognitive decline in women, the current researchers examined PTSD symptoms and their association with repeated measures of cognitive function among a large civilian trauma-exposed cohort of women aged 50-70 years at study baseline.

Participants were drawn from the Nurses’ Health Study II, a longitudinal study of a cohort of 116,429 U.S. female nurses who were between 25 and 42 years old at enrollment in 1989. Participants completed biennial questionnaires, with follow-up on an ongoing basis.

The current analysis included 12,270 trauma-exposed women (mean age at baseline, 61.1 years) who completed assessments every 1 or 12 months for up to 24 months after baseline. The mean follow-up time was 0.9 years.

In the study population, 95.9% were non-Hispanic White, 1.3% were Hispanic, 1% were Asian, 0.6% were Black, and 1.2% were classified as “other.”
 

Higher depression scores

Lifetime trauma exposure and PTSD symptoms were assessed from March 1, 2008, to Feb. 28, 2010, using the Short Screening Scale for DSM-IV PTSD.

In total, 67% of the participants reported experiencing PTSD symptoms. The women were divided into four groups, on the basis of symptom number: no PTSD symptoms (n = 4,052), one to three PTSD symptoms (n = 5,058), four to five PTSD symptoms (n = 2,018), and six to seven PTSD symptoms (n = 1,052).

The Cogstate Brief Battery, a validated and self-administered online cognitive assessment, was completed by participants between Oct. 3, 2014, and July 30, 2019. The researchers measured cognitive function with two composite scores: psychomotor speed and attention, and learning and working memory.

Covariates potentially associated with cognitive decline included demographic, educational, and behavior-related health factors such as body mass index, physical activity, cigarette smoking, diet quality, and alcohol consumption.

The researchers conducted secondary analyses that adjusted for symptoms and history of depression as well as the consequences of potential practice effects of taking the test multiple times.

Behavior-related health factors “did not substantially differ by PTSD symptom level,” the investigators noted. However, compared with women who did not have PTSD symptoms, those who had such symptoms had higher depressive symptom scores and higher rates of clinician-diagnosed depression.

Both cognitive composite scores improved through the follow-up period, “likely because of practice effects,” the researchers wrote. But after adjusting for practice effects, they found a decline over time in both composite scores.
 

Dose-related trajectories

Results showed that having more PTSD symptoms was associated with dose-related poorer cognitive trajectories.

After adjustment for demographic characteristics, women with the highest symptom level (six to seven symptoms) had a significantly worse rate of change in both composite domains of learning and working memory (beta = −0.08 SD/y; 95% confidence interval [CI], −0.11 to −0.04 SD/y; P < .001) and of psychomotor speed and attention (beta = −0.05 SD/y; 95% CI, −0.09 to −0.01 SD/y; P  = .02) compared with women with no PTSD symptoms.

Women with four to five PTSD symptoms showed a worse rate of change in learning and working memory compared with those who had no symptoms, but not in psychomotor speed and attention. Women with one to three PTSD symptoms had cognitive scores similar to those of women without PTSD symptoms.

Notably, the associations of PTSD with cognitive change remained evident after additional adjustment for behavioral factors and health conditions – and were only “partially attenuated but still evident” after further adjustment for practice effects and comorbid depression, the investigators wrote.

“We thought PTSD might be associated with worse cognitive decline through health behaviors like smoking and alcohol drinking and higher risk of other health conditions like hypertension and depression,” Ms. Liu said.

However, those factors did not account for the current study’s findings, she noted.

“We could not determine why women with PTSD had faster cognitive decline than those without PTSD,” she said.

Ms. Liu suggested that PTSD “may have effects on the brain, such as altering brain structures and affecting brain immune function.” However, more research is needed “to investigate these mechanisms that might underlie the association we found between PTSD and cognitive decline,” she said.
 

Neurotoxic effect

In a comment, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said, “It is well known that stress is neurotoxic, and PTSD is a particularly serious form of stress.”

Dr. Fillit, clinical professor of geriatric medicine and palliative care, medicine, and neuroscience at Mount Sinai Hospital, New York, was not involved with the study.

“We tend to think of PTSD in postacute settings, such as soldiers returning from war,” he said. “This study contributes to our understanding of the long-term effects of PTSD on cognitive decline, measured objectively over time”

Dr. Fillit noted that an important implication is that, by increasing the risk for cognitive decline, PTSD also increases risk for Alzheimer’s disease. This leads to the “main take-home, which is that PTSD is a risk factor not only for cognitive decline but also for Alzheimer’s and related dementias,” he said.

However, this opens a potential therapeutic approach, Dr. Fillit added.

Because cortisol and other stress hormones drive the stress response, finding ways to block the neurotoxic effects of these hormones “might be a target to prevent cognitive decline and decrease Alzheimer’s disease risk,” he said.

The study was supported by grants from the National Institute of Mental Health and the National Institutes of Health. Ms. Liu and Dr. Fillit report no relevant financial relationships.

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

Posttraumatic stress disorder (PTSD) is associated with accelerated cognitive decline over time, new research suggests.

In an analysis of more than 12,000 middle-aged women who had experienced at least one trauma in their lives, those with PTSD symptoms showed an approximately twofold faster decline in cognition during follow-up compared with those who did not have PTSD symptoms.

These associations were not fully explained by other known cognition-related factors such as depression, the researchers noted.

“PTSD may increase the risk of dementia by accelerating cognitive decline at midlife,” coinvestigator Jiaxuan Liu, a doctoral candidate at Harvard TH Chan School of Public Health, Boston, said in an interview.

“Our findings may suggest the value of earlier cognitive screening among individuals with PTSD and the importance of PTSD prevention and treatment across the lifespan,” she added.

The results were published online in JAMA Network Open.

Vital public health issue

“Cognitive decline at midlife and older is of vital public health interest,” Ms. Liu said. “It is a risk factor for a variety of poor health outcomes and strongly predicts Alzheimer’s disease and other dementias.

Although PTSD has been linked to lower cognitive function and dementia incidence, it has not been known whether it is associated with decline in cognitive function, she added.

“In addition, both PTSD and dementia are more common in women than men, so it’s important to understand a possible link,” Ms. Liu said.

Because no large-scale study had examined whether PTSD is associated with cognitive decline in women, the current researchers examined PTSD symptoms and their association with repeated measures of cognitive function among a large civilian trauma-exposed cohort of women aged 50-70 years at study baseline.

Participants were drawn from the Nurses’ Health Study II, a longitudinal study of a cohort of 116,429 U.S. female nurses who were between 25 and 42 years old at enrollment in 1989. Participants completed biennial questionnaires, with follow-up on an ongoing basis.

The current analysis included 12,270 trauma-exposed women (mean age at baseline, 61.1 years) who completed assessments every 1 or 12 months for up to 24 months after baseline. The mean follow-up time was 0.9 years.

In the study population, 95.9% were non-Hispanic White, 1.3% were Hispanic, 1% were Asian, 0.6% were Black, and 1.2% were classified as “other.”
 

Higher depression scores

Lifetime trauma exposure and PTSD symptoms were assessed from March 1, 2008, to Feb. 28, 2010, using the Short Screening Scale for DSM-IV PTSD.

In total, 67% of the participants reported experiencing PTSD symptoms. The women were divided into four groups, on the basis of symptom number: no PTSD symptoms (n = 4,052), one to three PTSD symptoms (n = 5,058), four to five PTSD symptoms (n = 2,018), and six to seven PTSD symptoms (n = 1,052).

The Cogstate Brief Battery, a validated and self-administered online cognitive assessment, was completed by participants between Oct. 3, 2014, and July 30, 2019. The researchers measured cognitive function with two composite scores: psychomotor speed and attention, and learning and working memory.

Covariates potentially associated with cognitive decline included demographic, educational, and behavior-related health factors such as body mass index, physical activity, cigarette smoking, diet quality, and alcohol consumption.

The researchers conducted secondary analyses that adjusted for symptoms and history of depression as well as the consequences of potential practice effects of taking the test multiple times.

Behavior-related health factors “did not substantially differ by PTSD symptom level,” the investigators noted. However, compared with women who did not have PTSD symptoms, those who had such symptoms had higher depressive symptom scores and higher rates of clinician-diagnosed depression.

Both cognitive composite scores improved through the follow-up period, “likely because of practice effects,” the researchers wrote. But after adjusting for practice effects, they found a decline over time in both composite scores.
 

Dose-related trajectories

Results showed that having more PTSD symptoms was associated with dose-related poorer cognitive trajectories.

After adjustment for demographic characteristics, women with the highest symptom level (six to seven symptoms) had a significantly worse rate of change in both composite domains of learning and working memory (beta = −0.08 SD/y; 95% confidence interval [CI], −0.11 to −0.04 SD/y; P < .001) and of psychomotor speed and attention (beta = −0.05 SD/y; 95% CI, −0.09 to −0.01 SD/y; P  = .02) compared with women with no PTSD symptoms.

Women with four to five PTSD symptoms showed a worse rate of change in learning and working memory compared with those who had no symptoms, but not in psychomotor speed and attention. Women with one to three PTSD symptoms had cognitive scores similar to those of women without PTSD symptoms.

Notably, the associations of PTSD with cognitive change remained evident after additional adjustment for behavioral factors and health conditions – and were only “partially attenuated but still evident” after further adjustment for practice effects and comorbid depression, the investigators wrote.

“We thought PTSD might be associated with worse cognitive decline through health behaviors like smoking and alcohol drinking and higher risk of other health conditions like hypertension and depression,” Ms. Liu said.

However, those factors did not account for the current study’s findings, she noted.

“We could not determine why women with PTSD had faster cognitive decline than those without PTSD,” she said.

Ms. Liu suggested that PTSD “may have effects on the brain, such as altering brain structures and affecting brain immune function.” However, more research is needed “to investigate these mechanisms that might underlie the association we found between PTSD and cognitive decline,” she said.
 

Neurotoxic effect

In a comment, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said, “It is well known that stress is neurotoxic, and PTSD is a particularly serious form of stress.”

Dr. Fillit, clinical professor of geriatric medicine and palliative care, medicine, and neuroscience at Mount Sinai Hospital, New York, was not involved with the study.

“We tend to think of PTSD in postacute settings, such as soldiers returning from war,” he said. “This study contributes to our understanding of the long-term effects of PTSD on cognitive decline, measured objectively over time”

Dr. Fillit noted that an important implication is that, by increasing the risk for cognitive decline, PTSD also increases risk for Alzheimer’s disease. This leads to the “main take-home, which is that PTSD is a risk factor not only for cognitive decline but also for Alzheimer’s and related dementias,” he said.

However, this opens a potential therapeutic approach, Dr. Fillit added.

Because cortisol and other stress hormones drive the stress response, finding ways to block the neurotoxic effects of these hormones “might be a target to prevent cognitive decline and decrease Alzheimer’s disease risk,” he said.

The study was supported by grants from the National Institute of Mental Health and the National Institutes of Health. Ms. Liu and Dr. Fillit report no relevant financial relationships.

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

When Amy Moser had a simple urinary tract infection in her late 20s, her doctor prescribed Cipro, a powerful antibiotic used to treat anthrax and some of the most fearsome bacterial infections.

Nearly 2 weeks after she finished her treatment, her left kneecap dislocated while she was trying on a swimsuit at a retail store. Shortly afterward, she had painful ligament ruptures in her wrists, then her shoulder dislocated, followed by three Achilles tendon tears.

“That’s when I fell apart,” says Ms. Moser, a Phoenix health blogger and book author. “From that moment on, for almost the next 2.5 years consistently, I had new tendon tears every few weeks.”

Ms. Moser’s doctors had no answer for what was causing her injuries, all of which required surgical fixes. A married mother of three, she was otherwise healthy and fit. So, after her third Achilles tear, she turned to the FDA’s website for answers. There, she found many warnings about side effects of Cipro, Levaquin, and other so-called fluoroquinolones, including risks for tendon and ligament injuries.

“When all the ruptures started to happen, my doctor kept asking me if I’d ever taken Levaquin, and every time I was like, ‘No.’ So I did what all doctors don’t want you to do: I Googled ‘Levaquin,’ ” she recalls.

Her search led to FDA warnings and articles about the possibility of tendon and ligament ruptures with fluroquinolones.

“That was the first time I’d ever even heard that word ‘fluroquinolones,’ and I found Cipro on that list ... and I realized that I’d just been prescribed that before everything started,” she says.

That was 12 years ago. Since then, the FDA has issued more warnings about fluoroquinolone risks. In that time, Ms. Moser, now 40, has had more than 30 surgeries to correct tendon ruptures and injuries, including a double-knee replacement this year.

“I am in chronic pain all the time,” she says. “I am chronically injured. I have a lot of tears that I’ve not fixed because they’re very complicated, and I don’t know if the rest of my body can handle the strain of recovering from those surgeries.”

Ms. Moser’s is hardly an isolated case. Since the 1980s, more than 60,000 patients have reported hundreds of thousands of serious events linked to fluoroquinolones to the FDA, including 6,575 reports of deaths.

The most common side effects were tendon rupture, as well as neurological and psychiatric symptoms. But experts estimate only 1%-10% of such events are reported to the FDA. That suggests that fluoroquinolones might have harmed hundreds of thousands of people in the United States alone, says Charles Bennett, MD, a hematologist at the University of South Carolina’s College of Pharmacy, Columbia.

Yet despite the many patient reports and FDA warnings on dangerous side effects, many doctors continue to wrongly prescribe fluoroquinolones for simple urinary tract infections, sinus infections, and respiratory issues better treated with less risky antibiotics.

“There probably is overprescription by primary care doctors for urinary tract infections and respiratory infections, when there could be alternatives that are safer to use,” says Amesh Adalja, MD, an infectious disease specialist and senior scholar with the Johns Hopkins Center for Health Security.

“I would say that’s probably the case in the outpatient setting, not necessarily in the hospital setting or among infectious disease doctors ... but I think it’s important to say there are still some judicious uses of fluoroquinolones,” he says. “However, there probably is a lot of injudicious use of fluoroquinolones along with many other antibiotics in the primary care setting.”
 

FDA warnings on fluoroquinolones

Fluoroquinolones are a class of broad-spectrum antibiotics used for decades to treat certain bacterial infections.

FDA-approved fluoroquinolones include ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, delafloxacin (Baxdela), gemifloxacin (Factive) levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin). More than 60 generic versions of these brand-name medicines are also on the market, making them among the most prescribed antibiotics in the U.S.

Over the past 2 decades, a wide range of physical and mental health side effects have been tied to fluoroquinolones. As a result of these “adverse event reports” and research published in medical literature, the FDA has required an escalating series of warnings and safety labeling changes for doctors who prescribe these drugs.

• In 2008, the FDA first added a “black box” warning to fluoroquinolones, citing an increased risk of tendinitis and tendon rupture in patients prescribed these meds.
• In 2011, the agency required the warning label to include risks of worsening symptoms for those with myasthenia gravis, a chronic autoimmune disease that causes muscle weakness, vision problems, and speech problems.
• In 2013, regulators required updated labels noting the potential for irreversible peripheral neuropathy (serious nerve damage).
• In 2016, the FDA issued its strongest warning against the use of such antibiotics for simple bacterial infections – such as uncomplicated urinary tract infections (UTIs), acute sinusitis, and acute bronchitis – saying the “association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system ... outweighs the benefits for patients.”
• And in 2018, regulators required safety labeling changes to include warnings about the risks of aortic aneurysm – a life-threatening enlargement of the main vessel that delivers blood to the body – as well as mental health side effects and serious blood sugar disturbances.

But FDA regulators have stopped short of barring fluoroquinolone use in the treatment of bacterial infections, citing the benefits for certain conditions.

“For some patients, the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections,” said former FDA Commissioner Scott Gottlieb, MD, “but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use.”

In December 2021, a study published in the journal JAMA Network Open found the FDA’s warnings may have helped lower prescribing of the drugs in Medicare patients. But not all doctors have been responsive to those warnings, researchers found.

“An overall decline in change over time and an immediate change in fluoroquinolone prescribing was observed after the 2016 FDA warning,” the authors concluded. “Certain physicians, such as primary care physicians, were more responsive to FDA warnings than others. ... Findings of this study suggest that identifying the association of physician and organizational characteristics with fluoroquinolone prescribing practices could help in developing mechanisms for improving de-adoption.”

Some critics say the FDA should do more to spotlight the dangers of fluoroquinolones and require doctors and patients to sign checklist consent forms to show they are aware of the potential side effects of these drugs.

Rachel Brummert, a patient advocate who sits on an FDA consumer advisory board, believes the FDA needs to improve its communication to doctors on fluoroquinolone risks and get tougher with those who continue to inappropriately prescribe the drugs.

“I think there needs to be a system in place, where if something comes down from the FDA about a drug, the physician has to sign off on it, the patient has to sign off on it and mark that they understand that there are these ‘black box’ warnings,” says Ms. Brummert, 52, a representative on the FDA’s Medical Devices Advisory Committee.

As an example, she points to Australia’s medical laws requiring doctors and patients to sign a checklist before any fluoroquinolone prescription is approved.

“When a physician prescribes a fluoroquinolone antibiotic, there’s a checklist – does the patient have an infection, is it a simple infection, do they have allergies?” she notes. “And you can’t even get the prescription out – it won’t even print out, it won’t go into the system – unless you check all of the boxes. But we don’t do that here. We don’t have that type of system right now.”

Ms. Brummert says such a system might have prevented the harm from taking Levaquin her doctor prescribed for a suspected sinus infection in 2006.

Soon after she began taking the antibiotic, she ruptured her Achilles tendon, requiring surgery. By 2009, she’d had three ruptures, each needing surgical fixes. To date, she’s had more than 30 surgeries to correct tendon ruptures. She’s also had seizures, blood pressure issues, depression, chronic pain, and memory problems she attributes to taking Levaquin.

As it turns out, her doctor misdiagnosed her condition – a misstep that would have been averted with a system like Australia’s, which requires doctors to verify the presence of a bacterial infection through a simple test before prescribing a fluoroquinolone.

“When I got the Levaquin, it was for a suspected sinus infection that it turned out I didn’t even have in the first place,” she notes. “So, I took the Levaquin basically for nothing. But what I would have asked my doctor had I known is: ‘Why should I take something so strong for so simple an infection?’

“It seems common sense to me now that you don’t prescribe something that can kill anthrax for a simple sinus infection. It’s like an atom bomb killing a mosquito. I agree that there are uses for these drugs, but they are being overprescribed. And so, here I am 16 years later – I’m still rupturing, I’m still having surgery, and I’m still in pain – all for something I didn’t even need medicine for in the first place.”
 

Should guidelines be stronger?

So, why are so many doctors continuing to prescribe fluoroquinolones for simple infections? Dr. Adalja and other experts say several things are at work.

For one thing, Dr. Adalja notes, fluoroquinolones are broad-spectrum antibiotics that are effective against dangerous germs, including “gram-negative” bacterial infections, and are “100% bioavailable.” That means they are as effective when given in pill form as they are if put directly into a vein. So they can be used in an outpatient setting or to allow a patient to be discharged from a hospital sooner because they don’t need an IV to receive treatment.

“There are still some uses for these drugs because they are so bioavailable, and I think that drives some of the use, and those are legitimate uses, knowing that there are risks when you do it,” he says. “But no drug is without risks, and you have to weigh risks and benefits – that’s what medicine is about: deciding what the best drug is for a patient.”

But Dr. Adalja says the overprescription of fluoroquinolones is part of the larger trend of antibiotic overuse. That is driving up antibiotic resistance, which in turn is another thing leading doctors to turn to Cipro and other fluoroquinolones after other drugs have proven ineffective.

“You can’t separate this from the fact that 80% of antibiotic prescriptions in the outpatient setting are probably illegitimate or not warranted,” he notes. “And because fluoroquinolones are highly effective drugs against certain pathogens, they are the go-to [drug] for many people who are prescribing antibiotics.”

That’s why patients should be wary whenever a doctor prescribes a fluoroquinolone, or any drug to treat a suspected infection, he says.

“Any time a patient is getting prescribed an antibiotic by a physician, they should ask: ‘Do I really need this antibiotic?’ That should be the first question they ask,” he advises. “And if they’re getting a fluoroquinolone, they may want to ask: ‘Is this the best antibiotic for me?’ ”
 

What you can do

Ms. Brummert and Ms. Moser say they are sharing their stories to raise awareness of the dangers of fluoroquinolones.

Ms. Moser has published a book on her experiences, “The Magnificent Story of a Lame Author,” and provides a wealth of consumer resources on her blog: Mountains and Mustard Seeds.

“As much as I hate what has happened to me, it has put me in a place where I am glad that I can inform other patients,” she says.

Ms. Brummert supplements her advocacy work as an FDA adviser with useful materials she provides on her website: Drugwatch.com.

“Pain into purpose – that’s what I call it,” she says. “I can’t change what happened to me, but I can warn others.”

The upshot for patients?

• the FDA’s Drug Safety Communication on Fluoroquinolones online to learn more about the risks and benefits of these powerful antibiotics.
• If you believe you’ve been harmed by fluoroquinolones, MedWatch website to report your experiences.

Ms. Brummert also advises patients to ask 12 critical questions of any doctor who wants to prescribe a fluoroquinolone, including the following listed on her website:

• For what condition is this medication prescribed, and is there another drug specific to my condition?
• What are the risks associated with this medication, and do the benefits outweigh them?
• Will this medication interact with my other drugs and/or other health conditions?
• What are the “boxed” warnings for this medication, and where can I report adverse events?

“I would also do my own research,” she says. “I wouldn’t just take a prescription from a physician and just say, ‘OK, doctor knows best.’ ”

Ms. Moser agrees that you have to be your own patient advocate and not simply take a doctor’s advice on any medical issue without having a deeper conversation.

“I’ve had arguments with doctors who legitimately did not believe me when I told them what happened to me,” she says. “And I actually told them, ‘Go get your Physicians’ Desk Reference [for prescription drugs]’ and they opened the book in front of me and read the warnings. Obviously, they had not been keeping up with the added warnings. So, I do think that doctors do need to be better informed.”

“So, yes, it’s the FDA’s responsibility, but it is also the doctors’ responsibility to make sure that they’re watching out for the side effects and they’re reporting them when their patients come up with them and making those connections.”

A version of this article first appeared on WebMD.com.

When Amy Moser had a simple urinary tract infection in her late 20s, her doctor prescribed Cipro, a powerful antibiotic used to treat anthrax and some of the most fearsome bacterial infections.

Nearly 2 weeks after she finished her treatment, her left kneecap dislocated while she was trying on a swimsuit at a retail store. Shortly afterward, she had painful ligament ruptures in her wrists, then her shoulder dislocated, followed by three Achilles tendon tears.

“That’s when I fell apart,” says Ms. Moser, a Phoenix health blogger and book author. “From that moment on, for almost the next 2.5 years consistently, I had new tendon tears every few weeks.”

Ms. Moser’s doctors had no answer for what was causing her injuries, all of which required surgical fixes. A married mother of three, she was otherwise healthy and fit. So, after her third Achilles tear, she turned to the FDA’s website for answers. There, she found many warnings about side effects of Cipro, Levaquin, and other so-called fluoroquinolones, including risks for tendon and ligament injuries.

“When all the ruptures started to happen, my doctor kept asking me if I’d ever taken Levaquin, and every time I was like, ‘No.’ So I did what all doctors don’t want you to do: I Googled ‘Levaquin,’ ” she recalls.

Her search led to FDA warnings and articles about the possibility of tendon and ligament ruptures with fluroquinolones.

“That was the first time I’d ever even heard that word ‘fluroquinolones,’ and I found Cipro on that list ... and I realized that I’d just been prescribed that before everything started,” she says.

That was 12 years ago. Since then, the FDA has issued more warnings about fluoroquinolone risks. In that time, Ms. Moser, now 40, has had more than 30 surgeries to correct tendon ruptures and injuries, including a double-knee replacement this year.

“I am in chronic pain all the time,” she says. “I am chronically injured. I have a lot of tears that I’ve not fixed because they’re very complicated, and I don’t know if the rest of my body can handle the strain of recovering from those surgeries.”

Ms. Moser’s is hardly an isolated case. Since the 1980s, more than 60,000 patients have reported hundreds of thousands of serious events linked to fluoroquinolones to the FDA, including 6,575 reports of deaths.

The most common side effects were tendon rupture, as well as neurological and psychiatric symptoms. But experts estimate only 1%-10% of such events are reported to the FDA. That suggests that fluoroquinolones might have harmed hundreds of thousands of people in the United States alone, says Charles Bennett, MD, a hematologist at the University of South Carolina’s College of Pharmacy, Columbia.

Yet despite the many patient reports and FDA warnings on dangerous side effects, many doctors continue to wrongly prescribe fluoroquinolones for simple urinary tract infections, sinus infections, and respiratory issues better treated with less risky antibiotics.

“There probably is overprescription by primary care doctors for urinary tract infections and respiratory infections, when there could be alternatives that are safer to use,” says Amesh Adalja, MD, an infectious disease specialist and senior scholar with the Johns Hopkins Center for Health Security.

“I would say that’s probably the case in the outpatient setting, not necessarily in the hospital setting or among infectious disease doctors ... but I think it’s important to say there are still some judicious uses of fluoroquinolones,” he says. “However, there probably is a lot of injudicious use of fluoroquinolones along with many other antibiotics in the primary care setting.”
 

FDA warnings on fluoroquinolones

Fluoroquinolones are a class of broad-spectrum antibiotics used for decades to treat certain bacterial infections.

FDA-approved fluoroquinolones include ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, delafloxacin (Baxdela), gemifloxacin (Factive) levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin). More than 60 generic versions of these brand-name medicines are also on the market, making them among the most prescribed antibiotics in the U.S.

Over the past 2 decades, a wide range of physical and mental health side effects have been tied to fluoroquinolones. As a result of these “adverse event reports” and research published in medical literature, the FDA has required an escalating series of warnings and safety labeling changes for doctors who prescribe these drugs.

• In 2008, the FDA first added a “black box” warning to fluoroquinolones, citing an increased risk of tendinitis and tendon rupture in patients prescribed these meds.
• In 2011, the agency required the warning label to include risks of worsening symptoms for those with myasthenia gravis, a chronic autoimmune disease that causes muscle weakness, vision problems, and speech problems.
• In 2013, regulators required updated labels noting the potential for irreversible peripheral neuropathy (serious nerve damage).
• In 2016, the FDA issued its strongest warning against the use of such antibiotics for simple bacterial infections – such as uncomplicated urinary tract infections (UTIs), acute sinusitis, and acute bronchitis – saying the “association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system ... outweighs the benefits for patients.”
• And in 2018, regulators required safety labeling changes to include warnings about the risks of aortic aneurysm – a life-threatening enlargement of the main vessel that delivers blood to the body – as well as mental health side effects and serious blood sugar disturbances.

But FDA regulators have stopped short of barring fluoroquinolone use in the treatment of bacterial infections, citing the benefits for certain conditions.

“For some patients, the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections,” said former FDA Commissioner Scott Gottlieb, MD, “but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use.”

In December 2021, a study published in the journal JAMA Network Open found the FDA’s warnings may have helped lower prescribing of the drugs in Medicare patients. But not all doctors have been responsive to those warnings, researchers found.

“An overall decline in change over time and an immediate change in fluoroquinolone prescribing was observed after the 2016 FDA warning,” the authors concluded. “Certain physicians, such as primary care physicians, were more responsive to FDA warnings than others. ... Findings of this study suggest that identifying the association of physician and organizational characteristics with fluoroquinolone prescribing practices could help in developing mechanisms for improving de-adoption.”

Some critics say the FDA should do more to spotlight the dangers of fluoroquinolones and require doctors and patients to sign checklist consent forms to show they are aware of the potential side effects of these drugs.

Rachel Brummert, a patient advocate who sits on an FDA consumer advisory board, believes the FDA needs to improve its communication to doctors on fluoroquinolone risks and get tougher with those who continue to inappropriately prescribe the drugs.

“I think there needs to be a system in place, where if something comes down from the FDA about a drug, the physician has to sign off on it, the patient has to sign off on it and mark that they understand that there are these ‘black box’ warnings,” says Ms. Brummert, 52, a representative on the FDA’s Medical Devices Advisory Committee.

As an example, she points to Australia’s medical laws requiring doctors and patients to sign a checklist before any fluoroquinolone prescription is approved.

“When a physician prescribes a fluoroquinolone antibiotic, there’s a checklist – does the patient have an infection, is it a simple infection, do they have allergies?” she notes. “And you can’t even get the prescription out – it won’t even print out, it won’t go into the system – unless you check all of the boxes. But we don’t do that here. We don’t have that type of system right now.”

Ms. Brummert says such a system might have prevented the harm from taking Levaquin her doctor prescribed for a suspected sinus infection in 2006.

Soon after she began taking the antibiotic, she ruptured her Achilles tendon, requiring surgery. By 2009, she’d had three ruptures, each needing surgical fixes. To date, she’s had more than 30 surgeries to correct tendon ruptures. She’s also had seizures, blood pressure issues, depression, chronic pain, and memory problems she attributes to taking Levaquin.

As it turns out, her doctor misdiagnosed her condition – a misstep that would have been averted with a system like Australia’s, which requires doctors to verify the presence of a bacterial infection through a simple test before prescribing a fluoroquinolone.

“When I got the Levaquin, it was for a suspected sinus infection that it turned out I didn’t even have in the first place,” she notes. “So, I took the Levaquin basically for nothing. But what I would have asked my doctor had I known is: ‘Why should I take something so strong for so simple an infection?’

“It seems common sense to me now that you don’t prescribe something that can kill anthrax for a simple sinus infection. It’s like an atom bomb killing a mosquito. I agree that there are uses for these drugs, but they are being overprescribed. And so, here I am 16 years later – I’m still rupturing, I’m still having surgery, and I’m still in pain – all for something I didn’t even need medicine for in the first place.”
 

Should guidelines be stronger?

So, why are so many doctors continuing to prescribe fluoroquinolones for simple infections? Dr. Adalja and other experts say several things are at work.

For one thing, Dr. Adalja notes, fluoroquinolones are broad-spectrum antibiotics that are effective against dangerous germs, including “gram-negative” bacterial infections, and are “100% bioavailable.” That means they are as effective when given in pill form as they are if put directly into a vein. So they can be used in an outpatient setting or to allow a patient to be discharged from a hospital sooner because they don’t need an IV to receive treatment.

“There are still some uses for these drugs because they are so bioavailable, and I think that drives some of the use, and those are legitimate uses, knowing that there are risks when you do it,” he says. “But no drug is without risks, and you have to weigh risks and benefits – that’s what medicine is about: deciding what the best drug is for a patient.”

But Dr. Adalja says the overprescription of fluoroquinolones is part of the larger trend of antibiotic overuse. That is driving up antibiotic resistance, which in turn is another thing leading doctors to turn to Cipro and other fluoroquinolones after other drugs have proven ineffective.

“You can’t separate this from the fact that 80% of antibiotic prescriptions in the outpatient setting are probably illegitimate or not warranted,” he notes. “And because fluoroquinolones are highly effective drugs against certain pathogens, they are the go-to [drug] for many people who are prescribing antibiotics.”

That’s why patients should be wary whenever a doctor prescribes a fluoroquinolone, or any drug to treat a suspected infection, he says.

“Any time a patient is getting prescribed an antibiotic by a physician, they should ask: ‘Do I really need this antibiotic?’ That should be the first question they ask,” he advises. “And if they’re getting a fluoroquinolone, they may want to ask: ‘Is this the best antibiotic for me?’ ”
 

What you can do

Ms. Brummert and Ms. Moser say they are sharing their stories to raise awareness of the dangers of fluoroquinolones.

Ms. Moser has published a book on her experiences, “The Magnificent Story of a Lame Author,” and provides a wealth of consumer resources on her blog: Mountains and Mustard Seeds.

“As much as I hate what has happened to me, it has put me in a place where I am glad that I can inform other patients,” she says.

Ms. Brummert supplements her advocacy work as an FDA adviser with useful materials she provides on her website: Drugwatch.com.

“Pain into purpose – that’s what I call it,” she says. “I can’t change what happened to me, but I can warn others.”

The upshot for patients?

• the FDA’s Drug Safety Communication on Fluoroquinolones online to learn more about the risks and benefits of these powerful antibiotics.
• If you believe you’ve been harmed by fluoroquinolones, MedWatch website to report your experiences.

Ms. Brummert also advises patients to ask 12 critical questions of any doctor who wants to prescribe a fluoroquinolone, including the following listed on her website:

• For what condition is this medication prescribed, and is there another drug specific to my condition?
• What are the risks associated with this medication, and do the benefits outweigh them?
• Will this medication interact with my other drugs and/or other health conditions?
• What are the “boxed” warnings for this medication, and where can I report adverse events?

“I would also do my own research,” she says. “I wouldn’t just take a prescription from a physician and just say, ‘OK, doctor knows best.’ ”

Ms. Moser agrees that you have to be your own patient advocate and not simply take a doctor’s advice on any medical issue without having a deeper conversation.

“I’ve had arguments with doctors who legitimately did not believe me when I told them what happened to me,” she says. “And I actually told them, ‘Go get your Physicians’ Desk Reference [for prescription drugs]’ and they opened the book in front of me and read the warnings. Obviously, they had not been keeping up with the added warnings. So, I do think that doctors do need to be better informed.”

“So, yes, it’s the FDA’s responsibility, but it is also the doctors’ responsibility to make sure that they’re watching out for the side effects and they’re reporting them when their patients come up with them and making those connections.”

A version of this article first appeared on WebMD.com.

When Amy Moser had a simple urinary tract infection in her late 20s, her doctor prescribed Cipro, a powerful antibiotic used to treat anthrax and some of the most fearsome bacterial infections.

Nearly 2 weeks after she finished her treatment, her left kneecap dislocated while she was trying on a swimsuit at a retail store. Shortly afterward, she had painful ligament ruptures in her wrists, then her shoulder dislocated, followed by three Achilles tendon tears.

“That’s when I fell apart,” says Ms. Moser, a Phoenix health blogger and book author. “From that moment on, for almost the next 2.5 years consistently, I had new tendon tears every few weeks.”

Ms. Moser’s doctors had no answer for what was causing her injuries, all of which required surgical fixes. A married mother of three, she was otherwise healthy and fit. So, after her third Achilles tear, she turned to the FDA’s website for answers. There, she found many warnings about side effects of Cipro, Levaquin, and other so-called fluoroquinolones, including risks for tendon and ligament injuries.

“When all the ruptures started to happen, my doctor kept asking me if I’d ever taken Levaquin, and every time I was like, ‘No.’ So I did what all doctors don’t want you to do: I Googled ‘Levaquin,’ ” she recalls.

Her search led to FDA warnings and articles about the possibility of tendon and ligament ruptures with fluroquinolones.

“That was the first time I’d ever even heard that word ‘fluroquinolones,’ and I found Cipro on that list ... and I realized that I’d just been prescribed that before everything started,” she says.

That was 12 years ago. Since then, the FDA has issued more warnings about fluoroquinolone risks. In that time, Ms. Moser, now 40, has had more than 30 surgeries to correct tendon ruptures and injuries, including a double-knee replacement this year.

“I am in chronic pain all the time,” she says. “I am chronically injured. I have a lot of tears that I’ve not fixed because they’re very complicated, and I don’t know if the rest of my body can handle the strain of recovering from those surgeries.”

Ms. Moser’s is hardly an isolated case. Since the 1980s, more than 60,000 patients have reported hundreds of thousands of serious events linked to fluoroquinolones to the FDA, including 6,575 reports of deaths.

The most common side effects were tendon rupture, as well as neurological and psychiatric symptoms. But experts estimate only 1%-10% of such events are reported to the FDA. That suggests that fluoroquinolones might have harmed hundreds of thousands of people in the United States alone, says Charles Bennett, MD, a hematologist at the University of South Carolina’s College of Pharmacy, Columbia.

Yet despite the many patient reports and FDA warnings on dangerous side effects, many doctors continue to wrongly prescribe fluoroquinolones for simple urinary tract infections, sinus infections, and respiratory issues better treated with less risky antibiotics.

“There probably is overprescription by primary care doctors for urinary tract infections and respiratory infections, when there could be alternatives that are safer to use,” says Amesh Adalja, MD, an infectious disease specialist and senior scholar with the Johns Hopkins Center for Health Security.

“I would say that’s probably the case in the outpatient setting, not necessarily in the hospital setting or among infectious disease doctors ... but I think it’s important to say there are still some judicious uses of fluoroquinolones,” he says. “However, there probably is a lot of injudicious use of fluoroquinolones along with many other antibiotics in the primary care setting.”
 

FDA warnings on fluoroquinolones

Fluoroquinolones are a class of broad-spectrum antibiotics used for decades to treat certain bacterial infections.

FDA-approved fluoroquinolones include ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, delafloxacin (Baxdela), gemifloxacin (Factive) levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin). More than 60 generic versions of these brand-name medicines are also on the market, making them among the most prescribed antibiotics in the U.S.

Over the past 2 decades, a wide range of physical and mental health side effects have been tied to fluoroquinolones. As a result of these “adverse event reports” and research published in medical literature, the FDA has required an escalating series of warnings and safety labeling changes for doctors who prescribe these drugs.

• In 2008, the FDA first added a “black box” warning to fluoroquinolones, citing an increased risk of tendinitis and tendon rupture in patients prescribed these meds.
• In 2011, the agency required the warning label to include risks of worsening symptoms for those with myasthenia gravis, a chronic autoimmune disease that causes muscle weakness, vision problems, and speech problems.
• In 2013, regulators required updated labels noting the potential for irreversible peripheral neuropathy (serious nerve damage).
• In 2016, the FDA issued its strongest warning against the use of such antibiotics for simple bacterial infections – such as uncomplicated urinary tract infections (UTIs), acute sinusitis, and acute bronchitis – saying the “association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system ... outweighs the benefits for patients.”
• And in 2018, regulators required safety labeling changes to include warnings about the risks of aortic aneurysm – a life-threatening enlargement of the main vessel that delivers blood to the body – as well as mental health side effects and serious blood sugar disturbances.

But FDA regulators have stopped short of barring fluoroquinolone use in the treatment of bacterial infections, citing the benefits for certain conditions.

“For some patients, the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections,” said former FDA Commissioner Scott Gottlieb, MD, “but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use.”

In December 2021, a study published in the journal JAMA Network Open found the FDA’s warnings may have helped lower prescribing of the drugs in Medicare patients. But not all doctors have been responsive to those warnings, researchers found.

“An overall decline in change over time and an immediate change in fluoroquinolone prescribing was observed after the 2016 FDA warning,” the authors concluded. “Certain physicians, such as primary care physicians, were more responsive to FDA warnings than others. ... Findings of this study suggest that identifying the association of physician and organizational characteristics with fluoroquinolone prescribing practices could help in developing mechanisms for improving de-adoption.”

Some critics say the FDA should do more to spotlight the dangers of fluoroquinolones and require doctors and patients to sign checklist consent forms to show they are aware of the potential side effects of these drugs.

Rachel Brummert, a patient advocate who sits on an FDA consumer advisory board, believes the FDA needs to improve its communication to doctors on fluoroquinolone risks and get tougher with those who continue to inappropriately prescribe the drugs.

“I think there needs to be a system in place, where if something comes down from the FDA about a drug, the physician has to sign off on it, the patient has to sign off on it and mark that they understand that there are these ‘black box’ warnings,” says Ms. Brummert, 52, a representative on the FDA’s Medical Devices Advisory Committee.

As an example, she points to Australia’s medical laws requiring doctors and patients to sign a checklist before any fluoroquinolone prescription is approved.

“When a physician prescribes a fluoroquinolone antibiotic, there’s a checklist – does the patient have an infection, is it a simple infection, do they have allergies?” she notes. “And you can’t even get the prescription out – it won’t even print out, it won’t go into the system – unless you check all of the boxes. But we don’t do that here. We don’t have that type of system right now.”

Ms. Brummert says such a system might have prevented the harm from taking Levaquin her doctor prescribed for a suspected sinus infection in 2006.

Soon after she began taking the antibiotic, she ruptured her Achilles tendon, requiring surgery. By 2009, she’d had three ruptures, each needing surgical fixes. To date, she’s had more than 30 surgeries to correct tendon ruptures. She’s also had seizures, blood pressure issues, depression, chronic pain, and memory problems she attributes to taking Levaquin.

As it turns out, her doctor misdiagnosed her condition – a misstep that would have been averted with a system like Australia’s, which requires doctors to verify the presence of a bacterial infection through a simple test before prescribing a fluoroquinolone.

“When I got the Levaquin, it was for a suspected sinus infection that it turned out I didn’t even have in the first place,” she notes. “So, I took the Levaquin basically for nothing. But what I would have asked my doctor had I known is: ‘Why should I take something so strong for so simple an infection?’

“It seems common sense to me now that you don’t prescribe something that can kill anthrax for a simple sinus infection. It’s like an atom bomb killing a mosquito. I agree that there are uses for these drugs, but they are being overprescribed. And so, here I am 16 years later – I’m still rupturing, I’m still having surgery, and I’m still in pain – all for something I didn’t even need medicine for in the first place.”
 

Should guidelines be stronger?

So, why are so many doctors continuing to prescribe fluoroquinolones for simple infections? Dr. Adalja and other experts say several things are at work.

For one thing, Dr. Adalja notes, fluoroquinolones are broad-spectrum antibiotics that are effective against dangerous germs, including “gram-negative” bacterial infections, and are “100% bioavailable.” That means they are as effective when given in pill form as they are if put directly into a vein. So they can be used in an outpatient setting or to allow a patient to be discharged from a hospital sooner because they don’t need an IV to receive treatment.

“There are still some uses for these drugs because they are so bioavailable, and I think that drives some of the use, and those are legitimate uses, knowing that there are risks when you do it,” he says. “But no drug is without risks, and you have to weigh risks and benefits – that’s what medicine is about: deciding what the best drug is for a patient.”

But Dr. Adalja says the overprescription of fluoroquinolones is part of the larger trend of antibiotic overuse. That is driving up antibiotic resistance, which in turn is another thing leading doctors to turn to Cipro and other fluoroquinolones after other drugs have proven ineffective.

“You can’t separate this from the fact that 80% of antibiotic prescriptions in the outpatient setting are probably illegitimate or not warranted,” he notes. “And because fluoroquinolones are highly effective drugs against certain pathogens, they are the go-to [drug] for many people who are prescribing antibiotics.”

That’s why patients should be wary whenever a doctor prescribes a fluoroquinolone, or any drug to treat a suspected infection, he says.

“Any time a patient is getting prescribed an antibiotic by a physician, they should ask: ‘Do I really need this antibiotic?’ That should be the first question they ask,” he advises. “And if they’re getting a fluoroquinolone, they may want to ask: ‘Is this the best antibiotic for me?’ ”
 

What you can do

Ms. Brummert and Ms. Moser say they are sharing their stories to raise awareness of the dangers of fluoroquinolones.

Ms. Moser has published a book on her experiences, “The Magnificent Story of a Lame Author,” and provides a wealth of consumer resources on her blog: Mountains and Mustard Seeds.

“As much as I hate what has happened to me, it has put me in a place where I am glad that I can inform other patients,” she says.

Ms. Brummert supplements her advocacy work as an FDA adviser with useful materials she provides on her website: Drugwatch.com.

“Pain into purpose – that’s what I call it,” she says. “I can’t change what happened to me, but I can warn others.”

The upshot for patients?

• the FDA’s Drug Safety Communication on Fluoroquinolones online to learn more about the risks and benefits of these powerful antibiotics.
• If you believe you’ve been harmed by fluoroquinolones, MedWatch website to report your experiences.

Ms. Brummert also advises patients to ask 12 critical questions of any doctor who wants to prescribe a fluoroquinolone, including the following listed on her website:

• For what condition is this medication prescribed, and is there another drug specific to my condition?
• What are the risks associated with this medication, and do the benefits outweigh them?
• Will this medication interact with my other drugs and/or other health conditions?
• What are the “boxed” warnings for this medication, and where can I report adverse events?

“I would also do my own research,” she says. “I wouldn’t just take a prescription from a physician and just say, ‘OK, doctor knows best.’ ”

Ms. Moser agrees that you have to be your own patient advocate and not simply take a doctor’s advice on any medical issue without having a deeper conversation.

“I’ve had arguments with doctors who legitimately did not believe me when I told them what happened to me,” she says. “And I actually told them, ‘Go get your Physicians’ Desk Reference [for prescription drugs]’ and they opened the book in front of me and read the warnings. Obviously, they had not been keeping up with the added warnings. So, I do think that doctors do need to be better informed.”

“So, yes, it’s the FDA’s responsibility, but it is also the doctors’ responsibility to make sure that they’re watching out for the side effects and they’re reporting them when their patients come up with them and making those connections.”

A version of this article first appeared on WebMD.com.

There are still misperceptions of palliative medicine, including when to consider referral to a palliative care specialist.

The World Health Organization defines palliative care as “an approach that improves the quality of life of patients (adults and children) and their families who are facing problems associated with life-threatening illness. It prevents and relieves suffering through the early identification, correct assessment, and treatment of pain and other problems, whether physical, psychosocial or spiritual.”¹

The common misperception is that palliative care is only for those at end of life or only in the advanced stages of their illness. However, palliative care is ideally most helpful following individuals from diagnosis through their illness trajectory. Another misperception is that palliative care and hospice are the same thing. Though all hospice is palliative care, all palliative care is not hospice. Both palliative care and hospice provide care for individuals facing a serious illness and focus on the same philosophy of care, but palliative care can be initiated at any stage of illness, even if the goal is to pursue curative and life-prolonging therapies/interventions.

In contrast, hospice is considered for those who are at the end of life and are usually not pursuing life-prolonging therapies or interventions, instead focusing on comfort, symptom management, and optimization of quality of life.

Though there is a growing need for palliative care, there is a shortage of specialist palliative care providers. Much of the palliative care needs can be met by all providers who can offer basic symptom management, identification surrounding goals of care and discussions of advance care planning, and understanding of illness/prognosis and treatment options, which is called primary palliative care.² In fact, two-thirds of patients with a serious illness other than cancer prefer discussion of end-of-life care or advance care planning with their primary care providers.³

Referral to specialty palliative care should be considered when there are more complexities to symptom/pain management and goals of care/end of life, transition to hospice, or complex communication dynamics.⁴

Though specialty palliative care was shown to be more comprehensive, both primary palliative care and specialty palliative care have led to improvements in the quality of life in individuals living with serious illness.⁵ Early integration of palliative care into routine care has been shown to improve symptom burden, mood, quality of life, survival, and health care costs.⁶

Updates in alternative and complementary therapies to palliative care

There are several alternative and complementary therapies to palliative care, including cannabis and psychedelics. These therapies are becoming or may become a familiar part of medical therapies that are listed in a patient’s history as part of their medical regimen, especially as more states continue to legalize and/or decriminalize the use of these alternative therapies for recreational or medicinal use.

Both cannabis and psychedelics have a longstanding history of therapeutic and holistic use. Cannabis has been used to manage symptoms such as pain since the 16th and 17th century.⁷ In palliative care, more patients may turn to various forms of cannabis as a source of relief from symptoms and suffering as their focus shifts more to quality of life.

Even with the increasing popularity of the use of cannabis among seriously ill patients, there is still a lack of evidence of the benefits of medical cannabis use in palliative care, and there is a lack of standardization of type of cannabis used and state regulations regarding their use.⁷

A recent systematic review found that despite the reported positive treatment effects of cannabis in palliative care, the results of the studies were conflicting. This highlights the need for further high-quality research to determine whether cannabis products are an effective treatment in palliative care patients.⁸

One limitation to note is that the majority of the included studies focused on cannabis use in patients with cancer for cancer-related symptoms. Few studies included patients with other serious conditions.
 

Psychedelics

There is evidence that psychedelic assisted therapy (PAT) is a safe and effective treatment for individuals with refractory depression, posttraumatic stress disorder, and substance use disorder.⁹ Plus, there have been ample studies providing support that PAT improves symptoms such as refractory anxiety/depression, demoralization, and existential distress in seriously ill patients, thus improving their quality of life and overall well-being.⁹

Nine U.S. cities and the State of Oregon have decriminalized or legalized the psychedelic psilocybin, based on the medical benefits patients have experienced evidenced from using it.¹⁰

In light of the increasing interest in PAT, Dr. Ira Byock provided the following points on what “all clinicians should know as they enter this uncharted territory”:

• Psychedelics have been around for a long time.
• Psychedelic-assisted therapies’ therapeutic effects are experiential.
• There are a variety of terms for specific categories of psychedelic compounds.
• Some palliative care teams are already caring for patients who undergo psychedelic experiences.
• Use of psychedelics should be well-observed by a skilled clinician with expertise.

I am hoping this provides a general refresher on palliative care and an overview of updates to alternative and complementary therapies for patients living with serious illness.⁹

Dr. Kang is a geriatrician and palliative care provider at the University of Washington, Seattle in the division of geriatrics and gerontology. She has no conflicts related to the content of this piece.

References

1. World Health Organization. Palliative care. 2020 Aug 5..

2. Weissman DE and Meier DE. Identifying patients in need of a palliative care assessment in the hospital setting a consensus report from the center to advance palliative care. J Palliat Med. 2011;14(1):17-23.

3. Sherry D et al. Is primary care physician involvement associated with earlier advance care planning? A study of patients in an academic primary care setting. J Palliat Med. 2022;25(1):75-80.

4. Quill TE and Abernethy AP. Generalist plus specialist palliative care-creating a more sustainable model. N Engl J Med. 2013;368:1173-75.

5. Ernecoff NC et al. Comparing specialty and primary palliative care interventions: Analysis of a systematic review. J Palliat Med. 2020;23(3):389-96.

6. Temmel JS et al. Early palliative care for patients with metastatic non–small-cell lung cancer. N Engl J Med. 2011;363:733-42.

7. Kogan M and Sexton M. Medical cannabis: A new old tool for palliative care. J Altern Complement Med . 2020 Sep;26(9):776-8.

8. Doppen M et al. Cannabis in palliative care: A systematic review of the current evidence. J Pain Symptom Manage. 2022 Jun 12;S0885-3924(22)00760-6.

9. Byock I. Psychedelics for serious illness: Five things clinicians need to know. The Center to Advance Palliative Care. Psychedelics for Serious Illness, Palliative in Practice, Center to Advance Palliative Care (capc.org). June 13, 2022.

10. Marks M. A strategy for rescheduling psilocybin. Scientific American. Oct. 11, 2021.

There are still misperceptions of palliative medicine, including when to consider referral to a palliative care specialist.

The World Health Organization defines palliative care as “an approach that improves the quality of life of patients (adults and children) and their families who are facing problems associated with life-threatening illness. It prevents and relieves suffering through the early identification, correct assessment, and treatment of pain and other problems, whether physical, psychosocial or spiritual.”¹

The common misperception is that palliative care is only for those at end of life or only in the advanced stages of their illness. However, palliative care is ideally most helpful following individuals from diagnosis through their illness trajectory. Another misperception is that palliative care and hospice are the same thing. Though all hospice is palliative care, all palliative care is not hospice. Both palliative care and hospice provide care for individuals facing a serious illness and focus on the same philosophy of care, but palliative care can be initiated at any stage of illness, even if the goal is to pursue curative and life-prolonging therapies/interventions.

In contrast, hospice is considered for those who are at the end of life and are usually not pursuing life-prolonging therapies or interventions, instead focusing on comfort, symptom management, and optimization of quality of life.

Though there is a growing need for palliative care, there is a shortage of specialist palliative care providers. Much of the palliative care needs can be met by all providers who can offer basic symptom management, identification surrounding goals of care and discussions of advance care planning, and understanding of illness/prognosis and treatment options, which is called primary palliative care.² In fact, two-thirds of patients with a serious illness other than cancer prefer discussion of end-of-life care or advance care planning with their primary care providers.³

Referral to specialty palliative care should be considered when there are more complexities to symptom/pain management and goals of care/end of life, transition to hospice, or complex communication dynamics.⁴

Though specialty palliative care was shown to be more comprehensive, both primary palliative care and specialty palliative care have led to improvements in the quality of life in individuals living with serious illness.⁵ Early integration of palliative care into routine care has been shown to improve symptom burden, mood, quality of life, survival, and health care costs.⁶

Updates in alternative and complementary therapies to palliative care

There are several alternative and complementary therapies to palliative care, including cannabis and psychedelics. These therapies are becoming or may become a familiar part of medical therapies that are listed in a patient’s history as part of their medical regimen, especially as more states continue to legalize and/or decriminalize the use of these alternative therapies for recreational or medicinal use.

Both cannabis and psychedelics have a longstanding history of therapeutic and holistic use. Cannabis has been used to manage symptoms such as pain since the 16th and 17th century.⁷ In palliative care, more patients may turn to various forms of cannabis as a source of relief from symptoms and suffering as their focus shifts more to quality of life.

Even with the increasing popularity of the use of cannabis among seriously ill patients, there is still a lack of evidence of the benefits of medical cannabis use in palliative care, and there is a lack of standardization of type of cannabis used and state regulations regarding their use.⁷

A recent systematic review found that despite the reported positive treatment effects of cannabis in palliative care, the results of the studies were conflicting. This highlights the need for further high-quality research to determine whether cannabis products are an effective treatment in palliative care patients.⁸

One limitation to note is that the majority of the included studies focused on cannabis use in patients with cancer for cancer-related symptoms. Few studies included patients with other serious conditions.
 

Psychedelics

There is evidence that psychedelic assisted therapy (PAT) is a safe and effective treatment for individuals with refractory depression, posttraumatic stress disorder, and substance use disorder.⁹ Plus, there have been ample studies providing support that PAT improves symptoms such as refractory anxiety/depression, demoralization, and existential distress in seriously ill patients, thus improving their quality of life and overall well-being.⁹

Nine U.S. cities and the State of Oregon have decriminalized or legalized the psychedelic psilocybin, based on the medical benefits patients have experienced evidenced from using it.¹⁰

In light of the increasing interest in PAT, Dr. Ira Byock provided the following points on what “all clinicians should know as they enter this uncharted territory”:

• Psychedelics have been around for a long time.
• Psychedelic-assisted therapies’ therapeutic effects are experiential.
• There are a variety of terms for specific categories of psychedelic compounds.
• Some palliative care teams are already caring for patients who undergo psychedelic experiences.
• Use of psychedelics should be well-observed by a skilled clinician with expertise.

I am hoping this provides a general refresher on palliative care and an overview of updates to alternative and complementary therapies for patients living with serious illness.⁹

Dr. Kang is a geriatrician and palliative care provider at the University of Washington, Seattle in the division of geriatrics and gerontology. She has no conflicts related to the content of this piece.

References

1. World Health Organization. Palliative care. 2020 Aug 5..

2. Weissman DE and Meier DE. Identifying patients in need of a palliative care assessment in the hospital setting a consensus report from the center to advance palliative care. J Palliat Med. 2011;14(1):17-23.

3. Sherry D et al. Is primary care physician involvement associated with earlier advance care planning? A study of patients in an academic primary care setting. J Palliat Med. 2022;25(1):75-80.

4. Quill TE and Abernethy AP. Generalist plus specialist palliative care-creating a more sustainable model. N Engl J Med. 2013;368:1173-75.

5. Ernecoff NC et al. Comparing specialty and primary palliative care interventions: Analysis of a systematic review. J Palliat Med. 2020;23(3):389-96.

6. Temmel JS et al. Early palliative care for patients with metastatic non–small-cell lung cancer. N Engl J Med. 2011;363:733-42.

7. Kogan M and Sexton M. Medical cannabis: A new old tool for palliative care. J Altern Complement Med . 2020 Sep;26(9):776-8.

8. Doppen M et al. Cannabis in palliative care: A systematic review of the current evidence. J Pain Symptom Manage. 2022 Jun 12;S0885-3924(22)00760-6.

9. Byock I. Psychedelics for serious illness: Five things clinicians need to know. The Center to Advance Palliative Care. Psychedelics for Serious Illness, Palliative in Practice, Center to Advance Palliative Care (capc.org). June 13, 2022.

10. Marks M. A strategy for rescheduling psilocybin. Scientific American. Oct. 11, 2021.

There are still misperceptions of palliative medicine, including when to consider referral to a palliative care specialist.

The World Health Organization defines palliative care as “an approach that improves the quality of life of patients (adults and children) and their families who are facing problems associated with life-threatening illness. It prevents and relieves suffering through the early identification, correct assessment, and treatment of pain and other problems, whether physical, psychosocial or spiritual.”¹

The common misperception is that palliative care is only for those at end of life or only in the advanced stages of their illness. However, palliative care is ideally most helpful following individuals from diagnosis through their illness trajectory. Another misperception is that palliative care and hospice are the same thing. Though all hospice is palliative care, all palliative care is not hospice. Both palliative care and hospice provide care for individuals facing a serious illness and focus on the same philosophy of care, but palliative care can be initiated at any stage of illness, even if the goal is to pursue curative and life-prolonging therapies/interventions.

In contrast, hospice is considered for those who are at the end of life and are usually not pursuing life-prolonging therapies or interventions, instead focusing on comfort, symptom management, and optimization of quality of life.

Though there is a growing need for palliative care, there is a shortage of specialist palliative care providers. Much of the palliative care needs can be met by all providers who can offer basic symptom management, identification surrounding goals of care and discussions of advance care planning, and understanding of illness/prognosis and treatment options, which is called primary palliative care.² In fact, two-thirds of patients with a serious illness other than cancer prefer discussion of end-of-life care or advance care planning with their primary care providers.³

Referral to specialty palliative care should be considered when there are more complexities to symptom/pain management and goals of care/end of life, transition to hospice, or complex communication dynamics.⁴

Though specialty palliative care was shown to be more comprehensive, both primary palliative care and specialty palliative care have led to improvements in the quality of life in individuals living with serious illness.⁵ Early integration of palliative care into routine care has been shown to improve symptom burden, mood, quality of life, survival, and health care costs.⁶

Updates in alternative and complementary therapies to palliative care

There are several alternative and complementary therapies to palliative care, including cannabis and psychedelics. These therapies are becoming or may become a familiar part of medical therapies that are listed in a patient’s history as part of their medical regimen, especially as more states continue to legalize and/or decriminalize the use of these alternative therapies for recreational or medicinal use.

Both cannabis and psychedelics have a longstanding history of therapeutic and holistic use. Cannabis has been used to manage symptoms such as pain since the 16th and 17th century.⁷ In palliative care, more patients may turn to various forms of cannabis as a source of relief from symptoms and suffering as their focus shifts more to quality of life.

Even with the increasing popularity of the use of cannabis among seriously ill patients, there is still a lack of evidence of the benefits of medical cannabis use in palliative care, and there is a lack of standardization of type of cannabis used and state regulations regarding their use.⁷

A recent systematic review found that despite the reported positive treatment effects of cannabis in palliative care, the results of the studies were conflicting. This highlights the need for further high-quality research to determine whether cannabis products are an effective treatment in palliative care patients.⁸

One limitation to note is that the majority of the included studies focused on cannabis use in patients with cancer for cancer-related symptoms. Few studies included patients with other serious conditions.
 

Psychedelics

There is evidence that psychedelic assisted therapy (PAT) is a safe and effective treatment for individuals with refractory depression, posttraumatic stress disorder, and substance use disorder.⁹ Plus, there have been ample studies providing support that PAT improves symptoms such as refractory anxiety/depression, demoralization, and existential distress in seriously ill patients, thus improving their quality of life and overall well-being.⁹

Nine U.S. cities and the State of Oregon have decriminalized or legalized the psychedelic psilocybin, based on the medical benefits patients have experienced evidenced from using it.¹⁰

In light of the increasing interest in PAT, Dr. Ira Byock provided the following points on what “all clinicians should know as they enter this uncharted territory”:

• Psychedelics have been around for a long time.
• Psychedelic-assisted therapies’ therapeutic effects are experiential.
• There are a variety of terms for specific categories of psychedelic compounds.
• Some palliative care teams are already caring for patients who undergo psychedelic experiences.
• Use of psychedelics should be well-observed by a skilled clinician with expertise.

I am hoping this provides a general refresher on palliative care and an overview of updates to alternative and complementary therapies for patients living with serious illness.⁹

Dr. Kang is a geriatrician and palliative care provider at the University of Washington, Seattle in the division of geriatrics and gerontology. She has no conflicts related to the content of this piece.

References

1. World Health Organization. Palliative care. 2020 Aug 5..

2. Weissman DE and Meier DE. Identifying patients in need of a palliative care assessment in the hospital setting a consensus report from the center to advance palliative care. J Palliat Med. 2011;14(1):17-23.

3. Sherry D et al. Is primary care physician involvement associated with earlier advance care planning? A study of patients in an academic primary care setting. J Palliat Med. 2022;25(1):75-80.

4. Quill TE and Abernethy AP. Generalist plus specialist palliative care-creating a more sustainable model. N Engl J Med. 2013;368:1173-75.

5. Ernecoff NC et al. Comparing specialty and primary palliative care interventions: Analysis of a systematic review. J Palliat Med. 2020;23(3):389-96.

6. Temmel JS et al. Early palliative care for patients with metastatic non–small-cell lung cancer. N Engl J Med. 2011;363:733-42.

7. Kogan M and Sexton M. Medical cannabis: A new old tool for palliative care. J Altern Complement Med . 2020 Sep;26(9):776-8.

8. Doppen M et al. Cannabis in palliative care: A systematic review of the current evidence. J Pain Symptom Manage. 2022 Jun 12;S0885-3924(22)00760-6.

9. Byock I. Psychedelics for serious illness: Five things clinicians need to know. The Center to Advance Palliative Care. Psychedelics for Serious Illness, Palliative in Practice, Center to Advance Palliative Care (capc.org). June 13, 2022.

10. Marks M. A strategy for rescheduling psilocybin. Scientific American. Oct. 11, 2021.

Every time Nathan Chomilo, MD, uses a clinical decision support tool, he tells his patients they have a choice: He can input their race or keep that field blank.

Until recently, many clinicians didn’t question the use of race as a datapoint in tools used to make decisions about diagnosis and care. But that is changing.

“I’ve almost universally had patients appreciate that someone actually told them that their kidney function was being scored differently because of the color of their skin or how they were identified in the medical chart along lines of race,” Dr. Chomilo, an adjunct assistant professor of pediatrics at the University of Minnesota Medical School, Minneapolis, said.

Dr. Chomilo is referring to the estimated glomerular filtration rate (eGFR), which combines results from a blood test with factors such as age, sex, and race to calculate kidney function.

The eGFR weighed an input of “African American” as automatically indicating a higher concentration of serum creatinine than a non African American patient on the basis of the unsubstantiated idea that Black people have more creatinine in their blood at baseline.

The calculator creates a picture of a Black patient who is not as sick as a White patient with the same levels of kidney failure. But race is based on the color of a patient’s skin, not on genetics or other clinical datapoints.

“I often use my own example of being a biracial Black man: My father’s family is from Cameroon, my mother’s family is from Norway. Are you going to assign my kidneys or my lungs to my mom’s side or my dad’s side? That’s not clear at all in the way we use race in medicine,” Dr. Chomilo, an executive committee member on the section on minority health equity and inclusion at the American Academy of Pediatrics (AAP), said.

Long before the COVID-19 pandemic so publicly exposed the depths of inequality in morbidity and mortality in the United States, health advocates had been pointing out these disparities in tools used by medical professionals. But efforts to recognize that race is a poor proxy for genetics is in its infancy.

In May, the AAP published a policy statement that kicked off its examination of clinical guidelines and policies that include race as a biological proxy. A committee for the society is combing through each guideline or calculator, evaluating the scientific basis for the use of race, and examining whether a stronger datapoint could be used instead.

The eGFR is perhaps the best example of a calculator that’s gone through the process: Health care stakeholders questioned the use of race, and investigators went back to study whether race was really a good datapoint. It wasn’t, and Dr. Chamilo’s hospital joined many others in retiring the calculator.

But the eGFR is one of countless clinical tools – from rudimentary algorithms to sophisticated machine-learning instruments – that change the course of care in part on the basis of race in the same way datapoints such as weight, age, and height are used to inform decisions about patient management. But unlike race, height, weight, and age can be objectively measured. A physician either makes a guess, or a patient enters their race on a form. And while that can be useful on a population level, race does not equal genetics or any other measurable datapoint.

In a study published in JAMA Pediatrics, researchers reviewed 414 clinical practice guidelines from sources such as PubMed and MetaLib.gov. Almost 1 in 6 guidelines included race in an inappropriate way, such as by conflating race as a biological risk factor or establishing testing or treatment thresholds using race.
 

Waiting for alternatives

The University of Maryland Medical System last year embarked on a project similar to the AAP initiative but within its own system. The first use of race to be eliminated was in the eGFR. The health system also recently removed the variable from a tool for diagnosing urinary tract infections (UTIs) in children younger than 2 years.

Part of that tool includes deciding to perform a catheterized urine test. If a doctor chose “White” as the race, the tool would recommend the test. If the doctor chose “Black,” the tool would recommend to not test. Joseph Wright, MD, MPH, chief health equity officer at University of Maryland Medical System, said this step in the tool is based on the unproven assumption that young Black children had a lower likelihood of UTIs than their White peers.

“We simply want folks to not by default lob race in as a decisionmaking point when we have, with a little bit more scientific diligence, the ability to include better clinical variables,” Dr. Wright, who is also an adjunct professor of health policy and management at the University of Maryland School of Public Health, College Park, said.

The developers of the UTI tool recently released a revised version that removes race in favor of two new medical datapoints: whether the patient has had a fever for over 48 hours, and whether the patient has previously had a UTI.

The process of re-examining tools, coming up with new datapoints, and implementing changes is not simple, according to Dr. Wright.

“This is just the baby step to fix the algorithms, because we’re all going to have to examine our own house, where these calculators live, whether it’s in a textbook, whether it’s in an electronic health record, and that’s the heavy lift,” he said. “All sources of clinical guidance have to be scrutinized, and it’s going to literally take years to unroot.”

Electronic medical record vendor Cerner said it generally revises its algorithms after medical societies make changes, then communicates those fixes to providers.

Rebecca C. Winokur, MD, MPH, lead physician executive and health equity service line leader at Cerner, explained that if doctors ordered an eGFR a year ago and then another today, the results might be different because of the new code that eliminates race.

“The numbers are so different, how do you know that the patient may or may not have the same function?” Dr. Winokur said.

Dr. Winokur said the company is trying to determine at which point a message should pop up in the records workflow that would inform clinicians that they may be comparing apples to cherries. The company also is reconsidering the use of race in tools that estimate the probability of a successful vaginal birth after prior cesarean delivery, a calculator that predicts the risk of urethral stones in patients with flank pain, and another that measures lung function to help diagnose pulmonary disease.

In addition to managing the logistics of removing race, health institutions also need buy-in from clinicians. At Mass General Brigham, Boston, Thomas Sequist, MD, MPH, chief medical officer, is leading a project to examine how the system uses race in calculators.

“People struggle mainly with, well, if we shouldn’t use this calculator, what should we use, because we need a calculator. And that’s a legitimate question,” Dr. Sequist said in an interview. “If we’re going to stop using this race-based calculator, I still need to know what dose of medication I give my patient. We’re not going to pull any of these calculators until we have a safe and reliable alternative.”

For each calculator, relevant specialty chiefs come to the table with Dr. Sequist and his team; current projects include examining bone density screenings and cardiac risk scores. A large part of the work is communicating the lack of science behind the inclusion of race as a variable.

“It’s hard because these tools have been in existence for decades, and people are used to using them,” Dr. Sequist said. “So this is a big-change management project.”

Some clinicians also have difficulty discerning why their health system may stratify patient outcomes by race while providers are being told that race is being removed from the calculators they use every day. The key difference is that stratifying outcomes by race illuminates systemic problems that can be targeted by a health system.

For instance, if readmission rates are higher for Black patients overall after surgery, the reason might be that nurses are not delivering the same level of care to them as they are to non-Black patients, possibly because of hidden bias. Or, perhaps Black patients at a hospital have less access to transportation for follow-up appointments after surgery. The potential reasons can be investigated, and solutions can be created.

“If you look at a population level, what you’re looking for is not for the evidence of race as a biological construct,” Dr. Chomilo said. “You’re looking for the impact of racism on populations, and that’s the difference: It’s racism, not race.”

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

Every time Nathan Chomilo, MD, uses a clinical decision support tool, he tells his patients they have a choice: He can input their race or keep that field blank.

Until recently, many clinicians didn’t question the use of race as a datapoint in tools used to make decisions about diagnosis and care. But that is changing.

“I’ve almost universally had patients appreciate that someone actually told them that their kidney function was being scored differently because of the color of their skin or how they were identified in the medical chart along lines of race,” Dr. Chomilo, an adjunct assistant professor of pediatrics at the University of Minnesota Medical School, Minneapolis, said.

Dr. Chomilo is referring to the estimated glomerular filtration rate (eGFR), which combines results from a blood test with factors such as age, sex, and race to calculate kidney function.

The eGFR weighed an input of “African American” as automatically indicating a higher concentration of serum creatinine than a non African American patient on the basis of the unsubstantiated idea that Black people have more creatinine in their blood at baseline.

The calculator creates a picture of a Black patient who is not as sick as a White patient with the same levels of kidney failure. But race is based on the color of a patient’s skin, not on genetics or other clinical datapoints.

“I often use my own example of being a biracial Black man: My father’s family is from Cameroon, my mother’s family is from Norway. Are you going to assign my kidneys or my lungs to my mom’s side or my dad’s side? That’s not clear at all in the way we use race in medicine,” Dr. Chomilo, an executive committee member on the section on minority health equity and inclusion at the American Academy of Pediatrics (AAP), said.

Long before the COVID-19 pandemic so publicly exposed the depths of inequality in morbidity and mortality in the United States, health advocates had been pointing out these disparities in tools used by medical professionals. But efforts to recognize that race is a poor proxy for genetics is in its infancy.

In May, the AAP published a policy statement that kicked off its examination of clinical guidelines and policies that include race as a biological proxy. A committee for the society is combing through each guideline or calculator, evaluating the scientific basis for the use of race, and examining whether a stronger datapoint could be used instead.

The eGFR is perhaps the best example of a calculator that’s gone through the process: Health care stakeholders questioned the use of race, and investigators went back to study whether race was really a good datapoint. It wasn’t, and Dr. Chamilo’s hospital joined many others in retiring the calculator.

But the eGFR is one of countless clinical tools – from rudimentary algorithms to sophisticated machine-learning instruments – that change the course of care in part on the basis of race in the same way datapoints such as weight, age, and height are used to inform decisions about patient management. But unlike race, height, weight, and age can be objectively measured. A physician either makes a guess, or a patient enters their race on a form. And while that can be useful on a population level, race does not equal genetics or any other measurable datapoint.

In a study published in JAMA Pediatrics, researchers reviewed 414 clinical practice guidelines from sources such as PubMed and MetaLib.gov. Almost 1 in 6 guidelines included race in an inappropriate way, such as by conflating race as a biological risk factor or establishing testing or treatment thresholds using race.
 

Waiting for alternatives

The University of Maryland Medical System last year embarked on a project similar to the AAP initiative but within its own system. The first use of race to be eliminated was in the eGFR. The health system also recently removed the variable from a tool for diagnosing urinary tract infections (UTIs) in children younger than 2 years.

Part of that tool includes deciding to perform a catheterized urine test. If a doctor chose “White” as the race, the tool would recommend the test. If the doctor chose “Black,” the tool would recommend to not test. Joseph Wright, MD, MPH, chief health equity officer at University of Maryland Medical System, said this step in the tool is based on the unproven assumption that young Black children had a lower likelihood of UTIs than their White peers.

“We simply want folks to not by default lob race in as a decisionmaking point when we have, with a little bit more scientific diligence, the ability to include better clinical variables,” Dr. Wright, who is also an adjunct professor of health policy and management at the University of Maryland School of Public Health, College Park, said.

The developers of the UTI tool recently released a revised version that removes race in favor of two new medical datapoints: whether the patient has had a fever for over 48 hours, and whether the patient has previously had a UTI.

The process of re-examining tools, coming up with new datapoints, and implementing changes is not simple, according to Dr. Wright.

“This is just the baby step to fix the algorithms, because we’re all going to have to examine our own house, where these calculators live, whether it’s in a textbook, whether it’s in an electronic health record, and that’s the heavy lift,” he said. “All sources of clinical guidance have to be scrutinized, and it’s going to literally take years to unroot.”

Electronic medical record vendor Cerner said it generally revises its algorithms after medical societies make changes, then communicates those fixes to providers.

Rebecca C. Winokur, MD, MPH, lead physician executive and health equity service line leader at Cerner, explained that if doctors ordered an eGFR a year ago and then another today, the results might be different because of the new code that eliminates race.

“The numbers are so different, how do you know that the patient may or may not have the same function?” Dr. Winokur said.

Dr. Winokur said the company is trying to determine at which point a message should pop up in the records workflow that would inform clinicians that they may be comparing apples to cherries. The company also is reconsidering the use of race in tools that estimate the probability of a successful vaginal birth after prior cesarean delivery, a calculator that predicts the risk of urethral stones in patients with flank pain, and another that measures lung function to help diagnose pulmonary disease.

In addition to managing the logistics of removing race, health institutions also need buy-in from clinicians. At Mass General Brigham, Boston, Thomas Sequist, MD, MPH, chief medical officer, is leading a project to examine how the system uses race in calculators.

“People struggle mainly with, well, if we shouldn’t use this calculator, what should we use, because we need a calculator. And that’s a legitimate question,” Dr. Sequist said in an interview. “If we’re going to stop using this race-based calculator, I still need to know what dose of medication I give my patient. We’re not going to pull any of these calculators until we have a safe and reliable alternative.”

For each calculator, relevant specialty chiefs come to the table with Dr. Sequist and his team; current projects include examining bone density screenings and cardiac risk scores. A large part of the work is communicating the lack of science behind the inclusion of race as a variable.

“It’s hard because these tools have been in existence for decades, and people are used to using them,” Dr. Sequist said. “So this is a big-change management project.”

Some clinicians also have difficulty discerning why their health system may stratify patient outcomes by race while providers are being told that race is being removed from the calculators they use every day. The key difference is that stratifying outcomes by race illuminates systemic problems that can be targeted by a health system.

For instance, if readmission rates are higher for Black patients overall after surgery, the reason might be that nurses are not delivering the same level of care to them as they are to non-Black patients, possibly because of hidden bias. Or, perhaps Black patients at a hospital have less access to transportation for follow-up appointments after surgery. The potential reasons can be investigated, and solutions can be created.

“If you look at a population level, what you’re looking for is not for the evidence of race as a biological construct,” Dr. Chomilo said. “You’re looking for the impact of racism on populations, and that’s the difference: It’s racism, not race.”

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

Every time Nathan Chomilo, MD, uses a clinical decision support tool, he tells his patients they have a choice: He can input their race or keep that field blank.

Until recently, many clinicians didn’t question the use of race as a datapoint in tools used to make decisions about diagnosis and care. But that is changing.

“I’ve almost universally had patients appreciate that someone actually told them that their kidney function was being scored differently because of the color of their skin or how they were identified in the medical chart along lines of race,” Dr. Chomilo, an adjunct assistant professor of pediatrics at the University of Minnesota Medical School, Minneapolis, said.

Dr. Chomilo is referring to the estimated glomerular filtration rate (eGFR), which combines results from a blood test with factors such as age, sex, and race to calculate kidney function.

The eGFR weighed an input of “African American” as automatically indicating a higher concentration of serum creatinine than a non African American patient on the basis of the unsubstantiated idea that Black people have more creatinine in their blood at baseline.

The calculator creates a picture of a Black patient who is not as sick as a White patient with the same levels of kidney failure. But race is based on the color of a patient’s skin, not on genetics or other clinical datapoints.

“I often use my own example of being a biracial Black man: My father’s family is from Cameroon, my mother’s family is from Norway. Are you going to assign my kidneys or my lungs to my mom’s side or my dad’s side? That’s not clear at all in the way we use race in medicine,” Dr. Chomilo, an executive committee member on the section on minority health equity and inclusion at the American Academy of Pediatrics (AAP), said.

Long before the COVID-19 pandemic so publicly exposed the depths of inequality in morbidity and mortality in the United States, health advocates had been pointing out these disparities in tools used by medical professionals. But efforts to recognize that race is a poor proxy for genetics is in its infancy.

In May, the AAP published a policy statement that kicked off its examination of clinical guidelines and policies that include race as a biological proxy. A committee for the society is combing through each guideline or calculator, evaluating the scientific basis for the use of race, and examining whether a stronger datapoint could be used instead.

The eGFR is perhaps the best example of a calculator that’s gone through the process: Health care stakeholders questioned the use of race, and investigators went back to study whether race was really a good datapoint. It wasn’t, and Dr. Chamilo’s hospital joined many others in retiring the calculator.

But the eGFR is one of countless clinical tools – from rudimentary algorithms to sophisticated machine-learning instruments – that change the course of care in part on the basis of race in the same way datapoints such as weight, age, and height are used to inform decisions about patient management. But unlike race, height, weight, and age can be objectively measured. A physician either makes a guess, or a patient enters their race on a form. And while that can be useful on a population level, race does not equal genetics or any other measurable datapoint.

In a study published in JAMA Pediatrics, researchers reviewed 414 clinical practice guidelines from sources such as PubMed and MetaLib.gov. Almost 1 in 6 guidelines included race in an inappropriate way, such as by conflating race as a biological risk factor or establishing testing or treatment thresholds using race.
 

Waiting for alternatives

The University of Maryland Medical System last year embarked on a project similar to the AAP initiative but within its own system. The first use of race to be eliminated was in the eGFR. The health system also recently removed the variable from a tool for diagnosing urinary tract infections (UTIs) in children younger than 2 years.

Part of that tool includes deciding to perform a catheterized urine test. If a doctor chose “White” as the race, the tool would recommend the test. If the doctor chose “Black,” the tool would recommend to not test. Joseph Wright, MD, MPH, chief health equity officer at University of Maryland Medical System, said this step in the tool is based on the unproven assumption that young Black children had a lower likelihood of UTIs than their White peers.

“We simply want folks to not by default lob race in as a decisionmaking point when we have, with a little bit more scientific diligence, the ability to include better clinical variables,” Dr. Wright, who is also an adjunct professor of health policy and management at the University of Maryland School of Public Health, College Park, said.

The developers of the UTI tool recently released a revised version that removes race in favor of two new medical datapoints: whether the patient has had a fever for over 48 hours, and whether the patient has previously had a UTI.

The process of re-examining tools, coming up with new datapoints, and implementing changes is not simple, according to Dr. Wright.

“This is just the baby step to fix the algorithms, because we’re all going to have to examine our own house, where these calculators live, whether it’s in a textbook, whether it’s in an electronic health record, and that’s the heavy lift,” he said. “All sources of clinical guidance have to be scrutinized, and it’s going to literally take years to unroot.”

Electronic medical record vendor Cerner said it generally revises its algorithms after medical societies make changes, then communicates those fixes to providers.

Rebecca C. Winokur, MD, MPH, lead physician executive and health equity service line leader at Cerner, explained that if doctors ordered an eGFR a year ago and then another today, the results might be different because of the new code that eliminates race.

“The numbers are so different, how do you know that the patient may or may not have the same function?” Dr. Winokur said.

Dr. Winokur said the company is trying to determine at which point a message should pop up in the records workflow that would inform clinicians that they may be comparing apples to cherries. The company also is reconsidering the use of race in tools that estimate the probability of a successful vaginal birth after prior cesarean delivery, a calculator that predicts the risk of urethral stones in patients with flank pain, and another that measures lung function to help diagnose pulmonary disease.

In addition to managing the logistics of removing race, health institutions also need buy-in from clinicians. At Mass General Brigham, Boston, Thomas Sequist, MD, MPH, chief medical officer, is leading a project to examine how the system uses race in calculators.

“People struggle mainly with, well, if we shouldn’t use this calculator, what should we use, because we need a calculator. And that’s a legitimate question,” Dr. Sequist said in an interview. “If we’re going to stop using this race-based calculator, I still need to know what dose of medication I give my patient. We’re not going to pull any of these calculators until we have a safe and reliable alternative.”

For each calculator, relevant specialty chiefs come to the table with Dr. Sequist and his team; current projects include examining bone density screenings and cardiac risk scores. A large part of the work is communicating the lack of science behind the inclusion of race as a variable.

“It’s hard because these tools have been in existence for decades, and people are used to using them,” Dr. Sequist said. “So this is a big-change management project.”

Some clinicians also have difficulty discerning why their health system may stratify patient outcomes by race while providers are being told that race is being removed from the calculators they use every day. The key difference is that stratifying outcomes by race illuminates systemic problems that can be targeted by a health system.

For instance, if readmission rates are higher for Black patients overall after surgery, the reason might be that nurses are not delivering the same level of care to them as they are to non-Black patients, possibly because of hidden bias. Or, perhaps Black patients at a hospital have less access to transportation for follow-up appointments after surgery. The potential reasons can be investigated, and solutions can be created.

“If you look at a population level, what you’re looking for is not for the evidence of race as a biological construct,” Dr. Chomilo said. “You’re looking for the impact of racism on populations, and that’s the difference: It’s racism, not race.”

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